Diagnosis and Management of Infantile Hemangioma

Comparative Effectiveness Review 

Number 168 

Diagnosis and 

Management 

of Infantile 

Hemangioma


Number 168 

Diagnosis and Management of Infantile Hemangioma 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

5600 Fishers Lane 

Rockville, MD 20857 

www.ahrq.gov 

Contract No. 290-2010-0009-I 

Prepared by: 

Vanderbilt Evidence-based Practice Center 

Nashville, TN 

Investigators: 

Sivakumar Chinnadurai, M.D., M.P.H. 

Kristen Snyder, M.D. 

Nila Sathe, M.A., M.L.I.S. 

Chris Fonnesbeck, Ph.D. 

Anna Morad, M.D. 

Frances E. Likis, Dr.P.H., N.P., C.N.M. 

Tanya Surawicz, M.P.H. 

Genevieve Ness, Pharm.D. 

Cathy Ficzere, Pharm.D. 

Melissa L. McPheeters, Ph.D., M.P.H. 

AHRQ Publication No. 16-EHC002-EF 

January 2016

This report is based on research conducted by the Vanderbilt Evidence-based Practice Center 

(EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, 

MD (Contract No. 290-2012-00009-I). The findings and conclusions in this document are those 

of the authors, who are responsible for its contents; the findings and conclusions do not 

necessarily represent the views of AHRQ. Therefore, no statement in this report should be 

construed as an official position of AHRQ or of the U.S. Department of Health and Human 

Services. 

None of the investigators have any affiliations or financial involvement that conflicts with 

the material presented in this report. 

The information in this report is intended to help health care decisionmakers—patients and 

clinicians, health system leaders, and policymakers, among others—make well informed 

decisions and thereby improve the quality of health care services. This report is not intended to 

be a substitute for the application of clinical judgment. Anyone who makes decisions concerning 

the provision of clinical care should consider this report in the same way as any medical 

reference and in conjunction with all other pertinent information, i.e., in the context of available 

resources and circumstances presented by individual patients. 

This report is made available to the public under the terms of a licensing agreement between the 

author and the Agency for Healthcare Research and Quality. This report may be used and 

reprinted without permission except those copyrighted materials that are clearly noted in the 

report. Further reproduction of those copyrighted materials is prohibited without the express 

permission of copyright holders. 

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative 

products that may be developed from this report, such as clinical practice guidelines, other 

quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. 

This report may periodically be assessed for the currency of conclusions. If an assessment is 

done, the resulting surveillance report describing the methodology and findings will be found on 

the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the 

title of the report. 

Persons using assistive technology may not be able to fully access information in this report. For 

assistance contact EffectiveHealthCare@ahrq.hhs.gov. 

Suggested citation: Chinnadurai S, Snyder K, Sathe N, Fonnesbeck C, Morad A, Likis FE, 

Surawicz T, Ness G, Ficzere C, McPheeters ML. Diagnosis and Management of Infantile 

Hemangioma. Comparative Effectiveness Review No. 168. (Prepared by the Vanderbilt 

University Evidence-based Practice Center under Contract No. 290-2010-0009-I.) AHRQ 

Publication No.16-EHC002-EF. Rockville, MD: Agency for Healthcare Research and Quality; 

January 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm. 

ii

Preface 

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based 

Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and 

private-sector organizations in their efforts to improve the quality of health care in the United 

States. These reviews provide comprehensive, science-based information on common, costly 

medical conditions, and new health care technologies and strategies. 

Systematic reviews are the building blocks underlying evidence-based practice; they focus 

attention on the strength and limits of evidence from research studies about the effectiveness and 

safety of a clinical intervention. In the context of developing recommendations for practice, 

systematic reviews can help clarify whether assertions about the value of the intervention are 

based on strong evidence from clinical studies. For more information about AHRQ EPC 

systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. 

AHRQ expects that these systematic reviews will be helpful to health plans, providers, 

purchasers, government programs, and the health care system as a whole. Transparency and 

stakeholder input are essential to the Effective Health Care Program. Please visit the Web site 

(www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an 

email list to learn about new program products and opportunities for input. 

If you have comments on this systematic review, they may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, 

Rockville, MD 20857, or by email to epc@ahrq.hhs.gov. 

Richard G. Kronick, Ph.D. 

Director 


Stephanie Chang, M.D., M.P.H. 

Director 

Evidence-based Practice Center Program 

Center for Evidence and Practice Improvement 


Arlene Bierman, M.D., M.S. 

Director 



Christine Chang, M.D., M.P.H. 

Task Order Officer 



iii

Acknowledgments 

The authors gratefully acknowledge the following individuals for their contributions to this 

project: Mamata Raj and Shanthi Krishnaswami assisted with data extraction and review of the 

data. Jessica Kimber and Sanura Latham assisted with locating papers, formatting of materials, 

and scheduling meetings. Annette Williams and Katherine Worley managed the topic refinement 

phase of the review. Our AHRQ Task Order Officer and Associate Editor and our Key 

Informants and Technical Expert Panel members provided invaluable input on structuring the 

report. 

Key Informants 

In designing the study questions, the EPC consulted several Key Informants who represent 

the end-users of research. The EPC sought the Key Informant input on the priority areas for 

research and synthesis. Key Informants are not involved in the analysis of the evidence or the 

writing of the report. Therefore, in the end, study questions, design, methodological approaches, 

and/or conclusions do not necessarily represent the views of individual Key Informants. 

Key Informants must disclose any financial conflicts of interest greater than $10,000 and any 

other relevant business or professional conflicts of interest. Because of their role as end-users, 

individuals with potential conflicts may be retained. The TOO and the EPC work to balance, 

manage, or mitigate any conflicts of interest. 

The list of Key Informants who participated in developing this report follows. 

Ilona J. Frieden, M.D.* 

University of California 

San Francisco, CA 

Arin K. Greene, M.D. 

Boston Children’s Hospital 

Boston, MA 

Karla Hall, B.S. 

National Organization of Vascular 

Anomalies 

Greensboro, NC 

Marcia Hogeling, M.D.* 

Phoenix Children’s Hospital 

Phoenix, AZ 

Anthony J. Mancini, M.D.* 

Ann & Robert H. Lurie Children’s Hospital 

Chicago, IL 

Gresham Richter, M.D. 

University of Arkansas 

Fayetteville, AR 

Linda Rozell-Shannon, Ph.D., M.S. 

Vascular Birthmarks Foundation 

*Individuals marked with an asterisk also 

peer reviewed the report. 

iv

Technical Expert Panel 

In designing the study questions and methodology at the outset of this report, the EPC 

consulted several technical and content experts. Broad expertise and perspectives were sought. 

Divergent and conflicted opinions are common and perceived as healthy scientific discourse that 

results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, 

methodologic approaches, and/or conclusions do not necessarily represent the views of 

individual technical and content experts. 

Technical Experts must disclose any financial conflicts of interest greater than $10,000 and 

any other relevant business or professional conflicts of interest. Because of their unique clinical 

or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC 

work to balance, manage, or mitigate any potential conflicts of interest identified. 

The list of Technical Experts who participated in developing this report follows. 

Denise M. Adams, M.D.* 

Cincinnati Children’s Medical Center 

Cincinnati, OH 

David Darrow, M.D.* 

Children’s Hospital of The King’s 

Daughters 

Norfolk, VA 

Ilona J. Frieden, M.D.* 

University of California 

San Francisco, CA 

Arin K. Greene, M.D. 

Boston Children’s Hospital 

Boston, MA 

Marcia Hogeling, M.D.* 

Phoenix Children’s Hospital 

Phoenix, AZ 

Dana Janssen, M.D. 

Monroe Carell Jr. Children’s Hospital at 

Vanderbilt 

Nashville, TN 

Anthony J. Mancini, M.D.* 

Ann & Robert H. Lurie Children’s Hospital 

Chicago, IL 

* Individuals marked with an asterisk also 

peer reviewed the report. 

v

Peer Reviewers 

Prior to publication of the final evidence report, EPCs sought input from independent Peer 

Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the 

scientific literature presented in this report do not necessarily represent the views of individual 

reviewers. 

Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any 

other relevant business or professional conflicts of interest. Because of their unique clinical or 

content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO 

and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest 

identified. 

The list of Peer Reviewers follows: 

Rongwei (Rochelle) Fu, Ph.D. 

School of Public Health 

Oregon Health and Science University 

Portland, OR 

Amy Jo Nopper, M.D. 

University of Missouri-Kansas City 

Kansas City, MO 

Anne Zajicek, MD, Pharm.D. 

Obstetric and Pediatric Pharmacology and 

Therapeutics Branch 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

Washington, DC 

Marco Sciveres, M.D. 

IsMeTT-University of Pittsburgh Medical 

Center Italy 

Palermo, Italy 

vi

Diagnosis and Management of Infantile Hemangioma 

Structured Abstract 

Objectives. To systematically review evidence addressing the diagnosis and management of 

infantile hemangiomas (IH). 

Data sources. Multiple databases from 1982 to June 2015. 

Review methods. We included comparative studies of interventions, case series addressing 

harms, and any study to address contextual questions. Two investigators independently screened 

studies and rated study quality. We extracted and summarized data qualitatively and 

quantitatively via network meta-analysis, which provides a relative ranking of anticipated effects 

among treatments. We also assessed strength of the evidence (SOE). 

Results. Among 148 unique studies, 42 addressed effectiveness outcomes (6 good, 22 fair, and 

14 poor quality), and 144 studies reported harms (14 good, 3 fair, and 127 poor quality). Two 

small studies reported differing findings for the sensitivity of ultrasound and effectiveness of 

imaging modalities. Studies of steroids assessed different agents; treated children typically had 

improvement in lesion size. Steroid harms frequently included Cushingoid facies, 

irritability/mood changes, and growth retardation. Beta-blockers typically demonstrated 

significantly greater effects on reducing lesion size than did control or other active comparators. 

In network meta-analysis, oral propranolol had the largest mean estimate of expected clearance 

(95%; 95% Bayesian credible interval [BCI]: 88% to 99%) relative to oral corticosteroids (43%, 

95% BCI: 21%-66%) and control (6%, 95% BCI: 1%-11%). Beta-blocker harms included 

hypotension, hypoglycemia, bradycardia, sleep disturbances, and cold extremities. Surgical 

intervention studies primarily addressed variations of pulse dye laser (PDL) to manage IH size. 

Most studies reported a higher success rate with longer-pulse PDL compared to observation, with 

differing magnitude of effect. Laser treatment harms included hypopigmentation and scarring. 

No studies explicitly evaluated treatments following failure of beta-blockers or corticosteroids. 

Literature addressing contextual questions suggested that referral indications include large size; 

segmental type; risk for complications including bleeding, ulceration, and pain; involvement of 

critical structures; risk factors for occult lesions (numerous cutaneous lesions, beard 

distribution); and potential for psychosocial concerns in some cases. Multiple case series 

reported associations between multiple cutaneous lesions and airway or hepatic IH and facial 

lesions in a beard distribution and airway IH. 

Conclusions. Our review for contextual questions described a range of indications for referral 

and suggested support for a higher index of suspicion of extracutaneous IH in children with 

multiple cutaneous lesions or facial lesions in a beard distribution. Corticosteroids demonstrated 

moderate effectiveness at reducing IH size/volume (moderate SOE for improvement in IH with 

oral steroids compared with observation/placebo; low SOE for intralesional steroids versus 

observation/placebo; moderate SOE for association with clinically important harms). Propranolol 

had high SOE for effects on reducing lesion size compared with observation/placebo. Clearance 

of IH was greater in propranolol arms compared with placebo/observation and active 

comparators in most studies. Meta-analysis indicated high mean rates of IH clearance with oral 

propranolol (95%, 95% BCI: 88%-99%) and moderate rates for steroids (43% to 58%, with wide 

vii

BCI; moderate SOE for effects of propranolol compared with steroids). Beta-blockers and 

steroids also may cause clinically important harms (moderate SOE for association of oral 

propranolol with harms). Laser studies generally found PDL more effective than other lasers, but 

effects remain unclear (insufficient to low SOE for effects of laser types on IH clearance; 

moderate SOE for association of PDL with skin pigmentation changes; low SOE for association 

with pain). Data were inadequate to address the role of imaging in guiding treatment (insufficient 

SOE). 

viii

Contents 

Executive Summary ................................................................................................................ES-1 

Introduction ....................................................................................................................................1 

Background ................................................................................................................................1 

Diagnosis and Treatment Decisions .....................................................................................1 

Interventions ........................................................................................................................2 

Scope and Key Questions ..........................................................................................................3 

Scope of Review ..................................................................................................................3 

Key Questions ......................................................................................................................3 

Analytic Framework ..................................................................................................................4 

Organization of This Report ......................................................................................................5 

Uses of This Evidence Report ....................................................................................................6 

Methods ..........................................................................................................................................7 

Topic Refinement and Review Protocol ....................................................................................7 

Literature Search Strategy..........................................................................................................7 

Search Strategy ....................................................................................................................7 

Grey Literature .....................................................................................................................8 

Inclusion and Exclusion Criteria ..........................................................................................8 

Study Selection ....................................................................................................................9 

Data Extraction ..................................................................................................................10 

Data Synthesis ....................................................................................................................10 

Quality (Risk of Bias) Assessment of Individual Studies ........................................................11 

Determining Quality Ratings .............................................................................................12 

Strength of the Body of Evidence ............................................................................................12 

Applicability ............................................................................................................................13 

Peer Review and Public Commentary .....................................................................................13 

Results ..........................................................................................................................................14 

CQ1. Natural History of Untreated IH and Adverse Outcomes of Untreated IH ....................14 

Natural History of IH .........................................................................................................14 

Indications for Treatment ...................................................................................................14 

CQ2. Evidence for Association of Cutaneous IH and Occult IH ............................................16 

Results of Literature Searches for Key Questions ...................................................................18 

Description of Included Studies .........................................................................................18 

Grey Literature ...................................................................................................................21 

Key Question 1. Effectiveness and Harms of Imaging Modalities ..........................................21 

Key Points ..........................................................................................................................21 

Overview of the Literature .................................................................................................21 

Detailed Analysis ...............................................................................................................21 

Key Question 2. Effectiveness and Harms of Corticosteroids or Beta-Blockers ....................22 

Network Meta-Analysis of the Effectiveness of Pharmacologic Agents...........................22 

Effectiveness and Harms of Corticosteroids ......................................................................24 

Effectiveness and Harms of Beta-Blockers .......................................................................34 

Key Question 3. Effectiveness and Harms of Drugs Administered After the Failure 

of Corticosteroids or Beta-Blockers...................................................................................65 

Key Question 4. Effectiveness and Harms of Surgical Interventions ......................................65 

Key Points ..........................................................................................................................65 

ix

Overview of the Literature .................................................................................................66 

Detailed Analysis ...............................................................................................................67 

Discussion .....................................................................................................................................78 

State of the Literature...............................................................................................................78 

Summary of Key Findings .......................................................................................................78 

Key Findings From Contextual Questions .........................................................................78 

Key Findings from Key (Comparative Effectiveness) Questions ......................................78 

Findings in Relation to What is Already Known ...................................................................101 

Applicability ..........................................................................................................................101 

Implications for Clinical and Policy Decisionmaking ...........................................................102 

Limitations of the Comparative Effectiveness Review Process ............................................103 

Limitations of the Evidence Base ..........................................................................................104 

Research Gaps and Areas for Future Research ......................................................................105 

Conclusions .................................................................................................................................107 

References ...................................................................................................................................108 

Acronymes and Abbreviations Used in This Report ..............................................................122 

Tables 

Table A. Inclusion criteria .........................................................................................................ES-6 

Table B. Summary of evidence in studies addressing imaging modalities ..............................ES-18 

Table C. Summary of evidence in studies addressing pharmacologic interventions ...............ES-19 

Table D. Sumary of evidence in studies addressing surgical interventions .............................ES-24 

Table 1. Inclusion criteria ................................................................................................................9 

Table 2. Strength of evidence grades and definitions ....................................................................13 

Table 3. Characteristics of included studies addressing effectiveness and harms .........................20 

Table 4. Posterior estimates of effect size .....................................................................................22 

Table 5. Key resolution outcomes in studies comparing intravenous or intralesional and oral 

corticosteroids ..........................................................................................................................27 

Table 6. Key resolution outcomes in studies comparing intralesional and topical 

corticosteroids ..........................................................................................................................28 

Table 7. Key resolution outcomes in studies comparing methylprednisolone and prednisolone ..29 

Table 8. Harms/adverse effects in comparative studies of steroids to treat IH ..............................30 

Table 9. Adverse effects in case series of steroids to treat IH .......................................................32 

Table 10. Key resolution outcomes in RCTs comparing propranolol and placebo or 

observation ...............................................................................................................................39 

Table 11. Resolution outcomes in studies comparing beta-blockers and steroids .........................43 

Table 12. Resolution outcomes in studies comparing intralesional propranolol and 

triamcinolone ...........................................................................................................................47 

Table 13. Resolution outcomes in studies comparing propranolol with laser and propranolol 

alone .........................................................................................................................................48 

Table 14. Resolution outcomes in studies comparing propranolol and bleomycin .......................49 

Table 15. Key outcomes in studies comparing propranolol and no propranolol ...........................50 

Table 16. Resolution outcomes in studies comparing beta-blockers .............................................51 

Table 17. Key resolution outcomes in studies comparing nadolol and propranolol ......................53 

Table 18. Resolution outcomes in studies comparing forms of propranolol .................................54 

Table 19. Key resolution outcomes in studies comparing timolol and observation or placebo ....55 

Table 20. Resolution outcomes in studies comparing timolol and imiquimod..............................57 

x

Table 21. Resolution outcomes in studies comparing timolol and laser........................................58 

Table 22. Harms/adverse effects in comparative studies of beta-blockers to treat IH ..................60 

Table 23. Harms/adverse events reported by dose in Leaute-Labreze et al. 2015 .........................61 

Table 24. Adverse effects in case series of propranolol to treat IH ...............................................62 

Table 25. Key resolution outcomes in studies comparing PDL and observation ..........................68 

Table 26. Key resolution outcomes in studies comparing PDL modalities ...................................69 

Table 27. Key resolution outcomes in comparative studies of Nd:YAG laser ..............................71 

Table 28. Key resolution outcomes in comparative studies of Nd:YAG laser with cooling .........72 

Table 29. Key resolution outcomes in comparative studies of photothermolysis with intense 

pulsed light and cryosurgery ....................................................................................................73 

Table 30. Key resolution outcomes in comparative studies of cryosurgical therapy ....................74 

Table 31. Harms/adverse effects in comparative studies of lasers to treat IH ...............................75 

Table 32. Adverse effects in case series of laser treatments for IH ...............................................76 

Table 33. Adverse effects in case series of surgical treatments for IH ..........................................77 

Table 34. Strength of evidence for effectiveness of imaging modalities .......................................80 

Table 35. Strength of evidence for effectiveness and harms of steroids .......................................82 

Table 36. Strength of evidence for effectiveness of beta-blockers ................................................85 

Table 37. Strength of evidence for harms of beta-blockers ...........................................................90 

Table 38. Strength of evidence for effectiveness of laser modalities ............................................94 

Table 39. Strength of evidence for harms of laser modalities .......................................................98 

Figures 

Figure A. Analytic Framework for KQ1....................................................................................ES-4 

Figure B. Analytic Framework for KQ2 and KQ3 ....................................................................ES-5 

Figure C. Analytic Framework for KQ4 ....................................................................................ES-5 

Figure D. Estimates of expected IH clearance .........................................................................ES-11 

Figure 1. Analytic framework for KQ1 ...........................................................................................4 

Figure 2. Analytic framework for KQ2 and KQ3 ............................................................................5 

Figure 3. Analytic framework for KQ4 ...........................................................................................5 

Figure 4. Disposition of studies identified for this review ............................................................18 

Figure 5. Estimates of expected IH clearance ................................................................................23 

Figure 6. Estimates of the variation of each treatment ..................................................................24 

Appendixes 

Appendix A. Search Strategies 

Appendix B. Screening and Quality Assessment Forms 

Appendix C. Excluded Studies 

Appendix D. Methods for Network Meta-Analysis 

Appendix E. Study Design Classification Algorithm 

Appendix F. Quality/Risk of Bias Ratings 

Appendix G. Applicability Tables 

Appendix H. Harms Reported in Package Insert Data and Other Sources 

xi

Executive Summary 

Introduction 

Infantile hemangiomas (IH) are the most common tumors of childhood. IH are benign but 

possess potential for local tissue damage, ulceration, infection, bleeding, functional impact, and 

pain. The International Society for the Study of Vascular Anomalies classifies IH as vascular 

tumors that are differentiated from vascular malformations in several ways including natural 

history, cellular composition, immunohistochemical expression, and pathology. 1 Due to 

historical inconsistencies in naming conventions, it is difficult to understand the true prevalence 

of IH, but it is estimated that they affect about 4 to 5 percent of children, 2 with higher prevalence 

in females and Caucasians. 3,4 IH tend to go through growth and involution phases, although the 

complete natural history of IH by various characteristics has not been described. In most 

children, IH will become apparent in the first few weeks of life and reach 80 percent of total size 

by around age 3 to 5 months. 5,6 With a course of expectant observation, many patients may 

experience a complete involution without significant sequelae; however, IH frequently occur in 

cosmetically and functionally sensitive areas. Even with complete involution, some patients have 

permanent disfigurement and functional compromise. 7 Early assessment of the extent of the 

hemangioma, and early, appropriate treatment of IH may potentially mitigate these 

complications; however, in one large multicenter treatment analysis, the first specialist visit for 

children in the study did not occur until a mean of 5 months of age. 6 

Furthermore, some lesions are particularly aggressive or morbid and can cause severe pain, 

ulceration, and bleeding even in early stages. 8,9 The rapid growth of IH leaves little time for 

prospective observation to determine which IH will lead to complications and require specialist 

attention and treatment before complications begin to manifest. Some types of IH, specifically 

segmental hemangiomas, are recognized as high risk, but no consensus exists on which nonsegmental 

lesions warrant referral for appropriate treatment to mitigate future complications 

(e.g., bleeding, ulceration) of the hemangioma or long-term sequelae (e.g., scarring, anatomical 

disfigurement, functional complications). 10-12 

Diagnosis and Treatment Decisions 

Evaluation through the use of various diagnostic imaging modalities has been generally 

reserved for deep lesions to help understand their extent or to confirm the diagnosis of IH. Purely 

cutaneous lesions do not require imaging, but opinions regarding the initial diagnostic test of 

choice for more extensive IH, including deep, segmental, and syndromic lesions, are conflicting. 

Furthermore, different disease sites or extents may be best handled with different imaging 

modalities. The questions of imaging necessity and type are especially important because 

imaging studies in infants often require general anesthesia and may be associated with adverse 

effects. Modalities such as computed tomography also involve exposure to radiation. 

Specific disease characteristics, such as lesion size, location, rate of growth, and persistence 

as well as modifiers such as patient age, functional impact, and IH subtype influence whether 

children are treated with pharmacologic agents or surgically. Many lesions can be treated with 

pharmacologic agents; however, refractory lesions that possess immediate risk for morbidity or 

mortality, such as hemangiomas obstructing the airway or visual axis, may require more 

immediate surgical intervention. Lesion characteristics such as size, location, and type (e.g., 

superficial, deep) also influence the choice of specific pharmacologic agents. For example, small, 

ES-1

superficial lesions may respond well to topical agents such as timolol, while deep lesions are less 

likely to respond. 13 Intralesional steroids may be the drug of choice for bulky, localized IH but 

are likely to be less effective for extensive superficial IH. Both medical and surgical treatment 

paradigms contain significant variability and lack of consensus. 

In many cases of IH, early referral and intervention are crucial to a satisfactory outcome and 

to mitigate structural changes to adjacent structures or disfiguring sequelae. In addition to 

structural damage, the psychological complications of having facial differences must be 

considered when determining the need for referral or treatment. While well-recognized clinical 

signs such as ulceration, airway obstruction, or vision-threatening involvement indicate need for 

urgent referral, there are no discrete guidelines that help direct primary care providers on when to 

refer patients with IH for subspecialty care. 

Interventions 

The beta-blocker propranolol was approved by the U.S. Food and Drug Administration 

(FDA) for use in IH in March 2014 14-16 and was historically used in children for cardiac 

conditions and off-label to treat IH after the serendipitous discovery of its effects on IH lesions in 

2008. 17 Prior to this, corticosteroids were the drug of choice, but propranolol has become the 

typical choice for initial medical management in children without contraindications to betablockers. 

Steroids may be used in children with contraindications to beta-blockers or who do not 

respond to beta-blockers. Additionally, there is no clear consensus as to when alternative or 

adjunctive or historically used medications such as chemotherapeutic drugs are appropriate if 

first-line treatment is unsuccessful. 18,19 

Surgical interventions for IH can be used for primary management of high risk lesions by 

resection or ablation using laser or radiofrequency. Some confusion and disagreement exists 

about what type of surgical treatment to use, when in the disease course to treat, and how the 

disease site informs treatment decisions. Interventions for IH are varied, involved, and not 

without risk (e.g., risk of permanent hypopigmentation, scarring from pulsed dye laser therapy, 

potential harms of anesthesia); therefore, universal treatment is unwarranted. 

Scope and Key Questions 

Scope and Uses of the Review 

This systematic review addresses the evidence for benefits and harms of commonly used 

treatments for children (ages 0-18 years) with IH: beta-blockers, corticosteroids, “second-line” 

drugs used after the failure of beta-blockers or steroids, and laser and surgical treatment. The 

decisional dilemmas that this review addresses are whether imaging modalities are useful both in 

diagnosis and for guiding treatment, and the expected comparative effectiveness (benefits and 

harms) of pharmacologic and surgical treatments, relative to observation or other active 

treatments. While pharmacologic and surgical interventions cannot be directly compared because 

of their inherent confounding by indication, we assess the comparative effectiveness of different 

options within both pharmacologic and surgical approaches. 

We include both contextual and Key Questions. We systematically reviewed and assessed the 

risk of bias of the literature meeting our inclusion criteria for Key Questions, which address the 

comparative effectiveness of interventions. We provide a narrative review of relevant literature 

ES-2

for contextual questions as few effectiveness studies address these questions, which are related to 

natural history of IH and markers for occult IH. 

We anticipate this report will be of primary value to organizations that develop guidelines for 

managing IH, to clinicians who provide care for children with IH, and for families making 

treatment decisions. IH is diagnosed and treated by clinicians including pediatricians, 

dermatologists, otolaryngologists, family physicians, nurses, nurse-practitioners, physician 

assistants, hematologists, and general and plastic surgeons. This report supplies practitioners and 

researchers up-to-date information about the current state of evidence, and assesses the quality of 

studies that aim to determine the outcomes and safety of treatments for IH. 

Key Questions 

We developed Key Questions (KQs) and Contextual Questions (CQs) in consultation with 

Key Informants and the Task Order Officer. Questions were posted for review to the AHRQ 

Effective Health Care Web site. Questions were as follows: 

CQ1. What is known about the natural history of infantile hemangiomas, by 

hemangioma site and subtype? What are the adverse outcomes of 

untreated infantile hemangiomas? What characteristics of the hemangioma 

(e.g., subtype, size, location, number of lesions) indicate risk of significant 

medical complications that would prompt immediate medical or surgical 

intervention? 

CQ2. What is the evidence that five or more cutaneous hemangiomas are 

associated with an increased risk of occult hemangiomas? 

KQ1. Among newborns, infants, and children up to 18 years of age with 

known or suspected infantile hemangiomas, what is the comparative 

effectiveness (benefits/harms) of various imaging modalities for identifying 

and characterizing hemangiomas? 

a. Does the comparative effectiveness differ by location and subtype of 

the hemangioma? 


infantile hemangiomas who have been referred for pharmacologic 

intervention, what is the comparative effectiveness (benefits/harms) of 

corticosteroids or beta-blockers? 


infantile hemangiomas for whom treatment with corticosteroids or betablockers 

is unsuccessful what is the comparative effectiveness of second 

line therapies including immunomodulators and angiotensin-converting 

enzyme inhibitors? 

ES-3


infantile hemangiomas who have been referred for surgical intervention, 

what is the comparative effectiveness (benefits/ harms) of various types of 

surgical interventions (including laser and resection)? 

Analytic Framework 

The analytic frameworks illustrate the population, interventions, and outcomes that guided 

the literature search and synthesis of comparative studies (Figures A-C). The frameworks depict 

the KQs within the context of the population, intervention, comparator, outcomes, timing, and 

setting (PICOTS) parameters described in the review. In general, the figures illustrate how 

imaging modalities or interventions such as magnetic resonance imaging (MRI), beta-blockers, 

or laser may result in intermediate outcomes such as change in hemangioma size or change in 

vision and/or in final health outcomes such as detection of hemangiomas for imaging modalities 

or resolution of hemangioma or changes in quality of life for medical or surgical treatments. 

Also, adverse events may occur at any point after imaging or receipt of the intervention. 

