Diagnosis and Management of Infantile Hemangioma
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Comparative Effectiveness Review<br />
Number 168<br />
<strong>Diagnosis</strong> <strong>and</strong><br />
<strong>Management</strong><br />
<strong>of</strong> <strong>Infantile</strong><br />
<strong>Hemangioma</strong>
Comparative Effectiveness Review<br />
Number 168<br />
<strong>Diagnosis</strong> <strong>and</strong> <strong>Management</strong> <strong>of</strong> <strong>Infantile</strong> <strong>Hemangioma</strong><br />
Prepared for:<br />
Agency for Healthcare Research <strong>and</strong> Quality<br />
U.S. Department <strong>of</strong> Health <strong>and</strong> Human Services<br />
5600 Fishers Lane<br />
Rockville, MD 20857<br />
www.ahrq.gov<br />
Contract No. 290-2010-0009-I<br />
Prepared by:<br />
V<strong>and</strong>erbilt Evidence-based Practice Center<br />
Nashville, TN<br />
Investigators:<br />
Sivakumar Chinnadurai, M.D., M.P.H.<br />
Kristen Snyder, M.D.<br />
Nila Sathe, M.A., M.L.I.S.<br />
Chris Fonnesbeck, Ph.D.<br />
Anna Morad, M.D.<br />
Frances E. Likis, Dr.P.H., N.P., C.N.M.<br />
Tanya Surawicz, M.P.H.<br />
Genevieve Ness, Pharm.D.<br />
Cathy Ficzere, Pharm.D.<br />
Melissa L. McPheeters, Ph.D., M.P.H.<br />
AHRQ Publication No. 16-EHC002-EF<br />
January 2016
This report is based on research conducted by the V<strong>and</strong>erbilt Evidence-based Practice Center<br />
(EPC) under contract to the Agency for Healthcare Research <strong>and</strong> Quality (AHRQ), Rockville,<br />
MD (Contract No. 290-2012-00009-I). The findings <strong>and</strong> conclusions in this document are those<br />
<strong>of</strong> the authors, who are responsible for its contents; the findings <strong>and</strong> conclusions do not<br />
necessarily represent the views <strong>of</strong> AHRQ. Therefore, no statement in this report should be<br />
construed as an <strong>of</strong>ficial position <strong>of</strong> AHRQ or <strong>of</strong> the U.S. Department <strong>of</strong> Health <strong>and</strong> Human<br />
Services.<br />
None <strong>of</strong> the investigators have any affiliations or financial involvement that conflicts with<br />
the material presented in this report.<br />
The information in this report is intended to help health care decisionmakers—patients <strong>and</strong><br />
clinicians, health system leaders, <strong>and</strong> policymakers, among others—make well informed<br />
decisions <strong>and</strong> thereby improve the quality <strong>of</strong> health care services. This report is not intended to<br />
be a substitute for the application <strong>of</strong> clinical judgment. Anyone who makes decisions concerning<br />
the provision <strong>of</strong> clinical care should consider this report in the same way as any medical<br />
reference <strong>and</strong> in conjunction with all other pertinent information, i.e., in the context <strong>of</strong> available<br />
resources <strong>and</strong> circumstances presented by individual patients.<br />
This report is made available to the public under the terms <strong>of</strong> a licensing agreement between the<br />
author <strong>and</strong> the Agency for Healthcare Research <strong>and</strong> Quality. This report may be used <strong>and</strong><br />
reprinted without permission except those copyrighted materials that are clearly noted in the<br />
report. Further reproduction <strong>of</strong> those copyrighted materials is prohibited without the express<br />
permission <strong>of</strong> copyright holders.<br />
AHRQ or U.S. Department <strong>of</strong> Health <strong>and</strong> Human Services endorsement <strong>of</strong> any derivative<br />
products that may be developed from this report, such as clinical practice guidelines, other<br />
quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.<br />
This report may periodically be assessed for the currency <strong>of</strong> conclusions. If an assessment is<br />
done, the resulting surveillance report describing the methodology <strong>and</strong> findings will be found on<br />
the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the<br />
title <strong>of</strong> the report.<br />
Persons using assistive technology may not be able to fully access information in this report. For<br />
assistance contact EffectiveHealthCare@ahrq.hhs.gov.<br />
Suggested citation: Chinnadurai S, Snyder K, Sathe N, Fonnesbeck C, Morad A, Likis FE,<br />
Surawicz T, Ness G, Ficzere C, McPheeters ML. <strong>Diagnosis</strong> <strong>and</strong> <strong>Management</strong> <strong>of</strong> <strong>Infantile</strong><br />
<strong>Hemangioma</strong>. Comparative Effectiveness Review No. 168. (Prepared by the V<strong>and</strong>erbilt<br />
University Evidence-based Practice Center under Contract No. 290-2010-0009-I.) AHRQ<br />
Publication No.16-EHC002-EF. Rockville, MD: Agency for Healthcare Research <strong>and</strong> Quality;<br />
January 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.<br />
ii
Preface<br />
The Agency for Healthcare Research <strong>and</strong> Quality (AHRQ), through its Evidence-based<br />
Practice Centers (EPCs), sponsors the development <strong>of</strong> systematic reviews to assist public- <strong>and</strong><br />
private-sector organizations in their efforts to improve the quality <strong>of</strong> health care in the United<br />
States. These reviews provide comprehensive, science-based information on common, costly<br />
medical conditions, <strong>and</strong> new health care technologies <strong>and</strong> strategies.<br />
Systematic reviews are the building blocks underlying evidence-based practice; they focus<br />
attention on the strength <strong>and</strong> limits <strong>of</strong> evidence from research studies about the effectiveness <strong>and</strong><br />
safety <strong>of</strong> a clinical intervention. In the context <strong>of</strong> developing recommendations for practice,<br />
systematic reviews can help clarify whether assertions about the value <strong>of</strong> the intervention are<br />
based on strong evidence from clinical studies. For more information about AHRQ EPC<br />
systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm.<br />
AHRQ expects that these systematic reviews will be helpful to health plans, providers,<br />
purchasers, government programs, <strong>and</strong> the health care system as a whole. Transparency <strong>and</strong><br />
stakeholder input are essential to the Effective Health Care Program. Please visit the Web site<br />
(www.effectivehealthcare.ahrq.gov) to see draft research questions <strong>and</strong> reports or to join an<br />
email list to learn about new program products <strong>and</strong> opportunities for input.<br />
If you have comments on this systematic review, they may be sent by mail to the Task Order<br />
Officer named below at: Agency for Healthcare Research <strong>and</strong> Quality, 5600 Fishers Lane,<br />
Rockville, MD 20857, or by email to epc@ahrq.hhs.gov.<br />
Richard G. Kronick, Ph.D.<br />
Director<br />
Agency for Healthcare Research <strong>and</strong> Quality<br />
Stephanie Chang, M.D., M.P.H.<br />
Director<br />
Evidence-based Practice Center Program<br />
Center for Evidence <strong>and</strong> Practice Improvement<br />
Agency for Healthcare Research <strong>and</strong> Quality<br />
Arlene Bierman, M.D., M.S.<br />
Director<br />
Center for Evidence <strong>and</strong> Practice Improvement<br />
Agency for Healthcare Research <strong>and</strong> Quality<br />
Christine Chang, M.D., M.P.H.<br />
Task Order Officer<br />
Center for Evidence <strong>and</strong> Practice Improvement<br />
Agency for Healthcare Research <strong>and</strong> Quality<br />
iii
Acknowledgments<br />
The authors gratefully acknowledge the following individuals for their contributions to this<br />
project: Mamata Raj <strong>and</strong> Shanthi Krishnaswami assisted with data extraction <strong>and</strong> review <strong>of</strong> the<br />
data. Jessica Kimber <strong>and</strong> Sanura Latham assisted with locating papers, formatting <strong>of</strong> materials,<br />
<strong>and</strong> scheduling meetings. Annette Williams <strong>and</strong> Katherine Worley managed the topic refinement<br />
phase <strong>of</strong> the review. Our AHRQ Task Order Officer <strong>and</strong> Associate Editor <strong>and</strong> our Key<br />
Informants <strong>and</strong> Technical Expert Panel members provided invaluable input on structuring the<br />
report.<br />
Key Informants<br />
In designing the study questions, the EPC consulted several Key Informants who represent<br />
the end-users <strong>of</strong> research. The EPC sought the Key Informant input on the priority areas for<br />
research <strong>and</strong> synthesis. Key Informants are not involved in the analysis <strong>of</strong> the evidence or the<br />
writing <strong>of</strong> the report. Therefore, in the end, study questions, design, methodological approaches,<br />
<strong>and</strong>/or conclusions do not necessarily represent the views <strong>of</strong> individual Key Informants.<br />
Key Informants must disclose any financial conflicts <strong>of</strong> interest greater than $10,000 <strong>and</strong> any<br />
other relevant business or pr<strong>of</strong>essional conflicts <strong>of</strong> interest. Because <strong>of</strong> their role as end-users,<br />
individuals with potential conflicts may be retained. The TOO <strong>and</strong> the EPC work to balance,<br />
manage, or mitigate any conflicts <strong>of</strong> interest.<br />
The list <strong>of</strong> Key Informants who participated in developing this report follows.<br />
Ilona J. Frieden, M.D.*<br />
University <strong>of</strong> California<br />
San Francisco, CA<br />
Arin K. Greene, M.D.<br />
Boston Children’s Hospital<br />
Boston, MA<br />
Karla Hall, B.S.<br />
National Organization <strong>of</strong> Vascular<br />
Anomalies<br />
Greensboro, NC<br />
Marcia Hogeling, M.D.*<br />
Phoenix Children’s Hospital<br />
Phoenix, AZ<br />
Anthony J. Mancini, M.D.*<br />
Ann & Robert H. Lurie Children’s Hospital<br />
Chicago, IL<br />
Gresham Richter, M.D.<br />
University <strong>of</strong> Arkansas<br />
Fayetteville, AR<br />
Linda Rozell-Shannon, Ph.D., M.S.<br />
Vascular Birthmarks Foundation<br />
*Individuals marked with an asterisk also<br />
peer reviewed the report.<br />
iv
Technical Expert Panel<br />
In designing the study questions <strong>and</strong> methodology at the outset <strong>of</strong> this report, the EPC<br />
consulted several technical <strong>and</strong> content experts. Broad expertise <strong>and</strong> perspectives were sought.<br />
Divergent <strong>and</strong> conflicted opinions are common <strong>and</strong> perceived as healthy scientific discourse that<br />
results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design,<br />
methodologic approaches, <strong>and</strong>/or conclusions do not necessarily represent the views <strong>of</strong><br />
individual technical <strong>and</strong> content experts.<br />
Technical Experts must disclose any financial conflicts <strong>of</strong> interest greater than $10,000 <strong>and</strong><br />
any other relevant business or pr<strong>of</strong>essional conflicts <strong>of</strong> interest. Because <strong>of</strong> their unique clinical<br />
or content expertise, individuals with potential conflicts may be retained. The TOO <strong>and</strong> the EPC<br />
work to balance, manage, or mitigate any potential conflicts <strong>of</strong> interest identified.<br />
The list <strong>of</strong> Technical Experts who participated in developing this report follows.<br />
Denise M. Adams, M.D.*<br />
Cincinnati Children’s Medical Center<br />
Cincinnati, OH<br />
David Darrow, M.D.*<br />
Children’s Hospital <strong>of</strong> The King’s<br />
Daughters<br />
Norfolk, VA<br />
Ilona J. Frieden, M.D.*<br />
University <strong>of</strong> California<br />
San Francisco, CA<br />
Arin K. Greene, M.D.<br />
Boston Children’s Hospital<br />
Boston, MA<br />
Marcia Hogeling, M.D.*<br />
Phoenix Children’s Hospital<br />
Phoenix, AZ<br />
Dana Janssen, M.D.<br />
Monroe Carell Jr. Children’s Hospital at<br />
V<strong>and</strong>erbilt<br />
Nashville, TN<br />
Anthony J. Mancini, M.D.*<br />
Ann & Robert H. Lurie Children’s Hospital<br />
Chicago, IL<br />
* Individuals marked with an asterisk also<br />
peer reviewed the report.<br />
v
Peer Reviewers<br />
Prior to publication <strong>of</strong> the final evidence report, EPCs sought input from independent Peer<br />
Reviewers without financial conflicts <strong>of</strong> interest. However, the conclusions <strong>and</strong> synthesis <strong>of</strong> the<br />
scientific literature presented in this report do not necessarily represent the views <strong>of</strong> individual<br />
reviewers.<br />
Peer Reviewers must disclose any financial conflicts <strong>of</strong> interest greater than $10,000 <strong>and</strong> any<br />
other relevant business or pr<strong>of</strong>essional conflicts <strong>of</strong> interest. Because <strong>of</strong> their unique clinical or<br />
content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO<br />
<strong>and</strong> the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts <strong>of</strong> interest<br />
identified.<br />
The list <strong>of</strong> Peer Reviewers follows:<br />
Rongwei (Rochelle) Fu, Ph.D.<br />
School <strong>of</strong> Public Health<br />
Oregon Health <strong>and</strong> Science University<br />
Portl<strong>and</strong>, OR<br />
Amy Jo Nopper, M.D.<br />
University <strong>of</strong> Missouri-Kansas City<br />
Kansas City, MO<br />
Anne Zajicek, MD, Pharm.D.<br />
Obstetric <strong>and</strong> Pediatric Pharmacology <strong>and</strong><br />
Therapeutics Branch<br />
Eunice Kennedy Shriver National Institute<br />
<strong>of</strong> Child Health <strong>and</strong> Human Development<br />
Washington, DC<br />
Marco Sciveres, M.D.<br />
IsMeTT-University <strong>of</strong> Pittsburgh Medical<br />
Center Italy<br />
Palermo, Italy<br />
vi
<strong>Diagnosis</strong> <strong>and</strong> <strong>Management</strong> <strong>of</strong> <strong>Infantile</strong> <strong>Hemangioma</strong><br />
Structured Abstract<br />
Objectives. To systematically review evidence addressing the diagnosis <strong>and</strong> management <strong>of</strong><br />
infantile hemangiomas (IH).<br />
Data sources. Multiple databases from 1982 to June 2015.<br />
Review methods. We included comparative studies <strong>of</strong> interventions, case series addressing<br />
harms, <strong>and</strong> any study to address contextual questions. Two investigators independently screened<br />
studies <strong>and</strong> rated study quality. We extracted <strong>and</strong> summarized data qualitatively <strong>and</strong><br />
quantitatively via network meta-analysis, which provides a relative ranking <strong>of</strong> anticipated effects<br />
among treatments. We also assessed strength <strong>of</strong> the evidence (SOE).<br />
Results. Among 148 unique studies, 42 addressed effectiveness outcomes (6 good, 22 fair, <strong>and</strong><br />
14 poor quality), <strong>and</strong> 144 studies reported harms (14 good, 3 fair, <strong>and</strong> 127 poor quality). Two<br />
small studies reported differing findings for the sensitivity <strong>of</strong> ultrasound <strong>and</strong> effectiveness <strong>of</strong><br />
imaging modalities. Studies <strong>of</strong> steroids assessed different agents; treated children typically had<br />
improvement in lesion size. Steroid harms frequently included Cushingoid facies,<br />
irritability/mood changes, <strong>and</strong> growth retardation. Beta-blockers typically demonstrated<br />
significantly greater effects on reducing lesion size than did control or other active comparators.<br />
In network meta-analysis, oral propranolol had the largest mean estimate <strong>of</strong> expected clearance<br />
(95%; 95% Bayesian credible interval [BCI]: 88% to 99%) relative to oral corticosteroids (43%,<br />
95% BCI: 21%-66%) <strong>and</strong> control (6%, 95% BCI: 1%-11%). Beta-blocker harms included<br />
hypotension, hypoglycemia, bradycardia, sleep disturbances, <strong>and</strong> cold extremities. Surgical<br />
intervention studies primarily addressed variations <strong>of</strong> pulse dye laser (PDL) to manage IH size.<br />
Most studies reported a higher success rate with longer-pulse PDL compared to observation, with<br />
differing magnitude <strong>of</strong> effect. Laser treatment harms included hypopigmentation <strong>and</strong> scarring.<br />
No studies explicitly evaluated treatments following failure <strong>of</strong> beta-blockers or corticosteroids.<br />
Literature addressing contextual questions suggested that referral indications include large size;<br />
segmental type; risk for complications including bleeding, ulceration, <strong>and</strong> pain; involvement <strong>of</strong><br />
critical structures; risk factors for occult lesions (numerous cutaneous lesions, beard<br />
distribution); <strong>and</strong> potential for psychosocial concerns in some cases. Multiple case series<br />
reported associations between multiple cutaneous lesions <strong>and</strong> airway or hepatic IH <strong>and</strong> facial<br />
lesions in a beard distribution <strong>and</strong> airway IH.<br />
Conclusions. Our review for contextual questions described a range <strong>of</strong> indications for referral<br />
<strong>and</strong> suggested support for a higher index <strong>of</strong> suspicion <strong>of</strong> extracutaneous IH in children with<br />
multiple cutaneous lesions or facial lesions in a beard distribution. Corticosteroids demonstrated<br />
moderate effectiveness at reducing IH size/volume (moderate SOE for improvement in IH with<br />
oral steroids compared with observation/placebo; low SOE for intralesional steroids versus<br />
observation/placebo; moderate SOE for association with clinically important harms). Propranolol<br />
had high SOE for effects on reducing lesion size compared with observation/placebo. Clearance<br />
<strong>of</strong> IH was greater in propranolol arms compared with placebo/observation <strong>and</strong> active<br />
comparators in most studies. Meta-analysis indicated high mean rates <strong>of</strong> IH clearance with oral<br />
propranolol (95%, 95% BCI: 88%-99%) <strong>and</strong> moderate rates for steroids (43% to 58%, with wide<br />
vii
BCI; moderate SOE for effects <strong>of</strong> propranolol compared with steroids). Beta-blockers <strong>and</strong><br />
steroids also may cause clinically important harms (moderate SOE for association <strong>of</strong> oral<br />
propranolol with harms). Laser studies generally found PDL more effective than other lasers, but<br />
effects remain unclear (insufficient to low SOE for effects <strong>of</strong> laser types on IH clearance;<br />
moderate SOE for association <strong>of</strong> PDL with skin pigmentation changes; low SOE for association<br />
with pain). Data were inadequate to address the role <strong>of</strong> imaging in guiding treatment (insufficient<br />
SOE).<br />
viii
Contents<br />
Executive Summary ................................................................................................................ES-1<br />
Introduction ....................................................................................................................................1<br />
Background ................................................................................................................................1<br />
<strong>Diagnosis</strong> <strong>and</strong> Treatment Decisions .....................................................................................1<br />
Interventions ........................................................................................................................2<br />
Scope <strong>and</strong> Key Questions ..........................................................................................................3<br />
Scope <strong>of</strong> Review ..................................................................................................................3<br />
Key Questions ......................................................................................................................3<br />
Analytic Framework ..................................................................................................................4<br />
Organization <strong>of</strong> This Report ......................................................................................................5<br />
Uses <strong>of</strong> This Evidence Report ....................................................................................................6<br />
Methods ..........................................................................................................................................7<br />
Topic Refinement <strong>and</strong> Review Protocol ....................................................................................7<br />
Literature Search Strategy..........................................................................................................7<br />
Search Strategy ....................................................................................................................7<br />
Grey Literature .....................................................................................................................8<br />
Inclusion <strong>and</strong> Exclusion Criteria ..........................................................................................8<br />
Study Selection ....................................................................................................................9<br />
Data Extraction ..................................................................................................................10<br />
Data Synthesis ....................................................................................................................10<br />
Quality (Risk <strong>of</strong> Bias) Assessment <strong>of</strong> Individual Studies ........................................................11<br />
Determining Quality Ratings .............................................................................................12<br />
Strength <strong>of</strong> the Body <strong>of</strong> Evidence ............................................................................................12<br />
Applicability ............................................................................................................................13<br />
Peer Review <strong>and</strong> Public Commentary .....................................................................................13<br />
Results ..........................................................................................................................................14<br />
CQ1. Natural History <strong>of</strong> Untreated IH <strong>and</strong> Adverse Outcomes <strong>of</strong> Untreated IH ....................14<br />
Natural History <strong>of</strong> IH .........................................................................................................14<br />
Indications for Treatment ...................................................................................................14<br />
CQ2. Evidence for Association <strong>of</strong> Cutaneous IH <strong>and</strong> Occult IH ............................................16<br />
Results <strong>of</strong> Literature Searches for Key Questions ...................................................................18<br />
Description <strong>of</strong> Included Studies .........................................................................................18<br />
Grey Literature ...................................................................................................................21<br />
Key Question 1. Effectiveness <strong>and</strong> Harms <strong>of</strong> Imaging Modalities ..........................................21<br />
Key Points ..........................................................................................................................21<br />
Overview <strong>of</strong> the Literature .................................................................................................21<br />
Detailed Analysis ...............................................................................................................21<br />
Key Question 2. Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids or Beta-Blockers ....................22<br />
Network Meta-Analysis <strong>of</strong> the Effectiveness <strong>of</strong> Pharmacologic Agents...........................22<br />
Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids ......................................................................24<br />
Effectiveness <strong>and</strong> Harms <strong>of</strong> Beta-Blockers .......................................................................34<br />
Key Question 3. Effectiveness <strong>and</strong> Harms <strong>of</strong> Drugs Administered After the Failure<br />
<strong>of</strong> Corticosteroids or Beta-Blockers...................................................................................65<br />
Key Question 4. Effectiveness <strong>and</strong> Harms <strong>of</strong> Surgical Interventions ......................................65<br />
Key Points ..........................................................................................................................65<br />
ix
Overview <strong>of</strong> the Literature .................................................................................................66<br />
Detailed Analysis ...............................................................................................................67<br />
Discussion .....................................................................................................................................78<br />
State <strong>of</strong> the Literature...............................................................................................................78<br />
Summary <strong>of</strong> Key Findings .......................................................................................................78<br />
Key Findings From Contextual Questions .........................................................................78<br />
Key Findings from Key (Comparative Effectiveness) Questions ......................................78<br />
Findings in Relation to What is Already Known ...................................................................101<br />
Applicability ..........................................................................................................................101<br />
Implications for Clinical <strong>and</strong> Policy Decisionmaking ...........................................................102<br />
Limitations <strong>of</strong> the Comparative Effectiveness Review Process ............................................103<br />
Limitations <strong>of</strong> the Evidence Base ..........................................................................................104<br />
Research Gaps <strong>and</strong> Areas for Future Research ......................................................................105<br />
Conclusions .................................................................................................................................107<br />
References ...................................................................................................................................108<br />
Acronymes <strong>and</strong> Abbreviations Used in This Report ..............................................................122<br />
Tables<br />
Table A. Inclusion criteria .........................................................................................................ES-6<br />
Table B. Summary <strong>of</strong> evidence in studies addressing imaging modalities ..............................ES-18<br />
Table C. Summary <strong>of</strong> evidence in studies addressing pharmacologic interventions ...............ES-19<br />
Table D. Sumary <strong>of</strong> evidence in studies addressing surgical interventions .............................ES-24<br />
Table 1. Inclusion criteria ................................................................................................................9<br />
Table 2. Strength <strong>of</strong> evidence grades <strong>and</strong> definitions ....................................................................13<br />
Table 3. Characteristics <strong>of</strong> included studies addressing effectiveness <strong>and</strong> harms .........................20<br />
Table 4. Posterior estimates <strong>of</strong> effect size .....................................................................................22<br />
Table 5. Key resolution outcomes in studies comparing intravenous or intralesional <strong>and</strong> oral<br />
corticosteroids ..........................................................................................................................27<br />
Table 6. Key resolution outcomes in studies comparing intralesional <strong>and</strong> topical<br />
corticosteroids ..........................................................................................................................28<br />
Table 7. Key resolution outcomes in studies comparing methylprednisolone <strong>and</strong> prednisolone ..29<br />
Table 8. Harms/adverse effects in comparative studies <strong>of</strong> steroids to treat IH ..............................30<br />
Table 9. Adverse effects in case series <strong>of</strong> steroids to treat IH .......................................................32<br />
Table 10. Key resolution outcomes in RCTs comparing propranolol <strong>and</strong> placebo or<br />
observation ...............................................................................................................................39<br />
Table 11. Resolution outcomes in studies comparing beta-blockers <strong>and</strong> steroids .........................43<br />
Table 12. Resolution outcomes in studies comparing intralesional propranolol <strong>and</strong><br />
triamcinolone ...........................................................................................................................47<br />
Table 13. Resolution outcomes in studies comparing propranolol with laser <strong>and</strong> propranolol<br />
alone .........................................................................................................................................48<br />
Table 14. Resolution outcomes in studies comparing propranolol <strong>and</strong> bleomycin .......................49<br />
Table 15. Key outcomes in studies comparing propranolol <strong>and</strong> no propranolol ...........................50<br />
Table 16. Resolution outcomes in studies comparing beta-blockers .............................................51<br />
Table 17. Key resolution outcomes in studies comparing nadolol <strong>and</strong> propranolol ......................53<br />
Table 18. Resolution outcomes in studies comparing forms <strong>of</strong> propranolol .................................54<br />
Table 19. Key resolution outcomes in studies comparing timolol <strong>and</strong> observation or placebo ....55<br />
Table 20. Resolution outcomes in studies comparing timolol <strong>and</strong> imiquimod..............................57<br />
x
Table 21. Resolution outcomes in studies comparing timolol <strong>and</strong> laser........................................58<br />
Table 22. Harms/adverse effects in comparative studies <strong>of</strong> beta-blockers to treat IH ..................60<br />
Table 23. Harms/adverse events reported by dose in Leaute-Labreze et al. 2015 .........................61<br />
Table 24. Adverse effects in case series <strong>of</strong> propranolol to treat IH ...............................................62<br />
Table 25. Key resolution outcomes in studies comparing PDL <strong>and</strong> observation ..........................68<br />
Table 26. Key resolution outcomes in studies comparing PDL modalities ...................................69<br />
Table 27. Key resolution outcomes in comparative studies <strong>of</strong> Nd:YAG laser ..............................71<br />
Table 28. Key resolution outcomes in comparative studies <strong>of</strong> Nd:YAG laser with cooling .........72<br />
Table 29. Key resolution outcomes in comparative studies <strong>of</strong> photothermolysis with intense<br />
pulsed light <strong>and</strong> cryosurgery ....................................................................................................73<br />
Table 30. Key resolution outcomes in comparative studies <strong>of</strong> cryosurgical therapy ....................74<br />
Table 31. Harms/adverse effects in comparative studies <strong>of</strong> lasers to treat IH ...............................75<br />
Table 32. Adverse effects in case series <strong>of</strong> laser treatments for IH ...............................................76<br />
Table 33. Adverse effects in case series <strong>of</strong> surgical treatments for IH ..........................................77<br />
Table 34. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> imaging modalities .......................................80<br />
Table 35. Strength <strong>of</strong> evidence for effectiveness <strong>and</strong> harms <strong>of</strong> steroids .......................................82<br />
Table 36. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> beta-blockers ................................................85<br />
Table 37. Strength <strong>of</strong> evidence for harms <strong>of</strong> beta-blockers ...........................................................90<br />
Table 38. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> laser modalities ............................................94<br />
Table 39. Strength <strong>of</strong> evidence for harms <strong>of</strong> laser modalities .......................................................98<br />
Figures<br />
Figure A. Analytic Framework for KQ1....................................................................................ES-4<br />
Figure B. Analytic Framework for KQ2 <strong>and</strong> KQ3 ....................................................................ES-5<br />
Figure C. Analytic Framework for KQ4 ....................................................................................ES-5<br />
Figure D. Estimates <strong>of</strong> expected IH clearance .........................................................................ES-11<br />
Figure 1. Analytic framework for KQ1 ...........................................................................................4<br />
Figure 2. Analytic framework for KQ2 <strong>and</strong> KQ3 ............................................................................5<br />
Figure 3. Analytic framework for KQ4 ...........................................................................................5<br />
Figure 4. Disposition <strong>of</strong> studies identified for this review ............................................................18<br />
Figure 5. Estimates <strong>of</strong> expected IH clearance ................................................................................23<br />
Figure 6. Estimates <strong>of</strong> the variation <strong>of</strong> each treatment ..................................................................24<br />
Appendixes<br />
Appendix A. Search Strategies<br />
Appendix B. Screening <strong>and</strong> Quality Assessment Forms<br />
Appendix C. Excluded Studies<br />
Appendix D. Methods for Network Meta-Analysis<br />
Appendix E. Study Design Classification Algorithm<br />
Appendix F. Quality/Risk <strong>of</strong> Bias Ratings<br />
Appendix G. Applicability Tables<br />
Appendix H. Harms Reported in Package Insert Data <strong>and</strong> Other Sources<br />
xi
Executive Summary<br />
Introduction<br />
<strong>Infantile</strong> hemangiomas (IH) are the most common tumors <strong>of</strong> childhood. IH are benign but<br />
possess potential for local tissue damage, ulceration, infection, bleeding, functional impact, <strong>and</strong><br />
pain. The International Society for the Study <strong>of</strong> Vascular Anomalies classifies IH as vascular<br />
tumors that are differentiated from vascular malformations in several ways including natural<br />
history, cellular composition, immunohistochemical expression, <strong>and</strong> pathology. 1 Due to<br />
historical inconsistencies in naming conventions, it is difficult to underst<strong>and</strong> the true prevalence<br />
<strong>of</strong> IH, but it is estimated that they affect about 4 to 5 percent <strong>of</strong> children, 2 with higher prevalence<br />
in females <strong>and</strong> Caucasians. 3,4 IH tend to go through growth <strong>and</strong> involution phases, although the<br />
complete natural history <strong>of</strong> IH by various characteristics has not been described. In most<br />
children, IH will become apparent in the first few weeks <strong>of</strong> life <strong>and</strong> reach 80 percent <strong>of</strong> total size<br />
by around age 3 to 5 months. 5,6 With a course <strong>of</strong> expectant observation, many patients may<br />
experience a complete involution without significant sequelae; however, IH frequently occur in<br />
cosmetically <strong>and</strong> functionally sensitive areas. Even with complete involution, some patients have<br />
permanent disfigurement <strong>and</strong> functional compromise. 7 Early assessment <strong>of</strong> the extent <strong>of</strong> the<br />
hemangioma, <strong>and</strong> early, appropriate treatment <strong>of</strong> IH may potentially mitigate these<br />
complications; however, in one large multicenter treatment analysis, the first specialist visit for<br />
children in the study did not occur until a mean <strong>of</strong> 5 months <strong>of</strong> age. 6<br />
Furthermore, some lesions are particularly aggressive or morbid <strong>and</strong> can cause severe pain,<br />
ulceration, <strong>and</strong> bleeding even in early stages. 8,9 The rapid growth <strong>of</strong> IH leaves little time for<br />
prospective observation to determine which IH will lead to complications <strong>and</strong> require specialist<br />
attention <strong>and</strong> treatment before complications begin to manifest. Some types <strong>of</strong> IH, specifically<br />
segmental hemangiomas, are recognized as high risk, but no consensus exists on which nonsegmental<br />
lesions warrant referral for appropriate treatment to mitigate future complications<br />
(e.g., bleeding, ulceration) <strong>of</strong> the hemangioma or long-term sequelae (e.g., scarring, anatomical<br />
disfigurement, functional complications). 10-12<br />
<strong>Diagnosis</strong> <strong>and</strong> Treatment Decisions<br />
Evaluation through the use <strong>of</strong> various diagnostic imaging modalities has been generally<br />
reserved for deep lesions to help underst<strong>and</strong> their extent or to confirm the diagnosis <strong>of</strong> IH. Purely<br />
cutaneous lesions do not require imaging, but opinions regarding the initial diagnostic test <strong>of</strong><br />
choice for more extensive IH, including deep, segmental, <strong>and</strong> syndromic lesions, are conflicting.<br />
Furthermore, different disease sites or extents may be best h<strong>and</strong>led with different imaging<br />
modalities. The questions <strong>of</strong> imaging necessity <strong>and</strong> type are especially important because<br />
imaging studies in infants <strong>of</strong>ten require general anesthesia <strong>and</strong> may be associated with adverse<br />
effects. Modalities such as computed tomography also involve exposure to radiation.<br />
Specific disease characteristics, such as lesion size, location, rate <strong>of</strong> growth, <strong>and</strong> persistence<br />
as well as modifiers such as patient age, functional impact, <strong>and</strong> IH subtype influence whether<br />
children are treated with pharmacologic agents or surgically. Many lesions can be treated with<br />
pharmacologic agents; however, refractory lesions that possess immediate risk for morbidity or<br />
mortality, such as hemangiomas obstructing the airway or visual axis, may require more<br />
immediate surgical intervention. Lesion characteristics such as size, location, <strong>and</strong> type (e.g.,<br />
superficial, deep) also influence the choice <strong>of</strong> specific pharmacologic agents. For example, small,<br />
ES-1
superficial lesions may respond well to topical agents such as timolol, while deep lesions are less<br />
likely to respond. 13 Intralesional steroids may be the drug <strong>of</strong> choice for bulky, localized IH but<br />
are likely to be less effective for extensive superficial IH. Both medical <strong>and</strong> surgical treatment<br />
paradigms contain significant variability <strong>and</strong> lack <strong>of</strong> consensus.<br />
In many cases <strong>of</strong> IH, early referral <strong>and</strong> intervention are crucial to a satisfactory outcome <strong>and</strong><br />
to mitigate structural changes to adjacent structures or disfiguring sequelae. In addition to<br />
structural damage, the psychological complications <strong>of</strong> having facial differences must be<br />
considered when determining the need for referral or treatment. While well-recognized clinical<br />
signs such as ulceration, airway obstruction, or vision-threatening involvement indicate need for<br />
urgent referral, there are no discrete guidelines that help direct primary care providers on when to<br />
refer patients with IH for subspecialty care.<br />
Interventions<br />
The beta-blocker propranolol was approved by the U.S. Food <strong>and</strong> Drug Administration<br />
(FDA) for use in IH in March 2014 14-16 <strong>and</strong> was historically used in children for cardiac<br />
conditions <strong>and</strong> <strong>of</strong>f-label to treat IH after the serendipitous discovery <strong>of</strong> its effects on IH lesions in<br />
2008. 17 Prior to this, corticosteroids were the drug <strong>of</strong> choice, but propranolol has become the<br />
typical choice for initial medical management in children without contraindications to betablockers.<br />
Steroids may be used in children with contraindications to beta-blockers or who do not<br />
respond to beta-blockers. Additionally, there is no clear consensus as to when alternative or<br />
adjunctive or historically used medications such as chemotherapeutic drugs are appropriate if<br />
first-line treatment is unsuccessful. 18,19<br />
Surgical interventions for IH can be used for primary management <strong>of</strong> high risk lesions by<br />
resection or ablation using laser or radi<strong>of</strong>requency. Some confusion <strong>and</strong> disagreement exists<br />
about what type <strong>of</strong> surgical treatment to use, when in the disease course to treat, <strong>and</strong> how the<br />
disease site informs treatment decisions. Interventions for IH are varied, involved, <strong>and</strong> not<br />
without risk (e.g., risk <strong>of</strong> permanent hypopigmentation, scarring from pulsed dye laser therapy,<br />
potential harms <strong>of</strong> anesthesia); therefore, universal treatment is unwarranted.<br />
Scope <strong>and</strong> Key Questions<br />
Scope <strong>and</strong> Uses <strong>of</strong> the Review<br />
This systematic review addresses the evidence for benefits <strong>and</strong> harms <strong>of</strong> commonly used<br />
treatments for children (ages 0-18 years) with IH: beta-blockers, corticosteroids, “second-line”<br />
drugs used after the failure <strong>of</strong> beta-blockers or steroids, <strong>and</strong> laser <strong>and</strong> surgical treatment. The<br />
decisional dilemmas that this review addresses are whether imaging modalities are useful both in<br />
diagnosis <strong>and</strong> for guiding treatment, <strong>and</strong> the expected comparative effectiveness (benefits <strong>and</strong><br />
harms) <strong>of</strong> pharmacologic <strong>and</strong> surgical treatments, relative to observation or other active<br />
treatments. While pharmacologic <strong>and</strong> surgical interventions cannot be directly compared because<br />
<strong>of</strong> their inherent confounding by indication, we assess the comparative effectiveness <strong>of</strong> different<br />
options within both pharmacologic <strong>and</strong> surgical approaches.<br />
We include both contextual <strong>and</strong> Key Questions. We systematically reviewed <strong>and</strong> assessed the<br />
risk <strong>of</strong> bias <strong>of</strong> the literature meeting our inclusion criteria for Key Questions, which address the<br />
comparative effectiveness <strong>of</strong> interventions. We provide a narrative review <strong>of</strong> relevant literature<br />
ES-2
for contextual questions as few effectiveness studies address these questions, which are related to<br />
natural history <strong>of</strong> IH <strong>and</strong> markers for occult IH.<br />
We anticipate this report will be <strong>of</strong> primary value to organizations that develop guidelines for<br />
managing IH, to clinicians who provide care for children with IH, <strong>and</strong> for families making<br />
treatment decisions. IH is diagnosed <strong>and</strong> treated by clinicians including pediatricians,<br />
dermatologists, otolaryngologists, family physicians, nurses, nurse-practitioners, physician<br />
assistants, hematologists, <strong>and</strong> general <strong>and</strong> plastic surgeons. This report supplies practitioners <strong>and</strong><br />
researchers up-to-date information about the current state <strong>of</strong> evidence, <strong>and</strong> assesses the quality <strong>of</strong><br />
studies that aim to determine the outcomes <strong>and</strong> safety <strong>of</strong> treatments for IH.<br />
Key Questions<br />
We developed Key Questions (KQs) <strong>and</strong> Contextual Questions (CQs) in consultation with<br />
Key Informants <strong>and</strong> the Task Order Officer. Questions were posted for review to the AHRQ<br />
Effective Health Care Web site. Questions were as follows:<br />
CQ1. What is known about the natural history <strong>of</strong> infantile hemangiomas, by<br />
hemangioma site <strong>and</strong> subtype? What are the adverse outcomes <strong>of</strong><br />
untreated infantile hemangiomas? What characteristics <strong>of</strong> the hemangioma<br />
(e.g., subtype, size, location, number <strong>of</strong> lesions) indicate risk <strong>of</strong> significant<br />
medical complications that would prompt immediate medical or surgical<br />
intervention?<br />
CQ2. What is the evidence that five or more cutaneous hemangiomas are<br />
associated with an increased risk <strong>of</strong> occult hemangiomas?<br />
KQ1. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
known or suspected infantile hemangiomas, what is the comparative<br />
effectiveness (benefits/harms) <strong>of</strong> various imaging modalities for identifying<br />
<strong>and</strong> characterizing hemangiomas?<br />
a. Does the comparative effectiveness differ by location <strong>and</strong> subtype <strong>of</strong><br />
the hemangioma?<br />
KQ2. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
infantile hemangiomas who have been referred for pharmacologic<br />
intervention, what is the comparative effectiveness (benefits/harms) <strong>of</strong><br />
corticosteroids or beta-blockers?<br />
KQ3. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
infantile hemangiomas for whom treatment with corticosteroids or betablockers<br />
is unsuccessful what is the comparative effectiveness <strong>of</strong> second<br />
line therapies including immunomodulators <strong>and</strong> angiotensin-converting<br />
enzyme inhibitors?<br />
ES-3
KQ4. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
infantile hemangiomas who have been referred for surgical intervention,<br />
what is the comparative effectiveness (benefits/ harms) <strong>of</strong> various types <strong>of</strong><br />
surgical interventions (including laser <strong>and</strong> resection)?<br />
Analytic Framework<br />
The analytic frameworks illustrate the population, interventions, <strong>and</strong> outcomes that guided<br />
the literature search <strong>and</strong> synthesis <strong>of</strong> comparative studies (Figures A-C). The frameworks depict<br />
the KQs within the context <strong>of</strong> the population, intervention, comparator, outcomes, timing, <strong>and</strong><br />
setting (PICOTS) parameters described in the review. In general, the figures illustrate how<br />
imaging modalities or interventions such as magnetic resonance imaging (MRI), beta-blockers,<br />
or laser may result in intermediate outcomes such as change in hemangioma size or change in<br />
vision <strong>and</strong>/or in final health outcomes such as detection <strong>of</strong> hemangiomas for imaging modalities<br />
or resolution <strong>of</strong> hemangioma or changes in quality <strong>of</strong> life for medical or surgical treatments.<br />
Also, adverse events may occur at any point after imaging or receipt <strong>of</strong> the intervention.<br />
Figure A. Analytic framework for KQ1<br />
IH = infantile hemangioma; KQ = Key Question<br />
ES-4
Figure B. Analytic framework for KQ2 <strong>and</strong> KQ3<br />
IH = infantile hemangioma; KQ = Key Question<br />
Figure C. Analytic framework for KQ4<br />
IH = infantile hemangioma; KQ = Key Question; ND:YAG = Neodymium Yttrium Aluminum Garnet<br />
ES-5
Methods<br />
Literature Search Strategy<br />
A librarian employed search strategies (Appendix A <strong>of</strong> the full report) to retrieve research on<br />
diagnostic modalities, <strong>and</strong> interventions for IH. We searched MEDLINE ® via the PubMed ®<br />
interface, the Cumulative Index <strong>of</strong> Nursing <strong>and</strong> Allied Health Literature (CINAHL ® ), <strong>and</strong><br />
Embase (Excerpta Medica Database). We limited searches to the English language <strong>and</strong> to studies<br />
published from 1982 to the present to reflect current st<strong>and</strong>ards <strong>of</strong> care <strong>and</strong> classification schema<br />
for IH. 20 We searched the same databases without date restrictions to identify contextual<br />
information. Our last search was conducted in June 2015. We manually searched reference lists<br />
<strong>of</strong> included studies <strong>and</strong> <strong>of</strong> recent narrative <strong>and</strong> systematic reviews <strong>and</strong> meta-analyses.<br />
Inclusion <strong>and</strong> Exclusion Criteria<br />
We developed criteria for inclusion <strong>and</strong> exclusion (Table A) in consultation with a Technical<br />
Expert Panel. We limited studies to those published in English. We also excluded studies<br />
evaluating multiple lesion types (e.g., cavernous hemangioma, hemangioblastoma, vascular<br />
malformations, noninvoluting congenital hemangiomas) unless we could clearly extract data<br />
pertaining to children with IH or if the majority <strong>of</strong> children had IH. To be included for KQ3,<br />
studies had to note explicitly that all children had received prior treatment with beta-blockers or<br />
steroids <strong>and</strong> were therefore receiving a second-line treatment. We also included case series with<br />
at least 25 children with IH to address harms, but not effectiveness. We selected the lower bound<br />
<strong>of</strong> 25 as a conservative value based on a preliminary review <strong>of</strong> case series.<br />
Table A. Inclusion criteria<br />
Category<br />
Criteria<br />
Study population<br />
Newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with infantile hemangiomas or<br />
suspected infantile hemangiomas<br />
Publication languages English only<br />
Publication year 1966-present (CQ 1 <strong>and</strong> 2)<br />
1982-present (KQ 1, 2, 3, 4)<br />
Admissible evidence Admissible designs<br />
Original research studies providing sufficient detail regarding methods <strong>and</strong> results to<br />
enable use <strong>and</strong> aggregation <strong>of</strong> the data <strong>and</strong> results<br />
Contextual Questions (CQ):<br />
• Systematic <strong>and</strong> non-systematic reviews, articles reporting on the history <strong>of</strong> IH<br />
diagnosis or treatment, practice guidelines, meta-analyses, RCTs, case series<br />
with at least 25 children with IH, <strong>and</strong> any comparative studies<br />
Comparative Effectiveness Key Questions (KQ):<br />
• Imaging accuracy: RCTs <strong>and</strong> any comparative studies<br />
• Benefits <strong>of</strong> interventions: RCTs <strong>and</strong> any comparative studies<br />
• Harms <strong>of</strong> interventions: RCTs, any comparative studies, <strong>and</strong> case series with<br />
at least 25 children with infantile hemangiomas<br />
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Table A. Inclusion criteria (continued)<br />
Category<br />
Criteria<br />
Other criteria<br />
Studies must address one or more <strong>of</strong> the following:<br />
• Diagnostic imaging (e.g., magnetic resonance imaging, computed tomography,<br />
magnetic resonance angiography, echocardiography, ultrasound, endoscopy)<br />
• Surgical interventions (e.g., cryotherapy, resection, embolization,<br />
radi<strong>of</strong>requency ablation therapy) or laser interventions (e.g., pulsed dye,<br />
fractionated laser, argon, carbon dioxide, neodymium (Nd): YAG, erbium)<br />
• Pharmacologic interventions (e.g., beta-blockers, corticosteroids,<br />
immunomodulators, immunosuppressants, angiotensin-converting enzyme<br />
inhibitors, antiangiogenic agents, antineoplastics)<br />
• Data (including harms) related to diagnostic modalities or interventions for<br />
infantile hemangiomas for the following outcomes:<br />
Imaging studies<br />
− Ability to identify presence, number, <strong>and</strong> extent <strong>of</strong> hemangiomas <strong>and</strong><br />
associated structural anomalies (sensitivity <strong>and</strong> specificity)<br />
− Harms<br />
Surgical or pharmacologic intervention studies<br />
− Size / volume <strong>of</strong> hemangioma<br />
− Impact on vision<br />
− Aesthetic appearance as assessed by clinician or parent<br />
− Degree <strong>of</strong> ulceration<br />
− Quality <strong>of</strong> life<br />
− Harms<br />
Relevant outcomes must be able to be abstracted from data in the papers<br />
Data must be presented in the aggregate (vs. individual participant data)<br />
Abbreviations: CQ = contextual question, KQ = Key Question, Nd:YAG = neodymium yttrium aluminum garnet, RCT =<br />
r<strong>and</strong>omized controlled trial<br />
Study Selection<br />
Two reviewers independently assessed each abstract. If one reviewer concluded that the<br />
article could be eligible to address a KQ based on the abstract, we retained it for review <strong>of</strong> the<br />
full text. Two reviewers independently assessed the full text <strong>of</strong> each included study potentially<br />
addressing a KQ, with any disagreements adjudicated by a senior reviewer. Reviewers could flag<br />
studies that potentially addressed a C Q identified in the screening process for KQs.<br />
We also screened studies identified in our separate database searches for studies<br />
potentially addressing CQs. We did not conduct dual screening <strong>of</strong> studies identified in our<br />
searches for CQs. If one reviewer determined that a study could be eligible, we assessed its<br />
relevance to the CQs. Excluded studies had no further analysis.<br />
Data Extraction <strong>and</strong> Synthesis<br />
We extracted data from included studies into templates that recorded study design,<br />
descriptions <strong>of</strong> the study population (for applicability), description <strong>of</strong> the interventions, <strong>and</strong><br />
baseline <strong>and</strong> outcome data on constructs <strong>of</strong> interest. Data were initially extracted by one team<br />
member <strong>and</strong> reviewed for accuracy by a second. Extracted data for KQs are available in the<br />
Systematic Review Data Repository.<br />
We summarized data for KQs qualitatively using summary tables where meta-analyses were<br />
not possible. We provided a narrative summary <strong>of</strong> relevant papers for CQs.<br />
ES-7
We identified sufficient data to address the effectiveness <strong>of</strong> pharmacologic interventions<br />
using quantitative meta-analysis methods. Studies were included in the meta-analysis subset<br />
provided that they satisfied the following additional inclusion criteria:<br />
• Outcomes were reported quantitatively, using an objective metric for reporting<br />
intervention effects that could be converted into a proportion <strong>of</strong> IH clearance.<br />
• One or more study arms evaluated a single intervention; study arms in which two or more<br />
treatments were applied were excluded.<br />
• Reported outcomes were accompanied by an associated measure <strong>of</strong> variation or precision.<br />
• Non-control pharmacologic treatments could be reasonably classified into one <strong>of</strong> the<br />
following classes <strong>of</strong> agents: oral, intralesional, or topical propranolol; intralesional<br />
triamcinolone; topical or ophthalmic timolol; <strong>and</strong> oral steroid.<br />
• Studies evaluated IH in multiple locations (vs. specific anatomic areas) as most studies<br />
included IH in multiple areas.<br />
In addition to the diverse suite <strong>of</strong> interventions, outcomes were reported in a variety <strong>of</strong> ways.<br />
Most identified an arbitrary threshold <strong>of</strong> IH clearance (e.g., >75%) as a positive outcome, or<br />
divided the continuous clearance measure into a small number <strong>of</strong> categories. Others reported<br />
visual analog scale scores or other measures. In order to incorporate as many quality studies as<br />
possible, we constructed a Bayesian latent variable model. This model allowed several different<br />
types <strong>of</strong> outcome data <strong>and</strong> a suite <strong>of</strong> pharmacologic interventions to be analyzed in the same<br />
model. The estim<strong>and</strong>s <strong>of</strong> interest were the expected proportion <strong>of</strong> clearance <strong>of</strong> IH associated with<br />
each intervention agent (i.e., with a mean expected clearance rate <strong>of</strong> 80% for a given agent, we<br />
would expect to see, on average, 80% clearance <strong>of</strong> IH in a child receiving that agent), along with<br />
associated posterior uncertainty. A full description <strong>of</strong> the meta-analytic methods is reported in<br />
Appendix D <strong>of</strong> the full report.<br />
Quality (Risk-<strong>of</strong>-Bias) Assessment <strong>of</strong> Individual Studies<br />
We used separate tools appropriate for specific study designs to assess quality <strong>of</strong> individual<br />
studies addressing KQs: questions adapted from the RTI item bank to assess RCTs, 21 the<br />
Newcastle-Ottawa Quality Assessment Scale for cohort studies, 22 the QUADAS tool for<br />
diagnostic imaging studies, 23 <strong>and</strong> a tool adapted from questions outlined in the RTI item bank<br />
<strong>and</strong> the McMaster McHarms tool to assess reporting <strong>of</strong> harms. 24 Appendix B <strong>of</strong> the full report<br />
includes questions used in each tool.<br />
Two team members independently assessed each included study, with discrepancies resolved<br />
through discussion to reach consensus <strong>and</strong>/or adjudication by a senior reviewer. The results <strong>of</strong><br />
these assessments were then translated to the Agency for Healthcare Research <strong>and</strong> Quality<br />
st<strong>and</strong>ard <strong>of</strong> “good,” “fair,” <strong>and</strong> “poor” quality designations, as described in the full report.<br />
Quality ratings for each study are in Appendix F <strong>of</strong> the full report.<br />
Strength <strong>of</strong> the Body <strong>of</strong> Evidence<br />
Two senior investigators graded the strength <strong>of</strong> the evidence (SOE) for key<br />
intervention/outcome pairs (i.e., the final outcomes listed in Figures A-C) using methods based<br />
on the “Methods Guide for Effectiveness <strong>and</strong> Comparative Effectiveness Reviews.” 25 We<br />
assessed the domains <strong>of</strong> study limitations (low, medium, high level <strong>of</strong> limitation), consistency<br />
(inconsistency not present, inconsistency present, unknown), directness (direct, indirect),<br />
ES-8
precision (precise, imprecise), <strong>and</strong> reporting bias. We did not assess SOE for contextual<br />
questions. The team reviewed the final SOE designation. The possible grades were:<br />
• High: High confidence that the evidence reflects the true effect. Further research is<br />
unlikely to change estimates.<br />
• Moderate: Moderate confidence that the evidence reflects the true effect. Further research<br />
may change our confidence in the estimate <strong>of</strong> effect <strong>and</strong> may change the estimate.<br />
• Low: Low confidence that the evidence reflects the true effect. Further research is likely<br />
to change confidence in the estimate <strong>of</strong> effect <strong>and</strong> is also likely to change the estimate.<br />
• Insufficient: Evidence is either unavailable or does not permit a conclusion.<br />
We assessed the SOE for the KQs only.<br />
Applicability<br />
We assessed the applicability <strong>of</strong> findings reported in the included literature addressing KQs<br />
to the general population <strong>of</strong> children with IH by determining the population, intervention,<br />
comparator, <strong>and</strong> setting in each study <strong>and</strong> developing an overview <strong>of</strong> these elements for each<br />
intervention category. We anticipated that areas in which applicability would be especially<br />
important to describe would include the diagnostic criteria for IH, age at treatment initiation, <strong>and</strong><br />
the anatomic location <strong>and</strong> morphology <strong>of</strong> IH. Applicability tables for each intervention are in<br />
Appendix G <strong>of</strong> the full report.<br />
Results<br />
CQs<br />
We included 68 studies in the narrative summary <strong>of</strong> information addressing CQ. The<br />
literature identified to answer contextual questions suggested that indications for referral include<br />
large size; segmental type; risk for complications including bleeding, ulceration, <strong>and</strong> pain;<br />
involvement <strong>of</strong> critical structures; <strong>and</strong> risk factors for occult lesions (numerous cutaneous<br />
lesions, beard distribution). Further, the potential for psychosocial concerns may support referral<br />
for patients with uncomplicated lesions in highly visible areas on a case-by-case basis.<br />
Overall, limited literature addressed the association <strong>of</strong> a higher number <strong>of</strong> cutaneous IH <strong>and</strong><br />
extracutaneous IH. Some data from case series suggested support for a higher index <strong>of</strong> suspicion<br />
in children with multiple lesions or with facial lesions in a beard distribution. Studies have<br />
primarily assessed associations between cutaneous IH <strong>and</strong> hepatic IH <strong>and</strong> cutaneous facial IH<br />
<strong>and</strong> airway IH.<br />
Comparative Effectiveness Questions<br />
Article Selection <strong>and</strong> Overview<br />
We identified 4132 nonduplicative titles or abstracts with potential relevance, with 2859<br />
proceeding to full text review. We included 148 unique studies (153 publications) in the review.<br />
These 148 studies included 42 comparative studies, 38 addressing effectiveness <strong>and</strong> harms <strong>of</strong><br />
therapies <strong>and</strong> 4 assessing effectiveness only, <strong>and</strong> 106 case series providing data on harms only.<br />
The 148 unique studies addressing KQs comprise 15 r<strong>and</strong>omized controlled trials (RCTs), 5<br />
prospective <strong>and</strong> 19 retrospective cohort studies, 2 diagnostic accuracy studies (defined as studies<br />
that compared the accuracy <strong>of</strong> imaging modalities in identifying or characterizing infantile<br />
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hemangioma [IH]), 1 prospective comparative study that used an untreated IH as a control, <strong>and</strong><br />
106 case series (used for harms data only).<br />
We considered 6 <strong>of</strong> these comparative studies to be good quality, 22 fair quality, <strong>and</strong> 14 poor<br />
quality. One-hundred <strong>and</strong> forty-four studies (comparative studies <strong>and</strong> case series) reported<br />
harms/adverse events data. We considered 14 <strong>of</strong> these as good quality for harms reporting, 3 as<br />
fair quality for harms reporting, <strong>and</strong> the remainder (n = 127) as poor quality for harms reporting.<br />
KQ1. Effectiveness <strong>and</strong> Harms <strong>of</strong> Imaging Modalities for IH<br />
Two poor quality diagnostic accuracy studies addressed imaging modalities. 26,27 Studies<br />
assessed IH in different anatomic locations <strong>and</strong> reported differing findings for the sensitivity <strong>of</strong><br />
ultrasound <strong>and</strong> effectiveness <strong>of</strong> imaging modalities depending on location or subtype. In one<br />
comparing magnetic resonance imaging (MRI) <strong>and</strong> ultrasound for imaging spinal anomalies<br />
(n=48), ultrasound had a sensitivity <strong>of</strong> 50 percent (95% CI: 18.7% to 81.3%) <strong>and</strong> specificity <strong>of</strong><br />
77.8 percent (95% CI: 40% to 97.2%) for identifying anomalies including tethered cords <strong>and</strong><br />
intraspinal IH. We calculated the sensitivity <strong>of</strong> both modalities for identifying intraspinal<br />
hemangioma specifically: assuming a false positive value <strong>of</strong> 0, ultrasound had a sensitivity <strong>of</strong> 20<br />
percent (95% CI: 3.30% to 71.19%), <strong>and</strong> the sensitivity <strong>of</strong> MRI was 100 percent (95% CI:<br />
66.21% to 100%). In another study, ultrasound identified hepatic IH in 42 <strong>of</strong> 44 patients<br />
(sensitivity <strong>of</strong> 95%). Overall, studies were limited by the size <strong>of</strong> cohorts, lack <strong>of</strong> st<strong>and</strong>ard<br />
processes, <strong>and</strong> lack <strong>of</strong> direct comparison at the same time point using the various imaging<br />
modalities. We considered the SOE for all imaging modalities to be insufficient given single,<br />
small studies addressing different approaches, using weaker study designs <strong>and</strong> precluding a<br />
meta-analysis. The studies did not address harms.<br />
KQ2. Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids <strong>and</strong> Beta-Blockers<br />
Summary <strong>of</strong> Meta-Analysis Results<br />
We included 18 studies in a network meta-analysis. All studies addressed pharmacologic<br />
agents <strong>and</strong> included five RCTs <strong>and</strong> four cohort studies evaluating oral propranolol <strong>and</strong> placebo<br />
or observation or another active agent; one RCT <strong>and</strong> one cohort study comparing oral<br />
propranolol <strong>and</strong> other oral beta-blockers; three cohort studies <strong>and</strong> two RCTs assessing topical<br />
timolol compared with placebo or observation or another agent; <strong>and</strong> one RCT <strong>and</strong> one cohort<br />
study evaluating different steroids. Four studies were good quality; nine were fair quality; <strong>and</strong><br />
five were poor quality. Studies included a total <strong>of</strong> 1265 children with IH.<br />
In our network meta-analysis, oral propranolol had the highest clearance rate (Figure D). As<br />
described in the qualitative results, there were substantially more studies <strong>of</strong> oral propranolol<br />
available for inclusion in the analysis. The expected efficacy <strong>of</strong> control arms was estimated to be<br />
6 percent (95% Bayesian credible interval [BCI]: 1% to 11%), <strong>and</strong> all non-control treatments<br />
were estimated to have a larger expected clearance than control arms. As noted, the largest mean<br />
estimate <strong>of</strong> expected clearance was for oral propranolol (95%, 95% BCI: 88% to 99%), followed<br />
by topical timolol (62%, 95% BCI: 39% to 83%), <strong>and</strong> intralesional triamcinolone (58%, 95%<br />
BCI: 21% to 93%). Oral steroids had a rate <strong>of</strong> 43 percent (95% BCI: 21% to 66%).<br />
The variation in treatment outcomes was high in beta-blocker studies. Thus, the potential for<br />
greater clearance was much higher in patients treated with oral propranolol, but the variability in<br />
outcomes makes it difficult to anticipate the likely outcome for a given patient. As noted,<br />
corticosteroid treatment demonstrated lower overall effectiveness.<br />
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Figure D. Estimates <strong>of</strong> expected IH clearance<br />
Note: Estimates <strong>of</strong> expected IH clearance are expressed as percent clearance relative to initial condition for each treatment, along<br />
with associated posterior interquartile range (thick lines) <strong>and</strong> 95% credible interval (thin lines).<br />
To assess for methodologic heterogeneity, we ran additional models with only RCTs <strong>and</strong><br />
with only good <strong>and</strong> fair quality studies. Estimates did not differ markedly when poor quality<br />
studies were removed, though BCI typically widened; thus, we report the model with poor<br />
quality studies included. To examine the possible effect <strong>of</strong> bias due to the inclusion <strong>of</strong> cohort<br />
studies, we fit the same model to RCT studies only. The resulting estimates were similar to those<br />
<strong>of</strong> the model fit to all studies, but with much wider posterior credible intervals. Since there was<br />
no obvious systematic bias due to study design, we reported the model estimates based on the<br />
entire body <strong>of</strong> evidence.<br />
Corticosteroids<br />
We identified 24 studies (three RCTs, one cohort study, <strong>and</strong> 20 case series) reporting<br />
outcomes <strong>and</strong>/or harms following corticosteroid use in children with IH. Comparative studies<br />
included a total <strong>of</strong> 239 children, <strong>and</strong> case series included 3508. We considered one RCT as good,<br />
one as fair, <strong>and</strong> one as poor quality <strong>and</strong> the cohort study as fair quality. We rated all case series<br />
as poor quality for harms reporting. Steroids studied varied in dose, type, <strong>and</strong> route <strong>of</strong><br />
administration, <strong>and</strong> the ages <strong>of</strong> children included in comparative studies ranged widely from 1 to<br />
72 months. IH size was reduced significantly in the oral prednisolone arm compared with<br />
intravenous methylprednisolone arm in one RCT.<br />
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More children in treatment arms than in an observation arm in another RCT comparing oral<br />
prednisolone, intralesional triamcinolone, <strong>and</strong> conservative management had at least a 50 percent<br />
reduction in lesion size. More children receiving intralesional triamcinolone than topical<br />
mometasone in a third RCT had an excellent response, but the study did not provide statistical<br />
comparisons. Lesion reduction did not differ among children receiving different doses <strong>of</strong><br />
prednisolone or methylprednisolone in a cohort study. Of the 219 children who received steroids<br />
in three comparative studies reporting such data, 140 had a “good” or “fair” response to steroids.<br />
One study reported that 92 <strong>of</strong> 238 children who underwent observation only had complete or<br />
near complete regression <strong>of</strong> IH at a median <strong>of</strong> 2 years <strong>of</strong> followup. In our network meta-analysis,<br />
oral steroids had a mean estimated expected clearance rate <strong>of</strong> 43 percent (95% BCI: 21% to<br />
66%) <strong>and</strong> intralesional triamcinolone had a rate <strong>of</strong> 58 percent with wide confidence boundaries<br />
(95% BCI: 22% to 93%). Overall, SOE is moderate for the effect <strong>of</strong> oral steroids on clearance<br />
rates <strong>and</strong> low SOE for intralesional steroids to have a modest (albeit larger) effect relative to<br />
control, with wide confidence bounds.<br />
Harms were varied <strong>and</strong> frequently included Cushingoid facies, irritability/mood changes,<br />
growth retardation, <strong>and</strong> skin atrophy or depigmentation. Studies typically did not explicitly<br />
report terminations due to adverse events, although one study <strong>of</strong> oral prednisolone noted<br />
discontinuation <strong>of</strong> the drug in 1 <strong>of</strong> 10 participants due to vomiting. Another comparing<br />
prednisolone (n=8) <strong>and</strong> propranolol (n=11) reported five discontinuations in the steroid arm due<br />
to growth or endocrine changes. Study enrollment was stopped due to adverse events. Overall,<br />
steroids were consistently associated with clinically important harms that may be important in<br />
making treatment decisions. The SOE is moderate for the association <strong>of</strong> steroids with clinically<br />
important harms.<br />
Beta-Blockers<br />
Eighty-one studies (25 comparative studies <strong>and</strong> 56 case series) evaluated propranolol (oral,<br />
topical, intralesional), oral nadolol, oral atenolol, or timolol (gel or ophthalmic solution). Betablockers<br />
typically demonstrated significantly greater effects on reducing lesion size or volume<br />
than did control or other active comparators. Compared with a mean estimated expected<br />
clearance rate <strong>of</strong> 6 percent (95% BCI: 1% to 11%) in placebo or observation arms, oral<br />
propranolol had a rate <strong>of</strong> 95 percent (95% BCI: 88% to 99%). We summarize effectiveness<br />
results by comparator below.<br />
Harms most frequently reported with beta-blockers included hypotension, hypoglycemia,<br />
bradycardia, sleep disturbances, cold extremities, gastrointestinal symptoms, <strong>and</strong> bronchial<br />
irritation (classified as hyperreactivity, bronchospasm, bronchiolitis, <strong>and</strong> cold induced wheezing;<br />
moderate SOE association <strong>of</strong> propranolol with clinically important <strong>and</strong> minor harms). Harms<br />
generally did not cause treatment discontinuation (n=40/2541 [1.6%] children in case series <strong>and</strong><br />
no children in comparative studies).<br />
Propranolol Versus Observation or Placebo<br />
We identified four studies (two good <strong>and</strong> one fair quality RCTs <strong>and</strong> one fair quality cohort<br />
study) evaluating propranolol versus placebo or observation. Propranolol was associated with<br />
significantly greater clearance <strong>of</strong> IH compared with the control arm in all four studies. In the<br />
largest RCT, which included 456 children without problematic IH receiving up to 3 mg/kg/day<br />
<strong>of</strong> propranolol, 60 percent <strong>of</strong> children in the propranolol group had complete or near complete<br />
resolution <strong>of</strong> IH after 24 weeks <strong>of</strong> treatment compared with 4 percent in the placebo group. The<br />
recommended dose <strong>of</strong> propranolol in this IH population remains to be determined, but the<br />
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majority <strong>of</strong> studies to date have investigated the 2 mg/kg/day dosing regimen. Despite changes in<br />
lesion size in many children receiving propranolol, some children do not appear to respond to<br />
propranolol, but these children are not well-characterized to date.<br />
In network meta-analysis, the mean expected clearance rate for oral propranolol was 95<br />
percent (95% BCI: 88% to 99%) relative to 6 percent for placebo/observation arms (95% BCI:<br />
1% to 11%); IH size reductions were greater in propranolol arms versus control in all individual<br />
studies, thus we considered the SOE as high for greater effectiveness <strong>of</strong> propranolol compared<br />
with placebo or observation based on individual comparisons <strong>and</strong> the meta-analysis.<br />
Propranolol Versus Other Active Modalities<br />
Ten studies compared propranolol to another modality including steroids, pulse dye laser<br />
(PDL), bleomycin, or historical treatments. Studies comparing propranolol <strong>and</strong> steroids to reduce<br />
IH size had conflicting findings. Propranolol was more effective than steroids in three studies,<br />
while two others studies did not find effectiveness differed significantly between these<br />
treatments. In network meta-analysis, pooling data from multiple studies, propranolol was<br />
superior to oral steroids (95% clearance [95% BCI: 88% to 99%]) versus 43% clearance [95%<br />
BCI: 22% to 66%]). These combined effects from individual studies <strong>and</strong> meta-analysis conferred<br />
moderate SOE for superiority <strong>of</strong> propranolol over steroids at achieving clearance.<br />
One additional retrospective cohort study assessing only vision outcomes reported no<br />
significant differences between oral propranolol <strong>and</strong> intralesional steroids in improving<br />
amblyopia, but children in the propranolol arm had a significantly shorter duration <strong>of</strong> therapy<br />
(p
Timolol was significantly more effective than observation or placebo in three studies, <strong>and</strong> one<br />
study comparing topical imiquimod with timolol did not demonstrate that one intervention was<br />
more effective than the other. In one study comparing timolol <strong>and</strong> PDL+Nd:YAG laser, timolol<br />
was associated with greater improvements in superficial lesions, while laser was associated with<br />
greater improvements in mixed (superficial <strong>and</strong> deep) lesions. In another comparing timolol<br />
alone with timolol plus PDL, mean global assessment scores were more improved in the<br />
combination arm than in the timolol arm, though IH in 97 percent <strong>of</strong> children in both arms<br />
improved from baseline. No harms <strong>of</strong> timolol were observed in any study.<br />
In network meta-analysis, the mean expected clearance rate for topical timolol was 62<br />
percent (95% BCI: 39% to 83%) relative to 6 percent (95% BCI: 1% to 11%) for placebo or<br />
observation arms. We considered SOE as low for the effectiveness <strong>of</strong> timolol compared with<br />
placebo or observation.<br />
KQ3. Effectiveness <strong>and</strong> Harms <strong>of</strong> Second-Line Therapies Following<br />
Beta-Blockers or Corticosteroids<br />
We did not identify any studies addressing this question.<br />
KQ4. Effectiveness <strong>and</strong> Harms <strong>of</strong> Surgical Interventions<br />
Studies <strong>of</strong> Laser Treatment<br />
Eleven comparative studies (three RCTs <strong>and</strong> seven retrospective <strong>and</strong> one prospective studies<br />
including a total <strong>of</strong> 1029 children) <strong>and</strong> 30 case series (n=3831) addressed surgical approaches.<br />
We considered one RCT as good, two RCTs <strong>and</strong> two cohort studies as fair, <strong>and</strong> the remainder <strong>of</strong><br />
studies as poor quality.<br />
Most comparative studies were small (≤55 participants), but one RCT <strong>and</strong> three retrospective<br />
cohort studies included more than 120 children. Lasers varied across studies in type, pulse width,<br />
or cooling materials. Most studies assessed variations <strong>of</strong> PDL (n=7) <strong>and</strong> examined heterogeneous<br />
endpoints. Most studies reported on treatment <strong>of</strong> cutaneous lesions. Several studies used<br />
historical controls, based on now superseded treatment regimens.<br />
In two RCTs reporting level <strong>of</strong> clearance, at least 40 percent <strong>of</strong> children in laser or<br />
observation arms had complete or near complete clearance <strong>of</strong> IH. RCTs included younger<br />
children with lesions likely in the proliferative phase. One reported no differences in level <strong>of</strong><br />
reduction between traditional <strong>and</strong> longer pulse PDL. Cohort studies assessed outcomes after<br />
carbon dioxide <strong>and</strong> Nd:YAG (neodymium yttrium aluminum garnet) lasers <strong>and</strong> typically<br />
reported some resolution <strong>of</strong> lesion size, but heterogeneity among studies limits our abilities to<br />
draw conclusions.<br />
Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for<br />
cutaneous lesions <strong>and</strong> Nd:YAG was the most commonly used intralesionally. Most studies<br />
reported a higher success rate with longer pulse PDL compared to observation in managing the<br />
size <strong>of</strong> IH, although the magnitude <strong>of</strong> effect differed substantially. CO2 laser was used for<br />
subglottic IH in a single study, <strong>and</strong> was noted to have a higher success rate <strong>and</strong> lower<br />
complication rate than both Nd:YAG <strong>and</strong> observation.<br />
Two comparative studies addressed surgical approaches (cryotherapy, intense pulsed light<br />
photothermolysis, sclerosis) <strong>and</strong> reported some positive effects in reducing IH size or improving<br />
appearance, but their smaller size <strong>and</strong> low quality preclude conclusions (insufficient SOE).<br />
Strength <strong>of</strong> evidence for outcomes after surgical treatments ranged from insufficient to low for<br />
ES-14
effectiveness outcomes. The evidence was limited by low sample size, lack <strong>of</strong> comparisons <strong>of</strong><br />
the same modalities, <strong>and</strong> variations in the laser settings used including wavelength <strong>and</strong> cooling<br />
protocols. For Nd:YAG <strong>and</strong> CO2 lasers, cryotherapy, <strong>and</strong> intense pulsed light photothermolysis,<br />
all studies were severely limited by sample size, <strong>and</strong> SOE was determined to be insufficient in all<br />
outcome parameters.<br />
Harms associated with laser treatment included skin atrophy, bleeding, scarring, ulceration<br />
purpura, <strong>and</strong> pigmentation changes. Bleeding <strong>and</strong> ulceration were observed in the immediate<br />
postoperative period, distinguishing these complications from the possible natural complications<br />
<strong>of</strong> IH themselves. Overall, we considered SOE to be moderate for pigmentation changes with<br />
PDL, which was most frequently hypopigmentation. SOE was low for bleeding in the immediate<br />
postoperative period. Due to low sample size <strong>and</strong> limitations in reporting, pain <strong>and</strong> scarring were<br />
found to have insufficient SOE. For Nd:YAG lasers, evaluation for scarring was most frequently<br />
reported, <strong>and</strong> there was low SOE to support no difference in scarring between Nd:YAG <strong>and</strong><br />
observation. Evidence was deemed insufficient to comment on pigmentation changes <strong>and</strong><br />
bleeding for children treated with Nd:YAG.<br />
Studies <strong>of</strong> Surgical Treatment<br />
Few comparative studies addressed surgical approaches. Two comparative studies addressed<br />
cryotherapy versusno treatment <strong>and</strong> intense pulsed light photothermolysis with or without<br />
sclerotherapy versus cryotherapy <strong>and</strong> reported improvements in IH but included few participants<br />
in each arm (total n = 263).<br />
Most surgical case series (n=13) were retrospective <strong>and</strong> included a total <strong>of</strong> 838 children. We<br />
considered all to be poor quality for harms reporting <strong>and</strong> insufficient SOE for association with<br />
any harms. Frequently reported harms included scarring <strong>and</strong> wound dehiscence.<br />
Discussion<br />
Key Findings From CQs<br />
The literature identified to answer contextual questions described a broader range <strong>of</strong><br />
indications for referral <strong>of</strong> patients with IH <strong>and</strong> suggested support for a higher index <strong>of</strong> suspicion<br />
<strong>of</strong> extracutaneous IH in children with multiple cutaneous lesions or with facial lesions in a beard<br />
distribution. Studies have primarily assessed associations between cutaneous IH <strong>and</strong> hepatic IH<br />
<strong>and</strong> cutaneous facial IH <strong>and</strong> airway IH.<br />
Key Findings <strong>and</strong> Strength <strong>of</strong> Evidence for KQs<br />
Until fairly recently, corticosteroids were the treatment <strong>of</strong> choice for IH. As reported in this<br />
review, corticosteroids demonstrate moderate effectiveness but may be associated with clinically<br />
important side effects. More recently, beta-blockers, <strong>and</strong> propranolol specifically, have been<br />
studied <strong>and</strong> recommended for use. Studies <strong>of</strong> propranolol have compared its effectiveness to<br />
placebo or observation arms, to corticosteroids <strong>and</strong> other modalities, <strong>and</strong> to other beta-blockers.<br />
Relative to observation or placebo, propranolol has been consistently shown to be superior in<br />
individual studies <strong>and</strong> in our meta-analysis. Relative to other modalities, including steroids <strong>and</strong><br />
bleomycin, we find that propranolol is generally superior. In two studies comparing steroids <strong>and</strong><br />
propranolol, however, differences in reduction <strong>of</strong> lesion size were not significantly different<br />
between groups. Finally, given that propranolol has been demonstrated to be associated with<br />
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positive outcomes, the question <strong>of</strong> whether effectiveness is associated with propranolol<br />
specifically or beta-blockers in general has been studied. Although there are only three small<br />
studies available, they suggest that other beta-blockers may also confer positive effects,<br />
potentially with fewer side effects, but these findings are preliminary. Studies <strong>of</strong> the beta-blocker<br />
timolol, used as a topical gel or solution, also reported greater effectiveness for timolol compared<br />
with placebo/observation in reducing IH lesion size <strong>and</strong> no differences in effects in one study<br />
comparing ophthalmic timolol <strong>and</strong> imiquimod.<br />
In our network meta-analysis, propranolol had the highest clearance rate, with high<br />
variability. The preponderance <strong>of</strong> available evidence used in the meta-analysis was derived from<br />
studies <strong>of</strong> propranolol <strong>and</strong> corticosteroids.<br />
In terms <strong>of</strong> surgical interventions, only laser has been adequately studied. Most studies<br />
focused on PDL <strong>and</strong> generally it was found to be more effective than other types <strong>of</strong> laser, but<br />
effects remain unclear as studies were significantly heterogeneous, <strong>and</strong> the role <strong>of</strong> laser vis-a-vis<br />
beta-blockers is not clearly described in the literature. Data are inadequate to address the role <strong>of</strong><br />
imaging in guiding treatment.<br />
We assessed strength <strong>of</strong> evidence for the effectiveness <strong>and</strong> harms <strong>of</strong> interventions using the<br />
qualitative <strong>and</strong> quantitative approaches described fully in the Methods section <strong>of</strong> the full report.<br />
Overall, the evidence to answer KQs about interventions for children with IH ranged from<br />
insufficient to moderate when the comparisons are made with the individual studies qualitatively.<br />
The network meta-analysis provided additional data. We assessed strength <strong>of</strong> evidence separately<br />
for the predicted outcomes <strong>of</strong> the meta-analysis <strong>and</strong> key direct comparisons available in the<br />
literature (Tables B-D).<br />
Imaging<br />
Studies <strong>of</strong> imaging modalities addressed different approaches <strong>and</strong> different anatomic locations<br />
(intraspinal, hepatic IH). The sensitivity <strong>of</strong> ultrasound in these two small studies ranged from 20<br />
percent to 95 percent. Sensitivity <strong>of</strong> MRI was 100 percent in one study. Findings are limited by<br />
the size <strong>of</strong> cohorts, lack <strong>of</strong> st<strong>and</strong>ard processes, <strong>and</strong> lack <strong>of</strong> direct comparison at the same time<br />
point using the various imaging modalities.<br />
We considered the strength <strong>of</strong> evidence for all imaging modalities to be insufficient given<br />
single, small studies addressing different approaches, using weaker study designs <strong>and</strong> precluding<br />
a meta-analysis (Table B). The studies did not address harms.<br />
Corticosteroids<br />
Studies <strong>of</strong> corticosteroids similarly evaluated different steroids, routes <strong>of</strong> administration, <strong>and</strong><br />