Figure A. Analytic framework for KQ1 

IH = infantile hemangioma; KQ = Key Question 

ES-4

Figure B. Analytic framework for KQ2 and KQ3 


Figure C. Analytic framework for KQ4 

IH = infantile hemangioma; KQ = Key Question; ND:YAG = Neodymium Yttrium Aluminum Garnet 

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Methods 

Literature Search Strategy 

A librarian employed search strategies (Appendix A of the full report) to retrieve research on 

diagnostic modalities, and interventions for IH. We searched MEDLINE ® via the PubMed ® 

interface, the Cumulative Index of Nursing and Allied Health Literature (CINAHL ® ), and 

Embase (Excerpta Medica Database). We limited searches to the English language and to studies 

published from 1982 to the present to reflect current standards of care and classification schema 

for IH. 20 We searched the same databases without date restrictions to identify contextual 

information. Our last search was conducted in June 2015. We manually searched reference lists 

of included studies and of recent narrative and systematic reviews and meta-analyses. 

Inclusion and Exclusion Criteria 

We developed criteria for inclusion and exclusion (Table A) in consultation with a Technical 

Expert Panel. We limited studies to those published in English. We also excluded studies 

evaluating multiple lesion types (e.g., cavernous hemangioma, hemangioblastoma, vascular 

malformations, noninvoluting congenital hemangiomas) unless we could clearly extract data 

pertaining to children with IH or if the majority of children had IH. To be included for KQ3, 

studies had to note explicitly that all children had received prior treatment with beta-blockers or 

steroids and were therefore receiving a second-line treatment. We also included case series with 

at least 25 children with IH to address harms, but not effectiveness. We selected the lower bound 

of 25 as a conservative value based on a preliminary review of case series. 

Table A. Inclusion criteria 

Category 

Criteria 

Study population 

Newborns, infants, and children up to 18 years of age with infantile hemangiomas or 

suspected infantile hemangiomas 

Publication languages English only 

Publication year 1966-present (CQ 1 and 2) 

1982-present (KQ 1, 2, 3, 4) 

Admissible evidence Admissible designs 

Original research studies providing sufficient detail regarding methods and results to 

enable use and aggregation of the data and results 

Contextual Questions (CQ): 

• Systematic and non-systematic reviews, articles reporting on the history of IH 

diagnosis or treatment, practice guidelines, meta-analyses, RCTs, case series 

with at least 25 children with IH, and any comparative studies 

Comparative Effectiveness Key Questions (KQ): 

• Imaging accuracy: RCTs and any comparative studies 

• Benefits of interventions: RCTs and any comparative studies 

• Harms of interventions: RCTs, any comparative studies, and case series with 

at least 25 children with infantile hemangiomas 

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Table A. Inclusion criteria (continued) 

Category 

Criteria 

Other criteria 

Studies must address one or more of the following: 

• Diagnostic imaging (e.g., magnetic resonance imaging, computed tomography, 

magnetic resonance angiography, echocardiography, ultrasound, endoscopy) 

• Surgical interventions (e.g., cryotherapy, resection, embolization, 

radiofrequency ablation therapy) or laser interventions (e.g., pulsed dye, 

fractionated laser, argon, carbon dioxide, neodymium (Nd): YAG, erbium) 

• Pharmacologic interventions (e.g., beta-blockers, corticosteroids, 

immunomodulators, immunosuppressants, angiotensin-converting enzyme 

inhibitors, antiangiogenic agents, antineoplastics) 

• Data (including harms) related to diagnostic modalities or interventions for 

infantile hemangiomas for the following outcomes: 

Imaging studies 

− Ability to identify presence, number, and extent of hemangiomas and 

associated structural anomalies (sensitivity and specificity) 

− Harms 

Surgical or pharmacologic intervention studies 

− Size / volume of hemangioma 

− Impact on vision 

− Aesthetic appearance as assessed by clinician or parent 

− Degree of ulceration 

− Quality of life 

− Harms 

Relevant outcomes must be able to be abstracted from data in the papers 

Data must be presented in the aggregate (vs. individual participant data) 

Abbreviations: CQ = contextual question, KQ = Key Question, Nd:YAG = neodymium yttrium aluminum garnet, RCT = 

randomized controlled trial 

Study Selection 

Two reviewers independently assessed each abstract. If one reviewer concluded that the 

article could be eligible to address a KQ based on the abstract, we retained it for review of the 

full text. Two reviewers independently assessed the full text of each included study potentially 

addressing a KQ, with any disagreements adjudicated by a senior reviewer. Reviewers could flag 

studies that potentially addressed a C Q identified in the screening process for KQs. 

We also screened studies identified in our separate database searches for studies 

potentially addressing CQs. We did not conduct dual screening of studies identified in our 

searches for CQs. If one reviewer determined that a study could be eligible, we assessed its 

relevance to the CQs. Excluded studies had no further analysis. 

Data Extraction and Synthesis 

We extracted data from included studies into templates that recorded study design, 

descriptions of the study population (for applicability), description of the interventions, and 

baseline and outcome data on constructs of interest. Data were initially extracted by one team 

member and reviewed for accuracy by a second. Extracted data for KQs are available in the 

Systematic Review Data Repository. 

We summarized data for KQs qualitatively using summary tables where meta-analyses were 

not possible. We provided a narrative summary of relevant papers for CQs. 

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We identified sufficient data to address the effectiveness of pharmacologic interventions 

using quantitative meta-analysis methods. Studies were included in the meta-analysis subset 

provided that they satisfied the following additional inclusion criteria: 

• Outcomes were reported quantitatively, using an objective metric for reporting 

intervention effects that could be converted into a proportion of IH clearance. 

• One or more study arms evaluated a single intervention; study arms in which two or more 

treatments were applied were excluded. 

• Reported outcomes were accompanied by an associated measure of variation or precision. 

• Non-control pharmacologic treatments could be reasonably classified into one of the 

following classes of agents: oral, intralesional, or topical propranolol; intralesional 

triamcinolone; topical or ophthalmic timolol; and oral steroid. 

• Studies evaluated IH in multiple locations (vs. specific anatomic areas) as most studies 

included IH in multiple areas. 

In addition to the diverse suite of interventions, outcomes were reported in a variety of ways. 

Most identified an arbitrary threshold of IH clearance (e.g., >75%) as a positive outcome, or 

divided the continuous clearance measure into a small number of categories. Others reported 

visual analog scale scores or other measures. In order to incorporate as many quality studies as 

possible, we constructed a Bayesian latent variable model. This model allowed several different 

types of outcome data and a suite of pharmacologic interventions to be analyzed in the same 

model. The estimands of interest were the expected proportion of clearance of IH associated with 

each intervention agent (i.e., with a mean expected clearance rate of 80% for a given agent, we 

would expect to see, on average, 80% clearance of IH in a child receiving that agent), along with 

associated posterior uncertainty. A full description of the meta-analytic methods is reported in 

Appendix D of the full report. 

Quality (Risk-of-Bias) Assessment of Individual Studies 

We used separate tools appropriate for specific study designs to assess quality of individual 

studies addressing KQs: questions adapted from the RTI item bank to assess RCTs, 21 the 

Newcastle-Ottawa Quality Assessment Scale for cohort studies, 22 the QUADAS tool for 

diagnostic imaging studies, 23 and a tool adapted from questions outlined in the RTI item bank 

and the McMaster McHarms tool to assess reporting of harms. 24 Appendix B of the full report 

includes questions used in each tool. 

Two team members independently assessed each included study, with discrepancies resolved 

through discussion to reach consensus and/or adjudication by a senior reviewer. The results of 

these assessments were then translated to the Agency for Healthcare Research and Quality 

standard of “good,” “fair,” and “poor” quality designations, as described in the full report. 

Quality ratings for each study are in Appendix F of the full report. 

Strength of the Body of Evidence 

Two senior investigators graded the strength of the evidence (SOE) for key 

intervention/outcome pairs (i.e., the final outcomes listed in Figures A-C) using methods based 

on the “Methods Guide for Effectiveness and Comparative Effectiveness Reviews.” 25 We 

assessed the domains of study limitations (low, medium, high level of limitation), consistency 

(inconsistency not present, inconsistency present, unknown), directness (direct, indirect), 

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precision (precise, imprecise), and reporting bias. We did not assess SOE for contextual 

questions. The team reviewed the final SOE designation. The possible grades were: 

• High: High confidence that the evidence reflects the true effect. Further research is 

unlikely to change estimates. 

• Moderate: Moderate confidence that the evidence reflects the true effect. Further research 

may change our confidence in the estimate of effect and may change the estimate. 

• Low: Low confidence that the evidence reflects the true effect. Further research is likely 

to change confidence in the estimate of effect and is also likely to change the estimate. 

• Insufficient: Evidence is either unavailable or does not permit a conclusion. 

We assessed the SOE for the KQs only. 

Applicability 

We assessed the applicability of findings reported in the included literature addressing KQs 

to the general population of children with IH by determining the population, intervention, 

comparator, and setting in each study and developing an overview of these elements for each 

intervention category. We anticipated that areas in which applicability would be especially 

important to describe would include the diagnostic criteria for IH, age at treatment initiation, and 

the anatomic location and morphology of IH. Applicability tables for each intervention are in 

Appendix G of the full report. 

Results 

CQs 

We included 68 studies in the narrative summary of information addressing CQ. The 

literature identified to answer contextual questions suggested that indications for referral include 

large size; segmental type; risk for complications including bleeding, ulceration, and pain; 

involvement of critical structures; and risk factors for occult lesions (numerous cutaneous 

lesions, beard distribution). Further, the potential for psychosocial concerns may support referral 

for patients with uncomplicated lesions in highly visible areas on a case-by-case basis. 

Overall, limited literature addressed the association of a higher number of cutaneous IH and 

extracutaneous IH. Some data from case series suggested support for a higher index of suspicion 

in children with multiple lesions or with facial lesions in a beard distribution. Studies have 

primarily assessed associations between cutaneous IH and hepatic IH and cutaneous facial IH 

and airway IH. 

Comparative Effectiveness Questions 

Article Selection and Overview 

We identified 4132 nonduplicative titles or abstracts with potential relevance, with 2859 

proceeding to full text review. We included 148 unique studies (153 publications) in the review. 

These 148 studies included 42 comparative studies, 38 addressing effectiveness and harms of 

therapies and 4 assessing effectiveness only, and 106 case series providing data on harms only. 

The 148 unique studies addressing KQs comprise 15 randomized controlled trials (RCTs), 5 

prospective and 19 retrospective cohort studies, 2 diagnostic accuracy studies (defined as studies 

that compared the accuracy of imaging modalities in identifying or characterizing infantile 

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hemangioma [IH]), 1 prospective comparative study that used an untreated IH as a control, and 

106 case series (used for harms data only). 

We considered 6 of these comparative studies to be good quality, 22 fair quality, and 14 poor 

quality. One-hundred and forty-four studies (comparative studies and case series) reported 

harms/adverse events data. We considered 14 of these as good quality for harms reporting, 3 as 

fair quality for harms reporting, and the remainder (n = 127) as poor quality for harms reporting. 

KQ1. Effectiveness and Harms of Imaging Modalities for IH 

Two poor quality diagnostic accuracy studies addressed imaging modalities. 26,27 Studies 

assessed IH in different anatomic locations and reported differing findings for the sensitivity of 

ultrasound and effectiveness of imaging modalities depending on location or subtype. In one 

comparing magnetic resonance imaging (MRI) and ultrasound for imaging spinal anomalies 

(n=48), ultrasound had a sensitivity of 50 percent (95% CI: 18.7% to 81.3%) and specificity of 

77.8 percent (95% CI: 40% to 97.2%) for identifying anomalies including tethered cords and 

intraspinal IH. We calculated the sensitivity of both modalities for identifying intraspinal 

hemangioma specifically: assuming a false positive value of 0, ultrasound had a sensitivity of 20 

percent (95% CI: 3.30% to 71.19%), and the sensitivity of MRI was 100 percent (95% CI: 

66.21% to 100%). In another study, ultrasound identified hepatic IH in 42 of 44 patients 

(sensitivity of 95%). Overall, studies were limited by the size of cohorts, lack of standard 

processes, and lack of direct comparison at the same time point using the various imaging 

modalities. We considered the SOE for all imaging modalities to be insufficient given single, 

small studies addressing different approaches, using weaker study designs and precluding a 

meta-analysis. The studies did not address harms. 

KQ2. Effectiveness and Harms of Corticosteroids and Beta-Blockers 

Summary of Meta-Analysis Results 

We included 18 studies in a network meta-analysis. All studies addressed pharmacologic 

agents and included five RCTs and four cohort studies evaluating oral propranolol and placebo 

or observation or another active agent; one RCT and one cohort study comparing oral 

propranolol and other oral beta-blockers; three cohort studies and two RCTs assessing topical 

timolol compared with placebo or observation or another agent; and one RCT and one cohort 

study evaluating different steroids. Four studies were good quality; nine were fair quality; and 

five were poor quality. Studies included a total of 1265 children with IH. 

In our network meta-analysis, oral propranolol had the highest clearance rate (Figure D). As 

described in the qualitative results, there were substantially more studies of oral propranolol 

available for inclusion in the analysis. The expected efficacy of control arms was estimated to be 

6 percent (95% Bayesian credible interval [BCI]: 1% to 11%), and all non-control treatments 

were estimated to have a larger expected clearance than control arms. As noted, the largest mean 

estimate of expected clearance was for oral propranolol (95%, 95% BCI: 88% to 99%), followed 

by topical timolol (62%, 95% BCI: 39% to 83%), and intralesional triamcinolone (58%, 95% 

BCI: 21% to 93%). Oral steroids had a rate of 43 percent (95% BCI: 21% to 66%). 

The variation in treatment outcomes was high in beta-blocker studies. Thus, the potential for 

greater clearance was much higher in patients treated with oral propranolol, but the variability in 

outcomes makes it difficult to anticipate the likely outcome for a given patient. As noted, 

corticosteroid treatment demonstrated lower overall effectiveness. 

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Figure D. Estimates of expected IH clearance 

Note: Estimates of expected IH clearance are expressed as percent clearance relative to initial condition for each treatment, along 

with associated posterior interquartile range (thick lines) and 95% credible interval (thin lines). 

To assess for methodologic heterogeneity, we ran additional models with only RCTs and 

with only good and fair quality studies. Estimates did not differ markedly when poor quality 

studies were removed, though BCI typically widened; thus, we report the model with poor 

quality studies included. To examine the possible effect of bias due to the inclusion of cohort 

studies, we fit the same model to RCT studies only. The resulting estimates were similar to those 

of the model fit to all studies, but with much wider posterior credible intervals. Since there was 

no obvious systematic bias due to study design, we reported the model estimates based on the 

entire body of evidence. 

Corticosteroids 

We identified 24 studies (three RCTs, one cohort study, and 20 case series) reporting 

outcomes and/or harms following corticosteroid use in children with IH. Comparative studies 

included a total of 239 children, and case series included 3508. We considered one RCT as good, 

one as fair, and one as poor quality and the cohort study as fair quality. We rated all case series 

as poor quality for harms reporting. Steroids studied varied in dose, type, and route of 

administration, and the ages of children included in comparative studies ranged widely from 1 to 

72 months. IH size was reduced significantly in the oral prednisolone arm compared with 

intravenous methylprednisolone arm in one RCT. 

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More children in treatment arms than in an observation arm in another RCT comparing oral 

prednisolone, intralesional triamcinolone, and conservative management had at least a 50 percent 

reduction in lesion size. More children receiving intralesional triamcinolone than topical 

mometasone in a third RCT had an excellent response, but the study did not provide statistical 

comparisons. Lesion reduction did not differ among children receiving different doses of 

prednisolone or methylprednisolone in a cohort study. Of the 219 children who received steroids 

in three comparative studies reporting such data, 140 had a “good” or “fair” response to steroids. 

One study reported that 92 of 238 children who underwent observation only had complete or 

near complete regression of IH at a median of 2 years of followup. In our network meta-analysis, 

oral steroids had a mean estimated expected clearance rate of 43 percent (95% BCI: 21% to 

66%) and intralesional triamcinolone had a rate of 58 percent with wide confidence boundaries 

(95% BCI: 22% to 93%). Overall, SOE is moderate for the effect of oral steroids on clearance 

rates and low SOE for intralesional steroids to have a modest (albeit larger) effect relative to 

control, with wide confidence bounds. 

Harms were varied and frequently included Cushingoid facies, irritability/mood changes, 

growth retardation, and skin atrophy or depigmentation. Studies typically did not explicitly 

report terminations due to adverse events, although one study of oral prednisolone noted 

discontinuation of the drug in 1 of 10 participants due to vomiting. Another comparing 

prednisolone (n=8) and propranolol (n=11) reported five discontinuations in the steroid arm due 

to growth or endocrine changes. Study enrollment was stopped due to adverse events. Overall, 

steroids were consistently associated with clinically important harms that may be important in 

making treatment decisions. The SOE is moderate for the association of steroids with clinically 

important harms. 

Beta-Blockers 

Eighty-one studies (25 comparative studies and 56 case series) evaluated propranolol (oral, 

topical, intralesional), oral nadolol, oral atenolol, or timolol (gel or ophthalmic solution). Betablockers 

typically demonstrated significantly greater effects on reducing lesion size or volume 

than did control or other active comparators. Compared with a mean estimated expected 

clearance rate of 6 percent (95% BCI: 1% to 11%) in placebo or observation arms, oral 

propranolol had a rate of 95 percent (95% BCI: 88% to 99%). We summarize effectiveness 

results by comparator below. 

Harms most frequently reported with beta-blockers included hypotension, hypoglycemia, 

bradycardia, sleep disturbances, cold extremities, gastrointestinal symptoms, and bronchial 

irritation (classified as hyperreactivity, bronchospasm, bronchiolitis, and cold induced wheezing; 

moderate SOE association of propranolol with clinically important and minor harms). Harms 

generally did not cause treatment discontinuation (n=40/2541 [1.6%] children in case series and 

no children in comparative studies). 

Propranolol Versus Observation or Placebo 

We identified four studies (two good and one fair quality RCTs and one fair quality cohort 

study) evaluating propranolol versus placebo or observation. Propranolol was associated with 

significantly greater clearance of IH compared with the control arm in all four studies. In the 

largest RCT, which included 456 children without problematic IH receiving up to 3 mg/kg/day 

of propranolol, 60 percent of children in the propranolol group had complete or near complete 

resolution of IH after 24 weeks of treatment compared with 4 percent in the placebo group. The 

recommended dose of propranolol in this IH population remains to be determined, but the 

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majority of studies to date have investigated the 2 mg/kg/day dosing regimen. Despite changes in 

lesion size in many children receiving propranolol, some children do not appear to respond to 

propranolol, but these children are not well-characterized to date. 

In network meta-analysis, the mean expected clearance rate for oral propranolol was 95 

percent (95% BCI: 88% to 99%) relative to 6 percent for placebo/observation arms (95% BCI: 

1% to 11%); IH size reductions were greater in propranolol arms versus control in all individual 

studies, thus we considered the SOE as high for greater effectiveness of propranolol compared 

with placebo or observation based on individual comparisons and the meta-analysis. 

Propranolol Versus Other Active Modalities 

Ten studies compared propranolol to another modality including steroids, pulse dye laser 

(PDL), bleomycin, or historical treatments. Studies comparing propranolol and steroids to reduce 

IH size had conflicting findings. Propranolol was more effective than steroids in three studies, 

while two others studies did not find effectiveness differed significantly between these 

treatments. In network meta-analysis, pooling data from multiple studies, propranolol was 

superior to oral steroids (95% clearance [95% BCI: 88% to 99%]) versus 43% clearance [95% 

BCI: 22% to 66%]). These combined effects from individual studies and meta-analysis conferred 

moderate SOE for superiority of propranolol over steroids at achieving clearance. 

One additional retrospective cohort study assessing only vision outcomes reported no 

significant differences between oral propranolol and intralesional steroids in improving 

amblyopia, but children in the propranolol arm had a significantly shorter duration of therapy 

(p

Timolol was significantly more effective than observation or placebo in three studies, and one 

study comparing topical imiquimod with timolol did not demonstrate that one intervention was 

more effective than the other. In one study comparing timolol and PDL+Nd:YAG laser, timolol 

was associated with greater improvements in superficial lesions, while laser was associated with 

greater improvements in mixed (superficial and deep) lesions. In another comparing timolol 

alone with timolol plus PDL, mean global assessment scores were more improved in the 

combination arm than in the timolol arm, though IH in 97 percent of children in both arms 

improved from baseline. No harms of timolol were observed in any study. 

In network meta-analysis, the mean expected clearance rate for topical timolol was 62 

percent (95% BCI: 39% to 83%) relative to 6 percent (95% BCI: 1% to 11%) for placebo or 

observation arms. We considered SOE as low for the effectiveness of timolol compared with 

placebo or observation. 

KQ3. Effectiveness and Harms of Second-Line Therapies Following 

Beta-Blockers or Corticosteroids 

We did not identify any studies addressing this question. 

KQ4. Effectiveness and Harms of Surgical Interventions 

Studies of Laser Treatment 

Eleven comparative studies (three RCTs and seven retrospective and one prospective studies 

including a total of 1029 children) and 30 case series (n=3831) addressed surgical approaches. 

We considered one RCT as good, two RCTs and two cohort studies as fair, and the remainder of 

studies as poor quality. 

Most comparative studies were small (≤55 participants), but one RCT and three retrospective 

cohort studies included more than 120 children. Lasers varied across studies in type, pulse width, 

or cooling materials. Most studies assessed variations of PDL (n=7) and examined heterogeneous 

endpoints. Most studies reported on treatment of cutaneous lesions. Several studies used 

historical controls, based on now superseded treatment regimens. 

In two RCTs reporting level of clearance, at least 40 percent of children in laser or 

observation arms had complete or near complete clearance of IH. RCTs included younger 

children with lesions likely in the proliferative phase. One reported no differences in level of 

reduction between traditional and longer pulse PDL. Cohort studies assessed outcomes after 

carbon dioxide and Nd:YAG (neodymium yttrium aluminum garnet) lasers and typically 

reported some resolution of lesion size, but heterogeneity among studies limits our abilities to 

draw conclusions. 

Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for 

cutaneous lesions and Nd:YAG was the most commonly used intralesionally. Most studies 

reported a higher success rate with longer pulse PDL compared to observation in managing the 

size of IH, although the magnitude of effect differed substantially. CO2 laser was used for 

subglottic IH in a single study, and was noted to have a higher success rate and lower 

complication rate than both Nd:YAG and observation. 

Two comparative studies addressed surgical approaches (cryotherapy, intense pulsed light 

photothermolysis, sclerosis) and reported some positive effects in reducing IH size or improving 

appearance, but their smaller size and low quality preclude conclusions (insufficient SOE). 

Strength of evidence for outcomes after surgical treatments ranged from insufficient to low for 

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effectiveness outcomes. The evidence was limited by low sample size, lack of comparisons of 

the same modalities, and variations in the laser settings used including wavelength and cooling 

protocols. For Nd:YAG and CO2 lasers, cryotherapy, and intense pulsed light photothermolysis, 

all studies were severely limited by sample size, and SOE was determined to be insufficient in all 

outcome parameters. 

Harms associated with laser treatment included skin atrophy, bleeding, scarring, ulceration 

purpura, and pigmentation changes. Bleeding and ulceration were observed in the immediate 

postoperative period, distinguishing these complications from the possible natural complications 

of IH themselves. Overall, we considered SOE to be moderate for pigmentation changes with 

PDL, which was most frequently hypopigmentation. SOE was low for bleeding in the immediate 

postoperative period. Due to low sample size and limitations in reporting, pain and scarring were 

found to have insufficient SOE. For Nd:YAG lasers, evaluation for scarring was most frequently 

reported, and there was low SOE to support no difference in scarring between Nd:YAG and 

observation. Evidence was deemed insufficient to comment on pigmentation changes and 

bleeding for children treated with Nd:YAG. 

Studies of Surgical Treatment 

Few comparative studies addressed surgical approaches. Two comparative studies addressed 

cryotherapy versusno treatment and intense pulsed light photothermolysis with or without 

sclerotherapy versus cryotherapy and reported improvements in IH but included few participants 

in each arm (total n = 263). 

Most surgical case series (n=13) were retrospective and included a total of 838 children. We 

considered all to be poor quality for harms reporting and insufficient SOE for association with 

any harms. Frequently reported harms included scarring and wound dehiscence. 

Discussion 

Key Findings From CQs 

The literature identified to answer contextual questions described a broader range of 

indications for referral of patients with IH and suggested support for a higher index of suspicion 

of extracutaneous IH in children with multiple cutaneous lesions or with facial lesions in a beard 

distribution. Studies have primarily assessed associations between cutaneous IH and hepatic IH 

and cutaneous facial IH and airway IH. 

Key Findings and Strength of Evidence for KQs 

Until fairly recently, corticosteroids were the treatment of choice for IH. As reported in this 

review, corticosteroids demonstrate moderate effectiveness but may be associated with clinically 

important side effects. More recently, beta-blockers, and propranolol specifically, have been 

studied and recommended for use. Studies of propranolol have compared its effectiveness to 

placebo or observation arms, to corticosteroids and other modalities, and to other beta-blockers. 

Relative to observation or placebo, propranolol has been consistently shown to be superior in 

individual studies and in our meta-analysis. Relative to other modalities, including steroids and 

bleomycin, we find that propranolol is generally superior. In two studies comparing steroids and 

propranolol, however, differences in reduction of lesion size were not significantly different 

between groups. Finally, given that propranolol has been demonstrated to be associated with 

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positive outcomes, the question of whether effectiveness is associated with propranolol 

specifically or beta-blockers in general has been studied. Although there are only three small 

studies available, they suggest that other beta-blockers may also confer positive effects, 

potentially with fewer side effects, but these findings are preliminary. Studies of the beta-blocker 

timolol, used as a topical gel or solution, also reported greater effectiveness for timolol compared 

with placebo/observation in reducing IH lesion size and no differences in effects in one study 

comparing ophthalmic timolol and imiquimod. 

In our network meta-analysis, propranolol had the highest clearance rate, with high 

variability. The preponderance of available evidence used in the meta-analysis was derived from 

studies of propranolol and corticosteroids. 

In terms of surgical interventions, only laser has been adequately studied. Most studies 

focused on PDL and generally it was found to be more effective than other types of laser, but 

effects remain unclear as studies were significantly heterogeneous, and the role of laser vis-a-vis 

beta-blockers is not clearly described in the literature. Data are inadequate to address the role of 

imaging in guiding treatment. 

We assessed strength of evidence for the effectiveness and harms of interventions using the 

qualitative and quantitative approaches described fully in the Methods section of the full report. 

Overall, the evidence to answer KQs about interventions for children with IH ranged from 

insufficient to moderate when the comparisons are made with the individual studies qualitatively. 

The network meta-analysis provided additional data. We assessed strength of evidence separately 

for the predicted outcomes of the meta-analysis and key direct comparisons available in the 

literature (Tables B-D). 

Imaging 

Studies of imaging modalities addressed different approaches and different anatomic locations 

(intraspinal, hepatic IH). The sensitivity of ultrasound in these two small studies ranged from 20 

percent to 95 percent. Sensitivity of MRI was 100 percent in one study. Findings are limited by 

the size of cohorts, lack of standard processes, and lack of direct comparison at the same time 

point using the various imaging modalities. 

We considered the strength of evidence for all imaging modalities to be insufficient given 

single, small studies addressing different approaches, using weaker study designs and precluding 

a meta-analysis (Table B). The studies did not address harms. 


Studies of corticosteroids similarly evaluated different steroids, routes of administration, and 

comparators. Children in treatment arms in individual studies typically had modest improvement 

in lesion size. In our network meta-analysis, oral steroids had a mean estimated expected 

clearance rate of 43 percent (95% BCI: 21% to 66%), and intralesional triamcinolone had a rate 

of 58 percent (95% BCI: 22% to 93%) but with wide confidence bounds. 

Studies of steroids assessed multiple agents, and we combined these in the meta-analysis into 

oral and intralesional groupings. Thus, while strength of evidence is insufficient on the basis of 

qualitative analysis of single studies of individual agents compared to one another, strength of 

evidence is moderate for the effect of oral steroids on clearance rates and low strength of 

evidence for intralesional steroids to have a modest (albeit larger) effect relative to control with 

wide confidence bounds. Steroids were consistently associated with clinically important harms 

including Cushingoid appearance, infection, growth retardation, hypertension, and mood 

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changes. We considered the strength of evidence to be moderate for the association of steroids 

with these clinically important harms (Table C). 

Beta-Blockers 

Studies of beta-blockers typically reported significantly greater resolution of IH in betablocker 

arms compared with placebo/observation or other active agents. Compared with a mean 

estimated expected clearance rate of 6 percent (95% BCI: 1% to 11%) in placebo or observation 

arms and 43 percent (95% BCI: 21% to 66%) for oral steroids, the mean estimated clearance rate 

for oral propranolol was much higher (95%, BCI: 88% to 99%) in our network meta-analysis. 