comparators. Children in treatment arms in individual studies typically had modest improvement<br />
in lesion size. In our network meta-analysis, oral steroids had a mean estimated expected<br />
clearance rate <strong>of</strong> 43 percent (95% BCI: 21% to 66%), <strong>and</strong> intralesional triamcinolone had a rate<br />
<strong>of</strong> 58 percent (95% BCI: 22% to 93%) but with wide confidence bounds.<br />
Studies <strong>of</strong> steroids assessed multiple agents, <strong>and</strong> we combined these in the meta-analysis into<br />
oral <strong>and</strong> intralesional groupings. Thus, while strength <strong>of</strong> evidence is insufficient on the basis <strong>of</strong><br />
qualitative analysis <strong>of</strong> single studies <strong>of</strong> individual agents compared to one another, strength <strong>of</strong><br />
evidence is moderate for the effect <strong>of</strong> oral steroids on clearance rates <strong>and</strong> low strength <strong>of</strong><br />
evidence for intralesional steroids to have a modest (albeit larger) effect relative to control with<br />
wide confidence bounds. Steroids were consistently associated with clinically important harms<br />
including Cushingoid appearance, infection, growth retardation, hypertension, <strong>and</strong> mood<br />
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changes. We considered the strength <strong>of</strong> evidence to be moderate for the association <strong>of</strong> steroids<br />
with these clinically important harms (Table C).<br />
Beta-Blockers<br />
Studies <strong>of</strong> beta-blockers typically reported significantly greater resolution <strong>of</strong> IH in betablocker<br />
arms compared with placebo/observation or other active agents. Compared with a mean<br />
estimated expected clearance rate <strong>of</strong> 6 percent (95% BCI: 1% to 11%) in placebo or observation<br />
arms <strong>and</strong> 43 percent (95% BCI: 21% to 66%) for oral steroids, the mean estimated clearance rate<br />
for oral propranolol was much higher (95%, BCI: 88% to 99%) in our network meta-analysis.<br />
In individual comparative studies, propranolol at doses <strong>of</strong> 2 to 3 mg/kg/day administered for<br />
6 months promoted lesion regression with few serious side effects in children with IH. While the<br />
majority <strong>of</strong> studies investigated propranolol at a total <strong>of</strong> 2 mg/kg/day, one RCT with the largest<br />
number <strong>of</strong> patients utilized a treatment <strong>of</strong> 3 mg/kg/day. The recommended dose <strong>of</strong> propranolol in<br />
this IH population remains to be determined, but the majority <strong>of</strong> studies to date have investigated<br />
the 2 mg/kg/day dosing regimen. Despite changes in lesion size in many children receiving<br />
propranolol, a percentage <strong>of</strong> patients do not appear to respond to propranolol, but these children<br />
are not well-characterized to date.<br />
Other oral beta-blockers (atenolol, nadolol) in small studies demonstrated promising effects<br />
on reducing lesion size <strong>and</strong> few adverse effects, which may suggest that improvements can be<br />
achieved in the propranolol safety pr<strong>of</strong>ile. Harms most frequently reported with use <strong>of</strong> oral betablockers<br />
(propranolol, atenolol, nadolol) included sleep disturbances, cold extremities,<br />
gastrointestinal symptoms, bronchial irritation (classified as hyperreactivity, bronchospasm,<br />
bronchiolitis, cold induced wheezing), <strong>and</strong> decreases in blood pressure or heart rate.<br />
In studies comparing propranolol with other active comparators including steroids, PDL,<br />
bleomycin, or historical treatments, findings were inconsistent, with two studies reporting greater<br />
effectiveness for propranolol compared with steroids <strong>and</strong> two noting no significant differences<br />
between propranolol <strong>and</strong> steroids. In network meta-analysis, oral propranolol was associated<br />
with a mean estimate <strong>of</strong> expected clearance <strong>of</strong> IH <strong>of</strong> 95 percent (95% BCI: 88% to 99%)<br />
compared with a lower rate for oral steroids <strong>of</strong> 43 percent (95% BCI: 21% to 66%). One study<br />
reported greater effectiveness for propranolol plus laser than propranolol alone. Another study<br />
found the likelihood <strong>of</strong> subsequent laser treatment was lower in participants treated with<br />
propranolol than participants who received other treatments. A study that compared propranolol<br />
with bleomycin did not demonstrate that one intervention was more effective than the other.<br />
Studies <strong>of</strong> the topical beta-blocker timolol reported significantly greater resolution in<br />
treatment groups compared with placebo or observation, <strong>and</strong> one study reported no differences<br />
when compared with imiquimod. In network meta-analysis, the mean expected clearance rate for<br />
topical timolol was 62 percent (95% BCI: 39% to 83%).<br />
With adequate data <strong>and</strong> good precision, we considered the strength <strong>of</strong> evidence to be high for<br />
the effect <strong>of</strong> propranolol on lesion size relative to observation or placebo. Individual studies<br />
assessed qualitatively also demonstrated greater effectiveness for propranolol compared with<br />
other active treatments.<br />
Other oral beta-blockers have demonstrated promising effectiveness; we considered the<br />
strength <strong>of</strong> evidence to be low for no difference in response to propranolol <strong>and</strong> nadolol or<br />
atenolol based on three small studies. We considered strength <strong>of</strong> evidence to be low for greater<br />
effectiveness <strong>of</strong> topical timolol compared with observation or placebo. We considered the<br />
ES-17
strength <strong>of</strong> evidence to be moderate for the association <strong>of</strong> propranolol with significant <strong>and</strong> minor<br />
harms (Table C).<br />
Surgical Approaches<br />
Lasers studied varied across studies in type, pulse width, or cooling materials. Most studies<br />
assessed variations <strong>of</strong> PDL <strong>and</strong> examined heterogeneous endpoints. Heterogeneity among studies<br />
limits our abilities to draw conclusions. Multiple variations in treatment protocols did not allow<br />
for demonstration <strong>of</strong> superiority <strong>of</strong> a single laser method.<br />
Harms associated with laser treatment included skin atrophy, bleeding, scarring, ulceration<br />
purpura, <strong>and</strong> pigmentation changes. Surgical harms included wound dehiscence.<br />
Strength <strong>of</strong> evidence for outcomes after laser treatments ranged from insufficient to low for<br />
effectiveness outcomes (Table D). The evidence was limited by low sample size, <strong>and</strong> variations<br />
in the laser settings used including wavelength <strong>and</strong> cooling protocols. For Nd:YAG <strong>and</strong> carbon<br />
dioxide lasers, all studies were severely limited by sample size, <strong>and</strong> strength <strong>of</strong> evidence was<br />
determined to be insufficient in all outcome parameters. For harms, we considered the strength <strong>of</strong><br />
evidence as moderate for pigmentation changes with PDL, which was most frequently<br />
hypopigmentation <strong>and</strong> strength <strong>of</strong> evidence as low for bleeding in the immediate postoperative<br />
period. Due to low sample size <strong>and</strong> limitations in reporting, pain <strong>and</strong> scarring were found to have<br />
insufficient strength <strong>of</strong> evidence. For Nd:YAG lasers, evaluation for scarring was most<br />
frequently reported, <strong>and</strong> there was low strength <strong>of</strong> evidence to support no difference in scarring<br />
between Nd:YAG <strong>and</strong> observation. Evidence was deemed insufficient to comment on<br />
pigmentation changes <strong>and</strong> bleeding for children treated with Nd:YAG <strong>and</strong> for any harms<br />
associated with other surgical approaches.<br />
Table B. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> imaging modalities<br />
Intervention<br />
Strength <strong>of</strong><br />
Key Outcome(s)<br />
Evidence<br />
(SOE)<br />
Findings<br />
Grade<br />
Type/Number<br />
<strong>of</strong> Studies<br />
(Total N<br />
Participants)<br />
MRI vs.<br />
Ultrasound<br />
Cohort studies:<br />
1 (48)<br />
MRI vs.<br />
Ultrasound vs.<br />
CT<br />
Accuracy in detecting<br />
spinal anomalies<br />
Accuracy in detecting liver<br />
IH<br />
Insufficient Ultrasound had a sensitivity <strong>of</strong> 50%<br />
for identifying spinal anomalies<br />
including but not limited to IH <strong>and</strong><br />
20% for identifying intraspinal IH<br />
only compared with 100% for MRI.<br />
Insufficient SOE due to single small<br />
study with high study limitations.<br />
Insufficient Ultrasound detected lesions in 42/44<br />
children (95% sensitivity).<br />
Insufficient SOE due to single small<br />
study with high study limitations.<br />
Cohort studies:<br />
1 (55)<br />
Abbreviations: CT = computed tomography; IH = infantile hemangioma; MRI = magnetic resonance imaging;<br />
RCT = r<strong>and</strong>omized controlled trial; SOE = strength <strong>of</strong> evidence<br />
ES-18
Table C. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> pharmacologic interventions<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Steroids<br />
Oral steroids vs.<br />
Observation or<br />
Placebo<br />
Findings<br />
Improvement in IH Moderate In network meta-analysis oral steroids had a mean expected clearance<br />
rate <strong>of</strong> 43% (95% BCI: 21%-66%) compared with 6% (95% BCI: 1%-<br />
11%) for placebo/observation arms.<br />
Network metaanalysis<br />
Intralesional Steroids<br />
vs. Observation or<br />
Placebo<br />
Moderate SOE for greater effectiveness <strong>of</strong> oral steroids vs.<br />
placebo/observation given low precision <strong>and</strong> high study limitations.<br />
Improvement in IH Low In network meta-analysis intralesional steroids had a mean expected<br />
clearance rate <strong>of</strong> 58% (95% BCI: 22%-93%) compared with 6% (95%<br />
BCI: 1%-11%) for placebo/observation arms.<br />
Network metaanalysis<br />
All steroids<br />
RCT: 3 (138)<br />
Cohort studies: 3<br />
(179)<br />
Case series: 10<br />
(2974)<br />
Clinically important<br />
harms (Cushingoid<br />
facies, growth<br />
retardation, mood<br />
changes /irritability,<br />
hypertension,<br />
infection)<br />
Moderate<br />
Low SOE for greater effectiveness <strong>of</strong> intralesional steroids vs.<br />
placebo/observation given relatively small numbers <strong>of</strong> participants<br />
contributing to this comparison <strong>and</strong> low precision.<br />
Comparative studies, case series, <strong>and</strong> package insert data consistently<br />
reported these adverse effects.<br />
Moderate SOE for association <strong>of</strong> steroids with clinically important harms<br />
due to high study limitations.<br />
ES-19
Table C. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> pharmacologic interventions (continued)<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Findings<br />
Beta-Blockers<br />
(continued)<br />
Oral propranolol vs.<br />
Placebo or<br />
Observation<br />
Network metaanalysis<br />
RCT: 3 (510)<br />
Improvement in IH High In network meta-analysis, the mean expected clearance rate for oral<br />
propranolol was 95% (95% BCI: 88%-99%) relative to 6% (95% BCI:<br />
1%-11%) for placebo/observation arms; greater reductions in IH size in<br />
propranolol arms vs. control in all individual studies.<br />
High SOE for greater effectiveness <strong>of</strong> propranolol vs. placebo or<br />
observation based on individual comparisons <strong>and</strong> the meta-analysis.<br />
Cohort studies: 1 (45)<br />
Propranolol vs.<br />
Placebo or<br />
Observation<br />
RCT: 1 (456)<br />
Cohort studies: 1 (45)<br />
Propranolol vs.<br />
Steroids<br />
Network metaanalysis<br />
RCT: 1 (19)<br />
Cohort studies: 4<br />
(216)<br />
Propranolol vs.<br />
Steroids<br />
Cohort studies: 1 (43)<br />
Rebound growth/Need<br />
for further treatment<br />
Moderate<br />
Fewer than 15% <strong>of</strong> children in treatment arms had rebound growth or<br />
required longer/additional treatment.<br />
Moderate SOE for low level <strong>of</strong> rebound growth/need for further<br />
treatment associated with propranolol given few studies addressing the<br />
outcome.<br />
Improvement in IH Moderate In head-to-head comparisons, propranolol more effective than steroids<br />
in 3 studies; 2 other studies reported no significant difference between<br />
oral or intralesional propranolol <strong>and</strong> oral or intralesional steroids. In<br />
network meta-analysis, pooling data from multiple studies, propranolol<br />
was superior to oral steroids (95% [95% BCI: 88% to 99%] clearance<br />
versus 43% [ 95% BCI: 21% to 66%] clearance).<br />
Moderate SOE for superiority <strong>of</strong> propranolol over steroids at achieving<br />
clearance based on combined effects from individual studies <strong>and</strong><br />
network meta-analysis, high study limitations, <strong>and</strong> inconsistency.<br />
Amblyopia Insufficient No significant difference in level <strong>of</strong> amblyopia between oral propranolol<br />
<strong>and</strong> intralesional triamcinolone arms<br />
in one small study.<br />
Insufficient SOE due to single study with high limitations.<br />
ES-20
Table C. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> pharmacologic interventions (continued)<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Findings<br />
Beta-Blockers<br />
(continued)<br />
Oral propranolol +<br />
prednisolone vs.<br />
Prednisolone vs.<br />
Propranolol alone<br />
Improvement in IH Insufficient Significant size reductions from baseline in propranolol <strong>and</strong> combined<br />
arms (p values
Table C. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> pharmacologic interventions (continued)<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Findings<br />
Beta-Blockers<br />
(continued)<br />
Topical timolol vs.<br />
PDL + Nd:YAG laser<br />
Improvement in IH Insufficient Greater response to timolol among superficial IH <strong>and</strong> greater response<br />
to laser among mixed IH (p=NR).<br />
RCT: 1 (60)<br />
Oral propranolol<br />
RCT: 3 (515)<br />
Cohort studies: 5<br />
(277)<br />
Case series: 16<br />
(1274)<br />
Topical timolol<br />
RCT: 1 (41)<br />
Cohort studies: 4<br />
(287)<br />
Significant <strong>and</strong> minor<br />
harms (significant:<br />
hypotension,<br />
bradycardia,<br />
bronchospasm,<br />
hypoglycemia; minor:<br />
cold extremities,<br />
diarrhea, sleep<br />
changes)<br />
Moderate<br />
Insufficient SOE due to single study with high limitations.<br />
Rates <strong>of</strong> clinically important harms ranged from 0 to 100% across<br />
studies <strong>and</strong> from 1% to 50% for minor harms.<br />
Moderate SOE for association <strong>of</strong> propranolol with these harms based<br />
on high study limitations.<br />
Lack <strong>of</strong> harms Low No harms observed with timolol in 5 comparative studies <strong>and</strong> 1 case<br />
series. Shortness <strong>of</strong> breath <strong>and</strong> insomnia observed in 1 <strong>of</strong> 30 children in<br />
one comparative study.<br />
Low SOE for lack <strong>of</strong> association <strong>of</strong> timolol with harms based on few<br />
studies.<br />
Case series: 1 (25)<br />
ES-22
Table C. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> pharmacologic interventions (continued)<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Findings<br />
Beta-Blockers<br />
(continued)<br />
Oral nadolol<br />
Cohort studies: 1 (19)<br />
Oral atenolol<br />
RCT: 1 (23)<br />
Cohort studies: 1 (58)<br />
Significant <strong>and</strong> minor<br />
harms (significant:<br />
hypotension,<br />
bradycardia,<br />
bronchospasm,<br />
hypoglycemia; minor:<br />
cold extremities,<br />
diarrhea, sleep<br />
changes)<br />
Significant <strong>and</strong> minor<br />
harms (significant:<br />
hypotension; minor:<br />
cold extremities,<br />
diarrhea, sleep<br />
changes)<br />
Insufficient<br />
Insufficient<br />
Harms reported in 20% to 50% <strong>of</strong> children.<br />
Insufficient SOE due to single, small study with high limitations.<br />
Harms reported ranged from 3% to 27% in 2 small studies<br />
Insufficient SOE due to high study limitations <strong>and</strong> few studies.<br />
BCI = Bayesian credible interval; IH = infantile hemangioma; PDL= pulse dye laser; RCT = r<strong>and</strong>omized controlled trial; SOE = strength <strong>of</strong> evidence<br />
ES-23
Table D. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> surgical interventions<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Lasers<br />
Longer pulse PDL vs<br />
other laser types <strong>and</strong><br />
protocols<br />
RCT: 1 (52)<br />
Findings<br />
Improvement in IH Low Resolution outcomes similar between laser types.<br />
Low SOE for no difference in effects on size reduction between longer<br />
pulse PDL <strong>and</strong> various other lasers given few studies, medium<br />
limitations, <strong>and</strong> inconsistent <strong>and</strong> imprecise findings.<br />
Cohort studies: 2<br />
(212)<br />
PDL vs. Observation<br />
RCT: 2 (143)<br />
PDL vs. Observation<br />
RCT: 2 (143)<br />
Nd:YAG with<br />
extended cooling vs.<br />
Nd:YAG with<br />
st<strong>and</strong>ard cooling<br />
Cohort studies:1<br />
(290)<br />
Nd:YAG vs. CO2<br />
laser vs.<br />
Tracheostomy<br />
Cohort studies: 1 (46)<br />
Improvement in IH Low No significant difference in measured volume or proportion <strong>of</strong> clearance<br />
between groups; greater observer-ratings <strong>of</strong> improvement for PDL arm<br />
in one study.<br />
Low SOE for effectiveness <strong>of</strong> PDL vs. observation in reducing lesion<br />
size.<br />
Quality <strong>of</strong> life Low No significant differences in parent ratings <strong>of</strong> QoL in one study; more<br />
parents <strong>of</strong> children in PDL arm in another considered appearance<br />
improved than in observation arm.<br />
Low SOE for no difference between PDL treatment <strong>and</strong> observation in<br />
reducing lesion size due to lack <strong>of</strong> precision, few studies..<br />
Improvement in IH Insufficient Improved resolution with extended cooling protocol vs. traditional in<br />
single study with medium limitations.<br />
Insufficient SOE given single study with medium limitations.<br />
Speech Insufficient 75% <strong>of</strong> children with tracheostomy had delayed speech vs. 0 with no<br />
tracheostomy in the laser treatment era.<br />
Insufficient SOE given small, single study with high limitations.<br />
ES-24
Table D. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> surgical interventions (continued)<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Lasers<br />
(continued)<br />
PDL<br />
RCT: 2 (173)<br />
Cohort studies: 2 (73)<br />
Findings<br />
Pigmentation changes Moderate Hypo- or hyper-pigmentation consistently reported, with<br />
hypopigmentation reported more frequently.<br />
Moderate SOE for association <strong>of</strong> PDL with skin pigmentation<br />
complications based on relatively few participants in studies.<br />
Case series: 5 (1017)<br />
PDL<br />
RCT: 1 (121)<br />
PDL<br />
RCT: 1 (121)<br />
PDL<br />
Cohort studies: 1 (50)<br />
Case series: 3 (769)<br />
Nd: YAG<br />
Cohort studies: 1 (50)<br />
Nd: YAG<br />
Cohort studies: 3<br />
(386)<br />
Bleeding Low No significant difference in bleeding between short pulse PDL <strong>and</strong><br />
observation groups.<br />
Low SOE for association <strong>of</strong> bleeding with PDL based on one study with<br />
low limitations, unknown consistency, <strong>and</strong> imprecision.<br />
Pain Insufficient 13% <strong>of</strong> parents reported pain for their children after PDL.<br />
Insufficient SOE for pain following PDL given low numbers <strong>of</strong> outcome.<br />
Pain is also difficult to assess in infant population.<br />
Scarring Insufficient 1/25 children receiving PDL in one study <strong>and</strong> 7/769 children in case<br />
series had scarring.<br />
Insufficient SOE due to few instances <strong>of</strong> the outcome reported in<br />
studies.<br />
Pigmentation changes Insufficient 2/25 children receiving Nd:YAG in one study had scarring.<br />
Insufficient SOE due to few instances <strong>of</strong> the outcome reported in<br />
studies.<br />
Scarring Low Most studies reported scarring in ≤5% <strong>of</strong> children in 6 studies.<br />
Low SOE for association <strong>of</strong> scarring with Nd:YAG treatment due to few<br />
occurrences <strong>of</strong> the outcome reported.<br />
Case series: 3 (954)<br />
Nd: YAG<br />
Case series: 2 (794)<br />
Bleeding Insufficient Bleeding noted in 13/794 children in 2 studies.<br />
Insufficient SOE due to few instances <strong>of</strong> the outcome reported in<br />
studies.<br />
ES-25
Table D. Summary <strong>of</strong> evidence in studies addressing effectiveness <strong>of</strong> surgical interventions (continued)<br />
Intervention<br />
Type/Number <strong>of</strong><br />
Studies (Total N<br />
Participants)<br />
Key Outcome(s)<br />
Strength <strong>of</strong><br />
Evidence<br />
(SOE) Grade<br />
Findings<br />
Surgical<br />
Cryotherapy vs.<br />
Observation<br />
Improvement in IH Insufficient 76% <strong>of</strong> IH in treated arm vs. 12% in untreated resolved without<br />
scarring.<br />
Comparative study: 1<br />
(13)<br />
Cryotherapy vs.<br />
Observation<br />
Comparative study: 1<br />
(13)<br />
Photothermolysis<br />
with<br />
Intense Pulsed Light<br />
With or Without<br />
Sclerosis vs.<br />
Cryotherapy<br />
Cohort studies: 1<br />
(250)<br />
Excision or resection<br />
Case series: 2 (142)<br />
Excision or resection<br />
Case series: 7 (483)<br />
Insufficient SOE given single, small study with high limitations.<br />
Scarring Insufficient Scarring in 4 <strong>of</strong> 17 IH treated with cryotherapy.<br />
Insufficient SOE due to single, small study with high limitations.<br />
Improvement in IH Insufficient More children had ≥50% reduction in IH size in the combined therapy<br />
arm than in other arms (p=NR).<br />
Scarring Insufficient Scarring in 11/192 children.<br />
Insufficient SOE given single study with high limitations.<br />
Insufficient SOE due to few instances <strong>of</strong> the outcome reported in<br />
studies.<br />
Wound dehiscence Insufficient Dehiscences in 20/483 children.<br />
Insufficient SOE due to few instances <strong>of</strong> the outcome reported in<br />
studies with high limitations.<br />
BCI = Bayesian credible interval; IH = infantile hemangioma; Nd:YAG = neodymium- yttrium aluminum garnet; PDL= pulse dye laser; QoL = quality <strong>of</strong> life; RCT = r<strong>and</strong>omized<br />
controlled trial; SOE = strength <strong>of</strong> evidence<br />
ES-26
Applicability<br />
We set inclusion criteria intended to identify studies with applicability to children with IH<br />
between the ages <strong>of</strong> 0 <strong>and</strong> 18 years. Studies differed in terms <strong>of</strong> study population <strong>and</strong> outcome<br />
measures. Most studies included children with IH in multiple anatomic locations <strong>and</strong> did not<br />
report effectiveness by lesion site or type. Most studies were non-comparative, <strong>and</strong> lack <strong>of</strong> direct<br />
comparisons <strong>of</strong> treatment options <strong>and</strong> few studies addressing the same interventions <strong>and</strong><br />
comparators further hinder our ability to underst<strong>and</strong> what findings will best extrapolate to<br />
children at specific ages, with specific lesion types, or in specific anatomic locations. Further,<br />
most comparative studies were conducted in larger medical centers or referral centers, which is<br />
in line with typical treatment as most children with IH are referred to specialists from general<br />
practitioners.<br />
Overall the available data on the effectiveness <strong>and</strong> harms <strong>of</strong> beta-blockers <strong>and</strong> corticosteroids<br />
are largely applicable to the general population <strong>of</strong> children with IH. Most studies included a<br />
majority <strong>of</strong> females, in line with the female predominance <strong>of</strong> IH, <strong>and</strong> ages in comparative studies<br />
generally ranged from 1 month to 9 years. One cohort study included individuals between 1<br />
month <strong>and</strong> 43 years <strong>of</strong> age, with a mean age <strong>of</strong> 2 years <strong>and</strong> 11 months.<br />
Few studies addressed imaging modalities, <strong>and</strong> those that did evaluated modalities to assess<br />
hepatic or intraspinal IH. Studies compared ultrasound, magnetic resonance imaging, computed<br />
tomography, <strong>and</strong> angiography. Imaging was sometimes not conducted at the same time, which<br />
limits comparability, <strong>and</strong> potentially the applicability <strong>of</strong> findings. Studies were also completed<br />
prior to 2010, so imaging techniques <strong>and</strong> practices may have changed.<br />
Studies addressing steroids compared various routes <strong>of</strong> steroid administration (oral, topical,<br />
<strong>and</strong> intralesional) <strong>and</strong> various agents (methylprednisolone, triamcinolone, mometasone furoate)<br />
in children with ages ranging from less than 1 to 72 months. Studies likely included children<br />
with IH in the proliferative <strong>and</strong> involution phase, which may limit applicability to younger or<br />
older children. One comparative study was conducted in Canada <strong>and</strong> the others in Turkey,<br />
Pakistan, <strong>and</strong> India. Applicability may be limited given differences in the systems <strong>of</strong> care in<br />
lower resource countries. Comparative studies were also published between 2001 <strong>and</strong> 2010 <strong>and</strong><br />
may not fully represent evolutions in st<strong>and</strong>ards <strong>of</strong> care.<br />
Studies <strong>of</strong> beta-blockers typically included infants <strong>of</strong> both sexes ages 1 to 12 months <strong>of</strong> age<br />
(range: 1 month - 9 years) with superficial, deep, <strong>and</strong> mixed lesions primarily involving the head<br />
<strong>and</strong> neck <strong>and</strong> occurring as focal or segmental lesions. Studies <strong>of</strong> topical or ophthalmic timolol<br />
typically included children with superficial lesions, though two <strong>of</strong> six comparative studies<br />
included children with superficial <strong>and</strong> deep lesions. Children were treated with a variety <strong>of</strong> betablockers<br />
including propranolol at various doses <strong>and</strong> administrations (oral, intralesional, or<br />
topical), timolol (topical or ophthalmic), atenolol (oral), or nadolol (oral), most commonly for up<br />
to 6 months duration. These agents <strong>and</strong> dosage forms are typically easily available in the United<br />
States <strong>and</strong> not universally available. Dosage amounts ranged from 1 to 4 mg/kg/day. Doses over<br />
2 mg/kg/day are not typically administered <strong>and</strong> may limit applicability <strong>of</strong> findings <strong>of</strong> two studies<br />
<strong>of</strong> propranolol.<br />
Surgical studies, conducted in the United States, the United Kingdom, the Netherl<strong>and</strong>s,<br />
Germany, Greece, Japan <strong>and</strong> Singapore, included infants <strong>of</strong> both sexes with a preponderance <strong>of</strong><br />
females (age range: 1 week to 43 years <strong>of</strong> age) with superficial <strong>and</strong> cutaneous infantile<br />
hemangiomas in varied locations. One study reported laser use for subglottic IH <strong>and</strong> one<br />
evaluated photothermolysis with intense pulsed light <strong>and</strong> cryosurgery in children <strong>of</strong> maxillary<br />
ES-27
IH. Most comparative studies evaluated laser treatments including short-pulse <strong>and</strong> longer pulse<br />
PDL, Nd:YAG, <strong>and</strong> argon. Two studies evaluated cryotherapy, one <strong>of</strong> which compared it to<br />
photothermolysis with intense pulsed light with or without concomitant sclerosis. Applicability<br />
<strong>of</strong> many <strong>of</strong> these studies is limited by historical changes in care <strong>and</strong> technology.<br />
Newer lasers <strong>and</strong> adjunctive features such as dynamic cooling have resulted in older lasers<br />
being out <strong>of</strong> date, thus limiting the applicability <strong>of</strong> studies conducted with those models. Most<br />
laser studies evaluated lasers as first-line treatment, which is currently less common in practice<br />
since the advent <strong>of</strong> beta-blocker treatment in countries, like the United States, where such<br />
treatments are readily available, as beta-blockers have generally superseded other treatments as<br />
first-line management <strong>of</strong> IH. Additionally, most comparative literature evaluated PDL, which is<br />
typically used only for the treatment <strong>of</strong> superficial lesions.<br />
Limitations <strong>of</strong> the Evidence Base<br />
The evidence base for IH treatment is limited by a small number <strong>of</strong> comparative studies<br />
including a limited number <strong>of</strong> participants. While cohort studies compared at least two different<br />
interventions, few presented truly comparative data. A number <strong>of</strong> studies reported only absolute<br />
differences in resolution or other outcomes, with no statistical comparison, in part likely due to<br />
their small sample sizes. Similarly, few studies reported baseline characteristics <strong>of</strong> the lesion, so<br />
underst<strong>and</strong>ing the magnitude <strong>of</strong> change reported is challenging. Most studies included children<br />
with problematic IH, so change was likely substantial, <strong>and</strong> parents <strong>and</strong> children may value any<br />
lessening <strong>of</strong> lesion size or change in color or texture.<br />
A growing number <strong>of</strong> studies address beta-blockers, but current studies are limited by a<br />
general lack <strong>of</strong> long-term followup <strong>and</strong> analyses to explore differences in response among<br />
subgroups. Studies may also have used compounded forms <strong>of</strong> beta-blockers, which may add to<br />
the complexity <strong>of</strong> interpreting dosage amounts. Few comparative studies addressed steroids, <strong>and</strong><br />
indications for steroid treatment compared with beta-blockers are unclear. Few comparative<br />
studies addressed surgical approaches besides laser modalities, <strong>and</strong> those addressing lasers used<br />
different interventions <strong>and</strong> comparators, limiting comparisons across studies. Technological<br />
advances have also changed the indications for treatment, <strong>and</strong> a historical trend towards treating<br />
smaller, less severe lesions, similarly make analyses difficult because <strong>of</strong> changing indications for<br />
<strong>and</strong> expectations <strong>of</strong> treatment.<br />
Studies are also limited by the use <strong>of</strong> multiple <strong>and</strong> variable outcome measures to assess<br />
resolution <strong>of</strong> lesions. As no objective lab value or other measures exist to determine size<br />
changes, investigators have developed multiple techniques, <strong>and</strong> studies did not always report<br />
scales or other approaches clearly. The variety <strong>of</strong> scales (e.g., percentage change, mean change,<br />
visual analog scale, hemangioma activity score) make combining outcomes challenging.<br />
Similarly, studies typically included multiple lesion types in multiple locations, which<br />
complicates determining potential differences in response , <strong>and</strong> treatment approaches varied<br />
across studies (e.g., doses <strong>and</strong> dosage forms, level <strong>of</strong> patient monitoring, timing <strong>of</strong> treatment <strong>and</strong><br />
followup).<br />
The most important deficiency in the reported outcomes across studies is the tendency for<br />
the reporting <strong>of</strong> discretized outcomes, when the underlying outcome is a continuous variable.<br />
Specifically, though outcomes are likely recorded as a continuous measure (i.e., the proportion <strong>of</strong><br />
an existing lesion that is cleared or reduced in size following treatment), authors <strong>of</strong>ten chose an<br />
arbitrary cut<strong>of</strong>f proportion (or a small number <strong>of</strong> bins) <strong>and</strong> reported only the numbers in each <strong>of</strong><br />
the resulting categories. This results in an immediate <strong>and</strong> unrecoverable loss in power for any<br />
ES-28
quantitative meta-analyses. Researchers should be encouraged to report outcome variables as<br />
they were recorded, without transforming them in such a way that information is lost. In<br />
addition, methods for measurement <strong>of</strong> outcomes such as rebound growth are not clearly reported;<br />
thus, our underst<strong>and</strong>ing <strong>of</strong> the magnitude <strong>of</strong> regrowth is limited.<br />
Implications for Clinical <strong>and</strong> Policy Decisionmaking<br />
This review provides evidence for use in clinical care <strong>of</strong> children who present with IH. It<br />
particularly points to moderate benefits with steroid treatment <strong>and</strong> greater improvements with<br />
beta-blockers, with propranolol being the most commonly studied. When a decision to treat is<br />
made, our review provides qualitative <strong>and</strong> quantitative evidence that beta-blockers are associated<br />
with substantial improvement in IH size/volume (mean expected clearance rate <strong>of</strong> 95% for oral<br />
propranolol [95% BCI: 88% to 99%] <strong>and</strong> 62% [95% BCI: 39% to 83%] for topical timolol<br />
compared with 6% for observation/placebo arms [95% BCI: 1% to 11%]).<br />
Steroids were associated with mean expected clearance rates <strong>of</strong> 43 percent for oral steroids<br />
(95% BCI: 21% to 66%) <strong>and</strong> 58 percent (95% BCI: 22% to 99%) for intralesional triamcinolone<br />
in our network meta-analysis, but side effects are significant, <strong>and</strong> clinicians <strong>and</strong> families will<br />
need to weigh the benefits <strong>and</strong> harms.<br />
It is important for clinicians to know that the literature summarized here primarily examines<br />
children with problematic or complicated IH <strong>and</strong> thus may not apply to all patients. In one large<br />
trial evaluating active treatment with propranolol for children without problematic IH,<br />
propranolol was associated with complete resolution or near complete resolution in 60 percent <strong>of</strong><br />
cases (vs. 4% in placebo arm). In addition, studies typically reported outcomes only in the short<br />
term (
Given the lack <strong>of</strong> long-term data on harms <strong>of</strong> interventions, clinicians <strong>and</strong> families must<br />
balance the potential <strong>of</strong> both short- <strong>and</strong> long-term harms with the benefits <strong>of</strong> potential resolution<br />
or size reduction <strong>of</strong> lesions.<br />
Research Gaps<br />
While a growing number <strong>of</strong> comparative studies address treatments for IH, a number <strong>of</strong><br />
research gaps exist. These gaps include a lack <strong>of</strong> information on:<br />
• Indications, optimal timing, <strong>and</strong> optimal modalities for imaging <strong>and</strong> diagnostic<br />
approaches. Few studies in the literature we reviewed reported imaging or diagnostic<br />
techniques, <strong>and</strong> data on optimal approaches for each are lacking in the current research<br />
base. In general, imaging is infrequently used to differentiate accurately an IH from other<br />
vascular lesions. When a diagnosis is in question, a tissue biopsy is the most accurate<br />
method to determine the diagnosis. Future studies should use imaging modalities at the<br />
same point in the IH course to allow direct comparison. Studies should also report<br />
adverse effects <strong>of</strong> imaging, which are not addressed in the literature meeting criteria for<br />
this review.<br />
• Indications for treatment <strong>and</strong> treatment referral. While it is likely that non-placebocontrolled<br />
studies reviewed here included mostly children with problematic IH (e.g.,<br />
lesions that are vision-threatening or disfiguring, ulcerated lesions, airway/lifethreatening<br />
lesions), studies did not always clearly report indications for treatment or<br />
referral for treatment. Children may be referred for life-, functional-, or visionthreatening<br />
reasons, but in the beta-blocker era, potential disfigurement is likely a cause<br />
for referral.<br />
• Appropriate dosing for propranolol <strong>and</strong> timing <strong>of</strong> treatment. The largest RCT to<br />
date 28 used doses <strong>of</strong> either 1 mg/kg or 3 mg/kg, but other studies typically used doses <strong>of</strong><br />
2-2.5 mg/kg, <strong>and</strong> ages <strong>of</strong> children <strong>and</strong> number, severity, <strong>and</strong> type <strong>of</strong> lesions varied among<br />
study populations. Existing studies do not provide data to determine optimal dosing.<br />
Similarly, few studies reported on resolution outcomes by phase (i.e., proliferative,<br />
involution). Studies likely included mostly children in the proliferative phase, but the<br />
effectiveness <strong>of</strong> propranolol during the involution phase is not clear. Similarly, because<br />
proliferation may occur up to <strong>and</strong> after 12 months <strong>of</strong> age, the effectiveness <strong>of</strong> starting<br />
beta-blockers in older children is not clear.<br />
• Optimal duration <strong>of</strong> beta-blocker use. Duration <strong>of</strong> propranolol treatment ranged from 3<br />
to 13 months in comparative studies, but the optimal duration <strong>of</strong> treatment is not clear.<br />
Studies generally treated children for 6 months, potentially so that effects observed were<br />
likely drug-related <strong>and</strong> not the result <strong>of</strong> natural involution. However, current studies have<br />
not addressed the question <strong>of</strong> optimal timing to achieve maximal benefit.<br />
• Long-term outcomes <strong>and</strong> harms <strong>of</strong> beta-blockers. While harms reported in studies <strong>of</strong><br />
beta-blockers were typically not severe, only one comparative study 29 had greater than 6<br />
months followup after the end <strong>of</strong> treatment. Longer term effects on cardiovascular <strong>and</strong><br />
metabolic parameters known to be affected by beta-blocker use as well as effects on<br />
cognition, memory, <strong>and</strong> the central nervous system are not well-understood in the<br />
population <strong>of</strong> very young children receiving beta-blockers for IH. 30<br />
• Treatment choice for specific lesion types <strong>and</strong> locations. Characteristics, such as lesion<br />
size, location, <strong>and</strong> persistence, as well as modifiers such as patient age, functional impact,<br />
<strong>and</strong> IH subtype influence whether children are treated with pharmacologic agents or<br />
ES-30
surgically. Lesion characteristics also influence the choice <strong>of</strong> specific pharmacologic<br />
agents. Most studies included multiple lesion types <strong>and</strong> in multiple locations, <strong>and</strong> few<br />
included specific modifier analyses or reported outcomes by lesion characteristics.<br />
Research to improve underst<strong>and</strong>ing <strong>of</strong> which lesions are likely to respond best to specific<br />
agents is critical, especially as underst<strong>and</strong>ing <strong>of</strong> the effectiveness <strong>of</strong> beta-blockers in the<br />
involution phase is limited. Optimal treatment in the proliferative phase may be key to<br />
maximal resolution <strong>of</strong> IH.<br />
• Assessment <strong>of</strong> methods for assessing rebound growth. A number <strong>of</strong> studies reported<br />
regrowth <strong>of</strong> lesions but typically did not indicate what constituted rebound growth.<br />
Greater clarity in reporting this outcome would help to clarify our underst<strong>and</strong>ing <strong>of</strong><br />
effectiveness.<br />
• Characteristics that may influence response to beta-blockers. Studies <strong>of</strong> beta-blockers<br />
were typically not powered to provide information on subgroups, but a percentage <strong>of</strong><br />
children did not respond or responded minimally to propranolol. In 10 comparative<br />
studies <strong>of</strong> beta-blockers reporting these data, 15,29,31-39 20 percent <strong>of</strong> children (n=63/314)<br />
had a limited or no response to the agent. We lack data to assess whether improvement in<br />
lesions or promotion <strong>of</strong> involution is affected by child age or number, severity, type, or<br />
anatomic location <strong>of</strong> lesions. Similarly, underst<strong>and</strong>ing the mechanisms <strong>of</strong> growth <strong>of</strong> IH<br />
will promote our underst<strong>and</strong>ing <strong>of</strong> response to treatments <strong>and</strong> treatment safety.<br />
• Use <strong>of</strong> beta-blockers other than propranolol. Small cohort studies <strong>of</strong> oral atenolol <strong>and</strong><br />
nadolol <strong>and</strong> topical or ophthalmic timolol showed positive effects on IH resolution with<br />
few side effects. Additional RCTs <strong>of</strong> these agents, with clear reporting <strong>of</strong> lesion<br />
parameters <strong>and</strong> child characteristics, would increase our underst<strong>and</strong>ing <strong>of</strong> their<br />
effectiveness <strong>and</strong> comparative effectiveness versus propranolol.<br />
• Treatments for hepatic IH. Few treatment studies explicitly reported if children had<br />
hepatic IH. Most studies included children with IH in multiple locations, so children<br />
could have had hepatic IH as well; however, the applicability <strong>of</strong> findings to children with<br />
visceral IH is not clear.<br />
• Use <strong>of</strong> steroids <strong>and</strong> laser treatments in the beta-blocker era. Clinical practice in the<br />
United States is moving toward use <strong>of</strong> a beta-blocker as the first-line treatment for IH; 40<br />
however, a number <strong>of</strong> recent studies report use <strong>of</strong> steroids <strong>and</strong> laser treatments in younger<br />
children with lesions in the proliferative stage. Given the side effect pr<strong>of</strong>ile <strong>of</strong> steroids,<br />
underst<strong>and</strong>ing <strong>of</strong> whether or when to use such agents in the absence <strong>of</strong> life-threatening<br />
lesions or contraindications to beta-blockers is needed. Current literature does not provide<br />
sufficient data to address these questions.<br />
• Interventions to follow beta-blockers or corticosteroids if such treatments fail. We<br />
did not identify any studies that clearly reported data on this question. While most<br />
children receiving beta-blockers in the studies reviewed here responded to the<br />
medication, some had no or minimal response.<br />
• St<strong>and</strong>ardization <strong>of</strong> scoring tools to assess change in IH. IH outcomes are necessarily<br />
assessed using subjective measures, <strong>and</strong> investigators typically reported grading scales<br />
used to assess change in IH size or appearance. Few studies, however, commented on<br />
interrater reliability <strong>of</strong> instruments. Research to improve st<strong>and</strong>ardization among tools <strong>and</strong><br />
the development <strong>of</strong> uniform scoring systems <strong>and</strong> measurements would improve our<br />
ability to combine outcomes across studies.<br />
ES-31
• St<strong>and</strong>ardization <strong>of</strong> nomenclature. Data extraction <strong>and</strong> comparisons in the review were<br />
limited by inconsistent naming conventions. Agreement <strong>and</strong> adherence to a st<strong>and</strong>ard<br />
classification <strong>of</strong> lesions would improve the ability <strong>of</strong> researchers to focus on individual<br />
lesion types <strong>and</strong> determine optimal treatment regimens for specific lesions.<br />
Conclusions<br />
Corticosteroids demonstrate some effectiveness at reducing IH size/volume, but may be<br />
associated with significant side effects. Propranolol is effective at reducing the size <strong>of</strong> IH, with<br />
high strength <strong>of</strong> evidence for effects on reducing lesion size, <strong>and</strong> compared with placebo,<br />
observation, <strong>and</strong> other treatment methods including steroids in most, but not all, studies. In a<br />
network meta-analysis, the largest mean estimate <strong>of</strong> expected clearance was for oral propranolol<br />
(95%, 95% BCI: 88% to 99%), followed by timolol (62%, 95% BCI: 39% to 83%) <strong>and</strong><br />
triamcinolone (58%, 95% BCI: 22% to 93%). The mean rate was 43 percent for oral steroids<br />
(95% BCI: 21% to 66%). With fairly wide confidence bounds <strong>and</strong> limited data in some areas, the<br />
relative differences among these estimates are <strong>of</strong> greater importance than the absolute effects.<br />
The estimates provide a relative ranking <strong>of</strong> anticipated rates <strong>of</strong> lesion clearance among treatment<br />
options. Families <strong>and</strong> clinicians making treatment decisions should also factor in elements such<br />
as lesion size, location, type, <strong>and</strong> number, which may affect choice <strong>of</strong> treatment modality, as well<br />
as patient/family preferences. Evidence pointed to substantial side effects for corticosteroids;<br />
harms were also noted with beta-blockers, but overall, these were well tolerated in the short term.<br />
Few studies have assessed potential long-term harms associated with beta-blocker use in infants<br />
<strong>and</strong> children. Laser studies generally found PDL more effective than other types <strong>of</strong> laser, but<br />
effects remain unclear as studies are heterogeneous <strong>and</strong> the role <strong>of</strong> laser vis-a-vis beta-blockers is<br />
not clearly described in the literature. Data are inadequate to address the role <strong>of</strong> imaging in<br />
guiding treatment.<br />
ES-32
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trial to assess the efficacy <strong>of</strong><br />
propranolol for treating infantile<br />
hemangiomas <strong>and</strong> for determining the<br />
decline in heart rate to predict response to<br />
propranolol. J Pediatr Hematol Oncol 2013<br />
Oct;35(7):493-9. PMID: 23929318.<br />
37. Reddy KK, Blei F, Brauer JA, et al.<br />
Retrospective study <strong>of</strong> the treatment <strong>of</strong><br />
infantile hemangiomas using a combination<br />
<strong>of</strong> propranolol <strong>and</strong> pulsed dye laser.<br />
Dermatol Surg 2013 Jun;39(6):923-33.<br />
PMID: 23458381.<br />
38. Awadein A, Fakhry MA. Evaluation <strong>of</strong><br />
intralesional propranolol for periocular<br />
capillary hemangioma. Clin Ophthalmol<br />
2011;5(1):1135-40. PMID: 2011458331.<br />
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39. Yu L, Li S, Su B, et al. Treatment <strong>of</strong><br />
superficial infantile hemangiomas with<br />
timolol: Evaluation <strong>of</strong> short-term efficacy<br />
<strong>and</strong> safety in infants. Exp Ther Med 2013<br />
August;6(2):388-90. PMID: 2013417689.<br />
40. Drolet BA, Frommelt PC, Chamlin SL, et al.<br />
Initiation <strong>and</strong> use <strong>of</strong> propranolol for infantile<br />
hemangioma: report <strong>of</strong> a consensus<br />
conference. Pediatrics 2013 Jan;131(1):128-<br />
40. PMID: 23266923.<br />
ES-35
Introduction<br />
Background<br />
<strong>Infantile</strong> hemangiomas (IH) are the most common tumors <strong>of</strong> childhood. IH are benign but<br />
possess potential for local tissue damage, ulceration, infection, bleeding, functional impact, <strong>and</strong><br />
pain. The International Society for the Study <strong>of</strong> Vascular Anomalies classifies IH as vascular<br />
tumors that are differentiated from vascular malformations in several ways including natural<br />
history, cellular composition, immunohistochemical expression, <strong>and</strong> pathology. 1 Due to<br />
historical inconsistencies in naming conventions, it is difficult to know the true prevalence <strong>of</strong> IH,<br />
but it is estimated that they affect about 4 to 5 percent <strong>of</strong> children, 2 with higher prevalence in<br />
females <strong>and</strong> Caucasians. 3,4 The most common locations <strong>of</strong> IH are the head, neck, <strong>and</strong> trunk, but<br />
they can occur almost anywhere throughout the body, including the extremities, the spine, <strong>and</strong><br />
visceral organs. 5-7 IH also can be associated with a constellation <strong>of</strong> congenital anomalies such as<br />
PHACES (posterior fossa malformations, hemangiomas, arterial anomalies, cardiac defects, eye<br />
abnormalities, sternal cleft <strong>and</strong> supraumbilical raphe) PELVIS (perineal hemangioma, external<br />
genitalia malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate anus,<br />
<strong>and</strong> skin tag) <strong>and</strong> LUMBAR (lower-body hemangioma <strong>and</strong> other cutaneous defects, urogenital<br />
anomalies, ulceration, myelopathy, bony deformities, anorectal malformations, arterial<br />
anomalies, <strong>and</strong> renal anomalies) syndromes.<br />
IH tend to go through growth <strong>and</strong> involution phases, although the complete natural history <strong>of</strong><br />
IH has not been described. In most children, IH will become apparent in the first few weeks <strong>of</strong><br />
life <strong>and</strong> reach 80 percent <strong>of</strong> total size by around 3 to 5 months. 8,9 With expectant observation,<br />
many patients may experience a complete or near complete involution without significant<br />
sequelae; however, IH frequently occur in cosmetically <strong>and</strong> functionally sensitive areas. Even<br />
with complete involution, some patients have permanent disfigurement <strong>and</strong> functional<br />
compromise. 10 Early assessment <strong>of</strong> the extent <strong>of</strong> the hemangioma, <strong>and</strong> early, appropriate<br />
treatment <strong>of</strong> IH may potentially mitigate these complications; however, in one large multicenter<br />
treatment analysis, the first specialist visit for infants <strong>and</strong> children in the study did not occur until<br />
a mean <strong>of</strong> 5 months <strong>of</strong> age. 9<br />
Furthermore, some lesions are particularly aggressive or morbid <strong>and</strong> can cause severe pain,<br />
ulceration, <strong>and</strong> bleeding even in early stages. 11,12 The rapid growth <strong>of</strong> IH leaves little time for<br />
prospective observation to determine which IH will lead to complications <strong>and</strong> require specialist<br />
attention <strong>and</strong> treatment before complications begin to manifest. Some types <strong>of</strong> IH, specifically<br />
segmental IH such as those associated with related syndromes like PHACES, LUMBAR, or<br />
PELVIS, are recognized as high risk, but no consensus exists on which non-segmental lesions<br />
warrant referral for appropriate treatment to mitigate future complications (e.g., bleeding,<br />
ulceration) <strong>of</strong> the hemangioma or long-term sequelae (e.g., scarring, anatomical disfigurement,<br />
functional complications). 5,7,13<br />
<strong>Diagnosis</strong> <strong>and</strong> Treatment Decisions<br />
Evaluation through the use <strong>of</strong> various diagnostic imaging modalities has generally been<br />
reserved for deep lesions to help underst<strong>and</strong> their extent or to confirm the diagnosis <strong>of</strong> IH. Purely<br />
cutaneous lesions do not require imaging, but opinions regarding the initial diagnostic test <strong>of</strong><br />
choice for more extensive IH, including deep, segmental, <strong>and</strong> syndromic lesions, are conflicting.<br />
Furthermore, different disease sites or extents may be best h<strong>and</strong>led with different imaging<br />
1
modalities. The questions <strong>of</strong> imaging necessity <strong>and</strong> type are especially important because many<br />
imaging studies in infants <strong>of</strong>ten require general anesthesia <strong>and</strong> may be associated with adverse<br />
effects. Modalities such as computed tomography also involve exposure to radiation.<br />
Specific disease characteristics, such as lesion size, location, rate <strong>of</strong> growth, <strong>and</strong> persistence<br />
as well as modifiers such as patient age, functional impact, <strong>and</strong> IH subtype influence whether<br />
children are treated with pharmacologic agents or surgically. Many lesions can be treated with<br />
pharmacologic agents; however, refractory lesions that possess immediate risk for morbidity or<br />
mortality, such as hemangiomas obstructing the airway or visual axis, may require more<br />
immediate surgical intervention. Lesion characteristics such as size, location, <strong>and</strong> type (e.g.,<br />
superficial, deep) also influence the choice <strong>of</strong> specific pharmacologic agents. For example, small,<br />
superficial lesions may respond well to topical agents such as timolol, while deep lesions are less<br />
likely to respond. 14 Both medical <strong>and</strong> surgical treatment paradigms contain significant variability<br />
<strong>and</strong> lack <strong>of</strong> consensus.<br />
Contraindications to specific treatments vary. Contraindications to beta-blockers include<br />
asthma, significant bradycardia, heart block, concurrent illness such s viral gastroenteritis or<br />
respiratory infection, history <strong>of</strong> reactive airway disease, <strong>and</strong> hypoglycemia. 15 Contraindications<br />
to steroids include diabetes, chronic or untreated infections, decreased bone density,<br />
immunodeficiency, <strong>and</strong> active wound healing, <strong>and</strong> contraindications to surgical approaches<br />
include personal or family history <strong>of</strong> adverse reactions to anesthesia.<br />
In many cases <strong>of</strong> IH, early referral <strong>and</strong> intervention are crucial to a satisfactory outcome,<br />
such as ocular IH disrupting the development <strong>of</strong> neural pathways during infancy. Further, some<br />
lesions, such as nasal tip IH, may cause permanent structural changes to adjacent structures. This<br />
may result in severe functional <strong>and</strong> disfiguring sequelae, even with complete resolution <strong>of</strong> the IH<br />
itself. In addition to structural damage, the psychological complications <strong>of</strong> having facial<br />
differences must be considered when determining the need for referral or treatment. While wellrecognized<br />
clinical signs such as ulceration, airway obstruction, or vision-threatening<br />
involvement indicate need for urgent referral, there are no discrete guidelines that help direct<br />
primary care providers when to refer patients with IH for subspecialty care.<br />
Interventions<br />
The beta-blocker propranolol was approved by the U.S. Food <strong>and</strong> Drug Administration<br />
(FDA) for use in IH in March 2014. 16-18 Propranolol was historically used in children for cardiac<br />
conditions <strong>and</strong> <strong>of</strong>f-label to treat IH after the serendipitous discovery <strong>of</strong> its effects on IH lesions in<br />
2008. 19 Prior to this, corticosteroids were the drug <strong>of</strong> choice, but propranolol has become the<br />
typical choice for initial medical management in children without contraindications to betablockers.<br />
Steroids may be used in children with contraindications to beta-blockers or who do not<br />
respond to beta-blockers. Additionally, there is no clear consensus as to when alternative or<br />
adjunctive or historically used medications such as chemotherapeutic drugs are appropriate if<br />
first-line treatment is unsuccessful. 20,21<br />
Surgical interventions for IH can be used for primary management <strong>of</strong> high risk lesions <strong>and</strong><br />
include resection or ablation using laser or radi<strong>of</strong>requency. Some confusion <strong>and</strong> disagreement<br />
exists about what type <strong>of</strong> surgical treatment to use, when in the disease course to treat, <strong>and</strong> how<br />
the disease site informs treatment decisions. Interventions for IH are varied, involved, <strong>and</strong> not<br />
without risk (e.g., risk <strong>of</strong> permanent hypopigmentation, scarring from pulsed dye laser therapy,<br />
potential harms <strong>of</strong> anesthesia); therefore, universal treatment is not recommended. 22<br />
2
Scope <strong>and</strong> Key Questions<br />
Scope <strong>of</strong> Review<br />
This systematic review addresses the evidence for benefits <strong>and</strong> harms <strong>of</strong> commonly used<br />
treatments for children (ages 0-18 years) with IH: beta-blockers, corticosteroids, “second-line”<br />
drugs used after the failure <strong>of</strong> beta-blockers or steroids, <strong>and</strong> laser <strong>and</strong> surgical treatment. The<br />
decisional dilemmas that this review addresses are whether imaging modalities are useful both in<br />
diagnosis <strong>and</strong> for guiding treatment, <strong>and</strong> the expected comparative effectiveness (benefits <strong>and</strong><br />
harms) <strong>of</strong> pharmacologic <strong>and</strong> surgical treatments, relative to observation or other active<br />
treatments. While pharmacologic <strong>and</strong> surgical interventions cannot be directly compared because<br />
<strong>of</strong> their inherent confounding by indication, we assess the comparative effectiveness <strong>of</strong> different<br />
options within both pharmacologic <strong>and</strong> surgical approaches.<br />
We include both contextual <strong>and</strong> Key Questions. We systematically reviewed <strong>and</strong> assessed the<br />
risk <strong>of</strong> bias <strong>of</strong> the literature meeting our inclusion criteria for Key Questions, which address the<br />
comparative effectiveness <strong>of</strong> interventions. We provide a narrative review <strong>of</strong> relevant literature<br />
for contextual questions as few effectiveness studies address these questions, which are related to<br />
natural history <strong>of</strong> IH <strong>and</strong> markers for occult IH.<br />
Key Questions<br />
Key Questions (KQs) <strong>and</strong> Contextual Questions (CQs) were developed in consultation with<br />
Key Informants <strong>and</strong> the Task Order Officer <strong>and</strong> were posted for review to the AHRQ Effective<br />
Health Care Web site. Questions were as follows:<br />
CQ1. What is known about the natural history <strong>of</strong> infantile hemangiomas, by<br />
hemangioma site <strong>and</strong> subtype? What are the adverse outcomes <strong>of</strong><br />
untreated infantile hemangiomas? What characteristics <strong>of</strong> the hemangioma<br />
(e.g., subtype, size, location, number <strong>of</strong> lesions) indicate risk <strong>of</strong> significant<br />
medical complications that would prompt immediate medical or surgical<br />
intervention?<br />
CQ2. What is the evidence that five or more cutaneous hemangiomas are<br />
associated with an increased risk <strong>of</strong> occult hemangiomas?<br />
KQ1. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
known or suspected infantile hemangiomas, what is the comparative<br />
effectiveness (benefits/harms) <strong>of</strong> various imaging modalities for identifying<br />
<strong>and</strong> characterizing hemangiomas?<br />
a. Does the comparative effectiveness differ by location <strong>and</strong> subtype <strong>of</strong><br />
the hemangioma?<br />
3
KQ2. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
infantile hemangiomas who have been referred for pharmacologic<br />
intervention, what is the comparative effectiveness (benefits/harms) <strong>of</strong><br />
corticosteroids or beta-blockers?<br />
KQ3. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
infantile hemangiomas for whom treatment with corticosteroids or betablockers<br />
is unsuccessful what is the comparative effectiveness <strong>of</strong> second<br />
line therapies including immunomodulators <strong>and</strong> angiotensin-converting<br />
enzyme inhibitors?<br />
KQ4. Among newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with<br />
infantile hemangiomas who have been referred for surgical intervention,<br />
what is the comparative effectiveness (benefits/ harms) <strong>of</strong> various types <strong>of</strong><br />
surgical interventions (including laser <strong>and</strong> resection)?<br />
Analytic Framework<br />
The analytic frameworks illustrate the population, interventions, <strong>and</strong> outcomes that guided<br />
the literature search <strong>and</strong> synthesis (Figures 1-3). The frameworks depict the Key Questions<br />
within the context <strong>of</strong> the population, intervention, comparator, outcomes, timing, <strong>and</strong> setting<br />
(PICOTS) parameters described in the review. In general, the figures illustrate how imaging<br />
modalities or interventions such as magnetic resonance imaging (MRI), beta-blockers, or laser<br />
may result in intermediate outcomes such as change in hemangioma size or change in vision<br />
<strong>and</strong>/or in final health outcomes such as detection <strong>of</strong> IH for imaging modalities or resolution <strong>of</strong><br />
hemangioma or changes in quality <strong>of</strong> life for medical or surgical treatments. Also, adverse events<br />
may occur at any point after the intervention is received.<br />
Figure 1. Analytic framework for KQ1<br />
IH = infantile hemangioma; KQ = Key Question<br />
4
Figure 2. Analytic framework for KQ2 <strong>and</strong> KQ3<br />
IH = infantile hemangioma; KQ = Key Question<br />
Figure 3. Analytic framework for KQ4<br />
IH = infantile hemangioma; KQ = Key Question; Nd:YAG = neodymium yttrium aluminum garnet<br />
Organization <strong>of</strong> This Report<br />
The Methods section describes the review processes including search strategy, inclusion <strong>and</strong><br />
exclusion criteria, approach to review <strong>of</strong> abstracts <strong>and</strong> full publications, methods for extraction<br />
5
<strong>of</strong> data, <strong>and</strong> compiling evidence. We also describe our approach to grading the quality <strong>of</strong> the<br />
literature <strong>and</strong> describing the strength <strong>of</strong> the body <strong>of</strong> evidence.<br />
The Results section presents the findings <strong>of</strong> the literature search <strong>and</strong> the review <strong>of</strong> the<br />
evidence by Key Question, synthesizing the findings across strategies. We present findings for<br />
the Contextual Questions followed by findings <strong>of</strong> the network meta-analysis, followed by<br />
findings for each Key Question organized by intervention <strong>and</strong> outcome area where possible.<br />
Summary tables for each Key Question outline key outcomes.<br />
The Discussion section <strong>of</strong> the report discusses the results <strong>and</strong> exp<strong>and</strong>s on methodologic<br />
considerations relevant to each Key Question. We also outline the current state <strong>of</strong> the literature<br />
<strong>and</strong> challenges for future research in the field. The report includes a number <strong>of</strong> appendices to<br />
provide further detail on our methods <strong>and</strong> the studies assessed. The appendices are as follows:<br />
• Appendix A: Search Strategies<br />
• Appendix B: Screening <strong>and</strong> Quality Assessment Forms<br />
• Appendix C: Excluded Studies<br />
• Appendix D: Methods for Network Meta-Analysis<br />
• Appendix E: Study Design Classification Algorithm<br />
• Appendix F: Quality/Risk <strong>of</strong> Bias Ratings<br />
• Appendix G: Applicability Tables<br />
• Appendix H: Harms Reported in Package Insert Data <strong>and</strong> Other Sources<br />
We also provide a list <strong>of</strong> abbreviations <strong>and</strong> acronyms at the end <strong>of</strong> the report.<br />
Uses <strong>of</strong> This Evidence Report<br />
We anticipate this report will be <strong>of</strong> primary value to organizations that develop guidelines for<br />
managing IH, to clinicians who provide care for children with IH, <strong>and</strong> for families making<br />
treatment decisions. IH is diagnosed <strong>and</strong> treated by clinicians including pediatricians,<br />
dermatologists, otolaryngologists, family physicians, nurses, nurse-practitioners, physician<br />
assistants, hematologists, <strong>and</strong> general <strong>and</strong> plastic surgeons. This report supplies practitioners <strong>and</strong><br />
researchers up-to-date information about the current state <strong>of</strong> evidence, <strong>and</strong> assesses the quality <strong>of</strong><br />
studies that aim to determine the outcomes <strong>and</strong> safety <strong>of</strong> treatments for IH.<br />
Researchers can obtain a concise analysis <strong>of</strong> the current state <strong>of</strong> knowledge <strong>of</strong> interventions<br />
in this field. They will be poised to pursue further investigations that are needed to advance<br />
research methods, develop new treatment strategies, <strong>and</strong> optimize the effectiveness <strong>and</strong> safety <strong>of</strong><br />
clinical care for children with this condition.<br />
6
Methods<br />
In this chapter, we document the procedures that this Evidence-based Practice Center (EPC)<br />
used to produce a comparative effectiveness review (CER) on approaches to treatment <strong>of</strong><br />
infantile hemangioma (IH). These procedures follow the methods outlined in the Agency for<br />
Healthcare Research <strong>and</strong> Quality (AHRQ) Effective Health Care Program “Methods Guide for<br />
Effectiveness <strong>and</strong> Comparative Effectiveness Reviews.” 23<br />
Topic Refinement <strong>and</strong> Review Protocol<br />
The topic for this report was nominated by the American Academy <strong>of</strong> Pediatrics in a public<br />
process using the Effective Health Care Program Web site. Working from the nomination, we<br />
drafted the initial Key Questions (KQ) <strong>and</strong> Contextual Questions (CQ) <strong>and</strong> analytic framework<br />
<strong>and</strong> refined them with input from key informants representing the fields <strong>of</strong> pediatrics,<br />
dermatology, otolaryngology, vascular anomalies, surgery, <strong>and</strong> patient advocacy. All members<br />
<strong>of</strong> the research team were required to submit information about potential conflicts <strong>of</strong> interest<br />
before initiation <strong>of</strong> the work. No members <strong>of</strong> the review team had any conflicts.<br />
After review from the AHRQ, the questions <strong>and</strong> framework were posted online for public<br />
comment. No changes to the questions or framework were recommended. We also developed<br />
population, interventions, outcomes, timing, <strong>and</strong> settings (PICOTS) criteria for intervention KQ.<br />
We identified technical experts on the topic to provide assistance during the project. The<br />
Technical Expert Panel (TEP), representing the fields <strong>of</strong> pediatrics, pediatric dermatology,<br />
otolaryngology, surgery, vascular anomalies, hematology/oncology, <strong>and</strong> pediatric cardiology,<br />
contributed to the AHRQ’s broader goals <strong>of</strong> (1) creating <strong>and</strong> maintaining science partnerships as<br />
well as public-private partnerships <strong>and</strong> (2) meeting the needs <strong>of</strong> an array <strong>of</strong> potential users <strong>of</strong> its<br />
products. Thus, the TEP was both an additional resource <strong>and</strong> a sounding board during the<br />
project. The TEP included seven members serving as technical or clinical experts. To ensure<br />
robust, scientifically relevant work, TEP members participated in conference calls <strong>and</strong><br />
discussions through e-mail to:<br />
• Help to refine the analytic framework <strong>and</strong> KQ at the beginning <strong>of</strong> the project; <strong>and</strong><br />
• Discuss inclusion/exclusion criteria.<br />
The final protocol was posted to the AHRQ Effective Health Care web site <strong>and</strong> registered in<br />
the PROSPERO international register <strong>of</strong> systematic reviews (ID#: CRD42015015765).<br />
Literature Search Strategy<br />
Search Strategy<br />
To ensure comprehensive retrieval <strong>of</strong> relevant studies <strong>of</strong> therapies for children with IH, we<br />
used three key databases: the MEDLINE ® medical literature database via the PubMed ® interface,<br />
the Cumulative Index <strong>of</strong> Nursing <strong>and</strong> Allied Health Literature (CINAHL ® ), <strong>and</strong> EMBASE<br />
(Excerpta Medica Database), an international biomedical <strong>and</strong> pharmacological literature database<br />
via the Ovid ® interface. Search strategies for Key Questions applied a combination <strong>of</strong> controlled<br />
vocabulary (Medical Subject Headings [MeSH], CINAHL medical headings, <strong>and</strong> Emtree<br />
headings) to focus specifically on management <strong>of</strong> IH <strong>and</strong> harms <strong>of</strong> interventions. We restricted<br />
literature searches for Key Questions to studies published from 1982 to the present to reflect the<br />
use <strong>of</strong> more st<strong>and</strong>ardized classification schema for IH. 24 We searched the same databases without<br />
date restrictions to identify contextual information.<br />
7
We only included studies published in English as a review <strong>of</strong> non-English citations retrieved<br />
by our MEDLINE search identified few studies <strong>of</strong> relevance. Appendix A lists our search terms<br />
<strong>and</strong> strategies <strong>and</strong> the yield from each database for both Key <strong>and</strong> Contextual Questions. Searches<br />
were last executed in June 2015.<br />
We carried out h<strong>and</strong> searches <strong>of</strong> the reference lists <strong>of</strong> recent systematic reviews or metaanalyses<br />
<strong>of</strong> therapies for IH. The investigative team also scanned the reference lists <strong>of</strong> studies<br />
included after the full-text review phase for additional studies that potentially could meet our<br />
inclusion criteria.<br />
Grey Literature<br />
AHRQ’s Scientific Resource Center requested Scientific Information Packets (SIPs) from<br />
companies that produce medications for management <strong>of</strong> infantile hemangioma (e.g., betablockers<br />
including propranolol, atenolol, <strong>and</strong> timolol; corticosteroids including prednisolone <strong>and</strong><br />
dexamethasone; imiquimod; interferon-alpha-2b; captopril; bleomycin; vinblastine; sodium<br />
tetradecyl sulfate; becaplermin); <strong>and</strong> devices for IH including pulsed dye lasers, Argon lasers,<br />
<strong>and</strong> neodymium yttrium aluminum garnet (Nd:YAG) lasers <strong>and</strong> searched for regulatory data for<br />
medications. We also searched ClinicalTrials.gov to assess reporting bias <strong>and</strong> to identify any<br />
study results that may not have been identified in our other database searches. We also searched<br />
the Web sites <strong>of</strong> relevant organizations <strong>and</strong> associations (e.g., American Academy <strong>of</strong> Pediatrics,<br />
Vascular Birthmarks Foundation) to identify relevant contextual information. We searched the<br />
U.S. Food <strong>and</strong> Drug Administration web site <strong>and</strong> package insert data for information on harms <strong>of</strong><br />
medications for IH. We applied the inclusion criteria described above <strong>and</strong> in Table 1 to studies<br />
identified via our grey literature searches.<br />
Inclusion <strong>and</strong> Exclusion Criteria<br />
Table 1 lists the inclusion/exclusion criteria we used based on our underst<strong>and</strong>ing <strong>of</strong> the<br />
literature, key informant <strong>and</strong> public comment during the topic-refinement phase, input from the<br />
TEP, <strong>and</strong> established principles <strong>of</strong> systematic review methods. We limited our searches for<br />
comparative effectiveness questions to studies published in English <strong>and</strong> from 1982 to the present<br />
for studies <strong>of</strong> the effectiveness <strong>of</strong> treatments. We also excluded studies evaluating multiple lesion<br />
types (e.g., cavernous hemangioma, hemangioblastoma, vascular malformations, noninvoluting<br />
congenital hemangiomas) unless we could clearly extract data pertaining to children with IH or if<br />
the majority <strong>of</strong> children had IH. We included studies with populations including individuals over<br />
age 18 if the majority <strong>of</strong> the participants were under age 18 or the mean age range was within 0<br />
to 18 years. To be included for KQ3 studies had to note explicitly that all children had received<br />
prior treatment with beta-blockers or steroids <strong>and</strong> were therefore receiving a second-line<br />
treatment following those agents. We also included case series with at least 25 children with IH<br />
to address harms but not effectiveness. We selected the lower bound <strong>of</strong> 25 as a conservative<br />
value based on a preliminary review <strong>of</strong> case series.<br />
8
Table 1. Inclusion criteria<br />
Category<br />
Criteria<br />
Study population<br />
Newborns, infants, <strong>and</strong> children up to 18 years <strong>of</strong> age with infantile hemangiomas or<br />
suspected infantile hemangiomas<br />
Publication languages English only<br />
Publication year 1966-present (CQ 1 <strong>and</strong> 2)<br />
1982-present (KQ 1, 2, 3, 4)<br />
Admissible evidence Admissible designs<br />
Original research studies providing sufficient detail regarding methods <strong>and</strong> results to<br />
enable use <strong>and</strong> aggregation <strong>of</strong> the data <strong>and</strong> results<br />
Contextual Questions (CQ):<br />
• Systematic <strong>and</strong> non-systematic reviews, articles reporting on the history <strong>of</strong> IH<br />
diagnosis or treatment, practice guidelines, meta-analyses, RCTs, case series<br />
with at least 25 children with IH, <strong>and</strong> any comparative studies<br />
Other criteria<br />
Comparative Effectiveness Key Questions (KQ):<br />
• Imaging accuracy: RCTs <strong>and</strong> any comparative studies<br />
• Benefits <strong>of</strong> interventions: RCTs <strong>and</strong> any comparative studies<br />
• Harms <strong>of</strong> interventions: RCTs, any comparative studies, <strong>and</strong> case series with<br />
at least 25 children with infantile hemangiomas<br />
Studies must address one or more <strong>of</strong> the following:<br />
• Diagnostic imaging (e.g., magnetic resonance imaging, computed tomography,<br />
magnetic resonance angiography, echocardiography, ultrasound, endoscopy)<br />
• Surgical interventions (e.g., cryotherapy, resection, embolization,<br />
radi<strong>of</strong>requency ablation therapy) or laser interventions (e.g., pulsed dye,<br />
fractionated laser, argon, carbon dioxide, neodymium (Nd): YAG, erbium)<br />
• Pharmacologic interventions (e.g., beta-blockers, corticosteroids,<br />
immunomodulators, immunosuppressants, angiotensin-converting enzyme<br />
inhibitors, antiangiogenic agents, antineoplastics)<br />
• Data (including harms) related to diagnostic modalities or interventions for<br />
infantile hemangiomas for the following outcomes:<br />
Imaging studies<br />
− Ability to identify presence, number, <strong>and</strong> extent <strong>of</strong> hemangiomas <strong>and</strong><br />
associated structural anomalies (sensitivity <strong>and</strong> specificity)<br />
− Harms<br />
Surgical or pharmacologic intervention studies<br />
− Size / volume <strong>of</strong> hemangioma<br />
− Impact on vision<br />
− Aesthetic appearance as assessed by clinician or parent<br />
− Degree <strong>of</strong> ulceration<br />
− Quality <strong>of</strong> life<br />
− Harms<br />
Relevant outcomes must be able to be abstracted from data in the papers<br />
Data must be presented in the aggregate (vs. individual participant data)<br />
CQ = contextual question, IH = infantile hemangioma, KQ = Key Question, Nd:YAG- = neodymium yttrium aluminum garnet,<br />
RCT = r<strong>and</strong>omized controlled trial<br />
Study Selection<br />
Once we identified articles through the electronic database searches <strong>and</strong> h<strong>and</strong>-searching, we<br />
examined abstracts <strong>of</strong> articles to determine whether studies met our criteria. Two reviewers<br />
separately evaluated the abstracts <strong>of</strong> studies identified in our searches for Key Questions for<br />
inclusion or exclusion, using an Abstract Review Form (Appendix B). If one reviewer concluded<br />
that the article could be eligible for the review based on the abstract, we retained it. Following<br />
abstract review, two reviewers independently assessed the full text <strong>of</strong> each included study using<br />
9
a st<strong>and</strong>ardized form (Appendix B) that included questions stemming from our<br />
inclusion/exclusion criteria. Disagreements between reviewers were resolved by a senior<br />
reviewer. Reviewers could flag studies that potentially addressed a Contextual Question<br />
identified in the screening process for Key Questions.<br />
We also screened studies identified in our separate database searches for studies potentially<br />
addressing Contextual Questions. We did not conduct dual screening <strong>of</strong> studies identified in our<br />
searches for Contextual Questions. If one reviewer determined that a study could be eligible, we<br />
assessed its relevance to the Contextual Questions. Excluded studies had no further analysis.<br />
All abstract <strong>and</strong> full text reviews were conducted using the DistillerSR online screening<br />
application (Evidence Partners Incorporated, Ottawa, Ontario). Appendix C includes a list <strong>of</strong><br />
excluded studies <strong>and</strong> the reasons for exclusion. Data extracted for each study are available via<br />
the Systematic Review Data Repository (http://srdr.ahrq.gov/).<br />
Data Extraction<br />
The staff members <strong>and</strong> clinical experts (including one otolaryngologist, one pediatric<br />
hematologist/oncologist, one pediatrician, one nurse practitioner, <strong>and</strong> two epidemiologists) who<br />
conducted this review jointly developed the data extraction forms for the Key Questions. We<br />
designed form to provide sufficient information to enable readers to underst<strong>and</strong> the studies <strong>and</strong> to<br />
determine their quality; we gave particular emphasis to essential information related to our Key<br />
Questions. We used two templates to facilitate the extraction <strong>of</strong> data based on study type; one<br />
form was designed for case series that reported harms data <strong>and</strong> one to accommodate all types <strong>of</strong><br />
comparative studies for effectiveness <strong>and</strong> harms data.<br />
The team was trained to extract data by extracting several articles into the template <strong>and</strong> then<br />
reconvening as a group to discuss the utility <strong>of</strong> the template. We repeated this process through<br />
several iterations until we decided that the templates included the appropriate categories for<br />
gathering the information contained in the articles <strong>and</strong> for potential meta-analyses. Team data<br />
extractors shared the task <strong>of</strong> initially entering information into the evidence tables. A second<br />
team member also reviewed the articles <strong>and</strong> edited all initial table entries for accuracy,<br />
completeness, <strong>and</strong> consistency. A senior reviewer reconciled disagreements concerning the<br />
information reported.<br />
The full research team met regularly during the article extraction period <strong>and</strong> discussed issues<br />
related to the data extraction process (e.g., determining instances <strong>of</strong> IH vs. other lesions). In<br />
addition to outcomes related to imaging or intervention effectiveness (sensitivity <strong>and</strong> specificity,<br />
change in lesion size, resolution, aesthetic appearance, ulceration, vision changes, quality <strong>of</strong> life),<br />
we extracted all data available on harms. Harms encompass the full range <strong>of</strong> specific negative<br />
effects, including the narrower definition <strong>of</strong> adverse events.<br />
Data Synthesis<br />
We summarized data for Key Questions qualitatively using summary tables where metaanalyses<br />
were not possible. We provided a narrative summary <strong>of</strong> relevant papers for contextual<br />
questions.<br />
We identified sufficient data to address the effectiveness <strong>of</strong> pharmacologic interventions<br />
using quantitative meta-analysis methods. Studies were included in the network meta-analysis<br />
subset provided that they satisfied the following additional inclusion criteria:<br />
• Outcomes were reported quantitatively, using an objective metric for reporting<br />
intervention effects that could be converted into a proportion <strong>of</strong> IH clearance.<br />
10
• One or more study arms evaluated a single intervention; study arms in which two or more<br />
treatments were applied were excluded.<br />
• Reported outcomes were accompanied by an associated measure <strong>of</strong> variation or precision.<br />
• Non-control pharmacologic treatments could be reasonably classified into one <strong>of</strong> the<br />
following classes <strong>of</strong> agents: oral, intralesional, or topical propranolol; intralesional<br />
triamcinolone; topical or ophthalmic timolol; <strong>and</strong> oral steroid.<br />
• Studies evaluated IH in multiple locations (vs. specific anatomic areas) as most studies<br />
included IH in multiple areas.<br />
In addition to the diverse suite <strong>of</strong> interventions, outcomes were reported in a variety <strong>of</strong> ways.<br />
Most identified an arbitrary threshold <strong>of</strong> IH clearance (e.g. >75%) as a positive outcome, or<br />
divided the continuous clearance measure into a small number <strong>of</strong> categories. Others reported<br />
visual analog scale scores, either for entire study arms or for individual patients within study<br />
arms. In order to incorporate as many quality studies as possible, by minimizing the number<br />
excluded due to technical constraints on statistical integration, we constructed a Bayesian latent<br />
variable model. This model allowed several different types <strong>of</strong> outcome data <strong>and</strong> a suite <strong>of</strong><br />
pharmacologic interventions to be analyzed in the same model, thereby maximizing the power<br />
for estimating parameters precisely. The estim<strong>and</strong>s <strong>of</strong> interest were the expected proportion <strong>of</strong><br />
clearance for each intervention agent, along with associated posterior uncertainty. A full<br />
description <strong>of</strong> the meta-analytic methods is reported in Appendix D.<br />
Quality (Risk <strong>of</strong> Bias) Assessment <strong>of</strong> Individual Studies<br />
We used separate tools appropriate for specific study designs to assess quality <strong>of</strong> individual<br />
studies meeting eligibility criteria for our Key Questions: questions adapted from the RTI item<br />
bank to assess r<strong>and</strong>omized controlled trials (RCTs), 25 the Newcastle-Ottawa Quality Assessment<br />
Scale for cohort studies, 26 the QUADAS tool for diagnostic imaging studies, 27 <strong>and</strong> a tool adapted<br />
from questions outlined in the RTI item bank <strong>and</strong> the McMaster McHarms tool to assess<br />
reporting <strong>of</strong> harms. 28<br />
Questions from the RTI item bank evaluate domains including selection bias, performance<br />
bias, attrition bias, detection bias, <strong>and</strong> reporting bias. We used the Newcastle-Ottawa Quality<br />
Assessment Scale to assess the quality <strong>of</strong> nonr<strong>and</strong>omized studies. It assesses three broad<br />
perspectives: the selection <strong>of</strong> study groups, the comparability <strong>of</strong> study groups, <strong>and</strong> the<br />
ascertainment <strong>of</strong> either the exposure or outcome <strong>of</strong> interest for case-control or cohort studies,<br />
respectively. The QUADAS tool considers questions related to participant characteristics,<br />
comparisons with a gold st<strong>and</strong>ard, <strong>and</strong> interpretation <strong>of</strong> the screening test. The harms assessment<br />
tool addresses questions related to pre-specification <strong>and</strong> reporting <strong>of</strong> harms.<br />
Quality assessment <strong>of</strong> each study was conducted independently by two team members using<br />
the forms presented in Appendix B. Any discrepancies were adjudicated by the two team<br />
members or a senior investigator. Investigators did not rely on the study design as described by<br />
authors <strong>of</strong> individual papers; rather, the methods section <strong>of</strong> each paper was reviewed to<br />
determine which rating tool to employ, <strong>and</strong> we used the algorithm in Appendix E to aid in<br />
determining study design. The results <strong>of</strong> these tools were then translated to “good,” “fair,” <strong>and</strong><br />
“poor” quality ratings as described below. Appendix F reports quality scoring for each study. We<br />
did not assess the quality <strong>of</strong> papers identified for Contextual Questions.<br />
11
Determining Quality Ratings<br />
• We required that RCTs receive a positive score (i.e., low risk <strong>of</strong> bias for RCTs) on<br />
roughly 80 percent (11 <strong>of</strong> 13) <strong>of</strong> the questions used to assess quality to receive a rating <strong>of</strong><br />
good/low risk <strong>of</strong> bias. RCTs had to receive eight to ten positive scores to receive a rating<br />
<strong>of</strong> fair/moderate risk <strong>of</strong> bias, <strong>and</strong> studies with ≤ seven positive ratings were considered<br />
poor quality/high risk <strong>of</strong> bias. We considered a score <strong>of</strong> “unclear” for a question as a<br />
negative score. We assessed the risk <strong>of</strong> bias for each major outcome <strong>of</strong> relevance reported<br />
but report an overall assessment unless the risk <strong>of</strong> bias varied by outcome.<br />
• We required that cohort studies receive positive scores (stars) on all elements, including<br />
use <strong>of</strong> blinded outcome assessors, <strong>and</strong> be prospective to receive a rating <strong>of</strong> good, ≤ 2<br />
negative ratings for fair, <strong>and</strong> > 2 negative scores for a rating <strong>of</strong> poor quality.<br />
• For imaging studies we required that studies receive positive scores on all questions to<br />
receive a rating <strong>of</strong> good. We considered studies with ≤ three negative ratings as fair<br />
quality <strong>and</strong> those with more than four as poor quality.<br />
• We required that studies assessed for harms reporting receive at least 3.5 <strong>of</strong> a possible<br />
four points available to receive a rating <strong>of</strong> “good.” We gave partial points to studies that<br />
reported monitoring for changes in blood pressure, heart rate, or hypoglycemia. Studies<br />
with 2.5 to three positive responses were considered fair quality <strong>and</strong> those with ≤ two<br />
positive responses were deemed to be poor quality.<br />
Strength <strong>of</strong> the Body <strong>of</strong> Evidence<br />
We applied explicit criteria for rating the overall strength <strong>of</strong> the evidence for each key<br />
intervention-outcome pair for which the overall risk <strong>of</strong> bias was not overwhelmingly high. We<br />
rated the strength <strong>of</strong> the evidence for the final outcomes <strong>of</strong> interest for our Key Questions<br />