In individual comparative studies, propranolol at doses of 2 to 3 mg/kg/day administered for 

6 months promoted lesion regression with few serious side effects in children with IH. While the 

majority of studies investigated propranolol at a total of 2 mg/kg/day, one RCT with the largest 

number of patients utilized a treatment of 3 mg/kg/day. The recommended dose of propranolol in 

this IH population remains to be determined, but the majority of studies to date have investigated 

the 2 mg/kg/day dosing regimen. Despite changes in lesion size in many children receiving 

propranolol, a percentage of patients do not appear to respond to propranolol, but these children 

are not well-characterized to date. 

Other oral beta-blockers (atenolol, nadolol) in small studies demonstrated promising effects 

on reducing lesion size and few adverse effects, which may suggest that improvements can be 

achieved in the propranolol safety profile. Harms most frequently reported with use of oral betablockers 

(propranolol, atenolol, nadolol) included sleep disturbances, cold extremities, 

gastrointestinal symptoms, bronchial irritation (classified as hyperreactivity, bronchospasm, 

bronchiolitis, cold induced wheezing), and decreases in blood pressure or heart rate. 

In studies comparing propranolol with other active comparators including steroids, PDL, 

bleomycin, or historical treatments, findings were inconsistent, with two studies reporting greater 

effectiveness for propranolol compared with steroids and two noting no significant differences 

between propranolol and steroids. In network meta-analysis, oral propranolol was associated 

with a mean estimate of expected clearance of IH of 95 percent (95% BCI: 88% to 99%) 

compared with a lower rate for oral steroids of 43 percent (95% BCI: 21% to 66%). One study 

reported greater effectiveness for propranolol plus laser than propranolol alone. Another study 

found the likelihood of subsequent laser treatment was lower in participants treated with 

propranolol than participants who received other treatments. A study that compared propranolol 

with bleomycin did not demonstrate that one intervention was more effective than the other. 

Studies of the topical beta-blocker timolol reported significantly greater resolution in 

treatment groups compared with placebo or observation, and one study reported no differences 

when compared with imiquimod. In network meta-analysis, the mean expected clearance rate for 

topical timolol was 62 percent (95% BCI: 39% to 83%). 

With adequate data and good precision, we considered the strength of evidence to be high for 

the effect of propranolol on lesion size relative to observation or placebo. Individual studies 

assessed qualitatively also demonstrated greater effectiveness for propranolol compared with 

other active treatments. 

Other oral beta-blockers have demonstrated promising effectiveness; we considered the 

strength of evidence to be low for no difference in response to propranolol and nadolol or 

atenolol based on three small studies. We considered strength of evidence to be low for greater 

effectiveness of topical timolol compared with observation or placebo. We considered the 

ES-17

strength of evidence to be moderate for the association of propranolol with significant and minor 

harms (Table C). 

Surgical Approaches 

Lasers studied varied across studies in type, pulse width, or cooling materials. Most studies 

assessed variations of PDL and examined heterogeneous endpoints. Heterogeneity among studies 

limits our abilities to draw conclusions. Multiple variations in treatment protocols did not allow 

for demonstration of superiority of a single laser method. 

Harms associated with laser treatment included skin atrophy, bleeding, scarring, ulceration 

purpura, and pigmentation changes. Surgical harms included wound dehiscence. 

Strength of evidence for outcomes after laser treatments ranged from insufficient to low for 

effectiveness outcomes (Table D). The evidence was limited by low sample size, and variations 

in the laser settings used including wavelength and cooling protocols. For Nd:YAG and carbon 

dioxide lasers, all studies were severely limited by sample size, and strength of evidence was 

determined to be insufficient in all outcome parameters. For harms, we considered the strength of 

evidence as moderate for pigmentation changes with PDL, which was most frequently 

hypopigmentation and strength of evidence as low for bleeding in the immediate postoperative 

period. Due to low sample size and limitations in reporting, pain and scarring were found to have 

insufficient strength of evidence. For Nd:YAG lasers, evaluation for scarring was most 

frequently reported, and there was low strength of evidence to support no difference in scarring 

between Nd:YAG and observation. Evidence was deemed insufficient to comment on 

pigmentation changes and bleeding for children treated with Nd:YAG and for any harms 

associated with other surgical approaches. 

Table B. Summary of evidence in studies addressing effectiveness of imaging modalities 

Intervention 

Strength of 

Key Outcome(s) 

Evidence 

(SOE) 

Findings 

Grade 

Type/Number 

of Studies 

(Total N 

Participants) 

MRI vs. 

Ultrasound 

Cohort studies: 

1 (48) 

MRI vs. 

Ultrasound vs. 

CT 

Accuracy in detecting 

spinal anomalies 

Accuracy in detecting liver 

IH 

Insufficient Ultrasound had a sensitivity of 50% 

for identifying spinal anomalies 

including but not limited to IH and 

20% for identifying intraspinal IH 

only compared with 100% for MRI. 

Insufficient SOE due to single small 

study with high study limitations. 

Insufficient Ultrasound detected lesions in 42/44 

children (95% sensitivity). 

Insufficient SOE due to single small 

study with high study limitations. 

Cohort studies: 

1 (55) 

Abbreviations: CT = computed tomography; IH = infantile hemangioma; MRI = magnetic resonance imaging; 

RCT = randomized controlled trial; SOE = strength of evidence 

ES-18

Table C. Summary of evidence in studies addressing effectiveness of pharmacologic interventions 

Intervention 

Type/Number of 

Studies (Total N 

Participants) 



Evidence 

(SOE) Grade 

Steroids 

Oral steroids vs. 

Observation or 

Placebo 

Findings 

Improvement in IH Moderate In network meta-analysis oral steroids had a mean expected clearance 

rate of 43% (95% BCI: 21%-66%) compared with 6% (95% BCI: 1%- 

11%) for placebo/observation arms. 

Network metaanalysis 

Intralesional Steroids 

vs. Observation or 

Placebo 

Moderate SOE for greater effectiveness of oral steroids vs. 

placebo/observation given low precision and high study limitations. 

Improvement in IH Low In network meta-analysis intralesional steroids had a mean expected 

clearance rate of 58% (95% BCI: 22%-93%) compared with 6% (95% 

BCI: 1%-11%) for placebo/observation arms. 


All steroids 

RCT: 3 (138) 

Cohort studies: 3 

(179) 

Case series: 10 

(2974) 

Clinically important 

harms (Cushingoid 

facies, growth 

retardation, mood 

changes /irritability, 

hypertension, 

infection) 

Moderate 

Low SOE for greater effectiveness of intralesional steroids vs. 

placebo/observation given relatively small numbers of participants 

contributing to this comparison and low precision. 

Comparative studies, case series, and package insert data consistently 

reported these adverse effects. 

Moderate SOE for association of steroids with clinically important harms 

due to high study limitations. 

ES-19

Table C. Summary of evidence in studies addressing effectiveness of pharmacologic interventions (continued) 

Intervention 



Participants) 



Evidence 

(SOE) Grade 

Findings 

Beta-Blockers 

(continued) 

Oral propranolol vs. 

Placebo or 

Observation 


RCT: 3 (510) 

Improvement in IH High In network meta-analysis, the mean expected clearance rate for oral 

propranolol was 95% (95% BCI: 88%-99%) relative to 6% (95% BCI: 

1%-11%) for placebo/observation arms; greater reductions in IH size in 

propranolol arms vs. control in all individual studies. 

High SOE for greater effectiveness of propranolol vs. placebo or 

observation based on individual comparisons and the meta-analysis. 

Cohort studies: 1 (45) 

Propranolol vs. 

Placebo or 

Observation 

RCT: 1 (456) 



Steroids 


RCT: 1 (19) 


(216) 


Steroids 


Rebound growth/Need 

for further treatment 

Moderate 

Fewer than 15% of children in treatment arms had rebound growth or 

required longer/additional treatment. 

Moderate SOE for low level of rebound growth/need for further 

treatment associated with propranolol given few studies addressing the 

outcome. 

Improvement in IH Moderate In head-to-head comparisons, propranolol more effective than steroids 

in 3 studies; 2 other studies reported no significant difference between 

oral or intralesional propranolol and oral or intralesional steroids. In 

network meta-analysis, pooling data from multiple studies, propranolol 

was superior to oral steroids (95% [95% BCI: 88% to 99%] clearance 

versus 43% [ 95% BCI: 21% to 66%] clearance). 

Moderate SOE for superiority of propranolol over steroids at achieving 

clearance based on combined effects from individual studies and 

network meta-analysis, high study limitations, and inconsistency. 

Amblyopia Insufficient No significant difference in level of amblyopia between oral propranolol 

and intralesional triamcinolone arms 

in one small study. 

Insufficient SOE due to single study with high limitations. 

ES-20


Intervention 



Participants) 



Evidence 

(SOE) Grade 

Findings 

Beta-Blockers 

(continued) 

Oral propranolol + 

prednisolone vs. 

Prednisolone vs. 

Propranolol alone 

Improvement in IH Insufficient Significant size reductions from baseline in propranolol and combined 

arms (p values


Intervention 



Participants) 



Evidence 

(SOE) Grade 

Findings 

Beta-Blockers 

(continued) 

Topical timolol vs. 

PDL + Nd:YAG laser 

Improvement in IH Insufficient Greater response to timolol among superficial IH and greater response 

to laser among mixed IH (p=NR). 

RCT: 1 (60) 

Oral propranolol 

RCT: 3 (515) 


(277) 


(1274) 

Topical timolol 

RCT: 1 (41) 


(287) 

Significant and minor 

harms (significant: 

hypotension, 

bradycardia, 

bronchospasm, 

hypoglycemia; minor: 

cold extremities, 

diarrhea, sleep 

changes) 

Moderate 

Insufficient SOE due to single study with high limitations. 

Rates of clinically important harms ranged from 0 to 100% across 

studies and from 1% to 50% for minor harms. 

Moderate SOE for association of propranolol with these harms based 

on high study limitations. 

Lack of harms Low No harms observed with timolol in 5 comparative studies and 1 case 

series. Shortness of breath and insomnia observed in 1 of 30 children in 

one comparative study. 

Low SOE for lack of association of timolol with harms based on few 

studies. 

Case series: 1 (25) 

ES-22


Intervention 



Participants) 



Evidence 

(SOE) Grade 

Findings 

Beta-Blockers 

(continued) 

Oral nadolol 


Oral atenolol 

RCT: 1 (23) 




hypotension, 

bradycardia, 

bronchospasm, 

hypoglycemia; minor: 



changes) 



hypotension; minor: 



changes) 

Insufficient 

Insufficient 

Harms reported in 20% to 50% of children. 

Insufficient SOE due to single, small study with high limitations. 

Harms reported ranged from 3% to 27% in 2 small studies 

Insufficient SOE due to high study limitations and few studies. 

BCI = Bayesian credible interval; IH = infantile hemangioma; PDL= pulse dye laser; RCT = randomized controlled trial; SOE = strength of evidence 

ES-23

Table D. Summary of evidence in studies addressing effectiveness of surgical interventions 

Intervention 



Participants) 



Evidence 

(SOE) Grade 

Lasers 

Longer pulse PDL vs 

other laser types and 

protocols 

RCT: 1 (52) 

Findings 

Improvement in IH Low Resolution outcomes similar between laser types. 

Low SOE for no difference in effects on size reduction between longer 

pulse PDL and various other lasers given few studies, medium 

limitations, and inconsistent and imprecise findings. 


(212) 

PDL vs. Observation 

RCT: 2 (143) 

PDL vs. Observation 

RCT: 2 (143) 

Nd:YAG with 

extended cooling vs. 

Nd:YAG with 

standard cooling 

Cohort studies:1 

(290) 

Nd:YAG vs. CO2 

laser vs. 

Tracheostomy 


Improvement in IH Low No significant difference in measured volume or proportion of clearance 

between groups; greater observer-ratings of improvement for PDL arm 

in one study. 

Low SOE for effectiveness of PDL vs. observation in reducing lesion 

size. 

Quality of life Low No significant differences in parent ratings of QoL in one study; more 

parents of children in PDL arm in another considered appearance 

improved than in observation arm. 

Low SOE for no difference between PDL treatment and observation in 

reducing lesion size due to lack of precision, few studies.. 

Improvement in IH Insufficient Improved resolution with extended cooling protocol vs. traditional in 

single study with medium limitations. 

Insufficient SOE given single study with medium limitations. 

Speech Insufficient 75% of children with tracheostomy had delayed speech vs. 0 with no 

tracheostomy in the laser treatment era. 

Insufficient SOE given small, single study with high limitations. 

ES-24

Table D. Summary of evidence in studies addressing effectiveness of surgical interventions (continued) 

Intervention 



Participants) 



Evidence 

(SOE) Grade 

Lasers 

(continued) 

PDL 

RCT: 2 (173) 


Findings 

Pigmentation changes Moderate Hypo- or hyper-pigmentation consistently reported, with 

hypopigmentation reported more frequently. 

Moderate SOE for association of PDL with skin pigmentation 

complications based on relatively few participants in studies. 


PDL 

RCT: 1 (121) 

PDL 

RCT: 1 (121) 

PDL 



Nd: YAG 


Nd: YAG 


(386) 

Bleeding Low No significant difference in bleeding between short pulse PDL and 

observation groups. 

Low SOE for association of bleeding with PDL based on one study with 

low limitations, unknown consistency, and imprecision. 

Pain Insufficient 13% of parents reported pain for their children after PDL. 

Insufficient SOE for pain following PDL given low numbers of outcome. 

Pain is also difficult to assess in infant population. 

Scarring Insufficient 1/25 children receiving PDL in one study and 7/769 children in case 

series had scarring. 

Insufficient SOE due to few instances of the outcome reported in 

studies. 

Pigmentation changes Insufficient 2/25 children receiving Nd:YAG in one study had scarring. 


studies. 

Scarring Low Most studies reported scarring in ≤5% of children in 6 studies. 

Low SOE for association of scarring with Nd:YAG treatment due to few 

occurrences of the outcome reported. 


Nd: YAG 


Bleeding Insufficient Bleeding noted in 13/794 children in 2 studies. 


studies. 

ES-25

Table D. Summary of evidence in studies addressing effectiveness of surgical interventions (continued) 

Intervention 



Participants) 



Evidence 

(SOE) Grade 

Findings 

Surgical 

Cryotherapy vs. 

Observation 

Improvement in IH Insufficient 76% of IH in treated arm vs. 12% in untreated resolved without 

scarring. 

Comparative study: 1 

(13) 

Cryotherapy vs. 

Observation 

Comparative study: 1 

(13) 

Photothermolysis 

with 

Intense Pulsed Light 

With or Without 

Sclerosis vs. 

Cryotherapy 


(250) 

Excision or resection 


Excision or resection 


Insufficient SOE given single, small study with high limitations. 

Scarring Insufficient Scarring in 4 of 17 IH treated with cryotherapy. 

Insufficient SOE due to single, small study with high limitations. 

Improvement in IH Insufficient More children had ≥50% reduction in IH size in the combined therapy 

arm than in other arms (p=NR). 

Scarring Insufficient Scarring in 11/192 children. 

Insufficient SOE given single study with high limitations. 


studies. 

Wound dehiscence Insufficient Dehiscences in 20/483 children. 


studies with high limitations. 

BCI = Bayesian credible interval; IH = infantile hemangioma; Nd:YAG = neodymium- yttrium aluminum garnet; PDL= pulse dye laser; QoL = quality of life; RCT = randomized 

controlled trial; SOE = strength of evidence 

ES-26

Applicability 

We set inclusion criteria intended to identify studies with applicability to children with IH 

between the ages of 0 and 18 years. Studies differed in terms of study population and outcome 

measures. Most studies included children with IH in multiple anatomic locations and did not 

report effectiveness by lesion site or type. Most studies were non-comparative, and lack of direct 

comparisons of treatment options and few studies addressing the same interventions and 

comparators further hinder our ability to understand what findings will best extrapolate to 

children at specific ages, with specific lesion types, or in specific anatomic locations. Further, 

most comparative studies were conducted in larger medical centers or referral centers, which is 

in line with typical treatment as most children with IH are referred to specialists from general 

practitioners. 

Overall the available data on the effectiveness and harms of beta-blockers and corticosteroids 

are largely applicable to the general population of children with IH. Most studies included a 

majority of females, in line with the female predominance of IH, and ages in comparative studies 

generally ranged from 1 month to 9 years. One cohort study included individuals between 1 

month and 43 years of age, with a mean age of 2 years and 11 months. 

Few studies addressed imaging modalities, and those that did evaluated modalities to assess 

hepatic or intraspinal IH. Studies compared ultrasound, magnetic resonance imaging, computed 

tomography, and angiography. Imaging was sometimes not conducted at the same time, which 

limits comparability, and potentially the applicability of findings. Studies were also completed 

prior to 2010, so imaging techniques and practices may have changed. 

Studies addressing steroids compared various routes of steroid administration (oral, topical, 

and intralesional) and various agents (methylprednisolone, triamcinolone, mometasone furoate) 

in children with ages ranging from less than 1 to 72 months. Studies likely included children 

with IH in the proliferative and involution phase, which may limit applicability to younger or 

older children. One comparative study was conducted in Canada and the others in Turkey, 

Pakistan, and India. Applicability may be limited given differences in the systems of care in 

lower resource countries. Comparative studies were also published between 2001 and 2010 and 

may not fully represent evolutions in standards of care. 

Studies of beta-blockers typically included infants of both sexes ages 1 to 12 months of age 

(range: 1 month - 9 years) with superficial, deep, and mixed lesions primarily involving the head 

and neck and occurring as focal or segmental lesions. Studies of topical or ophthalmic timolol 

typically included children with superficial lesions, though two of six comparative studies 

included children with superficial and deep lesions. Children were treated with a variety of betablockers 

including propranolol at various doses and administrations (oral, intralesional, or 

topical), timolol (topical or ophthalmic), atenolol (oral), or nadolol (oral), most commonly for up 

to 6 months duration. These agents and dosage forms are typically easily available in the United 

States and not universally available. Dosage amounts ranged from 1 to 4 mg/kg/day. Doses over 

2 mg/kg/day are not typically administered and may limit applicability of findings of two studies 

of propranolol. 

Surgical studies, conducted in the United States, the United Kingdom, the Netherlands, 

Germany, Greece, Japan and Singapore, included infants of both sexes with a preponderance of 

females (age range: 1 week to 43 years of age) with superficial and cutaneous infantile 

hemangiomas in varied locations. One study reported laser use for subglottic IH and one 

evaluated photothermolysis with intense pulsed light and cryosurgery in children of maxillary 

ES-27

IH. Most comparative studies evaluated laser treatments including short-pulse and longer pulse 

PDL, Nd:YAG, and argon. Two studies evaluated cryotherapy, one of which compared it to 

photothermolysis with intense pulsed light with or without concomitant sclerosis. Applicability 

of many of these studies is limited by historical changes in care and technology. 

Newer lasers and adjunctive features such as dynamic cooling have resulted in older lasers 

being out of date, thus limiting the applicability of studies conducted with those models. Most 

laser studies evaluated lasers as first-line treatment, which is currently less common in practice 

since the advent of beta-blocker treatment in countries, like the United States, where such 

treatments are readily available, as beta-blockers have generally superseded other treatments as 

first-line management of IH. Additionally, most comparative literature evaluated PDL, which is 

typically used only for the treatment of superficial lesions. 

Limitations of the Evidence Base 

The evidence base for IH treatment is limited by a small number of comparative studies 

including a limited number of participants. While cohort studies compared at least two different 

interventions, few presented truly comparative data. A number of studies reported only absolute 

differences in resolution or other outcomes, with no statistical comparison, in part likely due to 

their small sample sizes. Similarly, few studies reported baseline characteristics of the lesion, so 

understanding the magnitude of change reported is challenging. Most studies included children 

with problematic IH, so change was likely substantial, and parents and children may value any 

lessening of lesion size or change in color or texture. 

A growing number of studies address beta-blockers, but current studies are limited by a 

general lack of long-term followup and analyses to explore differences in response among 

subgroups. Studies may also have used compounded forms of beta-blockers, which may add to 

the complexity of interpreting dosage amounts. Few comparative studies addressed steroids, and 

indications for steroid treatment compared with beta-blockers are unclear. Few comparative 

studies addressed surgical approaches besides laser modalities, and those addressing lasers used 

different interventions and comparators, limiting comparisons across studies. Technological 

advances have also changed the indications for treatment, and a historical trend towards treating 

smaller, less severe lesions, similarly make analyses difficult because of changing indications for 

and expectations of treatment. 

Studies are also limited by the use of multiple and variable outcome measures to assess 

resolution of lesions. As no objective lab value or other measures exist to determine size 

changes, investigators have developed multiple techniques, and studies did not always report 

scales or other approaches clearly. The variety of scales (e.g., percentage change, mean change, 

visual analog scale, hemangioma activity score) make combining outcomes challenging. 

Similarly, studies typically included multiple lesion types in multiple locations, which 

complicates determining potential differences in response , and treatment approaches varied 

across studies (e.g., doses and dosage forms, level of patient monitoring, timing of treatment and 

followup). 

The most important deficiency in the reported outcomes across studies is the tendency for 

the reporting of discretized outcomes, when the underlying outcome is a continuous variable. 

Specifically, though outcomes are likely recorded as a continuous measure (i.e., the proportion of 

an existing lesion that is cleared or reduced in size following treatment), authors often chose an 

arbitrary cutoff proportion (or a small number of bins) and reported only the numbers in each of 

the resulting categories. This results in an immediate and unrecoverable loss in power for any 

ES-28

quantitative meta-analyses. Researchers should be encouraged to report outcome variables as 

they were recorded, without transforming them in such a way that information is lost. In 

addition, methods for measurement of outcomes such as rebound growth are not clearly reported; 

thus, our understanding of the magnitude of regrowth is limited. 

Implications for Clinical and Policy Decisionmaking 

This review provides evidence for use in clinical care of children who present with IH. It 

particularly points to moderate benefits with steroid treatment and greater improvements with 

beta-blockers, with propranolol being the most commonly studied. When a decision to treat is 

made, our review provides qualitative and quantitative evidence that beta-blockers are associated 

with substantial improvement in IH size/volume (mean expected clearance rate of 95% for oral 

propranolol [95% BCI: 88% to 99%] and 62% [95% BCI: 39% to 83%] for topical timolol 

compared with 6% for observation/placebo arms [95% BCI: 1% to 11%]). 

Steroids were associated with mean expected clearance rates of 43 percent for oral steroids 

(95% BCI: 21% to 66%) and 58 percent (95% BCI: 22% to 99%) for intralesional triamcinolone 

in our network meta-analysis, but side effects are significant, and clinicians and families will 

need to weigh the benefits and harms. 

It is important for clinicians to know that the literature summarized here primarily examines 

children with problematic or complicated IH and thus may not apply to all patients. In one large 

trial evaluating active treatment with propranolol for children without problematic IH, 

propranolol was associated with complete resolution or near complete resolution in 60 percent of 

cases (vs. 4% in placebo arm). In addition, studies typically reported outcomes only in the short 

term (

Given the lack of long-term data on harms of interventions, clinicians and families must 

balance the potential of both short- and long-term harms with the benefits of potential resolution 

or size reduction of lesions. 

Research Gaps 

While a growing number of comparative studies address treatments for IH, a number of 

research gaps exist. These gaps include a lack of information on: 

• Indications, optimal timing, and optimal modalities for imaging and diagnostic 

approaches. Few studies in the literature we reviewed reported imaging or diagnostic 

techniques, and data on optimal approaches for each are lacking in the current research 

base. In general, imaging is infrequently used to differentiate accurately an IH from other 

vascular lesions. When a diagnosis is in question, a tissue biopsy is the most accurate 

method to determine the diagnosis. Future studies should use imaging modalities at the 

same point in the IH course to allow direct comparison. Studies should also report 

adverse effects of imaging, which are not addressed in the literature meeting criteria for 

this review. 

• Indications for treatment and treatment referral. While it is likely that non-placebocontrolled 

studies reviewed here included mostly children with problematic IH (e.g., 

lesions that are vision-threatening or disfiguring, ulcerated lesions, airway/lifethreatening 

lesions), studies did not always clearly report indications for treatment or 

referral for treatment. Children may be referred for life-, functional-, or visionthreatening 

reasons, but in the beta-blocker era, potential disfigurement is likely a cause 

for referral. 

• Appropriate dosing for propranolol and timing of treatment. The largest RCT to 

date 28 used doses of either 1 mg/kg or 3 mg/kg, but other studies typically used doses of 

2-2.5 mg/kg, and ages of children and number, severity, and type of lesions varied among 

study populations. Existing studies do not provide data to determine optimal dosing. 

Similarly, few studies reported on resolution outcomes by phase (i.e., proliferative, 

involution). Studies likely included mostly children in the proliferative phase, but the 

effectiveness of propranolol during the involution phase is not clear. Similarly, because 

proliferation may occur up to and after 12 months of age, the effectiveness of starting 

beta-blockers in older children is not clear. 

• Optimal duration of beta-blocker use. Duration of propranolol treatment ranged from 3 

to 13 months in comparative studies, but the optimal duration of treatment is not clear. 

Studies generally treated children for 6 months, potentially so that effects observed were 

likely drug-related and not the result of natural involution. However, current studies have 

not addressed the question of optimal timing to achieve maximal benefit. 

• Long-term outcomes and harms of beta-blockers. While harms reported in studies of 

beta-blockers were typically not severe, only one comparative study 29 had greater than 6 

months followup after the end of treatment. Longer term effects on cardiovascular and 

metabolic parameters known to be affected by beta-blocker use as well as effects on 

cognition, memory, and the central nervous system are not well-understood in the 

population of very young children receiving beta-blockers for IH. 30 

• Treatment choice for specific lesion types and locations. Characteristics, such as lesion 

size, location, and persistence, as well as modifiers such as patient age, functional impact, 

and IH subtype influence whether children are treated with pharmacologic agents or 

ES-30

surgically. Lesion characteristics also influence the choice of specific pharmacologic 

agents. Most studies included multiple lesion types and in multiple locations, and few 

included specific modifier analyses or reported outcomes by lesion characteristics. 

Research to improve understanding of which lesions are likely to respond best to specific 

agents is critical, especially as understanding of the effectiveness of beta-blockers in the 

involution phase is limited. Optimal treatment in the proliferative phase may be key to 

maximal resolution of IH. 

• Assessment of methods for assessing rebound growth. A number of studies reported 

regrowth of lesions but typically did not indicate what constituted rebound growth. 

Greater clarity in reporting this outcome would help to clarify our understanding of 

effectiveness. 

• Characteristics that may influence response to beta-blockers. Studies of beta-blockers 

were typically not powered to provide information on subgroups, but a percentage of 

children did not respond or responded minimally to propranolol. In 10 comparative 

studies of beta-blockers reporting these data, 15,29,31-39 20 percent of children (n=63/314) 

had a limited or no response to the agent. We lack data to assess whether improvement in 

lesions or promotion of involution is affected by child age or number, severity, type, or 

anatomic location of lesions. Similarly, understanding the mechanisms of growth of IH 

will promote our understanding of response to treatments and treatment safety. 

• Use of beta-blockers other than propranolol. Small cohort studies of oral atenolol and 

nadolol and topical or ophthalmic timolol showed positive effects on IH resolution with 

few side effects. Additional RCTs of these agents, with clear reporting of lesion 

parameters and child characteristics, would increase our understanding of their 

effectiveness and comparative effectiveness versus propranolol. 

• Treatments for hepatic IH. Few treatment studies explicitly reported if children had 

hepatic IH. Most studies included children with IH in multiple locations, so children 

could have had hepatic IH as well; however, the applicability of findings to children with 

visceral IH is not clear. 

• Use of steroids and laser treatments in the beta-blocker era. Clinical practice in the 

United States is moving toward use of a beta-blocker as the first-line treatment for IH; 40 

however, a number of recent studies report use of steroids and laser treatments in younger 

children with lesions in the proliferative stage. Given the side effect profile of steroids, 

understanding of whether or when to use such agents in the absence of life-threatening 

lesions or contraindications to beta-blockers is needed. Current literature does not provide 

sufficient data to address these questions. 

• Interventions to follow beta-blockers or corticosteroids if such treatments fail. We 

did not identify any studies that clearly reported data on this question. While most 

children receiving beta-blockers in the studies reviewed here responded to the 

medication, some had no or minimal response. 

• Standardization of scoring tools to assess change in IH. IH outcomes are necessarily 

assessed using subjective measures, and investigators typically reported grading scales 

used to assess change in IH size or appearance. Few studies, however, commented on 

interrater reliability of instruments. Research to improve standardization among tools and 

the development of uniform scoring systems and measurements would improve our 

ability to combine outcomes across studies. 

ES-31

• Standardization of nomenclature. Data extraction and comparisons in the review were 

limited by inconsistent naming conventions. Agreement and adherence to a standard 

classification of lesions would improve the ability of researchers to focus on individual 

lesion types and determine optimal treatment regimens for specific lesions. 

Conclusions 

Corticosteroids demonstrate some effectiveness at reducing IH size/volume, but may be 

associated with significant side effects. Propranolol is effective at reducing the size of IH, with 

high strength of evidence for effects on reducing lesion size, and compared with placebo, 

observation, and other treatment methods including steroids in most, but not all, studies. In a 

network meta-analysis, the largest mean estimate of expected clearance was for oral propranolol 

(95%, 95% BCI: 88% to 99%), followed by timolol (62%, 95% BCI: 39% to 83%) and 

triamcinolone (58%, 95% BCI: 22% to 93%). The mean rate was 43 percent for oral steroids 

(95% BCI: 21% to 66%). With fairly wide confidence bounds and limited data in some areas, the 

relative differences among these estimates are of greater importance than the absolute effects. 

The estimates provide a relative ranking of anticipated rates of lesion clearance among treatment 

options. Families and clinicians making treatment decisions should also factor in elements such 

as lesion size, location, type, and number, which may affect choice of treatment modality, as well 

as patient/family preferences. Evidence pointed to substantial side effects for corticosteroids; 

harms were also noted with beta-blockers, but overall, these were well tolerated in the short term. 

Few studies have assessed potential long-term harms associated with beta-blocker use in infants 

and children. Laser studies generally found PDL more effective than other types of laser, but 

effects remain unclear as studies are heterogeneous and the role of laser vis-a-vis beta-blockers is 

not clearly described in the literature. Data are inadequate to address the role of imaging in 

guiding treatment. 

ES-32

References 

1. Wassef M, Blei F, Adams D, et al. Vascular 

Anomalies Classification: 

Recommendations From the International 

Society for the Study of Vascular 

Anomalies. Pediatrics 2015 Jul;136(1):e203- 

14. PMID: 26055853. 

2. Kilcline C, Frieden IJ. Infantile 

hemangiomas: how common are they? A 

systematic review of the medical literature. 

Pediatr Dermatol 2008 Mar-Apr;25(2):168- 

73. PMID: 18429772. 

3. Hoornweg MJ, Smeulders MJ, van der Horst 

CM. [Prevalence and characteristics of 

haemangiomas in young children]. Ned 

Tijdschr Geneeskd 2005 Oct 

29;149(44):2455-8. PMID: 16285361. 

4. Jacobs AH, Walton RG. The incidence of 

birthmarks in the neonate. Pediatrics 1976 

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5. Enjolras O, Mulliken JB. The current 

management of vascular birthmarks. Pediatr 

Dermatol 1993 Dec;10(4):311-3. PMID: 

8302734. 

6. Chang LC, Haggstrom AN, Drolet BA, et al. 

Growth characteristics of infantile 

hemangiomas: implications for 

management. Pediatrics 2008 

Aug;122(2):360-7. PMID: 18676554. 

7. Ceisler EJ, Santos L, Blei F. Periocular 

hemangiomas: what every physician should 

know. Pediatr Dermatol 2004 Jan- 

Feb;21(1):1-9. PMID: 14871317. 

8. Kim HJ, Colombo M, Frieden IJ. Ulcerated 

hemangiomas: clinical characteristics and 

response to therapy. J Am Acad Dermatol 

2001 Jun;44(6):962-72. PMID: 11369908. 

9. Chamlin SL, Haggstrom AN, Drolet BA, et 

al. Multicenter prospective study of 

ulcerated hemangiomas. J Pediatr 2007 

Dec;151(6):684-9, 9.e1. PMID: 18035154. 

10. Iacobas I, Burrows PE, Frieden IJ, et al. 

LUMBAR: association between cutaneous 

infantile hemangiomas of the lower body 

and regional congenital anomalies. J Pediatr 

2010 Nov;157(5):795-801.e1-7. PMID: 

20598318. 

11. Stockman A, Boralevi F, Taieb A, et al. 

SACRAL syndrome: spinal dysraphism, 

anogenital, cutaneous, renal and urologic 

anomalies, associated with an angioma of 

lumbosacral localization. Dermatology 

2007;214(1):40-5. PMID: 17191046. 

12. Hartemink DA, Chiu YE, Drolet BA, et al. 

PHACES syndrome: a review. Int J Pediatr 

Otorhinolaryngol 2009 Feb;73(2):181-7. 

PMID: 19101041. 

13. Tawfik AA, Alsharnoubi J. Topical timolol 

solution versus laser in treatment of infantile 

hemangioma: a comparative study. Pediatr 

Dermatol 2015 Mar 5PMID: 25740672. 

14. 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: 

19706583. 

15. Hogeling M, Adams S, Wargon O. A 

randomized controlled trial of propranolol 

for infantile hemangiomas. Pediatrics 2011 

Aug;128(2):e259-66. PMID: 21788220. 

16. Georgountzou A, Karavitakis E, 

Klimentopoulou A, et al. Propranolol 

treatment for severe infantile hemangiomas: 

a single-centre 3-year experience. Acta 

Paediatr 2012 Oct;101(10):e469-74. PMID: 

22804809. 

17. Leaute-Labreze C, Dumas de la Roque E, 

Hubiche T, et al. Propranolol for severe 

hemangiomas of infancy. N Engl J Med 

2008 Jun 12;358(24):2649-51. PMID: 

18550886. 

18. Chang E, Boyd A, Nelson CC, et al. 

Successful treatment of infantile 

hemangiomas with interferon-alpha-2b. J 

Pediatr Hematol Oncol 1997 May- 

Jun;19(3):237-44. PMID: 9201147. 

19. Metry DW, Hebert AA. Benign cutaneous 

vascular tumors of infancy: when to worry, 

what to do. Arch Dermatol 2000 

Jul;136(7):905-14. PMID: 10890993. 

20. Mulliken JB, Glowacki J. Hemangiomas and 

vascular malformations in infants and 

children: a classification based on 

endothelial characteristics. Plast Reconstr 

Surg 1982 Mar;69(3):412-22. PMID: 

7063565. 

ES-33

21. Viswanathan M, Ansari MT, Berkman ND, 

et al. Assessing the Risk of Bias of 

Individual Studies in Systematic Reviews of 

Health Care Interventions. Methods Guide 

for Effectiveness and Comparative 

Effectiveness Reviews. Rockville (MD); 

2008. 

22. Wells G, Shea B, O'Connell D, et al. The 

Newcastle-Ottawa Scale (NOS) for 

assessing the quality of nonrandomised 

studies in meta-analyses. Available at 

http://www.ohri.ca/programs/clinical_epide 

miology/oxford.asp. 

23. Whiting PF, Rutjes AW, Westwood ME, et 

al. QUADAS-2: a revised tool for the 

quality assessment of diagnostic accuracy 

studies. Ann Intern Med 2011 Oct 

18;155(8):529-36. PMID: 22007046. 

24. McMaster Centre for Evidence-based 

Practice. McMaster Quality Assessment 

Scale of Harms (McHarm) for primary 

studies. Hamilton ON: McMaster 

University; 2008. 

25. Methods Guide for Effectiveness and 

Comparative Effectiveness Reviews. AHRQ 

Publication No. 10(14)-EHC063-EF. 

Rockville, MD: Agency for Healthcare 

Research and Quality. January 2014. 

Chapters available at: 

www.effectivehealthcare.ahrq.gov. 

26. Drolet BA, Chamlin SL, Garzon MC, et al. 

Prospective study of spinal anomalies in 

children with infantile hemangiomas of the 

lumbosacral skin. J Pediatr 2010 

Nov;157(5):789-94. PMID: 20828712. 

27. Kassarjian A, Zurakowski D, Dubois J, et al. 

Infantile hepatic hemangiomas: clinical and 

imaging findings and their correlation with 

therapy. AJR Am J Roentgenol 2004 

Mar;182(3):785-95. PMID: 14975986. 

28. Léauté-Labrèze C, Hoeger P, Mazereeuw- 

Hautier J, et al. A randomized, controlled 

trial of oral propranolol in infantile 

hemangioma. N Engl J Med 

2015;372(8):735-46. PMID: 25693013. 

29. Chambers CB, Katowitz WR, Katowitz JA, 

et al. A controlled study of topical 0.25% 

timolol maleate gel for the treatment of 

cutaneous infantile capillary hemangiomas. 

Ophthal Plast Reconstr Surg 2012 Mar- 

Apr;28(2):103-6. PMID: 22410658. 

30. Mawn LA. Infantile hemangioma: treatment 

with surgery or steroids. Am Orthopt J 

2013;63:6-13. PMID: 24260801. 

31. Bauman NM, McCarter RJ, Guzzetta PC, et 

al. Propranolol vs prednisolone for 

symptomatic proliferating infantile 

hemangiomas: a randomized clinical trial. 

JAMA Otolaryngol Head Neck Surg 2014 

Apr;140(4):323-30. PMID: 24526257. 

32. Zaher H, Rasheed H, Esmat S, et al. 

Propranolol and infantile hemangiomas: 

different routes of administration, a 

randomized clinical trial. Eur J Dermatol 

2013 Sep-Oct;23(5):646-52. PMID: 

24135427. 

33. Chan H, McKay C, Adams S, et al. RCT of 

timolol maleate gel for superficial infantile 

hemangiomas in 5- to 24-week-olds. 

Pediatrics 2013 Jun;131(6):e1739-47. 

PMID: 23650294. 

34. De Graaf M, Araphael M, Breugem C, et al. 

Treatment of infantile hemangiomas with 

atenolol or propranolol: Cohort study with 

historical control group. European Journal of 

Pediatric Dermatology 2012 March;22 

(1):12. PMID: 70795379. 

35. de Graaf M, Raphael MF, Breugem CC, et 

al. Treatment of infantile haemangiomas 

with atenolol: comparison with a historical 

propranolol group. J Plast Reconstr Aesthet 

Surg 2013 Dec;66(12):1732-40. PMID: 

24011909. 

36. Sondhi V, Patnaik SK. Propranolol for 

infantile hemangioma (PINCH): an openlabel 

trial to assess the efficacy of 

propranolol for treating infantile 

hemangiomas and for determining the 

decline in heart rate to predict response to 

propranolol. J Pediatr Hematol Oncol 2013 

Oct;35(7):493-9. PMID: 23929318. 

37. Reddy KK, Blei F, Brauer JA, et al. 

Retrospective study of the treatment of 

infantile hemangiomas using a combination 

of propranolol and pulsed dye laser. 

Dermatol Surg 2013 Jun;39(6):923-33. 

PMID: 23458381. 

38. Awadein A, Fakhry MA. Evaluation of 

intralesional propranolol for periocular 

capillary hemangioma. Clin Ophthalmol 

2011;5(1):1135-40. PMID: 2011458331. 

ES-34

39. Yu L, Li S, Su B, et al. Treatment of 

superficial infantile hemangiomas with 

timolol: Evaluation of short-term efficacy 

and safety in infants. Exp Ther Med 2013 

August;6(2):388-90. PMID: 2013417689. 

40. Drolet BA, Frommelt PC, Chamlin SL, et al. 

Initiation and use of propranolol for infantile 

hemangioma: report of a consensus 

conference. Pediatrics 2013 Jan;131(1):128- 

40. PMID: 23266923. 

ES-35

Introduction 

Background 

Infantile hemangiomas (IH) are the most common tumors of childhood. IH are benign but 

possess potential for local tissue damage, ulceration, infection, bleeding, functional impact, and 

pain. The International Society for the Study of Vascular Anomalies classifies IH as vascular 

tumors that are differentiated from vascular malformations in several ways including natural 

history, cellular composition, immunohistochemical expression, and pathology. 1 Due to 

historical inconsistencies in naming conventions, it is difficult to know the true prevalence of IH, 

but it is estimated that they affect about 4 to 5 percent of children, 2 with higher prevalence in 

females and Caucasians. 3,4 The most common locations of IH are the head, neck, and trunk, but 

they can occur almost anywhere throughout the body, including the extremities, the spine, and 

visceral organs. 5-7 IH also can be associated with a constellation of congenital anomalies such as 

PHACES (posterior fossa malformations, hemangiomas, arterial anomalies, cardiac defects, eye 

abnormalities, sternal cleft and supraumbilical raphe) PELVIS (perineal hemangioma, external 

genitalia malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate anus, 

and skin tag) and LUMBAR (lower-body hemangioma and other cutaneous defects, urogenital 

anomalies, ulceration, myelopathy, bony deformities, anorectal malformations, arterial 

anomalies, and renal anomalies) syndromes. 

IH tend to go through growth and involution phases, although the complete natural history of 

IH has not been described. In most children, IH will become apparent in the first few weeks of 

life and reach 80 percent of total size by around 3 to 5 months. 8,9 With expectant observation, 

many patients may experience a complete or near complete involution without significant 

sequelae; however, IH frequently occur in cosmetically and functionally sensitive areas. Even 

with complete involution, some patients have permanent disfigurement and functional 

compromise. 10 Early assessment of the extent of the hemangioma, and early, appropriate 

treatment of IH may potentially mitigate these complications; however, in one large multicenter 

treatment analysis, the first specialist visit for infants and children in the study did not occur until 

a mean of 5 months of age. 9 

Furthermore, some lesions are particularly aggressive or morbid and can cause severe pain, 

ulceration, and bleeding even in early stages. 11,12 The rapid growth of IH leaves little time for 

prospective observation to determine which IH will lead to complications and require specialist 

attention and treatment before complications begin to manifest. Some types of IH, specifically 

segmental IH such as those associated with related syndromes like PHACES, LUMBAR, or 

PELVIS, are recognized as high risk, but no consensus exists on which non-segmental lesions 

warrant referral for appropriate treatment to mitigate future complications (e.g., bleeding, 

ulceration) of the hemangioma or long-term sequelae (e.g., scarring, anatomical disfigurement, 

functional complications). 5,7,13 

Diagnosis and Treatment Decisions 

Evaluation through the use of various diagnostic imaging modalities has generally been 

reserved for deep lesions to help understand their extent or to confirm the diagnosis of IH. Purely 

cutaneous lesions do not require imaging, but opinions regarding the initial diagnostic test of 

choice for more extensive IH, including deep, segmental, and syndromic lesions, are conflicting. 

Furthermore, different disease sites or extents may be best handled with different imaging 

1

modalities. The questions of imaging necessity and type are especially important because many 

imaging studies in infants often require general anesthesia and may be associated with adverse 

effects. Modalities such as computed tomography also involve exposure to radiation. 

Specific disease characteristics, such as lesion size, location, rate of growth, and persistence 

as well as modifiers such as patient age, functional impact, and IH subtype influence whether 

children are treated with pharmacologic agents or surgically. Many lesions can be treated with 

pharmacologic agents; however, refractory lesions that possess immediate risk for morbidity or 

mortality, such as hemangiomas obstructing the airway or visual axis, may require more 

immediate surgical intervention. Lesion characteristics such as size, location, and type (e.g., 

superficial, deep) also influence the choice of specific pharmacologic agents. For example, small, 

superficial lesions may respond well to topical agents such as timolol, while deep lesions are less 

likely to respond. 14 Both medical and surgical treatment paradigms contain significant variability 

and lack of consensus. 

Contraindications to specific treatments vary. Contraindications to beta-blockers include 

asthma, significant bradycardia, heart block, concurrent illness such s viral gastroenteritis or 

respiratory infection, history of reactive airway disease, and hypoglycemia. 15 Contraindications 

to steroids include diabetes, chronic or untreated infections, decreased bone density, 

immunodeficiency, and active wound healing, and contraindications to surgical approaches 

include personal or family history of adverse reactions to anesthesia. 

In many cases of IH, early referral and intervention are crucial to a satisfactory outcome, 

such as ocular IH disrupting the development of neural pathways during infancy. Further, some 

lesions, such as nasal tip IH, may cause permanent structural changes to adjacent structures. This 

may result in severe functional and disfiguring sequelae, even with complete resolution of the IH 

itself. In addition to structural damage, the psychological complications of having facial 

differences must be considered when determining the need for referral or treatment. While wellrecognized 

clinical signs such as ulceration, airway obstruction, or vision-threatening 

involvement indicate need for urgent referral, there are no discrete guidelines that help direct 

primary care providers when to refer patients with IH for subspecialty care. 

Interventions 

The beta-blocker propranolol was approved by the U.S. Food and Drug Administration 

(FDA) for use in IH in March 2014. 16-18 Propranolol was historically used in children for cardiac 

conditions and off-label to treat IH after the serendipitous discovery of its effects on IH lesions in 

2008. 19 Prior to this, corticosteroids were the drug of choice, but propranolol has become the 

typical choice for initial medical management in children without contraindications to betablockers. 

Steroids may be used in children with contraindications to beta-blockers or who do not 

respond to beta-blockers. Additionally, there is no clear consensus as to when alternative or 

adjunctive or historically used medications such as chemotherapeutic drugs are appropriate if 

first-line treatment is unsuccessful. 20,21 

Surgical interventions for IH can be used for primary management of high risk lesions and 

include resection or ablation using laser or radiofrequency. Some confusion and disagreement 

exists about what type of surgical treatment to use, when in the disease course to treat, and how 

the disease site informs treatment decisions. Interventions for IH are varied, involved, and not 

without risk (e.g., risk of permanent hypopigmentation, scarring from pulsed dye laser therapy, 

potential harms of anesthesia); therefore, universal treatment is not recommended. 22 

2

Scope and Key Questions 

Scope of Review 

This systematic review addresses the evidence for benefits and harms of commonly used 

treatments for children (ages 0-18 years) with IH: beta-blockers, corticosteroids, “second-line” 

drugs used after the failure of beta-blockers or steroids, and laser and surgical treatment. The 

decisional dilemmas that this review addresses are whether imaging modalities are useful both in 

diagnosis and for guiding treatment, and the expected comparative effectiveness (benefits and 

harms) of pharmacologic and surgical treatments, relative to observation or other active 

treatments. While pharmacologic and surgical interventions cannot be directly compared because 

of their inherent confounding by indication, we assess the comparative effectiveness of different 

options within both pharmacologic and surgical approaches. 

We include both contextual and Key Questions. We systematically reviewed and assessed the 

risk of bias of the literature meeting our inclusion criteria for Key Questions, which address the 

comparative effectiveness of interventions. We provide a narrative review of relevant literature 

for contextual questions as few effectiveness studies address these questions, which are related to 

natural history of IH and markers for occult IH. 

Key Questions 

Key Questions (KQs) and Contextual Questions (CQs) were developed in consultation with 

Key Informants and the Task Order Officer and were posted for review to the AHRQ Effective 

Health Care Web site. Questions were as follows: 

CQ1. What is known about the natural history of infantile hemangiomas, by 

hemangioma site and subtype? What are the adverse outcomes of 

untreated infantile hemangiomas? What characteristics of the hemangioma 

(e.g., subtype, size, location, number of lesions) indicate risk of significant 

medical complications that would prompt immediate medical or surgical 

intervention? 

CQ2. What is the evidence that five or more cutaneous hemangiomas are 

associated with an increased risk of occult hemangiomas? 


known or suspected infantile hemangiomas, what is the comparative 

effectiveness (benefits/harms) of various imaging modalities for identifying 

and characterizing hemangiomas? 

a. Does the comparative effectiveness differ by location and subtype of 

the hemangioma? 

3


infantile hemangiomas who have been referred for pharmacologic 

intervention, what is the comparative effectiveness (benefits/harms) of 

corticosteroids or beta-blockers? 


infantile hemangiomas for whom treatment with corticosteroids or betablockers 

is unsuccessful what is the comparative effectiveness of second 

line therapies including immunomodulators and angiotensin-converting 

enzyme inhibitors? 


infantile hemangiomas who have been referred for surgical intervention, 

what is the comparative effectiveness (benefits/ harms) of various types of 

surgical interventions (including laser and resection)? 

Analytic Framework 

The analytic frameworks illustrate the population, interventions, and outcomes that guided 

the literature search and synthesis (Figures 1-3). The frameworks depict the Key Questions 

within the context of the population, intervention, comparator, outcomes, timing, and setting 

(PICOTS) parameters described in the review. In general, the figures illustrate how imaging 

modalities or interventions such as magnetic resonance imaging (MRI), beta-blockers, or laser 

may result in intermediate outcomes such as change in hemangioma size or change in vision 

and/or in final health outcomes such as detection of IH for imaging modalities or resolution of 

hemangioma or changes in quality of life for medical or surgical treatments. Also, adverse events 

may occur at any point after the intervention is received. 

Figure 1. Analytic framework for KQ1 


4

Figure 2. Analytic framework for KQ2 and KQ3 


Figure 3. Analytic framework for KQ4 

IH = infantile hemangioma; KQ = Key Question; Nd:YAG = neodymium yttrium aluminum garnet 

Organization of This Report 

The Methods section describes the review processes including search strategy, inclusion and 

exclusion criteria, approach to review of abstracts and full publications, methods for extraction 

5

of data, and compiling evidence. We also describe our approach to grading the quality of the 

literature and describing the strength of the body of evidence. 

The Results section presents the findings of the literature search and the review of the 

evidence by Key Question, synthesizing the findings across strategies. We present findings for 

the Contextual Questions followed by findings of the network meta-analysis, followed by 

findings for each Key Question organized by intervention and outcome area where possible. 

Summary tables for each Key Question outline key outcomes. 

The Discussion section of the report discusses the results and expands on methodologic 

considerations relevant to each Key Question. We also outline the current state of the literature 

and challenges for future research in the field. The report includes a number of appendices to 

provide further detail on our methods and the studies assessed. The appendices are as follows: 

• Appendix A: Search Strategies 

• Appendix B: Screening and Quality Assessment Forms 

• Appendix C: Excluded Studies 

• Appendix D: Methods for Network Meta-Analysis 

• Appendix E: Study Design Classification Algorithm 

• Appendix F: Quality/Risk of Bias Ratings 

• Appendix G: Applicability Tables 

• Appendix H: Harms Reported in Package Insert Data and Other Sources 

We also provide a list of abbreviations and acronyms at the end of the report. 

Uses of This Evidence Report 

We anticipate this report will be of primary value to organizations that develop guidelines for 

managing IH, to clinicians who provide care for children with IH, and for families making 

treatment decisions. IH is diagnosed and treated by clinicians including pediatricians, 

dermatologists, otolaryngologists, family physicians, nurses, nurse-practitioners, physician 

assistants, hematologists, and general and plastic surgeons. This report supplies practitioners and 

researchers up-to-date information about the current state of evidence, and assesses the quality of 

studies that aim to determine the outcomes and safety of treatments for IH. 

Researchers can obtain a concise analysis of the current state of knowledge of interventions 

in this field. They will be poised to pursue further investigations that are needed to advance 

research methods, develop new treatment strategies, and optimize the effectiveness and safety of 

clinical care for children with this condition. 

6

Methods 

In this chapter, we document the procedures that this Evidence-based Practice Center (EPC) 

used to produce a comparative effectiveness review (CER) on approaches to treatment of 

infantile hemangioma (IH). These procedures follow the methods outlined in the Agency for 

Healthcare Research and Quality (AHRQ) Effective Health Care Program “Methods Guide for 

Effectiveness and Comparative Effectiveness Reviews.” 23 

Topic Refinement and Review Protocol 

The topic for this report was nominated by the American Academy of Pediatrics in a public 

process using the Effective Health Care Program Web site. Working from the nomination, we 

drafted the initial Key Questions (KQ) and Contextual Questions (CQ) and analytic framework 

and refined them with input from key informants representing the fields of pediatrics, 

dermatology, otolaryngology, vascular anomalies, surgery, and patient advocacy. All members 

of the research team were required to submit information about potential conflicts of interest 

before initiation of the work. No members of the review team had any conflicts. 

After review from the AHRQ, the questions and framework were posted online for public 

comment. No changes to the questions or framework were recommended. We also developed 

population, interventions, outcomes, timing, and settings (PICOTS) criteria for intervention KQ. 

We identified technical experts on the topic to provide assistance during the project. The 

Technical Expert Panel (TEP), representing the fields of pediatrics, pediatric dermatology, 

otolaryngology, surgery, vascular anomalies, hematology/oncology, and pediatric cardiology, 

contributed to the AHRQ’s broader goals of (1) creating and maintaining science partnerships as 

well as public-private partnerships and (2) meeting the needs of an array of potential users of its 

products. Thus, the TEP was both an additional resource and a sounding board during the 

project. The TEP included seven members serving as technical or clinical experts. To ensure 

robust, scientifically relevant work, TEP members participated in conference calls and 

discussions through e-mail to: 

• Help to refine the analytic framework and KQ at the beginning of the project; and 

• Discuss inclusion/exclusion criteria. 

The final protocol was posted to the AHRQ Effective Health Care web site and registered in 

the PROSPERO international register of systematic reviews (ID#: CRD42015015765). 

Literature Search Strategy 

Search Strategy 

To ensure comprehensive retrieval of relevant studies of therapies for children with IH, we 

used three key databases: the MEDLINE ® medical literature database via the PubMed ® interface, 

the Cumulative Index of Nursing and Allied Health Literature (CINAHL ® ), and EMBASE 

(Excerpta Medica Database), an international biomedical and pharmacological literature database 

via the Ovid ® interface. Search strategies for Key Questions applied a combination of controlled 

vocabulary (Medical Subject Headings [MeSH], CINAHL medical headings, and Emtree 

headings) to focus specifically on management of IH and harms of interventions. We restricted 

literature searches for Key Questions to studies published from 1982 to the present to reflect the 

use of more standardized classification schema for IH. 24 We searched the same databases without 

date restrictions to identify contextual information. 

7

We only included studies published in English as a review of non-English citations retrieved 

by our MEDLINE search identified few studies of relevance. Appendix A lists our search terms 

and strategies and the yield from each database for both Key and Contextual Questions. Searches 

were last executed in June 2015. 

We carried out hand searches of the reference lists of recent systematic reviews or metaanalyses 

of therapies for IH. The investigative team also scanned the reference lists of studies 

included after the full-text review phase for additional studies that potentially could meet our 

inclusion criteria. 

Grey Literature 

AHRQ’s Scientific Resource Center requested Scientific Information Packets (SIPs) from 

companies that produce medications for management of infantile hemangioma (e.g., betablockers 

including propranolol, atenolol, and timolol; corticosteroids including prednisolone and 

dexamethasone; imiquimod; interferon-alpha-2b; captopril; bleomycin; vinblastine; sodium 

tetradecyl sulfate; becaplermin); and devices for IH including pulsed dye lasers, Argon lasers, 

and neodymium yttrium aluminum garnet (Nd:YAG) lasers and searched for regulatory data for 

medications. We also searched ClinicalTrials.gov to assess reporting bias and to identify any 

study results that may not have been identified in our other database searches. We also searched 

the Web sites of relevant organizations and associations (e.g., American Academy of Pediatrics, 

Vascular Birthmarks Foundation) to identify relevant contextual information. We searched the 

U.S. Food and Drug Administration web site and package insert data for information on harms of 

medications for IH. We applied the inclusion criteria described above and in Table 1 to studies 

identified via our grey literature searches. 

Inclusion and Exclusion Criteria 

Table 1 lists the inclusion/exclusion criteria we used based on our understanding of the 

literature, key informant and public comment during the topic-refinement phase, input from the 

TEP, and established principles of systematic review methods. We limited our searches for 

comparative effectiveness questions to studies published in English and from 1982 to the present 

for studies of the effectiveness of treatments. We also excluded studies evaluating multiple lesion 

types (e.g., cavernous hemangioma, hemangioblastoma, vascular malformations, noninvoluting 

congenital hemangiomas) unless we could clearly extract data pertaining to children with IH or if 

the majority of children had IH. We included studies with populations including individuals over 

age 18 if the majority of the participants were under age 18 or the mean age range was within 0 

to 18 years. To be included for KQ3 studies had to note explicitly that all children had received 

prior treatment with beta-blockers or steroids and were therefore receiving a second-line 

treatment following those agents. We also included case series with at least 25 children with IH 

to address harms but not effectiveness. We selected the lower bound of 25 as a conservative 

value based on a preliminary review of case series. 