(Figures 1-3) <strong>and</strong> for clinically important harms. We used established concepts <strong>of</strong> the quantity <strong>of</strong><br />
evidence (e.g., numbers <strong>of</strong> studies, aggregate ending-sample sizes), the quality <strong>of</strong> evidence (from<br />
the quality ratings on individual articles), <strong>and</strong> the coherence or consistency <strong>of</strong> findings across<br />
similar <strong>and</strong> dissimilar studies <strong>and</strong> in comparison to known or theoretically sound ideas <strong>of</strong> clinical<br />
or behavioral knowledge.<br />
The strength <strong>of</strong> evidence evaluation that we used is described in the Effective Health Care<br />
Program’s “Methods Guide for Effectiveness <strong>and</strong> Comparative Effectiveness Reviews” 23 <strong>and</strong> in<br />
the updated strength <strong>of</strong> evidence guide, 29 which emphasizes five major domains: study limitations<br />
(low, medium, high level <strong>of</strong> limitation), consistency (inconsistency not present, inconsistency<br />
present, unknown or not applicable), directness (direct, indirect), precision (precise, imprecise),<br />
<strong>and</strong> reporting bias. Study limitations are derived from the quality assessment <strong>of</strong> the individual<br />
studies that addressed the Key Questions <strong>and</strong> specific outcome under consideration. Each key<br />
outcome for each comparison <strong>of</strong> interest is given an overall evidence grade based on the ratings<br />
for the individual domains.<br />
The overall strength <strong>of</strong> evidence was graded as outlined in Table 2. Two senior staff<br />
members independently graded the body <strong>of</strong> evidence; disagreements were resolved as needed<br />
through discussion or third-party adjudication. We recorded strength <strong>of</strong> evidence assessments in<br />
tables, summarizing results for each outcome. We considered case series in the assessment <strong>of</strong><br />
strength <strong>of</strong> the evidence for harms.<br />
12
Table 2. Strength <strong>of</strong> evidence grades <strong>and</strong> definitions *<br />
Grade<br />
Definition<br />
High We are very confident that the estimate <strong>of</strong> effect lies close to the true effect for this<br />
outcome. The body <strong>of</strong> evidence has few or no deficiencies. We believe that the findings are<br />
stable, i.e., another study would not change the conclusions.<br />
Moderate We are moderately confident that the estimate <strong>of</strong> effect lies close to the true effect for<br />
this outcome. The body <strong>of</strong> evidence has some deficiencies. We believe that the findings<br />
are likely to be stable, but some doubt remains.<br />
Low We have limited confidence that the estimate <strong>of</strong> effect lies close to the true effect for<br />
this outcome. The body <strong>of</strong> evidence has major or numerous deficiencies (or both). We<br />
believe that additional evidence is needed before concluding either that the findings are<br />
stable or that the estimate <strong>of</strong> effect is close to the true effect.<br />
Insufficient We have no evidence, we are unable to estimate an effect, or we have no confidence<br />
in the estimate <strong>of</strong> effect for this outcome. No evidence is available or the body <strong>of</strong><br />
evidence has unacceptable deficiencies, precluding reaching a conclusion.<br />
*<br />
Excerpted from Berkman et al. 2014 29<br />
Applicability<br />
We assessed the applicability <strong>of</strong> findings reported in the included literature addressing our<br />
Key Questions to the general population <strong>of</strong> children with IH by determining the population,<br />
intervention, comparator, <strong>and</strong> setting in each study <strong>and</strong> developing an overview <strong>of</strong> these<br />
elements for each intervention category. We anticipated that areas in which applicability would<br />
be especially important to describe would include the diagnostic criteria for IH, age at treatment<br />
initiation, <strong>and</strong> the anatomic location <strong>and</strong> morphology <strong>of</strong> IH. Applicability tables for each<br />
intervention are in Appendix G.<br />
Peer Review <strong>and</strong> Public Commentary<br />
Researchers <strong>and</strong> clinicians with expertise in managing IH <strong>and</strong> individuals representing<br />
stakeholder <strong>and</strong> user communities provided external peer review <strong>of</strong> this report; AHRQ, a<br />
statistical expert, <strong>and</strong> an associate editor also provided comments. The draft report was posted on<br />
the AHRQ Web site for 4 weeks to elicit public comment. We addressed all reviewer comments,<br />
revised the text as appropriate, <strong>and</strong> documented changes <strong>and</strong> revisions to the report in a<br />
disposition <strong>of</strong> comments report that will be made available 3 months after AHRQ posts the final<br />
review on the AHRQ Web site.<br />
13
Results<br />
We present results for Contextual Questions (CQ) followed by those for our network metaanalysis,<br />
which includes studies <strong>of</strong> beta-blockers <strong>and</strong> steroids. We then present results for each<br />
Key Question (comparative effectiveness questions).<br />
We identified 966 publications potentially relevant to the CQ in our database searches. We<br />
also flagged studies for potential relevance to CQ in our screening <strong>of</strong> studies for Key Questions.<br />
We included 68 studies in the narrative summary <strong>of</strong> information addressing CQ.<br />
CQ1. Natural History <strong>of</strong> Untreated IH <strong>and</strong> Adverse Outcomes<br />
<strong>of</strong> Untreated IH<br />
Natural History <strong>of</strong> IH<br />
IH have been estimated to occur in around 5 percent <strong>of</strong> neonates <strong>and</strong> infants. 2 IH may be<br />
classified into subtypes including localized, segmental, indeterminate, <strong>and</strong> multifocal. Several<br />
studies have shown most IH to be <strong>of</strong> the localized type, <strong>and</strong> regardless <strong>of</strong> type, most IH involute<br />
with time; 30-33 however, the presentation <strong>and</strong> course <strong>of</strong> IH in individual children are<br />
heterogeneous. 34 IH usually present within the first month <strong>of</strong> life <strong>and</strong> undergo rapid proliferation<br />
over the first several months <strong>of</strong> life. 35,36 One study found that IH reached 80 percent <strong>of</strong> their final<br />
size by 5 months <strong>of</strong> age. 9 Many experts recommend referral at an early age (as early as 4 to 8<br />
weeks <strong>of</strong> life) to subspecialists given this rapid proliferation. 9<br />
Segmental IH are more likely to have more prolonged growth, defined as after 9 months <strong>of</strong><br />
age. 9,37 Involution typically starts by 1 year <strong>of</strong> age, but the timing <strong>of</strong> involution varies<br />
markedly. 38,39 In one large retrospective review <strong>of</strong> 1109 referred patients (median age=8 months)<br />
conducted in the pre-propranolol era, 769 were returned to the care <strong>of</strong> their primary provider<br />
without subspecialty followup, <strong>and</strong> only 102 (9%) required intervention. 40<br />
Most lesions involute by age 5 to 7, 41,42 though timing varies, <strong>and</strong> disfigurement may<br />
remain. 22,38,43,44 The majority (80%) <strong>of</strong> lesions involuting after age 6 years in one series resulted<br />
in residual scarring or telangiectasia, compared with 38 percent involuting before age 6. 35 In<br />
studies <strong>of</strong> referred populations, residual lesions (e.g., telangiectasias, atrophy, fibr<strong>of</strong>atty tissue,<br />
hypopigmentation) were reported in 25 to 69 percent <strong>of</strong> untreated IH. 38,45 Lesions affecting<br />
visual cortex development may result in lasting deficits in vision even after resolution <strong>of</strong> the<br />
IH. 46<br />
Indications for Treatment<br />
The major indications for treatment <strong>of</strong> IH include risks <strong>of</strong> ulceration, disfigurement, <strong>and</strong><br />
functional impact. 39,47-52 While psychological impact on the child also plays a role in treatment<br />
decisions, data on the effects <strong>of</strong> IH on quality <strong>of</strong> life for the child suggest minimal impact. Such<br />
data are <strong>of</strong>ten limited by the necessity to parent-report in this young population. 22,53,54 Estimates<br />
<strong>of</strong> complications from IH vary but are generally noted to occur in approximately 30 percent <strong>of</strong><br />
the studied population. 31,32,55 One study found higher initial complication rates for patients<br />
referred to a surgical center, potentially due to the higher likelihood <strong>of</strong> more advanced lesions<br />
being referred. 56 Given that the literature typically includes children treated at referral centers, it<br />
is likely that the overall complication rate may be higher in study populations than in the general<br />
population.<br />
14
Risk <strong>of</strong> complication is generally related to the size <strong>of</strong> lesions, location <strong>of</strong> lesions, <strong>and</strong>/or<br />
subtype. 31,57-59 Larger lesions are more likely to have complications. One study found a 5 percent<br />
increase in the likelihood <strong>of</strong> experiencing complications for every 10 cm² increase in size (OR<br />
1.051, p
defects, urogenital anomalies, ulceration, myelopathy, bony deformities, anorectal<br />
malformations, arterial anomalies, <strong>and</strong> renal anomalies], PELVIS [perineal hemangioma,<br />
external genitalia malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate<br />
anus, <strong>and</strong> skin tag] <strong>and</strong> SACRAL [spinal dysraphism, anogenital, cutaneous, renal, <strong>and</strong> urologic<br />
anomalies, associated with an angioma <strong>of</strong> lumbosacral localization]) <strong>and</strong> may require treatment<br />
<strong>of</strong> the IH to avoid functional or disfiguring sequelae. 76,77<br />
CQ2. Evidence for Association <strong>of</strong> Cutaneous IH <strong>and</strong> Occult IH<br />
Overall, limited literature addresses the association <strong>of</strong> a higher number <strong>of</strong> cutaneous IH <strong>and</strong><br />
extracutaneous IH. Some data from case series suggest support for a higher index <strong>of</strong> suspicion in<br />
children with multiple lesions or with facial lesions in a beard distribution. Studies have<br />
primarily assessed associations between cutaneous IH <strong>and</strong> hepatic IH <strong>and</strong> cutaneous facial IH<br />
<strong>and</strong> airway IH. One study addressed associations with IH in the spinal area <strong>and</strong> reported that nine<br />
<strong>of</strong> 48 children with cutaneous IH on the lumbosacral skin had intraspinal lesions (19%), though<br />
the study did not report the number <strong>of</strong> cutaneous lesions. We summarize studies addressing<br />
hepatic <strong>and</strong> airway IH below.<br />
The basis for the association <strong>of</strong> a greater number <strong>of</strong> cutaneous IH with hepatic IH comes<br />
primarily from case series including 453 infants with IH. 71,72,78-82 In one retrospective series,<br />
investigators analyzed data from 26 children with hepatic IH (presentation <strong>of</strong> IH at birth or up to<br />
4 months <strong>of</strong> age). 72 Among the 26, 18 also had multiple or diffuse cutaneous lesions (69%) <strong>and</strong><br />
underwent imaging, <strong>and</strong> 15 <strong>of</strong> 18 had multiple or diffuse liver IH. Investigators classified the<br />
liver IH as focal (n=8 children), multifocal (n=12 children), or diffuse (n=6 children). Among<br />
children with focal lesions, three had multiple cutaneous IH, two had a single cutaneous IH, <strong>and</strong><br />
three had no cutaneous IH. In the multifocal group, 11 <strong>of</strong> 12 children had multiple cutaneous<br />
lesions (mean 14.25 ± 12.50 lesions) <strong>and</strong> liver IH. All but one <strong>of</strong> the 6 children with diffuse<br />
hepatic IH had multiple cutaneous lesions. Across lesion types, cutaneous lesions generally<br />
resolved before hepatic lesions.<br />
Another series included 37 children, 16 percent <strong>of</strong> whom had three to five small cutaneous<br />
lesions; 43 percent had six or more small cutaneous lesions; 16 percent had cutaneous miliary<br />
(30-100 pinpoint lesions) lesions; 11 percent had a single large IH; <strong>and</strong> 14 percent had a<br />
combination <strong>of</strong> a large <strong>and</strong> one or more small cutaneous IH. 78 Eight <strong>of</strong> 37 (22%) children had<br />
concurrent hepatic IH. Children with cutaneous miliary IH had a greater number <strong>of</strong> hepatic IH<br />
(n=7 to 35) than did infants with other cutaneous patterns. Another retrospective series reported<br />
that 17 <strong>of</strong> 23 infants (53%) with hepatic IH had multiple (≥5) cutaneous IH. 80<br />
In another retrospective series <strong>of</strong> children seen at referral centers, 62 children had six or more<br />
cutaneous IH or one large (≥5 cm) cutaneous IH <strong>and</strong> seven had three to five small (
a series <strong>of</strong> 43 infants with IH, 27 had at least 10 cutaneous IH (median=16) <strong>and</strong> 16 had between<br />
five <strong>and</strong> nine cutaneous lesions (median=6.5). 82 Among the nine children treated for their IH, 9<br />
had internal IH (8 hepatic, 1 splenic), <strong>and</strong> five <strong>of</strong> the nine had more than one internal lesion. All<br />
<strong>of</strong> these children had ≥10 cutaneous IH <strong>and</strong> had no symptoms <strong>of</strong> internal IH. The study does not<br />
clearly report if any internal IH were reported among the children who did not receive treatment<br />
for cutaneous IH.<br />
In a prospective case series including 201 infants between 0 <strong>and</strong> 6 months <strong>of</strong> age with IH<br />
seen at specialty pediatric dermatology clinics, 24 <strong>of</strong> the 151 (16%) infants with at least five<br />
cutaneous IH had hepatic IH, while none <strong>of</strong> the children with one to four IH had hepatic<br />
involvement (p=0.003). 71 Preterm birth (< 37 weeks gestation) <strong>and</strong> lower birth weight were<br />
associated with having five or more cutaneous IH (p values
Results <strong>of</strong> Literature Searches for Key Questions<br />
We identified 4132 nonduplicative titles or abstracts with potential relevance, with 1273<br />
proceeding to full text review (Figure 4). We excluded 1120 studies at full text review. We<br />
included 148 unique studies (153 publications) in the review. These 148 studies included 42<br />
comparative studies, 38 addressing effectiveness <strong>and</strong> harms <strong>of</strong> therapies four assessing<br />
effectiveness only, <strong>and</strong> 106 case series providing data on harms only. We present findings by<br />
intervention under each Key Question.<br />
Figure 4. Disposition <strong>of</strong> studies identified for this review<br />
KQ = Key Question; n = number<br />
†Numbers next to each Key Question indicate number <strong>of</strong> unique studies addressing the question. Studies could address more than<br />
one Key Question. Neither study identified for KQ1 addressed harms. Of the 105 studies identified for KQ2, 28 addressed<br />
benefits <strong>and</strong> harms, 1 addressed only benefits, <strong>and</strong> 76 addressed only harms. Of the 41 identified for KQ4, 10 addressed benefits<br />
<strong>and</strong> harms, one addressed only benefits, <strong>and</strong> 30 addressed only harms.<br />
* Numbers do not tally as studies could be excluded for multiple reasons.<br />
Description <strong>of</strong> Included Studies<br />
The 148 unique studies addressing Key Questions comprise 15 r<strong>and</strong>omized controlled trials<br />
(RCTs), five prospective <strong>and</strong> 19 retrospective cohort studies, two diagnostic accuracy studies<br />
(defined as studies that compared the accuracy <strong>of</strong> imaging modalities in identifying or<br />
18
characterizing infantile hemangioma [IH]), one prospective comparative study that used an<br />
untreated IH as a control, <strong>and</strong> 106 case series (used for harms data only). Most studies were<br />
conducted in Europe (n = 51) or Asia (n = 44). Forty-one were conducted in the United States or<br />
Canada <strong>and</strong> 12 in other countries including Australia, Egypt, Argentina, <strong>and</strong> Chile (Table 3).<br />
Forty-two comparative studies reported effectiveness outcomes. We considered six <strong>of</strong> these<br />
studies to be good quality, 22 fair quality, <strong>and</strong> 14 poor quality. One-hundred <strong>and</strong> forty-four<br />
studies (comparative studies <strong>and</strong> case series) reported harms/adverse events data. We considered<br />
14 <strong>of</strong> these as good quality for harms reporting, three as fair quality for harms reporting, <strong>and</strong> the<br />
remainder (n = 127) as poor quality for harms reporting. Most studies addressed beta-blockers (n<br />
= 81, 13 <strong>of</strong> which compared a beta-blocker to another category <strong>of</strong> intervention such as<br />
corticosteroids or laser); 26 addressed lasers; 24 addressed steroids; 15 addressed surgical<br />
approaches; <strong>and</strong> two addressed diagnostic modalities.<br />
We included 18 studies in a network meta-analysis. All studies addressed pharmacologic<br />
agents <strong>and</strong> included five RCTs <strong>and</strong> four cohort studies evaluating oral propranolol <strong>and</strong> placebo<br />
or observation or another active agent, 92-100 including steroids; 96-98,100 one RCT <strong>and</strong> one cohort<br />
study comparing propranolol <strong>and</strong> other beta-blockers; 101,102 three cohort studies <strong>and</strong> two RCTs<br />
assessing topical timolol compared with placebo or observation or another agent; 14,103-106 <strong>and</strong> one<br />
RCT <strong>and</strong> one cohort study comparing different steroids, including oral prednisone <strong>and</strong><br />
intralesional triamcinolone. 107,108 Four studies were good quality 92,98,104,107 ; nine were fair<br />
quality 14,93,94,96,97,99,100,102,105 ; <strong>and</strong> five were poor quality. 95,101,103,106,108 Studies in the metaanalysis<br />
included a total <strong>of</strong> 1265 children with IH.<br />
19
Table 3. Characteristics <strong>of</strong> included studies addressing effectiveness <strong>and</strong> harms<br />
Characteristic<br />
RCTs<br />
Prospective<br />
Cohort Studies†<br />
Retrospective<br />
Cohort Studies<br />
Diagnostic<br />
Studies<br />
Case<br />
Series*<br />
Total Literature<br />
Intervention Corticosteroid 3 0 1 0 20 24<br />
Beta-Blocker ** 9 5 11 0 56 81<br />
Laser 3 0 6 0 17 26<br />
Surgery 0 1 1 0 13 15<br />
MRI or ultrasound 0 0 0 2 0 2<br />
Population<br />
Characteristics<br />
Outcomes<br />
Reported<br />
Anatomic location <strong>of</strong> IH<br />
Multiple 15 5 15 1 93 129<br />
Periocular 0 1 1 0 7 9<br />
Airway 0 0 1 0 1 2<br />
Oral/Maxillary 0 0 1 0 3 4<br />
Parotid 0 0 0 0 1 1<br />
Lumbosacral 0 0 0 1 0 1<br />
Nasal 0 0 1 0 1 2<br />
Study population<br />
U.S./Canada 2 1 7 2 29 41<br />
Europe 4 1 9 0 37 51<br />
Asia 4 3 3 0 33 43<br />
Other 5 1 0 0 7 13<br />
Resolution/Clearance-related 15 6 15 0 0 36<br />
Vision 1 2 1 0 0 4<br />
Quality <strong>of</strong> life 2 0 1 0 0 3<br />
Number treatments/invasive<br />
1 0 6 0 0 7<br />
treatments needed<br />
Diagnostic accuracy 0 0 0 2 0 2<br />
Rebound growth 4 1 6 0 0 11<br />
Harms 15 6 17 0 106 144<br />
Total N participants 1117 243 1447 96 10972 13875<br />
MRI = magnetic resonance imaging; n = number; RCT = r<strong>and</strong>omized, controlled trial<br />
*Case series reported other outcomes; however, we only extracted harms data from case series for this review.<br />
**Studies (n=13) that compared a beta-blocker to another beta-blocker or placebo/observation or to another active comparator such as steroids, other agents, or laser are reported<br />
only in this row.<br />
† One study included in the prospective cohort column compared an IH treated with cryotherapy to an untreated IH.<br />
20
Grey Literature<br />
In response to 21 requests for Scientific Information Packets, we received four documents,<br />
all <strong>of</strong> which addressed medications (becaplermin gel, recombinant interferon alfa-2b) that were<br />
not evaluated in studies meeting our criteria. The documents yielded no citations <strong>of</strong> relevance for<br />
this review, <strong>and</strong> the documents themselves did not meet criteria for inclusion in the review (one<br />
case series <strong>of</strong> 8 individuals, one addendum to an article, two files <strong>of</strong> prescribing information).<br />
Our search <strong>of</strong> ClinicalTrials.gov did not yield any results not identified in our other searches,<br />
<strong>and</strong> our searches <strong>of</strong> the web sites <strong>of</strong> relevant organizations yielded background information for<br />
informing our contextual questions.<br />
Key Question 1. Effectiveness <strong>and</strong> Harms <strong>of</strong> Imaging<br />
Modalities<br />
Key Points<br />
• Strength <strong>of</strong> the evidence (SOE) for the effectiveness <strong>of</strong> imaging for IH was insufficient<br />
given few studies assessing varied outcomes.<br />
• Studies assessed IH in different anatomic locations <strong>and</strong> reported differing findings for the<br />
sensitivity <strong>of</strong> ultrasound <strong>and</strong> effectiveness <strong>of</strong> imaging modalities depending on location<br />
or subtype.<br />
Overview <strong>of</strong> the Literature<br />
Two poor quality diagnostic accuracy studies—one prospective 68 <strong>and</strong> one retrospective 70 —<br />
addressed imaging modalities. Both studies were conducted in tertiary care settings with care<br />
settings in the United States, Canada, <strong>and</strong> Spain. One study enrolled patients from nine centers<br />
<strong>and</strong> included patients less than18 years old with IH in the lumbosacral area measuring greater<br />
than 2.5 cm. 68 The retrospective cohort study reported chart review data from two tertiary care<br />
centers <strong>and</strong> included 55 patients (mean age <strong>of</strong> 30 days) with liver IH. 70<br />
Overall, studies were limited by the size <strong>of</strong> cohorts, lack <strong>of</strong> st<strong>and</strong>ard processes, <strong>and</strong> lack <strong>of</strong><br />
direct comparison at the same time point using the various imaging modalities. We considered<br />
the SOE for all imaging modalities to be insufficient given single, small studies addressing<br />
different approaches, using weaker study designs <strong>and</strong> precluding a meta-analysis. The studies did<br />
not address harms.<br />
Detailed Analysis<br />
In one prospective cohort study, seven out <strong>of</strong> 26 (26.9%) children who underwent ultrasound<br />
had an abnormality compared with 21 <strong>of</strong> the 41 (51.2%) patients who received MRI <strong>and</strong> were<br />
noted to have a spinal abnormality. 68 Nineteen <strong>of</strong> these patients underwent both ultrasound <strong>and</strong><br />
MRI. In five cases ultrasound did not reveal an abnormality later found on MRI. Agreement<br />
between ultrasound <strong>and</strong> MRI was 0.27 (95% CI: -0.15 to 0.7, p=0.21), which was consistent with<br />
chance. Ultrasound had a sensitivity <strong>of</strong> 50 percent (95% CI: 18.7% to 81.3%) <strong>and</strong> specificity <strong>of</strong><br />
77.8 percent (95% CI: 40% to 97.2%) for identifying anomalies including tethered cords <strong>and</strong><br />
intraspinal IH. We calculated the sensitivity <strong>of</strong> both modalities for identifying intraspinal IH<br />
specifically: assuming a false positive value <strong>of</strong> 0, ultrasound, which missed 4 intraspinal IH in 26<br />
21
scans, had a sensitivity <strong>of</strong> 20 percent (95% CI: 3.30% to 71.19%), <strong>and</strong> the sensitivity <strong>of</strong> MRI was<br />
100 percent (95% CI: 66.21% to 100%).<br />
In a retrospective cohort study, 70 ultrasound was commonly used as the first imaging<br />
technique <strong>and</strong> identified lesions in 42 <strong>of</strong> 44 patients (sensitivity <strong>of</strong> 95%). Ultrasound identified<br />
direct shunts in 9 <strong>of</strong> 10 patients with shunts identified by angiography. Children with findings <strong>of</strong><br />
congestive heart failure or aortic tapering on imaging were more likely to require intervention for<br />
their hepatic lesion. Given the small number <strong>of</strong> studies <strong>and</strong> heterogeneity <strong>of</strong> interventions <strong>and</strong><br />
outcomes, we considered SOE to be insufficient for all outcomes.<br />
Key Question 2. Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids<br />
or Beta-Blockers<br />
Network Meta-Analysis <strong>of</strong> the Effectiveness <strong>of</strong> Pharmacologic<br />
Agents<br />
Full <strong>and</strong> detailed methods <strong>and</strong> results <strong>of</strong> the network meta-analysis are available in Appendix<br />
D. Effect measures (Table 4) reflect effects on the logit scale <strong>and</strong> are not immediately clinically<br />
interpretable, but they demonstrate the nominal superiority <strong>of</strong> beta-blockers. Specifically, oral<br />
propranolol had the highest estimated effect size, though there is overlap among the credible<br />
intervals <strong>of</strong> the estimates. The estimated additive effect <strong>of</strong> intralesional delivery for propranolol<br />
was -6.9 (95% Bayesian credible interval [BCI]: -11.9 to -2.5).<br />
Table 4. Posterior estimates <strong>of</strong> effect size<br />
Agent Mean St<strong>and</strong>ard Error<br />
95% Credible<br />
Interval<br />
Oral propranolol 6.0 0.7 [4.7 7.5]<br />
Topical timolol 3.5 0.5 [2.4 4.6]<br />
Intralesional triamcinolone 3.3 0.8 [1.7 4.9]<br />
Oral steroid 2.6 0.5 [1.8 3.6]<br />
Note: Table illustrates posterior estimates <strong>of</strong> effect size, on logit scale, relative to control, along with st<strong>and</strong>ard error <strong>and</strong> 95%<br />
credible interval. Positive values indicate increased clearance relative to control, negative indicate decreased clearance.<br />
More clinically interpretable are the clearance rates, presented in Figure 5, which presents<br />
mean expected clearance rates <strong>and</strong> our confidence bounds around the estimates. The expected<br />
efficacy <strong>of</strong> control arms was estimated to be 6 percent (95% BCI: 1% to 11%), i.e., we would<br />
expect to see, on average, 6 percent clearance <strong>of</strong> IH in children who receive placebo or no<br />
treatment during the study period. All non-control treatments were estimated to have a larger<br />
expected clearance than control.<br />
The largest mean estimate <strong>of</strong> clearance was for oral propranolol (95%, 95% BCI: 88% to<br />
99%). Clearance associated with the use <strong>of</strong> oral steroids was 43% (95% BCI: 21% to 66%), thus<br />
providing a clearance rate intermediate to control <strong>and</strong> use <strong>of</strong> beta-blockers. Triamcinolone, an<br />
intralesional injectable steroid, had a higher clearance rate than oral steroids, with wide BCI<br />
(58%; 95% BCI: 22% to 99%). Few data were available for intralesional propranolol, which is<br />
reflected in its larger credible interval (estimated clearance: 9%, 95% BCI: 0 to 45%).<br />
With fairly wide confidence bounds <strong>and</strong> limited data in some areas, the relative differences<br />
among estimates are <strong>of</strong> greater importance than absolute effects in interpreting these results. The<br />
estimates provide a relative ranking <strong>of</strong> anticipated rates <strong>of</strong> lesion clearance among treatment<br />
options. Families <strong>and</strong> clinicians making treatment decisions should also factor in elements such<br />
22
as lesion size, location, type, <strong>and</strong> number, which may affect choice <strong>of</strong> treatment modality, as well<br />
as patient/family preferences.<br />
Figure 5. Estimates <strong>of</strong> expected IH clearance<br />
Note: Estimates <strong>of</strong> expected IH clearance are expressed as percent clearance relative to initial condition for each treatment, along<br />
with associated posterior interquartile range (thick lines) <strong>and</strong> 95% credible interval (thin lines).<br />
Figure 6 represents the variability in effects seen across the patient populations in terms <strong>of</strong><br />
percent clearance. Oral propranolol was estimated to have the largest variability in clearance rate<br />
with some patients experiencing much greater clearance than others (σ=2.5, 95% BCI: 2.1 to 2.9)<br />
with timolol (σ=1.5, 95% BCI: 1.4 to 1.6), intralesional triamcinolone (σ=1.8, 95% BCI: 1.3 to<br />
2.3), <strong>and</strong> oral steroids (σ=1.3, 95% BCI: 1.1 to 1.6) yielding similar, lower estimates. All <strong>of</strong> the<br />
estimates <strong>of</strong> effect st<strong>and</strong>ard deviation were at least nominally higher than the control st<strong>and</strong>ard<br />
deviation, which may be a reflection <strong>of</strong> the heterogeneity <strong>of</strong> the study population in terms <strong>of</strong><br />
response <strong>of</strong> IH to treatment.<br />
Because <strong>of</strong> relatively sparse information from several treatment agents, we were unable to<br />
separately estimate variance parameters for all <strong>of</strong> the interventions, <strong>and</strong> instead fit a simplified<br />
model that assumed variances were equal. To check the validity <strong>of</strong> this assumption, we also fit a<br />
model on the subset <strong>of</strong> interventions with sufficient numbers <strong>of</strong> studies (>3) to estimate variance<br />
parameters, <strong>and</strong> noted that the variance estimates ranged from 1.3 (1.1 to 1.6) to 2.6 (2.2 to 2.9)<br />
on the logit scale. This was reasonably close to the 1.8 (1.1 to 2.6) estimated as the pooled<br />
variance.<br />
To assess for methodologic heterogeneity, we ran additional models with only RCTs <strong>and</strong><br />
with only good <strong>and</strong> fair quality studies. Estimates did not differ markedly when poor quality<br />
studies were removed, though BCI typically widened; thus, we report the model with poor<br />
quality studies included. To examine the possible effect <strong>of</strong> bias due to the inclusion <strong>of</strong> cohort<br />
studies, we fit the same model to RCT studies only. The resulting estimates were similar to those<br />
23
<strong>of</strong> the model fit to all studies, but with much wider posterior credible intervals. Since there was<br />
no obvious systematic bias due to study design, we reported the model estimates based on the<br />
entire body <strong>of</strong> evidence.<br />
Figure 6. Estimates <strong>of</strong> the variation <strong>of</strong> each treatment<br />
Note: Estimates <strong>of</strong> the variation <strong>of</strong> each treatment are expressed as st<strong>and</strong>ard deviation, along with associated posterior<br />
interquartile range (thick lines) <strong>and</strong> 95% credible interval (thin lines).<br />
Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids<br />
Key Points<br />
• In our network meta-analysis, oral steroids had a clearance rate <strong>of</strong> 43 percent (95%<br />
Bayesian credible interval [BCI]: 21% to 66%), <strong>and</strong> the rate for intralesional<br />
triamcinolone was 58 percent (95% BCI: 22% to 93%) compared with 6 percent (95%<br />
BCI: 1% to 11%) for placebo or observation (moderate SOE for improvement in IH with<br />
oral steroids vs. observation or placebo; low SOE for greater effectiveness <strong>of</strong><br />
intralesional steroids vs. observation or placebo). This means that we would expect to<br />
see, on average, 43 percent clearance <strong>of</strong> IH in children receiving oral steroids relative to 6<br />
percent with placebo or no treatment.<br />
• Steroids studied varied in dose, type, <strong>and</strong> route <strong>of</strong> administration.<br />
• Children in treatment arms typically experienced reductions in lesion size, but outcomes<br />
across studies are difficult to compare given differences in scales.<br />
• Harms were varied <strong>and</strong> frequently included Cushingoid facies, irritability/mood changes,<br />
growth retardation, <strong>and</strong> skin atrophy or depigmentation. Ulceration was frequently<br />
reported in studies <strong>of</strong> intralesional steroids. SOE was moderate for the association <strong>of</strong><br />
steroids with clinically important harms.<br />
24
Overview <strong>of</strong> the Literature<br />
We identified 24 studies (three RCTs, one cohort study, <strong>and</strong> 20 case series) reporting<br />
outcomes <strong>and</strong>/or harms following corticosteroid use in children with IH. 40,107-129 One RCT <strong>and</strong><br />
one case series 120,122 likely report on a subset <strong>of</strong> the same children; however, the extent <strong>of</strong><br />
overlap is not clear. Three RCTs 107,108,122 <strong>and</strong> one retrospective cohort study 40 addressed<br />
corticosteroids <strong>and</strong> included a total <strong>of</strong> 239 children (age range 1-72 months) with IH in multiple<br />
anatomic sites. Studies were conducted in India, 122 Canada, 107 Pakistan, 108 <strong>and</strong> Turkey. 40 Two<br />
studies included children with cutaneous IH, <strong>and</strong> IH types across all studies included superficial,<br />
deep, <strong>and</strong> mixed.<br />
Comparative studies <strong>and</strong> case series assessed oral methylprednisolone, oral prednisolone,<br />
intravenous methylprednisolone, topical mometasone furoate, topical betamethasone, topical<br />
clobetasol, topical halobetasol, intralesional betamethasone, <strong>and</strong> intralesional triamcinolone<br />
acetonide <strong>and</strong> compared one agent to another or various doses <strong>of</strong> agents. One RCT included an<br />
observational/conservative control group. 108 Only one RCT explicitly noted that assessors were<br />
blinded to treatment status. 107 Treatment duration (where clearly reported) in comparative studies<br />
ranged from 3 weeks to 12 months. We rated one RCT as good, 107 one as fair, 122 <strong>and</strong> one as<br />
poor 108 quality <strong>and</strong> the cohort study 40 as fair quality for effectiveness outcomes. We considered<br />
the cohort study <strong>and</strong> one RCT 40,122 as poor quality for harms reporting <strong>and</strong> two RCTs as good<br />
quality for harms reporting. 107,108<br />
In our network meta-analysis, oral steroids had a mean estimated expected clearance rate <strong>of</strong><br />
43 percent (95% BCI: 21% to 66%). Intralesional triamcinolone had a rate <strong>of</strong> 58 percent but with<br />
wide confidence bounds (95% BCI: 22% to 93%). Thus, there is adequate evidence to support a<br />
moderate strength <strong>of</strong> evidence for oral steroids to have a modest effect on clearance rates <strong>and</strong><br />
low SOE for intralesional steroids to have a modest (albeit larger) effect relative to control with<br />
wide confidence bounds.<br />
We also report harms from two RCTs 98,100 <strong>and</strong> five cohort studies 96,97,130-133 that compared<br />
steroids with propranolol (effectiveness outcomes reported in Effectiveness <strong>and</strong> Harms <strong>of</strong> Beta-<br />
Blockers Compared With Other Active Modalities section below). These studies were conducted<br />
in the U.S., 97,98 Canada, 96 India, 100 , the Netherl<strong>and</strong>s, 131 Germany, 132,133 <strong>and</strong> Egypt 130 <strong>and</strong> included<br />
308 children with IH (age range=1 to more than 9 months). We rated these studies as good 98 <strong>and</strong><br />
poor 96,97,100,130-133 quality for harms reporting.<br />
Twenty case series provided harms data on corticosteroids. 109-121,123-129 Children in case series<br />
(n=3508) ranged in age from 0 to 19 years <strong>and</strong> typically had IH in multiple anatomic sites. Nine<br />
case series were conducted in the United States, three in India, two in the U.K., two in China,<br />
<strong>and</strong> one each in Qatar, Israel, Thail<strong>and</strong>, <strong>and</strong> the Netherl<strong>and</strong>s. Four studies reported on only<br />
orbital or periocular IH. 111,121,127,128 Treatment duration was frequently not reported. We rated all<br />
case series as poor quality for harms reporting.<br />
Steroids were consistently associated with clinically important harms including Cushingoid<br />
appearance, infection, growth retardation, hypertension, <strong>and</strong> mood changes that may be<br />
important in making treatment decisions. The SOE is moderate for the association <strong>of</strong> steroids<br />
with these clinically important harms.<br />
25
Detailed Analysis<br />
Effectiveness <strong>of</strong> Steroids<br />
Intravenous or Intralesional Versus Oral Steroids<br />
One good quality RCT conducted at a Canadian tertiary care hospital r<strong>and</strong>omized 20 children<br />
with problematic facial IH (defined as causing visual impairment or disfigurement) to oral<br />
prednisolone (2 mg/kg/day tapered over 9-12 months, n=10, mean age=11±4 weeks) or monthly<br />
IV methylprednisolone (30 mg/kg infused over 1 hour for 3 days for 3 months, n=10, mean<br />
age=12±3 weeks). 107 Children in the oral steroid group had greater improvement in size at both<br />
the 3-month post-treatment <strong>and</strong> first birthday followup timepoints (median VAS <strong>of</strong> 70 in oral<br />
group compared with 12 in IV group, p=0.002 <strong>and</strong> median VAS <strong>of</strong> 50 in oral group vs. -1.5 in IV<br />
group, p=0.005). Vision improved in six <strong>of</strong> the eight children with eye involvement (2 in oral<br />
group <strong>and</strong> 4 in IV group), <strong>and</strong> seven children in the oral group <strong>and</strong> six in the IV group required<br />
additional steroids due to rebound growth or lack or response. In combined group analyses,<br />
children with periorbital involvement had less improvement at both time points (median VAS <strong>of</strong><br />
4 vs. 48, p=0.049 at 1 year).<br />
A poor quality RCT conducted in Pakistan compared oral prednisolone (n=25) at a low dose<br />
(2 mg/kg/day on alternate days) <strong>and</strong> intralesional triamcinolone (n=25) <strong>and</strong> observation (n=25)<br />
in children (mean age=5.0±2.9 months) with superficial (73.3%), mixed (20%), <strong>and</strong> deep (6.6%)<br />
cutaneous IH. 108 Lesion sites varied significantly among groups at baseline (p
Table 5. Key resolution outcomes in studies comparing intravenous or intralesional <strong>and</strong> oral<br />
corticosteroids<br />
Author, Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
Age<br />
Type<br />
Location<br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
Resolution<br />
Outcomes<br />
Rebound Growth/<br />
Recurrence, n (%)<br />
Other Outcomes<br />
Pope et al.<br />
2007 107<br />
G1: Methylprednisolone,<br />
30 mg/kg<br />
infused over<br />
an hour for<br />
three days<br />
monthly (10)<br />
G2:<br />
Prednisolone,<br />
oral<br />
2/mg/kg/day<br />
(10)<br />
Quality:<br />
Good<br />
Jalil et al.<br />
2006 108<br />
G1:<br />
Triamcinolone<br />
1-5 mg/kg<br />
intra-lesional<br />
(25)<br />
G2:<br />
Prednisolone,<br />
oral 2/mg/kg/<br />
on alternate<br />
days (25)<br />
G3:<br />
Observation<br />
(25)<br />
Quality: Poor<br />
Age,<br />
mean±SD,<br />
weeks<br />
G1: 12 ± 3<br />
G2: 11 ± 4<br />
Type<br />
All children<br />
had mixed,<br />
superficial<br />
<strong>and</strong> deep<br />
facial IH<br />
Age,<br />
mean±SD,<br />
months<br />
(range)<br />
G1+G2+G3:<br />
5.0 ± 2.9<br />
(1 to 12)<br />
Type<br />
Superficial,<br />
%<br />
G1+G2+G3:<br />
73.3<br />
Deep<br />
G1+G2+G3:<br />
6.6<br />
Combined<br />
G1+G2+G3:<br />
20<br />
G1+G2:<br />
Multiple<br />
G1+G2+<br />
G3:<br />
Multiple<br />
• 100-mm visual<br />
analog scale<br />
(0:no change,<br />
+:decrease in<br />
size,<br />
-:increase in<br />
size)<br />
• Blinded<br />
assessors<br />
• Grade I greater<br />
than 50%<br />
reduction in size<br />
• Grade II less<br />
than 50%<br />
reduction in size<br />
• Grade III little or<br />
no decrease (or<br />
increase)<br />
• Blinded<br />
assessment: NR<br />
VAS score at 3<br />
months, median<br />
(IQR)<br />
G1: 12 (-18 to 39)<br />
G2: 70 (54 to 80)<br />
G1 vs. G2 p=0.002<br />
VAS score at 1<br />
year, median (IQR)<br />
G1: -1.5 (-35 to 22)<br />
G2: 50 (35 to 67)<br />
G1 vs. G2 p=0.005<br />
Lesion size<br />
reduction<br />
Grade I<br />
G1: 11<br />
G2: 8<br />
G3: 0<br />
Grade II<br />
G1: 8<br />
G2: 11<br />
G3: 1<br />
Grade III<br />
G1: 6<br />
G2: 6<br />
G3: 19<br />
No change<br />
G3: 5<br />
Need for additional<br />
treatment, n (%)<br />
G1: 7 (54)<br />
G2: 6 (46, additional<br />
treatment given for<br />
regrowth specifically)<br />
Vision outcomes<br />
• Eye involvement in 5<br />
children in G1 <strong>and</strong> 3<br />
in G2<br />
• No change in eye<br />
findings in 1 child in<br />
each group at 1 year,<br />
<strong>and</strong> improvement in 4<br />
in G1 <strong>and</strong> 2 in G2<br />
Rebound growth<br />
G1: 0<br />
G2: 1<br />
G3: 0<br />
G = group; IH = infantile hemangioma; IQR = interquartile range; kg = kilogram; mm = millimeter; mg= milligram; n = number;<br />
SD = st<strong>and</strong>ard deviation; VAS = visual analog scale<br />
Intralesional Versus Topical Steroids<br />
One fair quality RCT conducted in India r<strong>and</strong>omized children (age range=NR) with less than<br />
or equal to two superficial IH <strong>of</strong> less than 5 cm to daily topical mometasone furoate (n=52) or<br />
monthly intralesional triamcinolone (n=47) for 6 to 8 months (Table 6). 122 Patients in this study<br />
likely overlap with those described in a retrospective case series, 120 but the extent <strong>of</strong> overlap is<br />
not clear. Forty-five children in each group responded to treatment (mometasone: 50% excellent,<br />
36.5% good, 13.4% poor response; triamcinolone: 63.8% excellent, 31.9% good, 4.2% poor<br />
response). Response to steroids did not differ by age or sex.<br />
27
Table 6. Key resolution outcomes in studies comparing intralesional <strong>and</strong> topical corticosteroids<br />
Age at<br />
Initiation,<br />
Months Location<br />
Resolution Outcomes<br />
Author, Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
P<strong>and</strong>ey et al.<br />
2010 122<br />
G1:<br />
Mometasone<br />
furoate,<br />
topical thin<br />
film applied<br />
twice daily<br />
(52)<br />
G2:<br />
Triamcinolone<br />
acetonide,<br />
intralesional<br />
1-2 mg/kg<br />
(47)<br />
Age<br />
NR<br />
Type<br />
Type, %<br />
Superficial:100<br />
NR<br />
Measures <strong>of</strong><br />
Resolution/Response<br />
• Cessation <strong>of</strong> growth,<br />
lightening <strong>of</strong> color, <strong>and</strong><br />
flattening <strong>of</strong> surface<br />
• Positive response in all 3<br />
parameters=Excellent<br />
• Positive response in 2<br />
parameters=Good<br />
• Response in single or no<br />
parameter=Poor<br />
• Blinded assessment: NR<br />
Quality: Fair<br />
G = group; IH = infantile hemangioma; kg = kilogram; mg = milligram; n = number; NR = not reported<br />
Response rate, n (%)<br />
Excellent<br />
G1: 26 (50)<br />
G2: 30 (63.8)<br />
Good<br />
G1: 19 (36.5)<br />
G2: 15 (31.9)<br />
Poor<br />
G1: 7 (13.4)<br />
G2: 2 (4.2)<br />
Methylprednisolone Versus Prednisolone<br />
In one fair quality Turkish retrospective cohort study, 283 <strong>of</strong> 1,109 children with superficial<br />
(53.7%), deep (18.8%), or mixed (16%) IH seen over 23 years at one hospital received either<br />
observation (n=238), 2 mg/kg/day prednisolone (n=26, median age at initiation=5 months),<br />
10mg/kg/day methylprednisolone (n=11, median age at initiation=6 months), or<br />
methylprednisolone tapered from 30 mg/kg/day to 10 mg/kg/day for 7 days (n=8, median age at<br />
initiation=7 months). 40 Among the children in the observation group at a median <strong>of</strong> 2 years <strong>of</strong><br />
followup, 92 had complete or near complete (75-100%) regression, 37 had 50 to 75 percent<br />
regression, 20 had 25 to 50 percent regression, <strong>and</strong> 89 had less than 25 percent regression. By<br />
age 5, 68 percent out <strong>of</strong> an unstated number <strong>of</strong> children followed had complete regression, <strong>and</strong><br />
90 percent <strong>of</strong> 92 children followed had complete regression by age 9. Overall, 16 children (36%)<br />
had a good or excellent response to steroids; 15 (33%) had a fair response; <strong>and</strong> 14 (31%) had<br />
poor response. Response did not differ significantly among or between the three groups, but<br />
rebound growth was significantly higher (p=0.045) among those receiving methylprednisolone<br />
(dose not clearly reported, n=8 with rebound growth) compared with prednisolone (n=4 with<br />
rebound growth). Table 7 outlines resolution outcomes.<br />
28
Table 7. Key resolution outcomes in studies comparing methylprednisolone <strong>and</strong> prednisolone<br />
Age at<br />
Resolution Rebound Growth/<br />
Initiation,<br />
Outcomes Recurrence, n<br />
Months Location<br />
Author, Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
Akyuz et al.<br />
2001 40<br />
G1:<br />
Prednisolone,<br />
oral<br />
2mg/kg/day<br />
(26)<br />
G2:<br />
Methylpredniso<br />
lone, oral low<br />
dose<br />
10mg/kg/day<br />
tapered to 2<br />
mg/kg/day (11)<br />
G3:<br />
Methylpredniso<br />
lone, oral low<br />
dose<br />
30mg/kg/day<br />
tapered to 5<br />
mg/kg/day (8)<br />
Quality: Fair<br />
Type<br />
Age, mean<br />
(range)<br />
G1: 5 (2-72)<br />
G2: 4 (2-11)<br />
G3: 6 (1-36)<br />
Type<br />
Capillary, n<br />
(%)<br />
G1: 11 (42.3)<br />
G2: 2 (18)<br />
G3: 4 (50)<br />
Cavernous<br />
(Deep)<br />
G1: 8 (30.8)<br />
G2: 4 (36.4)<br />
G3: 4 (50)<br />
Mixed<br />
G1: 7 (27)<br />
G2: 5 (45.5)<br />
G3: 0<br />
G1+G2+<br />
G3:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/ Response<br />
• Change in<br />
dimension,<br />
lightening <strong>of</strong> color,<br />
<strong>and</strong> s<strong>of</strong>tening <strong>of</strong><br />
texture<br />
• Response graded<br />
as:<br />
Excellent: 75-100%<br />
Good: 50-75%<br />
Fair: 25-50%<br />
Poor: < 25%<br />
• Blinded assessment:<br />
NR<br />
Response, n<br />
(%)<br />
G1+G2+G3:<br />
Good or<br />
excellent: 16<br />
(36)<br />
Fair: 15 (33)<br />
Poor: 14 (31)<br />
G1 vs. G2 vs.<br />
G3: p=ns<br />
G = group; kg = kilogram; mg = milligram; n = number; NR = not reported; ns = not significant<br />
Harms <strong>of</strong> Steroids<br />
Other Outcomes<br />
Rebound Growth<br />
G1: 4<br />
G2+G3: 8<br />
G1 vs. G2+G3:<br />
p=0.045<br />
Effect Modifiers<br />
• No significant<br />
association<br />
between<br />
response to<br />
treatment <strong>and</strong><br />
sex, age, lesion<br />
type, size,<br />
location, <strong>and</strong><br />
age at<br />
treatment<br />
initiation in<br />
univariate<br />
analyses<br />
• In multivariate<br />
analyses,<br />
younger age<br />
<strong>and</strong> smaller<br />
lesion size<br />
associated with<br />
better response<br />
Harms Reported in Studies Included in This Review<br />
Two comparative studies that addressed steroids explicitly defined harms <strong>and</strong> were<br />
considered good quality for harms reporting. 107,108 Another RCT (good quality for harms<br />
reporting) that compared prednisolone <strong>and</strong> propranolol also predefined harms. 98 Studies included<br />
a limited number <strong>of</strong> participants <strong>and</strong> may not have been adequately powered to detect harms.<br />
One RCT that compared harms reported in the prednisolone arm with those reported in the<br />
methylprednisolone arm noted no significant differences in harms between groups, 107 as did an<br />
RCT comparing prednisolone, triamcinolone, <strong>and</strong> conservative management. 108 One child<br />
receiving oral prednisolone discontinued the study due to persistent vomiting. 107 Another RCT<br />
comparing oral propranolol alone, prednisolone alone, <strong>and</strong> propranolol plus prednisolone noted<br />
significantly more complications in the steroid arms compared with propranolol alone (p values<br />
not clearly reported). 100 Complications in the combination arm <strong>and</strong> prednisolone only arm<br />
included Cushingoid appearance (n=6/10 in combination , 5/10 in prednisolone arms) <strong>and</strong><br />
gastrointestinal upset (n=4/10 in combination arm <strong>and</strong> 3/10 in prednisolone). One child in the<br />
prednisolone arm discontinued the study due to ulceration <strong>and</strong> infection. 100 A final RCT reported<br />
harms using a general classification. 98 The frequency <strong>of</strong> harms between the prednisolone <strong>and</strong><br />
propranolol groups did not differ significantly (44 vs. 32, respectively), <strong>and</strong> harms associated<br />
29
with prednisolone included endocrine (n=0.18% <strong>of</strong> lesions), gastrointestinal (n=0.14% <strong>of</strong><br />
lesions), growth <strong>and</strong> development (n=0.23% <strong>of</strong> lesions), infection (n=0.09% <strong>of</strong> lesions),<br />
metabolic (n=0.02% <strong>of</strong> lesions), <strong>and</strong> pulmonary/respiratory (n=0.11% <strong>of</strong> lesions). Severe adverse<br />
events occurred more frequently in the prednisolone arm (11 vs. 1 in propranolol arm, p=0.01).<br />
Nine <strong>of</strong> the 11 severe events were related to growth restriction. Fewer children in the<br />
prednisolone arm had pulmonary events (typically upper respiratory tract infection) compared<br />
with children in the propranolol group (5 vs. 14, p70%) in<br />
both arms in this study also experienced blood pressures ≥ the 90 th percentile (>15% in either<br />
arm were ≥ the 95 th percentile) though only one required antihypertensive medication for<br />
persistent elevation, <strong>and</strong> 52 <strong>of</strong> 73 cortisol tests were abnormal (31 in prednisolone arm <strong>and</strong> 21 in<br />
methylprednisolone). Twelve cortisol levels in the prednisolone arm <strong>and</strong> one in the<br />
methylprednisolone arm were in the undetectable range, <strong>and</strong> blood glucose was transiently<br />
elevated in 5 <strong>of</strong> 70 tests. 107 In total, seven <strong>of</strong> 330 participants receiving steroids in comparative<br />
studies discontinued treatment due to adverse events.<br />
Table 8. Harms/adverse effects in comparative studies <strong>of</strong> steroids to treat IH<br />
N Studies Reporting<br />
Intervention<br />
Harm/Adverse Event<br />
Harm (# Participants<br />
With Harm/Total<br />
Participants)<br />
Prednisolone 2-2.6<br />
mg/kg/day<br />
Reported Rates<br />
Across Studies<br />
Irritability 107 1 (3/10) 30%<br />
Crying 107 1 (3/10) 30%<br />
Insomnia 107 1 (3/10) 30%<br />
Hyperactivity 107 1 (2/10) 20%<br />
Vomiting 107 1 (2/10) 20%<br />
Abdominal pain or<br />
2 (5/20) 20%-30%<br />
gastrointestinal distress 100,107<br />
Ulceration or infection 100,108 2 (5/35) 10%-16%<br />
Persistent high blood<br />
1 (1/10) 10%<br />
pressure 107<br />
Respiratory distress 107 1 (1/10) 10%<br />
Chickenpox 107 1 (1/10) 10%<br />
Cushingoid appearance 100 1 (5/10) 50%<br />
Failure to thrive 100 1 (1/10) 10%<br />
30
Table 8. Harms/adverse effects in comparative studies <strong>of</strong> steroids to treat IH (continued)<br />
N Studies Reporting<br />
Intervention<br />
Harm/Adverse Event<br />
Harm (# Participants<br />
With Harm/Total<br />
Participants)<br />
Prednisone 2-2.8<br />
mg/kg/day<br />
IV methylprednisolone<br />
30mg/kg<br />
Intralesional<br />
triamcinolone with or<br />
without other steroids 1-<br />
5 mg/kg<br />
Oral corticosteroids<br />
(undefined)<br />
Irritability or behavioral<br />
changes 96,132,133<br />
Reported Rates<br />
Across Studies<br />
2 (8/50) 6%-17%<br />
Oral thrush 96 1 (2/12) 17%<br />
Insomnia 96 1 (1/12) 8%<br />
Hypertension 96,132,133 2 (3/50) 5%-8%<br />
Growth failure 96,132,133 2 (4/50) 3%-8%<br />
Cushingoid appearance 132,133 1 (38/38) 100%<br />
Glucosuria 132,133 1 (1/38) 3%<br />
Irritability 107 1 (3/10) 30%<br />
Crying 107 1 (2/10) 20%<br />
Hyperactivity 107 1 (2/10) 20%<br />
Vomiting 107 1 (2/10) 20%<br />
Abdominal pain 107 1 (2/10) 20%<br />
Insomnia 107 1 (1/10) 10%<br />
Apathy 107 1 (1/10) 10%<br />
Behavioral change 107 1 (1/10) 10%<br />
Respiratory distress 107 1 (1/10) 10%<br />
Pain 122 1 (47/47) 100%<br />
Itching 122 1 (9/47) 19.1%<br />
Bleeding 122,131 2 (17/76) 17%-31%<br />
Infection 122 1 (8/47) 17%<br />
Ulceration 108,131 2 (8/54) 4%-24%<br />
Ulcer <strong>and</strong> depigmentation 108 1 (1/25) 4%<br />
Cushingoid appearance 122 1 (1/47) 2.1%<br />
Skin atrophy 108,122 2 (5/72) 4%-8.5%<br />
Skin depigmentation or<br />
2 (6/72) 6.4%-12%<br />
hypopigmentation 108,122<br />
Cushingoid appearance 97 1 (42/42) 100%<br />
Gastroesophageal reflux 97 1 (4/42) 10%<br />
Arterial bleed 97 1 (4/42) 10%<br />
Hirsutism 97 1 (4/42) 10%<br />
Growth retardation 97 1 (4/42) 10%<br />
Hypercholesterolemia 97 1 (4/42) 10%<br />
Scarring <strong>and</strong> lip contraction 97 1 (4/42) 10%<br />
Hypertension 97 1 (2/42) 5%<br />
Mometasone furoate Itching 122 1 (10/52) 19.2%<br />
(topical)<br />
Hypopigmentation 122 1 (4/52) 7.7%<br />
Observation Spontaneous ulceration 108 1 (4/25) 16%<br />
IH = infantile hemangioma; n = number<br />
Note: One study 40 comparing prednisolone <strong>and</strong> methylprednisolone regimens reported Cushingoid facies in 20/45 children,<br />
irritability in 16/45, <strong>and</strong> increased appetite in “almost all” children. The study does not report the regimen associated with each<br />
adverse event. One cohort study comparing propranolol <strong>and</strong> prednisone was reported in 2 publications. 132,133 we use the harms<br />
data reported in the 2008 publication. 133<br />
Case series included 3508 children receiving intralesional, oral, or topical steroids or<br />
combinations <strong>of</strong> agents, with doses <strong>of</strong> oral steroids ranging from 1 to 5 mg/kg/day <strong>and</strong><br />
intralesional doses (where reported) ranged from 0.5 to 6 ml (Table 9). We considered all studies<br />
as poor quality for harms reporting. No studies explicitly reported harms sought, <strong>and</strong> the lack <strong>of</strong><br />
a comparison group <strong>and</strong> typically small sample sizes limit our underst<strong>and</strong>ing <strong>of</strong> the significance<br />
<strong>of</strong> these harms.<br />
Frequently reported harms across agents were Cushingoid facies (reported in 0.45%-100%<br />
<strong>of</strong> children in 12 studies), diminished height or weight gain or growth retardation (0.45%-47% <strong>of</strong><br />
31
children in 8 studies), skin atrophy (0.95%-17% <strong>of</strong> children in five studies), hypopigmentation<br />
(1.4% to 16% <strong>of</strong> children in 6 studies), hypertension (0.11% to 5% <strong>of</strong> children in five studies),<br />
infection (2% to 15% <strong>of</strong> children in 5 studies), <strong>and</strong> behavioral changes (25% to 100% <strong>of</strong> children<br />
in four studies). Cushingoid appearance <strong>and</strong> growth retardation occurred regardless <strong>of</strong> dosage<br />
form (i.e., intralesional, oral).<br />
One study reported on several “ultrapotent” topical steroids (betamethasone dipropionate,<br />
clobetasol propionate, halobetasol propionate, 0.05%) in children with primarily superficial IH<br />
<strong>and</strong> noted that 2 <strong>of</strong> 34 children (agents received not specified) experienced hypopigmentation. 127<br />
Another reporting on several corticosteroids including oral prednisolone, clobetasol propionate,<br />
<strong>and</strong> intralesional triamcinolone plus betamethasone in 30 children with complicated IH reported<br />
adverse effects in the aggregate rather than by agent. 129 Most children received prednisolone, <strong>and</strong><br />
harms included decreased rate <strong>of</strong> linear growth (n=14), decreased weight gain (n=9), Cushingoid<br />
facies (n=7), increased weight gain (n=5), decreased head growth (n=4), hirsutism (n=4), delayed<br />
motor milestones (n=3), thrush (n=3), premature thelarche (n=2), increased rate <strong>of</strong> linear growth<br />
(n=1), sterid acne (n=1), gastritis (n=1), <strong>and</strong> varicella infection (n=1). 129 Three case series<br />
evaluating intralesional steroids reported that no adverse events occurred, 123,126,128 <strong>and</strong> none<br />
explicitly reported discontinuation <strong>of</strong> treatment due to adverse events.<br />
Table 9. Adverse effects in case series <strong>of</strong> steroids to treat IH<br />
Intervention<br />
Intralesional<br />
triamcinolone+betamethasone †<br />
Intralesional<br />
triamcinolone+dexamethasone<br />
Intralesional<br />
triamcinolone+prednisolone<br />
Harm/Adverse Event<br />
Number Of<br />
Studies<br />
(# Participants<br />
With Harm/Total<br />
Participants)<br />
Reported Rates<br />
Across Studies<br />
Cushingoid appearance 110,112 2 (5/100) 3%-10%<br />
Hypopigmentation 110 1 (2/70) 3%<br />
Periocular calcification 121 1 (1/34) 3%<br />
Abscess at injection site 111 1 (1/27) 4%<br />
Subcutaneous fat atrophy 111 1 (1/27) 4%<br />
Ulceration 120 1 (130/628) 21%<br />
Skin atrophy 120 1 (106/628) 17%<br />
Hypopigmentation 120 1 (101/628) 16%<br />
Infection 120 1 (91/628) 14%<br />
Cushingoid appearance 120 1 (37/628) 6%<br />
Growth retardation 120 1 (37/628) 6%<br />
Hypertension 120 1 (30/628) 5%<br />
Intralesional triamcinolone ** Ulceration 114,120 2 (150/1046) 4%-16%<br />
Infection 109,120 2 (105/991) 2%-12%<br />
Anaphylactic shock 115 1 (3/155) 2%<br />
Hypopigmentation 114,120 2 (93/1046) 1%-10%<br />
Peptic ulcer 114 1 (2/160) 1%<br />
* Skin atrophy 109,115,120 3 (106/1146) 0.95%-11%<br />
Entropion 114 1 (1/160) 0.63%<br />
Cushingoid appearance 115,120 2 (6/1041) 0.45%-1%<br />
Growth retardation 120 1 (4/886) 0.45%<br />
Hypertension 120 1 (1/886) 0.11%<br />
Intralesional<br />
betamethasone+dexamethasone<br />
Bruising at injection site 124 1 (NR/36) NR<br />
32
Table 9. Adverse effects in case series <strong>of</strong> steroids to treat IH (continued)<br />
Number Of<br />
Studies<br />
Intervention<br />
Harm/Adverse Event<br />
(# Participants<br />
With Harm/Total<br />
Participants)<br />
Oral prednisone or<br />
prednisolone<br />
Cushingoid appearance 116 1 (44/62) 71%<br />
Diminished weight gain 116 1 (26/62) 42%<br />
Diminished height gain 116 1 (22/62) 35%<br />
Irritable <strong>and</strong>/or napped less 116 1 (18/62) 29%<br />
Personality change 116 1 (18/62) 29%<br />
Gastric irritation 116 1 (13/62) 21%<br />
Insomnia 116 1 (8/62) 13%<br />
Fungal (oral or perineal) infection 116 1 (4/62) 6%<br />
Recurrent otitis media 116 1 (4/62) 6%<br />
Corticosteroid myopathy 116 1 (1/62) 2%<br />
Hypertension 116 1 (1/62) 2%<br />
Reported Rates<br />
Across Studies<br />
Oral prednisolone Cushingoid appearance 113,120 2 (26/524) 4%-20%<br />
Infection 120 1 (55/499) 11%<br />
Growth retardation 120 1 (21/499) 4%<br />
Hypertension 120 1 (20/499) 4%<br />
Skin atrophy 120 1 (16/499) 3%<br />
Ulceration 120 1 (13/499) 3%<br />
Hypopigmentation 120 1 (7/499) 1%<br />
Oral prednisone Cushingoid appearance 117 1 (32/60) 53%<br />
Behavior changes 117 1 (60/60) 100%<br />
Growth retardation 117 2 (2/60) 3%<br />
Osteoporosis 117 1 (1/60) 2%<br />
IH = infantile hemangioma; n = number; NR = Not reported<br />
* One study 109 reported “atrophy <strong>and</strong> ulceration.”<br />
** One study <strong>of</strong> intralesional triamcinolone reported “no systemic side effects.” 123 Another reported unspecified complications in<br />
3/30 children with complicated IH receiving intralesional triamcinolone. 125 Two other studies reported harms in the aggregate<br />
only <strong>and</strong> not by specific agent 127,129 <strong>and</strong> are thus not included in this table.<br />
† Two studies reported that there were no adverse effects with intralesional triamcinolone+betamethasone in 42 children with<br />
orbital IH 126 or eyelid IH. 128<br />
Harms Reported in Package Insert Data<br />
The safety <strong>and</strong> efficacy <strong>of</strong> pediatric use <strong>of</strong> corticosteroids has been studied in the literature<br />
for the treatment <strong>of</strong> nephrotic syndrome (>2 years <strong>of</strong> age), <strong>and</strong> aggressive lymphomas <strong>and</strong><br />
leukemias (>1 month <strong>of</strong> age). 134-139 It has been reported that the adverse events identified in<br />
pediatric patients were similar to the events experienced in adults. Monitoring pediatric patients<br />
for blood pressure, weight, height, intraocular pressure, <strong>and</strong> clinical evaluation for the presence<br />
<strong>of</strong> infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, <strong>and</strong><br />
osteoporosis is recommended. Specifically, pediatric patients may have a decrease in growth<br />
velocity after taking corticosteroids by any route <strong>of</strong> administration. Therefore, children should be<br />
titrated to the lowest effective dose.<br />
Common adverse events <strong>of</strong> corticosteroids include: fluid retention, alteration in glucose<br />
tolerance, elevation in blood pressure, behavioral <strong>and</strong> mood changes, increased appetite <strong>and</strong><br />
weight gain. 134-142 Additional adverse events include: anaphylactoid reaction, anaphylaxis,<br />
angioedema, bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory<br />
collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in<br />
premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema,<br />
syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, acne, allergic dermatitis,<br />
cutaneous <strong>and</strong> subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or<br />
33
hypopigmentation, impaired wound healing, increased sweating, petechiae <strong>and</strong> ecchymoses,<br />
rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp<br />
hair, urticaria, abnormal fat deposits, decreased carbohydrate tolerance, development <strong>of</strong><br />
Cushingoid state, hirsutism, manifestations <strong>of</strong> latent diabetes mellitus <strong>and</strong> increased requirements<br />
for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon faces,<br />
secondary adrenocortical <strong>and</strong> pituitary unresponsiveness (particularly in times <strong>of</strong> stress, as in<br />
trauma, surgery or illness), suppression <strong>of</strong> growth in children, potassium loss, hypokalemic<br />
alkalosis, sodium retention, abdominal distention, elevation in serum liver enzymes levels<br />
(usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis,<br />
peptic ulcer with possible perforation <strong>and</strong> hemorrhage, ulcerative esophagitis, osteonecrosis <strong>of</strong><br />
femoral <strong>and</strong> humeral heads, Charcot-like arthropathy, loss <strong>of</strong> muscle mass, muscle weakness,<br />
osteoporosis, pathologic fracture <strong>of</strong> long bones, steroid myopathy, tendon rupture, vertebral<br />
compression fractures, arachnoiditis, convulsions, depression, emotional instability, euphoria,<br />
headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually<br />
following discontinuation <strong>of</strong> treatment, insomnia, meningitis, mood swings, neuritis, neuropathy,<br />
paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo,<br />
exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts,<br />
alteration in motility <strong>and</strong> number <strong>of</strong> spermatozoa.<br />
We also identified safety data for another steroid evaluated in studies in this review,<br />
mometasone furoate. The use <strong>of</strong> this medication in pediatric patients (>2 years) is not<br />
recommended for more than 3 weeks. 143 This medication is administered topically, <strong>and</strong> pediatric<br />
patients will have an increase in the skin surface area to body mass ratio. As a result, adverse<br />
events such as hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, adrenal<br />
insufficiency upon cessation, skin atrophy, striae, linear growth retardation, delayed weight gain,<br />
<strong>and</strong> intracranial hypertension are more likely to occur in pediatric patients. We report additional<br />
harms data form package inserts <strong>and</strong> U.S. Food <strong>and</strong> Drug Administration (FDA) approval<br />
documents in Appendix H.<br />
Effectiveness <strong>and</strong> Harms <strong>of</strong> Beta-Blockers<br />
Key Points<br />
Propranolol Versus Observation or Placebo<br />
• In our network meta-analysis, oral propranolol was associated with a mean estimate <strong>of</strong><br />
expected clearance <strong>of</strong> IH <strong>of</strong> 95% (95% BCI: 88% to 99%) compared with 6 percent (95%<br />
BCI: 1% to 11%) for placebo or observation arms (high SOE for greater effectiveness <strong>of</strong><br />
propranolol versus placebo or observation).<br />
• Oral propranolol at doses <strong>of</strong> 2-3 mg/kg/day divided two to three times daily <strong>and</strong> given for<br />
up to 6 months promoted resolution or near resolution <strong>of</strong> IH in children under the age <strong>of</strong><br />
12 months with superficial, deep, mixed, or ulcerated IH in most studies.<br />
• Adverse events, measured in the short-term only, associated with these doses <strong>of</strong><br />
propranolol in this same population were limited in frequency <strong>and</strong> severity (moderate<br />
SOE association <strong>of</strong> propranolol with clinically important <strong>and</strong> minor harms).<br />
34
Propranolol Versus Other Active Modalities<br />
• In network meta-analysis, oral propranolol was associated with a mean estimate <strong>of</strong><br />
expected clearance <strong>of</strong> IH <strong>of</strong> 95% (95% BCI: 88% to 99%) compared with a lower rate for<br />
oral steroids (43% [95% BCI: 21% to 66%]), while in head-to-head comparisons three<br />
small studies found propranolol was more effective than corticosteroids, <strong>and</strong> two did not<br />
find a significant difference in effectiveness between the two therapies. Combined effects<br />
from individual studies <strong>and</strong> network meta-analysis conferred moderate SOE for the<br />
superiority <strong>of</strong> propranolol over steroids at achieving IH clearance.<br />
• In one cohort study comparing the effects <strong>of</strong> intralesional steroids <strong>and</strong> oral propranolol on<br />
vision outcomes, improvement in amblyopia did not differ between agents, but fewer<br />
children receiving propranolol required additional treatments or had side effects than<br />
those receiving steroids.<br />
• Propranolol combined with pulsed dye laser (PDL), either concurrently or sequentially,<br />
was more effective than propranolol alone in one study.<br />
• In a study comparing oral propranolol with intralesional bleomycin, 6 <strong>of</strong> 10 children in<br />
each arm had at least 75 percent clearance <strong>of</strong> IH.<br />
• One study found that patients who received propranolol had a lower likelihood <strong>of</strong><br />
subsequent laser treatment than those who received other interventions.<br />
• Propranolol was associated with faster healing <strong>of</strong> ulceration versus historical treatments<br />
including laser <strong>and</strong> antibiotics.<br />
Oral Propranolol Versus Other Beta-Blockers or Dosage Forms<br />
• Other oral beta-blockers (atenolol, nadolol) investigated in three studies were reported to<br />
be effective in promoting IH resolution <strong>and</strong> potentially associated with fewer adverse<br />
events than propranolol (low SOE for no difference in response <strong>of</strong> IH to propranolol,<br />
nadolol, or atenolol).<br />
Timolol Versus Placebo/Observation or Other Active Modalities<br />
• In our network meta-analysis, topical timolol had a mean expected clearance rate <strong>of</strong> 62<br />
percent (95% BCI: 39% to 83%) compared with 6 percent (95% BCI: 1% to 11%) for<br />
placebo or observation (low SOE for effectiveness <strong>of</strong> timolol versus placebo or<br />
observation).<br />
• Topical timolol 0.5 percent maleate gel promoted improvement <strong>of</strong> superficial IH without<br />
reported adverse effects in four comparative studies (low SOE for lack <strong>of</strong> association<br />
with harms). Studies reported effectiveness at 24 weeks with the noticeable change in IH<br />
lesions occurring approximately 12 to 16 weeks after initiation <strong>of</strong> treatment.<br />
Overview <strong>of</strong> the Literature<br />
We identified a total <strong>of</strong> 81 studies (nine RCTs, 14,17,92,93,98-100,102,104 16 cohort studies, 95-<br />
97,101,103,105,106,130-133,144-150<br />
<strong>and</strong> 56 case series 16,18,151-205 ) addressing beta-blockers including<br />
propranolol, atenolol, nadolol, <strong>and</strong> timolol. Comparative studies addressed the following<br />
interventions <strong>and</strong> comparators: propranolol compared with observation or placebo arms,<br />
propranolol compared with other active modalities (e.g., steroids), oral propranolol compared<br />
with other beta-blockers or dosage forms, <strong>and</strong> timolol compared with observation/placebo or<br />
another modality (e.g., laser). Comparative studies included a total <strong>of</strong> 1539 children between the<br />
ages <strong>of</strong> less than one month to 9 years. We considered four RCTs to be good quality <strong>and</strong> five as<br />
35
fair quality for effectiveness outcomes <strong>and</strong> 11 cohort studies as fair quality <strong>and</strong> five as poor<br />
quality for effectiveness outcomes.<br />
Propranolol Versus Observation or Placebo<br />
We identified four studies (two good 17,92 <strong>and</strong> one fair 99 quality RCTs <strong>and</strong> one fair quality<br />
cohort study 94 ) evaluating propranolol versus placebo or observation. Propranolol was associated<br />
with significantly greater clearance <strong>of</strong> IH compared with the control arm in all four studies. In<br />
the largest RCT, which included 456 children without problematic IH receiving up to 3<br />
mg/kg/day <strong>of</strong> propranolol, 60 percent <strong>of</strong> children in the propranolol group had complete or near<br />
complete resolution <strong>of</strong> IH after 24 weeks <strong>of</strong> treatment compared with 4 percent in the placebo<br />
group. 92 The recommended dose <strong>of</strong> propranolol in this IH population remains to be determined,<br />
but the majority <strong>of</strong> studies to date have investigated the 2 mg/kg/day dosing regimen. Despite<br />
changes in lesion size in many children receiving propranolol, some children do not appear to<br />
respond to propranolol, but these children are not well-characterized to date.<br />
In network meta-analysis, the mean expected clearance rate for oral propranolol was 95<br />
percent (95% BCI: 88% to 99%) relative to 6 percent (95% BCI: 1% to 11%) for<br />
placebo/observation arms; IH size reductions were greater in propranolol arms versus control in<br />
all individual studies, thus we considered the SOE as high for greater effectiveness <strong>of</strong><br />
propranolol compared with placebo or observation based on individual comparisons <strong>and</strong> the<br />
meta-analysis.<br />
Propranolol Versus Other Active Modalities<br />
Ten studies compared propranolol to another modality including steroids, pulse dye laser<br />
(PDL), bleomycin, or historical treatments. 95-98,130-133,145,149,150 Studies comparing propranolol<br />
<strong>and</strong> steroids to reduce IH size had conflicting findings. Propranolol was more effective than<br />
steroids in three studies, 96,97,132,133 while two others studies did not find effectiveness differed<br />
significantly between these treatments. 98,130 In network meta-analysis, pooling data from multiple<br />
studies, propranolol was superior to oral steroids (95% clearance [95% BCI: 88% to 99%])<br />
versus 43% clearance (95% BCI: 22% to 66%). These combined effects from individual studies<br />
<strong>and</strong> meta-analysis conferred moderate SOE for superiority <strong>of</strong> propranolol over steroids at<br />
achieving clearance.<br />
One additional retrospective cohort study assessing only vision outcomes reported no<br />
significant differences between oral propranolol <strong>and</strong> intralesional steroids in improving<br />
amblyopia, but children in the propranolol arm had a significantly shorter duration <strong>of</strong> therapy<br />
(p
Oral Propranolol Versus Other Beta-blockers or Dosage Forms<br />
Three small studies compared propranolol with nadolol 101 or atenolol, 102,146,147 <strong>and</strong> one study<br />
evaluated oral, intralesional, <strong>and</strong> topical propranolol. 93 Atenolol <strong>and</strong> nadolol demonstrated<br />
promising effects on lesion size (no significant differences in effectiveness <strong>of</strong> propranolol <strong>and</strong><br />
atenolol <strong>and</strong> greater effectiveness in a small study comparing nadolol <strong>and</strong> propranolol) <strong>and</strong> low<br />
levels <strong>of</strong> adverse effects, which may suggest that improvements can be achieved in the<br />
propranolol safety pr<strong>of</strong>ile. More children receiving oral propranolol had an excellent or good<br />
level <strong>of</strong> resolution than those receiving topical or intralesional (n=11/15, 8/15, 5/15,<br />
respectively), but the difference among groups was not significant. 93<br />
In head-to-head comparisons, there were no significant differences in response between<br />
propranolol <strong>and</strong> atenolol in two studies <strong>and</strong> better response to nadolol versus propranolol in one<br />
small study. We considered the SOE as low for no difference in response with propranolol,<br />
nadolol, or atenolol (systemic beta-blockers).<br />
Timolol Versus Placebo/Observation or Other Active Modality<br />
Six comparative studies addressed timolol (two RCTs 14,104 <strong>and</strong> four cohort<br />
studies 103,105,106,144 ). All studies included children with superficial IH, <strong>and</strong> two (one comparing<br />
timolol with observation <strong>and</strong> one comparing timolol <strong>and</strong> laser) also included children with mixed<br />
(superficial <strong>and</strong> deep) IH. 14,144 Timolol was significantly more effective than observation or<br />
placebo in three studies, 103,104,144 <strong>and</strong> one study comparing imiquimod with timolol did not<br />
demonstrate that one intervention was more effective than the other. 105 In one study comparing<br />
timolol <strong>and</strong> PDL+Nd:YAG laser, timolol was associated with greater improvements in<br />
superficial lesions, while laser was associated with greater improvements in mixed (superficial<br />
<strong>and</strong> deep) lesions. 106 In another comparing timolol alone with timolol plus PDL, mean global<br />
assessment scores were more improved in the combination arm than in the timolol arm, though<br />
IH in 97 percent <strong>of</strong> children in both arms improved from baseline. 14 No harms <strong>of</strong> timolol were<br />
observed in any study.<br />
In network meta-analysis, the mean expected clearance rate for topical timolol was 62<br />
percent (95% BCI: 39% to 83%) relative to 6 percent (95% BCI: 1% to 11%) for placebo or<br />
observation arms. We considered SOE as low for the effectiveness <strong>of</strong> timolol compared with<br />
placebo or observation.<br />
Harms <strong>of</strong> Beta-blockers<br />
In addition to these comparative studies, a total <strong>of</strong> 56 case series addressed harms <strong>of</strong> betablockers<br />
for IH. 16,18,151-205 We assessed four case series as good quality for harms<br />
reporting, 168,171,181,186 one as fair quality, 182 <strong>and</strong> 51 as poor quality. 16,18,151-167,169,170,172-180,183-185,187-<br />
205<br />
Twenty-four comparative studies also reported harms data, <strong>and</strong> we assessed four as good<br />
quality for harms reporting 92,98,104,105 <strong>and</strong> the remainder as poor quality for harms<br />
reporting. 14,17,93-97,99-103,106,130-133,144-147,150 Harms most frequently reported with use <strong>of</strong> oral betablockers<br />
(propranolol, atenolol, nadolol) included sleep disturbances, cold extremities,<br />
gastrointestinal symptoms, bronchial irritation (classified as hyperreactivity, bronchospasm,<br />
bronchiolitis, cold induced wheezing), <strong>and</strong> decreases in blood pressure or heart rate. Rates <strong>of</strong><br />
significant clinically important harms ranged from 0 to 100 percent across studies <strong>of</strong> propranolol<br />
<strong>and</strong> from 1 percent to 50 percent for minor harms. We considered SOE as moderate for the<br />
association <strong>of</strong> propranolol with these harms. Data were insufficient to comment on harms in<br />
37
studies <strong>of</strong> nadolol <strong>and</strong> atenolol. No harms were observed in four small studies <strong>of</strong> timolol. We<br />
considered SOE to be low for lack <strong>of</strong> association <strong>of</strong> timolol with harms.<br />
Detailed Analysis<br />
Propranolol Versus Placebo or Observation<br />
One good quality RCT conducted in 56 centers in 16 countries r<strong>and</strong>omized 460 infants with a<br />
proliferating IH measuring at least 1.5 cm in diameter to treatment with either placebo twice<br />
daily for 6 months (n=55) or one <strong>of</strong> four oral propranolol treatment regimens (1 mg/kg/day <strong>of</strong><br />
propranolol divided twice daily for 3 months (n= 99) or 6 months (n= 103); 3 mg/kg/day <strong>of</strong><br />
propranolol divided twice daily for 3 months (n= 101) or 6 months (n= 102). 92 Two independent,<br />
trained, validated readers centrally assessed digital photographs taken at each patient’s 15 study<br />
visits for complete or nearly complete resolution, hemangioma evolution, <strong>and</strong> change in<br />
hemangioma size <strong>and</strong> color. Investigators at each site performed these same assessments, <strong>and</strong><br />
assessed complications, adverse events, <strong>and</strong> use <strong>of</strong> other treatment for IH. Parents or guardians<br />
also assessed changes in IH since the previous visit.<br />
Overall, 61 <strong>of</strong> 101 patients (60%) assigned to propranolol 3mg/kg/day for 6 months <strong>and</strong> 2 <strong>of</strong><br />
55 patients (4%) assigned to placebo had complete or near complete resolution <strong>of</strong> hemangioma at<br />
week 24 (p
placebo group (p values ≤ 0.07). Of the 19 patients treated with propranolol, two responded only<br />
minimally (start <strong>of</strong> treatment at ages 5.5 <strong>and</strong> 11 months).<br />
In one fair quality cohort study conducted in India, thirty-three children up to 10 years <strong>of</strong> age<br />
with IH requiring treatment due to airway obstruction, ocular occlusion or compression, aesthetic<br />
disfigurement or ulceration, who may have failed other treatment modalities, <strong>and</strong> those patients<br />
greater than 12 months <strong>of</strong> age with continuous proliferation <strong>of</strong> their IH without signs <strong>of</strong><br />
resolution were treated with propranolol at a dose <strong>of</strong> 2 mg/kg/day divided twice daily. 94 The<br />
study compared these participants with historical controls who had not previously received<br />
therapy. Significant involution defined as a score <strong>of</strong> 5 to 9 on a 10-point scale (10=no change in<br />
original IH, 0=normal skin) was seen in 28/31 (90.3%). All children 6 months <strong>of</strong> age <strong>and</strong><br />
younger responded (20/20, 100%). No child greater than 36 months <strong>of</strong> age (0/2, 0%) responded<br />
to propranolol. Sixty-five to 80 percent <strong>of</strong> involution occurred in the first 8 weeks <strong>of</strong> propranolol<br />
therapy. The overall mean involution score for the propranolol group compared with the control<br />
group was 4.37 versus 8.38 (p< 0.0001). Table 10 outlines resolution outcomes in these studies.<br />
Table 10. Key resolution outcomes in RCTs comparing propranolol <strong>and</strong> placebo or observation<br />
Author, Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
Leaute-Labreze<br />
et al. 2015 92<br />
G1: Propranolol,<br />
oral 3mg/kg/day<br />
for 6 months<br />
(102)<br />
G2: Propranolol,<br />
oral 3mg/kg/day<br />
for 3 months<br />
(101)<br />
G3: Propranolol,<br />
oral 1mg/kg/day<br />
for 6 months<br />
(103)<br />
G4: Propranolol,<br />
oral 1mg/kg/day<br />
for 3 months<br />
(99)<br />
G5: placebo<br />
(55)<br />
Quality: Good<br />
Age<br />
Type<br />
Age, days<br />
mean±SD<br />
G1: 101.6 ±<br />
31.0<br />
G2: 107.5 ±<br />
30.1<br />
G3: 102.6 ±<br />
30.1<br />
G4: 103.6 ±<br />
33.1<br />
G5: 103.9 ±<br />
31.1<br />
Type, n (%)<br />
Segmental<br />
G1: 5 (5)<br />
G2: 7 (7)<br />
G3: 7 (7)<br />
G4: 4 (4)<br />
G5: 2 (4)<br />
Localized<br />
G1: 91 (90)<br />
G2: 88 (88)<br />
G3: 90 (88)<br />
G4: 89 (91)<br />
G5: 48 (87)<br />
Indeterminate<br />
G1: 5 (5)<br />
G2: 5 (5)<br />
G3: 5 (5)<br />
G4: 5 (5)<br />
G5: 5 (9)<br />
Location<br />
G1+G2+G<br />
3+G4+G5:<br />
Multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Serial<br />
photographs<br />
<strong>and</strong> clinical<br />
assessment by<br />
blinded<br />
investigators<br />
• Nearly<br />
complete<br />
resolution<br />
defined as<br />
minimal<br />
degree <strong>of</strong><br />
telangiectasis,<br />
erythema, skin<br />
thickening,<br />
s<strong>of</strong>t-tissue<br />
swelling, <strong>and</strong><br />
distortion <strong>of</strong><br />
anatomic<br />
l<strong>and</strong>marks<br />
Resolution<br />
Outcomes<br />
Complete or<br />
nearly<br />
complete<br />
resolution at<br />
24 weeks, n<br />
(%)<br />
G1: 61/101<br />
(60%)<br />
G5: 2/25 (4%)<br />
p< 0.0001<br />
Rebound Growth/<br />
Recurrence, n (%)<br />
Other Outcomes<br />
Need for additional<br />
treatment<br />
• 6 (10%) assigned to<br />
propranolol required<br />
systemic treatment<br />
from week 24 to week<br />
96<br />
• 7 (11%) required any<br />
additional hemangioma<br />
treatment<br />
39
Table 10. Key resolution outcomes in RCTs comparing propranolol <strong>and</strong> placebo or observation<br />
(continued)<br />
Author, Year<br />
Methods <strong>and</strong> Resolution Rebound Growth/<br />
Age<br />
Comparison<br />
Measures <strong>of</strong> Outcomes Recurrence, n (%)<br />
Location<br />
Groups (n)<br />
Resolution/<br />
Type<br />
Quality<br />
Response<br />
Other Outcomes<br />
Leaute-Labreze<br />
et al. 2013 99<br />
G1: Propranolol,<br />
oral 3-4<br />
mg/kg/day for 1<br />
month (7)<br />
G2: Placebo (7)<br />
Age, weeks<br />
mean±SD<br />
G1: 12.5 ± 2.1<br />
G2: 12.4 ± 2.6<br />
Type:<br />
NR<br />
G1+G2:<br />
multiple<br />
• Change in<br />
thickness as<br />
measured by<br />
ultrasound<br />
• Double-blinded<br />
assessment <strong>of</strong><br />
change<br />
Mean change<br />
in thickness, 5<br />
[95% CI]<br />
G1: -44.9%<br />
[36-76.2p<br />
G2: +11.3%<br />
G1 vs G2:<br />
p=0.004<br />
• NR<br />
Quality: Fair<br />
Percentage<br />
change in size<br />
G1: -15.8<br />
G2: +8.9<br />
G1 vs G2:<br />
p=0.041<br />
Hogeling et al.<br />
2011 17<br />
G1: Propranolol<br />
oral,<br />
2mg/kg/day in 3<br />
daily doses (19)<br />
G2: Placebo<br />
(20)<br />
Quality: Good<br />
Mean weeks,<br />
n<br />
G1: 67<br />
G2: 71<br />
Type<br />
Focal, n<br />
G1: 16<br />
G2: 17<br />
Segmental<br />
G1: 3<br />
G2: 3<br />
G1+G2:<br />
multiple<br />
• Photographs<br />
<strong>and</strong> serial<br />
hemispheric<br />
measurements<br />
<strong>of</strong> tumor<br />
volume<br />
assessed by<br />
blinded<br />
investigators<br />
Percent<br />
change in<br />
volume at 24<br />
weeks<br />
G1: -60%<br />
(n=18)<br />
G2: -14.1%<br />
(n=15)<br />
Difference<br />
between group<br />
-45.9 (95% CI:<br />
-80.3, -11.4)<br />
p=0.01<br />
• NR<br />
40
Table 10. Key resolution outcomes in RCTs comparing propranolol <strong>and</strong> placebo or observation,<br />
continued<br />
Author, Year<br />
Methods <strong>and</strong> Resolution Rebound Growth/<br />
Age<br />
Comparison<br />
Measures <strong>of</strong> Outcomes Recurrence, n (%)<br />
Location<br />
Groups (n)<br />
Resolution/<br />
Type<br />
Quality<br />
Response<br />
Other Outcomes<br />
Sondhi et al.<br />
2013 94<br />
G1: Propranolol<br />
oral,<br />
2mg/kg/day (31)<br />
G2: No<br />
treatment,<br />
historical<br />
controls (14)<br />
Quality: Fair<br />
Age, mean<br />
months<br />
(range)<br />
G1: 10.8 (1<br />
mo-9 years)<br />
G2: 8.6 (3-20<br />
mo)<br />
Type, n:<br />
Superficial<br />
G1: 11<br />
G2: 6<br />
Mixed<br />
G1: 9<br />
G2: 3<br />
Deep<br />
G1: 11<br />
G2: 5<br />
G1+G2:<br />
multiple<br />
• Photographs,<br />
color <strong>and</strong> size<br />
scored; degree<br />
<strong>of</strong> involution<br />
assessed by<br />
blinded<br />
investigators<br />
• Change score:<br />
0 considered<br />
completely<br />
normal skin, 10<br />
no change in<br />
IH from pretreatment<br />
Involution<br />
Significant<br />
involution (><br />
50%), n (%)<br />
G1: 28 (90.3)<br />
G2: 4 (28.6)<br />
Some<br />
involution<br />
(11%- 50%), n<br />
(%)<br />
G1: 0<br />
G2: 2 (14.3)<br />
No involution (≤<br />
10%), n (%)<br />
G1: 3 (9.7)<br />
G2: 6 (42.8)<br />
Overall mean<br />
score<br />
G1: 4.37 (95%<br />
CI: 3.15 to<br />
5.59)<br />
G2: 8.38 (95%<br />
CI: 7.71 to<br />
9.01)<br />
G1 vs.G2<br />
p
old. 100 Thirty percent <strong>of</strong> children with IH in the head <strong>and</strong> neck area had parotid IH, <strong>and</strong> 53<br />
percent <strong>of</strong> lesions overall were superficial (27% mixed, 20% deep). IH reduction from baseline<br />
was greater in the propranolol alone <strong>and</strong> propranolol plus prednisolone arms compared with the<br />
prednisolone arm (p values
Table 11. Resolution outcomes in studies comparing beta-blockers <strong>and</strong> steroids<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Baumann et al. 2014 98<br />
G1: Propranolol,<br />
2mg/kg/day in 3 daily<br />
doses (11)<br />
G2: Prednisolone,<br />
2mg/kg/day in two daily<br />
doses (8)<br />
Quality: Good<br />
Age, Months<br />
Type<br />
Age, mean<br />
(95% CI)<br />
G1: 2.5 (1.7-<br />
3.4)<br />
G2: 4.0 (2.8-<br />
5.2<br />
Type, n:<br />
Superficial<br />
G1: 3<br />
G2: 2<br />
Location<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Size measured by<br />
proportional<br />
change in total<br />
surface area<br />
(TSA) by blinded<br />
assessors<br />
Resolution<br />
Outcomes<br />
Change in size at<br />
4-5 months, TSA<br />
mean (95% CI)<br />
G1: 0.57 (0.34 to<br />
0.80) n=9<br />
G2: 0.63 (0.14 to<br />
1.11) n=6<br />
G1 vs. G2: p=ns<br />
Rebound<br />
Growth/<br />
Recurrence,<br />
n<br />
Other<br />
Outcomes,<br />
n (%)<br />
G1: 2<br />
G2: 1<br />
Mixed<br />
G1: 6<br />
G2: 4<br />
Deep<br />
G1: 2<br />
G2: 2<br />
Bertr<strong>and</strong> et al. 2011 96<br />
G1: Propranolol, oral<br />
2.7 mg/kg/day (12)<br />
G2: Prednisone, oral<br />
2.8 mg/kg/day (12)<br />
Quality: Fair<br />
Age, mean<br />
(range)<br />
G1: 3.7 (1.5-<br />
8.7)<br />
G2: 3.8 (1-9)<br />
Type, n:<br />
Superficial<br />
G1+G2: 2<br />
pairs<br />
Mixed<br />
G1+G2: 6<br />
pairs<br />
Deep<br />
G1+G2: 4<br />
pairs<br />
G1+G2:<br />
multiple<br />
• Photographs rated<br />
by blinded<br />
assessors for<br />
percentage <strong>of</strong><br />
improvement<br />
Stable or worse<br />
(0%)<br />
Slight<br />
improvement<br />
(75%)<br />
• Visual analog<br />
scale (VAS) used<br />
at 6 months (100<br />
complete<br />
resolution, 0 no<br />
change, -100<br />
doubling in size)<br />
Clinical<br />
improvement<br />
VAS, mean ± SD<br />
G1: 78.73 ± 22.47<br />
G1: 44.82 ± 12.21<br />
G1 vs.G2<br />
ICC=0.833 p<<br />
0.001<br />
Good to excellent<br />
response at 6<br />
months, n<br />
G1: 12<br />
Slight to moderate<br />
response<br />
G2: 9<br />
NR<br />
43
Table 11. Resolution outcomes in studies comparing beta-blockers <strong>and</strong> steroids (continued)<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Price et al. 2011 97<br />
G1: Propranolol, oral<br />
2/mg/kg/day in two daily<br />
doses (68)<br />
G2: Corticosteroids, oral<br />
2-4 mg/kg/day (42)<br />
Quality: Fair<br />
Age, Months<br />
Type<br />
Age, mean<br />
G1: 4.9<br />
G2: 4.5<br />
Type<br />
NR<br />
Location<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Degree <strong>of</strong><br />
clearance<br />
achieved reported<br />
as either<br />
1. ≥75% defined<br />
by correlating<br />
percentage <strong>of</strong><br />
decrease in<br />
volume,<br />
cosmetically<br />
acceptable result<br />
by physician<br />
<strong>and</strong>/or parent <strong>and</strong><br />
no need for further<br />
treatment or<br />
2.
Table 11. Resolution outcomes in studies comparing beta-blockers <strong>and</strong> steroids (continued)<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Hoornweg et al. 2014 131<br />
G1: Propranolol, oral 1-<br />
3/mg/kg/day (14)<br />
G2: Intralesional<br />
triamcinolone acetonide<br />
<strong>and</strong> methylprednisolone<br />
(29)<br />
Quality: Fair<br />
Age, Months<br />
Type<br />
Age, median<br />
(IQR)<br />
G1: 2.66<br />
(1.78)<br />
G2: 2.92<br />
(2.53)<br />
Type, %<br />
Proliferation<br />
G1: 93<br />
G2: 86<br />
Involution<br />
G1: 7<br />
G2: 14<br />
Location<br />
G1+G2:<br />
periorbital<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
Resolution<br />
Outcomes<br />
Rebound<br />
Growth/<br />
Recurrence,<br />
n<br />
Other<br />
Outcomes,<br />
n (%)<br />
• NR NR Level <strong>of</strong><br />
amblyopia<br />
0<br />
G1: 12 (86)<br />
G2: 11 (61)<br />
1<br />
G1: 1 (7)<br />
G2: 3 (17)<br />
2<br />
G1: 1 (7)<br />
G2: 0<br />
3<br />
G1: 0<br />
G2: 1 (6)<br />
4<br />
G1: 0<br />
G2: 2 (11)<br />
Need for<br />
additional<br />
therapies to<br />
reduce IH<br />
size<br />
G1: 1 (7)<br />
G2: 10 (34)<br />
G1 vs. G2:<br />
p=NS<br />
Duration <strong>of</strong><br />
therapy,<br />
median<br />
months<br />
(IQR)<br />
G1: 6.5<br />
(4.87)<br />
G2: 15.9<br />
(10.3)<br />
G1 vs G2:<br />
p
Table 11. Resolution outcomes in studies comparing beta-blockers <strong>and</strong> steroids (continued)<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Malik et al. 2013 100<br />
G1: Propranolol, oral 2-<br />
3/mg/kg/day in two daily<br />
doses (10)<br />
G2: Prednisolone, oral<br />
1-4 mg/kg/day (10)<br />
G3: Propranolol, oral 2-<br />
3/mg/kg/day <strong>and</strong><br />
Prednisolone, oral 1-4<br />
mg/kg/day (10)<br />
Quality: Fair<br />
Rossler et al, 2012 132,133<br />
G1: Oral propranolol, 2<br />
mg/kg/day (30)<br />
G2: Oral prednisone, 2<br />
mg/kg/day then reduced<br />
to 1 mg/kg/day (30)<br />
Quality: Poor<br />
Age, Months<br />
Type<br />
Age, mean<br />
G1: 4.6<br />
G2: 5.5<br />
G3: 4.7<br />
Type, %<br />
Superficial<br />
G1+G2+G3:<br />
53<br />
Mixed<br />
G1+G2+G3:<br />
26.7<br />
Deep<br />
G1+G2+G3:<br />
20<br />
Age, mean<br />
G1: 4.4<br />
G2: 2.8<br />
Type: NR<br />
Location<br />
G1+G2+G<br />
3: multiple<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Photographs<br />
assessed by 2<br />
blinded assessors<br />
• Color <strong>and</strong> size<br />
based on Visual<br />
Analog Scale<br />
(VAS)<br />
• Improvement<br />
graded as:<br />
75-100%<br />
50-74%<br />
25-49%<br />
0-24%<br />
• Size measuring<br />
length <strong>and</strong> width<br />
• Blinded<br />
assessment: NR<br />
• IH score based on<br />
color, skin level,<br />
<strong>and</strong> turgor (scale<br />
0-6)<br />
Resolution<br />
Outcomes<br />
Mean size<br />
reduction %, VAS<br />
G1: 89.8<br />
G2: 66.6<br />
G3: 82.6<br />
Color fading, VAS<br />
G1: -9<br />
G2: -8<br />
G3: -9<br />
Median size at<br />
end <strong>of</strong> therapy<br />
G1: 2.0 cm 2<br />
G2: 3.5 cm 2<br />
G1 vs G2:<br />
p=0.006<br />
Median score<br />
G1: 2<br />
G2: 3<br />
G1 vs G2:<br />
p
Table 12. Resolution outcomes in studies comparing intralesional propranolol <strong>and</strong> triamcinolone<br />
Rebound<br />
Resolution Growth/<br />
Age, Months<br />
Outcomes Recurrence<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Awadein et al. 2011 130<br />
G1: Propranolol,<br />
intralesional 1mg/ml<br />
(12)<br />
G2: Triamcinolone,<br />
intralesional<br />
40mg/ml(10)<br />
Quality: Poor<br />
Type<br />
Age,<br />
mean±SD<br />
G1: 5.9±2.7<br />
G2: 6.1±2.9<br />
Type<br />
NR<br />
Location<br />
G1+G2:<br />
Periocular<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Size measured<br />
by clinical<br />
examination<br />
<strong>and</strong><br />
photography<br />
• Response<br />
graded as:<br />
Excellentcomplete<br />
resolution<br />
achieved<br />
Goodsustained<br />
plateau with ≥<br />
50% reduction<br />
Fair-sustained<br />
plateau with <<br />
50% reduction<br />
Poor-no<br />
response or<br />
worsening<br />
• Blinded<br />
assessment:<br />
NR<br />
Regression <strong>of</strong> IH<br />
G1:10/12 (83%)<br />
G2: 8/10 (80%)<br />
Response<br />
Excellent<br />
response<br />
G1:5/12 (42%)<br />
G2: 4/10 (40%)<br />
Good<br />
G1:3/12 (25%)<br />
G2: 2/10 (20%)<br />
Fair<br />
G1:2/12 (17%)<br />
G2: 2/10 (20%)<br />
Poor<br />
G1:2/12 (17%)<br />
G2: 2/10 (20%)<br />
Other<br />
Outcomes<br />
Rebound<br />
growth, n<br />
G1:4<br />
G2: 3<br />
Abbreviations: G = group; IH = infantile hemangioma; mg = milligram; ml = milliliter; n= number; NR = not reported;<br />
SD = st<strong>and</strong>ard deviation<br />
Vision<br />
outcomes<br />
• Significant<br />
reduction in<br />
astigmatic<br />
error in both<br />
the<br />
propranolol<br />
group<br />
(p=0.02) <strong>and</strong><br />
the steroid<br />
group<br />
(p=0.03) but<br />
there was no<br />
between<br />
group<br />
differences<br />
(p=0.34,<br />
n=22)<br />
• No<br />
significant<br />
group<br />
difference in<br />
the degree<br />
<strong>of</strong> ptosis<br />
(p=0.46)<br />
Propranolol Plus Pulsed Dye Laser Versus Propranolol Alone<br />
A fair quality retrospective cohort study compared three treatments for facial segmental IH:<br />
concurrent propranolol <strong>and</strong> pulsed dye laser (n=12), propranolol followed by pulsed dye laser<br />
(n=5), <strong>and</strong> propranolol alone (n=8) (Table 13). 150 Mean hemangioma size was larger in the<br />
concurrent treatment group (41.65 cm 2 ) than the sequential (20.1 cm 2 ) <strong>and</strong> propranolol-only<br />
groups (18.0 cm 2 ). Among the 12 participants who received concurrent propranolol <strong>and</strong> pulsed<br />
dye laser, six (50%) had complete clearance <strong>and</strong> six (50%) had near-complete clearance. All five<br />
<strong>of</strong> the participants in the propranolol followed by pulsed dye laser group also had complete (n=2,<br />
40%) or near-complete (n=3, 60%) clearance. Among the eight participants who receive<br />
propranolol alone, one (13%) had complete clearance, two (25%) near-complete clearance, <strong>and</strong><br />
five (63%) partial clearance. The difference in effectiveness between combined therapy, either<br />
concurrently or sequentially, <strong>and</strong> propranolol alone was statistically significant. The number <strong>of</strong><br />
days <strong>of</strong> propranolol treatment until near-complete clearance was significantly lower (p
Table 13. Resolution outcomes in studies comparing propranolol with laser <strong>and</strong> propranolol alone<br />
Author, Year<br />
Methods <strong>and</strong> Resolution Rebound Growth/<br />
Age, Months<br />
Comparison Groups<br />
Measures <strong>of</strong> Outcomes Recurrence<br />
(n)<br />
Location Resolution/<br />
Type<br />
Quality<br />
Response<br />
Other Outcomes<br />
Reddy et al. 2013 150<br />
G1: Propranolol +<br />
pulsed dye laser<br />
concurrent (12)<br />
G2: Propranolol<br />
followed by pulsed dye<br />
laser (5)<br />
G3: Propranolol only (8)<br />
Quality: Fair<br />
Age, mean<br />
days<br />
G1: 43<br />
G2: 62<br />
G3: 47<br />
Type, n (%)<br />
Superficial<br />
G1: 7 (58)<br />
G2: 0<br />
G3: 3 (37.5)<br />
Compound<br />
G1: 5 (42)<br />
G2: 5 (100)<br />
G3:5 (62.5)<br />
G1+G2+G<br />
3: Large or<br />
segmental<br />
-<br />
distribution<br />
facial<br />
G = group; IH = infantile hemangioma; NR = not reported<br />
• Photographs<br />
used to rate<br />
degree <strong>of</strong><br />
clearance<br />
score by<br />
blinded<br />
physicians:<br />
1: no<br />
improvement<br />
2: partial<br />
improvement<br />
(significant<br />
residual<br />
superficial or<br />
deep IH)<br />
3: nearcomplete<br />
clearance (mild<br />
residual<br />
superficial IH)<br />
4: complete<br />
clearance<br />
(minimal to no<br />
residual<br />
superficial IH)<br />
Complete<br />
clearance<br />
G1: 6/12 (50)<br />
G2: 2/5 (40)<br />
G3: 1/8 (12.5)<br />
G1 vs.G2<br />
vs.G3: p=0.01<br />
Rebound growth<br />
NR<br />
Other outcomes<br />
• Significant<br />
difference<br />
between groups<br />
in the number <strong>of</strong><br />
days <strong>of</strong><br />
propranolol<br />
treatment until<br />
near-complete<br />
clearance <strong>of</strong><br />
lesions, p
Table 14. Resolution outcomes in studies comparing propranolol <strong>and</strong> bleomycin<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Thayal et al. 2012 95<br />
G1: Propranolol, oral 2<br />
mg/kg/day (10)<br />
G2: Bleomycin,<br />
intralesional 0.5 mg/kg<br />
(10)<br />
Quality: Poor<br />
Age, Months<br />
Age<br />
NR<br />
Type<br />
Type, %<br />
Cutaneous:<br />
G1+G2:100<br />
Location<br />
NR<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Regression in<br />
size <strong>of</strong> lesion 5<br />
grades:<br />
I Complete<br />
involution (><br />
90% response)<br />
II Reduction in<br />
size 75-90%<br />
III Reduction<br />
50-75%<br />
IV Reduction<br />
25-50%<br />
V Reduction <<br />
25%<br />
• Blinded<br />
assessment:<br />
NR<br />
G = group; kg = kilogram; mg = milligram; n = number; NR = not reported<br />
Resolution<br />
Outcomes<br />
Response, n<br />
Grade I response<br />
G1: 2<br />
G2: 1<br />
Grade II response<br />
G1: 4<br />
G2: 5<br />
Grade III response<br />
G1: 3<br />
G2: 2<br />
Grade IV<br />
response<br />
G1: 1<br />
G2: NR<br />
Rebound<br />
Growth/<br />
Recurrence<br />
NR<br />
Other<br />
Outcomes<br />
Propranolol Versus No Propranolol<br />
A fair quality retrospective cohort study examined the effect <strong>of</strong> propranolol on the incidence<br />
<strong>of</strong> invasive procedures in 58 children with nasal IH. 149 Participants fell into three groups: treated<br />
in the pre-propranolol era (n=20), treated in the post-propranolol era <strong>and</strong> received propranolol<br />
(n=25), <strong>and</strong> treated in the post-propranolol era <strong>and</strong> did not receive propranolol (n=13). Many<br />
participants received other therapies including corticosteroids, laser treatments, <strong>and</strong>/or surgery.<br />
Participants who received propranolol had a lower likelihood <strong>of</strong> laser treatment than those<br />
treated in the pre-propranolol era (hazard ratio 0.44, 95% CI: 0.27 to 0.78). The risks <strong>of</strong> surgical<br />
excision did not differ significantly (hazard ratio 0.45, 95% CI: 0.15 to1.38).<br />
Another fair quality cohort study conducted in the Netherl<strong>and</strong>s compared 20 children<br />
with ulcerated IH treated with propranolol with 20 historical controls (matched on age at IH<br />
onset, extent <strong>of</strong> ulceration, <strong>and</strong> type, location <strong>and</strong> size <strong>of</strong> the IH). 145 Children in the control group<br />
had received steroids (25%), PDL (1%), antibiotics (60%), <strong>and</strong> local wound care (100%). Mean<br />
age <strong>of</strong> the patients at the start <strong>of</strong> ulceration was 2.3 months, <strong>and</strong> complete healing occurred after<br />
an average total ulceration time <strong>of</strong> 8.7 weeks in the propranolol treated group versus 22.4 weeks<br />
(p= 0.012) in the historical control group. Four <strong>of</strong> 19 (20%) patients who completed propranolol<br />
treatment had regrowth. One (0.5%) patient restarted propranolol due to significant regrowth <strong>of</strong><br />
the IH, affecting surrounding structures. Table 15 outlines key outcomes.<br />
49
Table 15. Key outcomes in studies comparing propranolol <strong>and</strong> no propranolol<br />
Author, Year<br />
Age, Months<br />
Comparison Groups<br />
Location<br />
Key Outcomes, n<br />
(n)<br />
Type<br />
Quality<br />
Perkins et al. 2014 149<br />
G1: Propranolol era<br />
2mg/kg/day, received<br />
(25)<br />
G2: Propranolol era, did<br />
not receive (13)<br />
G3: Pre-propranolol era<br />
(20)<br />
Quality: Fair<br />
Hermans et al. 2011 145<br />
G1: Propranolol 2.0 to<br />
2.5/mg/kg/d in three<br />
daily doses (20)<br />
G2: Historical controls<br />
(varied treatments) (20)<br />
Quality: Fair<br />
Age, Mean (range)<br />
G1: 4.9 (2.0- 13.5)<br />
G2: 4.9 (2.2-14.7)<br />
G3: 4.8 (2.0-14.3)<br />
Type, %<br />
Superficial <strong>and</strong><br />
subcutaneous<br />
G1+G2+G3: 100<br />
Age, mean at start <strong>of</strong><br />
ulceration<br />
G1: 2.3<br />
G2: 2.7<br />
Type, n:<br />
Superficial nodular<br />
G1: 14<br />
Superficial macular<br />
G1: 4<br />
G1+G2:<br />
nasal<br />
G1+G2:<br />
multiple<br />
• 56% <strong>of</strong> G2 less likely to have any type <strong>of</strong><br />
invasive treatment when compared to G1<br />
(HR: 0.44, 95% CI: 0.27 to 0.73)<br />
• G2 <strong>and</strong> G3 were 35% less likely to have<br />
any type <strong>of</strong> invasive treatment (HR: 0.65,<br />
95% CI: 0.42 to 1.00) when compared to<br />
G1<br />
• 55% <strong>of</strong> G2 (HR: 0.45) less likely to have<br />
surgical excision <strong>and</strong> 56% (HR: 0.44, 95%<br />
CI: 0.27 to 0.78) less likely to have laser<br />
treatment when compared to G1<br />
• G2 <strong>and</strong> G3 61% (HR:0.39) less likely to<br />
have surgical excision <strong>and</strong> 25% (HR: 0.75;<br />
95% CI: 0.46 to 1.25) less likely to have<br />
laser treatment when compared to G1<br />
• Grade change assessed by two authors not<br />
involved in treatment planning or medical<br />
<strong>and</strong> surgical therapy<br />
• Complete healing from ulceration<br />
G1: 8.7 weeks<br />
G2: 22.4 weeks<br />
G1 vs.G2: p
contained more patients with ulceration (30% versus 4%). There were no statistically significant<br />
differences noted in quantitative improvement <strong>of</strong> IH by VAS scores or change in HAS scores<br />
between the groups. Twenty-seven <strong>of</strong> 30 infants treated with atenolol (90%) <strong>and</strong> all patients<br />
treated with propranolol showed clinical involution at the end <strong>of</strong> the treatment period (p= 0.09).<br />
Table 16 outlines key outcomes.<br />
Table 16. Resolution outcomes in studies comparing beta-blockers<br />
Author, Year<br />
Methods <strong>and</strong><br />
Age, Months<br />
Comparison<br />
Measures <strong>of</strong><br />
Location<br />
Groups (n)<br />
Resolution/<br />
Type<br />
Quality<br />
Response<br />
Abarrzua-<br />
Araya et al.<br />
2014 102<br />
G1:<br />
Propranolol,<br />
oral<br />
2mg/kg/day in<br />
3 daily doses<br />
for 6 months<br />
(10)<br />
G2: Atenolol,<br />
oral1mg/kg/day<br />
single daily<br />
dose for 6<br />
months (13)<br />
Quality: Fair<br />
Age, mean±SD<br />
G1+G2: 5.2±3.5<br />
(range: 2-14)<br />
Type, n:<br />
Superficial<br />
G1+G2: 9<br />
Mixed<br />
G1+G2: 13<br />
Deep<br />
G1+G2: 3<br />
G1+G2:<br />
multiple<br />
• Blinded<br />
assessment <strong>of</strong><br />
serial photographs<br />
plus clinical<br />
assessment<br />
• Complete<br />
response=<br />
complete<br />
resolution <strong>of</strong> IH<br />
• Telangiectasia<br />
<strong>and</strong> redundant<br />
tissue considered<br />
complete<br />
response<br />
• Partial<br />
response=any<br />
size reduction or<br />
change in<br />
color/consistency<br />
that did not meet<br />
complete<br />
response criteria<br />
• No response=no<br />
change in<br />
photographs<br />
<strong>and</strong>/or growth<br />
Resolution<br />
Outcomes<br />
Response<br />
Complete response<br />
G1: 6/10 (60%)<br />
G2: 7/13 (53.8%)<br />
G1 vs. G2: p=ns<br />
Partial response<br />
G1: 4/10 (40%)<br />
G2: 6/13 (46.1%)<br />
G1 vs. G2: p=ns<br />
Response by Type<br />
Superficial IH<br />
Complete response<br />
G1+G2: 5/9 (55.5)<br />
Mixed IH<br />
G1+G2: 3/13 (23)<br />
Deep IH<br />
G1+G2: 3/3 (100)<br />
Rebound<br />
Growth/<br />
Recurrence,<br />
n (%)<br />
Recurrence<br />
G1+G2: 6 (26%)<br />
G1: 4/10 (40%)<br />
G2: 2/13 (15.4)<br />
51
Table 16. Resolution outcomes in studies comparing beta-blockers (continued)<br />
Author, Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
De Graaf et al,<br />
2013 146-148<br />
G1: Atenolol,<br />
oral 1<br />
mg/kg/day up<br />
to 3 mg/kg (30)<br />
G2:<br />
Propranolol,<br />
oral<br />
2mg/kg/day<br />
(historical<br />
group) (28)<br />
Quality: Fair<br />
Age, Months<br />
Type<br />
Age, n (%)<br />
1-6 months<br />
G1: 12/24 (50)<br />
G2: 23/27 (85)<br />
6-12 months<br />
G1: 8/24 (33)<br />
G2: 4/27 (15)<br />
Over 12 months<br />
G1: 4/24 (17)<br />
G2: 0<br />
Type, n (%)<br />
Localized/<br />
nodular<br />
G1: 19/24 (79%)<br />
G2: 19/27 (70%)<br />
Segmental<br />
G1: 3/24 (13%)<br />
G2: 2/27 (8%)<br />
Indeterminate<br />
G1: 2/24 (8%)<br />
G2: 6/27 (22%)<br />
Multifocal<br />
G1: 0<br />
G2: 0<br />
Location<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Serial<br />
photographs <strong>and</strong><br />
clinical<br />
assessment <strong>of</strong><br />
involution (color<br />
change, s<strong>of</strong>tening<br />
to palpation <strong>and</strong><br />
reduction in size)<br />
by blinded<br />
assessors<br />
• Visual analog<br />
scale (VAS) <strong>and</strong><br />
hemangioma<br />
activity score<br />
(HAS)<br />
Resolution<br />
Outcomes<br />
Clinical<br />
involution, n (%)<br />
G1: 27 (90)<br />
G2: 28 (100)<br />
VAS <strong>and</strong> HAS<br />
scores shown in<br />
figures only<br />
G1 vs. G2<br />
p= NS<br />
Rebound<br />
Growth/<br />
Recurrence,<br />
n (%)<br />
G = group; HAS = hemangioma activity score; IH = infantile hemangioma; kg = kilogram; mg = milligram; n = number; NR =<br />
not reported; NS = not significant; SD = st<strong>and</strong>ard deviation; VAS = visual analog scale<br />
Nadolol Versus Propranolol<br />
In a poor quality cohort study conducted in Canada, oral nadolol was used in the six month<br />
treatment <strong>of</strong> 10 infants 1-month to 1-year <strong>of</strong> age <strong>and</strong> compared to a historical group <strong>of</strong> nine<br />
similar infants matched for age <strong>and</strong> hemangioma location who were treated with oral propranolol<br />
for at least six months (Table 17). 101 Infants were treated with oral nadolol starting at 0.5<br />
mg/kg/day divided twice daily <strong>and</strong> increased weekly by 0.5 mg/kg to a maximum dose <strong>of</strong> 4<br />
mg/kg/day (mean dose 2.19 ± 1.1 mg/kg). Propranolol was administered to a maximum <strong>of</strong> 2-3<br />
mg/kg/day divided three times daily (mean dose 1.89 ± 0.29 mg/kg). The nadolol treated group<br />
had a mean percentage IH shrinkage <strong>of</strong> 97 ± 3.05 percent at the 24-week visit compared with 86<br />
± 14.82 percent shrinkage observed in the propranolol group (p< 0.001).<br />
NR<br />
52
Table 17. Key resolution outcomes in studies comparing nadolol <strong>and</strong> propranolol<br />
Author,<br />
Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
Pope et al,<br />
2012 101<br />
G1: Nadolol<br />
suspension<br />
up to 4<br />
mg/kg/day<br />
(10)<br />
G2:<br />
Propranolol<br />
maximum<br />
dose 2-3<br />
mg/kg/day<br />
(historical<br />
group) (9)<br />
Quality:<br />
Poor<br />
Age,<br />
months<br />
Type<br />
Age,<br />
mean±SD<br />
G1: 4.1 ±<br />
2.23<br />
G2: 4.8 ±<br />
1.92<br />
Type, n:<br />
Superficial<br />
<strong>and</strong> deep<br />
G1: 6<br />
G2: 9<br />
Deep<br />
G1: 4<br />
G2: 0<br />
Location<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong> Measures<br />
<strong>of</strong><br />
Resolution/Response<br />
• Serial photographs<br />
<strong>and</strong> clinical<br />
assessment using<br />
100-mm visual<br />
analog scale (VAS);<br />
blinded assessors<br />
(-): 100% worsening<br />
0: no change<br />
(+): 100% shrinkage<br />
where 5 mm<br />
represented 10%<br />
change<br />
Resolution<br />
Outcomes<br />
Percentage IH<br />
shrinkage, mean ±<br />
SD<br />
G1: 97 ± 3.05%<br />
G2: 86 ± 14.82%<br />
G1 vs.G2: p< 0.008<br />
Rebound<br />
Growth/<br />
Recurrence,<br />
n (%)<br />
G = groups; IH = infantile hemangioma; kg = kilograms; mm = millimeter; mg = milligram; n = number; NR = not reported;<br />
SD = st<strong>and</strong>ard deviation<br />
Oral Propranolol Compared With Other Dosage Forms<br />
In a fair quality single blinded RCT conducted in Egypt, 45 consecutive patients with<br />
problematic, superficial IH (rapidly progressive, compromising vital or normal physiological<br />
function, or causing disfigurement) were assigned to one <strong>of</strong> three treatments: oral propranolol (2<br />
mg/kg/day divided into two daily doses, n=15), topical propranolol 1 percent ointment applied<br />
twice daily, or intralesional propranolol (1 mg propranolol hydrochloride as a 1 mL injection,<br />
n=15) repeated weekly (0.2 mL injected per 1 cm lesion diameter to a maximum <strong>of</strong> 1 mL, doses<br />
divided among multiple lesions, n=15) (Table 18). 93 Twelve (80%) patients treated with oral<br />
propranolol had improvement in their IH: nine (60%) patients showed a complete response; 2<br />
(13.3%) demonstrated a sustained plateau with > 50 percent reduction in size; 1 (6.7%) showed a<br />
sustained plateau with 50<br />
percent reduction in size, 2 (13.3%) showed a sustained plateau with < 50 percent reduction in<br />
size, <strong>and</strong> five (33.3%) had no response to treatment. Eight (53.3%) patients treated with<br />
intralesional propranolol showed improvement in their IH. Two (13.3%) participants had a<br />
complete response; three (20%) demonstrated a sustained plateau with ≥ 50 percent reduction in<br />
size; three (20%) had a sustained plateau with less than 50 percent reduction in size, seven<br />
children (46.7%) had no response. Rebound growth was documented in one (6.7%), one (6.7%)<br />
<strong>and</strong> two (13.3%) children treated with oral, topical, <strong>and</strong> intralesional propranolol, respectively.<br />
Time to achieve initial response <strong>and</strong> duration <strong>of</strong> treatment needed to achieve the final response<br />
were significantly greater in both the topical (3-8 weeks to initial response; 5-10 months<br />
treatment duration) <strong>and</strong> intralesional propranolol (4-8 weeks to initial response; 5-12 months<br />
treatment duration) groups as compared with the oral propranolol group (2-4 weeks to initial<br />
response; 3-9 months treatment duration, p values ≤ 0.01).<br />
NR<br />
53
Table 18. Resolution outcomes in studies comparing forms <strong>of</strong> propranolol<br />
Author,<br />
Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
Zaher et al.<br />
2013 93<br />
G1:<br />
Propranolol<br />
oral,<br />
2mg/kg/day<br />
in 2 daily<br />
doses (15)<br />
G2:<br />
Propranolol,<br />
topical, 1%<br />
ointment<br />
applied twice<br />
daily (15)<br />
G3:<br />
Propranolol,<br />
intralesional,<br />
1mg injected<br />
weekly (15)<br />
Quality: Fair<br />
Age,<br />
Months<br />
Type<br />
Age,<br />
mean±SD<br />
(range)<br />
G1+G2+G<br />
3:<br />
8.82±4.6<br />
(3-18)<br />
G1: 9.13<br />
(3-18)<br />
G2: 8.33<br />
(1-18)<br />
G3: 9.0 (3-<br />
18)<br />
Type<br />
NR<br />
Location<br />
G1+G2+<br />
G3:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/Response<br />
• Grading system<br />
comparing<br />
photographic<br />
documentation;<br />
unblinded<br />
assessment<br />
• Excellent: complete<br />
resolution achieved<br />
• Good: sustained<br />
plateau with ≥ 50%<br />
reduction in size<br />
• Fair: sustained<br />
plateau with < 50%<br />
reduction in size<br />
• Poor: no response<br />
or worsening <strong>of</strong> IH<br />
Resolution<br />
Outcomes<br />
Response to<br />
treatment, n (%)<br />
Excellent response<br />
G1: 9 (60)<br />
G2: 3 (20)<br />
G3: 2 (13.3)<br />
Good response<br />
G1: 2 (13.3)<br />
G2: 5 (33.3)<br />
G3: 3 (20)<br />
Fair<br />
G1: 1 (6.7)<br />
G2: 2 (13.3)<br />
G3: 3 (20)<br />
Poor<br />
G1: 3 (20)<br />
G2: 5 (33.3)<br />
G3: 7 (46.7)<br />
Rebound<br />
Growth/Recurrence,<br />
n (%)<br />
Rebound growth, n<br />
(%)<br />
G1: 1 (6.7)<br />
G2: 1 (6.7)<br />
G3: 2 (13.3)<br />
G = group; IH = infantile hemangioma; kg = kilogram; mg = milligram; n= number; NR = not reported; SD = st<strong>and</strong>ard deviation<br />
Timolol Versus Placebo/Observation or Other Modalities<br />
Timolol Compared With Placebo or Observation<br />
In a good quality double-blind, placebo-controlled RCT conducted in Australia, investigators<br />
r<strong>and</strong>omly assigned 41 infants ages 5 to 24 weeks with small, focal, superficial IH not requiring<br />
systemic therapy to treatment with placebo (n=22) or timolol maleate 0.5 percent gel (n=19). 104<br />
Investigators reported a significant increase in the number <strong>of</strong> IH lesions decreasing in size by<br />
≥5 percent in the timolol group compared with the placebo group at weeks 8 (37% vs. 5%, p=<br />
0.04), 20 (47% vs.6%, p= 0.02), <strong>and</strong> 24 (60% vs.11%, p= 0.01). At 24 weeks, 47 percent <strong>of</strong> the<br />
timolol treated group had significantly increased difference in blinded photo score <strong>of</strong> 0 (no<br />
redness) compared with 6 percent in the placebo group, while the proportion <strong>of</strong> lesions<br />
completely red in the treatment group (6%) was significantly less than the placebo group (55%, p<br />
values
esponse. Overall, timolol-treated patients had significantly improved responses compared with<br />
the observation group (p=0.001). One patient in whom timolol was prematurely stopped at 5<br />
months <strong>of</strong> age had rebound growth, which again regressed with resumption <strong>of</strong> topical timolol.<br />
In a poor quality prospective cohort study conducted in China, 124 infants < 12 months <strong>of</strong><br />
age with superficial IH (≤ 3 mm in height) <strong>and</strong> without prior treatment or tumor regression were<br />
treated with either topical 0.5% timolol maleate drops three times daily (n=101) or observed (n=<br />
23). 103 Timolol promoted regression in 57 patients (56.4%), controlled growth in 36 patients<br />
(35.6%), <strong>and</strong> was ineffective in 8 patients (7.9%) compared with the observation group where<br />
regression was seen in one patient (4.3%), controlled growth observed in seven (30.4%), <strong>and</strong><br />
continued growth observed in 15 patients (65.2%). Regression <strong>and</strong> efficacy rates in the timolol<br />
group compared to the observation group were significantly improved (p
Table 19. Key resolution outcomes in studies comparing timolol <strong>and</strong> observation or placebo<br />
(continued)<br />
Author,<br />
Year<br />
Comparison<br />
Groups (n)<br />
Quality<br />
Chambers et<br />
al. 2012 144<br />
G1: Timolol<br />
maleate gel<br />
0.25% (13)<br />
G2:<br />
Observation<br />
(10)<br />
Quality: Fair<br />
Yu et al.<br />
2013 103<br />
G1: Timolol ,<br />
topical,<br />
drops three<br />
times<br />
daily(101)<br />
G2:<br />
Observation<br />
(23)<br />
Age, Months<br />
Type<br />
Age,<br />
mean±SD<br />
G1: 4.8<br />
G2: 3.7<br />
Type, n<br />
Superficial<br />
G1: 5<br />
G2: 4<br />
Mixed<br />
G1: 7<br />
G2: 5<br />
Deep<br />
G1: 1<br />
G2: 1<br />
Age<br />
1-6 months<br />
G1+G2: 88<br />
7-12 months<br />
G1 +G2: 36<br />
Type, %<br />
Superficial:<br />
100<br />
Location<br />
Periocular<br />
(100%)<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/<br />
Response<br />
• Photographs<br />
• Response<br />
categorized as<br />
good (lesion<br />
decreased by<br />
more than 50%<br />
size), moderate<br />
(lesion<br />
decreased by<br />
50% or less)<br />
<strong>and</strong> poor (lesion<br />
enlarged or<br />
caused ptosis or<br />
induced<br />
astigmatism<br />
• Reviewed by<br />
blinded pediatric<br />
ophthalmologist<br />
• Photographs<br />
• Categorized as:<br />
Class 1:<br />
ineffective<br />
Class 2:<br />
controlled<br />
growth<br />
Class 3:<br />
promoted<br />
regression<br />
• Blinded<br />
assessment: NR<br />
Resolution<br />
Outcomes<br />
Response to<br />
treatment, n (%)<br />
Good<br />
G1: 8 (61)<br />
G2: 0<br />
Moderate<br />
G1: 4 (31)<br />
G2: 1 (10)<br />
Poor<br />
G1: 1 (8)<br />
G2: 9 (90)<br />
G1 vs.G2 p=0.001<br />
Response to<br />
treatment, n (%)<br />
Class 1<br />
G1: 8 (7.9)<br />
G2: 15 (65.2)<br />
Class 2<br />
G1: 36 (35.6)<br />
G2: 7 (30.4)<br />
Class 3<br />
Quality:<br />
G1: 57 (56.4)<br />
Poor<br />
G2: 1 (4.3)<br />
G = group; IH = infantile hemangioma; n = number; NR = not reported; SD = st<strong>and</strong>ard deviation<br />
Rebound<br />
Growth/<br />
Recurrence, n<br />
(%)<br />
NR<br />
In 12 patients<br />
with complete<br />
resolution, no<br />
regrowth noted<br />
at 3-5 month<br />
followup<br />
Timolol Ophthalmic Solution Versus Imiquimod Cream<br />
One fair quality retrospective cohort study evaluated imiquimod cream versus timolol<br />
ophthalmic solution for treatment <strong>of</strong> superficial proliferating IH (Table 20). 105 There were 40<br />
treated IH among the participants. The mean duration <strong>of</strong> therapy was 4.6 months in the<br />
imiquimod group <strong>and</strong> 4.3 months in the timolol group. Duration <strong>of</strong> followup was not reported.<br />
The VAS score <strong>and</strong> change in the hemangioma activity score did not differ significantly between<br />
the two groups.<br />
56
Table 20. Resolution outcomes in studies comparing timolol <strong>and</strong> imiquimod<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Qiu et al. 2013 105<br />
G1: Topical imiquimod<br />
5% cream (20)<br />
G2: Topical timolol<br />
ophthalmic 0.5%<br />
solution (20)<br />
Quality: Fair<br />
Age, Months<br />
Type<br />
Age,<br />
mean±SD,<br />
G1: 3.1 ± 1.20<br />
G2: 3.0 ± 1.96<br />
Type, %<br />
Proliferating<br />
superficial<br />
G1+G2: 100<br />
Location<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/Response<br />
• Visual analog scale<br />
(VAS)<br />
• <strong>Hemangioma</strong><br />
Activity Score (HAS)<br />
evaluations<br />
conducted by two<br />
study investigators<br />
• Blinded assessment:<br />
NR<br />
Resolution<br />
Outcomes, n<br />
VAS <strong>and</strong> HAS<br />
results<br />
presented in<br />
figures<br />
VAS<br />
G1 vs.G2<br />
p=0.11<br />
Δ HAS<br />
G1 vs.G2<br />
p=0.49<br />
Rebound<br />
Growth/<br />
Recurrence<br />
Other<br />
Outcomes<br />
G = group; HAS = hemangioma activity score; n = number; NR = not reported; SD = st<strong>and</strong>ard deviation; VAS = visual analog<br />
scale<br />
Topical Timolol Versus Laser<br />
One fair quality RCT conducted in Egypt compared topically applied timolol (0.5%<br />
ophthalmic solution) <strong>and</strong> sequential PDL <strong>and</strong> Nd:YAG laser in 60 children (age range not clear)<br />
with superficial or mixed IH. 14 Children received treatment for roughly 4 to 5.5 months. Forty<br />
percent <strong>of</strong> children in the timolol group <strong>and</strong> 20 percent in the laser group had an excellent<br />
response (defined as improvement <strong>of</strong> 76-100%), <strong>and</strong> IH hemoglobin level declined significantly<br />
from baseline in both groups. Improvement in IH in either group did not differ between children<br />
who were greater or less than 6 months <strong>of</strong> age, but response was greater in superficial lesions<br />
compared with mixed lesions in both groups. More mixed lesions responded to laser than to<br />
timolol, with deep components <strong>of</strong> superficial lesions not responding to timolol. Superficial<br />
lesions responded more quickly <strong>and</strong> more extensively to timolol than to laser (p=NR). The study<br />
provided few statistical comparisons <strong>of</strong> timolol versus laser.<br />
In a poor quality retrospective cohort study comparing topical timolol alone with timolol plus<br />
PDL in 102 children with superficial IH, children received treatment for between 2 <strong>and</strong> 24<br />
months. 106 Overall, 97 percent <strong>of</strong> children had improvement in IH (3 children in the timolol arm<br />
had no change, 28 had >75% improvement), with greater improvement in the combination arm<br />
compared with the timolol alone arm (mean global assessment score change <strong>of</strong> 2.66 vs. 1.88,<br />
p=0.02, score range=-1 to 4 with higher number indicating more improvement). Table 21<br />
outlines key outcomes.<br />
NR<br />
57
Table 21. Resolution outcomes in studies comparing timolol <strong>and</strong> laser<br />
Author, Year<br />
Comparison Groups<br />
(n)<br />
Quality<br />
Tawfik et al. 2015 14<br />
G1: Topical timolol<br />
ophthalmic 0.5%<br />
solution (30)<br />
G2: Combined<br />
sequential laser PDL<br />
(585 nm) <strong>and</strong> Nd:YAG<br />
(1064 nm) (30)<br />
Quality: Fair<br />
Age, Months<br />
Type<br />
Age, n (%)<br />
≤ 6 months<br />
G1: 8 (26.7)<br />
G2: 14 (46.7)<br />
> 6 months<br />
G1: 22 (73.3)<br />
G2: 16 (53.3)<br />
Type, %<br />
Superficial<br />
G1: 80<br />
G2: 86.7<br />
Mixed<br />
G1: 20<br />
G2: 13.3<br />
Location<br />
G1+G2:<br />
multiple<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/Response<br />
• Photographs<br />
• Efficacy evaluated by<br />
two blinded<br />
physicians<br />
• Response to<br />
treatment graded<br />
Excellent: 76-100%<br />
improvement<br />
Good: 51-75%<br />
Moderate: 26-50%<br />
Mild: < 25%<br />
No improvement: 0%<br />
Resolution<br />
Outcomes, n<br />
Response to<br />
treatment, n<br />
(%)<br />
Excellent<br />
G1: 9 (30)<br />
G2: 3 (10)<br />
Good<br />
G1: 9 (30)<br />
G2: 7 (23)<br />
Moderate<br />
G1: 4 (13)<br />
G2: 9 (30)<br />
Mild<br />
G1: 4 (13)<br />
G2: 7 (23)<br />
Poor<br />
G1: 4 (13)<br />
G2: 4 (13)<br />
Rebound<br />
Growth/<br />
Recurrence<br />
Other<br />
Outcomes<br />
No rebound<br />
growth in either<br />
group<br />
Park et al. 2014 106<br />
G1: Timolol ophthalmic<br />
0.5% solution (61)<br />
G2: Combination topical<br />
timolol ophthalmic 0.5%<br />
solution plus adjunctive<br />
pulsed dye laser<br />
treatment (41)<br />
Quality: Poor<br />
Age, Months<br />
NR<br />
Type, %<br />
Superficial<br />
G1+G2: 100%<br />
G1+G2:<br />
multiple<br />
• Photographs<br />
• Clinical evaluation <strong>of</strong><br />
efficacy by two<br />
independent<br />
physicians Global<br />
assessment score<br />
(GAS)<br />
4: 75-100%<br />
improvement<br />
3: 50-74%<br />
2: 25-49%<br />
1: 0-24%<br />
0: 0<br />
-1: < 0<br />
Mean GAS<br />
score change<br />
G1: 1.88<br />
G2: 2.66)<br />
G1 vs.G2:<br />
p=0.018<br />
%<br />
improvement,<br />
n (%)<br />
75-100<br />
G1: 14 (23)<br />
G2: 17 (41)<br />
50-74<br />
G1: 14 (23)<br />
G2: 12 (29)<br />
NR<br />
25-49<br />
G1: 11 (18)<br />
G2: 8 (20)<br />
0-24<br />
G1: 19 (31)<br />
G2: 4 (10)<br />
≤0<br />
G1: 3 (5)<br />
G2: 0<br />
G = group; GAS = global assessment score; n = number; nm = nanometer; NR = not reported<br />
58
Harms <strong>of</strong> Beta-Blockers<br />
Harms Reported in Studies Included in This Review<br />
Thirteen comparative studies specifically defined harms <strong>of</strong> beta-blockers used to treat<br />
IH. 17,92-94,98,101,102,104,105,132,133,144,145,147 Several studies specifically noted that no harms were<br />
observed: one study evaluating topical timolol maleate 0.5 percent gel compared to placebo; 104 a<br />
cohort study evaluating topical 0.25 percent timolol maleate gel; 144 one RCT <strong>of</strong> ophthalmic<br />
timolol, 105 <strong>and</strong> a cohort study <strong>of</strong> timolol that informed parents <strong>of</strong> potential adverse effects to<br />
monitor for, reported evaluating for safety (non-specified), <strong>and</strong> stated that no adverse effects<br />
were reported. 103 An RCT comparing atenolol versus propranolol 102 <strong>and</strong> two other cohort studies<br />
<strong>of</strong> intralesional propranolol 130 <strong>and</strong> up to 2mg/kg/day <strong>of</strong> oral propranolol 95 reported that no harms<br />
were observed. Another RCT <strong>of</strong> propranolol (3-4 mg/kg/day) including 14 participants reported<br />
asymptomatic hypotension <strong>and</strong> bradycardia in an unstated number <strong>of</strong> infants <strong>and</strong> discontinuation<br />
<strong>of</strong> treatment in one child due to drowsiness. 99<br />
One RCT comparing propranolol <strong>and</strong> prednisolone reported side effects associated with 2<br />
mg/kg/day dosing <strong>of</strong> propranolol in the categories <strong>of</strong> allergy/immunology (0.02% <strong>of</strong> lesions),<br />
dermatologic (0.05% <strong>of</strong> lesions), gastrointestinal (0.11% <strong>of</strong> lesions), infection (0.11% <strong>of</strong><br />
lesions), pulmonary/respiratory (0.32% <strong>of</strong> lesions), vascular (0.07% <strong>of</strong> lesions). 98 Fewer severe<br />
adverse events occurred in the propranolol arm compared with prednisolone (1 vs. 11, p=0.01);<br />
the one severe event in the propranolol arm was a case <strong>of</strong> dehydration necessitating<br />
hospitalization. Children in the propranolol group had more pulmonary events (typically upper<br />
respiratory tract infections) than those in the prednisolone arm (14 vs. 5, p
Table 22. Harms/adverse effects in comparative studies <strong>of</strong> beta-blockers to treat IH<br />
N Studies Reporting<br />
Intervention<br />
Harm/Adverse Event<br />
Harm (# Participants<br />
With Harm/Total<br />
Participants)<br />
Oral propranolol 2-3<br />
mg/kg/day<br />
Oral propranolol 4<br />
mg/kg/day<br />
Oral propranolol (2.2<br />
mg/kg/day) +<br />
prednisolone (1.6 mg)<br />
Intralesional<br />
propranolol 1 mg<br />
Oral atenolol<br />
3mg/kg/day<br />
Oral nadolol up to 4<br />
mg/kg/day<br />
Bronchial hyperreactivity 147 1 (4/28) 14%<br />
Bronchiolitis 17 1 (4/19) 21%<br />
Bronchospasm 94 1 (1/31) 3%<br />
Cold extremities 17,131,145 3 (13/53) 5%-43%<br />
Constipation or gastrointestinal<br />
complaints 96,145,147<br />
3 (5/60) 5%-11%<br />
Dental caries 17 1 (1/19) 5%<br />
Elevated alkaline 17 1 (1/19) 5%<br />
Hypoglycemia 97,100,147 3 (4/106) 1%-10%<br />
* Hypotension 93,96,147 3 (4/55) 4%-20%<br />
Ulceration 17 1 (1/19) 5%<br />
Sleep disturbance (insomnia,<br />
drowsiness, restless<br />
6 (31/150) 6%-50%<br />
sleep) 17,94,96,100,145,147<br />
Streptococcal infection 17 1 (1/19) 5%<br />
Syncopal attack 93 1 (1/15) 7%<br />
Viral gastroenteritis 17 1 (1/19) 5%<br />
** Viral upper respiratory<br />
2 (2/87) 1%-5%<br />
infection 17,97<br />
Poor feeding 145 1 (2/20) 10%<br />
Fever 97 1 (2/68) 3%<br />
Rash 97 1 (2/68) 3%<br />
Tachycardia 97 1 (1/68) 1%<br />
Hypotonia 132 1 (3/30) 10%<br />
Pulmonary obstruction 132 1 (2/30) 6.7%<br />
Drowsiness 99 1 (1/7) 14%<br />
Gastrointestinal upset 100 1 (4/10) 40%<br />
Infection 100 1 (1/10) 10%<br />
Cushingoid appearance 100 1 (6/10) 60%<br />
Pain/inconvenience <strong>of</strong> therapy 93 1 (3/15) 20%<br />
Hypotension 147 1 (1/30) 3%<br />
Restless sleep 147 1 (8/30) 27%<br />
Constipation 147 1 (2/30) 7%<br />
Diarrhea 147 1 (2/30) 7%<br />
Cold extremities 101 1 (2/10) 20%<br />
Cold induced wheezing 101 1 (1/10) 10%<br />
Sleep disturbance 101 1 (1/10) 10%<br />
Gastrointestinal symptoms 101 1 (5/10) 50%<br />
Placebo Sleep disturbance 17 1 (2/20) 10%<br />
Ulceration 17 1 (1/20) 5%<br />
Visual compromise 17 1 (1/20) 5%<br />
Bronchiolitis 17 1 (1/20) 5%<br />
IH = infantile hemangioma; kg = kilogram; mg = milligram; n = number<br />
* One study 93 reported hypotension <strong>and</strong> bradycardia in 3/15 children.<br />
** One study 97 reported upper respiratory infection <strong>and</strong> reactive airway disease in 1/68 children.<br />
Reported Rates<br />
Across Studies<br />
The safety population in a large RCT 92 included 456 patients in total (Table 23). Thirty-three<br />
serious events occurred in 26 patients, <strong>and</strong> no significant difference overall or in individual<br />
events between the placebo group <strong>and</strong> group receiving propranolol at 3 mg/kg/day for 6 months<br />
were noted. One serious adverse event <strong>of</strong> second-degree atrioventricular heart block (with a<br />
preexisting cardiac condition later documented) occurred after dose administration on day 0, <strong>and</strong><br />
60
treatment was discontinued. While hypotension <strong>and</strong> hypoglycemia were both documented in this<br />
trial, neither was clinically significant enough to lead to treatment discontinuation.<br />
Table 23. Harms/adverse events reported by dose in Leaute-Labreze et al. 2015<br />
1 mg/kg/day X 1 mg/kg/day X 3 mg/kg/day X 3 mg/kg/day X 6<br />
Adverse<br />
3 months 6 months 3 months months<br />
Event<br />
(n=98)<br />
(n=102) (n=100)<br />
(n=101)<br />
N experiencing harm (%)<br />
≥1 Serious<br />
adverse event<br />
5 (5) 3 (3) 9 (9) 6 (6) 3 (5)<br />
≥1 Adverse<br />
event occurred<br />
during<br />
89 (91) 92 (90) 92 (92) 97 (96) 42 (76)<br />
treatment<br />
Hypotension 2 (2) 1 (1) 3 (3) 0 (0) 1 (2)<br />
Bronchospasm 0 (0) 0 (0) 2 (2) 1 (1) 1 (2)<br />
Bradycardia 0 (0) 1 (1) 1 (1) 0 (0) 0 (0)<br />
Hypoglycemia 0 (0) 1 (1) 0 (0) 1 (1) 0 (0)<br />
Diarrhea 16 (16) 14 (14) 17 (17) 28 (28) 4 (7)<br />
Sleep disorder 28 (29) 14 (14) 19 (19) 22 (22) 7 (13)<br />
Bronchitis 5 (5) 7 (7) 11 (11) 17 (17) 1 (2)<br />
Vomiting 16 (16) 13 (13) 10 (10) 13 (13) 3 (5)<br />
Bronchiolitis 6 (6) 7 (7) 6 (6) 10 (10) 3 (5)<br />
Cold h<strong>and</strong>s<br />
8 (8) 10 (10) 1 (1) 10 (10) 1 (2)<br />
<strong>and</strong> feet<br />
Agitation 12 (12) 18 (18) 8 (8) 7 (7) 6 (11)<br />
Constipation 9 (9) 6 (6) 9 (9) 4 (4) 1 (2)<br />
Decreased<br />
5 (5) 3 (3) 5 (5) 1 (1) 1 (2)<br />
appetite<br />
Somnolence 6 (6) 4 (4) 1 (1) 1 (1) 1 (2)<br />
kg = kilogram; mg = milligram; n = number<br />
Placebo<br />
(n=55)<br />
Table 24 summarizes the incidence <strong>and</strong> type <strong>of</strong> adverse effects reported in case series.<br />
Consistent with the pharmacological action <strong>of</strong> propranolol, decreases in blood pressure <strong>and</strong> heart<br />
rate were the most frequently reported adverse events <strong>and</strong> were as high as 100 percent in some<br />
series. 168,171 However, reductions in these parameters were not always clinically significant. In<br />
most prospective case series, clinically important hypotension <strong>and</strong> bradycardia were not<br />
reported; asymptomatic changes were specifically noted in several series. 16,151-158,169,182,189,194,<br />
199,205<br />
The lack <strong>of</strong> cardiac events may be due to required cardiovascular evaluation prior to<br />
initiation <strong>of</strong> propranolol or discontinuation after short-term monitoring. The number <strong>of</strong> patients<br />
that did not qualify for propranolol therapy was not provided in any <strong>of</strong> these series. No adverse<br />
effects were reported in several case series, 154,156,157,196 <strong>and</strong> most studies <strong>of</strong> topical beta-blockers<br />
reported that no adverse events were observed, though studies typically did not describe methods<br />
for harms monitoring. 159,160,186 Two studies <strong>of</strong> topical applications reported recurrent itching<br />
associated with topical propranolol 187 in 3 percent <strong>of</strong> children <strong>and</strong> sleep disturbances in 1 percent<br />
<strong>of</strong> children receiving topical timolol. 161 The remaining case series reported few adverse events,<br />
<strong>and</strong> those reported rarely caused discontinuation <strong>of</strong> the medication. In total, 51/3810 (1.3%)<br />
children in case series discontinued treatment due to adverse events including sleep disturbances<br />
(n=13), bronchial hyperreactivity, wheezing, or asthma (n=9), <strong>and</strong> cold extremities (n=7).<br />
61
Table 24. Adverse effects in case series <strong>of</strong> propranolol to treat IH<br />
Intervention<br />
* Oral Propranolol<br />
1-1.5 mg/kg/day<br />
Oral Propranolol<br />
2-2.1 mg/kg/day<br />
Harm/Adverse Event<br />
Number <strong>of</strong><br />
Studies (#<br />
Participants<br />
With<br />
Harm/Total<br />
Participants)<br />
Reported<br />
Rates<br />
Across<br />
Studies<br />
Decrease in heart rate <strong>and</strong> blood pressure 171 1 (89/89) 100%<br />
Elevation <strong>of</strong> liver enzymes (ALT, AST) 171 1 (5/89) 6%<br />
Hypoglycemia 171 1 (4/89) 4.5%<br />
Anorexia 155 1 (1/35) 3%<br />
Diarrhea 153,189 2 (6/114) 3%-12%<br />
Asymptomatic hypotension 153 1 (1/60) 2%<br />
Nausea 171 1 (2/89) 2%<br />
Cold extremities 171 1 (1/89) 1%<br />
Restless sleep 171 1 (1/89) 1%<br />
**Hypotension 18,167,168,173,190,191,194,199,200,202,205 11 (89/944) 0.4%-62%<br />
ECG changes 167 1 (7/25) 28%<br />
Bradycardia 151,167,168,173,190,191,199 7 (51/577) 0.8%-38%<br />
Nausea/Vomiting/Diarrhea 151,153,162,175,178,179,181,190-193 12 (37/1048) 0.4%-24%<br />
Cold extremities 151,163,178,180,193,200,202 7 (17/626) 1%-10%<br />
Sleep disturbance/Light sleep 153,162,165,167,179,190-193,203 10 (88/729) 3%-29%<br />
Behavioral changes 162,167,175,178,193,200 6 (13/531) 0.5%-10.8%<br />
Respiratory<br />
10 (35/725) 2%-10%<br />
symptoms/Asthma/Dyspnea 151,162,163,165,178,180,190,192,194<br />
Fatigue/Somnolence 165,167,173,176,180,201 6 (15/289) 1%-25.9%<br />
Fever 162 1 (2/30) 7%<br />
Gross motor abnormalities 175 1 (13/188) 7%<br />
***Hypoglycemia 168,173,191,194,202 5 (14/328) 2%-6.8%<br />
Cutaneous symptoms/Rash 153,176,180 3 (5/172) 2%-5%<br />
Gastroesophageal issues 180,194 2 (3/99) 2.3%-4%<br />
Sweating 18,176 2 (2/85) 2%-4%<br />
Constipation 151,202 2 (3/186) 0.8%-3%<br />
Respiratory tract infection 162 1 (1/30) 3%<br />
Skin atrophy 156 1 (2/50) 3%<br />
Seizure 170 1 (1/45) 2%<br />
Agranulocytosis 163 1 (1/97) 1%<br />
Cyanotic breath-holding spells 183,184 1 (1/71) 1%<br />
Low body temperature 163 1 (1/97) 1%<br />
Stridor 183,184 1 (1/71) 1%<br />
Bronchospasm 168,193,203 3 (3/337) 0.4%-2.7%<br />
Worsening <strong>of</strong> ulceration 190 1 (4/250) 1.6%<br />
Peripheral cyanosis 190 1 (2/250) 0.8%<br />
Oral Propranolol<br />
† Sleep disturbances/Nightmares 158,164,166 3 (14/99) 3%-23%<br />
3-3.3 mg/kg/day Transient asymptomatic hypotension 158,164 2 (7/66) 3%-17%<br />
Daytime drowsiness 164 1 (6/35) 17%<br />
Benign infections 164 1 (4/35) 11%<br />
Digestive symptoms 164 1 (3/35) 9%<br />
Constipation 152 1 (2/30) 7%<br />
Tachypnea 152 1 (2/30) 7%<br />
Irritability 164 1 (2/35) 6%<br />
Cold extremities 152,166 2 (2/66) 3%<br />
Esophageal reflux 158,166 2 (2/64) 3%<br />
Poor weight gain 164 1 (1/35) 3%<br />
Decreased appetite 164 1 (1/35) 3%<br />
Bradycardia 164 1 (1/35) 3%<br />
Hypoglycemia 152 1 (1/30) 3%<br />
Increased appetite 164 1 (1/35) 3%<br />
Shortness <strong>of</strong> breath on activity 164 1 (1/35) 3%<br />
62
Table 24. Adverse effects in case series <strong>of</strong> propranolol to treat IH (continued)<br />
Number <strong>of</strong><br />
Studies (#<br />
Intervention<br />
Harm/Adverse Event<br />
Participants<br />
With Harm/Total<br />
Participants)<br />
Oral Propranolol 2-3<br />
mg/kg/day<br />
†† Oral Propranolol 1-4<br />
mg/kg/day<br />
Topical Propranolol 0.5-3%<br />
Reported<br />
Rates<br />
Across<br />
Studies<br />
Cold extremities 16,172 2 (64/206) 3%-36%<br />
Nocturnal restlessness 172 1 (39/174) 22%<br />
Daytime sleepiness/Inactivity 172 1 (28/174) 16%<br />
Gastrointestinal symptoms 172 1 (12/174) 7%<br />
Agitation 16 1 (2/32) 6%<br />
Insomnia 16 1 (2/32) 6%<br />
Restlessness/Increased daytime activity 172 1 (9/174) 5%<br />
Hypotension 16,172 2 (7/206) 3%<br />
Asthma/Wheezing 16,172 2 (18/206) 3%<br />
Nightmares 16 1 (1/32) 3%<br />
Sweating 16 1 (1/32) 3%<br />
Feeding difficulties 172 1 (3/174) 2%<br />
Ulceration (onset/worsening) 172 1 (4/174) 2%<br />
Breath holding spells 172 1 (2/174) 1%<br />
Somnolence 185,195 2 (5/83) 6%-6.7%<br />
Hypoglycemia 185 1 (1/53) 2%<br />
Hypotension 185 1 (1/53) 2%<br />
Pr<strong>of</strong>ound mottling <strong>of</strong> extremities 185 1 (1/53) 2%<br />
Severe bradycardia 185 1 (1/53) 2%<br />
Cold extremities 195 1 (3/30) 10%<br />
Bronchospasm 195 1 (3/30) 10%<br />
Transaminase increase 195 1 (1/30) 3.3%<br />
Skin changes (redness, rash, itching, 2 (9/249) 1.96%-4%<br />
erosion, eczema) 197,198,204<br />
Ulceration 204 1 (5/148) 3%<br />
63
Table 24. Adverse effects in case series <strong>of</strong> propranolol to treat IH (continued)<br />
Number <strong>of</strong><br />
Studies (#<br />
Intervention<br />
Harm/Adverse Event<br />
Participants<br />
With Harm/Total<br />
Participants)<br />
††† Oral Propranolol +<br />
Atenolol (dose not clearly<br />
reported)<br />
Cold extremities 188 1 (55/109) 51%<br />
Sleep disturbance 188 1 (47/109) 43%<br />
Gastrointestinal problems 188 1 (27/109) 25%<br />
Fatigue 188 1 (20/109) 18%<br />
Coughing 188 1 (19/109) 17%<br />
Sweating 188 1 (16/109) 15%<br />
Pallor 188 1 (14/109) 13%<br />
Agitation/irritation 188 1 (14/109) 13%<br />
Dyspnea/shortness <strong>of</strong> breath 188 1 (6/109) 6%<br />
Increased activity 188 1 (5/109) 5%<br />
Skin reaction 188 1 (5/109) 5%<br />
Nausea/vomiting 188 1 (4/109) 4%<br />
Decreased appetite 188 1 (4/109) 4%<br />
Increased appetite 188 1 (3/109) 3%<br />
Hypoglycemia 188 1 (3/109) 3%<br />
Syncope 188 1 (2/109) 2%<br />
Dizziness 188 1 (2/109) 2%<br />
Hair loss 188 1 (2/109) 2%<br />
Seizure 188 1 (1/109) 1%<br />
Dry mouth (xerostomia) 188 1 (1/109) 1%<br />
Hallucinations 188 1 (1/109) 1%<br />
Reported<br />
Rates<br />
Across<br />
Studies<br />
ALT = alanine aminotransferase; AST = aspartate transaminase; IH = infantile hemangioma; kg = kilogram; mg = milligram<br />
*One study <strong>of</strong> 1.5 mg/kg/day (not included in table) 174 reported that 23 <strong>of</strong> 109 children had adverse events (N <strong>of</strong> events not<br />
stated) including hypotension, insomnia, agitation, aggravation <strong>of</strong> bronchitis, cold extremities gastroesophageal issues, <strong>and</strong> dry<br />
skin. Four children discontinued propranolol due to aggravation <strong>of</strong> bronchitis (n=2) or gastroesophageal issues (n=2).<br />
** One study 168 also reported that 50/50 children had at least one low diastolic blood pressure, 38/50 had at least one low systolic<br />
blood pressure, <strong>and</strong> 7/50 had low diastolic, systolic blood pressure <strong>and</strong> heart rate (data not factored into table). Some children in<br />
another study 199 were also receiving steroids (n=20/76) or timolol (n=7/76) along with propranolol. In a third study evaluating<br />
propranolol, 190 29 <strong>of</strong> 250 children were also receiving concurrent steroids.<br />
***One study 168 reported “lethargy, viral illness, <strong>and</strong> hypoglycemia” in 2/250 children (data not factored into table).<br />
†<br />
One study 164 reported discontinuation <strong>of</strong> propranolol in 4/35 children because <strong>of</strong> “insomnia, nightmares, loss <strong>of</strong> energy.” These<br />
data are not factored into the table.<br />
†† Adverse events in Blatt 2011 were considered serious by the study investigators. 185<br />
††† Raphael 2015 is related to de Graaf 2013, 146-148 but the extent <strong>of</strong> overlap is unclear. The case series 188 also reports harms in 3<br />
individual case reports: among 45 children receiving 4 mg/kg/day propranolol, 1 had multiple episodes <strong>of</strong> decreased<br />
consciousness, 1 had nausea, 1 had an epileptic seizure after the first propranolol dose. Among those 64 receiving 3 mg/kg/day <strong>of</strong><br />
atenolol, 1 had difficulty waking <strong>and</strong> hypotonia, 1 had two episodes <strong>of</strong> loss <strong>of</strong> consciousness, 1 had three episodes <strong>of</strong> loss <strong>of</strong><br />
consciousness.<br />
Harms Reported in Package Insert Data<br />
Hemangeol ® is the only medication included in this review that has an FDA approved<br />
indication for infantile hemangioma. The safety <strong>of</strong> Hemageol® in pediatric patients has been<br />
reported in the medication package insert. 206 FDA medical review packages were not available<br />
for this medication. The most common adverse events, occurring in greater than 10% <strong>of</strong> infants,<br />
were sleep disorders, aggravated respiratory tract infections such as bronchitis <strong>and</strong> bronchiolitis<br />
associated with cough <strong>and</strong> fever, diarrhea, <strong>and</strong> vomiting. 206 In a study <strong>of</strong> pooled safety data<br />
(n=424), infants (63% aged 91-150 days) were treated with Hemangeol® 1.2 mg/kg/day or 3.4<br />
mg/kg/day for 3 or 6 months. Treatment emergent adverse events occurring in 3% or greater in<br />
infants receiving the Hemangeol ® 1.2 mg/kg/day (n=200) or Hemangeol ® 3.4 mg/kg/day (n=224)<br />
compared to placebo were provided. Adverse events <strong>and</strong> frequencies for patients receiving<br />
Hemangeol® 1.2 mg/kg/day included: sleep disorders (17.5%), bronchitis (8%), peripheral<br />
64
coldness (8%), agitation (8.5%), diarrhea (4.5%), somnolence (5.0%), nightmare (2.0%),<br />
irritability (5.5%), decreased appetite (2.5%), <strong>and</strong> abdominal pain (3.5%). Adverse events <strong>and</strong><br />
frequencies for patients receiving Hemangeol® 3.4 mg/kg/day (n=224) included: sleep disorders<br />
(16.1%), bronchitis (13.4%), peripheral coldness (6.7%), agitation (4.5%), diarrhea (6.3%),<br />
somnolence (0.9%), nightmare (6.3%), irritability (1.3%), decreased appetite (3.6%), <strong>and</strong><br />
abdominal pain (0.4%). Additional adverse events reported in less than 1% <strong>of</strong> patients<br />
participating in clinical trials included: second degree atrioventricular heart block (occurring in a<br />
patient with underlying conduction disorder), urticaria, alopecia, decreased blood glucose, <strong>and</strong><br />
decreased heart rate.<br />
The safety <strong>and</strong> efficacy <strong>of</strong> the oral tablet, oral capsule, <strong>and</strong> injectable formulations <strong>of</strong><br />
propranolol have not been investigated in pediatric patients. 207-209 The package inserts for these<br />
formulations state that reports <strong>of</strong> bronchospasm <strong>and</strong> congestive heart failure have been reported<br />
in pediatric patients receiving propranolol. Additional adverse events revealed during postmarketing<br />
surveillance include agranulocytosis, hallucination, <strong>and</strong> purpura. 206<br />
Harms <strong>of</strong> Other Active Comparator Agents<br />
Harms <strong>of</strong> corticosteroids <strong>and</strong> PDL are presented in those sections; this section only includes<br />
medications for which harms are not presented elsewhere in this review. In a study rated poor<br />
quality for harms reporting, reported complications <strong>of</strong> bleomycin included febrile episode,<br />
superficial ulceration, <strong>and</strong> raised alkaline phosphatase. 95 The proportion <strong>of</strong> participants who<br />
experienced these complications is unclear. In another study, which was rated good quality for<br />
harms reporting, adverse effects in 20 participants using imiquimod included crusting <strong>of</strong> lesions<br />
(65%), superficial scars (15%), <strong>and</strong> skin pigmentation (29%).<br />
Key Question 3. Effectiveness <strong>and</strong> Harms <strong>of</strong> Drugs<br />
Administered After the Failure <strong>of</strong> Corticosteroids or Beta-<br />
Blockers<br />
We did not identify any comparative studies addressing this Key Question.<br />
Key Question 4. Effectiveness <strong>and</strong> Harms <strong>of</strong> Surgical<br />
Interventions<br />
Key Points<br />
• Studies primarily addressed different laser modalities compared with observation or other<br />
laser modalities. PDL was the most commonly studied laser type, but multiple variations<br />
in treatment protocols did not allow for demonstration <strong>of</strong> superiority <strong>of</strong> a single method<br />
(low SOE for difference in effects on size reduction between longer pulse PDL <strong>and</strong> other<br />
lasers).<br />
• Two small studies addressed different surgical techniques (cryotherapy, intense pulsed<br />
light photothermolysis, sclerosis) <strong>and</strong> reported some positive effects in reducing IH size<br />
or improving appearance, but their smaller size <strong>and</strong> low quality preclude conclusions<br />
(insufficient SOE).<br />
• Many studies used historical controls, based on now superseded treatment regimens.<br />
65
• In two RCTs reporting level <strong>of</strong> clearance, at least 40 percent <strong>of</strong> children in laser or<br />
observation arms had complete or near complete clearance <strong>of</strong> IH (low SOE for lack <strong>of</strong><br />
difference between PDL <strong>and</strong> observation).<br />
• Cohort studies assessed outcomes after CO2 <strong>and</strong> Nd:YAG (neodymium yttrium<br />
aluminum garnet) lasers <strong>and</strong> typically reported some resolution <strong>of</strong> lesion size, but<br />
heterogeneity among studies limits our abilities to draw conclusions (insufficient SOE).<br />
• Harms associated with laser treatment included skin atrophy, bleeding, scarring,<br />
ulceration, purpura, <strong>and</strong> pigmentation changes. Bleeding <strong>and</strong> ulceration were observed in<br />
the immediate postoperative period, distinguishing these complications from the possible<br />
natural complications <strong>of</strong> IH themselves (moderate SOE for association <strong>of</strong> PDL with<br />
pigmentation changes; low for association with bleeding; <strong>and</strong> insufficient for scarring.<br />
Low SOE for association <strong>of</strong> Nd:YAG laser with scarring <strong>and</strong> insufficient for association<br />
with bleeding <strong>and</strong> pigmentation changes).<br />
Overview <strong>of</strong> the Literature<br />
Eleven comparative studies (three RCTs, 210-212 seven retrospective cohort studies, 213-219 <strong>and</strong><br />
one prospective comparative study that used treated <strong>and</strong> untreated lesions <strong>and</strong> intervention <strong>and</strong><br />
control groups 220 ) <strong>and</strong> 30 case series addressed surgical approaches. The RCTs were conducted<br />
in the Netherl<strong>and</strong>s, 210 Japan, 211 <strong>and</strong> the UK. 212 Cohort studies were performed in the United<br />
States, 216,217 Greece, 218 Singapore, 213 Russia, 219 <strong>and</strong> Germany. 214,215 Two RCTs 210,212 compared<br />
PDL to observation; one used traditional PDL in infants aged 1 to 14 weeks, 212 <strong>and</strong> the second<br />
used PDL with epidermal cooling in infants aged 0 to 6 months. 210 The third RCT 211 compared<br />
the use <strong>of</strong> non-cooled traditional PDL to longer pulse PDL with epidermal cooling in infants<br />
between 1 <strong>and</strong> 3 months old. We considered RCTs to be <strong>of</strong> good 210 <strong>and</strong> fair quality. 211,212<br />
Cohort studies examined various comparisons between different laser types including PDL<br />
versus Nd:YAG, 215 Argon versus Nd:YAG, 217 short pulse PDL versus longer pulse PDL. 213 One<br />
compared Nd:YAG <strong>and</strong> CO2 lasers <strong>and</strong> also included a non-surgical comparison group for<br />
airway IH. 214 Two studies compared different skin cooling protocols with the same laser types,<br />
including Nd:YAG 218 <strong>and</strong> PDL. 216 One cohort study compared cryosurgery, photothermolysis<br />
with intense pulsed light, <strong>and</strong> photothermolysis plus sclerosis with alcohol <strong>and</strong> lidocaine. 219 We<br />
considered two cohort studies as fair quality, 213,218 <strong>and</strong> the rest as poor. 214-217,219 We considered<br />
the self-controlled comparative study (rated using the Newcastle Ottawa tool) as poor quality. 220<br />
Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for<br />
cutaneous lesions <strong>and</strong> Nd:YAG was the most commonly used intralesionally. Most studies<br />
reported a higher success rate with longer pulse PDL compared to observation in managing the<br />
size <strong>of</strong> IH, although the magnitude <strong>of</strong> effect differed substantially. CO2 laser was used for<br />
subglottic IH in a single study, <strong>and</strong> was noted to have a higher success rate <strong>and</strong> lower<br />
complication rate than both Nd:YAG <strong>and</strong> observation. Studies addressing other surgical<br />
approaches (cryosurgery, intense pulsed light thermolysis) reported some improvements in IH<br />
but included few participants in each arm (total n = 263).<br />
SOE for outcomes after laser <strong>and</strong> surgical treatments ranged from insufficient to low for<br />
effectiveness outcomes. The evidence was limited by low sample size, <strong>and</strong> variations in the laser<br />
settings used including wavelength <strong>and</strong> cooling protocols. For Nd:YAG <strong>and</strong> CO2 lasers, all<br />
studies were limited by sample size, <strong>and</strong> SOE was insufficient for all outcome parameters.<br />
Thirty case series reported on harms <strong>of</strong> surgical approaches for IH (3831 children).<br />
Seventeen case series reported on harms from laser treatments, including 10 studies <strong>of</strong> PDL, 221-<br />
66
229,230<br />
four studies <strong>of</strong> Nd:YAG lasers, 231-234 one <strong>of</strong> combined PDL <strong>and</strong> Nd:YAG, 235 one <strong>of</strong> longpulse<br />
Alex<strong>and</strong>rite laser, 236 <strong>and</strong> one report <strong>of</strong> carbon dioxide laser. 237 Most studies included<br />
children with IH in multiple locations; one included children with only airway IH. 237 Ages <strong>of</strong><br />
children in these series, where clearly reported, ranged from less than 1 month to 11 years. We<br />
considered one study to be <strong>of</strong> good quality for harms reporting, 223 two <strong>of</strong> fair quality, 227,230 <strong>and</strong><br />
14 <strong>of</strong> poor quality. 221,222,224-226,228,229,231-237 We rated one cohort study that compared propranolol<br />
with concurrent PDL or followed by PDL <strong>and</strong> two comparing laser <strong>and</strong> topical timolol as poor<br />
quality for harms reporting <strong>and</strong> discuss harms <strong>of</strong> PDL here <strong>and</strong> harms <strong>of</strong> propranolol in the betablocker<br />
section <strong>of</strong> KQ2 above. 14,106,150<br />
Thirteen case series (840 children) reported harms from surgical procedures, typically<br />
excision or resection, to treat IH. 238-249 Ages ranged from 1 month to 19 years. The majority <strong>of</strong><br />
studies focused on treatment <strong>of</strong> facial IH, including three studies <strong>of</strong> lip IH, 240,244,248 two series <strong>of</strong><br />
periocular/periorbital IH, 242,245 two reports <strong>of</strong> various facial locations, 241,247 <strong>and</strong> one study <strong>of</strong><br />
nasal tip IH. 243 All <strong>of</strong> the studies were rated as poor quality for assessment <strong>of</strong> harms as data<br />
collection was not predefined.<br />
Detailed Analysis<br />
Effectiveness <strong>of</strong> Laser Treatment<br />
PDL Compared With Observation<br />
Two RCTs compared PDL to observation. One good quality RCT 210 r<strong>and</strong>omized 22 children<br />
with IH between 0 <strong>and</strong> 6 months <strong>of</strong> age into equal groups <strong>of</strong> observation or PDL with epidermal<br />
cooling. Twelve-month size change scores were used for analysis. Further, parents were asked to<br />
answer quality <strong>of</strong> life questionnaires at enrollment <strong>and</strong> at age 12 months. There was no statistical<br />
difference seen in echo depth or total surface area between the two groups; however color was<br />
significantly improved in the PDL group compared with control (p=0.03). Photographs reviewed<br />
for overall improvement also showed a “significant improvement” for the PDL group (46%) over<br />
the observation group (18%), but this “significant improvement” was not quantitatively defined.<br />
Parent-reported quality <strong>of</strong> life scales showed no difference in the severity <strong>of</strong> skin problems<br />
between groups. Sixty-three percent <strong>of</strong> parents in the PDL group reported improvement in the IH<br />
at 12 months compared with 33 percent in the observation group (p=NR). Thirteen percent <strong>of</strong><br />
parents perceived the treatments to be very painful.<br />
The second, fair-quality RCT r<strong>and</strong>omized 121 children to PDL (n=60) <strong>and</strong> observation<br />
(n=61) groups. 212,250 The investigators attempted to reduce bias by including a blinded panel <strong>of</strong><br />
parents <strong>of</strong> non-study children to describe whether they perceived the hemangioma to be a<br />
problem at 1 year <strong>of</strong> age. The investigators reported no differences in the number <strong>of</strong> children<br />
experiencing near complete resolution (42%-44% in each group) but more children in the PDL<br />
group (30%) than in the control arm (5%) experienced complete resolution (p=0.001). Outcomes<br />
between groups were similar at the 5-year followup <strong>of</strong> 117 children (32 <strong>of</strong> 57 in the PDL arm<br />
had complete clearance vs. 27 <strong>of</strong> 60 in the observation arm, p=0.31 <strong>and</strong> 41 <strong>of</strong> 57 <strong>and</strong> 48 <strong>of</strong> 60<br />
had minimal residual signs, p=0.39). Table 25 outlines key outcomes.<br />
67
Table 25. Key resolution outcomes in studies comparing PDL <strong>and</strong> observation<br />
Author, Year<br />
Groups (n)<br />
Quality<br />
Age, Months<br />
Type<br />
Location<br />
Methods <strong>and</strong> Measures<br />
<strong>of</strong> Resolution/<br />
Response<br />
Resolution Outcomes<br />
Kessels et al.<br />
2013 210<br />
G1: Pulsed dye<br />
laser (11)<br />
G2:<br />
Observation<br />
(11)<br />
Quality: Good<br />
Batta et al.<br />
2002 212<br />
G1: Pulsed dye<br />
laser (60)<br />
G2:<br />
Observation<br />
(61)<br />
Quality: Fair<br />
Age, median<br />
(range)<br />
G1: 3 (1.7-5.0)<br />
G2: 3 (1.5-4.5)<br />
Type<br />
Superficial <strong>and</strong><br />
cutaneous only<br />
Age, median<br />
(range, days<br />
G1: 38 (10 to<br />
101)<br />
G2: 32 (5 to<br />
79)<br />
Type, n (%)<br />
Flat<br />
G1: 31 (52)<br />
G2: 30 (49)<br />
Raised<br />
G1: 29 (48)<br />
G2: 31 (51)<br />
G1+G2:<br />
multiple<br />
G1+G2:<br />
multiple<br />
G = group; n = number; PDL = pulsed dye laser<br />
• Photographs<br />
• Color measured by<br />
reflectance<br />
photometer<br />
• Improvement scale<br />
evaluated by blinded<br />
panel<br />
1= no improvement<br />
2= moderate<br />
improvement<br />
3 = significant<br />
improvement<br />
• Photographs<br />
• Primary outcome<br />
measure assessed by<br />
investigator: complete<br />
clearance or<br />
minimum residual<br />
signs at age 1 year<br />
• Blinded medical<br />
observer assessed<br />
redness (secondary<br />
outcome measure)<br />
Change in echo depth, median<br />
(interquartile range)<br />
G1: -1.21 (-1.75 to 0.15)<br />
G2: -1.10 (-2.00 to 0.96)<br />
G1 vs.G2 p= 0.69<br />
Change in surface, median<br />
(interquartile range)<br />
G1: 0.40 (0.10 to 0.80)<br />
G2: 0.00 (-0.08 to 0.40)<br />
G1 vs.G2 p= 0.08<br />
Color change, median<br />
(interquartile range)<br />
G1: 10.16 (5.50 to 15.41)<br />
G2: 4.23 (0.84 to 5.28)<br />
G1 vs.G2 p= 0.03<br />
Complete clearance or minimum<br />
residual signs, n (%)<br />
G1: 25 (42)<br />
G2: 27 (44)<br />
G1 vs.G2: p=0.92<br />
Complete only<br />
G1: 18 (30)<br />
G2: 3 (5)<br />
G1 vs.G2: p=0.001<br />
Comparative Effectiveness <strong>of</strong> Various PDL Modalities<br />
One fair quality Japanese RCT 211 r<strong>and</strong>omized 52 patients to a “traditional PDL” group <strong>and</strong> a<br />
“long-pulse” dye laser group (pulse durations <strong>of</strong> 0.45 milliseconds vs. 10-20 milliseconds). The<br />
percentage <strong>of</strong> patients achieving an excellent (76-100%) clearance <strong>of</strong> the lesion did not differ<br />
between groups, with rates <strong>of</strong> 54 to 65 percent in each group. Time to maximal proliferation was<br />
significantly shorter (106 days) in the longer pulse PDL group compared with the traditional<br />
PDL group (177 days, p=0.01). Another fair quality cohort study comparing short <strong>and</strong> longer<br />
pulse PDL similarly reported no significant differences in the number <strong>of</strong> children with complete<br />
or near-complete resolution by age 3 to 3.5 years. 213<br />
In a poor quality cohort study evaluating cryogen spray cooling as an adjunct to PDL versus<br />
no cooling in 164 children (mean age overall= 2 years, 11 months), c 216 hildren in the cryogen<br />
cooling arm required fewer treatments <strong>and</strong> had greater improvements in volume <strong>and</strong> texture than<br />
children in the non-cooled PDL arm (p values
Table 26. Key resolution outcomes in studies comparing PDL modalities<br />
Author, Age,<br />
Methods <strong>and</strong><br />
Year Months<br />
Location Measures <strong>of</strong><br />
Resolution Outcomes<br />
Groups (n)<br />
Resolution/Response<br />
Quality Type<br />
Kono et al.<br />
2005 211<br />
G1: Longpulse<br />
dye<br />
laser (26)<br />
G2:<br />
Traditional<br />
pulsed dye<br />
laser(26)<br />
Quality: Fair<br />
Age,<br />
mean±SD,<br />
weeks<br />
G1: 11.2<br />
G2: 10.7<br />
Type, %<br />
Superficial<br />
G1+G2:<br />
100<br />
G1+G2:<br />
multiple<br />
• Serial photographs<br />
assessed by blinded<br />
medical observer<br />
using: Excellent: 76-<br />
100%<br />
Moderate: 51-75%<br />
Mild: 26-50%<br />
None or worse (0-<br />
25%)<br />
Complete clearance or minimal<br />
residual signs at 1 year, n (%)<br />
G1: 17 (65)<br />
G2: 14 (54)<br />
G1 vs.G2 p=0.397<br />
Excellent<br />
G1: 17<br />
G2: 14<br />
Moderate<br />
G1: 7<br />
G2: 5<br />
Mild<br />
G1: 2<br />
G2: 4<br />
Tay et al.<br />
2012 213<br />
G1: Short<br />
pulse 595-<br />
nm Pulsed<br />
dye laser<br />
(15)<br />
G2: Longer<br />
pulse 595-<br />
nm PDL (8)<br />
Quality: Fair<br />
Age mean<br />
(range)<br />
G1+G2: 6.5<br />
(2.5-19)<br />
Type, n<br />
Superficial<br />
G1: 7<br />
G2: 3<br />
Mixed<br />
G1: 8<br />
G2: 5<br />
G1+G2:<br />
multiple<br />
• Photographs<br />
evaluated by<br />
unblinded<br />
dermatologist<br />
None or worse<br />
G1: 0<br />
G2: 3<br />
Number <strong>of</strong> treatments needed for<br />
resolution<br />
G1: 3-14 mean=8 median=7<br />
G2: 4-14 mean=9 median=7<br />
G1 vs.G2: p=ns<br />
Average number <strong>of</strong> treatments<br />
needed for the clearance <strong>of</strong> mixed<br />
IH= 4 to 5 treatments more in both<br />
groups<br />
69
Table 26. Key resolution outcomes in studies comparing PDL modalities (continued)<br />
Author,<br />
Year<br />
Groups (n)<br />
Quality<br />