8

Table 1. Inclusion criteria 

Category 

Criteria 


Newborns, infants, and children up to 18 years of age with infantile hemangiomas or 

suspected infantile hemangiomas 

Publication languages English only 

Publication year 1966-present (CQ 1 and 2) 

1982-present (KQ 1, 2, 3, 4) 

Admissible evidence Admissible designs 

Original research studies providing sufficient detail regarding methods and results to 

enable use and aggregation of the data and results 

Contextual Questions (CQ): 

• Systematic and non-systematic reviews, articles reporting on the history of IH 

diagnosis or treatment, practice guidelines, meta-analyses, RCTs, case series 

with at least 25 children with IH, and any comparative studies 

Other criteria 

Comparative Effectiveness Key Questions (KQ): 

• Imaging accuracy: RCTs and any comparative studies 

• Benefits of interventions: RCTs and any comparative studies 

• Harms of interventions: RCTs, any comparative studies, and case series with 

at least 25 children with infantile hemangiomas 

Studies must address one or more of the following: 

• Diagnostic imaging (e.g., magnetic resonance imaging, computed tomography, 

magnetic resonance angiography, echocardiography, ultrasound, endoscopy) 

• Surgical interventions (e.g., cryotherapy, resection, embolization, 

radiofrequency ablation therapy) or laser interventions (e.g., pulsed dye, 

fractionated laser, argon, carbon dioxide, neodymium (Nd): YAG, erbium) 

• Pharmacologic interventions (e.g., beta-blockers, corticosteroids, 

immunomodulators, immunosuppressants, angiotensin-converting enzyme 

inhibitors, antiangiogenic agents, antineoplastics) 

• Data (including harms) related to diagnostic modalities or interventions for 

infantile hemangiomas for the following outcomes: 

Imaging studies 

− Ability to identify presence, number, and extent of hemangiomas and 

associated structural anomalies (sensitivity and specificity) 

− Harms 

Surgical or pharmacologic intervention studies 

− Size / volume of hemangioma 

− Impact on vision 

− Aesthetic appearance as assessed by clinician or parent 

− Degree of ulceration 

− Quality of life 

− Harms 

Relevant outcomes must be able to be abstracted from data in the papers 

Data must be presented in the aggregate (vs. individual participant data) 

CQ = contextual question, IH = infantile hemangioma, KQ = Key Question, Nd:YAG- = neodymium yttrium aluminum garnet, 

RCT = randomized controlled trial 

Study Selection 

Once we identified articles through the electronic database searches and hand-searching, we 

examined abstracts of articles to determine whether studies met our criteria. Two reviewers 

separately evaluated the abstracts of studies identified in our searches for Key Questions for 

inclusion or exclusion, using an Abstract Review Form (Appendix B). If one reviewer concluded 

that the article could be eligible for the review based on the abstract, we retained it. Following 

abstract review, two reviewers independently assessed the full text of each included study using 

9

a standardized form (Appendix B) that included questions stemming from our 

inclusion/exclusion criteria. Disagreements between reviewers were resolved by a senior 

reviewer. Reviewers could flag studies that potentially addressed a Contextual Question 

identified in the screening process for Key Questions. 

We also screened studies identified in our separate database searches for studies potentially 

addressing Contextual Questions. We did not conduct dual screening of studies identified in our 

searches for Contextual Questions. If one reviewer determined that a study could be eligible, we 

assessed its relevance to the Contextual Questions. Excluded studies had no further analysis. 

All abstract and full text reviews were conducted using the DistillerSR online screening 

application (Evidence Partners Incorporated, Ottawa, Ontario). Appendix C includes a list of 

excluded studies and the reasons for exclusion. Data extracted for each study are available via 

the Systematic Review Data Repository (http://srdr.ahrq.gov/). 

Data Extraction 

The staff members and clinical experts (including one otolaryngologist, one pediatric 

hematologist/oncologist, one pediatrician, one nurse practitioner, and two epidemiologists) who 

conducted this review jointly developed the data extraction forms for the Key Questions. We 

designed form to provide sufficient information to enable readers to understand the studies and to 

determine their quality; we gave particular emphasis to essential information related to our Key 

Questions. We used two templates to facilitate the extraction of data based on study type; one 

form was designed for case series that reported harms data and one to accommodate all types of 

comparative studies for effectiveness and harms data. 

The team was trained to extract data by extracting several articles into the template and then 

reconvening as a group to discuss the utility of the template. We repeated this process through 

several iterations until we decided that the templates included the appropriate categories for 

gathering the information contained in the articles and for potential meta-analyses. Team data 

extractors shared the task of initially entering information into the evidence tables. A second 

team member also reviewed the articles and edited all initial table entries for accuracy, 

completeness, and consistency. A senior reviewer reconciled disagreements concerning the 

information reported. 

The full research team met regularly during the article extraction period and discussed issues 

related to the data extraction process (e.g., determining instances of IH vs. other lesions). In 

addition to outcomes related to imaging or intervention effectiveness (sensitivity and specificity, 

change in lesion size, resolution, aesthetic appearance, ulceration, vision changes, quality of life), 

we extracted all data available on harms. Harms encompass the full range of specific negative 

effects, including the narrower definition of adverse events. 

Data Synthesis 

We summarized data for Key Questions qualitatively using summary tables where metaanalyses 

were not possible. We provided a narrative summary of relevant papers for contextual 

questions. 

We identified sufficient data to address the effectiveness of pharmacologic interventions 

using quantitative meta-analysis methods. Studies were included in the network meta-analysis 

subset provided that they satisfied the following additional inclusion criteria: 

• Outcomes were reported quantitatively, using an objective metric for reporting 

intervention effects that could be converted into a proportion of IH clearance. 

10

• One or more study arms evaluated a single intervention; study arms in which two or more 

treatments were applied were excluded. 

• Reported outcomes were accompanied by an associated measure of variation or precision. 

• Non-control pharmacologic treatments could be reasonably classified into one of the 

following classes of agents: oral, intralesional, or topical propranolol; intralesional 

triamcinolone; topical or ophthalmic timolol; and oral steroid. 

• Studies evaluated IH in multiple locations (vs. specific anatomic areas) as most studies 

included IH in multiple areas. 

In addition to the diverse suite of interventions, outcomes were reported in a variety of ways. 

Most identified an arbitrary threshold of IH clearance (e.g. >75%) as a positive outcome, or 

divided the continuous clearance measure into a small number of categories. Others reported 

visual analog scale scores, either for entire study arms or for individual patients within study 

arms. In order to incorporate as many quality studies as possible, by minimizing the number 

excluded due to technical constraints on statistical integration, we constructed a Bayesian latent 

variable model. This model allowed several different types of outcome data and a suite of 

pharmacologic interventions to be analyzed in the same model, thereby maximizing the power 

for estimating parameters precisely. The estimands of interest were the expected proportion of 

clearance for each intervention agent, along with associated posterior uncertainty. A full 

description of the meta-analytic methods is reported in Appendix D. 

Quality (Risk of Bias) Assessment of Individual Studies 

We used separate tools appropriate for specific study designs to assess quality of individual 

studies meeting eligibility criteria for our Key Questions: questions adapted from the RTI item 

bank to assess randomized controlled trials (RCTs), 25 the Newcastle-Ottawa Quality Assessment 

Scale for cohort studies, 26 the QUADAS tool for diagnostic imaging studies, 27 and a tool adapted 

from questions outlined in the RTI item bank and the McMaster McHarms tool to assess 

reporting of harms. 28 

Questions from the RTI item bank evaluate domains including selection bias, performance 

bias, attrition bias, detection bias, and reporting bias. We used the Newcastle-Ottawa Quality 

Assessment Scale to assess the quality of nonrandomized studies. It assesses three broad 

perspectives: the selection of study groups, the comparability of study groups, and the 

ascertainment of either the exposure or outcome of interest for case-control or cohort studies, 

respectively. The QUADAS tool considers questions related to participant characteristics, 

comparisons with a gold standard, and interpretation of the screening test. The harms assessment 

tool addresses questions related to pre-specification and reporting of harms. 

Quality assessment of each study was conducted independently by two team members using 

the forms presented in Appendix B. Any discrepancies were adjudicated by the two team 

members or a senior investigator. Investigators did not rely on the study design as described by 

authors of individual papers; rather, the methods section of each paper was reviewed to 

determine which rating tool to employ, and we used the algorithm in Appendix E to aid in 

determining study design. The results of these tools were then translated to “good,” “fair,” and 

“poor” quality ratings as described below. Appendix F reports quality scoring for each study. We 

did not assess the quality of papers identified for Contextual Questions. 

11

Determining Quality Ratings 

• We required that RCTs receive a positive score (i.e., low risk of bias for RCTs) on 

roughly 80 percent (11 of 13) of the questions used to assess quality to receive a rating of 

good/low risk of bias. RCTs had to receive eight to ten positive scores to receive a rating 

of fair/moderate risk of bias, and studies with ≤ seven positive ratings were considered 

poor quality/high risk of bias. We considered a score of “unclear” for a question as a 

negative score. We assessed the risk of bias for each major outcome of relevance reported 

but report an overall assessment unless the risk of bias varied by outcome. 

• We required that cohort studies receive positive scores (stars) on all elements, including 

use of blinded outcome assessors, and be prospective to receive a rating of good, ≤ 2 

negative ratings for fair, and > 2 negative scores for a rating of poor quality. 

• For imaging studies we required that studies receive positive scores on all questions to 

receive a rating of good. We considered studies with ≤ three negative ratings as fair 

quality and those with more than four as poor quality. 

• We required that studies assessed for harms reporting receive at least 3.5 of a possible 

four points available to receive a rating of “good.” We gave partial points to studies that 

reported monitoring for changes in blood pressure, heart rate, or hypoglycemia. Studies 

with 2.5 to three positive responses were considered fair quality and those with ≤ two 

positive responses were deemed to be poor quality. 

Strength of the Body of Evidence 

We applied explicit criteria for rating the overall strength of the evidence for each key 

intervention-outcome pair for which the overall risk of bias was not overwhelmingly high. We 

rated the strength of the evidence for the final outcomes of interest for our Key Questions 

(Figures 1-3) and for clinically important harms. We used established concepts of the quantity of 

evidence (e.g., numbers of studies, aggregate ending-sample sizes), the quality of evidence (from 

the quality ratings on individual articles), and the coherence or consistency of findings across 

similar and dissimilar studies and in comparison to known or theoretically sound ideas of clinical 

or behavioral knowledge. 

The strength of evidence evaluation that we used is described in the Effective Health Care 

Program’s “Methods Guide for Effectiveness and Comparative Effectiveness Reviews” 23 and in 

the updated strength of evidence guide, 29 which emphasizes five major domains: study limitations 

(low, medium, high level of limitation), consistency (inconsistency not present, inconsistency 

present, unknown or not applicable), directness (direct, indirect), precision (precise, imprecise), 

and reporting bias. Study limitations are derived from the quality assessment of the individual 

studies that addressed the Key Questions and specific outcome under consideration. Each key 

outcome for each comparison of interest is given an overall evidence grade based on the ratings 

for the individual domains. 

The overall strength of evidence was graded as outlined in Table 2. Two senior staff 

members independently graded the body of evidence; disagreements were resolved as needed 

through discussion or third-party adjudication. We recorded strength of evidence assessments in 

tables, summarizing results for each outcome. We considered case series in the assessment of 

strength of the evidence for harms. 

12

Table 2. Strength of evidence grades and definitions * 

Grade 

Definition 

High We are very confident that the estimate of effect lies close to the true effect for this 

outcome. The body of evidence has few or no deficiencies. We believe that the findings are 

stable, i.e., another study would not change the conclusions. 

Moderate We are moderately confident that the estimate of effect lies close to the true effect for 

this outcome. The body of evidence has some deficiencies. We believe that the findings 

are likely to be stable, but some doubt remains. 

Low We have limited confidence that the estimate of effect lies close to the true effect for 

this outcome. The body of evidence has major or numerous deficiencies (or both). We 

believe that additional evidence is needed before concluding either that the findings are 

stable or that the estimate of effect is close to the true effect. 

Insufficient We have no evidence, we are unable to estimate an effect, or we have no confidence 

in the estimate of effect for this outcome. No evidence is available or the body of 

evidence has unacceptable deficiencies, precluding reaching a conclusion. 

* 

Excerpted from Berkman et al. 2014 29 

Applicability 

We assessed the applicability of findings reported in the included literature addressing our 

Key Questions to the general population of children with IH by determining the population, 

intervention, comparator, and setting in each study and developing an overview of these 

elements for each intervention category. We anticipated that areas in which applicability would 

be especially important to describe would include the diagnostic criteria for IH, age at treatment 

initiation, and the anatomic location and morphology of IH. Applicability tables for each 

intervention are in Appendix G. 

Peer Review and Public Commentary 

Researchers and clinicians with expertise in managing IH and individuals representing 

stakeholder and user communities provided external peer review of this report; AHRQ, a 

statistical expert, and an associate editor also provided comments. The draft report was posted on 

the AHRQ Web site for 4 weeks to elicit public comment. We addressed all reviewer comments, 

revised the text as appropriate, and documented changes and revisions to the report in a 

disposition of comments report that will be made available 3 months after AHRQ posts the final 

review on the AHRQ Web site. 

13

Results 

We present results for Contextual Questions (CQ) followed by those for our network metaanalysis, 

which includes studies of beta-blockers and steroids. We then present results for each 

Key Question (comparative effectiveness questions). 

We identified 966 publications potentially relevant to the CQ in our database searches. We 

also flagged studies for potential relevance to CQ in our screening of studies for Key Questions. 

We included 68 studies in the narrative summary of information addressing CQ. 

CQ1. Natural History of Untreated IH and Adverse Outcomes 

of Untreated IH 

Natural History of IH 

IH have been estimated to occur in around 5 percent of neonates and infants. 2 IH may be 

classified into subtypes including localized, segmental, indeterminate, and multifocal. Several 

studies have shown most IH to be of the localized type, and regardless of type, most IH involute 

with time; 30-33 however, the presentation and course of IH in individual children are 

heterogeneous. 34 IH usually present within the first month of life and undergo rapid proliferation 

over the first several months of life. 35,36 One study found that IH reached 80 percent of their final 

size by 5 months of age. 9 Many experts recommend referral at an early age (as early as 4 to 8 

weeks of life) to subspecialists given this rapid proliferation. 9 

Segmental IH are more likely to have more prolonged growth, defined as after 9 months of 

age. 9,37 Involution typically starts by 1 year of age, but the timing of involution varies 

markedly. 38,39 In one large retrospective review of 1109 referred patients (median age=8 months) 

conducted in the pre-propranolol era, 769 were returned to the care of their primary provider 

without subspecialty followup, and only 102 (9%) required intervention. 40 

Most lesions involute by age 5 to 7, 41,42 though timing varies, and disfigurement may 

remain. 22,38,43,44 The majority (80%) of lesions involuting after age 6 years in one series resulted 

in residual scarring or telangiectasia, compared with 38 percent involuting before age 6. 35 In 

studies of referred populations, residual lesions (e.g., telangiectasias, atrophy, fibrofatty tissue, 

hypopigmentation) were reported in 25 to 69 percent of untreated IH. 38,45 Lesions affecting 

visual cortex development may result in lasting deficits in vision even after resolution of the 

IH. 46 

Indications for Treatment 

The major indications for treatment of IH include risks of ulceration, disfigurement, and 

functional impact. 39,47-52 While psychological impact on the child also plays a role in treatment 

decisions, data on the effects of IH on quality of life for the child suggest minimal impact. Such 

data are often limited by the necessity to parent-report in this young population. 22,53,54 Estimates 

of complications from IH vary but are generally noted to occur in approximately 30 percent of 

the studied population. 31,32,55 One study found higher initial complication rates for patients 

referred to a surgical center, potentially due to the higher likelihood of more advanced lesions 

being referred. 56 Given that the literature typically includes children treated at referral centers, it 

is likely that the overall complication rate may be higher in study populations than in the general 

population. 

14

Risk of complication is generally related to the size of lesions, location of lesions, and/or 

subtype. 31,57-59 Larger lesions are more likely to have complications. One study found a 5 percent 

increase in the likelihood of experiencing complications for every 10 cm² increase in size (OR 

1.051, p

defects, urogenital anomalies, ulceration, myelopathy, bony deformities, anorectal 

malformations, arterial anomalies, and renal anomalies], PELVIS [perineal hemangioma, 

external genitalia malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate 

anus, and skin tag] and SACRAL [spinal dysraphism, anogenital, cutaneous, renal, and urologic 

anomalies, associated with an angioma of lumbosacral localization]) and may require treatment 

of the IH to avoid functional or disfiguring sequelae. 76,77 

CQ2. Evidence for Association of Cutaneous IH and Occult IH 

Overall, limited literature addresses the association of a higher number of cutaneous IH and 

extracutaneous IH. Some data from case series suggest support for a higher index of suspicion in 

children with multiple lesions or with facial lesions in a beard distribution. Studies have 

primarily assessed associations between cutaneous IH and hepatic IH and cutaneous facial IH 

and airway IH. One study addressed associations with IH in the spinal area and reported that nine 

of 48 children with cutaneous IH on the lumbosacral skin had intraspinal lesions (19%), though 

the study did not report the number of cutaneous lesions. We summarize studies addressing 

hepatic and airway IH below. 

The basis for the association of a greater number of cutaneous IH with hepatic IH comes 

primarily from case series including 453 infants with IH. 71,72,78-82 In one retrospective series, 

investigators analyzed data from 26 children with hepatic IH (presentation of IH at birth or up to 

4 months of age). 72 Among the 26, 18 also had multiple or diffuse cutaneous lesions (69%) and 

underwent imaging, and 15 of 18 had multiple or diffuse liver IH. Investigators classified the 

liver IH as focal (n=8 children), multifocal (n=12 children), or diffuse (n=6 children). Among 

children with focal lesions, three had multiple cutaneous IH, two had a single cutaneous IH, and 

three had no cutaneous IH. In the multifocal group, 11 of 12 children had multiple cutaneous 

lesions (mean 14.25 ± 12.50 lesions) and liver IH. All but one of the 6 children with diffuse 

hepatic IH had multiple cutaneous lesions. Across lesion types, cutaneous lesions generally 

resolved before hepatic lesions. 

Another series included 37 children, 16 percent of whom had three to five small cutaneous 

lesions; 43 percent had six or more small cutaneous lesions; 16 percent had cutaneous miliary 

(30-100 pinpoint lesions) lesions; 11 percent had a single large IH; and 14 percent had a 

combination of a large and one or more small cutaneous IH. 78 Eight of 37 (22%) children had 

concurrent hepatic IH. Children with cutaneous miliary IH had a greater number of hepatic IH 

(n=7 to 35) than did infants with other cutaneous patterns. Another retrospective series reported 

that 17 of 23 infants (53%) with hepatic IH had multiple (≥5) cutaneous IH. 80 

In another retrospective series of children seen at referral centers, 62 children had six or more 

cutaneous IH or one large (≥5 cm) cutaneous IH and seven had three to five small (

a series of 43 infants with IH, 27 had at least 10 cutaneous IH (median=16) and 16 had between 

five and nine cutaneous lesions (median=6.5). 82 Among the nine children treated for their IH, 9 

had internal IH (8 hepatic, 1 splenic), and five of the nine had more than one internal lesion. All 

of these children had ≥10 cutaneous IH and had no symptoms of internal IH. The study does not 

clearly report if any internal IH were reported among the children who did not receive treatment 

for cutaneous IH. 

In a prospective case series including 201 infants between 0 and 6 months of age with IH 

seen at specialty pediatric dermatology clinics, 24 of the 151 (16%) infants with at least five 

cutaneous IH had hepatic IH, while none of the children with one to four IH had hepatic 

involvement (p=0.003). 71 Preterm birth (< 37 weeks gestation) and lower birth weight were 

associated with having five or more cutaneous IH (p values

Results of Literature Searches for Key Questions 

We identified 4132 nonduplicative titles or abstracts with potential relevance, with 1273 

proceeding to full text review (Figure 4). We excluded 1120 studies at full text review. We 

included 148 unique studies (153 publications) in the review. These 148 studies included 42 

comparative studies, 38 addressing effectiveness and harms of therapies four assessing 

effectiveness only, and 106 case series providing data on harms only. We present findings by 

intervention under each Key Question. 

Figure 4. Disposition of studies identified for this review 

KQ = Key Question; n = number 

†Numbers next to each Key Question indicate number of unique studies addressing the question. Studies could address more than 

one Key Question. Neither study identified for KQ1 addressed harms. Of the 105 studies identified for KQ2, 28 addressed 

benefits and harms, 1 addressed only benefits, and 76 addressed only harms. Of the 41 identified for KQ4, 10 addressed benefits 

and harms, one addressed only benefits, and 30 addressed only harms. 

* Numbers do not tally as studies could be excluded for multiple reasons. 

Description of Included Studies 

The 148 unique studies addressing Key Questions comprise 15 randomized controlled trials 

(RCTs), five prospective and 19 retrospective cohort studies, two diagnostic accuracy studies 

(defined as studies that compared the accuracy of imaging modalities in identifying or 

18

characterizing infantile hemangioma [IH]), one prospective comparative study that used an 

untreated IH as a control, and 106 case series (used for harms data only). Most studies were 

conducted in Europe (n = 51) or Asia (n = 44). Forty-one were conducted in the United States or 

Canada and 12 in other countries including Australia, Egypt, Argentina, and Chile (Table 3). 

Forty-two comparative studies reported effectiveness outcomes. We considered six of these 

studies to be good quality, 22 fair quality, and 14 poor quality. One-hundred and forty-four 

studies (comparative studies and case series) reported harms/adverse events data. We considered 

14 of these as good quality for harms reporting, three as fair quality for harms reporting, and the 

remainder (n = 127) as poor quality for harms reporting. Most studies addressed beta-blockers (n 

= 81, 13 of which compared a beta-blocker to another category of intervention such as 

corticosteroids or laser); 26 addressed lasers; 24 addressed steroids; 15 addressed surgical 

approaches; and two addressed diagnostic modalities. 

We included 18 studies in a network meta-analysis. All studies addressed pharmacologic 

agents and included five RCTs and four cohort studies evaluating oral propranolol and placebo 

or observation or another active agent, 92-100 including steroids; 96-98,100 one RCT and one cohort 

study comparing propranolol and other beta-blockers; 101,102 three cohort studies and two RCTs 

assessing topical timolol compared with placebo or observation or another agent; 14,103-106 and one 

RCT and one cohort study comparing different steroids, including oral prednisone and 

intralesional triamcinolone. 107,108 Four studies were good quality 92,98,104,107 ; nine were fair 

quality 14,93,94,96,97,99,100,102,105 ; and five were poor quality. 95,101,103,106,108 Studies in the metaanalysis 

included a total of 1265 children with IH. 

19

Table 3. Characteristics of included studies addressing effectiveness and harms 

Characteristic 

RCTs 

Prospective 

Cohort Studies† 

Retrospective 

Cohort Studies 

Diagnostic 

Studies 

Case 

Series* 

Total Literature 

Intervention Corticosteroid 3 0 1 0 20 24 

Beta-Blocker ** 9 5 11 0 56 81 

Laser 3 0 6 0 17 26 

Surgery 0 1 1 0 13 15 

MRI or ultrasound 0 0 0 2 0 2 

Population 

Characteristics 

Outcomes 

Reported 

Anatomic location of IH 

Multiple 15 5 15 1 93 129 

Periocular 0 1 1 0 7 9 

Airway 0 0 1 0 1 2 

Oral/Maxillary 0 0 1 0 3 4 

Parotid 0 0 0 0 1 1 

Lumbosacral 0 0 0 1 0 1 

Nasal 0 0 1 0 1 2 


U.S./Canada 2 1 7 2 29 41 

Europe 4 1 9 0 37 51 

Asia 4 3 3 0 33 43 

Other 5 1 0 0 7 13 

Resolution/Clearance-related 15 6 15 0 0 36 

Vision 1 2 1 0 0 4 

Quality of life 2 0 1 0 0 3 

Number treatments/invasive 

1 0 6 0 0 7 

treatments needed 

Diagnostic accuracy 0 0 0 2 0 2 

Rebound growth 4 1 6 0 0 11 

Harms 15 6 17 0 106 144 

Total N participants 1117 243 1447 96 10972 13875 

MRI = magnetic resonance imaging; n = number; RCT = randomized, controlled trial 

*Case series reported other outcomes; however, we only extracted harms data from case series for this review. 

**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 

only in this row. 

† One study included in the prospective cohort column compared an IH treated with cryotherapy to an untreated IH. 

20

Grey Literature 

In response to 21 requests for Scientific Information Packets, we received four documents, 

all of which addressed medications (becaplermin gel, recombinant interferon alfa-2b) that were 

not evaluated in studies meeting our criteria. The documents yielded no citations of relevance for 

this review, and the documents themselves did not meet criteria for inclusion in the review (one 

case series of 8 individuals, one addendum to an article, two files of prescribing information). 

Our search of ClinicalTrials.gov did not yield any results not identified in our other searches, 

and our searches of the web sites of relevant organizations yielded background information for 

informing our contextual questions. 

Key Question 1. Effectiveness and Harms of Imaging 

Modalities 

Key Points 

• Strength of the evidence (SOE) for the effectiveness of imaging for IH was insufficient 

given few studies assessing varied outcomes. 

• Studies assessed IH in different anatomic locations and reported differing findings for the 

sensitivity of ultrasound and effectiveness of imaging modalities depending on location 

or subtype. 

Overview of the Literature 

Two poor quality diagnostic accuracy studies—one prospective 68 and one retrospective 70 — 

addressed imaging modalities. Both studies were conducted in tertiary care settings with care 

settings in the United States, Canada, and Spain. One study enrolled patients from nine centers 

and included patients less than18 years old with IH in the lumbosacral area measuring greater 

than 2.5 cm. 68 The retrospective cohort study reported chart review data from two tertiary care 

centers and included 55 patients (mean age of 30 days) with liver IH. 70 

Overall, studies were limited by the size of cohorts, lack of standard processes, and lack of 

direct comparison at the same time point using the various imaging modalities. We considered 

the SOE for all imaging modalities to be insufficient given single, small studies addressing 

different approaches, using weaker study designs and precluding a meta-analysis. The studies did 

not address harms. 

Detailed Analysis 

In one prospective cohort study, seven out of 26 (26.9%) children who underwent ultrasound 

had an abnormality compared with 21 of the 41 (51.2%) patients who received MRI and were 

noted to have a spinal abnormality. 68 Nineteen of these patients underwent both ultrasound and 

MRI. In five cases ultrasound did not reveal an abnormality later found on MRI. Agreement 

between ultrasound and MRI was 0.27 (95% CI: -0.15 to 0.7, p=0.21), which was consistent with 

chance. Ultrasound had a sensitivity of 50 percent (95% CI: 18.7% to 81.3%) and specificity of 

77.8 percent (95% CI: 40% to 97.2%) for identifying anomalies including tethered cords and 

intraspinal IH. We calculated the sensitivity of both modalities for identifying intraspinal IH 

specifically: assuming a false positive value of 0, ultrasound, which missed 4 intraspinal IH in 26 

21

scans, had a sensitivity of 20 percent (95% CI: 3.30% to 71.19%), and the sensitivity of MRI was 

100 percent (95% CI: 66.21% to 100%). 

In a retrospective cohort study, 70 ultrasound was commonly used as the first imaging 

technique and identified lesions in 42 of 44 patients (sensitivity of 95%). Ultrasound identified 

direct shunts in 9 of 10 patients with shunts identified by angiography. Children with findings of 

congestive heart failure or aortic tapering on imaging were more likely to require intervention for 

their hepatic lesion. Given the small number of studies and heterogeneity of interventions and 

outcomes, we considered SOE to be insufficient for all outcomes. 

Key Question 2. Effectiveness and Harms of Corticosteroids 

or Beta-Blockers 

Network Meta-Analysis of the Effectiveness of Pharmacologic 

Agents 

Full and detailed methods and results of the network meta-analysis are available in Appendix 

D. Effect measures (Table 4) reflect effects on the logit scale and are not immediately clinically 

interpretable, but they demonstrate the nominal superiority of beta-blockers. Specifically, oral 

propranolol had the highest estimated effect size, though there is overlap among the credible 

intervals of the estimates. The estimated additive effect of intralesional delivery for propranolol 

was -6.9 (95% Bayesian credible interval [BCI]: -11.9 to -2.5). 

Table 4. Posterior estimates of effect size 

Agent Mean Standard Error 

95% Credible 

Interval 

Oral propranolol 6.0 0.7 [4.7 7.5] 

Topical timolol 3.5 0.5 [2.4 4.6] 

Intralesional triamcinolone 3.3 0.8 [1.7 4.9] 

Oral steroid 2.6 0.5 [1.8 3.6] 

Note: Table illustrates posterior estimates of effect size, on logit scale, relative to control, along with standard error and 95% 

credible interval. Positive values indicate increased clearance relative to control, negative indicate decreased clearance. 

More clinically interpretable are the clearance rates, presented in Figure 5, which presents 

mean expected clearance rates and our confidence bounds around the estimates. The expected 

efficacy of control arms was estimated to be 6 percent (95% BCI: 1% to 11%), i.e., we would 

expect to see, on average, 6 percent clearance of IH in children who receive placebo or no 

treatment during the study period. All non-control treatments were estimated to have a larger 

expected clearance than control. 

The largest mean estimate of clearance was for oral propranolol (95%, 95% BCI: 88% to 

99%). Clearance associated with the use of oral steroids was 43% (95% BCI: 21% to 66%), thus 

providing a clearance rate intermediate to control and use of beta-blockers. Triamcinolone, an 

intralesional injectable steroid, had a higher clearance rate than oral steroids, with wide BCI 

(58%; 95% BCI: 22% to 99%). Few data were available for intralesional propranolol, which is 

reflected in its larger credible interval (estimated clearance: 9%, 95% BCI: 0 to 45%). 

With fairly wide confidence bounds and limited data in some areas, the relative differences 

among estimates are of greater importance than absolute effects in interpreting these results. The 

estimates provide a relative ranking of anticipated rates of lesion clearance among treatment 


22


as patient/family preferences. 