Age,<br />
Months<br />
Type<br />
Location<br />
Methods <strong>and</strong><br />
Measures <strong>of</strong><br />
Resolution/Response<br />
Resolution Outcomes<br />
Chang et al.<br />
2001 216<br />
G1: Non<br />
cooled flash<br />
lamppumped<br />
pulsed dye<br />
laser (82)<br />
G2: Cryogen<br />
spray cooling<br />
plus flash<br />
lamppumped<br />
pulse dyed<br />
laser (82)<br />
Age, mean,<br />
years<br />
G1: 2.5<br />
G2: 3.4<br />
Type, %<br />
Cutaneous<br />
G1+G2:<br />
100<br />
G1+G2:<br />
multiple<br />
• Photographs<br />
assessed by blinded<br />
plastic surgeons<br />
• Volume reduction,<br />
texture, color<br />
• Excellent: 76-100%<br />
improvement<br />
Good: 51-75%<br />
Fair: 26-50%<br />
Poor:0-25%<br />
Volume reduction, mean score<br />
G1: 3.84<br />
G2: 3.96<br />
G1 vs.G2 p=0.008<br />
Texture<br />
G1: 3.57<br />
G2: 3.90<br />
G1 vs.G2 p=0.001<br />
Color<br />
G1: 3.98<br />
G2: 4.00<br />
G1 vs.G2 p=0.155<br />
Quality:<br />
Poor<br />
G = group; n = number; nm = nanometer; PDL = pulsed dye laser; SD = st<strong>and</strong>ard deviation<br />
Nd:YAG Laser Compared With Other Lasers or Observation<br />
Three poor quality cohort studies compared Nd:YAG laser to either argon laser, 217 traditional<br />
PDL, 215 or CO2 laser or observation. 214 One study included 55 children with sequelae from<br />
hemangioma <strong>and</strong> reported similar rates <strong>of</strong> excellent clearance (defined as 90-100% clearance)<br />
between Nd:YAG <strong>and</strong> Argon groups <strong>and</strong> a higher rate <strong>of</strong> children attaining 50 percent or greater<br />
clearance in the Nd:YAG group (72% vs. 52%). 217 Lesions were also scored for size length <strong>and</strong><br />
width, which showed little difference between groups. Heights <strong>of</strong> lesions were sub-analyzed,<br />
which showed a greater ability <strong>of</strong> Nd:YAG to treat thicker lesions, with no excellent results in<br />
the argon group for lesions 0.5 cm in height <strong>and</strong> greater.<br />
In a study comparing Nd:YAG <strong>and</strong> PDL <strong>and</strong> including 50 children, 41 percent <strong>of</strong> children<br />
receiving PDL <strong>and</strong> 30 percent receiving Nd:YAG had complete clearance <strong>of</strong> IH (p=NR). 215<br />
Similar numbers in each group had 70 to 99 percent or
had tracheostomy compared with those who had no tracheostomy, <strong>and</strong> parental worry about the<br />
fate <strong>of</strong> the child lessened earlier if the child did not have a tracheostomy. Table 27 outlines key<br />
outcomes.<br />
Table 27. Key resolution outcomes in comparative studies <strong>of</strong> Nd:YAG laser<br />
Age,<br />
Months<br />
Author, Year<br />
Groups (n)<br />
Quality<br />
Achauer et al.<br />
1989 217<br />
G1: Argon (30)<br />
G2: Nd:YAG<br />
(25)<br />
Quality: Poor<br />
Type<br />
Age<br />
G1+G2:<br />
range 2<br />
weeks to 5<br />
years<br />
Type<br />
NR<br />
Location<br />
G1+G2: multiple<br />
Methods <strong>and</strong> Measures<br />
<strong>of</strong> Resolution/Response<br />
• % reduction in volume<br />
graded:<br />
Excellent: 90-100%<br />
Good: 51-89%<br />
Fair: 25-50%<br />
Poor: 0-24%<br />
• Blinded assessment:<br />
not clear<br />
Resolution Outcomes<br />
Volume reduction, %<br />
Excellent<br />
G1: 35<br />
G2: 44<br />
Good<br />
G1: 17<br />
G2: 28<br />
Fair<br />
G1: 21<br />
G2: 12<br />
Raulin et al.<br />
2001 215<br />
G1: Flashlight<br />
pumped pulsed<br />
dye laser (25)<br />
G2: Long-pulse<br />
Nd:YAG laser<br />
(25)<br />
Age<br />
NR<br />
Type, %<br />
Superficial<br />
G1+G2: 100<br />
G1+G2: multiple<br />
• Photographs<br />
• Independent<br />
evaluation <strong>of</strong><br />
regression rated as<br />
100%, 70-99%,
Nd:YAG Laser With Cooling Compared With No Cooling<br />
In one fair quality cohort study, 235 patients (mean age= 9 months) received the same<br />
Nd:YAG laser treatment but different methods <strong>of</strong> epidermal cooling (ice chips during procedure,<br />
n=115; ice before, during, <strong>and</strong> after treatment, n=120). 218 Children were treated until they<br />
received an excellent (90-100% resolution) or good (50-89% resolution) result. Patients with<br />
more extensive cooling required a mean 1.45 sessions <strong>of</strong> laser treatment compared to 2.11 in the<br />
less extensive cooling group (Table 28).<br />
Table 28. Key resolution outcomes in comparative studies <strong>of</strong> Nd:YAG laser with cooling<br />
Author, Age,<br />
Year Months<br />
Methods <strong>and</strong> Measures<br />
Location<br />
Resolution Outcomes<br />
Groups (n)<br />
<strong>of</strong> Resolution/Response<br />
Quality Type<br />
Vlachakis et<br />
al. 2004 218<br />
G1: Nd:YAG<br />
laser, cooled<br />
with ice<br />
before,<br />
during <strong>and</strong><br />
after<br />
irradiation<br />
(120)<br />
G2: Nd:YAG<br />
laser, cooled<br />
with ice only<br />
during<br />
irradiation<br />
(115)<br />
Age mean<br />
(range)<br />
G1+G2: 9<br />
(3 months<br />
to 4 years)<br />
Type, %<br />
Cutaneous<br />
G1+G2:<br />
100<br />
G1+G2:<br />
multiple<br />
• Change in size<br />
Excellent: 90-100%<br />
area reduction<br />
Good: 50-89%<br />
Moderate: 20-49%<br />
Poor: 0-19%<br />
• Blinded assessment:<br />
NR<br />
Total resolution after session 1<br />
G1: 65<br />
G2: 39<br />
Total resolution after session 2<br />
Excellent<br />
G1: 55/55<br />
G2: 24/76<br />
Good<br />
G1: 0<br />
G2: 52/76<br />
Quality: Fair<br />
Abbreviations: G = group; n = number; Nd:YAG = neodymium yttrium aluminium garnet; NR = not reported<br />
Effectiveness <strong>of</strong> Surgical Treatments<br />
Photothermolysis With Intense Pulsed Light Compared With Cryosurgery<br />
Compared With Photothermolysis With Intense Pulsed Light Plus Sclerosis<br />
One retrospective cohort study compared three treatment modalities in 250 infants
Table 29. Key resolution outcomes in comparative studies <strong>of</strong> photothermolysis with intense<br />
pulsed light <strong>and</strong> cryosurgery<br />
Author, Age,<br />
Year Months<br />
Methods <strong>and</strong> Measures<br />
Location<br />
Resolution Outcomes<br />
Groups (n)<br />
<strong>of</strong> Resolution/Response<br />
Quality Type<br />
Ryzhevskiy<br />
et al. 219<br />
G1: Selective<br />
photothermol<br />
ysis (87)<br />
G2: Cyrodestruction<br />
with liquid<br />
nitrogen (79)<br />
G3:<br />
Combination<br />
<strong>of</strong> selective<br />
photothermol<br />
ysis <strong>and</strong><br />
sclerosis(84)<br />
Age mean<br />
(range)<br />
G1+G2: 9<br />
(3 months<br />
to 4 years)<br />
Type, %<br />
Cutaneous<br />
G1+G2:<br />
100<br />
Quality:<br />
Poor<br />
G = group; NR = not reported<br />
G1+G2:<br />
multiple<br />
• Lesion area measured<br />
with graph paper.<br />
Change in depth<br />
confirmed by<br />
ultrasound<br />
• Cosmetic results after<br />
first treatment session:<br />
Good: 50% or more<br />
reduction in area;<br />
Satisfactory: 10-50%<br />
reduction;<br />
Unsatisfactory: < 10%<br />
or no positive<br />
dynamics<br />
• Evaluation blinding:<br />
NR<br />
Resolution after session 1, %<br />
Good<br />
G1: 35.6<br />
G2: 22.8<br />
G3: 71.4<br />
Satisfactory<br />
G1: 44.8<br />
G2: 46.8<br />
G3: 23.8<br />
Unsatisfactory<br />
G1: 19.5<br />
G2: 30.4<br />
G3: 4.8<br />
Cryosurgery Versus No Treatment<br />
One study assessed cryosurgical treatment <strong>of</strong> IH in preterm infants with multiple IH by<br />
treating one IH lesion <strong>and</strong> not treating another. 220 Some children had more than one pair <strong>of</strong><br />
treated/untreated lesions, <strong>and</strong> the study followed infants up to age 1 or 2 years. Thirteen <strong>of</strong> 17<br />
treated IH <strong>and</strong> two <strong>of</strong> 17 untreated IH met the primary endpoint <strong>of</strong> intact, IH-free skin with mild<br />
or no pigmentation or scarring at 1 or 2 years <strong>of</strong> age (p
Table 30. Key resolution outcomes in comparative studies <strong>of</strong> cryosurgical therapy<br />
Author, Age,<br />
Methods <strong>and</strong><br />
Year Months<br />
Location Measures <strong>of</strong><br />
Resolution Outcomes<br />
Groups (n)<br />
Resolution/Response<br />
Quality Type<br />
Goelz et al.<br />
2014 220<br />
G1: nitrogencooled<br />
cryotherapy<br />
(13)<br />
G2: no<br />
treatment<br />
control (13)<br />
Quality:<br />
Poor<br />
Age<br />
NR<br />
(preterm<br />
infants)<br />
Type, %<br />
NR<br />
G1+G2:<br />
multiple<br />
NR<br />
Blinded assessment:<br />
NR<br />
Met primary endpoint, n IH (%)<br />
G1: 13/17 IH (76)<br />
G2: 2/17 (12)<br />
G1 vs G2: p
Table 31. Harms/adverse effects in comparative studies <strong>of</strong> lasers to treat * IH<br />
Intervention<br />
Harm/Adverse Event<br />
N Studies Reporting Harm<br />
Reported Rates<br />
(# Participants With<br />
Across Studies<br />
Harm/Total Participants)<br />
Pulsed dye laser Purpura 215 1 (25/25) 100%<br />
Swelling 215 1 (25/25 100%<br />
Skin atrophy 212 1 (17/60) 28%<br />
Minimal crusting 210 1 (2/11) 18.2%<br />
Ulceration 212 1 (4/60) 7%<br />
Painful ulceration 212 1 (3/60) 5%<br />
Ulcer formation 211 1 (1/26) 4%<br />
Bleeding 212 1 (2/60) 3%<br />
Infection 212 1 (2/60) 3%<br />
** Atrophic scarring 150,215 1 (2/42) 3%-6%<br />
Hyperpigmentation 211,213,215 3 (12/66) 13%-20%<br />
Texture change 211,213 2 (8/41) 13%-23%<br />
Hypopigmentation 211-213,215 4 (41/126) 10%-45%<br />
Blistering (crusts <strong>and</strong> blisters) 213,215 2 (21/40) 13%-76%<br />
Longer pulse PDL Hypopigmentation 211,213 2 (4/34) 12%-12.5%<br />
Hyperpigmentation 211,213 2 (3/34) 8%-12.5%<br />
Texture change 211,213 2 (2/34) 4%-12.5%<br />
Nd:YAG laser *** Hypopigmentation 215 1 (2/25) 6%<br />
Purpura 215 1 (5/25) 20%<br />
Crusts <strong>and</strong> blisters 215 1 (8/25) 24%<br />
Swelling 215 1 (25/25 100%<br />
Atrophic scarring 215 1 (1/25) 3%<br />
Scarring 217 1 (8/26) 30.8%<br />
Delayed healing 217 1 (1/26) 12.5%<br />
Postoperative bleeding 217 1 (2/26) 7.7%<br />
Postoperative complications 1(35/235) 14.9%<br />
(including bleeding, atrophic scars<br />
<strong>and</strong> hypertrophic scars) 218<br />
Argon laser Delayed healing 217 1 (2/31) 13%<br />
Postoperative bleeding 217 1 (1/31) 3.2%<br />
Reaction to local anesthesia 1 (1/31) 3.2%<br />
(seizure <strong>and</strong> hospitalization) 217<br />
Observation Hypopigmentation 212 1 (9/61) 15%<br />
Skin atrophy 212 1 (5/61) 8%<br />
Ulceration 212 1 (4/61) 7%<br />
Painful ulceration 212 1 (2/61) 3%<br />
Bleeding 212 1 (2/61) 3%<br />
Infection 212 1 (4/61) 7%<br />
IH = infantile hemangioma; n = number; Nd:YAG = neodymium yttrium aluminum garnet; PDL = pulsed dye laser<br />
* One study <strong>of</strong> cryosurgery reported harms by number <strong>of</strong> IH. Scarring occurred in 4/17 treated IH <strong>and</strong> on 1 untreated IH. 220<br />
**<br />
One study reported atrophic scarring <strong>and</strong> ulceration in 1/17 children receiving PDL <strong>and</strong> concurrent propranolol. 150 One study<br />
(not represented in table) reported that 12.4% <strong>of</strong> the parents <strong>of</strong> 11 children receiving PDL judged that the treatment was painful.<br />
Another study included followup at 5 years post-PDL or observation <strong>and</strong> noted more scarring in the PDL group (49% vs 28% in<br />
controls, p=0.02 <strong>and</strong> more hypopigmentation (44% vs 23% in observation group, p=0.03). The number with skin atrophy was<br />
similar between groups. 212,250<br />
r*** One cohort study comparing topical timolol with PDL plus Nd:YAG laser reported crusting <strong>and</strong> hyperpigmentation in 4/30<br />
children. 14 Another study comparing topical timolol plus PDL to timolol alone reported that no children experienced any adverse<br />
effects. 106<br />
Ten case series reported on 1785 children who were treated with PDL (Table 32). One<br />
Korean study (good quality for harms reporting) treated 47 superficial or mixed IH in 40 patients<br />
monitored for hyper- <strong>and</strong> hypo- pigmentation, skin atrophy, hypertrophic scarring, <strong>and</strong> ulceration<br />
during treatment. 223 The only adverse event noted in this study was hyperpigmentation in two<br />
patients with superficial IH. The final assessment in this study was at the end <strong>of</strong> treatment so no<br />
75
long term follow information was available. A fair quality case series reported on PDL treatment<br />
for 65 children with ulcerated IH. 227 There were no cases <strong>of</strong> the predefined complications <strong>of</strong><br />
hypo- or hyperpigmentation or epidermal textural changes. Some scarring occurred in an<br />
unknown number <strong>of</strong> patients that was comparable to scarring associated with healing <strong>of</strong><br />
conservative treatment. Another fair quality case series <strong>of</strong> h<strong>and</strong> hemangiomas noted atrophy,<br />
pigment change, ulceration <strong>and</strong> scarring. 230 The most frequently reported harms were<br />
hyperpigmentation (1% to 14% in four studies 221,223-225 ) <strong>and</strong> hypopigmentation (0-25% in five<br />
studies 221,223-225,228 ). Ulceration was also noted in three studies. Two studies reported no adverse<br />
events, 222,226 <strong>and</strong> another reported no permanent side effects but cases <strong>of</strong> hyper <strong>and</strong><br />
hypopigmentation. 225<br />
One thous<strong>and</strong> <strong>and</strong> seven children received treatment with Nd:YAG lasers reported in four<br />
case series. The most frequently reported adverse events from one large case series with 684<br />
children included skin burn (11%), infection (6.6%), <strong>and</strong> scarring (4.4%). 232 Another larger study<br />
with 160 participants reported complications including delayed healing, postoperative infection<br />
<strong>and</strong> scarring in 10 percent <strong>of</strong> their patients. 231 A single case series <strong>of</strong> 31 patients with subglottic<br />
IH noted one case <strong>of</strong> respiratory distress related to the ventilation system. 237<br />
Table 32. Adverse effects in case series <strong>of</strong> laser treatments for IH<br />
Number <strong>of</strong> Studies<br />
Intervention<br />
Harm/Adverse Event<br />
(# Participants With Reported Rates<br />
Harm/Total<br />
Across Studies<br />
Participants)<br />
Pulsed dye laser Hyperpigmentation 221,223-225 4 (17/357) 1%-14.5%<br />
Hypopigmentation 221,223-225,228 5 (192/1014) 0-25.1%<br />
Pigment change (increase or 2 (67/700) 7-9.7%<br />
decrease) 228,230<br />
Ulceration 224,228,230 3 (7/790) 0.76-2.3%<br />
Blisters 221 1 (3/62) 4.8%<br />
Atrophy 228,230 2 (50/700) 7%-7.15%<br />
Scarring 228,230 2 (7/700) 0.9%-2.3%<br />
Granuloma telangiectaticum 229 1 (4/548) 0.7%<br />
Cutaneous atrophy <strong>and</strong><br />
1 (22/657) 3.4%<br />
pigmentation 228<br />
Cutaneous atrophy <strong>and</strong><br />
1 (32/657) 4.9%<br />
hypopigmentation 228<br />
Nd:YAG laser Scarring 232,234 2 (36/794) 4.4%-5.5%<br />
Hypertrophic scarring 234 1 (2/110) 1.8%<br />
Ulceration 232 1 (15/684) 2.2%<br />
Skin burn 232 1 (75/684) 11%<br />
Bleeding 232,234 2 (13/794) 0.9%-1.8%<br />
Nerve injury 232 1 (9/684) 1.3%<br />
Infection 232 1 (45/684) 6.6%<br />
Undesirable texture change 232 1 (30/684) 4.4%<br />
Anemia <strong>and</strong> hyperkalemia 232 1 (1/684) 0.15%<br />
Postoperative stenosis 233 1 (1/53) 1.9%<br />
CO2 laser Respiratory distress 237 1 (1/31) 3.2%<br />
Subglottic scarring 237 1 (1/31) 3.2%<br />
76
Table 32. Adverse effects in case series <strong>of</strong> laser treatments for IH (continued)<br />
Intervention<br />
Harm/Adverse Event<br />
Number <strong>of</strong> Studies<br />
Reported Rates<br />
(# Participants With<br />
Across Studies<br />
Harm/Total Participants)<br />
Long-pulse<br />
Hypopigmentation 236 1 (48) 2.1%<br />
Alex<strong>and</strong>rite laser Blistering 236 1 99/48) 18.8%<br />
Marked edema <strong>and</strong> erosion 1 (1/48) 2.1%<br />
without residual scarring 236<br />
Combination (Pulsed<br />
Dye <strong>and</strong> ND:YAG)<br />
Blistering 235 1 (17/37) 45.9%<br />
Erosion 235 1 (1/37) 2.7%<br />
Scarring 235 1 (1/37) 2.7%<br />
CO2 = carbon dioxide; IH = infantile hemangioma; Nd:YAG = neodymium yttrium aluminum garnet<br />
One study 227 noted “some” scarring. One study 231 reported complications <strong>of</strong> “delayed healing, infection <strong>and</strong>/or scar formation” in<br />
16/160 (10%) <strong>of</strong> participants. One study 229 noted transient hypo- or hyperpigmentation in approximately 7% <strong>of</strong> cases <strong>and</strong> small<br />
atrophic scars in 4%.<br />
Table 33 outlines harms reported in surgical case series <strong>and</strong> in one comparative study <strong>of</strong><br />
cryosurgery. 220 Dehiscence rates ranged from 1.4 percent to 5.5 percent in five<br />
studies, 238,240,246,248,251 <strong>and</strong> single cases <strong>of</strong> postoperative trauma-related wound dehiscence were<br />
reported in an additional three studies. 238,241,243 Postoperative infections were noted in two<br />
studies. 240,249 Scarring, skin necrosis, <strong>and</strong> alopecia were also noted in two reports. Other<br />
complications including facial paresis, permanent palsy, hematoma, intraoperative bleeding,<br />
cellulitis, hypopigmentation were reported in a single study each. One study reported no adverse<br />
events. 247 One larger series <strong>of</strong> 127 patients with lip IH treated with liquid nitrogen cryotherapy<br />
reported five cases <strong>of</strong> hypopigmentation <strong>and</strong> three cases <strong>of</strong> hemorrhage <strong>and</strong> ulceration. Labial<br />
mucoceles were noted in three children 3 years after treatment. 244 Harms reported in one study <strong>of</strong><br />
cryosurgery included scarring in treated <strong>and</strong> untreated lesions. 220<br />
Table 33. Adverse effects in case series <strong>of</strong> surgical treatments for IH<br />
Intervention<br />
Harm/Adverse Event<br />
Number <strong>of</strong> Studies (#<br />
Reported Rates<br />
Participants With<br />
Across Studies<br />
Harm/Total Participants)<br />
Surgery including Dehiscences 238,240,246,248,251 5 (17/357) 1.4%-5.5%<br />
excision <strong>and</strong> Postoperative traumatic wound 3 (3/119) 2.3%-2.8%<br />
resection<br />
dehiscence 238,241,243<br />
Wound infections minor or<br />
1 (6/44) 13.6%<br />
dehiscence 241<br />
Postoperative infection 240,249 2 (1/264) 0-2%<br />
Postoperative hematoma 245 1 (1/67) 1.5%<br />
Intraoperative bleeding 249 1 (2/50) 4%<br />
Skin necrosis 243,245 2 (3/106) 2.6%-3%<br />
Hypertrophic scarring/cheloids 249,251 2 (10/142) 4%-9.8%<br />
Incomplete excision with scarring 249 1 (1/50) 2%<br />
Facial paresis, transient postop 239 1 (4/43) 9.3%<br />
Permanent palsy <strong>of</strong> facial nerve 239 1 (1/43) 2.3%<br />
Hemorrhage <strong>and</strong> ulceration 244 1 (3/127) 2.4%<br />
Hypopigmentation <strong>of</strong> the skin or 1 (5/127) 3.9%<br />
vermillion <strong>of</strong> the lip 244<br />
Labial mucoceles observed 3 years 1 (3/127) 2.4%<br />
post- surgery 244<br />
Alopecia/Loss <strong>of</strong> small eyelash 2 (2/125) 1.1%-3%<br />
segment 242,251<br />
Cellulitis 251 1 (2/92) 2.2%<br />
Functional impairment 251 1 (2/92) 2.2%<br />
IH-infantile hemangioma<br />
No complications were noted in one study. 247<br />
77
Discussion<br />
State <strong>of</strong> the Literature<br />
We identified 148 unique studies (15 r<strong>and</strong>omized controlled trials [RCTs], 5 prospective <strong>and</strong><br />
19 retrospective cohort studies, 2 diagnostic accuracy studies, 1 study comparing pairs <strong>of</strong> treated<br />
<strong>and</strong> untreated infantile hemangioma (IH), <strong>and</strong> 106 case series) addressing our Key Questions.<br />
Forty-two comparative studies reported effectiveness outcomes (6 good quality, 22 fair quality,<br />
<strong>and</strong> 14 poor quality). One-hundred <strong>and</strong> forty-four studies (comparative studies <strong>and</strong> case series)<br />
reported harms/adverse events data (14 good quality for harms reporting, 3 fair quality, 127 poor<br />
quality). Eighty-one studies addressed beta-blockers (13 <strong>of</strong> which compared a beta-blocker to<br />
another category <strong>of</strong> intervention such as corticosteroids or laser); 26 addressed lasers; 24<br />
addressed steroids; 15 addressed surgical approaches; <strong>and</strong> 2 addressed diagnostic modalities.<br />
The literature on pharmacologic <strong>and</strong> surgical approaches for the treatment <strong>of</strong> IH is<br />
heterogeneous in terms <strong>of</strong> populations, interventions, comparators, <strong>and</strong> outcomes. Comparative<br />
studies included individuals with ages <strong>of</strong> less than one month to over 40 years (though the mean<br />
age in this study was below 3 years), <strong>and</strong> lesion types <strong>and</strong> locations varied across studies. Most<br />
studies included children with IH in multiple anatomic locations <strong>and</strong> <strong>of</strong> multiple types (e.g.,<br />
deep, superficial) without stratifying outcomes on these characteristics. Studies typically did not<br />
clearly describe diagnostic criteria, <strong>and</strong> few clearly noted whether prior treatment had been<br />
administered (n=11/42 comparative studies).<br />
Studies assessed varied pharmacologic agents (corticosteroids, beta-blockers,<br />
immunomodulators) administered through various routes (topical, intralesional, intravenous,<br />
oral) at multiple doses <strong>and</strong> durations as well as varied forms <strong>of</strong> laser <strong>and</strong> surgical treatment (e.g.,<br />
pulsed dye laser [PDL], argon laser, neodymium yttrium aluminum garnet [Nd:YAG] laser,<br />
cryotherapy) using varied regimens. Few (n=2) comparative studies addressed surgical treatment<br />
aside from laser modalities. Comparators also varied across studies <strong>and</strong> included placebo,<br />
observation, historical control groups, <strong>and</strong> other active interventions. Outcome measures<br />
similarly differed. While studies generally assessed change in lesion size or appearance, scales<br />
<strong>and</strong> methods varied <strong>and</strong> included visual analog scales, assessment <strong>of</strong> percentage size change, <strong>and</strong><br />
more subjective assessments <strong>of</strong> good, fair, or poor response.<br />
Summary <strong>of</strong> Key Findings<br />
Key Findings From Contextual Questions<br />
The literature identified to answer contextual questions described a broader range <strong>of</strong><br />
indications for referral <strong>of</strong> patients with IH <strong>and</strong> suggested support for a higher index <strong>of</strong> suspicion<br />
<strong>of</strong> extracutaneous IH in children with multiple cutaneous lesions or with facial lesions in a beard<br />
distribution. Studies have primarily assessed associations between cutaneous IH <strong>and</strong> hepatic IH<br />
<strong>and</strong> cutaneous facial IH <strong>and</strong> airway IH.<br />
Key Findings From Key (Comparative Effectiveness) Questions<br />
Until fairly recently, corticosteroids were the treatment <strong>of</strong> choice for IH. As reported in this<br />
review, corticosteroids demonstrate some effectiveness but are associated with clinically<br />
significant side effects. More recently, beta-blockers, <strong>and</strong> propranolol specifically, have been<br />
78
studied <strong>and</strong> recommended for use. Studies <strong>of</strong> propranolol have compared its effectiveness to<br />
placebo/observation, to corticosteroids <strong>and</strong> other modalities, <strong>and</strong> to other beta-blockers. Relative<br />
to observation or placebo arms, oral propranolol has been consistently shown to be superior in<br />
individual studies <strong>and</strong> in our network meta-analysis. Relative to other modalities, including<br />
steroids <strong>and</strong> bleomycin, we find that propranolol is generally superior with the exception <strong>of</strong> no<br />
significant differences in reducing lesion size in two studies comparing it to steroids. Finally,<br />
given that propranolol has been demonstrated to be associated with positive outcomes, the<br />
question <strong>of</strong> whether effectiveness is associated with propranolol specifically or beta-blockers in<br />
general has been studied. Although there are only three small studies available, early results are<br />
as positive as those noted for propranolol, <strong>and</strong> we believe that they suggest that these <strong>and</strong><br />
potentially other beta-blockers may also be effective, potentially with fewer side effects. These<br />
findings, however, are preliminary. Studies <strong>of</strong> the beta-blocker timolol, used as a topical gel or<br />
solution typically to treat superficial IH, also reported greater effectiveness for timolol compared<br />
with placebo/observation in reducing IH lesion size, no differences in effects in one study<br />
comparing ophthalmic timolol <strong>and</strong> imiquimod; no differences in average overall improvement in<br />
another study comparing timolol <strong>and</strong> laser modalities; <strong>and</strong> greater response to timolol in<br />
superficial IH with greater response <strong>of</strong> mixed IH to timolol plus laser in a fourth study.<br />
In our network meta-analysis specifically, the expected efficacy <strong>of</strong> control arms was<br />
estimated to be 6 percent (95% Bayesian credible interval [BCI]=1% to 11%). All non-control<br />
treatments were estimated to have a larger expected clearance than control arms. The largest<br />
mean estimate <strong>of</strong> expected clearance was for oral propranolol (95%, 95% BCI: 88% to 99%),<br />
followed by timolol (62%, 95% BCI: 39% to 83%) <strong>and</strong> intralesional triamcinolone (58%, 95%<br />
BCI: 22% to 93%), albeit with wider confidence bounds. Oral steroids had a clearance rate <strong>of</strong> 43<br />
percent (95% BCI: 21% to 66%). The preponderance <strong>of</strong> available evidence used in the network<br />
meta-analysis was derived from studies <strong>of</strong> propranolol <strong>and</strong> corticosteroids.<br />
In terms <strong>of</strong> surgical interventions, only laser has been adequately studied. Most studies<br />
focused on PDL <strong>and</strong> generally it was found to be more effective than other types <strong>of</strong> laser, but<br />
effects remain unclear as studies were heterogeneous, <strong>and</strong> the role <strong>of</strong> laser vis-a-vis beta-blockers<br />
is not clearly described in the literature. Data are inadequate to address the role <strong>of</strong> imaging in<br />
guiding treatment.<br />
We review specific findings <strong>and</strong> strength <strong>of</strong> evidence (SOE) by Key Question <strong>and</strong> provide<br />
more detailed results from our network meta-analysis below.<br />
KQ1. Effectiveness <strong>and</strong> Harms <strong>of</strong> Imaging<br />
Two poor quality diagnostic accuracy studies addressed imaging modalities. 68,70 Studies<br />
assessed IH in different anatomic locations <strong>and</strong> reported differing findings for the sensitivity <strong>of</strong><br />
ultrasound <strong>and</strong> effectiveness <strong>of</strong> imaging modalities depending on location or subtype. Studies<br />
were limited by the size <strong>of</strong> cohorts, lack <strong>of</strong> st<strong>and</strong>ard processes, <strong>and</strong> lack <strong>of</strong> direct comparison at<br />
the same time point using the various imaging modalities.<br />
We considered the SOE for all imaging modalities to be insufficient given single, small<br />
studies addressing different approaches (Table 34) using weaker study designs <strong>and</strong> precluding a<br />
meta-analysis. The studies did not address harms.<br />
79
Table 34. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> imaging modalities<br />
Outcome<br />
Intervention<br />
MRI vs.<br />
Ultrasound<br />
MRI vs.<br />
Ultrasound<br />
vs. CT<br />
Study Design<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Accuracy in detecting<br />
spinal anomalies<br />
Cohort studies: 1 poor 68<br />
(48)<br />
Accuracy in detecting<br />
liver IH<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Unknown Direct Imprecise NA Ultrasound had a sensitivity <strong>of</strong> 50%<br />
for identifying spinal anomalies<br />
including but not limited to IH <strong>and</strong><br />
20% for identifying intraspinal IH<br />
only, compared with 100% for MRI.<br />
Insufficient SOE given small, single,<br />
poor quality study.<br />
High Unknown Direct Imprecise NA Ultrasound detected lesions in 42/44<br />
children (95% sensitivity).<br />
Cohort studies: 1 poor 70<br />
(55)<br />
CT = computed tomography; IH = infantile hemangioma; MRI = magnetic resonance imaging; n = number; NA = not applicable; SOE=strength <strong>of</strong> evidence<br />
Insufficient SOE given single small,<br />
poor quality study.<br />
80
KQ2. Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids <strong>and</strong> Beta-Blockers<br />
Effectiveness <strong>and</strong> Harms <strong>of</strong> Corticosteroids<br />
We identified 24 studies (3 RCTs, 1 cohort study, <strong>and</strong> 20 case series) reporting outcomes<br />
<strong>and</strong>/or harms following corticosteroid use in children with IH. 40,107-129,133 In addition, seven<br />
studies (described in the section on beta-blockers) compared beta-blockers <strong>and</strong> steroids. 96-<br />
98,100,130-133<br />
Steroids studied varied in dose, type, <strong>and</strong> route <strong>of</strong> administration, <strong>and</strong> the ages <strong>of</strong><br />
children included in comparative studies ranged widely from 1 to 72 months. Children in<br />
treatment arms typically had improvement in lesion size. Of the 219 children who received<br />
steroids in three studies 108,122,252 reporting lesion change data, 140 had a “good” or “fair”<br />
response to steroids. In our network meta-analysis, oral steroids had a mean estimated expected<br />
clearance rate <strong>of</strong> 43 percent (95% BCI: 21% to 66%). Intralesional triamcinolone had a rate <strong>of</strong> 58<br />
percent but with wide confidence bounds (95% BCI: 22% to 93%).<br />
Thus, there is adequate evidence to support a moderate strength <strong>of</strong> evidence for oral steroids<br />
to have a modest effect on clearance rates <strong>and</strong> low SOE for intralesional steroids to have a<br />
modest (albeit larger) effect relative to control with wide confidence bounds.<br />
However, steroids were consistently associated with clinically important harms including<br />
Cushingoid appearance, infection, growth retardation, hypertension, <strong>and</strong> mood changes that may<br />
be important in making treatment decisions. The SOE is moderate for the association <strong>of</strong> steroids<br />
with these clinically important harms (Table 35).<br />
81
Table 35. Strength <strong>of</strong> evidence for effectiveness <strong>and</strong> harms <strong>of</strong> steroids<br />
Outcome<br />
Intevention<br />
Oral steroids<br />
vs. Observation<br />
or Placebo<br />
Intralesional<br />
steroids vs.<br />
Observation or<br />
Placebo<br />
Study Design<br />
Quality <strong>and</strong><br />
Number <strong>of</strong> Studies<br />
(N Total)<br />
Improvement in IH<br />
Network metaanalysis<br />
Improvement in IH<br />
Network metaanalysis<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Consistent Indirect Imprecise Undetected In network meta-analysis oral steroids<br />
had a mean expected clearance rate<br />
<strong>of</strong> 43% (95% BCI: 21% to 66%)<br />
compared with 6% (95% BCI: 1% to<br />
11%) for placebo/observation arms.<br />
Moderate SOE for greater<br />
effectiveness <strong>of</strong> oral steroids vs.<br />
placebo/observation given low<br />
precision <strong>and</strong> high study limitations.<br />
High Consistent Indirect Imprecise Undetected In network meta-analysis intralesional<br />
steroids had a mean expected<br />
clearance rate <strong>of</strong> 58% (95% BCI: 22%<br />
to 99%) compared with 6% (95% BCI:<br />
1% to 11%) for placebo/observation<br />
arms.<br />
Low SOE for greater effectiveness <strong>of</strong><br />
intralesional steroids vs.<br />
placebo/observation given relatively<br />
small numbers <strong>of</strong> participants<br />
contributing to this comparison <strong>and</strong> low<br />
precision.<br />
82
Table 35. Strength <strong>of</strong> evidence for effectiveness <strong>and</strong> harms <strong>of</strong> steroids (continued)<br />
Outcome<br />
Intervention<br />
All Steroids<br />
Study Design<br />
Quality <strong>and</strong><br />
Number <strong>of</strong> Studies<br />
(N Total)<br />
Clinically<br />
important harms<br />
(Cushingoid<br />
facies, growth<br />
retardation, mood<br />
changes<br />
/irritability,<br />
hypertension,<br />
infection)<br />
RCT: 2 good 98,107<br />
1 poor 122 (138)<br />
Cohort: 3 poor 40,96,97<br />
(179)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Consistent Direct Precise Undetected Studies consistently reported these<br />
adverse effects.<br />
Moderate SOE for the association <strong>of</strong><br />
steroids with clinically important harms<br />
due to high study limitations.<br />
Case series: 10<br />
poor 109,110,112,113,115-<br />
117,120,129,133<br />
(2974)<br />
BCI = bayesian credible interval; IH = infantile hemangioma; n = number; NA = not applicable; RCT = r<strong>and</strong>omized, controlled trial; SOE = strength <strong>of</strong> evidence<br />
83
Effectiveness <strong>and</strong> Harms <strong>of</strong> Beta-Blockers<br />
Eighty-one studies (25 comparative studies <strong>and</strong> 56 case series) evaluated propranolol (oral,<br />
topical, intralesional), oral nadolol, oral atenolol, or timolol (topical gel or ophthalmic solution).<br />
Beta-blockers typically demonstrated significantly greater effects on reducing lesion size or<br />
volume than did control or other active comparators.<br />
Compared with a mean estimated expected clearance rate <strong>of</strong> 6 percent (95% BCI: 1% to<br />
11%) in placebo or observation arms, oral propranolol had a rate <strong>of</strong> 95 percent (95% BCI: 88%<br />
to 99%). With adequate data <strong>and</strong> precision, we considered the SOE to be high for the effect <strong>of</strong><br />
oral propranolol on lesion size relative to observation or placebo arms. Individual studies<br />
assessed qualitatively typically also demonstrated greater effectiveness for propranolol compared<br />
with other active treatments.<br />
Other oral beta-blockers have demonstrated promising effectiveness; we considered the SOE<br />
to be low for no difference in response <strong>of</strong> propranolol <strong>and</strong> nadolol or atenolol based on three<br />
small studies. We considered SOE to be low for greater effectiveness <strong>of</strong> topical timolol<br />
compared with observation or placebo (Table 36); SOE was insufficient for studies comparing<br />
timolol to other modalities including laser <strong>and</strong> imiquimod. Most studies <strong>of</strong> timolol included<br />
children with superficial lesions.<br />
84
Table 36. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> beta-blockers<br />
Outcome<br />
Intervention<br />
Oral propranolol<br />
vs. Placebo or<br />
Observation<br />
Study Design<br />
Quality <strong>and</strong><br />
Number <strong>of</strong><br />
Studies (N Total)<br />
Improvement in IH<br />
Network metaanalysis<br />
RCT: 2 good, 17,92 1<br />
fair 99 (510)<br />
Cohort studies: 1<br />
fair 94 (45)<br />
Rebound<br />
growth/Need for<br />
additional<br />
treatment<br />
RCT: 1 good 92<br />
(456)<br />
Cohort studies: 1<br />
fair 94 (45)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
Low Consistent Indirect Precise Undetected In network meta-analysis, the mean<br />
expected clearance rate for oral<br />
propranolol was 95% (95% BCI: 88%<br />
to 99%) relative to 6% (95% BCI: 1%<br />
to 11%) for placebo/observation<br />
arms; greater reductions in IH size in<br />
propranolol arms vs. control in all<br />
individual studies.<br />
High SOE for greater effectiveness<br />
<strong>of</strong> oral propranolol vs. placebo or<br />
observation based on individual<br />
comparisons <strong>and</strong> the network metaanalysis.<br />
Low Consistent Direct Precise Undetected Fewer than 15% <strong>of</strong> children in<br />
treatment arms had rebound growth<br />
or required longer/additional<br />
treatment.<br />
Moderate SOE for low level <strong>of</strong><br />
rebound growth/need for further<br />
treatment associated with<br />
propranolol given few studies<br />
addressing the outcome.<br />
85
Table 36. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> beta-blockers (continued)<br />
Outcome<br />
Intervention<br />
Oral propranolol<br />
vs. Steroids<br />
Oral propranolol<br />
plus prednisolone<br />
vs. prednisolone<br />
vs. propranolol<br />
alone<br />
Study Design<br />
Quality <strong>and</strong><br />
Number <strong>of</strong><br />
Studies (N Total)<br />
Improvement in IH<br />
Network metaanalysis<br />
RCT: 1 good 98 (19)<br />
Cohort studies: 2<br />
fair, 2<br />
poor 96,97,130,132,133<br />
(216)<br />
Amblyopia<br />
Cohort studies: 1<br />
fair 131 (43)<br />
Improvement in IH<br />
RCT: 1 fair 100 (30)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Inconsistent Indirect Precise Undetected In head-to-head comparisons,<br />
propranolol more effective than oral<br />
steroids in 3 studies 96,97,132,133 ; two<br />
other studies reported no significant<br />
difference between oral or<br />
intralesional propranolol <strong>and</strong> oral or<br />
intralesional steroids. 98,130 . In a<br />
network meta-analysis, pooling data<br />
from multiple studies, propranolol<br />
was clearly superior to oral steroids<br />
(95% [95% BCI: 88% to 99%]<br />
clearance versus 43% [95% BCI:<br />
21% to 66%] clearance).<br />
Moderate SOE for superiority <strong>of</strong><br />
propranolol over steroids at<br />
achieving clearance based on<br />
combined effects from individual<br />
studies <strong>and</strong> network metaanalysis,high<br />
study limitations, <strong>and</strong><br />
inconsistency...<br />
High Unknown Direct Imprecise NA No significant difference in level <strong>of</strong><br />
amblyopia between oral propranolol<br />
<strong>and</strong> intralesional triamcinolone arms.<br />
Insufficient SOE given single small<br />
study with high limitations.<br />
High Unknown Direct Imprecise Undetected Significant size reductions from<br />
baseline in propranolol <strong>and</strong><br />
combined arms (p values
Table 36. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> beta-blockers (continued)<br />
Outcome<br />
Intervention<br />
Oral propranolol<br />
vs. Other betablocker<br />
Oral propranolol<br />
vs. Intralesional<br />
bleomycin<br />
Topical timolol vs.<br />
Placebo or<br />
Observation<br />
Study Design<br />
Quality <strong>and</strong><br />
Number <strong>of</strong><br />
Studies (N Total)<br />
Improvement in IH<br />
RCT: 1 fair 102 (23)<br />
Cohort studies: 1<br />
fair, 1 poor 101,146-148<br />
(77)<br />
Improvement in IH<br />
Cohort studies: 1<br />
poor 95 (20)<br />
Improvement in IH<br />
Network metaanalysis<br />
RCT: 1 good 104 (41)<br />
Cohort studies: 1<br />
fair, 1 poor 103,144<br />
(147)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Consistent Indirect Imprecise Undetected In head-to-head comparisons, no<br />
significant differences in response<br />
between propranolol <strong>and</strong> atenolol in<br />
2 studies; better response to nadolol<br />
vs. propranolol in one small study.<br />
Low SOE for no difference in<br />
response with propranolol, nadolol,<br />
or atenolol (systemic beta-blockers)<br />
based on few, small studies.<br />
High Unknown Direct Imprecise NA No difference between agents in one<br />
small study.<br />
Insufficient SOE due to single study<br />
with high limitations.<br />
Medium Consistent Indirect Precise Undetected Timolol more effective than placebo<br />
or observation in three comparative<br />
studies.<br />
In network meta-analysis, the mean<br />
expected clearance rate for topical<br />
timolol was 62% (95% BCI: 39% to<br />
83%) relative to 6% (95% BCI: 1% to<br />
11%) for placebo or observation<br />
arms.<br />
Low SOE for effectiveness <strong>of</strong> timolol<br />
vs. placebo or observation based on<br />
medium study limitations <strong>and</strong> few<br />
studies.<br />
87
Table 36. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> beta-blockers (continued)<br />
Outcome<br />
Intervention<br />
Topical timolol vs.<br />
timolol+PDL<br />
Topical timolol vs.<br />
PDL + Nd:YAG<br />
laser<br />
Study Design<br />
Quality <strong>and</strong><br />
Number <strong>of</strong><br />
Studies (N Total)<br />
Improvement in IH<br />
Cohort studies: 1<br />
poor 106 (102)<br />
Improvement in IH<br />
RCT: 1 fair 14 (60)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Unknown Direct Imprecise NA Timolol+PDL more effective than<br />
timolol alone (p=0.02).<br />
Insufficient SOE due to single study<br />
with high limitations.<br />
High Unknown Direct Imprecise Undetected Greater response to timolol among<br />
superficial IH <strong>and</strong> greater response<br />
to laser among mixed IH (p=NR).<br />
Topical timolol vs.<br />
Topical Imiquimod<br />
Improvement in IH<br />
Cohort studies: 1<br />
fair 105 (38)<br />
Insufficient SOE due to single study<br />
with high limitations.<br />
High Unknown Direct Imprecise NA No significant differences in<br />
improvement in IH between groups.<br />
Insufficient SOE due to single study<br />
with high limitations.<br />
BCI = bayesian credible interval; IH = infantile hemangioma; N = number; Nd:YAG = neodymium yttrium aluminum garnet ; PDL = pulsed dye laser; RCT = r<strong>and</strong>omized<br />
controlled trial; SOE = strength <strong>of</strong> evidence<br />
88
Harms most frequently reported with beta-blockers included hypotension, hypoglycemia,<br />
bradycardia, sleep disturbances, cold extremities, gastrointestinal symptoms, <strong>and</strong> bronchial<br />
irritation (classified as hyperreactivity, bronchospasm, bronchiolitis, cold induced wheezing).<br />
Harms generally were not severe enough to cause treatment discontinuation (n=75/4872 children<br />
receiving beta-blockers [1.5%]) in case series <strong>and</strong> comparative studies). We considered the SOE<br />
to be moderate for the association <strong>of</strong> propranolol with clinically important <strong>and</strong> minor harms<br />
(Table 37).<br />
89
Table 37. Strength <strong>of</strong> evidence for harms <strong>of</strong> beta-blockers<br />
Outcome<br />
Study<br />
Limitations<br />
Study Design<br />
Intervention<br />
Consistency Directness Precision<br />
Oral<br />
propranolol<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Clinically important harms<br />
(hypotension, bradycardia,<br />
bronchospasm,<br />
hypoglycemia)<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence<br />
Grade<br />
High Consistent Direct Precise Undetected Rates <strong>of</strong> these harms with<br />
oral propranolol ranged<br />
from 0 to 100% across<br />
studies.<br />
RCT: 2 good, 1 poor 17,92,98<br />
(515)<br />
Cohort studies: 3 poor 94,97,147<br />
(213)<br />
Moderate SOE for<br />
association <strong>of</strong> propranolol<br />
with these harms based on<br />
high study limitations.<br />
Case series: 1 good, 15<br />
poor 16,153,171,172,185,190,191,193-<br />
195,199,200,202,203,205<br />
(1249)<br />
Minor harms (cold<br />
extremities, diarrhea, sleep<br />
changes)<br />
RCT: 1 good, 3 poor 17,92,98,100<br />
(545)<br />
Cohort studies: 6<br />
poor 94,96,131,132,145,147 (270)<br />
High Consistent Direct Precise Undetected Rates <strong>of</strong> these harms with<br />
propranolol ranged from<br />
1% to 50% across studies.<br />
Moderate SOE for<br />
association <strong>of</strong> propranolol<br />
with these harms given<br />
relatively low numbers <strong>of</strong><br />
participants in studies.<br />
Case series: 1 good, 12<br />
poor 16,171,172,185,189-<br />
191,193,195,200,202,203<br />
(1140)<br />
90
Table 37. Strength <strong>of</strong> evidence for harms <strong>of</strong> beta-blockers (continued)<br />
Intervention<br />
Timolol<br />
Outcome<br />
Study Design<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Lack <strong>of</strong> harms<br />
RCT: 1 good, 1 poor 14,104<br />
(71)<br />
Cohort studies: 1 good, 3<br />
poor 103,105,106,144 (287)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence<br />
Grade<br />
Medium Unknown Direct Imprecise Undetected No harms observed with<br />
timolol in 5 comparative<br />
studies <strong>and</strong> 1 case series.<br />
Shortness <strong>of</strong> breath <strong>and</strong><br />
insomnia observed in 1 <strong>of</strong><br />
30 children in one<br />
comparative study. 14<br />
Nadolol<br />
Case series: 1 poor 159 (25)<br />
Clinically important harms<br />
(hypotension, bradycardia,<br />
bronchospasm,<br />
hypoglycemia)<br />
Cohort studies: 1 poor 101<br />
(19)<br />
Minor harms (cold<br />
extremities, diarrhea, sleep<br />
changes)<br />
Cohort studies: 1 poor 101 (19)<br />
Low SOE for lack <strong>of</strong><br />
association <strong>of</strong> timolol with<br />
harms based on few<br />
studies.<br />
High Unknown Direct Imprecise NA Harms <strong>of</strong> nadolol reported<br />
in 10%-20% <strong>of</strong> children.<br />
Insufficient SOE for<br />
association with clinically<br />
important harms given<br />
single, small poor quality<br />
cohort study.<br />
High Unknown Direct Imprecise NA Harms <strong>of</strong> nadolol reported<br />
in 10%-50% <strong>of</strong> children.<br />
Insufficient SOE for<br />
association with minor<br />
harms given single, small<br />
poor quality study.<br />
91
Table 37. Strength <strong>of</strong> evidence for harms <strong>of</strong> beta-blockers (continued)<br />
Intervention<br />
Atenolol<br />
Outcome<br />
Study Design<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Hypotension<br />
Cohort studies: 1 poor 147 (58)<br />
Minor harms (cold<br />
extremities, diarrhea, sleep<br />
changes)<br />
RCT: 1 poor 102 (23)<br />
Cohort studies: 1 poor 147 (58)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence<br />
Grade<br />
High Unknown Direct Imprecise NA Hypotension reported in<br />
3% <strong>of</strong> children in one<br />
study.<br />
Insufficient SOE for<br />
association with<br />
hypotension given only a<br />
single, small poor quality<br />
study.<br />
High Consistent direct Imprecise Undetected Minor hams occurred in<br />
7%-27% <strong>of</strong> children.<br />
IH = infantile hemangioma; n = number; NA = not applicable; RCT = r<strong>and</strong>omized, controlled trial; SOE = strength <strong>of</strong> evidence<br />
Low SOE for the lack <strong>of</strong><br />
association with minor<br />
harms given two small<br />
studies with high<br />
limitations.<br />
92
KQ3. Effectiveness <strong>and</strong> Harms <strong>of</strong> Second-Line Drugs<br />
We did not identify any studies addressing this question.<br />
KQ4. Effectiveness <strong>and</strong> Harms <strong>of</strong> Surgical Interventions<br />
Effectiveness <strong>and</strong> Harms <strong>of</strong> Laser <strong>and</strong> Surgical Treatment<br />
Eleven comparative studies (three RCTs, 210-212 seven retrospective cohort studies, 213-219 <strong>and</strong><br />
one study that compared cryotherapy-treated <strong>and</strong> untreated IH pairs in individual children 220 )<br />
addressed surgical approaches. In addition, one RCT <strong>and</strong> one cohort study (described in KQ2<br />
above) compared topical timolol <strong>and</strong> laser modalities, 14,106 <strong>and</strong> 28 case series addressed surgical<br />
approaches. 221-228,230-249 Most comparative studies were small (≤55 participants), but one RCT <strong>and</strong><br />
three retrospective cohort studies included more than 120 children. Lasers varied across studies<br />
in type, pulse width, or cooling materials. Most studies assessed variations <strong>of</strong> PDL (n=7) <strong>and</strong><br />
examined heterogeneous endpoints. Most studies reported on treatment <strong>of</strong> cutaneous lesions.<br />
Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for<br />
cutaneous lesions <strong>and</strong> Nd:YAG was the most commonly used intralesionally. Most studies<br />
reported a higher success rate with longer pulse PDL compared to observation in managing the<br />
size <strong>of</strong> IH, although the magnitude <strong>of</strong> effect differed substantially. CO2 laser was used for<br />
subglottic IH in a single study, <strong>and</strong> was noted to have a higher success rate <strong>and</strong> lower<br />
complication rate than both Nd:YAG <strong>and</strong> observation.<br />
Two comparative studies addressed surgical approaches (cryotherapy, intense pulsed light<br />
photothermolysis, sclerosis) <strong>and</strong> reported some positive effects in reducing IH size or improving<br />
appearance, but their smaller size <strong>and</strong> low quality preclude conclusions (insufficient SOE).<br />
Strength <strong>of</strong> evidence for outcomes after surgical treatments ranged from insufficient to low for<br />
effectiveness outcomes. The evidence was limited by low sample size, lack <strong>of</strong> comparisons <strong>of</strong><br />
the same modalities, <strong>and</strong> variations in the laser settings used including wavelength <strong>and</strong> cooling<br />
protocols. For Nd:YAG <strong>and</strong> CO2 lasers, cryotherapy, <strong>and</strong> intense pulsed light photothermolysis,<br />
all studies were severely limited by sample size, <strong>and</strong> SOE was determined to be insufficient in all<br />
outcome parameters (Table 38).<br />
93
Table 38. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> laser modalities<br />
Outcome<br />
Intervention<br />
Longer pulse<br />
PDL vs. other<br />
laser types<br />
<strong>and</strong> protocols<br />
Study Design<br />
Quality <strong>and</strong> Number<br />
<strong>of</strong> Studies (N Total)<br />
Improvement in IH<br />
RCT: 1 fair 211 (52)<br />
Cohort studies: 2<br />
poor 215,216 (212)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
Medium Inconsistent Direct Imprecise Undetected In 1 RCT, resolution outcomes<br />
similar between laser types; greater<br />
clearance in PDL +cooling arm in<br />
one cohort study, 216 <strong>and</strong> more<br />
children in PDL arm had complete<br />
regression than in Nd:YAG in<br />
another 215 ; typically more than 50%<br />
<strong>of</strong> children receiving any laser had<br />
at least 50% clearance.<br />
PDL vs.<br />
Observation<br />
Improvement in IH<br />
RCT: 1 good, 1<br />
fair 210,212 (143)<br />
Low SOE for no difference in<br />
effects on size reduction between<br />
longer pulse PDL <strong>and</strong> various other<br />
lasers given few studies, medium<br />
limitations, <strong>and</strong> inconsistent <strong>and</strong><br />
imprecise findings.<br />
Low Consistent Direct Imprecise Suspected No significant difference in<br />
measured volume or proportion <strong>of</strong><br />
clearance between groups in either<br />
study when considering complete<br />
<strong>and</strong> near complete clearance;<br />
greater observer-ratings <strong>of</strong><br />
improvement for PDL arm vs.<br />
observation in one study. 210<br />
Low SOE for lack <strong>of</strong> difference<br />
between PDL treatment <strong>and</strong><br />
observation in reducing lesion size<br />
due to lack <strong>of</strong> precision, few<br />
studies.<br />
94
Table 38. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> laser modalities (continued)<br />
Intervention<br />
PDL vs.<br />
Observation<br />
Outcome<br />
Study Design<br />
Quality <strong>and</strong> Number<br />
<strong>of</strong> Studies (N Total)<br />
Quality <strong>of</strong> life<br />
RCT: 1 good, 1<br />
fair 210,212 (143)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
Medium Inconsistent Indirect Imprecise Undetected No significant differences in parent<br />
ratings <strong>of</strong> QoL in one study; more<br />
parents <strong>of</strong> children in PDL arm in<br />
another considered appearance<br />
improved than in observation arm.<br />
Nd:YAG with<br />
extended<br />
cooling vs.<br />
Nd:YAG with<br />
st<strong>and</strong>ard<br />
cooling<br />
Nd:YAG vs.<br />
CO2 laser vs.<br />
Tracheostomy<br />
Improvement in IH<br />
Cohort studies: 1<br />
fair 218 (290)<br />
Speech<br />
Cohort studies: 1<br />
poor 214 (46)<br />
Low SOE for lack <strong>of</strong> difference in<br />
QoL with PDL compared with<br />
observation due to lack <strong>of</strong><br />
consistency <strong>and</strong> precision, few<br />
studies.<br />
Medium Unknown Direct Imprecise NA Improved resolution with extended<br />
cooling protocol vs. traditional.<br />
Insufficient SOE given single study<br />
with medium limitations.<br />
High Unknown Indirect Imprecise NA 75% <strong>of</strong> children with tracheostomy<br />
had delayed speech vs. 0 with no<br />
tracheostomy in the laser treatment<br />
era.<br />
Insufficient SOE given small, single<br />
study.<br />
95
Table 38. Strength <strong>of</strong> evidence for effectiveness <strong>of</strong> laser modalities (continued)<br />
Intervention<br />
Cryotherapy<br />
vs.<br />
Observation<br />
Photothermolysis<br />
with Intense<br />
Pulsed Light<br />
With or<br />
Without<br />
Sclerosis vs.<br />
Cryotherapy<br />
Outcome<br />
Study Design<br />
Quality <strong>and</strong> Number<br />
<strong>of</strong> Studies (N Total)<br />
Improvement in IH<br />
Comparative study<br />
with treated/untreated<br />
IH per child: 1 poor 220<br />
(13)<br />
Improvement in IH<br />
Cohort studies: 1<br />
poor 219 (250)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Unknown Direct Imprecise NA 76% <strong>of</strong> IH in treated arm vs. 12% in<br />
untreated resolved without scarring.<br />
Insufficient SOE given single, small<br />
study with high limitations.<br />
High Unknown Direct Imprecise NA More children had ≥50% reduction<br />
in IH size in the combined therapy<br />
arm than in other arms (p=NR).<br />
Insufficient SOE given single study<br />
with high limitations.<br />
CO2 = carbon dioxide; IH = infantile hemangioma; NA = not applicable; NR = not reported; Nd:YAG = neodymium yttrium aluminum garnet; PDL= pulse dye laser; QoL =<br />
quality <strong>of</strong> life; RCT = r<strong>and</strong>omized controlled trial<br />
96
For harms, a moderate strength <strong>of</strong> evidence was noted for pigmentation changes with PDL,<br />
which was most frequently hypopigmentation. Low SOE was noted for bleeding in the<br />
immediate postoperative period. Due to low sample size <strong>and</strong> limitations in reporting, pain <strong>and</strong><br />
scarring were found to have insufficient SOE. For Nd:YAG lasers, evaluation for scarring was<br />
most frequently reported, <strong>and</strong> there was low SOE to support no difference in scarring between<br />
Nd:YAG <strong>and</strong> observation. Evidence was deemed insufficient to comment on pigmentation<br />
changes <strong>and</strong> bleeding for children treated with Nd:YAG <strong>and</strong> scarring after cryotherapy.<br />
Most surgical case series (n=13) were retrospective <strong>and</strong> included a total <strong>of</strong> 838 children. We<br />
considered all to be poor quality for harms reporting. Frequently reported harms included<br />
scarring <strong>and</strong> wound dehiscence. SOE was insufficient for the association <strong>of</strong> surgical approaches<br />
with harms given the small numbers <strong>of</strong> harms reported (Table 39).<br />
97
Table 39. Strength <strong>of</strong> evidence for harms <strong>of</strong> laser modalities<br />
Outcome<br />
Intervention<br />
PDL<br />
Study Design<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Pigmentation changes<br />
RCT: 1 good, 1 poor 211,212<br />
(173)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
Low Consistent Direct Precise Undetected Hypo- or hyper-pigmentation<br />
consistently reported, with<br />
hypopigmentation reported more<br />
frequently.<br />
Cohort studies: 1 good, 1<br />
poor 213,215 (73)<br />
Case series: 1 fair, 4<br />
poor 221,224,225,228,230 (1017)<br />
Bleeding<br />
RCT: 1 good 212 (121)<br />
Pain<br />
RCT: 1 good 212 (121)<br />
Scarring<br />
Cohort studies: 1 good 215<br />
(50)<br />
Case series: 2 fair, 1<br />
poor 227,228,230 (769)<br />
Moderate SOE for association <strong>of</strong><br />
PDL with skin pigmentation<br />
complications based on relatively<br />
few participants in studies.<br />
Low Unknown Direct Imprecise Undetected No significant difference in<br />
bleeding between short pulse<br />
PDL <strong>and</strong> observation groups.<br />
Low SOE for association <strong>of</strong><br />
bleeding with PDL based on one<br />
study with low limitations,<br />
unknown consistency, <strong>and</strong><br />
imprecision.<br />
Low Unknown Indirect Imprecise Undetected 13% <strong>of</strong> parents reported pain for<br />
their children after PDL.<br />
Insufficient SOE for pain<br />
following PDL given few<br />
occurrences <strong>of</strong> outcome. Pain is<br />
also difficult to assess in infant<br />
population.<br />
Medium Inconsistent Direct Imprecise NA 1/25 children receiving PDL in<br />
one study 7/769 children in case<br />
series had scarring.<br />
Insufficient SOE due to few<br />
occurrences <strong>of</strong> the outcome<br />
reported in studies.<br />
98
Table 39. Strength <strong>of</strong> evidence for harms <strong>of</strong> laser modalities (continued)<br />
Intervention<br />
Nd:YAG<br />
Cryotherapy<br />
vs.<br />
Observation<br />
Outcome<br />
Study Design<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Pigmentation changes<br />
Cohort studies: 1 good 215<br />
(50)<br />
Scarring<br />
Cohort studies: 1 good, 2<br />
poor 214,215,218 (386)<br />
Case series: 3<br />
poor 231,232,234 (954)<br />
Bleeding<br />
Case series: 2 poor 232,234<br />
(794)<br />
Scarring<br />
Comparative study with<br />
treated/untreated IH per<br />
child: 1 poor 220 (13)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
Low Unknown Direct Imprecise NA 2/25 children receiving Nd:YAG<br />
in one study had scarring.<br />
Insufficient SOE due to few<br />
occurrences <strong>of</strong> the outcome<br />
reported.<br />
Medium Consistent Direct Precise NA Most studies reported scarring in<br />
≤5% <strong>of</strong> children.<br />
Low SOE for association <strong>of</strong><br />
scarring with Nd:YAG treatment<br />
due to few occurrences <strong>of</strong> the<br />
outcome reported.<br />
High Unknown Direct Precise Undetected Bleeding noted in 13/794<br />
children.<br />
Insufficient SOE due to few<br />
occurrences <strong>of</strong> the outcome<br />
reported in studies.<br />
High Unknown Direct Imprecise NA Scarring in 4 <strong>of</strong> 17 IH treated with<br />
cryotherapy.<br />
Insufficient SOE due to single,<br />
small study.<br />
99
Table 39. Strength <strong>of</strong> evidence for harms <strong>of</strong> laser modalities (continued)<br />
Intervention<br />
Surgical<br />
Excision or<br />
Resection<br />
Outcome<br />
Study Design<br />
Quality <strong>and</strong> Number <strong>of</strong><br />
Studies (N Total)<br />
Scarring<br />
Case series: 2 poor 249,251<br />
(142)<br />
Study<br />
Limitations<br />
Consistency Directness Precision<br />
Reporting<br />
Bias<br />
Finding<br />
Strength <strong>of</strong> Evidence Grade<br />
High Consistent Direct Imprecise NA Scarring in 11/192 children.<br />
Insufficient SOE due to few<br />
occurrences <strong>of</strong> the outcome<br />
reported in studies.<br />
Wound dehisecence<br />
Case series: 7<br />
poor 238,240,241,243,246,248,251<br />
(483)<br />
High Consistent Direct Imprecise NA Dehiscences in 20/483 children.<br />
Insufficient SOE due to few<br />
occurrences <strong>of</strong> the outcome<br />
reported in studies with high<br />
limitations.<br />
IH = infantile hemangioma; n = number; NA = not applicable; Nd:YAG = neodymium yttrium aluminium garnet; QoL = quality <strong>of</strong> life; PDL = pulse dye laser;<br />
RCT = r<strong>and</strong>omized, controlled trial; SOE = strength <strong>of</strong> evidence<br />
100
Findings in Relation to What is Already Known<br />
We identified ten recent (2010-present) systematic review or meta-analyses assessing<br />
interventions for IH. 91,253-261 Most reviews addressed propranolol or beta-blockers: three<br />
addressed propranolol generally; 258,259,261 two examined effectiveness specifically for airway<br />
IH; 91,260 one for periocular IH; 262 <strong>and</strong> two compared beta-blockers <strong>and</strong> steroids. 253,254 One<br />
Cochrane review assessed multiple interventions, 257 <strong>and</strong> two additional reviews examined<br />
intralesional steroids 256 <strong>and</strong> laser treatment. 255<br />
Across reviews, investigators commented on small sample sizes, disparate outcome<br />
measures, <strong>and</strong> typically low to moderate quality studies. Most reviews noted the promise <strong>of</strong><br />
propranolol for reducing IH lesion size but also a need for additional, larger studies with longer<br />
term followup. Overall, our findings related to the effectiveness <strong>of</strong> propranolol in most children<br />
<strong>and</strong> limited effectiveness <strong>of</strong> steroids for cutaneous IH align with findings in prior reviews. One<br />
review <strong>and</strong> meta-analysis <strong>of</strong> 10 comparative studies (six considered high quality, four <strong>of</strong><br />
moderate quality) <strong>of</strong> children with cutaneous IH meta-analyzed data related to adverse events<br />
<strong>and</strong> reported no differences in the rate <strong>of</strong> adverse events between propranolol <strong>and</strong> corticosteroids<br />
(18 events in propranolol studies <strong>and</strong> 19 in steroid, p=0.73, 95% CI: 0.56 to 1.50). 253<br />
Only one prior review addressed laser treatments (two IH studies) <strong>and</strong> concluded that, despite<br />
favorable results, the evidence is weak to support the use <strong>of</strong> lasers in IH treatment (level 3b on<br />
the Oxford Centre <strong>of</strong> Evidence-based Medicine scale). 255<br />
Applicability<br />
We set inclusion criteria intended to identify studies with applicability to children with IH<br />
between the ages <strong>of</strong> 0 <strong>and</strong> 18 years. Studies differed in terms <strong>of</strong> study population <strong>and</strong> outcome<br />
measures. Most studies included children with IH in multiple anatomic locations <strong>and</strong> did not<br />
report effectiveness by lesion site or type. Most studies were non-comparative, <strong>and</strong> lack <strong>of</strong> direct<br />
comparisons <strong>of</strong> treatment options <strong>and</strong> few studies addressing the same interventions <strong>and</strong><br />
comparators further hinder our ability to underst<strong>and</strong> what findings will best extrapolate to<br />
children at specific ages, with specific lesion types, or in specific anatomic locations. Further,<br />
most comparative studies were conducted in larger medical centers or referral centers, which is<br />
in line with typical treatment as most children with IH are referred to specialists from general<br />
practitioners.<br />
Overall the available data on the effectiveness <strong>and</strong> harms <strong>of</strong> beta-blockers <strong>and</strong> corticosteroids<br />
are largely applicable to the general population <strong>of</strong> children with IH. Most studies included a<br />
majority <strong>of</strong> females, in line with the female predominance <strong>of</strong> IH, <strong>and</strong> ages in comparative studies<br />
generally ranged from 1 month to 9 years. One cohort study included individuals between 1<br />
month <strong>and</strong> 43 years <strong>of</strong> age, with a mean age <strong>of</strong> 2 years <strong>and</strong> 11 months. 216<br />
Few studies addressed imaging modalities, <strong>and</strong> those that did evaluated modalities to assess<br />
hepatic or intraspinal IH. Studies compared ultrasound, magnetic resonance imaging, computed<br />
tomography, <strong>and</strong> angiography. Imaging was sometimes not conducted at the same time, which<br />
limits comparability, <strong>and</strong> potentially the applicability <strong>of</strong> findings. Studies were also completed<br />
prior to 2010, so imaging techniques <strong>and</strong> practices may have changed.<br />
Studies addressing steroids compared various routes <strong>of</strong> steroid administration (oral, topical,<br />
<strong>and</strong> intralesional) <strong>and</strong> various agents (methylprednisolone, triamcinolone, mometasone furoate)<br />
in children with ages ranging from less than 1 to 72 months. Studies likely included children<br />
with IH in the proliferative <strong>and</strong> involution phase, which may limit applicability to younger or<br />
101
older children. One comparative study was conducted in Canada <strong>and</strong> the others in Turkey,<br />
Pakistan, <strong>and</strong> India. Applicability may be limited given differences in the systems <strong>of</strong> care in<br />
these lower resource countries. Comparative studies were also published between 2001 <strong>and</strong> 2014<br />
<strong>and</strong> may not fully represent evolutions in st<strong>and</strong>ards <strong>of</strong> care.<br />
Studies <strong>of</strong> beta-blockers typically included infants <strong>of</strong> both sexes ages 1 to 12 months <strong>of</strong> age<br />
(range: 1 month - 9 years) with superficial, deep, <strong>and</strong> mixed lesions primarily involving the head<br />
<strong>and</strong> neck <strong>and</strong> occurring as focal or segmental lesions. Studies <strong>of</strong> topical or ophthalmic timolol<br />
typically included children with superficial lesions, though two <strong>of</strong> six comparative studies<br />
included children with superficial <strong>and</strong> deep lesions. Children were treated with a variety <strong>of</strong> betablockers<br />
including propranolol at various doses <strong>and</strong> administrations (oral, intralesional, or<br />
topical), timolol (topical or ophthalmic), atenolol (oral), or nadolol (oral), most commonly for up<br />
to 6 months duration. These agents <strong>and</strong> dosage forms are typically easily available in the United<br />
States <strong>and</strong> not universally available. Dosage amounts ranged from 1 to 4 mg/kg/day. Doses over<br />
2 mg/kg/day are not typically administered <strong>and</strong> may limit applicability <strong>of</strong> findings <strong>of</strong> two studies<br />
<strong>of</strong> propranolol. 92,97<br />
Surgical studies, conducted in the United States, the United Kingdom, the Netherl<strong>and</strong>s,<br />
Germany, Greece, Japan <strong>and</strong> Singapore, included infants <strong>of</strong> both sexes with a preponderance <strong>of</strong><br />
females (age range: 1 week to 43 years <strong>of</strong> age) with superficial <strong>and</strong> cutaneous infantile<br />
hemangiomas in varied locations. One study reported laser use for subglottic IH <strong>and</strong> one<br />
evaluated photothermolysis with intense pulsed light <strong>and</strong> cryosurgery in children <strong>of</strong> maxillary<br />
IH. Most comparative studies evaluated laser treatments including short-pulse <strong>and</strong> longer pulse<br />
PDL, Nd:YAG, <strong>and</strong> argon. Two studies evaluated cryotherapy, one <strong>of</strong> which compared it to<br />
photothermolysis with intense pulsed light with or without concomitant sclerosis. Applicability<br />
<strong>of</strong> many <strong>of</strong> these studies is limited by historical changes in care <strong>and</strong> technology.<br />
Newer lasers <strong>and</strong> adjunctive features such as dynamic cooling have resulted in older lasers<br />
being out <strong>of</strong> date, thus limiting the applicability <strong>of</strong> studies conducted with those models. Most<br />
laser studies evaluated lasers as first-line treatment, which is currently less common in practice<br />
since the advent <strong>of</strong> beta-blocker treatment in countries, like the United States, where such<br />
treatments are readily available, as beta-blockers have generally superseded other treatments as<br />
first-line management <strong>of</strong> IH. Additionally, most comparative literature evaluated PDL, which is<br />
typically used only for the treatment <strong>of</strong> superficial lesions. Appendix G contains full applicability<br />
tables.<br />
Implications for Clinical <strong>and</strong> Policy Decisionmaking<br />
This review provides evidence for use in clinical care <strong>of</strong> children who present with IH. It<br />
particularly demonstrates that there are moderate benefits with steroid treatment <strong>and</strong> significantly<br />
greater improvements with beta-blockers, with propranolol being the agent most commonly<br />
studied. When a decision to treat is made, our review provides qualitative <strong>and</strong> quantitative<br />
evidence that beta-blockers are associated with substantial improvement in IH size/volume<br />
(mean expected clearance rates <strong>of</strong> 95% for oral propranolol [95% BCI: 88% to 99%] <strong>and</strong> 62%<br />
for topical timolol [95% BCI: 39% to 83%], compared with 6% for observation/placebo arms<br />
[95% BCI: 1% to 11%]).<br />
Steroids were associated with mean expected clearance rates <strong>of</strong> 43 percent (95% BCI: 21% to<br />
66%) for oral steroids <strong>and</strong> 58 percent (95% BCI: 22% to 99%) for intralesional triamcinolone in<br />
our network meta-analysis, but side effects are clinically significant, <strong>and</strong> clinicians <strong>and</strong> families<br />
will need to weigh the benefits <strong>and</strong> harms.<br />
102
It is important for clinicians to know that the literature summarized here typically examines<br />
children with problematic or complicated IH <strong>and</strong> thus may not apply to all children, particularly<br />
those with minor IH. In one large trial evaluating active treatment with propranolol for children<br />
without problematic IH, propranolol was associated with complete resolution or near complete<br />
resolution in 60 percent <strong>of</strong> cases (vs. 4% in placebo arm). 92 In addition, studies typically reported<br />
outcomes only in the short term (generally ≤12 months followup); thus, our underst<strong>and</strong>ing <strong>of</strong> the<br />
longer term effects <strong>of</strong> these medications is lacking. Further, though the literature demonstrates a<br />
strong shift towards beta-blocker therapy, uncertainty still remains about the most effective<br />
agent, dosage, <strong>and</strong> duration <strong>of</strong> treatment, <strong>and</strong> the need for pre-treatment evaluation <strong>and</strong><br />
monitoring while on beta-blockers.<br />
Limited research is available to guide decision-making about the use <strong>of</strong> lasers as the initial<br />
intervention. Historically, lasers provided a fair benefit in primary management <strong>of</strong> IH, which was<br />
comparable in many cases series to steroid treatment, <strong>and</strong> generally was superior to observation.<br />
The advent <strong>of</strong> propranolol, however, has largely relegated laser treatment to secondary<br />
management. There is little comparative data between lasers <strong>and</strong> beta-blockers, but the success<br />
rates for complete or near complete resolution in historical laser studies are notably lower than<br />
those in more recent propranolol studies. Under current treatment paradigms, PDL with<br />
epidermal cooling is most <strong>of</strong>ten used for residual cutaneous changes after the completion <strong>of</strong> the<br />
proliferative growth phase <strong>and</strong> with incomplete resolution after pharmacologic management,<br />
while Nd:YAG laser is most <strong>of</strong>ten used intralesionally for medically refractory lesions. A variety<br />
<strong>of</strong> other lasers are used for intralesional treatment or resection, though no conclusions can be<br />
drawn regarding the superiority <strong>of</strong> any <strong>of</strong> these modalities over any other.<br />
The literature identified to answer contextual questions describes a broader range <strong>of</strong><br />
indications for referral <strong>of</strong> patients with IH <strong>and</strong> suggests that indications for referral include large<br />
size; segmental type; risk for complications including bleeding, ulceration, <strong>and</strong> pain;<br />
involvement <strong>of</strong> critical structures; <strong>and</strong> risk factors for occult lesions (numerous cutaneous<br />
lesions, beard distribution). Further, the potential for psychosocial concerns may support referral<br />
for patients with uncomplicated lesions in highly visible areas on a case-by-case basis.<br />
Given the lack <strong>of</strong> long-term data on harms <strong>of</strong> interventions, clinicians <strong>and</strong> families must<br />
balance the potential <strong>of</strong> both short- <strong>and</strong> long-term harms with the benefits <strong>of</strong> potential resolution<br />
or size reduction <strong>of</strong> lesions.<br />
Limitations <strong>of</strong> the Comparative Effectiveness Review<br />
Process<br />
We included studies published in English only <strong>and</strong> did not seek or include unpublished data.<br />
In our scan <strong>of</strong> the non-English language literature published since 1982 <strong>and</strong> located via our<br />
MEDLINE search, we determined that the majority would not meet our review criteria. Given<br />
the high percentage <strong>of</strong> non-eligible items in this scan, we feel that excluding non-English studies<br />
did not introduce significant bias into the review.<br />
We also required that studies reporting on “second-line” treatments such as imiquimod,<br />
bleomycin, or alpha interferon address such treatments after a trial <strong>of</strong> beta-blockers or<br />
corticosteroids, <strong>and</strong> we did not identify any such studies. While this undoubtedly means that<br />
some treatment outcomes are not included in this review, these drugs are not frequently used<br />
since the advent <strong>of</strong> beta-blocker treatment for IH in the opinion <strong>of</strong> our clinical experts.<br />
We also used only comparative studies to address questions <strong>of</strong> effectiveness <strong>and</strong> case series<br />
with at least 25 participants to provide harms data. These requirements eliminated some smaller<br />
103
case series reporting on rarer presentations <strong>of</strong> IH (e.g., liver IH). We were also dependent upon<br />
the characterization <strong>of</strong> IH as presented in each study. Given changes in nomenclature <strong>and</strong><br />
variations in the way IH are described, it may be that some studies included non-IH lesions.<br />
However, our clinical experts carefully reviewed studies to attempt to ascertain that included<br />
studies were reporting on true IH. We also note that other approaches to meta-analysis could be<br />
used, but that our estimates <strong>of</strong> a high anticipated response to propranolol largely align with those<br />
in other reviews <strong>of</strong> propranolol. 254,258,259,261<br />
Limitations <strong>of</strong> the Evidence Base<br />
The evidence base for IH treatment is limited by a small number <strong>of</strong> comparative studies<br />
including a limited number <strong>of</strong> participants. While cohort studies compared at least two different<br />
interventions, few presented truly comparative data. A number <strong>of</strong> studies reported only absolute<br />
differences in resolution or other outcomes, with no statistical comparison, in part likely due to<br />
their small sample sizes. Similarly, few studies reported baseline characteristics <strong>of</strong> the lesion, so<br />
underst<strong>and</strong>ing the magnitude <strong>of</strong> change reported is challenging. Most studies included children<br />
with problematic IH, so change was likely substantial, <strong>and</strong> parents <strong>and</strong> children may value any<br />
lessening <strong>of</strong> lesion size or change in color or texture.<br />
A growing number <strong>of</strong> studies address beta-blockers, but current studies are limited by a<br />
general lack <strong>of</strong> long-term followup <strong>and</strong> analyses to explore differences in response among<br />
subgroups. Studies may also have used compounded forms <strong>of</strong> beta-blockers, which may add to<br />
the complexity <strong>of</strong> interpreting dosage amounts. Few comparative studies addressed steroids, <strong>and</strong><br />
indications for steroid treatment compared with beta-blockers are unclear. Few comparative<br />
studies addressed surgical approaches besides laser modalities, <strong>and</strong> those addressing lasers used<br />
different interventions <strong>and</strong> comparators, limiting comparisons across studies. Technological<br />
advances have also changed the indications for treatment, <strong>and</strong> a historical trend towards treating<br />
smaller, less severe lesions, similarly make analyses difficult because <strong>of</strong> changing indications for<br />
<strong>and</strong> expectations <strong>of</strong> treatment.<br />
Studies are also limited by the use <strong>of</strong> multiple <strong>and</strong> variable outcome measures to assess<br />
resolution <strong>of</strong> lesions. As no objective lab value or other measures exist to determine size<br />
changes, investigators have developed multiple techniques, <strong>and</strong> studies did not always report<br />
scales or other approaches clearly. The variety <strong>of</strong> scales (e.g., percentage change, mean change,<br />
VAS, HAS) makes combining outcomes challenging. Similarly, studies typically included<br />
multiple lesion types in multiple locations, which complicates determining potential differences<br />
in response, <strong>and</strong> treatment approaches varied across studies (e.g., doses <strong>and</strong> dosage forms, level<br />
<strong>of</strong> patient monitoring, timing <strong>of</strong> treatment <strong>and</strong> followup).<br />
The most important deficiency in the reported outcomes across studies is the tendency for the<br />
reporting <strong>of</strong> discretized outcomes, when the underlying outcome is a continuous variable.<br />
Specifically, though outcomes are likely recorded as a continuous measure (i.e., the proportion <strong>of</strong><br />
an existing lesion that is cleared or reduced in size following treatment), authors <strong>of</strong>ten chose an<br />
arbitrary cut<strong>of</strong>f proportion (or a small number <strong>of</strong> bins) <strong>and</strong> reported only the numbers in each <strong>of</strong><br />
the resulting categories. This results in an immediate <strong>and</strong> unrecoverable loss in power for any<br />
quantitative meta-analyses. Researchers should be encouraged to report outcome variables as<br />
they were recorded, without transforming them in such a way that information is lost. In<br />
addition, methods for measurement <strong>of</strong> outcomes such as rebound growth are not clearly reported;<br />
thus, our underst<strong>and</strong>ing <strong>of</strong> the magnitude <strong>of</strong> regrowth is limited.<br />
104
Research Gaps <strong>and</strong> Areas for Future Research<br />
While a growing number <strong>of</strong> comparative studies address treatments for IH, a number <strong>of</strong><br />
research gaps exist. These gaps include a lack <strong>of</strong> information on:<br />
• Indications, optimal timing, <strong>and</strong> optimal modalities for imaging <strong>and</strong> diagnostic<br />
approaches. Few studies in the literature we reviewed reported imaging or diagnostic<br />
techniques, <strong>and</strong> data on optimal approaches for each are lacking in the current research<br />
base. In general, imaging is infrequently used to differentiate accurately an IH from other<br />
vascular lesions. When a diagnosis is in question, a tissue biopsy is the most accurate<br />
method to determine the diagnosis. Future studies should use imaging modalities at the<br />
same point in the IH course to allow direct comparison. Studies should also report<br />
adverse effects <strong>of</strong> imaging, which are not addressed in the literature meeting criteria for<br />
this review.<br />
• Indications for treatment <strong>and</strong> treatment referral. While it is likely that non-placebocontrolled<br />
studies reviewed here included mostly children with problematic IH (e.g.,<br />
lesions that are vision-threatening or disfiguring, ulcerated lesions, airway/lifethreatening<br />
lesions), studies did not always clearly report indications for treatment or<br />
referral for treatment. Children may be referred for life-, functional-, or visionthreatening<br />
reasons, but in the beta-blocker era, potential disfigurement is likely a cause<br />
for referral.<br />
• Appropriate dosing for propranolol <strong>and</strong> timing <strong>of</strong> treatment. The largest RCT to<br />
date 92 used doses <strong>of</strong> either 1 mg/kg or 3 mg/kg, but other studies typically used doses <strong>of</strong><br />
2-2.5 mg/kg, <strong>and</strong> ages <strong>of</strong> children <strong>and</strong> number, severity, <strong>and</strong> type <strong>of</strong> lesions varied among<br />
study populations. Existing studies do not provide data to determine optimal dosing.<br />
Similarly, few studies reported on resolution outcomes by phase (i.e., proliferative,<br />
involution). Studies likely included mostly children in the proliferative phase, but the<br />
effectiveness <strong>of</strong> propranolol during the involution phase is not clear. Similarly, because<br />
proliferation may occur up to <strong>and</strong> after 12 months <strong>of</strong> age, the effectiveness <strong>of</strong> starting<br />
beta-blockers in older children is not clear.<br />
• Optimal duration <strong>of</strong> beta-blocker use. Duration <strong>of</strong> propranolol treatment ranged from 3<br />
to 13 months in comparative studies, but the optimal duration <strong>of</strong> treatment is not clear.<br />
Studies generally treated children for 6 months, potentially so that effects observed were<br />
likely drug-related <strong>and</strong> not the result <strong>of</strong> natural involution. However, current studies have<br />
not addressed the question <strong>of</strong> optimal timing to achieve maximal benefit.<br />
• Long-term outcomes <strong>and</strong> harms <strong>of</strong> beta-blockers. While harms reported in studies <strong>of</strong><br />
beta-blockers were typically not severe, only one comparative study 144 had greater than 6<br />
months followup after the end <strong>of</strong> treatment. Longer term effects on cardiovascular <strong>and</strong><br />
metabolic parameters known to be affected by beta-blocker use as well as effects on<br />
cognition, memory, <strong>and</strong> the central nervous system are not well-understood in the<br />
population <strong>of</strong> very young children receiving beta-blockers for IH. 263<br />
• Treatment choice for specific lesion types <strong>and</strong> locations. Characteristics, such as lesion<br />
size, location, <strong>and</strong> persistence, as well as modifiers such as patient age, functional impact,<br />
<strong>and</strong> IH subtype influence whether children are treated with pharmacologic agents or<br />
surgically. Lesion characteristics also influence the choice <strong>of</strong> specific pharmacologic<br />
agents. Most studies included multiple lesion types <strong>and</strong> in multiple locations, <strong>and</strong> few<br />
included specific modifier analyses or reported outcomes by lesion characteristics.<br />
Research to improve underst<strong>and</strong>ing <strong>of</strong> which lesions are likely to respond best to specific<br />
105
agents is critical, especially as underst<strong>and</strong>ing <strong>of</strong> the effectiveness <strong>of</strong> beta-blockers in the<br />
involution phase is limited. Optimal treatment in the proliferative phase may be key to<br />
maximal resolution <strong>of</strong> IH.<br />
• Assessment <strong>of</strong> methods for assessing rebound growth. A number <strong>of</strong> studies reported<br />
regrowth <strong>of</strong> lesions but typically did not indicate what constituted rebound growth.<br />
Greater clarity in reporting this outcome would help to clarify our underst<strong>and</strong>ing <strong>of</strong><br />
effectiveness.<br />
• Characteristics that may influence response to beta-blockers. Studies <strong>of</strong> beta-blockers<br />
were typically not powered to provide information on subgroups, but a percentage <strong>of</strong><br />
children did not respond or responded minimally to propranolol. In 10 comparative<br />
studies <strong>of</strong> beta-blockers reporting these data, 17,93,94,98,103,104,130,144,146,147,150 20 percent <strong>of</strong><br />
children (n=63/314) had a limited or no response to the agent. We lack data to assess<br />
whether improvement in lesions or promotion <strong>of</strong> involution is affected by child age or<br />
number, severity, type, or anatomic location <strong>of</strong> lesions. Similarly, underst<strong>and</strong>ing the<br />
mechanisms <strong>of</strong> growth <strong>of</strong> IH will promote our underst<strong>and</strong>ing <strong>of</strong> response to treatments<br />
<strong>and</strong> treatment safety.<br />
• Use <strong>of</strong> beta-blockers other than propranolol. Small cohort studies <strong>of</strong> oral atenolol <strong>and</strong><br />
nadolol <strong>and</strong> topical or ophthalmic timolol showed positive effects on IH resolution with<br />
few side effects. Additional RCTs <strong>of</strong> these agents, with clear reporting <strong>of</strong> lesion<br />
parameters <strong>and</strong> child characteristics, would increase our underst<strong>and</strong>ing <strong>of</strong> their<br />
effectiveness <strong>and</strong> comparative effectiveness versus propranolol.<br />
• Treatments for hepatic IH. Few treatment studies explicitly reported if children had<br />
hepatic IH. Most studies included children with IH in multiple locations, so children<br />
could have had hepatic IH as well; however, the applicability <strong>of</strong> findings to children with<br />
visceral IH is not clear.<br />
• Use <strong>of</strong> steroids <strong>and</strong> laser treatments in the beta-blocker era. Clinical practice in the<br />
United States is moving toward use <strong>of</strong> a beta-blocker as the first-line treatment for IH; 15<br />
however, a number <strong>of</strong> recent studies report use <strong>of</strong> steroids <strong>and</strong> laser treatments in younger<br />
children with lesions in the proliferative stage. Given the side effect pr<strong>of</strong>ile <strong>of</strong> steroids,<br />
underst<strong>and</strong>ing <strong>of</strong> whether or when to use such agents in the absence <strong>of</strong> life-threatening<br />
lesions or contraindications to beta-blockers is needed. Current literature does not provide<br />
sufficient data to address these questions.<br />
• Interventions to follow beta-blockers or corticosteroids if such treatments fail. We<br />
did not identify any studies that clearly reported data on this question. While most<br />
children receiving beta-blockers in the studies reviewed here responded to the<br />
medication, some had no or minimal response.<br />
• St<strong>and</strong>ardization <strong>of</strong> scoring tools to assess change in IH. IH outcomes are necessarily<br />
assessed using subjective measures, <strong>and</strong> investigators typically reported grading scales<br />
used to assess change in IH size or appearance. Few studies, however, commented on<br />
interrater reliability <strong>of</strong> instruments. Research to improve st<strong>and</strong>ardization among tools <strong>and</strong><br />
the development <strong>of</strong> uniform scoring systems <strong>and</strong> measurements would improve our<br />
ability to combine outcomes across studies.<br />
• St<strong>and</strong>ardization <strong>of</strong> nomenclature. Data extraction <strong>and</strong> comparisons in the review were<br />
limited by inconsistent naming conventions. Agreement <strong>and</strong> adherence to a st<strong>and</strong>ard<br />
classification <strong>of</strong> lesions would improve the ability <strong>of</strong> researchers to focus on individual<br />
lesion types <strong>and</strong> determine optimal treatment regimens for specific lesions.<br />
106
Conclusions<br />
Corticosteroids demonstrate some effectiveness at reducing IH size/volume, but may be<br />
associated with clinically important side effects. Propranolol is effective at reducing the size <strong>of</strong><br />
IH, with high strength <strong>of</strong> evidence for effects on reducing lesion size, <strong>and</strong> compared with<br />
placebo, observation, <strong>and</strong> other treatment methods including steroids in most, but not all, studies.<br />
In a network meta-analysis, the largest mean estimate <strong>of</strong> expected clearance was for oral<br />
propranolol (95%, 95% BCI: 88% to 99%), followed by timolol (62%, 95% BCI: 39% to 83%)<br />
<strong>and</strong> triamcinolone (58%, 95% BCI: 22% to 93%). The mean rate was 43 percent for oral steroids<br />
(95% BCI: 21% to 66%). With fairly wide confidence bounds <strong>and</strong> limited data in some areas, the<br />
relative differences among these estimates are <strong>of</strong> greater importance than the absolute effects.<br />
The estimates provide a relative ranking <strong>of</strong> anticipated rates <strong>of</strong> lesion clearance among treatment<br />
options. Families <strong>and</strong> clinicians making treatment decisions should also factor in elements such<br />
as lesion size, location, type, <strong>and</strong> number, which may affect choice <strong>of</strong> treatment modality, as well<br />
as patient/family preferences. Evidence pointed to substantial side effects for corticosteroids;<br />
harms were also noted with beta-blockers, but overall, these were well tolerated in the short term.<br />
Few studies have assessed potential long-term harms associated with beta-blocker use in infants<br />
<strong>and</strong> children. Laser studies generally found PDL more effective than other types <strong>of</strong> laser, but<br />
effects remain unclear as studies are heterogeneous <strong>and</strong> the role <strong>of</strong> laser vis-a-vis beta-blockers is<br />
not clearly described in the literature. Data are inadequate to address the role <strong>of</strong> imaging in<br />
guiding treatment.<br />
107
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254. Izadpanah A, Izadpanah A, Kanevsky J, et<br />
al. Propranolol versus corticosteroids in the<br />
treatment <strong>of</strong> infantile hemangioma: a<br />
systematic review <strong>and</strong> meta-analysis. Plast<br />
Reconstr Surg 2013 Mar;131(3):601-13.<br />
PMID: 23142941.<br />
255. Wat H, Wu DC, Rao J, et al. Application <strong>of</strong><br />
intense pulsed light in the treatment <strong>of</strong><br />
dermatologic disease: a systematic review.<br />
Dermatol Surg 2014 Apr;40(4):359-77.<br />
PMID: 24495252.<br />
120
256. Prasetyono TO, Djoenaedi I. Efficacy <strong>of</strong><br />
intralesional steroid injection in head <strong>and</strong><br />
neck hemangioma: a systematic review. Ann<br />
Plast Surg 2011 Jan;66(1):98-106. PMID:<br />
21042190.<br />
257. Leonardi-Bee J, Batta K, O'Brien C, et al.<br />
Interventions for infantile haemangiomas<br />
(strawberry birthmarks) <strong>of</strong> the skin.<br />
Cochrane Database Syst Rev 2011(5).<br />
258. Gunturi N, Ramgopal S, Balagopal S, et al.<br />
Propranolol therapy for infantile<br />
hemangioma. Indian Pediatr 2013<br />
Mar;50(3):307-13. PMID: 23680605.<br />
259. Marqueling AL, Oza V, Frieden IJ, et al.<br />
Propranolol <strong>and</strong> infantile hemangiomas four<br />
years later: a systematic review. Pediatr<br />
Dermatol 2013 Mar-Apr;30(2):182-91.<br />
PMID: 23405852.<br />
260. Peridis S, Pilgrim G, Athanasopoulos I, et<br />
al. A meta-analysis on the effectiveness <strong>of</strong><br />
propranolol for the treatment <strong>of</strong> infantile<br />
airway haemangiomas. Int J Pediatr<br />
Otorhinolaryngol 2011 Apr;75(4):455-60.<br />
PMID: 21333364.<br />
261. Lou Y, Peng WJ, Cao Y, et al. The<br />
effectiveness <strong>of</strong> propranolol in treating<br />
infantile haemangiomas: a meta-analysis<br />
including 35 studies. Br J Clin Pharmacol<br />
2014 Jul;78(1):44-57. PMID: 24033819.<br />
262. Spiteri Cornish K, Reddy AR. The use <strong>of</strong><br />
propranolol in the management <strong>of</strong> periocular<br />
capillary haemangioma--a systematic<br />
review. Eye (Lond) 2011 Oct;25(10):1277-<br />
83. PMID: 21738233.<br />
263. Mawn LA. <strong>Infantile</strong> hemangioma: treatment<br />
with surgery or steroids. Am Orthopt J<br />
2013;63:6-13. PMID: 24260801.<br />
121
Abbreviations <strong>and</strong> Acronyms Used in This Report<br />
AHRQ<br />
BCI<br />
CER<br />
CI<br />
cm<br />
CO2<br />
CT<br />
CQ<br />
EPC<br />
G<br />
HAS<br />
HR<br />
IH<br />
IQR<br />
IV<br />
kg<br />
KQ<br />
LUMBAR<br />
mg<br />
mL<br />
Mm<br />
MRI<br />
n<br />
NA<br />
Nd:YAG<br />
NR<br />
NS<br />
OR<br />
OSD<br />
PDL<br />
PELVIS<br />
PHACES<br />
PICOTS<br />
QoL<br />
RCT<br />
SD<br />
SOE<br />
TEP<br />
TSA<br />
Agency for Healthcare Research <strong>and</strong> Quality<br />
Bayesian Credible Interval<br />
Comparative Effectiveness Review<br />
Confidence Interval<br />
Centimeters<br />
Carbon Dioxide<br />
Computed Tomography<br />
Contextual Questions<br />
Evidence-based Practice Center<br />
Group<br />
<strong>Hemangioma</strong> Activity Score<br />
Hazard Ratio<br />
<strong>Infantile</strong> <strong>Hemangioma</strong><br />
Interquartile Range<br />
Intravenous<br />
Kilograms<br />
Key Questions<br />
Lower-body hemangioma <strong>and</strong> other cutaneous defects, Urogenital<br />
anomalies, Ulceration, Myelopathy, Bony deformities, Anorectal<br />
malformations, Arterial anomalies, <strong>and</strong> Renal anomalies<br />
Milligrams<br />
Milliliters<br />
Millimeters<br />
Magnetic Resonance Imaging<br />
Number<br />
Not Applicable<br />
Neodymium Yttrium Aluminum Garnet<br />
Not Reported<br />
Not Significant<br />
Odds ratio<br />
Occult Spinal Dysraphism<br />
Pulsed Dye Laser<br />
Perineal hemangioma, External genitalia malformations,<br />
Lipomyelomeningocele, Vesicorenal abnormalities, Imperforate anus, <strong>and</strong><br />
Skin tag<br />
Posterior fossa malformations, <strong>Hemangioma</strong>s, Arterial anomalies, Cardiac<br />
defects, Eye abnormalities, Sternal cleft <strong>and</strong> supraumbilical raphe<br />
Population, Interventions, Outcomes, Timing, <strong>and</strong> Setting<br />
Quality <strong>of</strong> Life<br />
R<strong>and</strong>omized, Controlled Trial<br />
St<strong>and</strong>ard Deviation<br />
Strength <strong>of</strong> Evidence<br />
Technical Expert Panel<br />
Total Surface Area<br />
122
US<br />
VAS<br />
Ultrasound<br />
Visual Analog Scale<br />
123
Appendix A. Search Strategies<br />
Searches for Contextual Questions<br />
Table A-1. MEDLINE (PubMed)<br />
Search Terms<br />
Search Results<br />
#1 hemangioma[mh] OR hemangioma, capillary infantile[nm] OR infantile<br />
33,062<br />
hemangioma*[tiab] OR infantile haemangioma*[tiab] OR capillary hemangioma*[tiab]<br />
OR capillary haemangioma*[tiab] OR congenital hemangioma*[tiab] OR congenital<br />
haemangioma*[tiab] OR IH[tiab]<br />
#2 infant[mh] OR infant[tiab] OR infants[tiab] OR infantile[tiab] OR child[mh] OR<br />
2,235,431<br />
Children[tiab] OR youth[tiab] OR pediatric[tiab] OR neonat*[tiab]<br />
#3 #1 AND #2 10,049<br />
#4 #3 AND eng[la] 7,297<br />
#5 #4 AND (review[pt] OR historical article[pt] OR practice guideline[pt] OR metaanalysis[pt])<br />
897<br />
#6 #5 AND Humans[mh] 892<br />
#7 #6 AND (Therapeutics[mh] OR therapy[sh] OR Treatment Outcome[mh] OR<br />
630<br />
therapy[tiab] OR therapies[tiab] OR therapeutic[tiab] OR therapeutics[tiab] OR<br />
outcome[tiab] OR outcomes[tiab] OR surgical[tiab] OR surgery[sh] OR surgery[tiab]<br />
OR Embolization, Therapeutic[mh] OR embolization[tiab] OR embolization[tiab] OR<br />
cryotherapy[mh] OR cryotherapy[tiab] OR Catheter Ablation[mh] OR radi<strong>of</strong>requency<br />
ablation[tiab ]OR Laser, dye [mh] OR Laser, Gas/therapeutic use[mh] OR Laser<br />
Therapy[mh] OR “carbon dioxide laser”[tiab] OR “carbon dioxide lasers”[tiab] OR<br />
CO2 laser[tiab] OR CO2 lasers[tiab] OR “fractionated laser”[tiab] OR “fractionated<br />
lasers”[tiab] OR argon[tiab] OR Lasers, Solid-State[mh] OR Neodymium YAG[tiab]<br />
OR YAG[tiab] OR Erbium[tiab] OR Propranolol[mh] OR propranolol[tiab] OR<br />
Timolol[mh] OR timolol[tiab] OR Imiquimod[NM] OR angiotensin OR Adrenergic<br />
beta-Antagonists[mh] OR Angiotensin-converting enzyme inhibitors[mh] OR<br />
Immunosuppressive agents[mh] OR Angiogenesis Inhibitors[mh] OR Bleomycin[mh]<br />
OR bleomycin[tiab] OR Antineoplastic agents[mh] OR Vincristine[mh] OR<br />
vincristine[tiab] OR corticosteroids[tiab] OR beta-blockers[tiab] OR beta blockers[tiab]<br />
OR beta blocker[tiab] OR beta-blockers[tiab] OR angiotensin[tiab] OR intralesional<br />
interferon[tiab])<br />
Key: [mh] medical subject heading; [nm] supplementary concept; [tiab] keyword in title or abstract; [la] language; [pt]<br />
publication type; [sh] subheading<br />
Table A-2. CINAHL search strategies (EBSCO Host interface)<br />
Search Terms<br />
Search Results<br />
#1 (MH “<strong>Hemangioma</strong>”) OR (MH “<strong>Hemangioma</strong>, Cavernous”) OR “infantile 1,164<br />
hemangioma” OR “infantile hemangiomas” OR “infantile haemangiomas” OR<br />
“infantile haemangiomas” OR “IH”<br />
#2 (MH “ Infant, Newborn, Diseases”) OR (MH “Infant”) OR (MH “Infant, Newborn”) 377,138<br />
OR (MH “Child”) OR “infant” OR “infants” OR “infantile” OR “newborn” OR<br />
“child” OR “children” OR “pediatric” or “neonat*”<br />
#3 S1 AND S2 452<br />
#4 S3 AND limiters: English language 449<br />
#5 S4 AND limiters: Exclude MEDLINE records 90<br />
Key: MH CINAHL medical subject heading; MW CINAHL subheading<br />
A-1
Table A-3. EMBASE search strategies (OvidSP interface)<br />
Search Terms<br />
#1 Capillary hemangioma / or infantile hemangioma.tw. or infantile<br />
hemangiomas.tw. or infantile haemangioma.tw. or infantile haemangiomas.tw.<br />
or haemangioma.tw. or hemangiomas.tw. or IH.tw.<br />
#2 Infant/ or child/ or newborn/ or congenital disorder/ or infant*.tw. or infantile.tw.<br />
or child.tw. or children.tw. or newborn.tw. or newborns.tw.<br />
Search Results<br />
15,518<br />
2,257,155<br />
#3 1 AND 2 4658<br />
#4 Limit 3 to English 3782<br />
#5 Limit 4 to human 3392<br />
#6 5 not (editorial.pt. or letter.pt. or note.pt. or short survey.pt. or conference 3155<br />
paper.pt.)<br />
#7 Limit 6 to exclude MEDLINE journals 236<br />
Key: / Emtree heading; .tw. abstract, title <strong>and</strong> drug trade name; /cn congenital; .fs. subheading; si.fs. side effects<br />
subheading; th.fs. therapy subheading; su.fs. surgery subheading; co.fs. complications subheading; pt. publication<br />
type<br />
A-2
Searches for Comparative Effectiveness Questions<br />
Table A-4. MEDLINE (PubMed)<br />
Search Terms<br />
Search Results<br />
#1 hemangioma[mh] OR hemangioma, capillary infantile[nm] OR infantile<br />
hemangioma*[tiab] OR infantile haemangioma*[tiab] OR capillary hemangioma*[tiab]<br />
OR capillary haemangioma*[tiab] OR congenital hemangioma*[tiab] OR congenital<br />
haemangioma*[tiab] OR IH[tiab]<br />
#2 infant[mh] OR infant[tiab] OR infants[tiab] OR infantile[tiab] OR pediatric[tiab] OR<br />
neonat*[tiab] OR child[mh] OR children[tiab] OR youth[tiab]<br />
33,062<br />
2,335,431<br />
#3 Therapeutics[mh] OR therapy[sh] OR Treatment Outcome[mh] OR therapy[tiab] OR 10,334,120<br />
therapies[tiab] OR therapeutic[tiab] OR therapeutics[tiab] OR outcome[tiab] OR<br />
outcomes[tiab] OR surgical[tiab] OR surgery[sh] OR surgery[tiab] OR Embolization,<br />
Therapeutic[mh] OR embolization[tiab] OR embolization[tiab] OR cryotherapy[mh]<br />
OR cryotherapy[tiab] OR Catheter Ablation[mh] OR radi<strong>of</strong>requency ablation[tiab ]OR<br />
Laser, dye [mh] OR Laser, Gas/therapeutic use[mh] OR Laser Therapy[mh] OR<br />
“carbon dioxide laser”[tiab] OR “carbon dioxide lasers”[tiab] OR CO2 laser[tiab] OR<br />
CO2 lasers[tiab] OR “fractionated laser”[tiab] OR “fractionated lasers”[tiab] OR<br />
argon[tiab] OR Lasers, Solid-State[mh] OR Neodymium YAG[tiab] OR YAG[tiab] OR<br />
Erbium[tiab] OR Propranolol[mh] OR propranolol[tiab] OR Timolol[mh] OR<br />
timolol[tiab] OR Imiquimod[NM] OR Adrenergic beta-Antagonists[mh] OR<br />
Angiotensin-converting enzyme inhibitors[mh] OR Immunosuppressive agents[mh]<br />
OR Angiogenesis Inhibitors[mh] OR Bleomycin[mh] OR bleomycin[tiab] OR<br />
Antineoplastic agents[mh] OR Vincristine[mh] OR vincristine[tiab] OR<br />
corticosteroids[tiab] OR beta-blockers[tiab] OR beta blockers[tiab] OR beta<br />
blocker[tiab] OR beta-blockers[tiab] OR angiotensin[tiab] OR intralesional<br />
interferon[tiab] OR “adverse effects"[Subheading] OR unsafe[tiab] OR safety[tiab]<br />
OR harm[tiab] OR harms[tiab] OR harmful[tiab] OR complication[tiab] OR<br />
complications[tiab] OR side-effect[tiab] OR "side-effects"[tiab] OR<br />
Undesirable effect[tiab] OR undesirable effects[tiab] OR undesirable reaction[tiab]<br />
OR undesirable reactions[tiab] OR undesirable event[tiab] OR undesirable<br />
events[tiab] OR undesirable outcome[tiab] OR undesirable outcomes[tiab] OR<br />
adverse effect[tiab] OR adverse effects[tiab] OR adverse reaction[tiab] OR adverse<br />
reactions[tiab] OR adverse event[tiab] OR adverse events[tiab] OR adverse<br />
outcome[tiab] OR adverse outcomes[tiab] OR "Postoperative Complications"[Mesh]<br />
OR postoperative complication[tiab] OR postoperative complications[tiab] OR post<br />
operative complication[tiab] OR post operative complications[tiab] OR surgical<br />
complication[tiab] OR surgical complications[tiab] OR postsurgical complication[tiab]<br />
OR postsurgical complications[tiab] OR post surgical complication[tiab] OR post<br />
surgical complications[tiab] OR adverse effects[Subheading] OR<br />
complications[Subheading] OR contraindications[Subheading] OR bleeding[tiab] OR<br />
Hemorrhage[mh] OR scarring[tiab] OR scars[tiab] OR residual hemangiomas[tiab]<br />
OR residual hemangioma[tiab] OR residual haemangioma[tiab] OR residual<br />
haemangiomas[tiab] OR pain[mh] OR pain[tiab] OR “Skin atrophy”[tiab] OR venous<br />
prominence[tiab] OR facial injuries[mh] OR skin ulcer[mh] OR ulceration[tiab] OR<br />
“surgical wound infection”[mh] OR wound infection[mh] OR infection[tiab]<br />
#4 #1 AND #2 AND #3 7392<br />
#5 #4 AND eng[la] 5441<br />
#6 #5 AND Humans[mh] 5203<br />
#7 #6 AND ("1982/01/01"[Date - Publication] : "3000"[Date - Publication]) 4358<br />
#8 #7 NOT (editorial[pt] OR letter[pt] OR comment[pt] OR review[pt] OR news[pt] OR 3409<br />
historical article[pt] OR practice guideline[pt] OR meta-analysis[pt])<br />
Key: [mh] medical subject heading; [nm] supplementary concept; [tiab] keyword in title or abstract; [la] language; [pt]<br />
publication type; [sh] subheading<br />
A-3
Table A-5. CINAHL search strategies (EBSCO Host interface)<br />
Search Terms<br />
#1 (MH “<strong>Hemangioma</strong>”) OR (MH “<strong>Hemangioma</strong>, Cavernous”) OR “infantile<br />
hemangioma” OR “infantile hemangiomas” OR “infantile haemangiomas” OR<br />
“infantile haemangiomas” OR “IH”<br />
#2 (MH “ Infant, Newborn, Diseases”) OR (MH “Infant”) OR (MH “Infant, Newborn”)<br />
OR “infant” OR “infants” OR “infantile” OR “newborn” OR “pediatric” OR<br />
“neonat*” OR (MH “Child”) OR “child” OR “children”<br />
#3 S1 AND S2 452<br />
#4 S3 AND limiters: English language 449<br />
#5 S4 AND limiters: 1982- 448<br />
#6 S5 AND limiters: Exclude MEDLINE records 90<br />
Key: MH CINAHL medical subject heading; MW CINAHL subheading<br />
Search Results<br />
1,163<br />
376,639<br />
Table A-6. EMBASE search strategies (OvidSP interface)<br />
Search Terms<br />
Search Results<br />
#1 Capillary hemangioma / or infantile hemangioma.tw. or infantile<br />
15,410<br />
hemangiomas.tw. or infantile haemangioma.tw. or infantile haemangiomas.tw.<br />
or haemangioma.tw. or hemangiomas.tw. or IH.tw.<br />
#2 Infant/ or child/ or newborn/ or congenital disorder/ or infant*.tw. or infantile.tw. 2,316,140<br />
or child.tw. or children.tw. or newborn.tw. or newborns.tw. or neonat*.tw<br />
#3 1 AND 2 4,615<br />
#4 Limit 3 to English 3,756<br />
#5 Limit 4 to human 3,343<br />
#6 5 not (review.pt. or editorial.pt. or letter.pt. or note.pt. or short survey.pt. or 2,699<br />
conference paper.pt. or meta analysis/ or practice guideline/ or systematic<br />
review/)<br />
#7 Limit 6 to 1982- 2645<br />
#8 Limit 7 to exclude MEDLINE journals 207<br />
Key: / Emtree heading; .tw. abstract, title <strong>and</strong> drug trade name; /cn congenital; .fs. subheading; si.fs. side effects<br />
subheading; th.fs. therapy subheading; su.fs. surgery subheading; co.fs. complications subheading; pt. publication<br />
type<br />
A-4
Appendix B. Screening <strong>and</strong> Quality Assessment<br />
Forms<br />
<strong>Infantile</strong> <strong>Hemangioma</strong> Abstract Review Form<br />
1. Does this reference include an abstract?<br />
□ Yes □ No □ Cannot Determine<br />
2. Does this study include newborns, infants or children (ages 0-18) with diagnosis <strong>of</strong><br />
infantile hemangioma (or suspected hemangioma)?<br />
(Do not include hemangioblastomas, hemangioendothelioma, cavernous<br />
hemangiomas/lesions/malformation, non-involuting congenital hemangiomas (NICH), rapid<br />
involuting congenital hemangiomas (RICH), vascular malformations, choroidal hemangiomas,<br />
diffuse hemangiomatosis, angiomas, verrucous hemangiomas)<br />
□ Yes □ No □ Cannot Determine<br />
3. Is this study original research (e.g., not commentaries, literature reviews, or systematic<br />
reviews, letters to the editor, editorials, case reports)?<br />
□ Yes □ No □ Cannot Determine<br />
4. Does this study address the effectiveness or harms <strong>of</strong> a diagnostic modality or surgical,<br />
laser or pharmacological intervention for infantile hemangioma?<br />
□ Yes □ No □ Cannot Determine<br />
Diagnostic modality/workup evaluation Including but not limited to:<br />
Diagnostic imaging including MRI, CT, MRA, Echo, Ultrasound<br />
Surgical interventions Including but not limited to: cryotherapy, resection, embolization,<br />
radi<strong>of</strong>requency ablation therapy, incisional biopsy<br />
Laser treatment Including but not limited to:<br />
Pulsed dye, fractionated, argon, carbon dioxide, neodymium (Nd): YAG, Erbium lasers<br />
Pharmacologic interventions Including but not limited to:<br />
Beta-blockers (e.g., systemic propranolol, topical timolol); corticosteroids (topical, intralesional,<br />
systemic); sirolimus, imiquimod, interferon, bleomycin, vincristine, ACE inhibitors,<br />
antiangiogenic agents<br />
5. Does this article address contextual questions including natural history, adverse<br />
outcomes <strong>of</strong> untreated infantile hemangioma, characteristics <strong>of</strong> the hemangioma that<br />
indicate risk <strong>of</strong> significant medical complications that would prompt immediate medical or<br />
surgical intervention, or evidence for the association <strong>of</strong> multiple cutaneous hemangiomas<br />
<strong>and</strong> increased risk <strong>of</strong> occult hemangiomas?<br />
□ Yes □ No □ Cannot Determine<br />
Retain for:<br />
□ Background/Discussion □ Review <strong>of</strong> References □ Other: ____________________<br />
Comments:<br />
B-1
<strong>Infantile</strong> <strong>Hemangioma</strong> Full Text Review Form<br />
1. Eligible study design:<br />
□ RCT<br />
□ Cohort study with comparison group<br />
□ Case-control<br />
□ Case series reporting harms <strong>and</strong> including at least 25 children with IH<br />
□ Case series with
Harms Risk <strong>of</strong> Bias Assessment Form<br />
RefID: __________________<br />
Reviewer:____________________<br />
Question Yes No Unclear Comments<br />
1. Are any important harms<br />
or adverse events that<br />
may be a consequence<br />
<strong>of</strong> the<br />
intervention/exposure<br />
missing from the results?<br />
(RTI cohort)<br />
2. Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions? (mcharms)<br />
Pre-defined indicates that the harms<br />
that were expected are explicitly<br />
defined prior to the collection <strong>of</strong> these<br />
expected events. For example, if<br />
bleeding is listed as a harmful event,<br />
the criteria by which they determine<br />
the bleeding (i.e. body location, type,<br />
or amount <strong>of</strong> blood loss that counts<br />
as an event, etc) should be specified.<br />
St<strong>and</strong>ardized classification <strong>of</strong> harms<br />
can be derived from any <strong>of</strong> the<br />
following:<br />
1) reference to st<strong>and</strong>ard terminology<br />
or classifications <strong>of</strong> harms from a<br />
recognized external<br />
organization(s)(such as government<br />
regulatory or health agencies.<br />
Examples <strong>of</strong> st<strong>and</strong>ardized<br />
terminology for harms includes,<br />
WHO-ART, MEDra, HTA report on<br />
the Measurement <strong>and</strong> Monitoring <strong>of</strong><br />
Surgical Adverse Events)<br />
2) previously explicitly defined<br />
classifications <strong>of</strong> harms in the<br />
literature, or<br />
3) based on pre-specified clinical<br />
criteria, or<br />
4) pre-specified laboratory test (may<br />
not need to have a specific cut-<strong>of</strong>f<br />
level specified in all cases)<br />
In some instances only<br />
some <strong>of</strong> the harms identified<br />
in a study will be precisely<br />
defined. In this case, there<br />
must be some judgement if<br />
the nature <strong>of</strong> the harms not<br />
pre-defined.<br />
3. Are all pre-specified<br />
harms reported? (RTI<br />
case series)<br />
4. Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection? (mcharms)<br />
IF #2 is<br />
NO, this is<br />
unclear<br />
B-3
St<strong>and</strong>ard scales or checklists are<br />
those that have at least one <strong>of</strong> the<br />
following:<br />
-Established reliability <strong>and</strong> validity<br />
(specified in the text);<br />
-Are very widely used within the<br />
discipline (may have to check the<br />
reference list for the scale)<br />
In the instance where the<br />
methods indicate that a<br />
NEW scale or checklist was<br />
developed for the study<br />
specifically, the author(s)<br />
must explicitly specify the<br />
CONTENT <strong>of</strong> the new scale<br />
or checklist in sufficient<br />
detail (for example, the body<br />
systems evaluated, or the<br />
specific tests or questions<br />
included.)<br />
5. Are the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate? (RTI cohort)<br />
Note: This form derived from questions from the RTI Item bank <strong>and</strong> McHarms tool.<br />
Good= 4-5 “yes”; Fair=3 “yes” out <strong>of</strong> 5; Poor=2 “yes” or less<br />
B-4
QUADAS Diagnostic Accuracy Rating Tool – For <strong>Diagnosis</strong> studies Form<br />
1 Was the spectrum <strong>of</strong> patients representative <strong>of</strong><br />
the patients who will receive the test in<br />
practice?<br />
Yes No Unclear Comments<br />
2 Were selection criteria clearly described?<br />
3 Is the reference st<strong>and</strong>ard likely to correctly<br />
classify the target condition?<br />
4 Is the time period between reference st<strong>and</strong>ard<br />
<strong>and</strong> index test short enough to be reasonably<br />
sure that the target condition did not change<br />
between the two tests?<br />
5 Did the whole sample or a r<strong>and</strong>om selection <strong>of</strong><br />
the sample, receive verification using a<br />
reference st<strong>and</strong>ard <strong>of</strong> diagnosis?<br />
6 Did patients receive the same reference<br />
st<strong>and</strong>ard regardless <strong>of</strong> the index test result?<br />
7 Was the reference st<strong>and</strong>ard independent <strong>of</strong><br />
the index test (i.e. the index test did not form<br />
part <strong>of</strong> the reference st<strong>and</strong>ard)?<br />
8 Was the execution <strong>of</strong> the index test described<br />
in sufficient detail to permit replication <strong>of</strong> the<br />
test?<br />
9 Was the execution <strong>of</strong> the reference st<strong>and</strong>ard<br />
described in sufficient detail to permit its<br />
replication?<br />
10 Were the index test results interpreted without<br />
knowledge <strong>of</strong> the results <strong>of</strong> the reference<br />
st<strong>and</strong>ard?<br />
11 Were the reference st<strong>and</strong>ard results<br />
interpreted without knowledge <strong>of</strong> the results <strong>of</strong><br />
the index test?<br />
12 Were the same clinical data available when<br />
test results were interpreted as would be<br />
available when the test is used in practice?<br />
13 Were uninterpretable/ intermediate test results<br />
reported?<br />
14 Were withdrawals from the study explained?<br />
B-5
Newcastle-Ottawa Quality Assessment Form for Cohort Studies Form<br />
Note: A study can be given a maximum <strong>of</strong> one star for each numbered item within the Selection <strong>and</strong> Outcome<br />
categories. A maximum <strong>of</strong> two stars can be given for Comparability.<br />
REFID:___________________<br />
Reviewer:________________<br />
Selection<br />
1) Representativeness <strong>of</strong> the exposed cohort:<br />
a) Truly representative (one star)<br />
b) Somewhat representative (one star)<br />
c) Selected group<br />
d) No description <strong>of</strong> the derivation <strong>of</strong> the cohort<br />
2) Selection <strong>of</strong> the non-exposed cohort<br />
a) Drawn from the same community as the exposed cohort (one star)<br />
b) Drawn from a different source<br />
c) No description <strong>of</strong> the derivation <strong>of</strong> the non exposed cohort<br />
3) Ascertainment <strong>of</strong> exposure:<br />
a) Secure record (e.g., surgical record) (one star)<br />
b) Structured interview (one star)<br />
c) Written self report<br />
d) No description<br />
e) Other<br />
4) Demonstration that outcome <strong>of</strong> interest was not present at start <strong>of</strong> study:<br />
a) Yes (one star)<br />
b) No<br />
Comparability<br />
5) Comparability <strong>of</strong> cohorts on the basis <strong>of</strong> the design or analysis controlled for confounders:<br />
a) The study controls for age (one star)<br />
b) Study controls for other factors (list) _________________________________(one star)<br />
c) Cohorts are not comparable on the basis <strong>of</strong> the design or analysis controlled for confounders<br />
Outcome<br />
6) Assessment <strong>of</strong> outcome:<br />
a) Independent blind assessment (one star)<br />
b) Record linkage (one star)<br />
c) Self report<br />
d) No description<br />
e) Other<br />
7) Was follow-up long enough for outcomes to occur:<br />
a) Yes (one star)<br />
b) No<br />
Indicate the median duration <strong>of</strong> follow-up <strong>and</strong> a brief rationale for the assessment<br />
above:____________________<br />
8) Adequacy <strong>of</strong> follow-up <strong>of</strong> cohorts:<br />
a) Complete follow up- all subject accounted for (one star)<br />
b) Subjects lost to follow up unlikely to introduce bias- number lost less than or equal to 20% or description <strong>of</strong><br />
those lost suggested no different from those followed. (one star)<br />
c) Follow up rate greater than 80% <strong>and</strong> no description <strong>of</strong> those lost<br />
d) No statement<br />
9) Would answers to any <strong>of</strong> these questions vary based on the specific outcome assessed? If yes, please explain:<br />
_____________________________________________________________________________________________<br />
_____________________________________________________________________________________________<br />
B-6
<strong>Infantile</strong> <strong>Hemangioma</strong> CER: Risk <strong>of</strong> Bias for RCTs Form<br />
Reviewer Initials: _____ Ref ID: __________<br />
Risk <strong>of</strong><br />
Bias<br />
Selection<br />
bias<br />
Performa<br />
nce bias<br />
Attrition<br />
bias<br />
Detection<br />
bias<br />
Criterion Yes No Unclear COMMENTS<br />
Was the allocation sequence generated adequately (e.g., r<strong>and</strong>om number table,<br />
computer-generated r<strong>and</strong>omization)?<br />
Was the allocation <strong>of</strong> treatment adequately concealed (e.g., pharmacycontrolled<br />
r<strong>and</strong>omization or use <strong>of</strong> sequentially numbered sealed envelopes)?<br />
Were participants analyzed within the groups they were originally assigned to?<br />
Does the design or analysis control account for important confounding <strong>and</strong><br />
modifying variables through matching, stratification, multivariable analysis, or<br />
other approaches?<br />
Did researchers rule out any impact from a concurrent intervention or an<br />
unintended exposure that might bias results?<br />
Did the study maintain fidelity to the intervention protocol?<br />
If attrition (overall or differential nonresponse, dropout, loss to follow-up, or<br />
exclusion <strong>of</strong> participants) was a concern, were missing data h<strong>and</strong>led<br />
appropriately (e.g., intention-to-treat analysis <strong>and</strong> imputation)?<br />
Was the length <strong>of</strong> follow-up different between the groups?<br />
Were the outcome assessors blinded to the intervention or exposure status <strong>of</strong><br />
participants?<br />
Reporting<br />
bias<br />
Other<br />
Were interventions/exposures assessed/defined using clearly defined measures,<br />
implemented consistently across all study participants?<br />
Were outcomes assessed using clearly defined measures, implemented<br />
consistently across all study participants?<br />
Were the potential outcomes prespecified by the researchers?<br />
Are all prespecified outcomes reported?<br />
List outcomes <strong>of</strong> interest assessed:<br />
______________________________________________________________<br />
Would answers to any <strong>of</strong> these questions vary by the specific outcome<br />
assessed? If yes, please explain in Comments box.<br />
OUTCOMES OF INTEREST FOR REVIEW<br />
Imaging: Ability to identify presence, number, <strong>and</strong> extent <strong>of</strong> hemangiomas <strong>and</strong> associated structural anomalies (sensitivity <strong>and</strong> specificity)<br />
Treatment: Size / volume <strong>of</strong> hemangioma; Impact on vision; Aesthetic appearance as assessed by clinician or parent; Degree <strong>of</strong> ulceration; Quality <strong>of</strong> life<br />
B-7
Appendix C. Excluded Studies<br />
Reasons for Exclusion<br />
X-1 Does not include children with infantile hemangioma<br />
X-2 Not original research<br />
X-3 Does not address interventions/outcomes <strong>of</strong> interest<br />
X-4 Ineligible study design<br />
X-5 Not obtainable<br />
X-6 Not in English<br />
1. Argenta LC, Bishop E, Cho KJ, et al. Complete<br />
resolution <strong>of</strong> life-threatening hemangioma by<br />
embolization <strong>and</strong> corticosteroids. Plast Reconstr<br />
Surg. 1982 Dec;70(6):739-44. PMID: 6890694;<br />
X-1, X-2<br />
2. Bardelli AM, Lasorella G. Primary <strong>and</strong><br />
secondary ocular tumors in children. J Neurosurg<br />
Sci. 1982 Jan-Mar;26(1):11-6. PMID: 6815311;<br />
X-1<br />
3. Biller HF, Krespi YP, Som PM. Combined<br />
therapy for vascular lesions <strong>of</strong> the head <strong>and</strong> neck<br />
with intra-arterial embolization <strong>and</strong> surgical<br />
excision. Otolaryngol Head Neck Surg. 1982<br />
Jan-Feb;90(1):37-47. PMID: 6806755; X-1, X-2<br />
4. Bloom DA, Scardino PT, Ehrlich RM, et al. The<br />
significance <strong>of</strong> lymph nodal involvement in renal<br />
angiomyolipoma. J Urol. 1982 Dec;128(6):1292-<br />
5. PMID: 7154190; X-1<br />
5. Bookstein JJ, Cho KJ, Davis GB, et al.<br />
Arterioportal communications: observations <strong>and</strong><br />
hypotheses concerning transsinusoidal <strong>and</strong><br />
transvasal types. Radiology. 1982<br />
Mar;142(3):581-90. PMID: 7063671; X-1<br />
6. Bradley PJ, Singh SD. Congenital nasal masses:<br />
diagnosis <strong>and</strong> management. Clin Otolaryngol<br />
Allied Sci. 1982 Apr;7(2):87-97. PMID:<br />
7094387; X-1<br />
7. Brooks BS, El Gammal T, Beveridge WD.<br />
Erosion <strong>of</strong> vertebral pedicles by unusual vascular<br />
causes. Report <strong>of</strong> three cases. Neuroradiology.<br />
1982;23(2):107-12. PMID: 7078720; X-1<br />
8. Brown BZ, Huffaker G. Local injection <strong>of</strong><br />
steroids for juvenile hemangiomas which disturb<br />
the visual axis. Ophthalmic Surg. 1982<br />
Aug;13(8):630-3. PMID: 7133606; X-2<br />
9. Carruth JA. The argon laser in he treatment <strong>of</strong><br />
vascular naevi. Br J Dermatol. 1982<br />
Sep;107(3):365-8. PMID: 7115616; X-1<br />
10. Carruth JA, McKenzie AL. The argon laser in<br />
dermatology: safety aspects. Clin Exp Dermatol.<br />
1982 May;7(3):247-53. PMID: 7105476; X-1<br />
11. de Tribolet N, Kaech D, Perentes E. Cerebellar<br />
haematoma due to a cavernous angioma in a<br />
child. Acta Neurochir (Wien). 1982;60(1-2):37-<br />
43. PMID: 7058698; X-1<br />
12. Demakas JJ, Sonntag VK, Kaplan AM, et al.<br />
Surgical management <strong>of</strong> pineal area tumors in<br />
early childhood. Surg Neurol. 1982<br />
Jun;17(6):435-40. PMID: 7112375; X-1<br />
13. Di Trapani G, Di Rocco C, Abbamondi AL, et<br />
al. Light microscopy <strong>and</strong> ultrastructural studies<br />
<strong>of</strong> Sturge-Weber disease. Childs Brain.<br />
1982;9(1):23-36. PMID: 6460599; X-1<br />
14. Edgerton MT. Vascular hamartomas <strong>and</strong><br />
hemangiomas: classification <strong>and</strong> treatment.<br />
South Med J. 1982 Dec;75(12):1541-7. PMID:<br />
7146992; X-1, X-2<br />
15. Fabian JT, Rose AG. Tumours <strong>of</strong> the heart. A<br />
study <strong>of</strong> 89 cases. S Afr Med J. 1982 Jan<br />
16;61(3):71-7. PMID: 6277017; X-1<br />
16. Felder KS, Brockhurst RJ. Neovascular fundus<br />
abnormalities in peripheral uveitis. Arch<br />
Ophthalmol. 1982 May;100(5):750-4. PMID:<br />
6177305; X-1<br />
17. Fischer EG, Sotrel A, Welch K. Cerebral<br />
hemangioma with glial neoplasia<br />
(angioglioma?). Report <strong>of</strong> two cases. J<br />
Neurosurg. 1982 Mar;56(3):430-4. PMID:<br />
7057243; X-1<br />
18. Gilchrest BA, Rosen S, Noe JM. Chilling port<br />
wine stains improves the response to argon laser<br />
therapy. Plast Reconstr Surg. 1982<br />
Feb;69(2):278-83. PMID: 7054797; X-1<br />
19. Gresty MA, Ell JJ, Findley LJ. Acquired<br />
pendular nystagmus: its characteristics,<br />
localising value <strong>and</strong> pathophysiology. J Neurol<br />
Neurosurg Psychiatry. 1982 May;45(5):431-9.<br />
PMID: 7086456; X-1<br />
C-1
20. Grundfest-Broniatowski S, Carey WD, Sivak<br />
MV, Jr., et al. Klippel-Trenaunay-Weber<br />
syndrome with visceral involvement <strong>and</strong> portal<br />
hypertension. Cleve Clin Q. 1982<br />
Winter;49(4):239-47. PMID: 6301708; X-1<br />
21. Hayman LA, Evans RA, Ferrell RE, et al.<br />
Familial cavernous angiomas: natural history <strong>and</strong><br />
genetic study over a 5-year period. Am J Med<br />
Genet. 1982 Feb;11(2):147-60. PMID: 6950664;<br />
X-1<br />
22. Hurvitz CH, Greenberg SH, Song CH, et al.<br />
<strong>Hemangioma</strong>tosis <strong>of</strong> the pleura with hemorrhage<br />
<strong>and</strong> disseminated intravascular coagulation. J<br />
Pediatr Surg. 1982 Feb;17(1):73-5. PMID:<br />
7077482; X-1, X-2<br />
23. Ilbawi M, DeLeon S, Riggs T, et al. Primary<br />
vascular tumors <strong>of</strong> the heart in infancy. Report <strong>of</strong><br />
a case with successful surgical management.<br />
Chest. 1982 Apr;81(4):511-2. PMID: 7067518;<br />
X-1<br />
24. Kaibara N, Mitsuyasu M, Katsuki I, et al.<br />
Generalized enchondromatosis with unusual<br />
complications <strong>of</strong> s<strong>of</strong>t tissue calcifications <strong>and</strong><br />
hemangiomas. Follow-up for over a twelve-year<br />
period. Skeletal Radiol. 1982;8(1):43-6. PMID:<br />
7079783; X-1<br />
25. Kalicinski ZH, Joszt W, Perdzynski W, et al.<br />
<strong>Hemangioma</strong> <strong>of</strong> the superior caval vein. J Pediatr<br />
Surg. 1982 Apr;17(2):178-9. PMID: 7077501;<br />
X-2<br />
26. Kobus K, Licznerski A, Stepniewski J, et al.<br />
The surgical treatment <strong>of</strong> vascular tumours <strong>of</strong> the<br />
face. J Maxill<strong>of</strong>ac Surg. 1982 May;10(2):99-112.<br />
PMID: 7047664; X-3, X-4<br />
27. Kushner BJ. Intralesional corticosteroid<br />
injection for infantile adnexal hemangioma. Am<br />
J Ophthalmol. 1982 Apr;93(4):496-506. PMID:<br />
7072814; X-4<br />
28. Kveton JF, Pillsbury HC. Conservative<br />
treatment <strong>of</strong> infantile subglottic hemangioma<br />
with corticosteroids. Arch Otolaryngol. 1982<br />
Feb;108(2):117-9. PMID: 7059313; X-2<br />
29. Ladurner G, Fritsch G, Sager WD, et al.<br />
Computer tomography in children with stroke.<br />
Eur Neurol. 1982;21(4):235-41. PMID:<br />
7117310; X-1<br />
30. Liberski PP, Alwasiak J, Wegrzyn Z, et al.<br />
Sturge-Weber syndrome with a unilateral<br />
developmental anomaly <strong>of</strong> the cerebral<br />
hemisphere. Neuropatol Pol. 1982;20(3-4):505-<br />
10. PMID: 7183945; X-1<br />
31. McCarthy JC, Goldberg MJ, Zimbler S.<br />
Orthopaedic dysfunction in the blue rubber-bleb<br />
nevus syndrome. J Bone Joint Surg Am. 1982<br />
Feb;64(2):280-3. PMID: 7056783; X-1<br />
32. Mencke HJ, Zilkens J, Bigalke KH, et al. The<br />
problem <strong>of</strong> intramuscular haemangioma. Arch<br />
Orthop Trauma Surg. 1982;100(4):243-7. PMID:<br />
7159196; X-1<br />
33. Moazam F, Talbert JL, Rodgers BM. Primary<br />
tumors <strong>of</strong> the liver in infancy <strong>and</strong> childhood. J<br />
Fla Med Assoc. 1982 Dec;69(12):991-6. PMID:<br />
6296270; X-2<br />
34. Moss LA, Stueber K, Hafiz MA. Congenital<br />
hemangioendothelioma <strong>of</strong> the h<strong>and</strong>--case report.<br />
J H<strong>and</strong> Surg Am. 1982 Jan;7(1):53-6. PMID:<br />
7061809; X-1<br />
35. Nguyen L, Sh<strong>and</strong>ling B, Ein S, et al. Hepatic<br />
hemangioma in childhood: medical management<br />
or surgical management? J Pediatr Surg. 1982<br />
Oct;17(5):576-9. PMID: 7175647; X-1<br />
36. Niechajev IA, Karlsson S. Angiomatosis<br />
osteohypotrophica. Sc<strong>and</strong> J Plast Reconstr Surg.<br />
1982;16(1):77-85. PMID: 7112039; X-1<br />
37. Niechajev IA, Karlsson S. Vascular tumours <strong>of</strong><br />
the h<strong>and</strong>. Sc<strong>and</strong> J Plast Reconstr Surg.<br />
1982;16(1):67-75. PMID: 7112038; X-1<br />
38. Norins AL, Treadwell PA. The management <strong>of</strong><br />
persistent pediatric skin problems. Pediatr Clin<br />
North Am. 1982 Feb;29(1):37-53. PMID:<br />
6460218; X-1, X-2<br />
39. Ogawa Y, Inoue K. Electrothrombosis as a<br />
treatment <strong>of</strong> cirsoid angioma in the face <strong>and</strong><br />
scalp <strong>and</strong> varicosis <strong>of</strong> the leg. Plast Reconstr<br />
Surg. 1982 Sep;70(3):310-8. PMID: 7111485;<br />
X-1<br />
40. Pereyra R, Andrassy RJ, Mahour GH.<br />
<strong>Management</strong> <strong>of</strong> massive hepatic hemangiomas in<br />
infants <strong>and</strong> children: a review <strong>of</strong> 13 cases.<br />
Pediatrics. 1982 Aug;70(2):254-8. PMID:<br />
7099792; X-3, X-4<br />
41. Polus K. Skin haemangioma: treatment by<br />
cryosurgery. Acta Paediatr Acad Sci Hung.<br />
1982;23(2):167-70. PMID: 7136598; X-3, X-4<br />
42. Pretorius HT, Katikineni M, Kinsella TJ, et al.<br />
Thyroid nodules after high-dose external<br />
radiotherapy. Fine-needle aspiration cytology in<br />
diagnosis <strong>and</strong> management. Jama. 1982 Jun<br />
18;247(23):3217-20. PMID: 7087060; X-1, X-2<br />
C-2
43. Price JB, Jr., Schullinger JN, Santulli TV.<br />
Major hepatic resections for neoplasia in<br />
children. Arch Surg. 1982 Sep;117(9):1139-41.<br />
PMID: 6287966; X-1<br />
44. Ramming KP, Holmes EC, Zarem HA, et al.<br />
Surgical management <strong>and</strong> reconstruction <strong>of</strong><br />
extensive chest wall malignancies. Am J Surg.<br />
1982 Jul;144(1):146-52. PMID: 6953769; X-1<br />
45. R<strong>and</strong>all PA. Vascular mass. Preoperative<br />
occlusion <strong>of</strong> feeding vessel. N Y State J Med.<br />
1982 Feb;82(2):189-91. PMID: 6952084; X-1,<br />
X-2<br />
46. Ricketts RR, Stryker S, Raffensperger JG.<br />
Ventral fasciotomy in the management <strong>of</strong> hepatic<br />
hemangioendothelioma. J Pediatr Surg. 1982<br />
Apr;17(2):187-8. PMID: 6210769; X-1<br />
47. Sadan N, Sade J, Grunebaum M. The treatment<br />
<strong>of</strong> subglottic hemangiomas <strong>of</strong> infants with<br />
prednisone. Int J Pediatr Otorhinolaryngol. 1982<br />
Mar;4(1):7-14. PMID: 7095995; X-4<br />
48. Sanborn GE, Augsburger JJ, Shields JA.<br />
Treatment <strong>of</strong> circumscribed choroidal<br />
hemangiomas. Ophthalmology. 1982<br />
Dec;89(12):1374-80. PMID: 6891765; X-1<br />
49. Schneeweiss A, Blieden LC, Shem-Tov A, et al.<br />
Coarctation <strong>of</strong> the aorta with congenital<br />
hemangioma <strong>of</strong> the face <strong>and</strong> neck <strong>and</strong> aneurysm<br />
or dilatation <strong>of</strong> a subclavian or innominate<br />
artery. A new syndrome? Chest. 1982<br />
Aug;82(2):186-7. PMID: 7047095; X-1<br />
50. Shannon K, Buchanan GR, Votteler TP.<br />
Multiple hepatic hemangiomas: failure <strong>of</strong><br />
corticosteroid therapy <strong>and</strong> successful hepatic<br />
artery ligation. Am J Dis Child. 1982<br />
Mar;136(3):275-6. PMID: 7064957; X-2<br />
51. Starzl TE, Iwatsuki S, Shaw BW, Jr., et al. Left<br />
hepatic trisegmentectomy. Surg Gynecol Obstet.<br />
1982 Jul;155(1):21-7. PMID: 6283687; X-1<br />
52. Verity CM, Strauss EH, Moyes PD, et al. Longterm<br />
follow-up after cerebral hemispherectomy:<br />
neurophysiologic, radiologic, <strong>and</strong> psychological<br />
findings. Neurology. 1982 Jun;32(6):629-39.<br />
PMID: 7201093; X-1<br />
53. Abad JM, Alvarez F, Manrique M, et al.<br />
Cerebral arteriovenous malformations.<br />
Comparative results <strong>of</strong> surgical vs conservative<br />
treatment in 112 cases. J Neurosurg Sci. 1983<br />
Jul-Sep;27(3):203-10. PMID: 6663354; X-1<br />
54. Bart RS, Kopf AW. Tumor conference #50.<br />
Untreated massive hemangioma with satisfactory<br />
outcome. J Dermatol Surg Oncol. 1983<br />
Nov;9(11):875-7. PMID: 6630701; X-2<br />
55. Becht EW, Rumpelt HJ, Frohneberg D, et al.<br />
Angioma-like pseudometamorphosis in Wilms'<br />
tumors subjected to preoperative radio- <strong>and</strong><br />
chemotherapy. Pathol Res Pract. 1983<br />
Jun;177(1):22-31. PMID: 6312438; X-1<br />
56. Bendl BJ, Bashir R, Dowling AD. Sturge-<br />
Weber syndrome. Cutis. 1983 Mar;31(3):286-94.<br />
PMID: 6839805; X-1<br />
57. Benjamin B, Carter P. Congenital laryngeal<br />
hemangioma. Ann Otol Rhinol Laryngol. 1983<br />
Sep-Oct;92(5 Pt 1):448-55. PMID: 6625442; X-<br />
2<br />
58. Bernhard LM, Brant RG, Bakst MJ, et al.<br />
Hypertrophic hemangioma vs.<br />
hemangiopericytoma. J Foot Surg. 1983<br />
Winter;22(4):308-13. PMID: 6643939; X-1<br />
59. Bouwman DL, Walt AJ. Current status <strong>of</strong><br />
resection for hepatic neoplasms. Semin Liver<br />
Dis. 1983 Aug;3(3):193-202. PMID: 6623102;<br />
X-1<br />
60. Browne AF, Katz S, Miser J, et al. Blue Rubber<br />
Bleb Nevi as a cause <strong>of</strong> intussusception. J<br />
Pediatr Surg. 1983 Feb;18(1):7-9. PMID:<br />
6834229; X-1<br />
61. Charboneau JW, Hattery RR, Ernst EC, 3rd, et<br />
al. Spectrum <strong>of</strong> sonographic findings in 125<br />
renal masses other than benign simple cyst. AJR<br />
Am J Roentgenol. 1983 Jan;140(1):87-94.<br />
PMID: 6295123; X-1<br />
62. Chew E, Morin JD. Glaucoma in children.<br />
Pediatr Clin North Am. 1983 Dec;30(6):1043-<br />
60. PMID: 6646864; X-1<br />
63. Corbella F, Arico M, Podesta AF, et al. <strong>Infantile</strong><br />
hepatic hemangioendothelioma treated by<br />
radiotherapy. Pediatr Radiol. 1983;13(5):297-<br />
300. PMID: 6622093; X-1<br />
64. Crow J, Gibbs DA, Cozens W, et al.<br />
Biochemical <strong>and</strong> histopathological studies on<br />
patients with mucopolysaccharidoses, two <strong>of</strong><br />
whom had been treated by fibroblast<br />
transplantation. J Clin Pathol. 1983<br />
Apr;36(4):415-30. PMID: 6403596; X-1<br />
C-3
65. Dachman AH, Lichtenstein JE, Friedman AC,<br />
et al. <strong>Infantile</strong> hemangioendothelioma <strong>of</strong> the<br />
liver: a radiologic-pathologic-clinical correlation.<br />
AJR Am J Roentgenol. 1983 Jun;140(6):1091-6.<br />
PMID: 6602472; X-1<br />
66. David TJ, Evans DI, Stevens RF. Haemangioma<br />
with thrombocytopenia (Kasabach-Merritt<br />
syndrome). Arch Dis Child. 1983<br />
Dec;58(12):1022-3. PMID: 6660888; X-1<br />
67. Edmondson HA, Peters RL. Tumors <strong>of</strong> the<br />
liver: pathologic features. Semin Roentgenol.<br />
1983 Apr;18(2):75-83. PMID: 6306841; X-1, X-<br />
2<br />
68. Ehren H, Mahour GH, Isaacs H, Jr. Benign liver<br />
tumors in infancy <strong>and</strong> childhood. Report <strong>of</strong> 48<br />
cases. Am J Surg. 1983 Mar;145(3):325-9.<br />
PMID: 6837854; X-3, X-4<br />
69. Esterly NB. Kasabach-Merritt syndrome in<br />
infants. J Am Acad Dermatol. 1983<br />
Apr;8(4):504-13. PMID: 6853783; X-1<br />
70. Ford CN. Serial excision <strong>and</strong> advancement flaps<br />
in the management <strong>of</strong> facial lesions. Otolaryngol<br />
Head Neck Surg. 1983 Apr;91(2):156-64. PMID:<br />
6408572; X-1<br />
71. Gibbs DA, Spellacy E, Tompkins R, et al. A<br />
clinical trial <strong>of</strong> fibroblast transplantation for the<br />
treatment <strong>of</strong> mucopolysaccharidoses. J Inherit<br />
Metab Dis. 1983;6(2):62-81. PMID: 6410119;<br />
X-1<br />
72. Gonzalez DG, Breur K. Clinical data from<br />
irradiated growing long bones in children. Int J<br />
Radiat Oncol Biol Phys. 1983 Jun;9(6):841-6.<br />
PMID: 6863057; X-1<br />
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Si{dotless}ni{dotless}rli{dotless} ve difuz koroid<br />
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Tek tarafli{dotless} Inguinal herni operasyonu<br />
uygulanan cocuklarda aci{dotless}k ve<br />
laparoskopik cerrahi tekniklerinin anestezi<br />
suresi, postoperatif agri{dotless} ve analjezik<br />
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Mixed capillary-cavernous extramedullary<br />
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X-1<br />
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lumbosacral hemangioma with spinal<br />
dysraphism. J Pediatr. 2015 Feb;166(2):495.<br />
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3954. Durack A, Gass JK. Assessing skin disease in<br />
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Kingdom). 2015 01 Feb;25(2):49-53. PMID: X-<br />
2, X-4<br />
3955. Dutkiewicz AS, Ezzedine K, Mazereeuw-<br />
Hautier J, et al. A prospective study <strong>of</strong> risk for<br />
Sturge-Weber syndrome in children with upper<br />
facial port-wine stain. J Am Acad Dermatol.<br />
2015 Mar;72(3):473-80. PMID: 25592619; X-3,<br />
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3957. Hasson M, Kahl KL, Te N. in the journals.<br />
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utero sonographic findings <strong>of</strong> giant hepatic<br />
hemangioma <strong>and</strong> associated perinatal<br />
complications: A report <strong>of</strong> two cases. Journal <strong>of</strong><br />
Medical Ultrasound. 2015 01 Mar;23(1):46-51.<br />
PMID: X-4<br />
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PMID: X-1<br />
3960. Karikari IO, Nimjee SM, Hodges TR, et al.<br />
Impact <strong>of</strong> tumor histology on resectability <strong>and</strong><br />
neurological outcome in primary intramedullary<br />
spinal cord tumors: a single-center experience<br />
with 102 patients. Neurosurgery. 2015 Mar;76<br />
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Ophthalmol. 2015 May;30(3):214-7. PMID:<br />
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3962. Li P, Guo Z, Gao Y, et al. Propranolol<br />
represses infantile hemangioma cell growth<br />
through the beta2-adrenergic receptor in a HIF-<br />
1alpha-dependent manner. Oncol Rep. 2015 Apr<br />
14PMID: 25872592; X-1<br />
3963. Liu H, Yang MB, Li SK, et al. Effects <strong>of</strong><br />
Dosing Protocol on Distribution <strong>of</strong> Propranolol<br />
in Periocular Tissues after Topical Ocular<br />
Instillation. Curr Eye Res. 2015 May;40(6):638-<br />
45. PMID: 25167079; X-1<br />
3964. Mishra AK, Tomer V, Yadav SS, et al. Adult<br />
giant genital hemangioma & pure intrascrotal<br />
hemangioma: A rare benign genital tumor <strong>of</strong><br />
adult. Indian Journal <strong>of</strong> Urology. 2015<br />
January;31:S113. PMID: X-1<br />
3965. Munabi NC, Tan QK, Garzon MC, et al.<br />
Growth Hormone Induces Recurrence <strong>of</strong><br />
<strong>Infantile</strong> <strong>Hemangioma</strong>s After Apparent<br />
Involution: Evidence <strong>of</strong> Growth Hormone<br />
Receptors in <strong>Infantile</strong> <strong>Hemangioma</strong>. Pediatr<br />
Dermatol. 2015 Feb 18PMID: 25690955; X-4<br />
3966. Pan WK, Li P, Guo ZT, et al. Propranolol<br />
induces regression <strong>of</strong> hemangioma cells via the<br />
down-regulation <strong>of</strong> the PI3K/Akt/eNOS/VEGF<br />
pathway. Pediatr Blood Cancer. 2015 Mar<br />
1PMID: 25728347; X-1<br />
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Neonatal bone marrow transplantation prevents<br />
bone pathology in a mouse model <strong>of</strong><br />
mucopolysaccharidosis type I. Blood. 2015 Mar<br />
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(United Kingdom). 2015 01 Feb;25(2):60-5.<br />
PMID: X-2, X-4<br />
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al. Ovarian <strong>Hemangioma</strong>s Do Not Harbor<br />
EWSR1 Rearrangements: Clinicopathologic<br />
Characterization <strong>of</strong> 10 Cases. Int J Gynecol<br />
Pathol. 2015 Apr 3PMID: 25851709; X-1<br />
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Pulmonary infantile hemangioma presenting as a<br />
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Gastrointestinal <strong>Infantile</strong> <strong>Hemangioma</strong>:<br />
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Jan;73(1):92-8. PMID: 25511959; X-4<br />
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3976. Verma SK, Singh PK, Garg K, et al. Giant<br />
calvarial cavernous hemangioma. Journal <strong>of</strong><br />
Pediatric Neurosciences. 2015 01 Jan;10(1):41-4.<br />
PMID: X-1<br />
3977. Vivas-Colmenares GV, Bernabeu-Wittel J,<br />
Alonso-Arroyo V, et al. Effectiveness <strong>of</strong><br />
Propranolol in the Treatment <strong>of</strong> <strong>Infantile</strong><br />
<strong>Hemangioma</strong> Beyond the Proliferation Phase.<br />
Pediatr Dermatol. 2015 Feb 26PMID: 25721095;<br />
X-4<br />
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three-dimensional reconstruction <strong>of</strong> main vessels<br />
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Clinical <strong>and</strong> Experimental Medicine. 2015 28<br />
Feb;8(2):1747-54. PMID: X-1<br />
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al. The effect <strong>of</strong> oral propranolol on intraocular<br />
pressure in infants with Sturge-Weber syndrome<br />
glaucoma. Eur J Ophthalmol. 2015 Mar-<br />
Apr;25(2):134-6. PMID: 25044138; X-1<br />
C-188
Appendix D. Methods for Network Meta-Analysis<br />
Using data extracted by the systematic review, we conducted a multi-intervention (network)<br />
meta-analysis to estimate the effectiveness <strong>of</strong> several corticosteroids <strong>and</strong> beta-blockers for the<br />
treatment <strong>of</strong> infantile hemangioma. Of particular interest was the estimation <strong>of</strong> the efficacy <strong>of</strong><br />
propranolol, a beta-blocker that was used in a large number <strong>of</strong> studies in the review. To this end,<br />
we estimated the expected clearance <strong>of</strong> IH following intervention based on outcomes from 17<br />