Figure 5. Estimates of expected IH clearance 

Note: Estimates of expected IH clearance are expressed as percent clearance relative to initial condition for each treatment, along 


Figure 6 represents the variability in effects seen across the patient populations in terms of 

percent clearance. Oral propranolol was estimated to have the largest variability in clearance rate 

with some patients experiencing much greater clearance than others (σ=2.5, 95% BCI: 2.1 to 2.9) 

with timolol (σ=1.5, 95% BCI: 1.4 to 1.6), intralesional triamcinolone (σ=1.8, 95% BCI: 1.3 to 

2.3), and oral steroids (σ=1.3, 95% BCI: 1.1 to 1.6) yielding similar, lower estimates. All of the 

estimates of effect standard deviation were at least nominally higher than the control standard 

deviation, which may be a reflection of the heterogeneity of the study population in terms of 

response of IH to treatment. 

Because of relatively sparse information from several treatment agents, we were unable to 

separately estimate variance parameters for all of the interventions, and instead fit a simplified 

model that assumed variances were equal. To check the validity of this assumption, we also fit a 

model on the subset of interventions with sufficient numbers of studies (>3) to estimate variance 

parameters, and noted that the variance estimates ranged from 1.3 (1.1 to 1.6) to 2.6 (2.2 to 2.9) 

on the logit scale. This was reasonably close to the 1.8 (1.1 to 2.6) estimated as the pooled 

variance. 

To assess for methodologic heterogeneity, we ran additional models with only RCTs and 

with only good and fair quality studies. Estimates did not differ markedly when poor quality 

studies were removed, though BCI typically widened; thus, we report the model with poor 

quality studies included. To examine the possible effect of bias due to the inclusion of cohort 

studies, we fit the same model to RCT studies only. The resulting estimates were similar to those 

23

of the model fit to all studies, but with much wider posterior credible intervals. Since there was 

no obvious systematic bias due to study design, we reported the model estimates based on the 

entire body of evidence. 

Figure 6. Estimates of the variation of each treatment 

Note: Estimates of the variation of each treatment are expressed as standard deviation, along with associated posterior 

interquartile range (thick lines) and 95% credible interval (thin lines). 

Effectiveness and Harms of Corticosteroids 

Key Points 

• In our network meta-analysis, oral steroids had a clearance rate of 43 percent (95% 

Bayesian credible interval [BCI]: 21% to 66%), and the rate for intralesional 

triamcinolone was 58 percent (95% BCI: 22% to 93%) compared with 6 percent (95% 

BCI: 1% to 11%) for placebo or observation (moderate SOE for improvement in IH with 

oral steroids vs. observation or placebo; low SOE for greater effectiveness of 

intralesional steroids vs. observation or placebo). This means that we would expect to 

see, on average, 43 percent clearance of IH in children receiving oral steroids relative to 6 

percent with placebo or no treatment. 

• Steroids studied varied in dose, type, and route of administration. 

• Children in treatment arms typically experienced reductions in lesion size, but outcomes 

across studies are difficult to compare given differences in scales. 

• Harms were varied and frequently included Cushingoid facies, irritability/mood changes, 

growth retardation, and skin atrophy or depigmentation. Ulceration was frequently 

reported in studies of intralesional steroids. SOE was moderate for the association of 

steroids with clinically important harms. 

24


We identified 24 studies (three RCTs, one cohort study, and 20 case series) reporting 

outcomes and/or harms following corticosteroid use in children with IH. 40,107-129 One RCT and 

one case series 120,122 likely report on a subset of the same children; however, the extent of 

overlap is not clear. Three RCTs 107,108,122 and one retrospective cohort study 40 addressed 

corticosteroids and included a total of 239 children (age range 1-72 months) with IH in multiple 

anatomic sites. Studies were conducted in India, 122 Canada, 107 Pakistan, 108 and Turkey. 40 Two 

studies included children with cutaneous IH, and IH types across all studies included superficial, 

deep, and mixed. 

Comparative studies and case series assessed oral methylprednisolone, oral prednisolone, 

intravenous methylprednisolone, topical mometasone furoate, topical betamethasone, topical 

clobetasol, topical halobetasol, intralesional betamethasone, and intralesional triamcinolone 

acetonide and compared one agent to another or various doses of agents. One RCT included an 

observational/conservative control group. 108 Only one RCT explicitly noted that assessors were 

blinded to treatment status. 107 Treatment duration (where clearly reported) in comparative studies 

ranged from 3 weeks to 12 months. We rated one RCT as good, 107 one as fair, 122 and one as 

poor 108 quality and the cohort study 40 as fair quality for effectiveness outcomes. We considered 

the cohort study and one RCT 40,122 as poor quality for harms reporting and two RCTs as good 

quality for harms reporting. 107,108 

In our network meta-analysis, oral steroids had a mean estimated expected clearance rate of 

43 percent (95% BCI: 21% to 66%). Intralesional triamcinolone had a rate of 58 percent but with 

wide confidence bounds (95% BCI: 22% to 93%). Thus, there is adequate evidence to support a 

moderate strength of evidence for oral steroids to have a modest effect on clearance rates and 

low SOE for intralesional steroids to have a modest (albeit larger) effect relative to control with 

wide confidence bounds. 

We also report harms from two RCTs 98,100 and five cohort studies 96,97,130-133 that compared 

steroids with propranolol (effectiveness outcomes reported in Effectiveness and Harms of Beta- 

Blockers Compared With Other Active Modalities section below). These studies were conducted 

in the U.S., 97,98 Canada, 96 India, 100 , the Netherlands, 131 Germany, 132,133 and Egypt 130 and included 

308 children with IH (age range=1 to more than 9 months). We rated these studies as good 98 and 

poor 96,97,100,130-133 quality for harms reporting. 

Twenty case series provided harms data on corticosteroids. 109-121,123-129 Children in case series 

(n=3508) ranged in age from 0 to 19 years and typically had IH in multiple anatomic sites. Nine 

case series were conducted in the United States, three in India, two in the U.K., two in China, 

and one each in Qatar, Israel, Thailand, and the Netherlands. Four studies reported on only 

orbital or periocular IH. 111,121,127,128 Treatment duration was frequently not reported. We rated all 

case series as poor quality for harms reporting. 

Steroids were consistently associated with clinically important harms including Cushingoid 

appearance, infection, growth retardation, hypertension, and mood changes that may be 

important in making treatment decisions. The SOE is moderate for the association of steroids 

with these clinically important harms. 

25


Effectiveness of Steroids 

Intravenous or Intralesional Versus Oral Steroids 

One good quality RCT conducted at a Canadian tertiary care hospital randomized 20 children 

with problematic facial IH (defined as causing visual impairment or disfigurement) to oral 

prednisolone (2 mg/kg/day tapered over 9-12 months, n=10, mean age=11±4 weeks) or monthly 

IV methylprednisolone (30 mg/kg infused over 1 hour for 3 days for 3 months, n=10, mean 

age=12±3 weeks). 107 Children in the oral steroid group had greater improvement in size at both 

the 3-month post-treatment and first birthday followup timepoints (median VAS of 70 in oral 

group compared with 12 in IV group, p=0.002 and median VAS of 50 in oral group vs. -1.5 in IV 

group, p=0.005). Vision improved in six of the eight children with eye involvement (2 in oral 

group and 4 in IV group), and seven children in the oral group and six in the IV group required 

additional steroids due to rebound growth or lack or response. In combined group analyses, 

children with periorbital involvement had less improvement at both time points (median VAS of 

4 vs. 48, p=0.049 at 1 year). 

A poor quality RCT conducted in Pakistan compared oral prednisolone (n=25) at a low dose 

(2 mg/kg/day on alternate days) and intralesional triamcinolone (n=25) and observation (n=25) 

in children (mean age=5.0±2.9 months) with superficial (73.3%), mixed (20%), and deep (6.6%) 

cutaneous IH. 108 Lesion sites varied significantly among groups at baseline (p

Table 5. Key resolution outcomes in studies comparing intravenous or intralesional and oral 

corticosteroids 

Author, Year 

Comparison 

Groups (n) 

Quality 

Age 

Type 

Location 

Measures of 

Resolution/ 

Response 

Resolution 

Outcomes 

Rebound Growth/ 

Recurrence, n (%) 

Other Outcomes 

Pope et al. 

2007 107 

G1: Methylprednisolone, 

30 mg/kg 

infused over 

an hour for 

three days 

monthly (10) 

G2: 

Prednisolone, 

oral 

2/mg/kg/day 

(10) 

Quality: 

Good 

Jalil et al. 

2006 108 

G1: 

Triamcinolone 

1-5 mg/kg 

intra-lesional 

(25) 

G2: 

Prednisolone, 

oral 2/mg/kg/ 

on alternate 

days (25) 

G3: 

Observation 

(25) 

Quality: Poor 

Age, 

mean±SD, 

weeks 

G1: 12 ± 3 

G2: 11 ± 4 

Type 

All children 

had mixed, 

superficial 

and deep 

facial IH 

Age, 

mean±SD, 

months 

(range) 

G1+G2+G3: 

5.0 ± 2.9 

(1 to 12) 

Type 

Superficial, 

% 

G1+G2+G3: 

73.3 

Deep 

G1+G2+G3: 

6.6 

Combined 

G1+G2+G3: 

20 

G1+G2: 

Multiple 

G1+G2+ 

G3: 

Multiple 

• 100-mm visual 

analog scale 

(0:no change, 

+:decrease in 

size, 

-:increase in 

size) 

• Blinded 

assessors 

• Grade I greater 

than 50% 

reduction in size 

• Grade II less 

than 50% 


• Grade III little or 

no decrease (or 

increase) 

• Blinded 

assessment: NR 

VAS score at 3 

months, median 

(IQR) 

G1: 12 (-18 to 39) 

G2: 70 (54 to 80) 

G1 vs. G2 p=0.002 

VAS score at 1 

year, median (IQR) 

G1: -1.5 (-35 to 22) 

G2: 50 (35 to 67) 

G1 vs. G2 p=0.005 

Lesion size 

reduction 

Grade I 

G1: 11 

G2: 8 

G3: 0 

Grade II 

G1: 8 

G2: 11 

G3: 1 

Grade III 

G1: 6 

G2: 6 

G3: 19 

No change 

G3: 5 

Need for additional 

treatment, n (%) 

G1: 7 (54) 

G2: 6 (46, additional 

treatment given for 

regrowth specifically) 

Vision outcomes 

• Eye involvement in 5 

children in G1 and 3 

in G2 

• No change in eye 

findings in 1 child in 

each group at 1 year, 

and improvement in 4 

in G1 and 2 in G2 

Rebound growth 

G1: 0 

G2: 1 

G3: 0 

G = group; IH = infantile hemangioma; IQR = interquartile range; kg = kilogram; mm = millimeter; mg= milligram; n = number; 

SD = standard deviation; VAS = visual analog scale 

Intralesional Versus Topical Steroids 

One fair quality RCT conducted in India randomized children (age range=NR) with less than 

or equal to two superficial IH of less than 5 cm to daily topical mometasone furoate (n=52) or 

monthly intralesional triamcinolone (n=47) for 6 to 8 months (Table 6). 122 Patients in this study 

likely overlap with those described in a retrospective case series, 120 but the extent of overlap is 

not clear. Forty-five children in each group responded to treatment (mometasone: 50% excellent, 

36.5% good, 13.4% poor response; triamcinolone: 63.8% excellent, 31.9% good, 4.2% poor 

response). Response to steroids did not differ by age or sex. 

27

Table 6. Key resolution outcomes in studies comparing intralesional and topical corticosteroids 

Age at 

Initiation, 

Months Location 

Resolution Outcomes 

Author, Year 

Comparison 

Groups (n) 

Quality 

Pandey et al. 

2010 122 

G1: 

Mometasone 

furoate, 

topical thin 

film applied 

twice daily 

(52) 

G2: 

Triamcinolone 

acetonide, 

intralesional 

1-2 mg/kg 

(47) 

Age 

NR 

Type 

Type, % 

Superficial:100 

NR 


Resolution/Response 

• Cessation of growth, 

lightening of color, and 

flattening of surface 

• Positive response in all 3 

parameters=Excellent 

• Positive response in 2 

parameters=Good 

• Response in single or no 

parameter=Poor 

• Blinded assessment: NR 

Quality: Fair 

G = group; IH = infantile hemangioma; kg = kilogram; mg = milligram; n = number; NR = not reported 

Response rate, n (%) 

Excellent 

G1: 26 (50) 

G2: 30 (63.8) 

Good 

G1: 19 (36.5) 

G2: 15 (31.9) 

Poor 

G1: 7 (13.4) 

G2: 2 (4.2) 

Methylprednisolone Versus Prednisolone 

In one fair quality Turkish retrospective cohort study, 283 of 1,109 children with superficial 

(53.7%), deep (18.8%), or mixed (16%) IH seen over 23 years at one hospital received either 

observation (n=238), 2 mg/kg/day prednisolone (n=26, median age at initiation=5 months), 

10mg/kg/day methylprednisolone (n=11, median age at initiation=6 months), or 

methylprednisolone tapered from 30 mg/kg/day to 10 mg/kg/day for 7 days (n=8, median age at 

initiation=7 months). 40 Among the children in the observation group at a median of 2 years of 

followup, 92 had complete or near complete (75-100%) regression, 37 had 50 to 75 percent 

regression, 20 had 25 to 50 percent regression, and 89 had less than 25 percent regression. By 

age 5, 68 percent out of an unstated number of children followed had complete regression, and 

90 percent of 92 children followed had complete regression by age 9. Overall, 16 children (36%) 

had a good or excellent response to steroids; 15 (33%) had a fair response; and 14 (31%) had 

poor response. Response did not differ significantly among or between the three groups, but 

rebound growth was significantly higher (p=0.045) among those receiving methylprednisolone 

(dose not clearly reported, n=8 with rebound growth) compared with prednisolone (n=4 with 

rebound growth). Table 7 outlines resolution outcomes. 

28

Table 7. Key resolution outcomes in studies comparing methylprednisolone and prednisolone 

Age at 

Resolution Rebound Growth/ 

Initiation, 

Outcomes Recurrence, n 

Months Location 

Author, Year 

Comparison 

Groups (n) 

Quality 

Akyuz et al. 

2001 40 

G1: 

Prednisolone, 

oral 

2mg/kg/day 

(26) 

G2: 

Methylpredniso 

lone, oral low 

dose 

10mg/kg/day 

tapered to 2 

mg/kg/day (11) 

G3: 

Methylpredniso 

lone, oral low 

dose 

30mg/kg/day 

tapered to 5 

mg/kg/day (8) 

Quality: Fair 

Type 

Age, mean 

(range) 

G1: 5 (2-72) 

G2: 4 (2-11) 

G3: 6 (1-36) 

Type 

Capillary, n 

(%) 

G1: 11 (42.3) 

G2: 2 (18) 

G3: 4 (50) 

Cavernous 

(Deep) 

G1: 8 (30.8) 

G2: 4 (36.4) 

G3: 4 (50) 

Mixed 

G1: 7 (27) 

G2: 5 (45.5) 

G3: 0 

G1+G2+ 

G3: 

multiple 

Methods and 


Resolution/ Response 

• Change in 

dimension, 

lightening of color, 

and softening of 

texture 

• Response graded 

as: 

Excellent: 75-100% 

Good: 50-75% 

Fair: 25-50% 

Poor: < 25% 

• Blinded assessment: 

NR 

Response, n 

(%) 

G1+G2+G3: 

Good or 

excellent: 16 

(36) 

Fair: 15 (33) 

Poor: 14 (31) 

G1 vs. G2 vs. 

G3: p=ns 

G = group; kg = kilogram; mg = milligram; n = number; NR = not reported; ns = not significant 

Harms of Steroids 


Rebound Growth 

G1: 4 

G2+G3: 8 

G1 vs. G2+G3: 

p=0.045 

Effect Modifiers 

• No significant 

association 

between 

response to 

treatment and 

sex, age, lesion 

type, size, 

location, and 

age at 

treatment 

initiation in 

univariate 

analyses 

• In multivariate 

analyses, 

younger age 

and smaller 

lesion size 

associated with 

better response 

Harms Reported in Studies Included in This Review 

Two comparative studies that addressed steroids explicitly defined harms and were 

considered good quality for harms reporting. 107,108 Another RCT (good quality for harms 

reporting) that compared prednisolone and propranolol also predefined harms. 98 Studies included 

a limited number of participants and may not have been adequately powered to detect harms. 

One RCT that compared harms reported in the prednisolone arm with those reported in the 

methylprednisolone arm noted no significant differences in harms between groups, 107 as did an 

RCT comparing prednisolone, triamcinolone, and conservative management. 108 One child 

receiving oral prednisolone discontinued the study due to persistent vomiting. 107 Another RCT 

comparing oral propranolol alone, prednisolone alone, and propranolol plus prednisolone noted 

significantly more complications in the steroid arms compared with propranolol alone (p values 

not clearly reported). 100 Complications in the combination arm and prednisolone only arm 

included Cushingoid appearance (n=6/10 in combination , 5/10 in prednisolone arms) and 

gastrointestinal upset (n=4/10 in combination arm and 3/10 in prednisolone). One child in the 

prednisolone arm discontinued the study due to ulceration and infection. 100 A final RCT reported 

harms using a general classification. 98 The frequency of harms between the prednisolone and 

propranolol groups did not differ significantly (44 vs. 32, respectively), and harms associated 

29

with prednisolone included endocrine (n=0.18% of lesions), gastrointestinal (n=0.14% of 

lesions), growth and development (n=0.23% of lesions), infection (n=0.09% of lesions), 

metabolic (n=0.02% of lesions), and pulmonary/respiratory (n=0.11% of lesions). Severe adverse 

events occurred more frequently in the prednisolone arm (11 vs. 1 in propranolol arm, p=0.01). 

Nine of the 11 severe events were related to growth restriction. Fewer children in the 

prednisolone arm had pulmonary events (typically upper respiratory tract infection) compared 

with children in the propranolol group (5 vs. 14, p70%) in 

both arms in this study also experienced blood pressures ≥ the 90 th percentile (>15% in either 

arm were ≥ the 95 th percentile) though only one required antihypertensive medication for 

persistent elevation, and 52 of 73 cortisol tests were abnormal (31 in prednisolone arm and 21 in 

methylprednisolone). Twelve cortisol levels in the prednisolone arm and one in the 

methylprednisolone arm were in the undetectable range, and blood glucose was transiently 

elevated in 5 of 70 tests. 107 In total, seven of 330 participants receiving steroids in comparative 

studies discontinued treatment due to adverse events. 

Table 8. Harms/adverse effects in comparative studies of steroids to treat IH 

N Studies Reporting 

Intervention 

Harm/Adverse Event 

Harm (# Participants 

With Harm/Total 

Participants) 

Prednisolone 2-2.6 

mg/kg/day 

Reported Rates 

Across Studies 

Irritability 107 1 (3/10) 30% 

Crying 107 1 (3/10) 30% 

Insomnia 107 1 (3/10) 30% 

Hyperactivity 107 1 (2/10) 20% 

Vomiting 107 1 (2/10) 20% 

Abdominal pain or 

2 (5/20) 20%-30% 

gastrointestinal distress 100,107 

Ulceration or infection 100,108 2 (5/35) 10%-16% 

Persistent high blood 

1 (1/10) 10% 

pressure 107 

Respiratory distress 107 1 (1/10) 10% 

Chickenpox 107 1 (1/10) 10% 

Cushingoid appearance 100 1 (5/10) 50% 

Failure to thrive 100 1 (1/10) 10% 

30

Table 8. Harms/adverse effects in comparative studies of steroids to treat IH (continued) 


Intervention 




Participants) 

Prednisone 2-2.8 

mg/kg/day 

IV methylprednisolone 

30mg/kg 

Intralesional 

triamcinolone with or 

without other steroids 1- 

5 mg/kg 

Oral corticosteroids 

(undefined) 

Irritability or behavioral 

changes 96,132,133 



2 (8/50) 6%-17% 

Oral thrush 96 1 (2/12) 17% 

Insomnia 96 1 (1/12) 8% 

Hypertension 96,132,133 2 (3/50) 5%-8% 

Growth failure 96,132,133 2 (4/50) 3%-8% 

Cushingoid appearance 132,133 1 (38/38) 100% 

Glucosuria 132,133 1 (1/38) 3% 


Crying 107 1 (2/10) 20% 

Hyperactivity 107 1 (2/10) 20% 

Vomiting 107 1 (2/10) 20% 

Abdominal pain 107 1 (2/10) 20% 

Insomnia 107 1 (1/10) 10% 

Apathy 107 1 (1/10) 10% 

Behavioral change 107 1 (1/10) 10% 

Respiratory distress 107 1 (1/10) 10% 

Pain 122 1 (47/47) 100% 

Itching 122 1 (9/47) 19.1% 

Bleeding 122,131 2 (17/76) 17%-31% 

Infection 122 1 (8/47) 17% 

Ulceration 108,131 2 (8/54) 4%-24% 

Ulcer and depigmentation 108 1 (1/25) 4% 

Cushingoid appearance 122 1 (1/47) 2.1% 

Skin atrophy 108,122 2 (5/72) 4%-8.5% 

Skin depigmentation or 

2 (6/72) 6.4%-12% 

hypopigmentation 108,122 


Gastroesophageal reflux 97 1 (4/42) 10% 

Arterial bleed 97 1 (4/42) 10% 

Hirsutism 97 1 (4/42) 10% 

Growth retardation 97 1 (4/42) 10% 

Hypercholesterolemia 97 1 (4/42) 10% 

Scarring and lip contraction 97 1 (4/42) 10% 

Hypertension 97 1 (2/42) 5% 

Mometasone furoate Itching 122 1 (10/52) 19.2% 

(topical) 

Hypopigmentation 122 1 (4/52) 7.7% 

Observation Spontaneous ulceration 108 1 (4/25) 16% 

IH = infantile hemangioma; n = number 

Note: One study 40 comparing prednisolone and methylprednisolone regimens reported Cushingoid facies in 20/45 children, 

irritability in 16/45, and increased appetite in “almost all” children. The study does not report the regimen associated with each 

adverse event. One cohort study comparing propranolol and prednisone was reported in 2 publications. 132,133 we use the harms 

data reported in the 2008 publication. 133 

Case series included 3508 children receiving intralesional, oral, or topical steroids or 

combinations of agents, with doses of oral steroids ranging from 1 to 5 mg/kg/day and 

intralesional doses (where reported) ranged from 0.5 to 6 ml (Table 9). We considered all studies 

as poor quality for harms reporting. No studies explicitly reported harms sought, and the lack of 

a comparison group and typically small sample sizes limit our understanding of the significance 

of these harms. 

Frequently reported harms across agents were Cushingoid facies (reported in 0.45%-100% 

of children in 12 studies), diminished height or weight gain or growth retardation (0.45%-47% of 

31

children in 8 studies), skin atrophy (0.95%-17% of children in five studies), hypopigmentation 

(1.4% to 16% of children in 6 studies), hypertension (0.11% to 5% of children in five studies), 

infection (2% to 15% of children in 5 studies), and behavioral changes (25% to 100% of children 

in four studies). Cushingoid appearance and growth retardation occurred regardless of dosage 

form (i.e., intralesional, oral). 

One study reported on several “ultrapotent” topical steroids (betamethasone dipropionate, 

clobetasol propionate, halobetasol propionate, 0.05%) in children with primarily superficial IH 

and noted that 2 of 34 children (agents received not specified) experienced hypopigmentation. 127 

Another reporting on several corticosteroids including oral prednisolone, clobetasol propionate, 

and intralesional triamcinolone plus betamethasone in 30 children with complicated IH reported 

adverse effects in the aggregate rather than by agent. 129 Most children received prednisolone, and 

harms included decreased rate of linear growth (n=14), decreased weight gain (n=9), Cushingoid 

facies (n=7), increased weight gain (n=5), decreased head growth (n=4), hirsutism (n=4), delayed 

motor milestones (n=3), thrush (n=3), premature thelarche (n=2), increased rate of linear growth 

(n=1), sterid acne (n=1), gastritis (n=1), and varicella infection (n=1). 129 Three case series 

evaluating intralesional steroids reported that no adverse events occurred, 123,126,128 and none 

explicitly reported discontinuation of treatment due to adverse events. 

Table 9. Adverse effects in case series of steroids to treat IH 

Intervention 

Intralesional 

triamcinolone+betamethasone † 

Intralesional 

triamcinolone+dexamethasone 

Intralesional 

triamcinolone+prednisolone 


Number Of 

Studies 

(# Participants 


Participants) 



Cushingoid appearance 110,112 2 (5/100) 3%-10% 

Hypopigmentation 110 1 (2/70) 3% 

Periocular calcification 121 1 (1/34) 3% 

Abscess at injection site 111 1 (1/27) 4% 

Subcutaneous fat atrophy 111 1 (1/27) 4% 

Ulceration 120 1 (130/628) 21% 

Skin atrophy 120 1 (106/628) 17% 


Infection 120 1 (91/628) 14% 



Hypertension 120 1 (30/628) 5% 

Intralesional triamcinolone ** Ulceration 114,120 2 (150/1046) 4%-16% 

Infection 109,120 2 (105/991) 2%-12% 

Anaphylactic shock 115 1 (3/155) 2% 

Hypopigmentation 114,120 2 (93/1046) 1%-10% 

Peptic ulcer 114 1 (2/160) 1% 

* Skin atrophy 109,115,120 3 (106/1146) 0.95%-11% 

Entropion 114 1 (1/160) 0.63% 

Cushingoid appearance 115,120 2 (6/1041) 0.45%-1% 

Growth retardation 120 1 (4/886) 0.45% 

Hypertension 120 1 (1/886) 0.11% 

Intralesional 

betamethasone+dexamethasone 

Bruising at injection site 124 1 (NR/36) NR 

32

Table 9. Adverse effects in case series of steroids to treat IH (continued) 

Number Of 

Studies 

Intervention 


(# Participants 


Participants) 

Oral prednisone or 

prednisolone 


Diminished weight gain 116 1 (26/62) 42% 

Diminished height gain 116 1 (22/62) 35% 

Irritable and/or napped less 116 1 (18/62) 29% 

Personality change 116 1 (18/62) 29% 

Gastric irritation 116 1 (13/62) 21% 

Insomnia 116 1 (8/62) 13% 

Fungal (oral or perineal) infection 116 1 (4/62) 6% 

Recurrent otitis media 116 1 (4/62) 6% 

Corticosteroid myopathy 116 1 (1/62) 2% 

Hypertension 116 1 (1/62) 2% 



Oral prednisolone Cushingoid appearance 113,120 2 (26/524) 4%-20% 

Infection 120 1 (55/499) 11% 


Hypertension 120 1 (20/499) 4% 

Skin atrophy 120 1 (16/499) 3% 

Ulceration 120 1 (13/499) 3% 


Oral prednisone Cushingoid appearance 117 1 (32/60) 53% 

Behavior changes 117 1 (60/60) 100% 


Osteoporosis 117 1 (1/60) 2% 

IH = infantile hemangioma; n = number; NR = Not reported 

* One study 109 reported “atrophy and ulceration.” 

** One study of intralesional triamcinolone reported “no systemic side effects.” 123 Another reported unspecified complications in 

3/30 children with complicated IH receiving intralesional triamcinolone. 125 Two other studies reported harms in the aggregate 

only and not by specific agent 127,129 and are thus not included in this table. 

† Two studies reported that there were no adverse effects with intralesional triamcinolone+betamethasone in 42 children with 

orbital IH 126 or eyelid IH. 128 

Harms Reported in Package Insert Data 

The safety and efficacy of pediatric use of corticosteroids has been studied in the literature 

for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and 

leukemias (>1 month of age). 134-139 It has been reported that the adverse events identified in 

pediatric patients were similar to the events experienced in adults. Monitoring pediatric patients 

for blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence 

of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and 

osteoporosis is recommended. Specifically, pediatric patients may have a decrease in growth 

velocity after taking corticosteroids by any route of administration. Therefore, children should be 

titrated to the lowest effective dose. 

Common adverse events of corticosteroids include: fluid retention, alteration in glucose 

tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and 

weight gain. 134-142 Additional adverse events include: anaphylactoid reaction, anaphylaxis, 

angioedema, bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory 

collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in 

premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, 

syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, acne, allergic dermatitis, 

cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or 

33

hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, 

rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp 

hair, urticaria, abnormal fat deposits, decreased carbohydrate tolerance, development of 

Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements 

for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon faces, 

secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in 

trauma, surgery or illness), suppression of growth in children, potassium loss, hypokalemic 

alkalosis, sodium retention, abdominal distention, elevation in serum liver enzymes levels 

(usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis, 

peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis, osteonecrosis of 

femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, 

osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral 

compression fractures, arachnoiditis, convulsions, depression, emotional instability, euphoria, 

headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually 

following discontinuation of treatment, insomnia, meningitis, mood swings, neuritis, neuropathy, 

paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo, 

exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, 

alteration in motility and number of spermatozoa. 

We also identified safety data for another steroid evaluated in studies in this review, 

mometasone furoate. The use of this medication in pediatric patients (>2 years) is not 

recommended for more than 3 weeks. 143 This medication is administered topically, and pediatric 

patients will have an increase in the skin surface area to body mass ratio. As a result, adverse 

events such as hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, adrenal 

insufficiency upon cessation, skin atrophy, striae, linear growth retardation, delayed weight gain, 

and intracranial hypertension are more likely to occur in pediatric patients. We report additional 

harms data form package inserts and U.S. Food and Drug Administration (FDA) approval 

documents in Appendix H. 

Effectiveness and Harms of Beta-Blockers 

Key Points 


• In our network meta-analysis, oral propranolol was associated with a mean estimate of 

expected clearance of IH of 95% (95% BCI: 88% to 99%) compared with 6 percent (95% 

BCI: 1% to 11%) for placebo or observation arms (high SOE for greater effectiveness of 

propranolol versus placebo or observation). 

• Oral propranolol at doses of 2-3 mg/kg/day divided two to three times daily and given for 

up to 6 months promoted resolution or near resolution of IH in children under the age of 

12 months with superficial, deep, mixed, or ulcerated IH in most studies. 

• Adverse events, measured in the short-term only, associated with these doses of 

propranolol in this same population were limited in frequency and severity (moderate 

SOE association of propranolol with clinically important and minor harms). 

34


• In network meta-analysis, oral propranolol was associated with a mean estimate of 

expected clearance of IH of 95% (95% BCI: 88% to 99%) compared with a lower rate for 

oral steroids (43% [95% BCI: 21% to 66%]), while in head-to-head comparisons three 

small studies found propranolol was more effective than corticosteroids, and two did not 

find a significant difference in effectiveness between the two therapies. Combined effects 

from individual studies and network meta-analysis conferred moderate SOE for the 

superiority of propranolol over steroids at achieving IH clearance. 

• In one cohort study comparing the effects of intralesional steroids and oral propranolol on 

vision outcomes, improvement in amblyopia did not differ between agents, but fewer 

children receiving propranolol required additional treatments or had side effects than 

those receiving steroids. 

• Propranolol combined with pulsed dye laser (PDL), either concurrently or sequentially, 

was more effective than propranolol alone in one study. 

• In a study comparing oral propranolol with intralesional bleomycin, 6 of 10 children in 

each arm had at least 75 percent clearance of IH. 

• One study found that patients who received propranolol had a lower likelihood of 

subsequent laser treatment than those who received other interventions. 

• Propranolol was associated with faster healing of ulceration versus historical treatments 

including laser and antibiotics. 

Oral Propranolol Versus Other Beta-Blockers or Dosage Forms 

• Other oral beta-blockers (atenolol, nadolol) investigated in three studies were reported to 

be effective in promoting IH resolution and potentially associated with fewer adverse 

events than propranolol (low SOE for no difference in response of IH to propranolol, 

nadolol, or atenolol). 

Timolol Versus Placebo/Observation or Other Active Modalities 

• In our network meta-analysis, topical timolol had a mean expected clearance rate of 62 

percent (95% BCI: 39% to 83%) compared with 6 percent (95% BCI: 1% to 11%) for 

placebo or observation (low SOE for effectiveness of timolol versus placebo or 

observation). 

• Topical timolol 0.5 percent maleate gel promoted improvement of superficial IH without 

reported adverse effects in four comparative studies (low SOE for lack of association 

with harms). Studies reported effectiveness at 24 weeks with the noticeable change in IH 

lesions occurring approximately 12 to 16 weeks after initiation of treatment. 


We identified a total of 81 studies (nine RCTs, 14,17,92,93,98-100,102,104 16 cohort studies, 95- 

97,101,103,105,106,130-133,144-150 

and 56 case series 16,18,151-205 ) addressing beta-blockers including 

propranolol, atenolol, nadolol, and timolol. Comparative studies addressed the following 

interventions and comparators: propranolol compared with observation or placebo arms, 

propranolol compared with other active modalities (e.g., steroids), oral propranolol compared 

with other beta-blockers or dosage forms, and timolol compared with observation/placebo or 

another modality (e.g., laser). Comparative studies included a total of 1539 children between the 

ages of less than one month to 9 years. We considered four RCTs to be good quality and five as 

35

fair quality for effectiveness outcomes and 11 cohort studies as fair quality and five as poor 

quality for effectiveness outcomes. 


We identified four studies (two good 17,92 and one fair 99 quality RCTs and one fair quality 

cohort study 94 ) evaluating propranolol versus placebo or observation. Propranolol was associated 

with significantly greater clearance of IH compared with the control arm in all four studies. In 

the largest RCT, which included 456 children without problematic IH receiving up to 3 

mg/kg/day of propranolol, 60 percent of children in the propranolol group had complete or near 

complete resolution of IH after 24 weeks of treatment compared with 4 percent in the placebo 

group. 92 The recommended dose of propranolol in this IH population remains to be determined, 

but the majority of studies to date have investigated the 2 mg/kg/day dosing regimen. Despite 

changes in lesion size in many children receiving propranolol, some children do not appear to 

respond to propranolol, but these children are not well-characterized to date. 

In network meta-analysis, the mean expected clearance rate for oral propranolol was 95 

percent (95% BCI: 88% to 99%) relative to 6 percent (95% BCI: 1% to 11%) for 

placebo/observation arms; IH size reductions were greater in propranolol arms versus control in 

all individual studies, thus we considered the SOE as high for greater effectiveness of 

propranolol compared with placebo or observation based on individual comparisons and the 

meta-analysis. 


Ten studies compared propranolol to another modality including steroids, pulse dye laser 

(PDL), bleomycin, or historical treatments. 95-98,130-133,145,149,150 Studies comparing propranolol 

and steroids to reduce IH size had conflicting findings. Propranolol was more effective than 

steroids in three studies, 96,97,132,133 while two others studies did not find effectiveness differed 

significantly between these treatments. 98,130 In network meta-analysis, pooling data from multiple 

studies, propranolol was superior to oral steroids (95% clearance [95% BCI: 88% to 99%]) 

versus 43% clearance (95% BCI: 22% to 66%). These combined effects from individual studies 

and meta-analysis conferred moderate SOE for superiority of propranolol over steroids at 

achieving clearance. 

One additional retrospective cohort study assessing only vision outcomes reported no 

significant differences between oral propranolol and intralesional steroids in improving 

amblyopia, but children in the propranolol arm had a significantly shorter duration of therapy 

(p

Oral Propranolol Versus Other Beta-blockers or Dosage Forms 

Three small studies compared propranolol with nadolol 101 or atenolol, 102,146,147 and one study 

evaluated oral, intralesional, and topical propranolol. 93 Atenolol and nadolol demonstrated 

promising effects on lesion size (no significant differences in effectiveness of propranolol and 

atenolol and greater effectiveness in a small study comparing nadolol and propranolol) and low 

levels of adverse effects, which may suggest that improvements can be achieved in the 

propranolol safety profile. More children receiving oral propranolol had an excellent or good 

level of resolution than those receiving topical or intralesional (n=11/15, 8/15, 5/15, 

respectively), but the difference among groups was not significant. 93 

In head-to-head comparisons, there were no significant differences in response between 

propranolol and atenolol in two studies and better response to nadolol versus propranolol in one 

small study. We considered the SOE as low for no difference in response with propranolol, 

nadolol, or atenolol (systemic beta-blockers). 

Timolol Versus Placebo/Observation or Other Active Modality 

Six comparative studies addressed timolol (two RCTs 14,104 and four cohort 

studies 103,105,106,144 ). All studies included children with superficial IH, and two (one comparing 

timolol with observation and one comparing timolol and laser) also included children with mixed 

(superficial and deep) IH. 14,144 Timolol was significantly more effective than observation or 

placebo in three studies, 103,104,144 and one study comparing imiquimod with timolol did not 

demonstrate that one intervention was more effective than the other. 105 In one study comparing 

timolol and PDL+Nd:YAG laser, timolol was associated with greater improvements in 

superficial lesions, while laser was associated with greater improvements in mixed (superficial 

and deep) lesions. 106 In another comparing timolol alone with timolol plus PDL, mean global 

assessment scores were more improved in the combination arm than in the timolol arm, though 

IH in 97 percent of children in both arms improved from baseline. 14 No harms of timolol were 

observed in any study. 

In network meta-analysis, the mean expected clearance rate for topical timolol was 62 

percent (95% BCI: 39% to 83%) relative to 6 percent (95% BCI: 1% to 11%) for placebo or 

observation arms. We considered SOE as low for the effectiveness of timolol compared with 

placebo or observation. 

Harms of Beta-blockers 

In addition to these comparative studies, a total of 56 case series addressed harms of betablockers 

for IH. 16,18,151-205 We assessed four case series as good quality for harms 

reporting, 168,171,181,186 one as fair quality, 182 and 51 as poor quality. 16,18,151-167,169,170,172-180,183-185,187- 

205 

Twenty-four comparative studies also reported harms data, and we assessed four as good 

quality for harms reporting 92,98,104,105 and the remainder as poor quality for harms 

reporting. 14,17,93-97,99-103,106,130-133,144-147,150 Harms most frequently reported with use of oral betablockers 

(propranolol, atenolol, nadolol) included sleep disturbances, cold extremities, 

gastrointestinal symptoms, bronchial irritation (classified as hyperreactivity, bronchospasm, 

bronchiolitis, cold induced wheezing), and decreases in blood pressure or heart rate. Rates of 

significant clinically important harms ranged from 0 to 100 percent across studies of propranolol 

and from 1 percent to 50 percent for minor harms. We considered SOE as moderate for the 

association of propranolol with these harms. Data were insufficient to comment on harms in 

37

studies of nadolol and atenolol. No harms were observed in four small studies of timolol. We 

considered SOE to be low for lack of association of timolol with harms. 


Propranolol Versus Placebo or Observation 

One good quality RCT conducted in 56 centers in 16 countries randomized 460 infants with a 

proliferating IH measuring at least 1.5 cm in diameter to treatment with either placebo twice 

daily for 6 months (n=55) or one of four oral propranolol treatment regimens (1 mg/kg/day of 

propranolol divided twice daily for 3 months (n= 99) or 6 months (n= 103); 3 mg/kg/day of 

propranolol divided twice daily for 3 months (n= 101) or 6 months (n= 102). 92 Two independent, 

trained, validated readers centrally assessed digital photographs taken at each patient’s 15 study 

visits for complete or nearly complete resolution, hemangioma evolution, and change in 

hemangioma size and color. Investigators at each site performed these same assessments, and 

assessed complications, adverse events, and use of other treatment for IH. Parents or guardians 

also assessed changes in IH since the previous visit. 

Overall, 61 of 101 patients (60%) assigned to propranolol 3mg/kg/day for 6 months and 2 of 

55 patients (4%) assigned to placebo had complete or near complete resolution of hemangioma at 

week 24 (p

placebo group (p values ≤ 0.07). Of the 19 patients treated with propranolol, two responded only 

minimally (start of treatment at ages 5.5 and 11 months). 

In one fair quality cohort study conducted in India, thirty-three children up to 10 years of age 

with IH requiring treatment due to airway obstruction, ocular occlusion or compression, aesthetic 

disfigurement or ulceration, who may have failed other treatment modalities, and those patients 

greater than 12 months of age with continuous proliferation of their IH without signs of 

resolution were treated with propranolol at a dose of 2 mg/kg/day divided twice daily. 94 The 

study compared these participants with historical controls who had not previously received 

therapy. Significant involution defined as a score of 5 to 9 on a 10-point scale (10=no change in 

original IH, 0=normal skin) was seen in 28/31 (90.3%). All children 6 months of age and 

younger responded (20/20, 100%). No child greater than 36 months of age (0/2, 0%) responded 

to propranolol. Sixty-five to 80 percent of involution occurred in the first 8 weeks of propranolol 

therapy. The overall mean involution score for the propranolol group compared with the control 

group was 4.37 versus 8.38 (p< 0.0001). Table 10 outlines resolution outcomes in these studies. 

Table 10. Key resolution outcomes in RCTs comparing propranolol and placebo or observation 

Author, Year 

Comparison 

Groups (n) 

Quality 

Leaute-Labreze 

et al. 2015 92 

G1: Propranolol, 

oral 3mg/kg/day 

for 6 months 

(102) 



for 3 months 

(101) 



for 6 months 

(103) 



for 3 months 

(99) 

G5: placebo 

(55) 

Quality: Good 

Age 

Type 

Age, days 

mean±SD 

G1: 101.6 ± 

31.0 

G2: 107.5 ± 

30.1 

G3: 102.6 ± 

30.1 

G4: 103.6 ± 

33.1 

G5: 103.9 ± 

31.1 

Type, n (%) 

Segmental 

G1: 5 (5) 

G2: 7 (7) 

G3: 7 (7) 

G4: 4 (4) 

G5: 2 (4) 

Localized 

G1: 91 (90) 

G2: 88 (88) 

G3: 90 (88) 

G4: 89 (91) 

G5: 48 (87) 

Indeterminate 

G1: 5 (5) 

G2: 5 (5) 

G3: 5 (5) 

G4: 5 (5) 

G5: 5 (9) 

Location 

G1+G2+G 

3+G4+G5: 

Multiple 



Resolution/ 

Response 

• Serial 

photographs 

and clinical 

assessment by 

blinded 

investigators 

• Nearly 

complete 

resolution 

defined as 

minimal 

degree of 

telangiectasis, 

erythema, skin 

thickening, 

soft-tissue 

swelling, and 

distortion of 

anatomic 

landmarks 

Resolution 

Outcomes 

Complete or 

nearly 

complete 

resolution at 

24 weeks, n 

(%) 

G1: 61/101 

(60%) 

G5: 2/25 (4%) 

p< 0.0001 

Rebound Growth/ 

Recurrence, n (%) 


Need for additional 

treatment 

• 6 (10%) assigned to 

propranolol required 

systemic treatment 

from week 24 to week 

96 

• 7 (11%) required any 

additional hemangioma 

treatment 

39

Table 10. Key resolution outcomes in RCTs comparing propranolol and placebo or observation 

(continued) 

Author, Year 

Methods and Resolution Rebound Growth/ 

Age 

Comparison 

Measures of Outcomes Recurrence, n (%) 

Location 

Groups (n) 

Resolution/ 

Type 

Quality 

Response 


Leaute-Labreze 

et al. 2013 99 


oral 3-4 

mg/kg/day for 1 

month (7) 

G2: Placebo (7) 

Age, weeks 

mean±SD 

G1: 12.5 ± 2.1 

G2: 12.4 ± 2.6 

Type: 

NR 

G1+G2: 

multiple 

• Change in 

thickness as 

measured by 

ultrasound 

• Double-blinded 

assessment of 

change 

Mean change 

in thickness, 5 

[95% CI] 

G1: -44.9% 

[36-76.2p 

G2: +11.3% 

G1 vs G2: 

p=0.004 

• NR 

Quality: Fair 

Percentage 

change in size 

G1: -15.8 

G2: +8.9 

G1 vs G2: 

p=0.041 

Hogeling et al. 

2011 17 

G1: Propranolol 

oral, 

2mg/kg/day in 3 

daily doses (19) 

G2: Placebo 

(20) 

Quality: Good 

Mean weeks, 

n 

G1: 67 

G2: 71 

Type 

Focal, n 

G1: 16 

G2: 17 

Segmental 

G1: 3 

G2: 3 

G1+G2: 

multiple 

• Photographs 

and serial 

hemispheric 

measurements 

of tumor 

volume 

assessed by 

blinded 

investigators 

Percent 

change in 

volume at 24 

weeks 

G1: -60% 

(n=18) 

G2: -14.1% 

(n=15) 

Difference 

between group 

-45.9 (95% CI: 

-80.3, -11.4) 

p=0.01 

• NR 

40

Table 10. Key resolution outcomes in RCTs comparing propranolol and placebo or observation, 

continued 

Author, Year 


Age 

Comparison 

Measures of Outcomes Recurrence, n (%) 

Location 

Groups (n) 

Resolution/ 

Type 

Quality 

Response 


Sondhi et al. 

2013 94 


oral, 

2mg/kg/day (31) 

G2: No 

treatment, 

historical 

controls (14) 

Quality: Fair 

Age, mean 

months 

(range) 

G1: 10.8 (1 

mo-9 years) 

G2: 8.6 (3-20 

mo) 

Type, n: 

Superficial 

G1: 11 

G2: 6 

Mixed 

G1: 9 

G2: 3 

Deep 

G1: 11 

G2: 5 

G1+G2: 

multiple 

• Photographs, 

color and size 

scored; degree 

of involution 

assessed by 

blinded 

investigators 

• Change score: 

0 considered 

completely 

normal skin, 10 

no change in 

IH from pretreatment 

Involution 

Significant 

involution (> 

50%), n (%) 

G1: 28 (90.3) 

G2: 4 (28.6) 

Some 

involution 

(11%- 50%), n 

(%) 

G1: 0 

G2: 2 (14.3) 

No involution (≤ 

10%), n (%) 

G1: 3 (9.7) 

G2: 6 (42.8) 

Overall mean 

score 

G1: 4.37 (95% 

CI: 3.15 to 

5.59) 

G2: 8.38 (95% 

CI: 7.71 to 

9.01) 

G1 vs.G2 

p

old. 100 Thirty percent of children with IH in the head and neck area had parotid IH, and 53 

percent of lesions overall were superficial (27% mixed, 20% deep). IH reduction from baseline 

was greater in the propranolol alone and propranolol plus prednisolone arms compared with the 

prednisolone arm (p values

Table 11. Resolution outcomes in studies comparing beta-blockers and steroids 

Author, Year 

Comparison Groups 

(n) 

Quality 

Baumann et al. 2014 98 


2mg/kg/day in 3 daily 

doses (11) 

G2: Prednisolone, 

2mg/kg/day in two daily 

doses (8) 

Quality: Good 

Age, Months 

Type 

Age, mean 

(95% CI) 

G1: 2.5 (1.7- 

3.4) 

G2: 4.0 (2.8- 

5.2 

Type, n: 

Superficial 

G1: 3 

G2: 2 

Location 

G1+G2: 

multiple 



Resolution/ 

Response 

• Size measured by 

proportional 

change in total 

surface area 

(TSA) by blinded 

assessors 

Resolution 

Outcomes 

Change in size at 

4-5 months, TSA 

mean (95% CI) 

G1: 0.57 (0.34 to 

0.80) n=9 

G2: 0.63 (0.14 to 

1.11) n=6 

G1 vs. G2: p=ns 

Rebound 

Growth/ 

Recurrence, 

n 

Other 

Outcomes, 

n (%) 

G1: 2 

G2: 1 

Mixed 

G1: 6 

G2: 4 

Deep 

G1: 2 

G2: 2 

Bertrand et al. 2011 96 

G1: Propranolol, oral 

2.7 mg/kg/day (12) 

G2: Prednisone, oral 

2.8 mg/kg/day (12) 

Quality: Fair 

Age, mean 

(range) 

G1: 3.7 (1.5- 

8.7) 

G2: 3.8 (1-9) 

Type, n: 

Superficial 

G1+G2: 2 

pairs 

Mixed 

G1+G2: 6 

pairs 

Deep 

G1+G2: 4 

pairs 

G1+G2: 

multiple 

• Photographs rated 

by blinded 

assessors for 

percentage of 

improvement 

Stable or worse 

(0%) 

Slight 

improvement 

(75%) 

• Visual analog 

scale (VAS) used 

at 6 months (100 

complete 

resolution, 0 no 

change, -100 

doubling in size) 

Clinical 

improvement 

VAS, mean ± SD 

G1: 78.73 ± 22.47 

G1: 44.82 ± 12.21 

G1 vs.G2 

ICC=0.833 p< 

0.001 

Good to excellent 

response at 6 

months, n 

G1: 12 

Slight to moderate 

response 

G2: 9 

NR 

43

Table 11. Resolution outcomes in studies comparing beta-blockers and steroids (continued) 

Author, Year 


(n) 

Quality 

Price et al. 2011 97 

G1: Propranolol, oral 

2/mg/kg/day in two daily 

doses (68) 

G2: Corticosteroids, oral 

2-4 mg/kg/day (42) 

Quality: Fair 

Age, Months 

Type 

Age, mean 

G1: 4.9 

G2: 4.5 

Type 

NR 

Location 

G1+G2: 

multiple 



Resolution/ 

Response 

• Degree of 

clearance 

achieved reported 

as either 

1. ≥75% defined 

by correlating 

percentage of 

decrease in 

volume, 

cosmetically 

acceptable result 

by physician 

and/or parent and 

no need for further 

treatment or 

2.


Author, Year 


(n) 

Quality 

Hoornweg et al. 2014 131 

G1: Propranolol, oral 1- 

3/mg/kg/day (14) 

G2: Intralesional 

triamcinolone acetonide 

and methylprednisolone 

(29) 

Quality: Fair 

Age, Months 

Type 

Age, median 

(IQR) 

G1: 2.66 

(1.78) 

G2: 2.92 

(2.53) 

Type, % 

Proliferation 

G1: 93 

G2: 86 

Involution 

G1: 7 

G2: 14 

Location 

G1+G2: 

periorbital 



Resolution/ 

Response 

Resolution 

Outcomes 

Rebound 

Growth/ 

Recurrence, 

n 

Other 

Outcomes, 

n (%) 

• NR NR Level of 

amblyopia 

0 

G1: 12 (86) 

G2: 11 (61) 

1 

G1: 1 (7) 

G2: 3 (17) 

2 

G1: 1 (7) 

G2: 0 

3 

G1: 0 

G2: 1 (6) 

4 

G1: 0 

G2: 2 (11) 

Need for 

additional 

therapies to 

reduce IH 

size 

G1: 1 (7) 

G2: 10 (34) 

G1 vs. G2: 

p=NS 

Duration of 

therapy, 

median 

months 

(IQR) 

G1: 6.5 

(4.87) 

G2: 15.9 

(10.3) 

G1 vs G2: 

p


Author, Year 


(n) 

Quality 

Malik et al. 2013 100 


3/mg/kg/day in two daily 

doses (10) 

G2: Prednisolone, oral 

1-4 mg/kg/day (10) 


3/mg/kg/day and 

Prednisolone, oral 1-4 


Quality: Fair 

Rossler et al, 2012 132,133 

G1: Oral propranolol, 2 


G2: Oral prednisone, 2 

mg/kg/day then reduced 

to 1 mg/kg/day (30) 

Quality: Poor 

Age, Months 

Type 

Age, mean 

G1: 4.6 

G2: 5.5 

G3: 4.7 

Type, % 

Superficial 

G1+G2+G3: 

53 

Mixed 

G1+G2+G3: 

26.7 

Deep 

G1+G2+G3: 

20 

Age, mean 

G1: 4.4 

G2: 2.8 

Type: NR 

Location 

G1+G2+G 

3: multiple 

G1+G2: 

multiple 



Resolution/ 

Response 


assessed by 2 

blinded assessors 

• Color and size 

based on Visual 

Analog Scale 

(VAS) 

• Improvement 

graded as: 

75-100% 

50-74% 

25-49% 

0-24% 

• Size measuring 

length and width 

• Blinded 


• IH score based on 

color, skin level, 

and turgor (scale 

0-6) 

Resolution 

Outcomes 

Mean size 

reduction %, VAS 

G1: 89.8 

G2: 66.6 

G3: 82.6 

Color fading, VAS 

G1: -9 

G2: -8 

G3: -9 

Median size at 

end of therapy 

G1: 2.0 cm 2 

G2: 3.5 cm 2 

G1 vs G2: 

p=0.006 

Median score 

G1: 2 

G2: 3 

G1 vs G2: 

p

Table 12. Resolution outcomes in studies comparing intralesional propranolol and triamcinolone 

Rebound 

Resolution Growth/ 

Age, Months 

Outcomes Recurrence 

Author, Year 


(n) 

Quality 

Awadein et al. 2011 130 


intralesional 1mg/ml 

(12) 

G2: Triamcinolone, 

intralesional 

40mg/ml(10) 

Quality: Poor 

Type 

Age, 

mean±SD 

G1: 5.9±2.7 

G2: 6.1±2.9 

Type 

NR 

Location 

G1+G2: 

Periocular 



Resolution/ 

Response 

• Size measured 

by clinical 

examination 

and 

photography 

• Response 

graded as: 

Excellentcomplete 

resolution 

achieved 

Goodsustained 

plateau with ≥ 

50% reduction 

Fair-sustained 

plateau with < 

50% reduction 

Poor-no 

response or 

worsening 

• Blinded 

assessment: 

NR 

Regression of IH 

G1:10/12 (83%) 

G2: 8/10 (80%) 

Response 

Excellent 

response 

G1:5/12 (42%) 

G2: 4/10 (40%) 

Good 

G1:3/12 (25%) 

G2: 2/10 (20%) 

Fair 

G1:2/12 (17%) 

G2: 2/10 (20%) 

Poor 

G1:2/12 (17%) 

G2: 2/10 (20%) 

Other 

Outcomes 

Rebound 

growth, n 

G1:4 

G2: 3 

Abbreviations: G = group; IH = infantile hemangioma; mg = milligram; ml = milliliter; n= number; NR = not reported; 

SD = standard deviation 

Vision 

outcomes 

• Significant 

reduction in 

astigmatic 

error in both 

the 

propranolol 

group 

(p=0.02) and 

the steroid 

group 

(p=0.03) but 

there was no 

between 

group 

differences 

(p=0.34, 

n=22) 

• No 

significant 

group 

difference in 

the degree 

of ptosis 

(p=0.46) 

Propranolol Plus Pulsed Dye Laser Versus Propranolol Alone 

A fair quality retrospective cohort study compared three treatments for facial segmental IH: 

concurrent propranolol and pulsed dye laser (n=12), propranolol followed by pulsed dye laser 

(n=5), and propranolol alone (n=8) (Table 13). 150 Mean hemangioma size was larger in the 

concurrent treatment group (41.65 cm 2 ) than the sequential (20.1 cm 2 ) and propranolol-only 

groups (18.0 cm 2 ). Among the 12 participants who received concurrent propranolol and pulsed 

dye laser, six (50%) had complete clearance and six (50%) had near-complete clearance. All five 

of the participants in the propranolol followed by pulsed dye laser group also had complete (n=2, 

40%) or near-complete (n=3, 60%) clearance. Among the eight participants who receive 

propranolol alone, one (13%) had complete clearance, two (25%) near-complete clearance, and 

five (63%) partial clearance. The difference in effectiveness between combined therapy, either 

concurrently or sequentially, and propranolol alone was statistically significant. The number of 

days of propranolol treatment until near-complete clearance was significantly lower (p

Table 13. Resolution outcomes in studies comparing propranolol with laser and propranolol alone 

Author, Year 


Age, Months 


Measures of Outcomes Recurrence 

(n) 

Location Resolution/ 

Type 

Quality 

Response 


Reddy et al. 2013 150 

G1: Propranolol + 

pulsed dye laser 

concurrent (12) 


followed by pulsed dye 

laser (5) 

G3: Propranolol only (8) 

Quality: Fair 

Age, mean 

days 

G1: 43 

G2: 62 

G3: 47 

Type, n (%) 

Superficial 

G1: 7 (58) 

G2: 0 

G3: 3 (37.5) 

Compound 

G1: 5 (42) 

G2: 5 (100) 

G3:5 (62.5) 

G1+G2+G 

3: Large or 

segmental 

- 

distribution 

facial 

G = group; IH = infantile hemangioma; NR = not reported 


used to rate 

degree of 

clearance 

score by 

blinded 

physicians: 

1: no 

improvement 

2: partial 

improvement 

(significant 

residual 

superficial or 

deep IH) 

3: nearcomplete 

clearance (mild 

residual 

superficial IH) 

4: complete 

clearance 

(minimal to no 

residual 

superficial IH) 

Complete 

clearance 

G1: 6/12 (50) 

G2: 2/5 (40) 

G3: 1/8 (12.5) 

G1 vs.G2 

vs.G3: p=0.01 

Rebound growth 

NR 

Other outcomes 

• Significant 

difference 

between groups 

in the number of 

days of 

propranolol 

treatment until 

near-complete 

clearance of 

lesions, p

Table 14. Resolution outcomes in studies comparing propranolol and bleomycin 

Author, Year 


(n) 

Quality 

Thayal et al. 2012 95 

G1: Propranolol, oral 2 


G2: Bleomycin, 

intralesional 0.5 mg/kg 

(10) 

Quality: Poor 

Age, Months 

Age 

NR 

Type 

Type, % 

Cutaneous: 

G1+G2:100 

Location 

NR 



Resolution/ 

Response 

• Regression in 

size of lesion 5 

grades: 

I Complete 

involution (> 

90% response) 

II Reduction in 

size 75-90% 

III Reduction 

50-75% 

IV Reduction 

25-50% 

V Reduction < 

25% 

• Blinded 

assessment: 

NR 

G = group; kg = kilogram; mg = milligram; n = number; NR = not reported 

Resolution 

Outcomes 

Response, n 

Grade I response 

G1: 2 

G2: 1 

Grade II response 

G1: 4 

G2: 5 

Grade III response 

G1: 3 

G2: 2 

Grade IV 

response 

G1: 1 

G2: NR 

Rebound 

Growth/ 

Recurrence 

NR 

Other 

Outcomes 

Propranolol Versus No Propranolol 

A fair quality retrospective cohort study examined the effect of propranolol on the incidence 

of invasive procedures in 58 children with nasal IH. 149 Participants fell into three groups: treated 

in the pre-propranolol era (n=20), treated in the post-propranolol era and received propranolol 

(n=25), and treated in the post-propranolol era and did not receive propranolol (n=13). Many 

participants received other therapies including corticosteroids, laser treatments, and/or surgery. 