unique studies obtained from the systematic review. This set included outcomes for 4 different<br />
non-control pharmacologic interventions: propranolol, timolol, triamcinolone, <strong>and</strong> oral steroids.<br />
A challenge for meta-analyzing these outcomes is the diversity in outcome reporting among<br />
the constituent studies. Though most used some measure <strong>of</strong> the reduction in the original IH at<br />
end <strong>of</strong> treatment, typically results were reported as counts <strong>of</strong> subjects achieving some arbitrary<br />
minimum clearance threshold, such as 50% or 75%. An approach to analyzing outcomes<br />
reported in this way is via a binomial model. For this model, the response variable is the number<br />
<strong>of</strong> individuals in study j under intervention k that achieve the clearance threshold:<br />
nn jjjj<br />
yy jjjj = II ii (aaaaaaaaaa cccccccccccccccccc tthrrrrrrhoooooo)<br />
ii=1<br />
where I is the indicator function, returning 1 if the argument is true, or 0 otherwise. This outcome<br />
can then modeled as a binomial response:<br />
yy jjjj ~ BBBBBB(nn jjjj , ππ jjjj )<br />
where ππ jjjj is the probability <strong>of</strong> a positive response for study j under intervention k. To allow for<br />
heterogeneity in this probability across studies, we can specify it as a r<strong>and</strong>om effect:<br />
llllllllllππ jjjj = θθ jjjj<br />
θθ jjjj ~NNNNNNNNNNll(μμ kk , σσ kk )<br />
where μμ kk , σσ kk are the parameters <strong>of</strong> a normal distribution (which, inverse logit-transformed,<br />
models quantities on the [0,1] interval).<br />
However, the use <strong>of</strong> an arbitrary cut<strong>of</strong>f value as a threshold <strong>of</strong> success is an unsatisfactory<br />
modeling choice because there is an inherent loss <strong>of</strong> information in the dichotomization or<br />
discretization <strong>of</strong> continuous variables, <strong>and</strong> this loss is magnified here by having to discard data<br />
from studies that use a different response threshold than the adopted value (e.g. 75%). Since the<br />
clearance rate is a continuous measure, one can hypothesize a latent, continuous probability<br />
distribution that each study reports relative to specific quantiles: 50%, 75%, etc. If there is<br />
sufficient information, one may use a Bayesian approach to attempt to reconstruct this latent<br />
distribution, which would allow for more <strong>of</strong> the available information to be used in the metaanalytic<br />
procedure.<br />
Under treatment k, one can consider a notional distribution <strong>of</strong> hemangioma clearance rates,<br />
from no effect (0) to complete clearance (1)—for our purposes, we will not consider IH<br />
enlargement, other than assigning it a “no effect” outcome. As a matter <strong>of</strong> convenience in a<br />
particular study j, researchers chose a clearance threshold cj, only reporting whether a particular<br />
subject occupied one side or the other <strong>of</strong> this threshold. We can characterize the true, latent<br />
response distribution by estimating the parameters via the following identity:<br />
ππ jjjj = 1 − ΦΦ(cc jj |μμ kk , σσ kk )<br />
D-1
where ΦΦ(xx) is the cumulative distribution function <strong>of</strong> the normal distribution (our latent<br />
ditribution) under parameters evaluated at x. The resulting probability is the same as specified<br />
above, <strong>and</strong> can be used in the same binomial likelihood:<br />
yy jjjj ~ BBBBBB(nn jjjj , ππ jjjj )<br />
This can be readily generalized to studies that report multiple thresholds, simply by dividing the<br />
distribution <strong>of</strong> ππ jjjj into regions corresponding to each threshold. This corresponds to a<br />
multinomial, rather than binomial, likelihood.<br />
In principle, one may incorporate covariates to improve the prediction <strong>of</strong> intervention<br />
effectiveness. For example, the mode <strong>of</strong> delivery (oral, intralesional, topical), dose, or the<br />
hemangioma location may be predictive <strong>of</strong> intervention effectiveness. In this work, only<br />
propanolol had a sufficient number <strong>of</strong> studies to estimate covariate effects; we included an<br />
indicator variable for intralesional mode <strong>of</strong> delivery, relative to the oral mode that was used as a<br />
baseline. The logit-expected value <strong>of</strong> treatment k from study j was modeled as:<br />
θθ jjjj = μμ + ββ kk + ψψzz jj + εε jj<br />
where μμ is the baseline (control) clearance rate, ββ kk is the relative effect <strong>of</strong> treatment k, zj is an<br />
indicator for the use <strong>of</strong> intralesional propranolol, <strong>and</strong> ψψ the associated relative intralesional<br />
effect. Finally, εε jj is a study r<strong>and</strong>om effect that is assigned to all treatment arms <strong>of</strong> study j, which<br />
accounts for the lack <strong>of</strong> independence within-study. This r<strong>and</strong>om effect was assumed to be<br />
normally distributed with zero mean <strong>and</strong> variance σσ 2 that was estimated from the data.<br />
A h<strong>and</strong>ful <strong>of</strong> studies, rather than reporting threshold counts, reported summary statistics <strong>of</strong><br />
VAS scores for each study arm. Using the latent variable framework described above under a<br />
Bayesian estimation approach, this information can also be brought to bear on the estimation <strong>of</strong><br />
the model parameters. This required the transformation <strong>of</strong> the reported outcomes from the VAS<br />
scale (0-100) to values on the real line (i.e. a logit transformation), including the reported<br />
st<strong>and</strong>ard deviation, which was transformed using the delta method. The resulting transformed<br />
values can then be used to inform the expected outcome for the corresponding intervention via a<br />
normal likelihood:<br />
llllllllllVVVVSS jjjj ∼ NN(θθ kk , ss jjjj δδ )<br />
where ss jj δδ is the transformed st<strong>and</strong>ard deviation for the outcome.<br />
Finally, one study (Qiu 2013) reported individual patient data in the form <strong>of</strong> VAS scores.<br />
This data was integrated into the study via the same method as for the summarized VAS score<br />
output outlined above, except that the delta transformation was not necessary, since the data were<br />
used directly.<br />
This model was implemented in the PyMC package for Bayesian analysis in Python (Patil et<br />
al. 2010). Parameter estimates were obtained using Markov chain Monte Carlo (MCMC, Brooks<br />
et al. 2011) methods. Sampling was carried out for 100,000 iterations, with the first 90,000<br />
conservatively discarded as burn-in to ensure convergence <strong>of</strong> the sampler. In order to evaluate<br />
convergence using the Gelman-Rubin diagnostic (Gelman <strong>and</strong> Rubin 1992), a second chain was<br />
sampled <strong>of</strong> identical size. The complete analysis is available is an open-access GitHub repository<br />
(https://github.com/fonnesbeck/IH_meta-analysis), including an IPython Notebook containing<br />
the model described above (https://github.com/fonnesbeck/IH_metaanalysis/blob/master/<strong>Infantile</strong>%20<strong>Hemangioma</strong>%20Meta-analysis.ipynb).<br />
D-2
Model Results<br />
The expected efficacy <strong>of</strong> control arms was estimated to be 0.06 (95% Bayesian credible<br />
interval = [0.01, 0.11]). All non-control treatments were estimated to have a larger expected<br />
clearance than control (Figure D-1). The largest mean estimate was oral propranolol (0.95, 95%<br />
BCI = [0.88, 0.99]), followed by timolol (0.62, 95% BCI = [0.39, 0.83]) <strong>and</strong> triamcinolone (0.58,<br />
95% BCI = [0.22, 0.93]). Oral steroids had a mean clearance estimate <strong>of</strong> 0.43(95% BCI = [0.21,<br />
0.66]).<br />
We calculated the probability that each <strong>of</strong> the non-control interventions is the best treatment,<br />
based on expected clearance rate. This was estimated from the MCMC simulation that tallied the<br />
number <strong>of</strong> iterations that each intervention had the highest expected value, <strong>and</strong> calculating the<br />
proportion for each intervention as an estimate <strong>of</strong> the probability <strong>of</strong> being best. Oral propranolol<br />
had the highest probability (99%), followed by triamcinolone (1%); all others had probabilities<br />
less than 1% combined. To better account for the uncertainty in the estimated treatment effects,<br />
we also calculated the surface under the cumulative ranking curve (SUCRA) for each treatment,<br />
which provides a probabilistic summary <strong>of</strong> the rankings <strong>of</strong> the treatments (Figure D-3). Oral<br />
propranolol had the highest SUCRA score (0.902), intralesional propanolol the lowest (0.119),<br />
with the other treatments intermediate.<br />
Propanolol was estimated to have the largest variability in clearance rate (Figure D-2, σ=2.5,<br />
95% BCI = [2.1, 2.9]) with timolol (σ=1.5, 95% BCI: 1.4 to 1.6), intralesional triamcinolone<br />
(σ=1.8, 95% BCI: 1.3 to 2.3), <strong>and</strong> oral steroids (σ=1.3, 95% BCI: 1.1 to 1.6) yielding similar,<br />
lower estimates. With the exception <strong>of</strong> Timolol, interventions with larger effect sizes tended to<br />
have larger effect size variance.<br />
Table D-1. Posterior estimates <strong>of</strong> effect size<br />
Mean SE 95% Credible interval<br />
Oral propranolol 6.0 0.7 [4.6 7.5]<br />
Timolol 3.5 0.5 [2.4 4.6]<br />
Triamcinolone 3.3 0.8 [1.7 4.9]<br />
Oral steroid 2.6 0.5 [1.8 3.6]<br />
Note: Posterior estimates <strong>of</strong> effect size, on logit scale, relative to control, along with st<strong>and</strong>ard error <strong>and</strong> 95% credible interval.<br />
Positive values indicate increased clearance relative to control, negative indicate decreased clearance.<br />
D-3
Figure D-1. Estimates <strong>of</strong> expected IH clearance<br />
Note: Estimates <strong>of</strong> expected IH clearance (expressed as percent clearance relative to initial condition) for each treatment, along<br />
with associated posterior interquartile range (thick lines) <strong>and</strong> 95% credible interval (thin lines).<br />
D-4
Figure D-2. Estimates <strong>of</strong> the variation <strong>of</strong> each treatment<br />
Note: Estimates <strong>of</strong> the variation <strong>of</strong> each treatment, expressed as st<strong>and</strong>ard deviation, along with associated posterior interquartile<br />
range (thick lines) <strong>and</strong> 95% credible interval (thin lines).<br />
D-5
Figure D-3. Posterior SUCRA estimates for each treatment<br />
To give an overview <strong>of</strong> the expected distribution <strong>of</strong> clearance rates across treatments, Figure<br />
D-4 plots estimated probability distribution functions based on the posterior clearance rates <strong>and</strong><br />
st<strong>and</strong>ard deviations <strong>of</strong> four treatments. For each <strong>of</strong> 100 iterations, a sample was drawn from the<br />
posterior distributions <strong>of</strong> both the mean <strong>and</strong> st<strong>and</strong>ard deviation for oral propranolol, timolol,<br />
triamcinolone, <strong>and</strong> oral steroid. Inverse-logit transforming the normal probability distribution<br />
function resulted in plots that integrate the residual uncertainty <strong>of</strong> the parameters with the<br />
sampling variability <strong>of</strong> the model.<br />
D-6
Figure D-4. 100 posterior samples <strong>of</strong> distribution <strong>of</strong> clearance rates under oral propranolol,<br />
timolol, triamcinolone, <strong>and</strong> oral steroid<br />
The network diagram in Figure D-5 illustrates the relative numbers <strong>of</strong> direct comparisons<br />
between intervention types. The largest number (thickest line) is four comparisons.<br />
D-7
Figure D-5. Network diagram <strong>of</strong> comparisons<br />
D-8
References<br />
1. Patil A, Huard D, Fonnesbeck CJ. PyMC: Bayesian Stochastic Modelling in Python. J Stat S<strong>of</strong>tw. 2010;35(4):1-<br />
81.<br />
2. Brooks S, Gelman A, Jones G, Meng X-L. H<strong>and</strong>book <strong>of</strong> Markov Chain Monte Carlo. CRC Press; 2011.<br />
3. Gelman A, Rubin DB. Inference from iterative simulation using multiple sequences. Statist Sci. 1992:457-472.<br />
4. Salanti G, Ades AE, Ioannidis JPA. Graphical methods <strong>and</strong> numerical summaries for presenting results from<br />
multiple-treatment meta-analysis: an overview <strong>and</strong> tutorial. J Clin Epidemiol. 2011;64(2):163-171.<br />
doi:10.1016/j.jclinepi.2010.03.016.<br />
D-9
Appendix E. Study Design Classification Algorithm<br />
Figure E-1. Study design algorithm<br />
E-1
Appendix F. Quality/Risk <strong>of</strong> Bias Ratings<br />
Table F-1. Quality assessment <strong>of</strong> r<strong>and</strong>omized controlled trials<br />
Author, Year<br />
Leaute-<br />
Labreze 2015 1<br />
Allocation Sequence<br />
Generated Adequately<br />
Allocation Treatment<br />
Adequately Concealed<br />
Participants Analyzed In<br />
Groups Originally<br />
Assigned<br />
Design Account for<br />
Confounding<br />
Rule Out Impact from<br />
Concurrent Intervention<br />
or Unintended Exposure<br />
Fidelity Maintained to<br />
Intervention Protocol<br />
If Attrition, Were<br />
Missing Data H<strong>and</strong>led<br />
Appropriately<br />
Difference in Length <strong>of</strong><br />
Follow-up Between<br />
Groups<br />
Outcome Assessors<br />
Blinded<br />
Interventions/<br />
Exposures Assessed<br />
Clearly<br />
Outcomes Assessed<br />
Clearly<br />
Potential Outcomes<br />
Prespecified<br />
All Prespecified<br />
Outcomes Reported<br />
Risk <strong>of</strong> Bias<br />
Rating for<br />
Outcome<br />
Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Good<br />
Tawfik 2015 2 Unclear Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Fair<br />
Abarzua-Araya<br />
2014 3<br />
Unclear Unclear Yes No No Unclear Yes No Yes Yes Yes Yes Yes Fair<br />
Bauman 2014 4 Yes Yes Yes Yes Yes Yes Unclear No Yes Yes Yes Yes Yes Good<br />
Chan 2013 5 Yes Yes Yes Yes Unclear Yes Yes No Yes Yes Yes Yes Yes Good<br />
Kessels 2013 6 Yes Yes Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Good<br />
Leaute-<br />
Labreze 2013 7<br />
Yes Unclear Yes No Unclear Yes Yes No Yes Yes Yes Yes Yes Fair<br />
Malik 2013 8 Yes Unclear Yes No Yes Yes Unclear No Yes Yes Yes Yes Yes Fair<br />
Zaher 2013 9 Unclear Unclear yes No Yes Yes Yes Unclear Unclear Yes Yes Yes Yes Fair<br />
F-1
Author, Year<br />
Hogeling<br />
2011 10<br />
Allocation Sequence<br />
Generated Adequately<br />
Allocation Treatment<br />
Adequately Concealed<br />
Participants Analyzed In<br />
Groups Originally<br />
Assigned<br />
Design Account for<br />
Confounding<br />
Rule Out Impact from<br />
Concurrent Intervention<br />
or Unintended Exposure<br />
Fidelity Maintained to<br />
Intervention Protocol<br />
If Attrition, Were<br />
Missing Data H<strong>and</strong>led<br />
Appropriately<br />
Difference in Length <strong>of</strong><br />
Follow-up Between<br />
Groups<br />
Outcome Assessors<br />
Blinded<br />
Interventions/<br />
Exposures Assessed<br />
Clearly<br />
Outcomes Assessed<br />
Clearly<br />
Potential Outcomes<br />
Prespecified<br />
All Prespecified<br />
Outcomes Reported<br />
Risk <strong>of</strong> Bias<br />
Rating for<br />
Outcome<br />
Yes Yes Yes Yes No Yes Yes No Yes Yes Unclear Yes Yes Good<br />
P<strong>and</strong>ey 2010 11 Unclear Unclear Yes Yes Unclear Unclear Yes No Unclear Yes Yes Yes Yes Fair<br />
Pope 2007 12 Yes Yes Yes Yes Unclear No Yes No Yes Yes Yes Yes Yes Good<br />
Jalil 2006 13 Unclear No Yes Unclear Unclear Unclear Yes No Unclear Yes Yes Yes Yes Poor<br />
Kono 2006 14 Unclear Unclear Yes Yes Yes Unclear Yes No Yes Yes No Yes Yes Fair<br />
Batta 2002 15 Yes Yes Yes Yes Unclear No Yes No No Yes Yes Yes Yes Fair<br />
F-2
Table F-2. Quality assessment <strong>of</strong> cohort studies<br />
Author, Year<br />
Representativeness<br />
<strong>of</strong><br />
exposed cohort<br />
Selection <strong>of</strong><br />
non-exposed<br />
cohort<br />
Goelz 2014 16 Selected group Drawn from<br />
same<br />
community<br />
Hoornweg<br />
2014 17<br />
Park 2014 18<br />
Perkins<br />
2014 19<br />
Ryzhevskiy<br />
2014 20<br />
de Graaf<br />
2013 21-23<br />
Pope 2013 24<br />
Qiu 2013 25<br />
Reddy 2013 26<br />
Sondhi<br />
2013 27<br />
Truly<br />
representative<br />
Somewhat<br />
representative<br />
Truly<br />
representative<br />
Truly<br />
representative<br />
Somewhat<br />
representative<br />
Truly<br />
representative<br />
Truly<br />
representative<br />
Somewhat<br />
representative<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Ascertainment<br />
<strong>of</strong> exposure<br />
Outcome <strong>of</strong><br />
interest not<br />
present at<br />
start <strong>of</strong><br />
study<br />
Comparability<br />
<strong>of</strong> cohorts<br />
No description Yes Cohorts not<br />
comparable<br />
Assessment<br />
<strong>of</strong> outcome<br />
No<br />
description<br />
Secure record Yes Controls for age Record<br />
linkage<br />
Secure record Yes Cohorts not<br />
comparable<br />
Record<br />
linkage<br />
Secure record Yes Controls for age Record<br />
linkage<br />
Secure record Yes Cohorts not<br />
comparable<br />
No<br />
description<br />
Secure record Yes Controls for age Independent<br />
blind<br />
assessment<br />
Secure record Yes Controls for<br />
other factors<br />
Secure record Yes Controls for<br />
other factors<br />
Secure record Yes Controls for<br />
other factors<br />
Secure record Yes Cohorts not<br />
comparable<br />
Independent<br />
blind<br />
assessment<br />
Record<br />
linkage<br />
Independent<br />
blind<br />
assessment<br />
Independent<br />
blind<br />
assessment<br />
Followup<br />
long<br />
enough<br />
Yes<br />
Yes<br />
Yes<br />
Yes<br />
Yes<br />
Yes<br />
Adequacy <strong>of</strong><br />
follow-up <strong>of</strong><br />
cohorts<br />
Complete<br />
follow-up<br />
Follow up<br />
rate less than<br />
80% <strong>and</strong> no<br />
description <strong>of</strong><br />
those lost<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Quality<br />
Rating<br />
Poor<br />
Fair<br />
Poor<br />
Fair<br />
Poor<br />
Good<br />
No No statement Poor<br />
Yes<br />
Yes<br />
Yes<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Subjects lost<br />
to follow up<br />
unlikely to<br />
introduce<br />
bias<br />
Fair<br />
Fair<br />
Fair<br />
F-3
Author, Year<br />
Representativeness<br />
<strong>of</strong><br />
exposed cohort<br />
Selection <strong>of</strong><br />
non-exposed<br />
cohort<br />
Ascertainment<br />
<strong>of</strong> exposure<br />
Outcome <strong>of</strong><br />
interest not<br />
present at<br />
start <strong>of</strong><br />
study<br />
Comparability<br />
<strong>of</strong> cohorts<br />
Assessment<br />
<strong>of</strong> outcome<br />
Followup<br />
long<br />
enough<br />
Adequacy <strong>of</strong><br />
follow-up <strong>of</strong><br />
cohorts<br />
Quality<br />
Rating<br />
Yu 2013 28<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
No description Yes Controls for age No<br />
description<br />
Yes<br />
Complete<br />
follow-up<br />
Poor<br />
Chambers<br />
2012 29<br />
Somewhat<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Controls for age Independent<br />
blind<br />
assessment<br />
Yes<br />
Complete<br />
follow-up<br />
Fair<br />
Pope 2012 24<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Controls for<br />
other factors<br />
Independent<br />
blind<br />
assessment<br />
No No statement Poor<br />
Rossler<br />
201230, 31<br />
Tay 2012 32<br />
Thayal 2012 33<br />
No description <strong>of</strong><br />
the derivation <strong>of</strong><br />
cohort<br />
Truly<br />
representative<br />
Somewhat<br />
representative<br />
No description<br />
<strong>of</strong> derivation <strong>of</strong><br />
non-exposed<br />
cohort<br />
Drawn from<br />
same<br />
community<br />
No description<br />
<strong>of</strong> derivation <strong>of</strong><br />
non-exposed<br />
cohort<br />
Secure record Yes Cohorts not<br />
comparable<br />
Record<br />
linkage<br />
Secure record Yes Controls for age Record<br />
linkage<br />
Secure record Yes Cohorts not<br />
comparable<br />
Record<br />
linkage<br />
No<br />
Yes<br />
Yes<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Subjects lost<br />
to follow up<br />
unlikely to<br />
introduce<br />
bias<br />
Poor<br />
Fair<br />
Poor<br />
Awadein<br />
2011 34<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Structured<br />
interview<br />
Yes Controls for age Independent<br />
blind<br />
assessment<br />
No<br />
Complete<br />
follow-up<br />
Fair<br />
Bertr<strong>and</strong><br />
2011 35<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Controls for age Independent<br />
blind<br />
assessment<br />
Yes<br />
Complete<br />
follow-up<br />
Fair<br />
Hermans<br />
2011 36<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Controls for<br />
other factors<br />
Record<br />
linkage<br />
Yes<br />
Complete<br />
follow-up<br />
Fair<br />
Price 2011 37<br />
Somewhat<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Controls for<br />
other factors<br />
Record<br />
linkage<br />
Yes<br />
Complete<br />
follow-up<br />
Fair<br />
F-4
Author, Year<br />
Representativeness<br />
<strong>of</strong><br />
exposed cohort<br />
Selection <strong>of</strong><br />
non-exposed<br />
cohort<br />
Ascertainment<br />
<strong>of</strong> exposure<br />
Outcome <strong>of</strong><br />
interest not<br />
present at<br />
start <strong>of</strong><br />
study<br />
Comparability<br />
<strong>of</strong> cohorts<br />
Assessment<br />
<strong>of</strong> outcome<br />
Followup<br />
long<br />
enough<br />
Adequacy <strong>of</strong><br />
follow-up <strong>of</strong><br />
cohorts<br />
Quality<br />
Rating<br />
Nicolai 2005 38<br />
Vlachakis<br />
2004 39<br />
Akyuz 2001 40<br />
Chang 2001 41<br />
Raulin 2001 42<br />
Truly<br />
representative<br />
Truly<br />
representative<br />
Truly<br />
representative<br />
No description <strong>of</strong><br />
the derivation <strong>of</strong><br />
cohort<br />
No description <strong>of</strong><br />
the derivation <strong>of</strong><br />
cohort<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Cohorts not<br />
comparable<br />
Secure record Yes Cohorts not<br />
comparable<br />
Self report Yes Subjects lost<br />
to follow up<br />
unlikely to<br />
introduce<br />
bias<br />
Record<br />
linkage<br />
Secure record Yes Controls for age Record<br />
linkage<br />
Secure record Yes Cohorts not<br />
comparable<br />
Secure record Yes Cohorts not<br />
comparable<br />
Independent<br />
blind<br />
assessment<br />
Record<br />
linkage<br />
Yes<br />
Yes<br />
Yes<br />
Yes<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Complete<br />
follow-up<br />
Subjects lost<br />
to follow up<br />
unlikely to<br />
introduce<br />
bias<br />
Poor<br />
Fair<br />
Fair<br />
Poor<br />
Poor<br />
Achauer<br />
1997 43<br />
Truly<br />
representative<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Cohorts not<br />
comparable<br />
Record<br />
linkage<br />
No<br />
Complete<br />
follow-up<br />
Poor<br />
Achauer<br />
1989 44<br />
Selected group<br />
Drawn from<br />
same<br />
community<br />
Secure record Yes Cohorts not<br />
comparable<br />
Record<br />
linkage<br />
Yes<br />
Subjects lost<br />
to follow up<br />
unlikely to<br />
introduce<br />
bias<br />
Poor<br />
Table F-3. Quality assessment <strong>of</strong> studies reporting harms<br />
F-5
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Chen 2015 45<br />
Chen 2015 46<br />
Leaute-Labreze 2015 1<br />
Raphael 2015 47<br />
Tawfik 2015 2<br />
Xu 2015 48<br />
Abarzua-Araya 2014 3<br />
Andersen 2014 49<br />
Bauman 2014 4<br />
Chai 2014 50<br />
Chen 2014 51<br />
Chu 2014 52<br />
Couto 2014 53<br />
El Ezzi 2014 54<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Yes Yes Yes Yes Good<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial No Poor<br />
Partial Unclear Partial Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Yes Yes Yes Yes Good<br />
Partial Unclear Partial Yes Poor<br />
Yes Yes Unclear Yes Fair<br />
Partial Unclear Partial Yes Poor<br />
No Unclear No No Poor<br />
Partial Unclear Partial Yes Poor<br />
F-6
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Giachetti 2014 55<br />
Goelz 2014 16<br />
Hassan 2014 56<br />
Hoornweg 2014 17<br />
Jian 2014 57<br />
Kaune 2014 58<br />
Ke 2014 59<br />
Kwon 2014 60<br />
Lynch 2014 61<br />
Martinez Roca 2014 62<br />
May 2014 63<br />
Muzaffar 2014 64<br />
Park 2014 18<br />
Park 2014 65<br />
Partial Unclear Partial Yes Poor<br />
No Unclear No Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Unclear Yes Poor<br />
Partial Unclear No Yes Poor<br />
Yes Unclear Unclear Yes Poor<br />
No Unclear Unclear No Poor<br />
Yes Yes Yes Yes Good<br />
Partial Unclear Unclear No Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear No Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear No Poor<br />
Partial Unclear Partial Yes Poor<br />
F-7
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Sagi 2014 66<br />
Schneider 2014 67<br />
Schneider 2014 68<br />
Solman 2014 69<br />
Su 2014 70<br />
Szychta 2014 71<br />
Bonifazi 2013 72<br />
Chan 2013 5<br />
de Graaf 2013 21-23<br />
Gan 2013 73<br />
Hermans 2013 74<br />
Hong 2013 75<br />
Kessels 2013 6<br />
Leaute-Labreze 2013 7<br />
Partial Unclear Partial No Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial No Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Yes Yes Yes Yes Good<br />
Unclear Unclear Unclear Yes Poor<br />
Partial Unclear Partial No Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial No Poor<br />
F-8
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Liu 2013 76<br />
Ma 2013 77<br />
Malik 2013 8<br />
Puttgen 2013 78<br />
Qiu 2013 25<br />
Reddy 2013 26<br />
Sadykov 201379, 80<br />
Semkova 2013 81<br />
Sondhi 2013 27<br />
Vercellino 2013 82<br />
Xiao 2013 83<br />
Yu 2013 28<br />
Yuan 2013 84<br />
Zaher 2013 9<br />
Partial Unclear Partial Yes Poor<br />
Yes Yes Yes Yes Good<br />
No Unclear Unclear Yes Poor<br />
Yes Yes Yes Yes Good<br />
Yes Yes Yes Yes Good<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear No Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
F-9
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Balma-Mena 2012 85<br />
Bertr<strong>and</strong> 2012 86<br />
Celik 2012 87<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Chakkittak<strong>and</strong>iyil<br />
2012 88 No Unclear Unclear Yes Poor<br />
Chambers 2012 29<br />
Georgountzou 2012 89<br />
Janmohamed 2012 90<br />
Kunzi-Rapp 2012 91<br />
Lv 2012 92<br />
Phillips 2012 93<br />
Pope 2012 24<br />
Samimi 2012 94<br />
Talaat 2012 95<br />
Tay 2012 32<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear No Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
F-10
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Thayal 2012 33<br />
Wang 2012 96<br />
Xu 2012 97<br />
Zegpi-Trueba 2012 98<br />
Awadein 2011 34<br />
Bertr<strong>and</strong> 2011 35<br />
Blatt 2011 99<br />
Chang 2011 100<br />
Cushing 2011 101<br />
Daramola 2011 102<br />
Di Maio 2011 103<br />
Fuchsmann 2011 104<br />
Greene 2011 105<br />
Hermans 2011 36<br />
Partial Unclear Partial Unclear Poor<br />
Partial Unclear Partial Yes Poor<br />
Yes Yes Yes Yes Good<br />
Unclear Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Unclear Unclear Unclear Yes Poor<br />
Yes Yes Yes Unclear Fair<br />
No Unclear Unclear Yes Poor<br />
Yes Yes Yes No Fair<br />
Yes Yes Yes Yes Good<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
F-11
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Hogeling 2011 10<br />
Holmes 2011 106<br />
Kulbersh 2011 107<br />
Li 2011 108<br />
Price 2011 37<br />
Rossler 201130, 31<br />
Saint-Jean 2011 109<br />
Schiestl 2011 110<br />
Schupp 2011 111<br />
Snir 2011 112<br />
Zaher 2011 113<br />
Zvulunov 2011 114<br />
Arneja 2010 115<br />
Hamou 2010 116<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
Partial Unclear Partial Unclear Poor<br />
No Unclear No Yes Poor<br />
No Unclear No Yes Poor<br />
No Unclear No Yes Poor<br />
F-12
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Li 2010 117<br />
Manunza 2010 118<br />
P<strong>and</strong>ey 2010 11<br />
Chen 2009 119<br />
P<strong>and</strong>ey 2009 120<br />
Rizzo 2009 121<br />
Saleh 2009 122<br />
Sans 2009 123<br />
Wu 2009 124<br />
No Unclear Unclear No Poor<br />
Partial Unclear Partial Unclear Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear No Yes Poor<br />
No Unclear No No Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear No Yes Poor<br />
Chantharatanapiboon<br />
2008 125 No Unclear Unclear Yes Poor<br />
Chen 2008 126<br />
Claude 2008 127<br />
Baraldini 2007 128<br />
Pope 2007 12<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Yes Yes Yes Yes Good<br />
F-13
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Jalil 2006 13<br />
Kono 2006 14<br />
Garzon 2005 129<br />
McHeik 2005 130<br />
Nicolai 2005 38<br />
Waldschmidt 2005 131<br />
Vlachakis 2004 39<br />
David 2003 132<br />
Vlachakis 2003 133<br />
Batta 2002 15<br />
Akyuz 2001 40<br />
Chang 2001 41<br />
Demiri 2001 134<br />
Hohenleutner 2001 135<br />
Yes Yes Yes Yes Good<br />
Unclear Unclear Unclear Yes Poor<br />
No Unclear No No Poor<br />
No Unclear No Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Unclear Poor<br />
No Unclear Unclear Unclear Poor<br />
No Unclear No Yes Poor<br />
Yes Yes Yes Yes Good<br />
No Unclear Unclear Unclear Poor<br />
No Unclear Unclear Unclear Poor<br />
No Unclear Unclear Yes Poor<br />
Unclear Unclear Unclear No Poor<br />
F-14
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Raulin 2001 42<br />
Chen 2000 136<br />
Poetke 2000 137<br />
Blei 1999 138<br />
Boon 1999 139<br />
Zide 1997 140<br />
Gangopadhyay 1996 141<br />
Sadan 1996 142<br />
Chowdri 1994 143<br />
Morelli 1994 144<br />
Preeyanont 1994 145<br />
Morrell 1991 146<br />
Kushner 1990 147<br />
Achauer 1989 44<br />
Yes Yes Yes Yes Good<br />
No Unclear No Yes Poor<br />
No Unclear Unclear Yes Poor<br />
Partial Unclear Partial Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear No Yes Poor<br />
No Unclear Unclear Yes Poor<br />
No Unclear No No Poor<br />
No Unclear No Yes Poor<br />
No Unclear No Yes Poor<br />
Yes Yes Yes Yes Good<br />
F-15
Author, Year<br />
Were the harms<br />
predefined using<br />
st<strong>and</strong>ardized or precise<br />
definitions?<br />
Were all pre-specified<br />
harms reported?<br />
Did the author(s) use<br />
STANDARD scale(s) or<br />
checklist(s) for harms<br />
collection?<br />
Were the statistical<br />
methods used to assess<br />
the main harm or adverse<br />
event outcomes<br />
adequate?<br />
Rating<br />
Sloan 1989 148<br />
Kushner 1985 149<br />
Healy 1984 150<br />
Sharma 1983 151<br />
No Unclear No Yes Poor<br />
No Unclear No No Poor<br />
No Unclear No Yes Poor<br />
No Unclear Unclear Yes Poor<br />
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81. Semkova K, Kaz<strong>and</strong>jieva J. Topical timolol maleate for treatment <strong>of</strong> infantile haemangiomas: preliminary results <strong>of</strong> a prospective study. Clin Exp Dermatol<br />
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82. Vercellino N, Romanini MV, Pelegrini M, et al. The use <strong>of</strong> propranolol for complicated infantile hemangiomas. Int J Dermatol 2013 Sep;52(9):1140-6.<br />
PMID: 23829783.<br />
83. Xiao Q, Li Q, Zhang B, et al. Propranolol therapy <strong>of</strong> infantile hemangiomas: efficacy, adverse effects, <strong>and</strong> recurrence. Pediatr Surg Int 2013 Jun;29(6):575-<br />
81. PMID: 23519547.<br />
84. Yuan WL, Jin ZL, Wei JJ, et al. Propranolol given orally for proliferating infantile haemangiomas: analysis <strong>of</strong> efficacy <strong>and</strong> serological changes in vascular<br />
endothelial growth factor <strong>and</strong> endothelial nitric oxide synthase in 35 patients. Br J Oral Maxill<strong>of</strong>ac Surg 2013 Oct;51(7):656-61. PMID: 23291092.<br />
85. Balma-Mena A, Chakkittak<strong>and</strong>iyil A, Weinstein M, et al. Propranolol in the management <strong>of</strong> infantile hemangiomas: clinical response <strong>and</strong> predictors. J Cutan<br />
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86. Bertr<strong>and</strong> J, Sammour R, McCuaig C, et al. Propranolol in the treatment <strong>of</strong> problematic infantile hemangioma: review <strong>of</strong> 35 consecutive patients from a<br />
vascular anomalies clinic. J Cutan Med Surg 2012 Sep-Oct;16(5):317-23. PMID: 22971306.<br />
87. Celik A, Tiryaki S, Musayev A, et al. Propranolol as the first-line therapy for infantile hemangiomas: preliminary results <strong>of</strong> two centers. J Drugs Dermatol<br />
2012 Jul;11(7):808-11. PMID: 22777220.<br />
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88. Chakkittak<strong>and</strong>iyil A, Phillips R, Frieden IJ, et al. Timolol maleate 0.5% or 0.1% gel-forming solution for infantile hemangiomas: a retrospective, multicenter,<br />
cohort study. Pediatr Dermatol 2012 Jan-Feb;29(1):28-31. PMID: 22150436.<br />
89. Georgountzou A, Karavitakis E, Klimentopoulou A, et al. Propranolol treatment for severe infantile hemangiomas: a single-centre 3-year experience. Acta<br />
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90. Janmohamed SR, Madern GC, Nieuwenhuis K, et al. Evaluation <strong>of</strong> intra-lesional corticosteroids in the treatment <strong>of</strong> peri-ocular haemangioma <strong>of</strong> infancy: still<br />
an alternative besides propranolol. Pediatr Surg Int 2012 Apr;28(4):393-8. PMID: 22200732.<br />
91. Kunzi-Rapp K. Topical propranolol therapy for infantile hemangiomas. Pediatr Dermatol 2012 Mar-Apr;29(2):154-9. PMID: 22141326.<br />
92. Lv MM, Fan XD, Su LX. Propranolol for problematic head <strong>and</strong> neck hemangiomas: an analysis <strong>of</strong> 37 consecutive patients. Int J Pediatr Otorhinolaryngol<br />
2012 Apr;76(4):574-8. PMID: 22326207.<br />
93. Phillips RJ, Penington AJ, Bekhor PS, et al. Use <strong>of</strong> propranolol for treatment <strong>of</strong> infantile haemangiomas in an outpatient setting. J Paediatr Child Health 2012<br />
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94. Samimi DB, Alabiad CR, Tse DT. An anatomically based approach to intralesional corticosteroid injection for eyelid capillary hemangiomas. Ophthalmic<br />
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95. Talaat AA, Elbasiouny MS, Elgendy DS, et al. Propranolol treatment <strong>of</strong> infantile hemangioma: clinical <strong>and</strong> radiologic evaluations. J Pediatr Surg 2012<br />
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96. Wang L, Xia Y, Zhai Y, et al. Topical propranolol hydrochloride gel for superficial infantile hemangiomas. J Huazhong Univ Sci Technolog Med Sci 2012<br />
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97. Xu G, Lv R, Zhao Z, et al. Topical propranolol for treatment <strong>of</strong> superficial infantile hemangiomas. J Am Acad Dermatol 2012 Dec;67(6):1210-3. PMID:<br />
22516113.<br />
98. Zegpi-Trueba MS, Abarzua-Araya A, Silva-Valenzuela S, et al. Oral propranolol for treating infantile hemangiomas: a case series <strong>of</strong> 57 patients. Actas<br />
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99. Blatt J, Morrell DS, Buck S, et al. beta-blockers for infantile hemangiomas: a single-institution experience. Clin Pediatr (Phila) 2011 Aug;50(8):757-63.<br />
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100. Chang CJ. Long term follow-up <strong>of</strong> intralesional laser photocoagulation (ILP) for hemangioma patients. Laser Therapy 2011;20(4):255-63. PMID:<br />
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101. Cushing SL, Boucek RJ, Manning SC, et al. Initial experience with a multidisciplinary strategy for initiation <strong>of</strong> propranolol therapy for infantile<br />
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102. Daramola OO, Chun RH, Nash JJ, et al. Surgical treatment <strong>of</strong> infantile hemangioma in a multidisciplinary vascular anomalies clinic. Int J Pediatr<br />
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103. Di Maio L, Baldi A, Dimaio V, et al. Use <strong>of</strong> flashlamp-pumped pulsed dye laser in the treatment <strong>of</strong> superficial vascular malformations <strong>and</strong> ulcerated<br />
hemangiomas. In Vivo 2011 Jan-Feb;25(1):117-23. PMID: 21282744.<br />
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104. Fuchsmann C, Quintal MC, Giguere C, et al. Propranolol as first-line treatment <strong>of</strong> head <strong>and</strong> neck hemangiomas. Arch Otolaryngol Head Neck Surg 2011<br />
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105. Greene AK, Couto RA. Oral prednisolone for infantile hemangioma: efficacy <strong>and</strong> safety using a st<strong>and</strong>ardized treatment protocol. Plast Reconstr Surg 2011<br />
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106. Holmes WJ, Mishra A, Gorst C, et al. Propranolol as first-line treatment for rapidly proliferating infantile haemangiomas. J Plast Reconstr Aesthet Surg<br />
2011 Apr;64(4):445-51. PMID: 20797926.<br />
107. Kulbersh J, Hochman M. Serial excision <strong>of</strong> facial hemangiomas. Arch Facial Plast Surg 2011 May-Jun;13(3):199-202. PMID: 21576667.<br />
108. Li WY, Chaudhry O, Reinisch JF. Guide to early surgical management <strong>of</strong> lip hemangiomas based on our experience <strong>of</strong> 214 cases. Plast Reconstr Surg 2011<br />
Nov;128(5):1117-24. PMID: 21738083.<br />
109. Saint-Jean M, Leaute-Labreze C, Mazereeuw-Hautier J, et al. Propranolol for treatment <strong>of</strong> ulcerated infantile hemangiomas. J Am Acad Dermatol 2011<br />
May;64(5):827-32. PMID: 21353332.<br />
110. Schiestl C, Neuhaus K, Zoller S, et al. Efficacy <strong>and</strong> safety <strong>of</strong> propranolol as first-line treatment for infantile hemangiomas. Eur J Pediatr 2011<br />
Apr;170(4):493-501. PMID: 20936416.<br />
111. Schupp CJ, Kleber JB, Gunther P, et al. Propranolol therapy in 55 infants with infantile hemangioma: dosage, duration, adverse effects, <strong>and</strong> outcome.<br />
Pediatr Dermatol 2011 Nov-Dec;28(6):640-4. PMID: 21995836.<br />
112. Snir M, Reich U, Siegel R, et al. Refractive <strong>and</strong> structural changes in infantile periocular capillary haemangioma treated with propranolol. Eye (Lond) 2011<br />
Dec;25(12):1627-34. PMID: 21921959.<br />
113. Zaher H, Rasheed H, Hegazy RA, et al. Oral propranolol: an effective, safe treatment for infantile hemangiomas. Eur J Dermatol 2011 Jul-Aug;21(4):558-<br />
63. PMID: 21697036.<br />
114. Zvulunov A, McCuaig C, Frieden IJ, et al. Oral propranolol therapy for infantile hemangiomas beyond the proliferation phase: a multicenter retrospective<br />
study. Pediatr Dermatol 2011 Mar-Apr;28(2):94-8. PMID: 21362031.<br />
115. Arneja JS, Mulliken JB. Resection <strong>of</strong> amblyogenic periocular hemangiomas: indications <strong>and</strong> outcomes. Plast Reconstr Surg 2010 Jan;125(1):274-81. PMID:<br />
20048618.<br />
116. Hamou C, Diner PA, Dalmonte P, et al. Nasal tip haemangiomas: guidelines for an early surgical approach. J Plast Reconstr Aesthet Surg 2010<br />
Jun;63(6):934-9. PMID: 19540825.<br />
117. Li DN, Gold MH, Sun ZS, et al. Treatment <strong>of</strong> infantile hemangioma with optimal pulse technology. J Cosmet Laser Ther 2010 Jun;12(3):145-50. PMID:<br />
20482239.<br />
118. Manunza F, Syed S, Laguda B, et al. Propranolol for complicated infantile haemangiomas: a case series <strong>of</strong> 30 infants. Br J Dermatol 2010 Feb<br />
1;162(2):466-8. PMID: 20055816.<br />
119. Chen WL, Zhang B, Li JS, et al. Liquid nitrogen cryotherapy <strong>of</strong> lip mucosa hemangiomas under inhalation general anesthesia with sev<strong>of</strong>lurane in early<br />
infancy. Ann Plast Surg 2009 Feb;62(2):154-7. PMID: 19158525.<br />
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120. P<strong>and</strong>ey A, Gangopadhyay AN, Gopal SC, et al. Twenty years' experience <strong>of</strong> steroids in infantile hemangioma--a developing country's perspective. J Pediatr<br />
Surg 2009 Apr;44(4):688-94. PMID: 19361627.<br />
121. Rizzo C, Brightman L, Chapas AM, et al. Outcomes <strong>of</strong> childhood hemangiomas treated with the pulsed-dye laser with dynamic cooling: a retrospective<br />
chart analysis. Dermatol Surg 2009 Dec;35(12):1947-54. PMID: 19889007.<br />
122. Saleh KH. Steroids in complicated hemangioma. Iranian Red Crescent Medical Journal 2009;11(2):217.<br />
123. Sans V, de la Roque ED, Berge J, et al. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics 2009 Sep;124(3):e423-31. PMID:<br />
19706583.<br />
124. Wu JK, Rohde CH. Purse-string closure <strong>of</strong> hemangiomas: early results <strong>of</strong> a follow-up study. Ann Plast Surg 2009 May;62(5):581-5. PMID: 19387166.<br />
125. Chantharatanapiboon W. Intralesional corticosteroid therapy in hemangiomas: clinical outcome in 160 cases. J Med Assoc Thai 2008 Oct;91 Suppl 3:S90-6.<br />
PMID: 19253502.<br />
126. Chen W, Li J, Yang Z, et al. SMAS fold flap <strong>and</strong> ADM repair <strong>of</strong> the parotid bed following removal <strong>of</strong> parotid haemangiomas via pre- <strong>and</strong> retroauricular<br />
incisions to improve cosmetic outcome <strong>and</strong> prevent Frey's syndrome. J Plast Reconstr Aesthet Surg 2008 Aug;61(8):894-9; discussion 9-900. PMID:<br />
18504166.<br />
127. Claude O, Picard A, O'Sullivan N, et al. Use <strong>of</strong> ultrasonic dissection in the early surgical management <strong>of</strong> periorbital haemangiomas. J Plast Reconstr<br />
Aesthet Surg 2008 Dec;61(12):1479-85. PMID: 18037085.<br />
128. Baraldini V, Coletti M, Cigognetti F, et al. Haemostatic squeezing <strong>and</strong> purse-string sutures: optimising surgical techniques for early excision <strong>of</strong> critical<br />
infantile haemangiomas. J Pediatr Surg 2007 Feb;42(2):381-5. PMID: 17270553.<br />
129. Garzon MC, Lucky AW, Hawrot A, et al. Ultrapotent topical corticosteroid treatment <strong>of</strong> hemangiomas <strong>of</strong> infancy. J Am Acad Dermatol 2005<br />
Feb;52(2):281-6. PMID: 15692474.<br />
130. McHeik JN, Renauld V, Duport G, et al. Surgical treatment <strong>of</strong> haemangioma in infants. Br J Plast Surg 2005 Dec;58(8):1067-72. PMID: 16039624.<br />
131. Waldschmidt J, Giest H, Meyer L. Endoscopic laser application in 56 children with hemangiomas <strong>of</strong> the larynx <strong>and</strong> trachea. Med Laser Appl 2005 08<br />
Dec;20(4):297-302. PMID: 2005531370.<br />
132. David LR, Malek MM, Argenta LC. Efficacy <strong>of</strong> pulse dye laser therapy for the treatment <strong>of</strong> ulcerated haemangiomas: a review <strong>of</strong> 78 patients. Br J Plast<br />
Surg 2003 Jun;56(4):317-27. PMID: 12873458.<br />
133. Vlachakis I, Gardikis S, Michailoudi E, et al. Treatment <strong>of</strong> hemangiomas in children using a Nd:YAG laser in conjunction with ice cooling <strong>of</strong> the epidermis:<br />
techniques <strong>and</strong> results. BMC Pediatr 2003 Apr 12;3:2. PMID: 12697072.<br />
134. Demiri EC, Pelissier P, Genin-Etcheberry T, et al. Treatment <strong>of</strong> facial haemangiomas: the present status <strong>of</strong> surgery. Br J Plast Surg 2001 Dec;54(8):665-74.<br />
PMID: 11728108.<br />
135. Hohenleutner S, Badur-Ganter E, L<strong>and</strong>thaler M, et al. Long-term results in the treatment <strong>of</strong> childhood hemangioma with the flashlamp-pumped pulsed dye<br />
laser: an evaluation <strong>of</strong> 617 cases. Lasers Surg Med 2001;28(3):273-7. PMID: 11295764.<br />
136. Chen MT, Yeong EK, Horng SY. Intralesional corticosteroid therapy in proliferating head <strong>and</strong> neck hemangiomas: a review <strong>of</strong> 155 cases. J Pediatr Surg<br />
2000 Mar;35(3):420-3. PMID: 10726680.<br />
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137. Poetke M, Philipp C, Berlien HP. Flashlamp-pumped pulsed dye laser for hemangiomas in infancy: treatment <strong>of</strong> superficial vs mixed hemangiomas. Arch<br />
Dermatol 2000 May;136(5):628-32. PMID: 10815856.<br />
138. Blei F, & Chianese, J. Corticosteroid toxicity in infants treated for endangering hemangiomas: experience <strong>and</strong> guidelines for monitoring. International<br />
Pediatrics 1999;14:146-53.<br />
139. Boon LM, MacDonald DM, Mulliken JB. Complications <strong>of</strong> systemic corticosteroid therapy for problematic hemangioma. Plast Reconstr Surg 1999<br />
Nov;104(6):1616-23. PMID: 10541160.<br />
140. Zide BM, Glat PM, Stile FL, et al. Vascular lip enlargement: Part I. <strong>Hemangioma</strong>s--tenets <strong>of</strong> therapy. Plast Reconstr Surg 1997 Dec;100(7):1664-73. PMID:<br />
9393462.<br />
141. Gangopadhyay AN, Sharma SP, Gopal SC, et al. Local steroid therapy in cutaneous hemangiomas. Indian Pediatr 1996 Jan;33(1):31-3. PMID: 8772948.<br />
142. Sadan N, Wolach B. Treatment <strong>of</strong> hemangiomas <strong>of</strong> infants with high doses <strong>of</strong> prednisone. J Pediatr 1996 Jan;128(1):141-6. PMID: 8551406.<br />
143. Chowdri NA, Darzi MA, Fazili Z, et al. Intralesional corticosteroid therapy for childhood cutaneous hemangiomas. Ann Plast Surg 1994 Jul;33(1):46-51.<br />
PMID: 7944196.<br />
144. Morelli JG, Tan OT, Yohn JJ, et al. Treatment <strong>of</strong> ulcerated hemangiomas infancy. Arch Pediatr Adolesc Med 1994 Oct;148(10):1104-5. PMID: 7921107.<br />
145. Preeyanont P, Nimsakul N. The Nd:YAG laser treatment <strong>of</strong> hemangioma. J Clin Laser Med Surg 1994 Aug;12(4):225-9. PMID: 10147482.<br />
146. Morrell AJ, Willshaw HE. Normalisation <strong>of</strong> refractive error after steroid injection for adnexal haemangiomas. Br J Ophthalmol 1991 May;75(5):301-5.<br />
PMID: 2036349.<br />
147. Kushner BJ. <strong>Infantile</strong> orbital hemangiomas. International Pediatrics 1990;5(3):249-57.<br />
148. Sloan GM, Reinisch JF, Nichter LS, et al. Intralesional corticosteroid therapy for infantile hemangiomas. Plast Reconstr Surg 1989 Mar;83(3):459-67.<br />
PMID: 2919200.<br />
149. Kushner BJ. The treatment <strong>of</strong> periorbital infantile hemangioma with intralesional corticosteroid. Plast Reconstr Surg 1985 Oct;76(4):517-26. PMID:<br />
4034770.<br />
150. Healy G, McGill T, Friedman EM. Carbon dioxide laser in subglottic hemangioma. An update. Ann Otol Rhinol Laryngol 1984 Jul-Aug;93(4 Pt 1):370-3.<br />
PMID: 6431866.<br />
151. Sharma LK, Dalal SS. Corticosteroid therapy in the treatment <strong>of</strong> cutaneous hemangioma <strong>of</strong> infancy <strong>and</strong> childhood. Indian J Pediatr 1983 Mar-<br />
Apr;50(403):153-6. PMID: 6618575.<br />
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Appendix G. Applicability Tables<br />
Table G-1. Applicability <strong>of</strong> studies assessing imaging modalities<br />
Domain Description <strong>of</strong> applicability <strong>of</strong> evidence<br />
Population<br />
Intervention<br />
Comparator<br />
s<br />
Outcomes<br />
Setting<br />
Infants with hemangiomas (with mean ages <strong>of</strong> 30 days <strong>and</strong> 34 weeks). Fair distribution <strong>of</strong> male<br />
<strong>and</strong> female patients.<br />
Radiologic evaluation <strong>of</strong> hepatic hemangioma to determine which lesions required intervention <strong>and</strong><br />
radiologic evaluation <strong>of</strong> lumbosacral cutaneous hemangiomas to evaluate which were associated<br />
with occult spinal dysraphism<br />
Comparators included ultrasound, magnetic resonance imaging, computed tomography <strong>and</strong><br />
angiography. If different modalities were utilized on the same patient, it was sometimes not at the<br />
same time point making comparison between methods difficult.<br />
Studies assessed imaging <strong>and</strong> clinical findings <strong>and</strong> with need for intervention for hepatic<br />
hemangiomas <strong>and</strong> the second study reviewed incidence <strong>of</strong> occult spinal dysraphism found in<br />
patients with lumbosacral hemangioma<br />
Studies were conducted in the US, Canada <strong>and</strong> Spain at tertiary care centers with referral<br />
programs for hemangiomas / vascular malformations<br />
Table G-2. Applicability <strong>of</strong> studies assessing steroids<br />
Domain Description <strong>of</strong> applicability <strong>of</strong> evidence<br />
Population<br />
Intervention<br />
Comparator<br />
s<br />
Outcomes<br />
Setting<br />
IH-infantile hemangioma<br />
Infants <strong>and</strong> children with IH (ages ranging from less than one to 72 months). Typically more<br />
females.<br />
Corticosteroids including topical, intralesional, intravenous, <strong>and</strong> oral forms.<br />
Comparators included another steroid or observation.<br />
Studies generally assessed change in lesion size <strong>and</strong>/or appearance <strong>and</strong> rebound growth. Two<br />
studies assessed vision outcomes. Comparative studies <strong>and</strong> case series also reported harms.<br />
One comparative study was conducted in Canada <strong>and</strong> the others in the Netherl<strong>and</strong>s, Germany,<br />
Turkey, Pakistan, <strong>and</strong> India. Applicability <strong>of</strong> some findings may be limited given differences in the<br />
systems <strong>of</strong> care in lower resource countries. Several comparative studies were also published<br />
between 2001 <strong>and</strong> 2010 <strong>and</strong> may not reflect current st<strong>and</strong>ards <strong>of</strong> care.<br />
Table G-3. Applicability <strong>of</strong> studies assessing beta-blockers<br />
Domain Description <strong>of</strong> applicability <strong>of</strong> evidence<br />
Population Studies typically included infants <strong>of</strong> both sexes ages 1 to 12 months <strong>of</strong> age (range: 1 month to 9<br />
years <strong>of</strong> age) with infantile hemangiomas which included superficial, deep, <strong>and</strong> mixed lesions<br />
primarily involving the head <strong>and</strong> neck <strong>and</strong> occurring as focal or segmental lesions.<br />
Intervention Patients were treated with a variety <strong>of</strong> beta-blockers including propranolol at various doses <strong>and</strong><br />
administrations (oral, intralesional, or topical), timolol (topical), atenolol (oral), or nadolol (oral) for a<br />
variety <strong>of</strong> treatment durations most commonly up to 6 months duration.<br />
Comparator<br />
s<br />
Outcomes<br />
Setting<br />
Comparators included other formulations <strong>of</strong> the same beta-blocker, other beta-blockers, untreated<br />
historical controls, treated historical controls, <strong>and</strong> non-beta-blocker comparators (topical imiquimod,<br />
oral <strong>and</strong> intralesional steroids, laser, <strong>and</strong> intralesional bleomycin).<br />
Studies commonly assessed final response based on size, volume, <strong>and</strong>/or coloration <strong>of</strong> IH,<br />
resolution <strong>of</strong> ulceration if present at initiation <strong>of</strong> therapy, <strong>and</strong> visual acuity or resolution <strong>of</strong> ptosis for<br />
periocular lesions. Assessments were obtained throughout therapy but final outcome assessments<br />
were typically performed following 24 weeks <strong>of</strong> treatment. Additional assessments for serious<br />
harms including bronchial hyperreactivity, hypoglycemia, bradycardia, <strong>and</strong> hypotension <strong>and</strong> less<br />
severe harms including sleep disturbances, cold extremities, <strong>and</strong> gastrointestinal complaints were<br />
monitored in the majority <strong>of</strong> studies.<br />
Studies were conducted globally, <strong>of</strong>ten in speciality referral centers.<br />
G-1
IH-infantile hemangioma<br />
Table G-4. Applicability <strong>of</strong> studies assessing surgical <strong>and</strong> laser studies<br />
Domain Description <strong>of</strong> applicability <strong>of</strong> evidence<br />
Population Studies typically included infants <strong>of</strong> both sexes, with preponderance <strong>of</strong> females ages 1 week to 43<br />
years <strong>of</strong> age with superficial <strong>and</strong> cutaneous infantile hemangiomas in varied locations.<br />
Intervention<br />
Comparator<br />
s<br />
Outcomes<br />
Setting<br />
IH-infantile hemangioma<br />
Patients were treated with a variety <strong>of</strong> lasers including pulse dyed, Nd:YAG, argon, cryotherapy,<br />
<strong>and</strong> intense pulsed light photothermolysis; in most cases, lasers were used as first-line treatment,<br />
which is not general, current clinical practice. Some studies used laser in combination with a betablocker<br />
like timolol or propranolol or combined laser modalities.<br />
Comparators included other lasers, different pulse lengths, different cooling regimens, <strong>and</strong><br />
observation.<br />
Studies commonly assessed final response based on size, volume, <strong>and</strong>/or coloration <strong>of</strong> IH. Harms<br />
associated with laser treatment included skin atrophy, bleeding, scarring, ulceration <strong>and</strong> pigment<br />
changes.<br />
Studies were conducted in the United States, United Kingdom, Netherl<strong>and</strong>s, Germany, Greece,<br />
Japan <strong>and</strong> Singapore, typically in referral centers.<br />
G-2
Appendix H. Harms Reported in Package Insert Data <strong>and</strong> Other Sources<br />
<strong>Infantile</strong> <strong>Hemangioma</strong> Package Insert <strong>and</strong> FDA Harms Data<br />
The harms data provided in this section were gathered from analyzing available gray literature (i.e., package inserts <strong>and</strong> FDA<br />
review packages). FDA approval packages were limited to those available on the FDA website that contained a “Medical Review”<br />
section <strong>of</strong> the document. Many <strong>of</strong> the review packages did not contain pediatric data <strong>and</strong> therefore the adult data was used. Table 1<br />
includes the relevant indications for pediatric medications referenced in the clinical studies included in this review. Medications that<br />
have not been approved as safe <strong>and</strong> effective in pediatric patients <strong>and</strong> therefore are only FDA approved in adults are referenced in<br />
Table 2. Notable contraindications <strong>and</strong> warnings/precautions that would be relevant to consider in the pediatric population were<br />
included in the tables (drug interactions were not included). As a result, the data provided in this chart is not an all-inclusive list <strong>of</strong><br />
these package insert sections. For complete data please see the corresponding package insert.<br />
Table H-1: FDA Approved Pediatric Medications Included in Literature Review<br />
Drug<br />
Dosage<br />
Form<br />
FDA Approved Indication Contraindications Warnings/ Precautions<br />
Hemangeol<br />
®<br />
(propranolol<br />
hydrochlorid<br />
e) 1<br />
Oral<br />
solution<br />
Beta-adrenergic blocker<br />
indicated for the treatment<br />
<strong>of</strong> proliferating infantile<br />
hemangioma requiring<br />
systemic therapy<br />
• Premature infants with<br />
corrected age
Orapred<br />
ODT<br />
(prednisolon<br />
e sodium<br />
phosphate) 3<br />
Rayos®<br />
(prednisone)<br />
4<br />
ODT tablet<br />
Delayed<br />
release<br />
tablet<br />
conventional treatment in<br />
adults <strong>and</strong> pediatric<br />
populations with:<br />
o Atopic dermatitis<br />
o Drug hypersensitivity<br />
reactions<br />
o Seasonal or perennial<br />
allergic rhinitis<br />
o Serum sickness<br />
• Dermatologic Diseases<br />
o Bullous dermatitis<br />
herpetiformis<br />
o Contact dermatitis<br />
o Exfoliative<br />
erythroderma<br />
o Mycosis fungoides<br />
o Pemphigus<br />
o Severe erythema<br />
multiforme (Stevens-<br />
Johnson syndrome)<br />
• Endocrine Conditions<br />
o Congenital adrenal<br />
hyperplasia<br />
o Hypercalcemia <strong>of</strong><br />
malignancy<br />
o Nonsuppurative<br />
thyroiditis<br />
o Primary or secondary<br />
adrenocortical<br />
insufficiency:<br />
hydrocortisone or<br />
cortisone is the first<br />
choice: synthetic<br />
analogs may be used<br />
in conjunction with<br />
mineralocorticoids<br />
where applicable<br />
• Gastrointestinal Diseases:<br />
During acute episodes in:<br />
o Crohn's Disease<br />
o Ulcerative colitis<br />
• Hematologic Diseases<br />
• Infections: Increased susceptibility to new infection <strong>and</strong> increased<br />
risk <strong>of</strong> exacerbation, dissemination, or reactivation <strong>of</strong> latent<br />
infection. Signs <strong>and</strong> symptoms <strong>of</strong> infection may be masked<br />
• Elevated blood pressure, salt <strong>and</strong> water retention <strong>and</strong> hypokalemia:<br />
Monitor blood pressure <strong>and</strong> sodium, potassium serum levels<br />
• GI perforation: increased risk in patients with certain GI disorders.<br />
Signs <strong>and</strong> symptoms may be masked<br />
• Behavioral <strong>and</strong> mood disturbances: May Include euphoria,<br />
insomnia, mood swings, personality changes, severe depression,<br />
<strong>and</strong> psychosis. Existing conditions may be aggravated.<br />
• Decreases in bone density: Monitor bone density in patients<br />
receiving long-term corticosteroid therapy.<br />
• Ophthalmic effects: May include cataracts, infections <strong>and</strong><br />
glaucoma. Monitor intraocular pressure if corticosteroid therapy is<br />
continued for more than 6 weeks.<br />
• Live or live attenuated vaccines: Do not administer to patients<br />
receiving immunosuppressive doses <strong>of</strong> corticosteroids.<br />
• Negative effects on growth <strong>and</strong> development: Monitor pediatric<br />
patients on long-term corticosteroid therapy.<br />
• Kaposi's sarcoma has been reported to occur in patients receiving<br />
corticosteroid therapy, most <strong>of</strong>ten for chronic conditions.<br />
Discontinuation <strong>of</strong> corticosteroids may result in clinical<br />
improvement.<br />
• Although controlled clinical trials have shown corticosteroids to be<br />
effective in speeding the resolution <strong>of</strong> acute exacerbations <strong>of</strong><br />
multiple sclerosis, they do not show that corticosteroids affect the<br />
ultimate outcome or natural history <strong>of</strong> the disease. The studies do<br />
show that relatively high doses <strong>of</strong> corticosteroids are necessary to<br />
demonstrate a significant effect.<br />
• An acute myopathy has been observed with the use <strong>of</strong> high doses<br />
<strong>of</strong> corticosteroids, most <strong>of</strong>ten occurring in patients with disorders <strong>of</strong><br />
neuromuscular transmission (e.g., myasthenia gravis), or in<br />
patients receiving concomitant therapy with neuromuscular<br />
blocking drugs (e.g., pancuronium). This acute myopathy is<br />
generalized, may involve ocular <strong>and</strong> respiratory muscles, <strong>and</strong> may<br />
result in quadriparesis. Elevation <strong>of</strong> creatinine kinase may occur.<br />
Clinical improvement or recovery after stopping corticosteroids may<br />
require weeks to years.<br />
H-2
o Acquired<br />
(autoimmune)<br />
hemolytic anemia<br />
o Diamond-Blackfan<br />
anemia<br />
o Pure red cell aplasia<br />
• Neoplastic Conditions:<br />
o Acute leukemia<br />
o Aggressive<br />
lymphomas<br />
• Nervous System<br />
Conditions<br />
o Acute exacerbations <strong>of</strong><br />
multiple sclerosis<br />
o Cerebral edema<br />
associated with<br />
primary or metastatic<br />
brain tumor,<br />
craniotomy or head<br />
injury<br />
• Ophthalmic Conditions<br />
o Sympathetic<br />
ophthalmia<br />
o Uveitis <strong>and</strong> ocular<br />
inflammatory<br />
conditions<br />
unresponsive to<br />
topical steroids<br />
• Conditions Related to<br />
Organ Transplantation<br />
o Acute or chronic solid<br />
organ rejection<br />
• Pulmonary Diseases<br />
o Allergic<br />
bronchopulmonary<br />
aspergillosis<br />
o Aspiration pneumonitis<br />
o Asthma<br />
o Fulminating or<br />
disseminated<br />
pulmonary<br />
tuberculosis when<br />
used concurrently with<br />
H-3
appropriate<br />
chemotherapy<br />
o Hypersensitivity<br />
pneumonitis<br />
o Idiopathic bronchiolitis<br />
obliterans with<br />
organizing pneumonia<br />
o Idiopathic eosinophilic<br />
pneumonias<br />
o Idiopathic pulmonary<br />
fibrosis<br />
o Pneumocystis carinii<br />
pneumonia (PCP)<br />
associated with<br />
hypoxemia occurring<br />
in an HIV(+) individual<br />
who is also under<br />
treatment with<br />
appropriate anti-PCP<br />
antibiotics.<br />
o Symptomatic<br />
sarcoidosis<br />
• Renal Conditions<br />
o To induce a diuresis or<br />
remission <strong>of</strong><br />
proteinuria in nephrotic<br />
syndrome, without<br />
uremia, <strong>of</strong> the<br />
idiopathic type or that<br />
due to lupus<br />
erythematosus<br />
• Rheumatologic<br />
Conditions: As<br />
adjunctive therapy for<br />
short-term administration<br />
(to tide the patient over<br />
an acute episode or<br />
exacerbation) in:<br />
o Acute gouty arthritis<br />
• During an exacerbation<br />
or as maintenance<br />
therapy in selected<br />
cases <strong>of</strong>:<br />
H-4
o Ankylosing spondylitis<br />
o Dermatomyositis/poly<br />
myositis<br />
o Polymyalgia<br />
rheumatica<br />
o Psoriatic arthritis<br />
o Relapsing<br />
polychondritis<br />
o Rheumatoid arthritis,<br />
including juvenile<br />
rheumatoid arthritis<br />
(selected cases may<br />
require low dose<br />
maintenance therapy)<br />
o Systemic lupus<br />
erythematosus<br />
o Vasculitis<br />
• Specific Infectious<br />
Diseases<br />
o Trichinosis with<br />
neurologic or<br />
myocardial<br />
involvement.<br />
o Tuberculous<br />
meningitis with<br />
subarachnoid block or<br />
impending block used<br />
concurrently with<br />
appropriate<br />
antituberculous<br />
chemotherapy.<br />
Medrol®<br />
(methylpred<br />
nisolone) 5<br />
Depo-<br />
Medrol®<br />
(methylpred<br />
nisolone<br />
acetate) 6<br />
Oral tablet<br />
Intramuscul<br />
ar injection<br />
• Similar Indications as<br />
listed in the prednisolone<br />
row with the following<br />
additional:<br />
o Acute <strong>and</strong> subacute<br />
bursitis<br />
o Synovitis <strong>of</strong><br />
osteoarthritis<br />
o Acute nonspecific<br />
tenosynovitis<br />
• Systemic fungal<br />
infections<br />
• Injectable<br />
formulation: NOT<br />
FOR USE IN<br />
NEWBORNS<br />
Similar Warnings/Precautions the prednisolone with the following<br />
additional:<br />
• In patients on corticosteroid therapy subjected to unusual stress,<br />
increased dosage <strong>of</strong> rapidly acting corticosteroids before, during,<br />
<strong>and</strong> after the stressful situation is indicated.<br />
• The use <strong>of</strong> methylprednisolone tablets in active tuberculosis should<br />
be restricted to those cases <strong>of</strong> fulminating or disseminated<br />
tuberculosis in which the corticosteroid is used for the management<br />
<strong>of</strong> the disease in conjunction with an appropriate antituberculous<br />
regimen.<br />
H-5
Solu-<br />
Medrol®<br />
(methylpred<br />
nisolone<br />
sodium<br />
succinate) 7<br />
Intravenou<br />
s or<br />
intramuscul<br />
ar injection<br />
o Post-traumatic<br />
osteoarthritis<br />
o Epicondylitis<br />
o Severe seborrheic<br />
dermatitis<br />
o Severe psoriasis<br />
o Allergic corneal<br />
marginal ulcers<br />
o Herpes zoster<br />
ophthalmicus<br />
o Loeffler's syndrome<br />
not manageable by<br />
other means<br />
o Erythroblastopenia<br />
• Not indicated for:<br />
o Crohn’s Disease<br />
o Transfusion reactions<br />
o Pure red cell aplasia<br />
o Vasculitis<br />
o Allergic<br />
bronchopulmonary<br />
aspergillosis<br />
o Aspiration pneumonitis<br />
o Hypersensitivity<br />
pneumonitis<br />
o Idiopathic bronchiolitis<br />
obliterans with<br />
organizing pneumonia<br />
o Idiopathic pulmonary<br />
fibrosis<br />
o Pneumocystis carinii<br />
pneumonia (PCP)<br />
associated with<br />
hypoxemia occurring<br />
in an HIV(+) individual<br />
who is also under<br />
treatment with<br />
appropriate anti-PCP<br />
antibiotics.<br />
o Polymyalgia<br />
rheumatica<br />
o Relapsing<br />
polychondritis<br />
• If corticosteroids are indicated in patients with latent tuberculosis or<br />
tuberculin reactivity, close observation is necessary as reactivation<br />
<strong>of</strong> the disease may occur. During prolonged corticosteroid therapy,<br />
these patients should receive chemoprophylaxis.<br />
• Persons who are on drugs which suppress the immune system are<br />
more susceptible to infections than healthy individuals. Druginduced<br />
secondary adrenocortical insufficiency may be minimized<br />
by gradual reduction <strong>of</strong> dosage. This type <strong>of</strong> relative insufficiency<br />
may persist for months after discontinuation <strong>of</strong> therapy; therefore,<br />
in any situation <strong>of</strong> stress occurring during that period, hormone<br />
therapy should be reinstituted. Since mineralocorticoid secretion<br />
may be impaired, salt <strong>and</strong>/or a mineralocorticoid should be<br />
administered concurrently.<br />
• There is an enhanced effect <strong>of</strong> corticosteroids on patients with<br />
hypothyroidism <strong>and</strong> in those with cirrhosis.<br />
• Corticosteroids should be used cautiously in patients with ocular<br />
herpes simplex because <strong>of</strong> possible corneal perforation.<br />
• The lowest possible dose <strong>of</strong> corticosteroid should be used to<br />
control the condition under treatment, <strong>and</strong> when reduction in<br />
dosage is possiathyble, the reduction should be gradual.<br />
• Steroids should be used with caution in nonspecific ulcerative<br />
colitis, if there is a probability <strong>of</strong> impending perforation, abscess or<br />
other pyogenic infection; diverticulitis; fresh intestinal anastomoses;<br />
active or latent peptic ulcer; renal insufficiency; hypertension;<br />
osteoporosis; <strong>and</strong> myasthenia gravis.<br />
• Since complications <strong>of</strong> treatment with glucocorticoids are<br />
dependent on the size <strong>of</strong> the dose <strong>and</strong> the duration <strong>of</strong> treatment, a<br />
risk/benefit decision must be made in each individual case as to<br />
dose <strong>and</strong> duration <strong>of</strong> treatment <strong>and</strong> as to whether daily or<br />
intermittent therapy should be used.<br />
Injection Specific:<br />
• This product contains benzyl alcohol. Benzyl alcohol has been<br />
associated with a fatal “Gasping Syndrome” in premature infants<br />
<strong>and</strong> infants <strong>of</strong> low birth weight. Exposure to excessive amounts <strong>of</strong><br />
benzyl alcohol has been associated with toxicity (hypotension,<br />
metabolic acidosis), particularly in neonates, <strong>and</strong> an increased<br />
incidence <strong>of</strong> kernicterus, particularly in small preterm infants. There<br />
have been rare reports <strong>of</strong> deaths, primarily in preterm infants,<br />
associated with exposure to excessive amounts <strong>of</strong> benzyl alcohol.<br />
• Rare instances <strong>of</strong> anaphylactoid reactions have occurred in<br />
patients receiving corticosteroid therapy<br />
H-6
H-7<br />
• Increased dosage <strong>of</strong> rapidly acting corticosteroids is indicated in<br />
patients on corticosteroid therapy subjected to any unusual stress<br />
before, during, <strong>and</strong> after the stressful situation.<br />
• Literature reports suggest an apparent association between use <strong>of</strong><br />
corticosteroids <strong>and</strong> left ventricular free wall rupture after a recent<br />
myocardial infarction; therefore, therapy with corticosteroids should<br />
be used with great caution in these patients.<br />
• Metabolic clearance <strong>of</strong> corticosteroids is decreased in hypothyroid<br />
patients <strong>and</strong> increased in hyperthyroid patients. Changes in thyroid<br />
status <strong>of</strong> the patient may necessitate adjustment in dosage.<br />
• Fungal Infections: Corticosteroids may exacerbate systemic fungal<br />
infections <strong>and</strong> therefore should not be used in the presence <strong>of</strong> such<br />
infections unless they are needed to control drug reactions.<br />
Corticosteroids should not be used in cerebral malaria.<br />
• Latent disease may be activated or there may be an exacerbation<br />
<strong>of</strong> intercurrent infections due to pathogens, including those caused<br />
by Amoeba, C<strong>and</strong>ida, Cryptococcus, Mycobacterium, Nocardia,<br />
Pneumocystis, <strong>and</strong> Toxoplasma.<br />
• Tuberculosis: If corticosteroids are indicated in patients with latent<br />
tuberculosis or tuberculin reactivity, close observation is necessary<br />
as reactivation <strong>of</strong> the disease may occur. During prolonged<br />
corticosteroid therapy, these patients should receive<br />
chemoprophylaxis.<br />
• Viral Infections: Chicken pox <strong>and</strong> measles can have a more serious<br />
or even fatal course in pediatric <strong>and</strong> adult patients on<br />
corticosteroids<br />
• This product, like many other steroid formulations, is sensitive to<br />
heat. Therefore, it should not be autoclaved when it is desirable to<br />
sterilize the exterior <strong>of</strong> the vial.<br />
• The lowest possible dose <strong>of</strong> corticosteroid should be used to<br />
control the condition under treatment. When reduction in dosage is<br />
possible, the reduction must be gradual.<br />
• Cardio-renal: As sodium retention with resultant edema <strong>and</strong><br />
potassium loss may occur in patients receiving corticosteroids,<br />
these agents should be used with caution in patients with<br />
congestive heart failure, hypertension, or renal insufficiency.<br />
• Endocrine: Drug-induced secondary adrenocortical insufficiency<br />
may be minimized by gradual reduction <strong>of</strong> dosage.<br />
• Although controlled clinical trials have shown corticosteroids to be<br />
effective in speeding the resolution <strong>of</strong> acute exacerbations <strong>of</strong><br />
multiple sclerosis, they do not show that they affect the ultimate<br />
outcome or natural history <strong>of</strong> the disease.
• An acute myopathy has been observed with the use <strong>of</strong> high doses<br />
<strong>of</strong> corticosteroids, most <strong>of</strong>ten occurring in patients with disorders <strong>of</strong><br />
neuromuscular transmission (e.g., myasthenia gravis), or in<br />
patients receiving concomitant therapy with neuromuscular<br />
blocking drugs (e.g., pancuronium).<br />
• Corticosteroids may suppress reactions to skin tests.<br />
• Vaccines: Patients on prolonged corticosteroid therapy may exhibit<br />
a diminished response to toxoids <strong>and</strong> live or inactivated vaccines<br />
due to inhibition <strong>of</strong> antibody response. Corticosteroids may also<br />
potentiate the replication <strong>of</strong> some organisms contained in live<br />
attenuated vaccines. Routine administration <strong>of</strong> vaccines or toxoids<br />
should be deferred until corticosteroid therapy is discontinued if<br />
possible<br />
Aristospan®<br />
(triamcinolon<br />
e<br />
hexacetonid<br />
e) 8<br />
Kenalog-<br />
10®<br />
(triamcinolon<br />
e<br />
acetonide) 9<br />
Intralesiona<br />
l injection<br />
The intralesional<br />
administration <strong>of</strong><br />
triamcinolone hexacetonide<br />
injectable suspension is<br />
indicated for:<br />
• alopecia areata<br />
• discoid lupus<br />
erythematosus<br />
• keloids<br />
• localized hypertrophic<br />
• infiltrated<br />
• inflammatory lesions <strong>of</strong><br />
granuloma annulare<br />
• lichen planus<br />
• lichen simplex chronicus<br />
(neurodermatitis)<br />
• psoriatic plaques<br />
• necrobiosis lipoidica<br />
diabeticorum<br />
• cystic tumors <strong>of</strong> an<br />
aponeurosis or tendon<br />
(ganglia)<br />
NOT FOR USE IN<br />
NEWBORNS<br />
Similar Warnings/Precautions the prednisolone with injection specific<br />
warnings in the methylprednisolone row.<br />
Celestone<br />
Soluspan®<br />
(betamethas<br />
one) 10<br />
Intralesiona<br />
l injection<br />
Intralesional injection has<br />
similar indications as listed<br />
in the triamcinolone row.<br />
NOT FOR USE IN<br />
NEWBORNS<br />
Similar Warnings/Precautions the prednisolone with injection specific<br />
warnings in the methylprednisolone row.<br />
H-8
Elocon®<br />
(mometason<br />
e furoate) 11<br />
Topical<br />
cream<br />
Corticosteroid indicated for<br />
the relief <strong>of</strong> the inflammatory<br />
<strong>and</strong> pruritic manifestations<br />
<strong>of</strong> corticosteroid-responsive<br />
dermatoses in patients 2<br />
years <strong>of</strong> age or older<br />
--- • Reversible HPA axis suppression with the potential for<br />
glucocorticosteroid insufficiency after withdrawal <strong>of</strong> treatment,<br />
Cushing's syndrome, <strong>and</strong> hyperglycemia may occur due to<br />
systemic absorption. Patients applying a topical steroid to a large<br />
surface area or to areas under occlusion should be evaluated<br />
periodically for evidence <strong>of</strong> HPA axis suppression. Modify use<br />
should HPA axis suppression develop.<br />
• Pediatric patients may be more susceptible to systemic toxicity.<br />
• Allergic Contact Dermatitis: If irritation develops, mometasone<br />
furoate should be discontinued <strong>and</strong> appropriate therapy instituted.<br />
• Concomitant Skin Infections: If concomitant skin infections are<br />
present or develop, an appropriate antifungal or antibacterial agent<br />
should be used. If a favorable response does not occur promptly,<br />
mometasone furoate use <strong>of</strong> should be discontinued until the<br />
infection has been adequately controlled.<br />
Zyclara®<br />
(imiquimod) 1<br />
2<br />
Aldara®<br />
(imiquimod) 1<br />
3<br />
2.5% to<br />
3.75%<br />
Topical<br />
cream<br />
5% Topical<br />
cream<br />
Indicated for the treatment<br />
<strong>of</strong> external genital <strong>and</strong><br />
perianal warts<br />
(EGW)/condyloma<br />
acuminata in patients 12<br />
years or older.<br />
--- • Local Skin Reactions: Intense local skin reactions including skin<br />
weeping or erosion can occur after a few applications <strong>and</strong> may<br />
require an interruption <strong>of</strong> dosing. Imiquimod has the potential to<br />
exacerbate inflammatory conditions <strong>of</strong> the skin, including chronic<br />
graft versus host disease.<br />
Severe local inflammatory reactions <strong>of</strong> the female external genitalia<br />
can lead to severe vulvar swelling. Severe vulvar swelling can lead<br />
to urinary retention. Dosing should be interrupted or discontinued<br />
for severe vulvar swelling.<br />
Administration <strong>of</strong> imiquimod is not recommended until the skin is<br />
healed from any previous drug or surgical treatment.<br />
• Systemic Reactions Flu-like signs <strong>and</strong> symptoms may accompany,<br />
or even precede, local skin reactions <strong>and</strong> may include fatigue,<br />
nausea, fever, myalgias, arthralgias, malaise <strong>and</strong> chills.<br />
• Ultraviolet Light Exposure Risks: Exposure to sunlight (including<br />
sunlamps) should be avoided or minimized during use <strong>of</strong><br />
imiquimod.<br />
• Increased Risk <strong>of</strong> Adverse Reactions with Concomitant Imiquimod<br />
Use<br />
• Immune Cell Activation in Autoimmune Disease: Imiquimod should<br />
be used with caution in patients with pre-existing autoimmune<br />
conditions because imiquimod activates immune cells<br />
H-9
Table H-2: FDA Approved Adult Medications (Prescribed Off-Label in Pediatric Patients) Included in Literature Review<br />
Drug<br />
Dosage<br />
Form<br />
FDA Approved Indication Contraindications Warnings/ Precautions<br />
Tenormin®<br />
(atenolol) 14<br />
Oral tablet<br />
• Treatment <strong>of</strong><br />
hypertension, to lower<br />
blood pressure<br />
• Long-term management<br />
<strong>of</strong> patients with angina<br />
pectoris.<br />
• <strong>Management</strong> <strong>of</strong><br />
hemodynamically stable<br />
patients with definite or<br />
suspected acute<br />
myocardial infarction to<br />
reduce cardiovascular<br />
mortality<br />
• Sinus bradycardia<br />
• Heart block greater<br />
than first degree<br />
• Cardiogenic shock<br />
• Overt cardiac failure<br />
• Cardiac Failure: Sympathetic stimulation is necessary in supporting<br />
circulatory function in congestive heart failure, <strong>and</strong> beta blockade<br />
carries the potential hazard <strong>of</strong> further depressing myocardial<br />
contractility <strong>and</strong> precipitating more severe failure.<br />
• In Patients Without a History <strong>of</strong> Cardiac Failure: Continued<br />
depression <strong>of</strong> the myocardium with beta-blocking agents over a<br />
period <strong>of</strong> time can, in some cases, lead to cardiac failure<br />
• Cessation <strong>of</strong> Therapy with Atenolol: Patients with coronary artery<br />
disease, who are being treated with atenolol, should be advised<br />
against abrupt discontinuation <strong>of</strong> therapy.<br />
• Concomitant Use <strong>of</strong> Calcium Channel Blockers: Bradycardia <strong>and</strong><br />
heart block can occur <strong>and</strong> the left ventricular end diastolic pressure<br />
can rise when beta-blockers are administered with verapamil or<br />
diltiazem. Patients with pre-existing conduction abnormalities or left<br />
ventricular dysfunction are particularly susceptible.<br />
• Bronchospastic Diseases: Patients with bronchospastic disease<br />
should, in general, not receive beta blockers. Because <strong>of</strong> its relative<br />
beta1 selectivity, however, atenolol may be used with caution in<br />
patients with bronchospastic disease who do not respond to, or<br />
cannot tolerate, other antihypertensive treatment.<br />
• Major Surgery: Chronically administered beta-blocking therapy<br />
should not be routinely withdrawn prior to major surgery, however<br />
the impaired ability <strong>of</strong> the heart to respond to reflex adrenergic<br />
stimuli may augment the risks <strong>of</strong> general anesthesia <strong>and</strong> surgical<br />
procedures.<br />
• Diabetes <strong>and</strong> Hypoglycemia: atenolol should be used with caution<br />
in diabetic patients if a beta-blocking agent is required. Beta<br />
blockers may mask tachycardia occurring with hypoglycemia, but<br />
other manifestations such as dizziness <strong>and</strong> sweating may not be<br />
significantly affected.<br />
• Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical<br />
signs (eg, tachycardia) <strong>of</strong> hyperthyroidism. Abrupt withdrawal <strong>of</strong><br />
beta blockade might precipitate a thyroid storm; therefore, patients<br />
suspected <strong>of</strong> developing thyrotoxicosis from whom atenolol therapy<br />
is to be withdrawn should be monitored closely.<br />
• Untreated Pheochromocytoma: atenolol should not be given to<br />
patients with untreated pheochromocytoma.<br />
H-10
Timoptic®<br />
(timolol<br />
maleate) 15<br />
Timoptic-<br />
XE® (timolol<br />
maleate) 16<br />
Betimol®<br />
(timolol) 17<br />
Ophthalmic<br />
Solution<br />
Treatment <strong>of</strong> elevated<br />
intraocular pressure in<br />
patients with ocular<br />
hypertension or open-angle<br />
glaucoma.<br />
• Bronchial asthma<br />
• A history <strong>of</strong> bronchial<br />
asthma<br />
• Severe chronic<br />
obstructive<br />
pulmonary disease<br />
• Sinus bradycardia<br />
• Second or third<br />
degree<br />
atrioventricular block<br />
• Overt cardiac failure<br />
• Cardiogenic shock<br />
.<br />
• Cardiac Failure: sympathetic stimulation may be essential for<br />
support <strong>of</strong> the circulation in individuals with diminished myocardial<br />
contractility, <strong>and</strong> its inhibition <strong>of</strong> beta-adrenergic receptor blockade<br />
may precipitate more severe failure.<br />
• In Patients Without a History <strong>of</strong> Cardiac Failure: continued<br />
depression <strong>of</strong> the myocardium with beta-blocking agents over a<br />
period <strong>of</strong> time can, in some cases, lead to cardiac failure. At the<br />
first sign or symptom <strong>of</strong> cardiac failure, timolol should be<br />
discontinued.<br />
• Major Surgery: Beta-adrenergic receptor blockade impairs the<br />
ability <strong>of</strong> the heart to respond to beta-adrenergically mediated reflex<br />
stimuli. This may augment the risk <strong>of</strong> general anesthesia in surgical<br />
procedures. In patients undergoing elective surgery, some<br />
authorities recommend gradual withdrawal <strong>of</strong> beta-adrenergic<br />
receptor blocking agents.<br />
• Diabetes Mellitus: Beta-adrenergic blocking agents should be<br />
administered with caution in patients subject to spontaneous<br />
hypoglycemia or to diabetic patients (especially those with labile<br />
diabetes) who are receiving insulin or oral hypoglycemic agents.<br />
Beta-adrenergic receptor blocking agents may mask the signs <strong>and</strong><br />
symptoms <strong>of</strong> acute hypoglycemia.<br />
• Thyrotoxicosis: Beta-adrenergic blocking agents may mask certain<br />
clinical signs (e.g., tachycardia) <strong>of</strong> hyperthyroidism.:<br />
• Because <strong>of</strong> potential effects <strong>of</strong> beta-adrenergic blocking agents on<br />
blood pressure <strong>and</strong> pulse, these agents should be used with<br />
caution in patients with cerebrovascular insufficiency<br />
• There have been reports <strong>of</strong> bacterial keratitis associated with the<br />
use <strong>of</strong> multiple-dose containers <strong>of</strong> topical ophthalmic products.<br />
• Choroidal detachment after filtration procedures has been reported<br />
with the administration <strong>of</strong> aqueous suppressant therapy (e.g.<br />
timolol).<br />
• Angle-closure glaucoma: In patients with angle-closure glaucoma,<br />
the immediate objective <strong>of</strong> treatment is to reopen the angle. This<br />
requires constricting the pupil. Timolol maleate has little or no effect<br />
on the pupil. Timolol should not be used alone in the treatment <strong>of</strong><br />
angle-closure glaucoma.<br />
• Anaphylaxis: While taking beta-blockers, patients with a history <strong>of</strong><br />
atopy or a history <strong>of</strong> severe anaphylactic reactions to a variety <strong>of</strong><br />
allergens may be more reactive to repeated accidental, diagnostic,<br />
or therapeutic challenge with such allergens.<br />
• Muscle Weakness: Beta-adrenergic blockade has been reported to<br />
potentiate muscle weakness consistent with certain myasthenic<br />
symptoms (e.g., diplopia, ptosis, <strong>and</strong> generalized weakness).<br />
H-11
H-12<br />
Timolol has been reported rarely to increase muscle weakness in<br />
some patients with myasthenia gravis or myasthenic symptoms.
Harms Data for Medications Included in the Analysis<br />
The following sections provide an overview <strong>of</strong> the common <strong>and</strong> notable adverse events <strong>of</strong><br />
each medication. When possible, adverse event data specific for pediatric patients have been<br />
included. It is important to note that the information provided in this section is not an allinclusive<br />
list <strong>of</strong> adverse events. Consult the corresponding package insert for complete<br />
information. Many <strong>of</strong> the adverse events reported are from various clinical trials used in support<br />
<strong>of</strong> the medication’s FDA approval. As a result, these trials many have been conducted under<br />
varying conditions <strong>and</strong> the adverse event rates may not reflect what is observed in clinical<br />
practice. In addition, these rates may not necessarily be able to be compared to the rates observed<br />
in the clinical trials <strong>of</strong> different drugs. Post-marketing adverse events are reported on a voluntary<br />
basis <strong>and</strong> therefore do not represent complete patient data.<br />
Hemangeol® (propranolol hydrochloride)<br />
Hemangeol® is the only medication included in this review that has an FDA approved<br />
indication for infantile hemangioma. The safety <strong>of</strong> Hemageol® in pediatric patients has been<br />
reported in the medication package insert. 1 FDA medical review packages were not available for<br />
this medication.<br />
The most common adverse events, occurring in greater than 10% <strong>of</strong> infants, were sleep<br />
disorders, aggravated respiratory tract infections such as bronchitis <strong>and</strong> bronchiolitis associated<br />
with cough <strong>and</strong> fever, diarrhea, <strong>and</strong> vomiting. 1 In a study <strong>of</strong> pooled safety data (n=424), infants<br />
(63% aged 91-150 days) were treated with Hemangeol® 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or<br />
6 months. Treatment emergent adverse events occurring in 3% or greater in infants receiving the<br />
Hemangeol® 1.2 mg/kg/day (n=200) or Hemangeol® 3.4 mg/kg/day (n=224) compared to<br />
placebo were provided. Adverse events <strong>and</strong> frequencies for patients receiving Hemangeol® 1.2<br />
mg/kg/day included: sleep disorders (17.5%), bronchitis (8%), peripheral coldness (8%),<br />
agitation (8.5%), diarrhea (4.5%), somnolence (5.0%), nightmare (2.0%), irritability (5.5%),<br />
decreased appetite (2.5%), <strong>and</strong> abdominal pain (3.5%). Adverse events <strong>and</strong> frequencies for<br />
patients receiving Hemangeol® 3.4 mg/kg/day (n=224) included: sleep disorders (16.1%),<br />
bronchitis (13.4%), peripheral coldness (6.7%), agitation (4.5%), diarrhea (6.3%), somnolence<br />
(0.9%), nightmare (6.3%), irritability (1.3%), decreased appetite (3.6%), <strong>and</strong> abdominal pain<br />
(0.4%). Additional adverse events reported in less than 1% <strong>of</strong> patients participating in clinical<br />
trials included: second degree atrioventricular heart block (occurring in a patient with underlying<br />
conduction disorder), urticaria, alopecia, decreased blood glucose, <strong>and</strong> decreased heart rate.<br />
Additional Formulations<br />
The safety <strong>and</strong> efficacy <strong>of</strong> the oral tablet, oral capsule, <strong>and</strong> injectable formulations <strong>of</strong><br />
propranolol have not been investigated in pediatric patients. 18-20 The package inserts for these<br />
formulations state that reports <strong>of</strong> bronchospasm <strong>and</strong> congestive heart failure have been reported<br />
in pediatric patients receiving propranolol.<br />
Post-marketing Adverse Events<br />
Additional adverse events revealed during post-marketing surveillance include:<br />
agranulocytosis, hallucination <strong>and</strong> purpura. 1<br />
H-13
Corticosteroids<br />
The safety <strong>and</strong> efficacy <strong>of</strong> pediatric use <strong>of</strong> corticosteroids has been studied in the literature<br />
for the treatment <strong>of</strong> nephrotic syndrome (>2 years <strong>of</strong> age), <strong>and</strong> aggressive lymphomas <strong>and</strong><br />
leukemias (>1 month <strong>of</strong> age). 2-4,6,7,10 It has been reported that the adverse events identified in<br />
pediatric patients were similar to the events experienced in adults. Monitoring pediatric patients<br />
for blood pressure, weight, height, intraocular pressure, <strong>and</strong> clinical evaluation for the presence<br />
<strong>of</strong> infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, <strong>and</strong><br />
osteoporosis is recommended. Specifically, pediatric patients may have a decrease in growth<br />
velocity after taking corticosteroids by any route <strong>of</strong> administration. Therefore, children should be<br />
titrated to the lowest effective dose.<br />
Common adverse events <strong>of</strong> corticosteroids include: fluid retention, alteration in glucose<br />
tolerance, elevation in blood pressure, behavioral <strong>and</strong> mood changes, increased appetite <strong>and</strong><br />
weight gain. 2-10 Additional adverse events include: anaphylactoid reaction, anaphylaxis,<br />
angioedema, bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory<br />
collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in<br />
premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema,<br />
syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, acne, allergic dermatitis,<br />
cutaneous <strong>and</strong> subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or<br />
hypopigmentation, impaired wound healing, increased sweating, petechiae <strong>and</strong> ecchymoses,<br />
rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp<br />
hair, urticaria, abnormal fat deposits, decreased carbohydrate tolerance, development <strong>of</strong><br />
Cushingoid state, hirsutism, manifestations <strong>of</strong> latent diabetes mellitus <strong>and</strong> increased requirements<br />
for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon faces,<br />
secondary adrenocortical <strong>and</strong> pituitary unresponsiveness (particularly in times <strong>of</strong> stress, as in<br />
trauma, surgery or illness), suppression <strong>of</strong> growth in children, potassium loss, hypokalemic<br />
alkalosis, sodium retention, abdominal distention, elevation in serum liver enzymes levels<br />
(usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis,<br />
peptic ulcer with possible perforation <strong>and</strong> hemorrhage, ulcerative esophagitis, osteonecrosis <strong>of</strong><br />
femoral <strong>and</strong> humeral heads, charcot-like arthropathy, loss <strong>of</strong> muscle mass, muscle weakness,<br />
osteoporosis, pathologic fracture <strong>of</strong> long bones, steroid myopathy, tendon rupture, vertebral<br />
compression fractures, arachnoiditis, convulsions, depression, emotional instability, euphoria,<br />
headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually<br />
following discontinuation <strong>of</strong> treatment, insomnia, meningitis, mood swings, neuritis, neuropathy,<br />
paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo,<br />
exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts,<br />
alteration in motility <strong>and</strong> number <strong>of</strong> spermatozoa.<br />
Flo-pred® (prednisolone acetate), Orapred ODT (prednisolone sodium phosphate)<br />
The adverse events reported for Flo-pred® <strong>and</strong> Orapred ODT® in adult patients has been<br />
compiled from the package insert <strong>and</strong> the original FDA approval package assessing the safety <strong>of</strong><br />
adult patients with rheumatoid arthritis. 2,3,21 Common adverse events for Flo-pred <strong>and</strong> Orapred<br />
ODT have been reported in the common adverse events for corticosteroids in general (see<br />
above). 2,3 Bioequivalence studies conducted in healthy volunteers assessing prednisolone oral<br />
suspension, prednisolone syrup, <strong>and</strong> prednisolone tablet were reported in the Flo-pred® original<br />
FDA approval document. 21 The following adverse events were reported across 3 <strong>of</strong> these studies<br />
(see table 3).<br />
H-14
Table H-3: Adverse Events from Flo-pred® Bioequivalence Studies 21<br />
Study #<br />
Dosage form<br />
1 1 1 2 2 2 3 3 3<br />
Suspension<br />
(n=24)<br />
Syrup<br />
(n=24)<br />
Arthralgia 0 0<br />
Tablet<br />
(n=24)<br />
1<br />
(4%)<br />
Suspension<br />
(n=24)<br />
Headache 1 (4%) 0 0 3 (13%)<br />
Somnolence 0<br />
Dyspepsia 1 (4%)<br />
1<br />
(4%)<br />
1<br />
(4%)<br />
Syrup<br />
(n=23)<br />
0 0<br />
1<br />
(4%)<br />
Tablet<br />
(n=24)<br />
1<br />
(4%)<br />
6<br />
(25%)<br />
Suspension<br />
(n=24)<br />
Syrup<br />
(n=23)<br />
0 0<br />
1 (4%)<br />
1<br />
(4%)<br />
0 1 (4%) 0 0 0 0<br />
1<br />
(4%)<br />
1 (4%)<br />
1<br />
(4%)<br />
Fatigue 1 (4%) 0 0 1 (4%) 0<br />
Tablet<br />
(n=23)<br />
1<br />
(4%)<br />
1<br />
(4%)<br />
1<br />
(4%)<br />
0 --- --- ---<br />
1<br />
(4%)<br />
--- --- ---<br />
1<br />
1<br />
Hot Flash 0<br />
0 1 (4%)<br />
0 --- --- --<br />
(4%)<br />
(4%)<br />
Venipuncture site<br />
1<br />
1<br />
1 (4%) 0<br />
0<br />
0 --- --- ---<br />
pain<br />
(4%)<br />
(4%)<br />
Lymphocyte count<br />
2 2<br />
1 1<br />
2 (8%)<br />
1 (4%)<br />
--- --- ---<br />
increased<br />
(8%) (8%)<br />
(4%) (4%)<br />
Neutrophil count<br />
1 1<br />
2 2<br />
1 (4%)<br />
--- --- --- 2 (8%)<br />
decreased<br />
(4%) (4%)<br />
(9%) (9%)<br />
Ocular<br />
1<br />
1<br />
--- --- --- 1 (4%) 0<br />
0 0<br />
hyperaemia<br />
(4%)<br />
(4%)<br />
1<br />
1<br />
Lip dry --- --- --- 1 (4%)<br />
0 0 0<br />
(4%)<br />
(4%)<br />
1 1<br />
Nausea --- --- --- 2 (8%)<br />
1 (4%) 0 0<br />
(4%) (4%)<br />
1<br />
1<br />
Dizziness --- --- --- 1 (4%)<br />
0 0<br />
0<br />
(4%)<br />
(4%)<br />
Venipuncture site<br />
1 (4%) 0 0 --- --- --- --- --- ---<br />
swelling<br />
Blood Bilirubin<br />
1 1<br />
1 (4%)<br />
--- --- --- --- --- ---<br />
increase<br />
(4%) (4%)<br />
1<br />
Increased appetite 0 0<br />
--- --- --- --- --- ---<br />
(4%)<br />
Pharyngolaryngeal<br />
1<br />
0 0<br />
--- --- --- --- --- ---<br />
Pain<br />
(4%)<br />
Blister 1 (4%) 0 0<br />
Abdominal<br />
1<br />
--- --- --- 0 0<br />
--- --- ---<br />
distension<br />
(4%)<br />
1<br />
Abdominal pain --- --- --- 0 0<br />
--- --- ---<br />
(4%)<br />
Upper abdominal<br />
1<br />
--- --- --- 0 0<br />
--- --- ---<br />
pain<br />
(4%)<br />
1<br />
Diarrhea --- --- --- 0 0<br />
--- --- --<br />
(4%)<br />
Dry mouth --- --- --- 1 (4%) 0 0 --- --- ---<br />
Flatulence --- --- --- 1 (4%) 0 0 --- --- ---<br />
1<br />
Vomiting --- --- --- 1 (4%) 0<br />
--- --- ---<br />
(4%)<br />
Vessel puncture<br />
site bruise<br />
--- --- --- 1 (4%) 0 0 --- --- ---<br />
Tremor --- --- --- 1 (4%) 0 0 --- --- ---<br />
Metrorrhagia --- --- --- 1 (4%) 0 0 --- --- ---<br />
Nasal congestion --- --- --- 0 0<br />
1<br />
(4%)<br />
--- --- ---<br />
Rhinorrhea --- --- --- 0 0<br />
1<br />
(4%)<br />
--- --- ---<br />
H-15
Fixed eruption --- --- --- 1 (4%) 0 0 --- --- ---<br />
Catheter site pain --- --- --- --- --- --- 1 (4%) 0 0<br />
Catheter site<br />
reaction<br />
--- --- --- --- --- --- 1 (4%) 0 0<br />
Shivering --- --- --- --- --- --- 1 (4%) 0 0<br />
Blood potassium --- --- --- --- --- --- 1 (4%)<br />
1<br />
(4%)<br />
Hypoaesthesia --- --- --- --- --- --- 0<br />
1<br />
(4%)<br />
0<br />
Bioavailability studies were also conducted for Orapred ODT® in 24 health patients each<br />
receiving Orapred ODT® 30mg tablet, Pediapred® oral solution 30mg <strong>and</strong> Orapred® oral<br />
solution 30mg. Adverse events reported in patients taking Oprapred ODT® included: face<br />
edema/swelling face, pharyngolaryngeal pain, blood in stool, eye irritation, <strong>and</strong> eyelid edema.<br />
A search <strong>of</strong> the literature for adverse events associated with prednisolone was conducted by<br />
Taro Pharmaceuticals <strong>and</strong> reported in the FDA review package. 21 The most common adverse<br />
events reported in 4 pediatric studies (mean age 2% <strong>of</strong><br />
patients participating in phase 3 clinical studies. 23 These patients were treated with prednisone<br />
extended release (XL) (n=375) <strong>and</strong> prednisone immediate release tablets (IR) (n=144). Adverse<br />
events included: abdominal pain upper: XL=6 (
(
An additional clinical trial assessing the safety <strong>of</strong> prednisone extended release was conducted<br />
in Germany <strong>and</strong> included 2676 patients in the safety analysis. 23 Serious adverse events reported<br />
included: gastrointestinal disorders (5 events,
thromboembolism, thrombophlebitis, vasculitis, acne, cutaneous <strong>and</strong> subcutaneous atrophy, dry<br />
scalp, edema, hyper or hypopigmentation, sterile abscess, striae, thinning scalp hair, hirsutism,<br />
moon faces, hepatomegaly, hiccups, malaise, nausea, charcot-like arthropathy, arachnoiditis,<br />
depression, emotional instability, euphoria, insomnia, meningitis, neuritis, neuropathy,<br />
paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, <strong>and</strong> alteration in<br />
motility/number <strong>of</strong> spermatozoa.<br />
Warnings for the use <strong>of</strong> Depo-Medrol® <strong>and</strong> Solu-Medrol® in pediatric patients due to the<br />
presence <strong>of</strong> benzyl alcohol have been described above (see table 1). 6,7<br />
Adverse events for Depo-Medrol® <strong>and</strong> Solu-Medrol® were similar to those listed in general<br />
for corticosteroids (see above) with the addition <strong>of</strong>: dry scaly skin, glycosuria, hypertrichosis,<br />
negative nitrogen balance due to protein catabolism, injection site infections following nonsterile<br />
administration, postinjection flare (following intra-articular use), temporary/permanent<br />
visual impairment including blindness associated with periocular injections <strong>and</strong> decreased<br />
resistance to infection. 6,7<br />
Depo-Medrol® has unique adverse events reported in addition to those listed above:<br />
calcinosis (following intra-articular or intra-lesional use), seizures, ocular <strong>and</strong> periocular<br />
inflammation including allergic reactions, <strong>and</strong> residue or slough at injection site. 6<br />
Additional adverse events reported for Solu-Medrol® included: rhinitis <strong>and</strong> burning or<br />
tingling (especially in the perineal area after intravenous injection). 7<br />
Aristospan® (triamcinolone hexacetonide), Kenalog-10® (triamcinolone<br />
acetonide)<br />
Aristospan® (triamcinolone hexacetonide), Kenalog-10® (triamcinolone acetonide) includes<br />
pediatric dosing in the FDA approved labeling. 8,9 FDA review packages were not available for<br />
this medication. Warnings for the use <strong>of</strong> Aristospan® <strong>and</strong> Kenalog-10® in pediatric patients due<br />
to the presence <strong>of</strong> benzyl alcohol have been described above (see table 1).<br />
Adverse events for Aristospan® <strong>and</strong> Kenalog-10® were similar to those listed in general for<br />
corticosteroids (see above) with the addition <strong>of</strong>: dry scaly skin, glucosuria, hypertrichosis,<br />
negative nitrogen balance due to protein catabolism, calcinosis (following intra-articular or<br />
intralesional use), postinjection flare (following intra-articular use), rare instances <strong>of</strong> blindness<br />
associated with periocular injections, <strong>and</strong> decreased resistance to infection. 8,9 FDA medical<br />
review packages were not available for these medications.<br />
Celestone Soluspan® (betamethasone)<br />
Adverse event data for Celestone Soluspan® was gathered from the package insert. 10 FDA<br />
approval packages were not available for review.<br />
Adverse events for Celestone Soluspan® were similar to those listed in general for<br />
corticosteroids (see above) with the addition <strong>of</strong>: dry scaly skin, glucosuria, hypertrichosis,<br />
negative nitrogen balance due to protein catabolism, calcinosis (following intra-articular or<br />
intralesional use), postinjection flare (following intra-articular use), rare instances <strong>of</strong> blindness<br />
associated with periocular injections, <strong>and</strong> decreased resistance to infection. 10 The following<br />
adverse events have been reported for general corticosteroids but were NOT included as adverse<br />
events for Celestone Soluspan®: manifestations <strong>of</strong> latent diabetes mellitus <strong>and</strong> menstrual<br />
irregularities.<br />
H-19
Elocon® (mometasone furoate)<br />
The use <strong>of</strong> this medication in pediatric patients (>2 years) is recommended for less than 3<br />
weeks. 11 This medication is administered topically <strong>and</strong> pediatric patients will have an increase in<br />
the skin surface area to body mass ratio. As a result, adverse events such as HPA axis<br />
suppression, Cushing’s syndrome, adrenal insufficiency upon withdraw, skin atrophy, striae,<br />
linear growth retardation, delayed weight gain, <strong>and</strong> intracranial hypertension are more likely to<br />
occur in pediatric patients.<br />
The adverse event data for Elocon® was obtained from the package insert. 11 FDA approval<br />
packages were not available for this medication. The package insert notes that rates <strong>of</strong> adverse<br />
events may differ in clinical practice because clinical trials for Elocon® were conducted under<br />
variable conditions. In pediatric studies (n=74), 7% <strong>of</strong> patients experienced adverse events<br />
including: stinging, pruritus, <strong>and</strong> furunculosis. In a pediatric trial, 24 patients (age 6 to 23<br />
months) used Elcon® cream for 3 weeks covering a mean body surface area <strong>of</strong> 41%. Sixteen<br />
percent <strong>of</strong> patients reported HPA axis suppression after treatment. Additional adverse events<br />
reported in pediatric (age 6 months to 2 years) trials (n=182) included: decreased glucocorticoid<br />
levels (2), paresthesia (2), folliculitis (1) moniliasis (1), bacterial infection (1), skin<br />
depigmentation (1). Ninety seven patients, participating in a clinical trial, experienced skin<br />
atrophy including: shininess (4), telangiectasia (1), loss <strong>of</strong> elasticity (4), loss <strong>of</strong> normal skin<br />
markings (4), thinness (1), <strong>and</strong> bruising (1). Adverse events that have been reported for topical<br />
corticosteroids in general include: irritation, dryness, folliculitis, hypertrichosis, acneiform<br />
eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection,<br />
striae, <strong>and</strong> miliaria.<br />
Aldara® (imiquimod), Zyclara® (imiquimod)<br />
Package inserts <strong>and</strong> original FDA approval packages were utilized to gather safety<br />
information for these medications. 12,13,24<br />
It has been reported that the pediatric patients applying Aldara® for molluscum contagiosum<br />
experienced application site reactions most <strong>of</strong>ten. 12,13,25 Additional adverse events reported in<br />
these trials were similar to those reported in adult patient with the addition <strong>of</strong>: otitis media (5%)<br />
<strong>and</strong> conjunctivitis (3%). Local skin reactions reported in pediatric patients <strong>and</strong> considered severe<br />
include: erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion<br />
(2%) <strong>and</strong> weeping/exudate (2%).<br />
The Aldara® package insert notes that rates <strong>of</strong> adverse events may differ in clinical practice<br />
because clinical trials were conducted under variable conditions. 13 The following adverse events<br />
were reported in >1% <strong>of</strong> adult patients applying Aldara® to the face or scalp 2 times a week for<br />
16 weeks for actinic keratosis (n=215): application site reaction: 71 (33%), upper respiratory<br />
tract infection: 33 (15%), sinusitis: 16 (7%), headache: 11 (5%), carcinoma squamous: 8 (4%),<br />
diarrhea: 6 (3%), eczema: 4 (2%), back pain: 3 (1%), fatigue: 3 (1%), atrial fibrillation: 3 (1%),<br />
viral infection: 3 (1%), dizziness: 3 (1%), vomiting: 3 (1%), UTI: 3 (1%), fever: 3 (1%), rigors: 3<br />
(1%), <strong>and</strong> alopecia: 3 (1%). Specific application site reactions that were reported in >1% <strong>of</strong><br />
adult patients taking Aldara® for actinic keratosis (n=215) included: itching: 44 (20%), burning:<br />
13 (6%), bleeding: 7 (3%), stinging: 6 (3%), pain: 6 (3%), induration: 5 (2%), tenderness: 4<br />
(2%), <strong>and</strong> irritation: 4 (2%). The following local skin reactions have been reported in adult<br />
patients applying Aldara® for actinic keratosis (n=215): erythema (all grades): 209 (97%),<br />
erythema (severe): 38 (18%), flaking/scaling/dryness (all grades): 199 (93%),<br />
flaking/scaling/dryness (severe): 16 (7%), scabbing/crusting (all grades): 169 (79%),<br />
scabbing/crusting (severe): 18 (8%), edema (all grades): 106 (49%), erosion/ulceration (all<br />
H-20
grades): 103 (48%), erosion/ulceration (severe): 5 (2%), weeping/exudate (all grades): 45 (22%),<br />
<strong>and</strong> vesicles (all grades): 19 (9%). Increased scarring scores were reported in 2.9% (6/206)<br />
patients with a baseline <strong>and</strong> 8-week post treatment scarring assessment.<br />
In patients applying Aldara® for genital warts, female patients reported severe skin reactions<br />
including: erythema (3%), ulceration (2%), <strong>and</strong> edema (1%); <strong>and</strong> for males, erosion (2%), <strong>and</strong><br />
erythema (1%), edema (1%), induration (1%), <strong>and</strong> excoriation/flaking (1%). 13 The following<br />
adverse reactions were reported by >1% <strong>of</strong> patients: burning, hypopigmentation, irritation,<br />
itching, pain, rash, sensitivity, soreness, stinging, tenderness, bleeding, burning, itching, pain,<br />
tenderness, tinea cruris, fatigue, fever, influenza-like symptoms, headache, diarrhea <strong>and</strong> myalgia.<br />
Aldara® was studied in male <strong>and</strong> female patients (n=784) aged 15-77 (mean age 31.5) with<br />
genital warts. Patients applied Aldara® three times a week for 16 weeks. 25 Some patients were<br />
treated for up to 32 weeks if their warts were not cleared after the initial 16 week treatment.<br />
Common adverse events reported in >2% <strong>of</strong> patients included: application site reactions 26.7%,<br />
infection 3.8%, upper respiratory infection 3.3%, headache 2.5%, fatigue 2.1%, nausea 2.1%,<br />
herpes simplex 2.1%, <strong>and</strong> myalgia 2.0%. In a similar study <strong>of</strong> male <strong>and</strong> female patients (n=943)<br />
age 16-78 (mean 31.2) with genital warts, adverse events reported in >2% <strong>of</strong> patients included:<br />
application site reactions 27.7%, infection 4.5%, headache 2.9%, respiratory infection 2.1%, <strong>and</strong><br />
myalgia 2%.<br />
Similar to the Aldara® package insert, Zyclara® adverse events may differ in clinical<br />
practice because clinical trials were conducted under variable conditions. 12 Adult patients with<br />
actinic keratosis completing clinical trials applied Zyclara® daily for 2 weeks to their entire face<br />
or blading scalp. Treatment cycles were separated by 2 weeks <strong>of</strong> no treatment. Adverse reactions<br />
reported in clinical trials are listed below (see table 5). In addition to the adverse events included<br />
in the chart, the following events have been reported: application site bleeding, application site<br />
swelling, chills, dermatitis, herpes zoster, insomnia, lethargy, myalgia, pancytopenia, pruritus,<br />
squamous cell carcinoma, <strong>and</strong> vomiting.<br />
Table H-5: Zyclara® Adverse Event Data<br />
Zyclara® 2.5%<br />
(n=160)<br />
Zyclara® 3.75%<br />
(n=160)<br />
Adverse Events reported in >2% <strong>of</strong> Patients<br />
Headache 3(2%) 10(6%)<br />
Application site pruritus 6(4%) 7(4%)<br />
Fatigue 2(1%) 7(4%)<br />
Nausea 1(1%) 6(4%)<br />
Influenza like illness 6(4%) 1(
(mild, moderate or severe)<br />
Severe scabbing/crusting 9% 14%<br />
Edema<br />
63% 75%<br />
(mild, moderate or severe)<br />
Severe edema 4% 6%<br />
Erosion/Ulceration<br />
52% 62%<br />
(mild, moderate or severe)<br />
Severe erosion/ulceration 9% 11%<br />
Exudate<br />
39% 51%<br />
(mild, moderate or severe)<br />
Severe Exudate 1% 6%<br />
Flaking/Scaling/Dryness (mild, moderate or<br />
88% 91%<br />
severe):<br />
Severe Flaking/Scaling/Dryness 4% 8%<br />
An additional database review <strong>of</strong> Zyclara® (n=779) across two clinical trials, revealed the<br />
following adverse events reported in >1% <strong>of</strong> patients (see table 6). 25<br />
Tablet H-6: Common Adverse Events Reported in >1% <strong>of</strong> Patients<br />
Zyclara® 3.75%<br />
(n=400)<br />
Zyclara® 2.5%<br />
(n=379)<br />
Application site pain 28 (7.0%) 20 (5.3%)<br />
Application site irritation 24 (6.0%) 13 (3.4%)<br />
Nasopharyngitis 16 (4.0%) 21 (5.5%)<br />
Upper respiratory tract infection 12 (3.0%) 7 (1.8%)<br />
Application site pruritus 11 (2.8%) 17 (4.5%)<br />
Headache 9 (2.3%) 8 (2.1%)<br />
Vaginitis bacterial 8 (2.0%) 6 (1.6%)<br />
Nausea 7 (1.8%) 4 (1.1%)<br />
Back pain 7 (1.8%) 4 (1.1%)<br />
Urinary tract infection 6 (1.5%) 6 (1.6%)<br />
Sinusitis 6 (1.5%) 4 (1.1%)<br />
Sinus congestion 6 (1.5%) 1 (0.3%)<br />
Cough 5 (1.3%) 5 (1.3%)<br />
Rash 5 (1.3%) 2 (0.5%)<br />
Vomiting 5 (1.3%) 1 (0.3%)<br />
Skin laceration 5 (1.3%) 1 (0.3%)<br />
In patients applying Zyclara® 3.75% for genital warts (n=400) for up to 8 weeks, adverse<br />
events occurring in greater than >2% included: application site pain: 28 (7%), application site<br />
irritation: 24 (6%), application site pruritus: 11 (3%), vaginitis bacterial: 6/216 (3%), <strong>and</strong><br />
headache: 6(2%). Additional local skin reactions that required medical attention, caused patients<br />
to discontinue the study or extended beyond the treatment area included: erythema (mild,<br />
moderate or severe): 70%, severe erythema: 9%, edema (mild, moderate or severe): 41%, severe<br />
edema: 2%, erosion/ulceration (mild, moderate or severe): 36%, severe erosion/ulceration: 11%,<br />
exudate (mild, moderate or severe): 34%, <strong>and</strong> severe exudate: 2%. In addition to the adverse<br />
events included above, these events have been reported: rash, back pain, application site rash,<br />
application site cellulitis, application site excoriation, application site bleeding, scrotal pain,<br />
scrotal erythema, scrotal ulcer, scrotal edema, sinusitis, nausea, pyrexia, <strong>and</strong> influenza-like<br />
symptoms.<br />
Adverse events reported for Zyclara® from the sponsor’s clinical trial safety database<br />
include: anginal pain (angia pectoris, prinzmetal angina): 3 (Rate=0.035%), arrhythmia: 15<br />
(Rate=0.177%), ventricular arrthythmia: 2 (Rate=0.024%), cardiac arrest: 1 (Rate=0.012%),<br />
cardiac failure: 7 (Rate=0.083%), chest pain: 12 (Rate=0.142%), dizziness: 66 (Rate=0.780%),<br />
dyspnea: 2 (Rate=0.024%), fibrillation atrial: 12 (Rate=0.142%), hypotension: 2 (Rate=0.024%),<br />
H-22
acute myocardial infarction: 3 (Rate=0.035%), palpitation: 9 (Rate=0.106%), pulmonary edema:<br />
1 (Rate=0.012%), syncope: 7 (Rate=0.083%), tachycardia: 8 (Rate=0.095%), presyncope: 1<br />
(Rate=0.012%), <strong>and</strong> tachycardia ventricular: 2 (Rate=0.024%). 24 It is important to note that the<br />
original FDA approval document only contains data for adult patients. Across five clinical trials,<br />
patients applying the medication for 2 to 3 week cycles (n=665) experienced the following<br />
adverse events most <strong>of</strong>ten: headache, local site reactions, fatigue <strong>and</strong> nausea. Patients using the<br />
higher dose (3.75%) <strong>of</strong> Zyclara experienced local cite reactions more <strong>of</strong>ten.<br />
Two clinical trials assessing the use <strong>of</strong> Zyclara® 2.5% <strong>and</strong> 3.75% in adult patients with<br />
actinic keratosis were submitted in the original FDA approval document. 24 Patients age 36 to 90<br />
applied the medication using one <strong>of</strong> two treatment cycles: 1) 3 weeks <strong>of</strong> treatment followed by 3<br />
weeks <strong>of</strong> rest, 2) 3 weeks <strong>of</strong> treatment followed by 8 weeks <strong>of</strong> rest. Adverse events reported most<br />
<strong>of</strong>ten in patients applying Zyclara® included: application site adverse events, fatigue, headache,<br />
lymphadenopathy <strong>and</strong> influenza like illness.<br />
Serious Adverse Events<br />
Aldara® was studied in male <strong>and</strong> female patients (n=784) aged 15-77 (mean age 31.5) with<br />
genital warts. Patients applied Aldara® three times a week for 16 weeks. 25 Some patients were<br />
treated for up to 32 weeks if their warts were not cleared after the initial 16 weeks. Serious<br />
adverse events reported in this study included: acute appendicititis (1), skull fracture (1),<br />
increased depression/suicide attempt (1), suicide attempt/drug overdose (1), inferior mypcardial<br />
infarction (1), pyelonephritis (1), pacemaker generator exchange (1), pancreatitis (1), cervical<br />
cancer (1), exacerbation <strong>of</strong> depression (1), incomplete abortion (1), possible infection <strong>of</strong> GI tract<br />
(1), <strong>and</strong> heroin addiction (1). In a similar study <strong>of</strong> male <strong>and</strong> female patients (n=943) age 16-78<br />
(mean 31.2) with genital warts, 14 patients experienced serious adverse events including:<br />
alteration in speech <strong>and</strong> sensation <strong>of</strong> spaciness (1), fracture <strong>of</strong> left clavicle (1); exacerbation <strong>of</strong><br />
eczema at non-wart site (1), rectal pain due to internal warts-remote site (1), nephrotic syndrome<br />
(1), carcinoma <strong>of</strong> vulva (1), vulval pain (with anorexia <strong>and</strong> fatigue) (1), depression (1),<br />
lymphangitis due to dog bite (1), axillary abscess (1), laryngeal cancer (1), vomiting <strong>and</strong><br />
abdominal pain (1), cholecystectomy (1), flu (1), tonsil abscess (1), metrorrhagia (1), <strong>and</strong> act<br />
fetal distress (1).<br />
The first clinical trial reviewed in the original FDA approval document for Zyclara® (GW01-<br />
0702) had 227 patients complete the study. 24 Severe adverse events reported in patients applying<br />
the 3.75% cream included: cerebrovascular accident, gout, <strong>and</strong> atrial fibrillation. Severe adverse<br />
events reported in patients applying the 2.5% cream included: oral herpes, sinusitis, pneumonia,<br />
application site infection, bacterial pneumonia, application site irritation, pruritic rash, procedural<br />
pain, <strong>and</strong> cartilage injury. The second clinical trial (GW01-704) reported the following severe<br />
adverse events in patients applying the 3.75% cream: influenza-like illness, chest pain, diarrhea,<br />
vascular graft, <strong>and</strong> anxiety. Severe adverse events reported in patients applying the 2.75% cream<br />
included: bronchiectasis, influenza-like illness twice, cheilitis, lymphadenopathy twice, angina<br />
pectoris, atrial fibrillation, <strong>and</strong> arteriosclerosis.<br />
Serious Adverse events reported across trials (n=160) <strong>of</strong> adult patients (mean age 64.4)<br />
applying Zyclara® 2.5% cream for 2 weeks included: atrial fibrillation (1), chest pain (1),<br />
pneumonia (2), acute myocardial infarction (1), non-cardiac chest pain (1), <strong>and</strong> ventricular<br />
tachycardia (1). 24 Events reported in adult patients (n=160) applying Zyclara® 3.75% cream for<br />
2 weeks included: cerebrovascular accident (1), atrial fibrillation (1), small intestine obstruction<br />
(1), chest pain (1), anxiety (1), <strong>and</strong> diarrhea (1).<br />
H-23
Serious Adverse events reported across trials (n=160) <strong>of</strong> adult patients (mean age 64.7)<br />
applying Zyclara® 2.5% cream for 3 weeks included: chest pain (1), pneumonia (1), aortic valve<br />
stenosis (1), syncope (1), <strong>and</strong> bronchitis (1). 24 Events reported in adult patients (n=160) applying<br />
Zyclara® 3.75% cream for 3 weeks included: pneumonia (1), breast cancer (1), surgery (1),<br />
dyspnea (1), hip fracture (1), arthralgia (1), wound infection (1), coronary artery disease (1), Non<br />
Hodgkin lymphoma (1), <strong>and</strong> pancytopenia (1).<br />
An additional database review <strong>of</strong> Zyclara® (n=779) across two clinical trials revealed the<br />
following severe adverse events (see table 7). 25<br />
Table H-7: Severe Adverse Events Reported in Patients Applying Zyclara®<br />
Zyclara® 3.75%<br />
(n=400)<br />
Zyclara® 2.5%<br />
(n=379)<br />
Application site pain 6 (1.5%) 5 (1.3%)<br />
Application site irritation 2 (0.5%) 3 (0.8%)<br />
Application site reaction 1 (0.3%) 3 (0.8%)<br />
Application site pruritus 1 (0.3%) 2 (0.5%)<br />
Application site rash 2 (0.5%) 0<br />
Application site dermatitis 0 1 (0.3%)<br />
Application site erythema 0 1 (0.3%)<br />
Application site ulcer 0 1 (0.3%)<br />
Application site vesicles 1 (0.3%) 0<br />
Chest pain 1 (0.3%) 0<br />
Influenza like illness 1 (0.3%) 0<br />
Pelvic mass 1 (0.3%) 0<br />
Infections <strong>and</strong> infestation 3 (0.8%) 3 (1.1%)<br />
Nasopharyngitis 1 (0.3%) 1 (0.3%)<br />
Application site infection 0 1 (0.3%)<br />
Bronchitis 0 1 (0.3%)<br />
Influenza 1 (0.3%) 0<br />
Pharyngitis streptococcal 0 1 (0.3%)<br />
Vaginal infection 1 (0.3%) 0<br />
Gastrointestinal disorders 3 (0.8%) 2 (0.5%)<br />
Acute abdomen 1 (0.3%) 0<br />
Diarrhea 0 1 (0.3%)<br />
Haemorrhoidal haemorrhage 1 (0.3%) 0<br />
Haemorrhoids 0 1 (0.3%)<br />
Proctalgia 1 (0.3%) 0<br />
Reproductive system <strong>and</strong> breast disorders 4 (1.0%) 2 (0.5%)<br />
Scrotal erythema 2 (0.5%) 1 (0.3%)<br />
Dysmenorrhea 2 (0.5%) 0<br />
Vulval ulceration 0 1 (0.3%)<br />
Injury, poisoning <strong>and</strong> procedural complications 1 (0.3%) 1 (0.3%)<br />
Gunshot wound 1 (0.3%) 0<br />
Upper limb fracture 0 1 (0.3%)<br />
Musculoskeletal <strong>and</strong> connective tissue disorders 0 1 (0.3%)<br />
Groin pain 0 1 (0.3%)<br />
Nervous system disorders 1 (0.3%) 1 (0.3%)<br />
Headache 1 (0.3%) 0<br />
Migraine 0 1 (0.3%)<br />
Respiratory, thoracic <strong>and</strong> mediastinal disorders 1 (0.3%) 0<br />
Dyspnea 1 (0.3%) 0<br />
Iron deficiency anemia 0 1 (0.3%)<br />
Tooth extraction 1 (0.3) 0<br />
H-24
Discontinuations<br />
Patients utilizing Aldara® for actinic keratosis withdrew from studies or initialed rest periods<br />
most <strong>of</strong>ten due to application site reactions <strong>and</strong> local skin reactions. 13 Specifically, 2% (5/215) <strong>of</strong><br />
patients discontinued from clinical trials due to local skin/application site reactions. Rest periods<br />
occurred in 16% (35/215), 11% (17/160), <strong>and</strong> 7% (11/160) <strong>of</strong> patients using Aldara®, Zyclara®<br />
3.75% <strong>and</strong> Zyclara® 2.5% cream respectively. 12,13 Four out <strong>of</strong> 327 (1.2%) patients applying<br />
Aldara® <strong>and</strong> 3 out <strong>of</strong> 400 (1%) patients applying Zyclara® for genital warts reported<br />
discontinuing due to local skin/application reactions. 12,13 Thirty-two percent (126/400) <strong>of</strong><br />
patients taking Zyclara® temporarily discontinued treatment due to local skin reactions. 12<br />
Aldara® was studied in male <strong>and</strong> female patients (n=784) aged 15-77 (mean age 31.5) with<br />
genital warts. Patients applied Aldara® three times a week for 16 weeks. 25 Some patients were<br />
treated for up to 32 weeks if their warts were not cleared after the initial 16 weeks. Patients<br />
discontinued due to the following adverse events: intolerable local skin reactions: burning,<br />
tenderness, itching, pain (31); flu-like symptoms (2); fatigue (1); bacterial infection at the wart<br />
site (1); urethral irritation (1); <strong>and</strong> intraepithelial vulvar neoplasia (1). In a similar study <strong>of</strong> male<br />
<strong>and</strong> female patients (n=943) age 16-78 (mean 31.2) with genital warts, 105 patients discontinued<br />
due to an adverse event including: local site reaction: burning, tenderness, itching, <strong>and</strong> pain (89);<br />
flu-like symptoms (8); headache, chills <strong>and</strong> fever (3); worsening <strong>of</strong> psoriasis (1); generalized<br />
itching (1); diarrhea (1); vaginal c<strong>and</strong>idiasis (1); <strong>and</strong> fatigue (1).<br />
Out <strong>of</strong> the 227 patients applying Zyclara® <strong>and</strong> completed the GW01-0702 trial, two<br />
withdrew from the treatment due to safety reasons: tachycardia, chest pain, hypertension, <strong>and</strong><br />
increased tremors. 24<br />
Postmarking Adverse Events<br />
Additional adverse events identified after Aldara® <strong>and</strong> Zyclara® were brought to the market<br />
include: tingling at the application site, angioedema, capillary leak syndrome, cardiac failure,<br />
cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations),<br />
chest pain, ischemia, myocardial infarction, syncope, thyroiditis, abdominal pain, decreases in<br />
red cell, white cell <strong>and</strong> platelet counts (including idiopathic thrombocytopenic purpura),<br />
lymphoma, abnormal liver function, herpes simplex, arthralgia, agitation, cerebrovascular<br />
accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis<br />
aggravation, paresis, suicide, dyspnea, proteinuria, dysuria, urinary retention, exfoliative<br />
dermatitis, erythema multiforme, hyper/hypo pigmentation, hypertrophic scar, <strong>and</strong> Henoch-<br />
Schönlein purpura syndrome. 12,13 Post-marketing data was gathered by the sponsor in 2004 <strong>and</strong><br />
was included in the Zyclara® original FDA approval document. 24 Adverse reported include:<br />
chest pain (2), angina (1), myocardial infarction (1), tachycardia (2), syncope (2), palpitation (1),<br />
sudden death (1) (potentially due to arrhythmia), atrial fibrillation (1).<br />
Tenormin® (atenolol)<br />
Tenormin® is not FDA approved for use in pediatric patients <strong>and</strong> therefore safety data in this<br />
population is not available. 14 The adverse event data provided below was gathered from the<br />
Tenormin® package insert <strong>and</strong> is specific for adult hypertensive patients. Adverse events<br />
specific for patients using this medication for acute myocardial infarction was not included in<br />
this analysis.<br />
Controlled studies in conducted in the United States <strong>and</strong> in unspecified foreign countries<br />
revealed the following adverse events associated with atenolol (n=399): bradycardia (3%), cold<br />
extremities (12%), postural hypotension (4%), leg pain (3%), dizziness (13%), vertigo (2%),<br />
H-25
light-headedness (3%), tiredness (26%); fatigue (6%), lethargy (3%), drowsiness (2%),<br />
depression (12%); dreaming (3%), diarrhea (3%), nausea (3%), wheeziness (3%), <strong>and</strong> dyspnea<br />
(6%). 14<br />
Adverse events reported for beta-adrengeric blocking agents in general include:<br />
agranulocytosis; fever, combined with aching <strong>and</strong> sore throat, laryngospasm, <strong>and</strong> respiratory<br />
distress; reversible mental depression progressing to catatonia; acute reversible syndrome<br />
characterized by disorientation <strong>of</strong> time <strong>and</strong> place; short-term memory loss; emotional lability<br />
with slightly clouded sensorium; decreased performance on neuropsychometrics; mesenteric<br />
arterial thrombosis, ischemic colitis, erythematous rash; skin rashes <strong>and</strong>/or dry eyes. 14<br />
Post-marketing Adverse Events<br />
Additional adverse events revealed during post-marketing surveillance include: dry mouth,<br />
headache, elevated liver enzymes <strong>and</strong>/or bilirubin, hallucinations, impotence, purpura, reversible<br />
alopecia, Peyronie's disease, postural hypotension which may be associated with syncope,<br />
psoriasiform rash or exacerbation <strong>of</strong> psoriasis, psychoses, thrombocytopenia, visual disturbance,<br />
sick sinus syndrome, development <strong>of</strong> antinuclear antibodies (ANA), lupus syndrome, <strong>and</strong><br />
Raynaud’s phenomenon. 14<br />
Timoptic® (timolol maleate), Timoptic-XE® (timolol maleate), Betimol® (timolol)<br />
Timoptic®, Timoptic-XE®, <strong>and</strong> Betimol® are not FDA approved for use in pediatric<br />
patients <strong>and</strong> therefore safety data in this population is not available. 15-17 The adverse event data<br />
provided below is gathered from the package inserts for these medications <strong>and</strong> is specific for<br />
adult patients. These medications are ophthalmic preparations <strong>and</strong> therefore many <strong>of</strong> the<br />
common adverse events are associated with the ophthalmic route <strong>of</strong> administration. One in eight<br />
patients reported stinging <strong>and</strong> burning after administration <strong>of</strong> all three <strong>of</strong> these medications. 15-17<br />
In patients taking Timoptic-XE®, one in three patients, in clinical trials, experienced blurred<br />
vision upon drop administration lasting 30 seconds to 5 minutes. 16 One in eight patients reported<br />
stinging <strong>and</strong> burning after use. Additional adverse events reported in 1-5% <strong>of</strong> patients included:<br />
pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching <strong>and</strong> tearing,<br />
headache, dizziness, <strong>and</strong> upper respiratory infections.<br />
In patients taking Betimol® 0.25% or 0.5%, adverse events that occurred more than 5% in<br />
two controlled clinical studies (n=184 patients) included: dry eyes, itching, foreign body<br />
sensation, discomfort in the eye, eyelid erythema, conjunctival injection, <strong>and</strong> headache. 17<br />
Adverse events occurring at a frequency <strong>of</strong> 1-5% included: eye pain, epiphora, photophobia,<br />
blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis <strong>and</strong> cataract,<br />
allergic reaction, asthenia, common cold <strong>and</strong> pain in extremities, hypertension, nausea,<br />
peripheral edema, dizziness, dry mouth, respiratory infection <strong>and</strong> sinusitis. Additional adverse<br />
events reported in ophthalmic use <strong>of</strong> beta-blockers include: blepharoptosis, retinal vascular<br />
disorder, bronchospasm.<br />
The following adverse events were reported in the package inserts <strong>of</strong> both Timpotic® <strong>and</strong><br />
Timoptic-XE®: headache; asthenia/fatigue; arrhythmia; hypertension; worsening <strong>of</strong> angina<br />
pectoris; pulmonary edema; edema; claudication; Raynaud's phenomenon; cold h<strong>and</strong>s <strong>and</strong> feet;<br />
nausea; dyspepsia; anorexia; dry mouth; systemic lupus erythematosus; dizziness; somnolence;<br />
insomnia; nightmares; behavioral changes <strong>and</strong> psychic disturbances including confusion,<br />
hallucinations, anxiety, disorientation, nervousness, <strong>and</strong> memory loss; alopecia <strong>and</strong> psoriasiform<br />
rash or exacerbation <strong>of</strong> psoriasis; signs <strong>and</strong> symptoms <strong>of</strong> systemic allergic reactions, including<br />
anaphylaxis, <strong>and</strong> angioedema; cough <strong>and</strong> upper respiratory infections; signs <strong>and</strong> symptoms <strong>of</strong><br />
H-26
ocular irritation including blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign<br />
body sensation, itching <strong>and</strong> tearing, <strong>and</strong> dry eyes; ptosis; cystoid macular edema; visual<br />
disturbances including refractive changes <strong>and</strong> diplopia; pseudopemphigoid; choroidal<br />
detachment following filtration surgery; tinnitus; retroperitoneal fibrosis; decreased libido; <strong>and</strong><br />
Peyronie's disease. 15,16<br />
Adverse events reported for Betimol®, Timpotic®, Timoptic-XE® included: conjunctivitis,<br />
decreased corneal sensitivity, visual disturbances including refractive changes <strong>and</strong> diplopia, chest<br />
pain, arrhythmia, palpitation, bradycardia, hypotension, syncope, heart block, cerebral vascular<br />
accident, cerebral ischemia, cardiac failure, cardiac arrest, masked symptoms <strong>of</strong> hypoglycemia in<br />
diabetic patients, diarrhea, depression, impotence, increase in signs <strong>and</strong> symptoms <strong>of</strong> myasthenia<br />
gravis <strong>and</strong> paresthesia, dyspnea, bronchospasm (predominantly in patients with preexisting<br />
bronchospastic disease), respiratory failure, nasal congestion; alopecia, urticaria, <strong>and</strong><br />
localized/generalized rash. 15-17<br />
Adverse events reported for oral timolol <strong>and</strong> oral beta-blocking agents that could be<br />
considered potential adverse events for ophthalmic timolol include: erythematous rash; fever<br />
combined with aching <strong>and</strong> sore throat; laryngospasm with respiratory distress; extremity pain;<br />
decreased exercise tolerance; weight loss; worsening <strong>of</strong> arterial insufficiency; vasodilatation;<br />
gastrointestinal pain; hepatomegaly; vomiting; mesenteric arterial thrombosis; ischemic colitis;<br />
nonthrombocytopenic purpura; thrombocytopenic purpura; agranulocytosis; hyperglycemia;<br />
hypoglycemia; pruritus; skin irritation; increased pigmentation; sweating; arthralgia; vertigo;<br />
local weakness; diminished concentration; reversible mental depression progressing to catatonia;<br />
an acute reversible syndrome characterized by disorientation for time <strong>and</strong> place; emotional<br />
lability; slightly clouded sensorium; <strong>and</strong> decreased performance on neuropsychometrics; rales;<br />
bronchial obstruction; urination difficulties. 15,16<br />
H-27
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Drug Administration Center for Drug<br />
Evaluation <strong>and</strong> Research; 2011.<br />
H-28