Participants who received propranolol had a lower likelihood of laser treatment than those 

treated in the pre-propranolol era (hazard ratio 0.44, 95% CI: 0.27 to 0.78). The risks of surgical 

excision did not differ significantly (hazard ratio 0.45, 95% CI: 0.15 to1.38). 

Another fair quality cohort study conducted in the Netherlands compared 20 children 

with ulcerated IH treated with propranolol with 20 historical controls (matched on age at IH 

onset, extent of ulceration, and type, location and size of the IH). 145 Children in the control group 

had received steroids (25%), PDL (1%), antibiotics (60%), and local wound care (100%). Mean 

age of the patients at the start of ulceration was 2.3 months, and complete healing occurred after 

an average total ulceration time of 8.7 weeks in the propranolol treated group versus 22.4 weeks 

(p= 0.012) in the historical control group. Four of 19 (20%) patients who completed propranolol 

treatment had regrowth. One (0.5%) patient restarted propranolol due to significant regrowth of 

the IH, affecting surrounding structures. Table 15 outlines key outcomes. 

49

Table 15. Key outcomes in studies comparing propranolol and no propranolol 

Author, Year 

Age, Months 


Location 

Key Outcomes, n 

(n) 

Type 

Quality 

Perkins et al. 2014 149 

G1: Propranolol era 

2mg/kg/day, received 

(25) 

G2: Propranolol era, did 

not receive (13) 

G3: Pre-propranolol era 

(20) 

Quality: Fair 

Hermans et al. 2011 145 

G1: Propranolol 2.0 to 

2.5/mg/kg/d in three 

daily doses (20) 

G2: Historical controls 

(varied treatments) (20) 

Quality: Fair 

Age, Mean (range) 

G1: 4.9 (2.0- 13.5) 

G2: 4.9 (2.2-14.7) 

G3: 4.8 (2.0-14.3) 

Type, % 

Superficial and 

subcutaneous 

G1+G2+G3: 100 

Age, mean at start of 

ulceration 

G1: 2.3 

G2: 2.7 

Type, n: 

Superficial nodular 

G1: 14 

Superficial macular 

G1: 4 

G1+G2: 

nasal 

G1+G2: 

multiple 

• 56% of G2 less likely to have any type of 

invasive treatment when compared to G1 

(HR: 0.44, 95% CI: 0.27 to 0.73) 

• G2 and G3 were 35% less likely to have 

any type of invasive treatment (HR: 0.65, 

95% CI: 0.42 to 1.00) when compared to 

G1 

• 55% of G2 (HR: 0.45) less likely to have 

surgical excision and 56% (HR: 0.44, 95% 

CI: 0.27 to 0.78) less likely to have laser 

treatment when compared to G1 

• G2 and G3 61% (HR:0.39) less likely to 

have surgical excision and 25% (HR: 0.75; 

95% CI: 0.46 to 1.25) less likely to have 

laser treatment when compared to G1 

• Grade change assessed by two authors not 

involved in treatment planning or medical 

and surgical therapy 

• Complete healing from ulceration 

G1: 8.7 weeks 

G2: 22.4 weeks 

G1 vs.G2: p

contained more patients with ulceration (30% versus 4%). There were no statistically significant 

differences noted in quantitative improvement of IH by VAS scores or change in HAS scores 

between the groups. Twenty-seven of 30 infants treated with atenolol (90%) and all patients 

treated with propranolol showed clinical involution at the end of the treatment period (p= 0.09). 

Table 16 outlines key outcomes. 

Table 16. Resolution outcomes in studies comparing beta-blockers 

Author, Year 


Age, Months 

Comparison 


Location 

Groups (n) 

Resolution/ 

Type 

Quality 

Response 

Abarrzua- 

Araya et al. 

2014 102 

G1: 

Propranolol, 

oral 

2mg/kg/day in 

3 daily doses 

for 6 months 

(10) 

G2: Atenolol, 

oral1mg/kg/day 

single daily 

dose for 6 

months (13) 

Quality: Fair 

Age, mean±SD 

G1+G2: 5.2±3.5 

(range: 2-14) 

Type, n: 

Superficial 

G1+G2: 9 

Mixed 

G1+G2: 13 

Deep 

G1+G2: 3 

G1+G2: 

multiple 

• Blinded 


serial photographs 

plus clinical 

assessment 

• Complete 

response= 

complete 

resolution of IH 

• Telangiectasia 

and redundant 

tissue considered 

complete 

response 

• Partial 

response=any 

size reduction or 

change in 

color/consistency 

that did not meet 

complete 

response criteria 

• No response=no 

change in 

photographs 

and/or growth 

Resolution 

Outcomes 

Response 

Complete response 

G1: 6/10 (60%) 

G2: 7/13 (53.8%) 


Partial response 

G1: 4/10 (40%) 

G2: 6/13 (46.1%) 


Response by Type 

Superficial IH 

Complete response 

G1+G2: 5/9 (55.5) 

Mixed IH 

G1+G2: 3/13 (23) 

Deep IH 

G1+G2: 3/3 (100) 

Rebound 

Growth/ 

Recurrence, 

n (%) 

Recurrence 

G1+G2: 6 (26%) 

G1: 4/10 (40%) 

G2: 2/13 (15.4) 

51

Table 16. Resolution outcomes in studies comparing beta-blockers (continued) 

Author, Year 

Comparison 

Groups (n) 

Quality 

De Graaf et al, 

2013 146-148 

G1: Atenolol, 

oral 1 

mg/kg/day up 

to 3 mg/kg (30) 

G2: 

Propranolol, 

oral 

2mg/kg/day 

(historical 

group) (28) 

Quality: Fair 

Age, Months 

Type 

Age, n (%) 

1-6 months 

G1: 12/24 (50) 

G2: 23/27 (85) 

6-12 months 

G1: 8/24 (33) 

G2: 4/27 (15) 

Over 12 months 

G1: 4/24 (17) 

G2: 0 

Type, n (%) 

Localized/ 

nodular 

G1: 19/24 (79%) 

G2: 19/27 (70%) 

Segmental 

G1: 3/24 (13%) 

G2: 2/27 (8%) 

Indeterminate 

G1: 2/24 (8%) 

G2: 6/27 (22%) 

Multifocal 

G1: 0 

G2: 0 

Location 

G1+G2: 

multiple 



Resolution/ 

Response 

• Serial 

photographs and 

clinical 


involution (color 

change, softening 

to palpation and 

reduction in size) 

by blinded 

assessors 

• Visual analog 

scale (VAS) and 

hemangioma 

activity score 

(HAS) 

Resolution 

Outcomes 

Clinical 

involution, n (%) 

G1: 27 (90) 

G2: 28 (100) 

VAS and HAS 

scores shown in 

figures only 

G1 vs. G2 

p= NS 

Rebound 

Growth/ 

Recurrence, 

n (%) 

G = group; HAS = hemangioma activity score; IH = infantile hemangioma; kg = kilogram; mg = milligram; n = number; NR = 

not reported; NS = not significant; SD = standard deviation; VAS = visual analog scale 

Nadolol Versus Propranolol 

In a poor quality cohort study conducted in Canada, oral nadolol was used in the six month 

treatment of 10 infants 1-month to 1-year of age and compared to a historical group of nine 

similar infants matched for age and hemangioma location who were treated with oral propranolol 

for at least six months (Table 17). 101 Infants were treated with oral nadolol starting at 0.5 

mg/kg/day divided twice daily and increased weekly by 0.5 mg/kg to a maximum dose of 4 

mg/kg/day (mean dose 2.19 ± 1.1 mg/kg). Propranolol was administered to a maximum of 2-3 

mg/kg/day divided three times daily (mean dose 1.89 ± 0.29 mg/kg). The nadolol treated group 

had a mean percentage IH shrinkage of 97 ± 3.05 percent at the 24-week visit compared with 86 

± 14.82 percent shrinkage observed in the propranolol group (p< 0.001). 

NR 

52

Table 17. Key resolution outcomes in studies comparing nadolol and propranolol 

Author, 

Year 

Comparison 

Groups (n) 

Quality 

Pope et al, 

2012 101 

G1: Nadolol 

suspension 

up to 4 

mg/kg/day 

(10) 

G2: 

Propranolol 

maximum 

dose 2-3 

mg/kg/day 

(historical 

group) (9) 

Quality: 

Poor 

Age, 

months 

Type 

Age, 

mean±SD 

G1: 4.1 ± 

2.23 

G2: 4.8 ± 

1.92 

Type, n: 

Superficial 

and deep 

G1: 6 

G2: 9 

Deep 

G1: 4 

G2: 0 

Location 

G1+G2: 

multiple 

Methods and Measures 

of 


• Serial photographs 

and clinical 

assessment using 

100-mm visual 

analog scale (VAS); 

blinded assessors 

(-): 100% worsening 

0: no change 

(+): 100% shrinkage 

where 5 mm 

represented 10% 

change 

Resolution 

Outcomes 

Percentage IH 

shrinkage, mean ± 

SD 

G1: 97 ± 3.05% 

G2: 86 ± 14.82% 

G1 vs.G2: p< 0.008 

Rebound 

Growth/ 

Recurrence, 

n (%) 

G = groups; IH = infantile hemangioma; kg = kilograms; mm = millimeter; mg = milligram; n = number; NR = not reported; 

SD = standard deviation 

Oral Propranolol Compared With Other Dosage Forms 

In a fair quality single blinded RCT conducted in Egypt, 45 consecutive patients with 

problematic, superficial IH (rapidly progressive, compromising vital or normal physiological 

function, or causing disfigurement) were assigned to one of three treatments: oral propranolol (2 

mg/kg/day divided into two daily doses, n=15), topical propranolol 1 percent ointment applied 

twice daily, or intralesional propranolol (1 mg propranolol hydrochloride as a 1 mL injection, 

n=15) repeated weekly (0.2 mL injected per 1 cm lesion diameter to a maximum of 1 mL, doses 

divided among multiple lesions, n=15) (Table 18). 93 Twelve (80%) patients treated with oral 

propranolol had improvement in their IH: nine (60%) patients showed a complete response; 2 

(13.3%) demonstrated a sustained plateau with > 50 percent reduction in size; 1 (6.7%) showed a 

sustained plateau with 50 

percent reduction in size, 2 (13.3%) showed a sustained plateau with < 50 percent reduction in 

size, and five (33.3%) had no response to treatment. Eight (53.3%) patients treated with 

intralesional propranolol showed improvement in their IH. Two (13.3%) participants had a 

complete response; three (20%) demonstrated a sustained plateau with ≥ 50 percent reduction in 

size; three (20%) had a sustained plateau with less than 50 percent reduction in size, seven 

children (46.7%) had no response. Rebound growth was documented in one (6.7%), one (6.7%) 

and two (13.3%) children treated with oral, topical, and intralesional propranolol, respectively. 

Time to achieve initial response and duration of treatment needed to achieve the final response 

were significantly greater in both the topical (3-8 weeks to initial response; 5-10 months 

treatment duration) and intralesional propranolol (4-8 weeks to initial response; 5-12 months 

treatment duration) groups as compared with the oral propranolol group (2-4 weeks to initial 

response; 3-9 months treatment duration, p values ≤ 0.01). 

NR 

53

Table 18. Resolution outcomes in studies comparing forms of propranolol 

Author, 

Year 

Comparison 

Groups (n) 

Quality 

Zaher et al. 

2013 93 

G1: 

Propranolol 

oral, 

2mg/kg/day 

in 2 daily 

doses (15) 

G2: 

Propranolol, 

topical, 1% 

ointment 

applied twice 

daily (15) 

G3: 

Propranolol, 

intralesional, 

1mg injected 

weekly (15) 

Quality: Fair 

Age, 

Months 

Type 

Age, 

mean±SD 

(range) 

G1+G2+G 

3: 

8.82±4.6 

(3-18) 

G1: 9.13 

(3-18) 

G2: 8.33 

(1-18) 

G3: 9.0 (3- 

18) 

Type 

NR 

Location 

G1+G2+ 

G3: 

multiple 




• Grading system 

comparing 

photographic 

documentation; 

unblinded 

assessment 

• Excellent: complete 

resolution achieved 

• Good: sustained 

plateau with ≥ 50% 


• Fair: sustained 

plateau with < 50% 


• Poor: no response 

or worsening of IH 

Resolution 

Outcomes 

Response to 


Excellent response 

G1: 9 (60) 

G2: 3 (20) 

G3: 2 (13.3) 

Good response 

G1: 2 (13.3) 

G2: 5 (33.3) 

G3: 3 (20) 

Fair 

G1: 1 (6.7) 

G2: 2 (13.3) 

G3: 3 (20) 

Poor 

G1: 3 (20) 

G2: 5 (33.3) 

G3: 7 (46.7) 

Rebound 

Growth/Recurrence, 

n (%) 

Rebound growth, n 

(%) 

G1: 1 (6.7) 

G2: 1 (6.7) 

G3: 2 (13.3) 

G = group; IH = infantile hemangioma; kg = kilogram; mg = milligram; n= number; NR = not reported; SD = standard deviation 

Timolol Versus Placebo/Observation or Other Modalities 

Timolol Compared With Placebo or Observation 

In a good quality double-blind, placebo-controlled RCT conducted in Australia, investigators 

randomly assigned 41 infants ages 5 to 24 weeks with small, focal, superficial IH not requiring 

systemic therapy to treatment with placebo (n=22) or timolol maleate 0.5 percent gel (n=19). 104 

Investigators reported a significant increase in the number of IH lesions decreasing in size by 

≥5 percent in the timolol group compared with the placebo group at weeks 8 (37% vs. 5%, p= 

0.04), 20 (47% vs.6%, p= 0.02), and 24 (60% vs.11%, p= 0.01). At 24 weeks, 47 percent of the 

timolol treated group had significantly increased difference in blinded photo score of 0 (no 

redness) compared with 6 percent in the placebo group, while the proportion of lesions 

completely red in the treatment group (6%) was significantly less than the placebo group (55%, p 

values

esponse. Overall, timolol-treated patients had significantly improved responses compared with 

the observation group (p=0.001). One patient in whom timolol was prematurely stopped at 5 

months of age had rebound growth, which again regressed with resumption of topical timolol. 

In a poor quality prospective cohort study conducted in China, 124 infants < 12 months of 

age with superficial IH (≤ 3 mm in height) and without prior treatment or tumor regression were 

treated with either topical 0.5% timolol maleate drops three times daily (n=101) or observed (n= 

23). 103 Timolol promoted regression in 57 patients (56.4%), controlled growth in 36 patients 

(35.6%), and was ineffective in 8 patients (7.9%) compared with the observation group where 

regression was seen in one patient (4.3%), controlled growth observed in seven (30.4%), and 

continued growth observed in 15 patients (65.2%). Regression and efficacy rates in the timolol 

group compared to the observation group were significantly improved (p

Table 19. Key resolution outcomes in studies comparing timolol and observation or placebo 

(continued) 

Author, 

Year 

Comparison 

Groups (n) 

Quality 

Chambers et 

al. 2012 144 

G1: Timolol 

maleate gel 

0.25% (13) 

G2: 

Observation 

(10) 

Quality: Fair 

Yu et al. 

2013 103 

G1: Timolol , 

topical, 

drops three 

times 

daily(101) 

G2: 

Observation 

(23) 

Age, Months 

Type 

Age, 

mean±SD 

G1: 4.8 

G2: 3.7 

Type, n 

Superficial 

G1: 5 

G2: 4 

Mixed 

G1: 7 

G2: 5 

Deep 

G1: 1 

G2: 1 

Age 

1-6 months 

G1+G2: 88 

7-12 months 

G1 +G2: 36 

Type, % 

Superficial: 

100 

Location 

Periocular 

(100%) 

G1+G2: 

multiple 



Resolution/ 

Response 


• Response 

categorized as 

good (lesion 

decreased by 

more than 50% 

size), moderate 

(lesion 

decreased by 

50% or less) 

and poor (lesion 

enlarged or 

caused ptosis or 

induced 

astigmatism 

• Reviewed by 

blinded pediatric 

ophthalmologist 


• Categorized as: 

Class 1: 

ineffective 

Class 2: 

controlled 

growth 

Class 3: 

promoted 

regression 

• Blinded 


Resolution 

Outcomes 

Response to 


Good 

G1: 8 (61) 

G2: 0 

Moderate 

G1: 4 (31) 

G2: 1 (10) 

Poor 

G1: 1 (8) 

G2: 9 (90) 

G1 vs.G2 p=0.001 

Response to 


Class 1 

G1: 8 (7.9) 

G2: 15 (65.2) 

Class 2 

G1: 36 (35.6) 

G2: 7 (30.4) 

Class 3 

Quality: 

G1: 57 (56.4) 

Poor 

G2: 1 (4.3) 

G = group; IH = infantile hemangioma; n = number; NR = not reported; SD = standard deviation 

Rebound 

Growth/ 

Recurrence, n 

(%) 

NR 

In 12 patients 

with complete 

resolution, no 

regrowth noted 

at 3-5 month 

followup 

Timolol Ophthalmic Solution Versus Imiquimod Cream 

One fair quality retrospective cohort study evaluated imiquimod cream versus timolol 

ophthalmic solution for treatment of superficial proliferating IH (Table 20). 105 There were 40 

treated IH among the participants. The mean duration of therapy was 4.6 months in the 

imiquimod group and 4.3 months in the timolol group. Duration of followup was not reported. 

The VAS score and change in the hemangioma activity score did not differ significantly between 

the two groups. 

56

Table 20. Resolution outcomes in studies comparing timolol and imiquimod 

Author, Year 


(n) 

Quality 

Qiu et al. 2013 105 

G1: Topical imiquimod 

5% cream (20) 

G2: Topical timolol 

ophthalmic 0.5% 

solution (20) 

Quality: Fair 

Age, Months 

Type 

Age, 

mean±SD, 

G1: 3.1 ± 1.20 

G2: 3.0 ± 1.96 

Type, % 

Proliferating 

superficial 

G1+G2: 100 

Location 

G1+G2: 

multiple 




• Visual analog scale 

(VAS) 

• Hemangioma 

Activity Score (HAS) 

evaluations 

conducted by two 

study investigators 


NR 

Resolution 

Outcomes, n 

VAS and HAS 

results 

presented in 

figures 

VAS 

G1 vs.G2 

p=0.11 

Δ HAS 

G1 vs.G2 

p=0.49 

Rebound 

Growth/ 

Recurrence 

Other 

Outcomes 

G = group; HAS = hemangioma activity score; n = number; NR = not reported; SD = standard deviation; VAS = visual analog 

scale 

Topical Timolol Versus Laser 

One fair quality RCT conducted in Egypt compared topically applied timolol (0.5% 

ophthalmic solution) and sequential PDL and Nd:YAG laser in 60 children (age range not clear) 

with superficial or mixed IH. 14 Children received treatment for roughly 4 to 5.5 months. Forty 

percent of children in the timolol group and 20 percent in the laser group had an excellent 

response (defined as improvement of 76-100%), and IH hemoglobin level declined significantly 

from baseline in both groups. Improvement in IH in either group did not differ between children 

who were greater or less than 6 months of age, but response was greater in superficial lesions 

compared with mixed lesions in both groups. More mixed lesions responded to laser than to 

timolol, with deep components of superficial lesions not responding to timolol. Superficial 

lesions responded more quickly and more extensively to timolol than to laser (p=NR). The study 

provided few statistical comparisons of timolol versus laser. 

In a poor quality retrospective cohort study comparing topical timolol alone with timolol plus 

PDL in 102 children with superficial IH, children received treatment for between 2 and 24 

months. 106 Overall, 97 percent of children had improvement in IH (3 children in the timolol arm 

had no change, 28 had >75% improvement), with greater improvement in the combination arm 

compared with the timolol alone arm (mean global assessment score change of 2.66 vs. 1.88, 

p=0.02, score range=-1 to 4 with higher number indicating more improvement). Table 21 

outlines key outcomes. 

NR 

57

Table 21. Resolution outcomes in studies comparing timolol and laser 

Author, Year 


(n) 

Quality 

Tawfik et al. 2015 14 

G1: Topical timolol 

ophthalmic 0.5% 

solution (30) 

G2: Combined 

sequential laser PDL 

(585 nm) and Nd:YAG 

(1064 nm) (30) 

Quality: Fair 

Age, Months 

Type 

Age, n (%) 

≤ 6 months 

G1: 8 (26.7) 

G2: 14 (46.7) 

> 6 months 

G1: 22 (73.3) 

G2: 16 (53.3) 

Type, % 

Superficial 

G1: 80 

G2: 86.7 

Mixed 

G1: 20 

G2: 13.3 

Location 

G1+G2: 

multiple 





• Efficacy evaluated by 

two blinded 

physicians 

• Response to 

treatment graded 


improvement 

Good: 51-75% 

Moderate: 26-50% 

Mild: < 25% 

No improvement: 0% 

Resolution 

Outcomes, n 

Response to 

treatment, n 

(%) 

Excellent 

G1: 9 (30) 

G2: 3 (10) 

Good 

G1: 9 (30) 

G2: 7 (23) 

Moderate 

G1: 4 (13) 

G2: 9 (30) 

Mild 

G1: 4 (13) 

G2: 7 (23) 

Poor 

G1: 4 (13) 

G2: 4 (13) 

Rebound 

Growth/ 

Recurrence 

Other 

Outcomes 

No rebound 

growth in either 

group 

Park et al. 2014 106 

G1: Timolol ophthalmic 

0.5% solution (61) 

G2: Combination topical 

timolol ophthalmic 0.5% 

solution plus adjunctive 

pulsed dye laser 

treatment (41) 

Quality: Poor 

Age, Months 

NR 

Type, % 

Superficial 

G1+G2: 100% 

G1+G2: 

multiple 


• Clinical evaluation of 

efficacy by two 

independent 

physicians Global 

assessment score 

(GAS) 

4: 75-100% 

improvement 

3: 50-74% 

2: 25-49% 

1: 0-24% 

0: 0 

-1: < 0 

Mean GAS 

score change 

G1: 1.88 

G2: 2.66) 

G1 vs.G2: 

p=0.018 

% 

improvement, 

n (%) 

75-100 

G1: 14 (23) 

G2: 17 (41) 

50-74 

G1: 14 (23) 

G2: 12 (29) 

NR 

25-49 

G1: 11 (18) 

G2: 8 (20) 

0-24 

G1: 19 (31) 

G2: 4 (10) 

≤0 

G1: 3 (5) 

G2: 0 

G = group; GAS = global assessment score; n = number; nm = nanometer; NR = not reported 

58

Harms of Beta-Blockers 

Harms Reported in Studies Included in This Review 

Thirteen comparative studies specifically defined harms of beta-blockers used to treat 

IH. 17,92-94,98,101,102,104,105,132,133,144,145,147 Several studies specifically noted that no harms were 

observed: one study evaluating topical timolol maleate 0.5 percent gel compared to placebo; 104 a 

cohort study evaluating topical 0.25 percent timolol maleate gel; 144 one RCT of ophthalmic 

timolol, 105 and a cohort study of timolol that informed parents of potential adverse effects to 

monitor for, reported evaluating for safety (non-specified), and stated that no adverse effects 

were reported. 103 An RCT comparing atenolol versus propranolol 102 and two other cohort studies 

of intralesional propranolol 130 and up to 2mg/kg/day of oral propranolol 95 reported that no harms 

were observed. Another RCT of propranolol (3-4 mg/kg/day) including 14 participants reported 

asymptomatic hypotension and bradycardia in an unstated number of infants and discontinuation 

of treatment in one child due to drowsiness. 99 

One RCT comparing propranolol and prednisolone reported side effects associated with 2 

mg/kg/day dosing of propranolol in the categories of allergy/immunology (0.02% of lesions), 

dermatologic (0.05% of lesions), gastrointestinal (0.11% of lesions), infection (0.11% of 

lesions), pulmonary/respiratory (0.32% of lesions), vascular (0.07% of lesions). 98 Fewer severe 

adverse events occurred in the propranolol arm compared with prednisolone (1 vs. 11, p=0.01); 

the one severe event in the propranolol arm was a case of dehydration necessitating 

hospitalization. Children in the propranolol group had more pulmonary events (typically upper 

respiratory tract infections) than those in the prednisolone arm (14 vs. 5, p

Table 22. Harms/adverse effects in comparative studies of beta-blockers to treat IH 


Intervention 




Participants) 

Oral propranolol 2-3 

mg/kg/day 

Oral propranolol 4 

mg/kg/day 

Oral propranolol (2.2 

mg/kg/day) + 

prednisolone (1.6 mg) 

Intralesional 

propranolol 1 mg 

Oral atenolol 

3mg/kg/day 

Oral nadolol up to 4 

mg/kg/day 

Bronchial hyperreactivity 147 1 (4/28) 14% 

Bronchiolitis 17 1 (4/19) 21% 

Bronchospasm 94 1 (1/31) 3% 

Cold extremities 17,131,145 3 (13/53) 5%-43% 

Constipation or gastrointestinal 

complaints 96,145,147 

3 (5/60) 5%-11% 

Dental caries 17 1 (1/19) 5% 

Elevated alkaline 17 1 (1/19) 5% 

Hypoglycemia 97,100,147 3 (4/106) 1%-10% 

* Hypotension 93,96,147 3 (4/55) 4%-20% 

Ulceration 17 1 (1/19) 5% 

Sleep disturbance (insomnia, 

drowsiness, restless 

6 (31/150) 6%-50% 

sleep) 17,94,96,100,145,147 

Streptococcal infection 17 1 (1/19) 5% 

Syncopal attack 93 1 (1/15) 7% 

Viral gastroenteritis 17 1 (1/19) 5% 

** Viral upper respiratory 

2 (2/87) 1%-5% 

infection 17,97 

Poor feeding 145 1 (2/20) 10% 

Fever 97 1 (2/68) 3% 

Rash 97 1 (2/68) 3% 

Tachycardia 97 1 (1/68) 1% 

Hypotonia 132 1 (3/30) 10% 

Pulmonary obstruction 132 1 (2/30) 6.7% 

Drowsiness 99 1 (1/7) 14% 

Gastrointestinal upset 100 1 (4/10) 40% 

Infection 100 1 (1/10) 10% 


Pain/inconvenience of therapy 93 1 (3/15) 20% 

Hypotension 147 1 (1/30) 3% 

Restless sleep 147 1 (8/30) 27% 

Constipation 147 1 (2/30) 7% 

Diarrhea 147 1 (2/30) 7% 

Cold extremities 101 1 (2/10) 20% 

Cold induced wheezing 101 1 (1/10) 10% 

Sleep disturbance 101 1 (1/10) 10% 

Gastrointestinal symptoms 101 1 (5/10) 50% 

Placebo Sleep disturbance 17 1 (2/20) 10% 

Ulceration 17 1 (1/20) 5% 

Visual compromise 17 1 (1/20) 5% 

Bronchiolitis 17 1 (1/20) 5% 

IH = infantile hemangioma; kg = kilogram; mg = milligram; n = number 

* One study 93 reported hypotension and bradycardia in 3/15 children. 

** One study 97 reported upper respiratory infection and reactive airway disease in 1/68 children. 



The safety population in a large RCT 92 included 456 patients in total (Table 23). Thirty-three 

serious events occurred in 26 patients, and no significant difference overall or in individual 

events between the placebo group and group receiving propranolol at 3 mg/kg/day for 6 months 

were noted. One serious adverse event of second-degree atrioventricular heart block (with a 

preexisting cardiac condition later documented) occurred after dose administration on day 0, and 

60

treatment was discontinued. While hypotension and hypoglycemia were both documented in this 

trial, neither was clinically significant enough to lead to treatment discontinuation. 

Table 23. Harms/adverse events reported by dose in Leaute-Labreze et al. 2015 

1 mg/kg/day X 1 mg/kg/day X 3 mg/kg/day X 3 mg/kg/day X 6 

Adverse 

3 months 6 months 3 months months 

Event 

(n=98) 

(n=102) (n=100) 

(n=101) 

N experiencing harm (%) 

≥1 Serious 

adverse event 

5 (5) 3 (3) 9 (9) 6 (6) 3 (5) 

≥1 Adverse 

event occurred 

during 

89 (91) 92 (90) 92 (92) 97 (96) 42 (76) 

treatment 

Hypotension 2 (2) 1 (1) 3 (3) 0 (0) 1 (2) 

Bronchospasm 0 (0) 0 (0) 2 (2) 1 (1) 1 (2) 

Bradycardia 0 (0) 1 (1) 1 (1) 0 (0) 0 (0) 

Hypoglycemia 0 (0) 1 (1) 0 (0) 1 (1) 0 (0) 

Diarrhea 16 (16) 14 (14) 17 (17) 28 (28) 4 (7) 

Sleep disorder 28 (29) 14 (14) 19 (19) 22 (22) 7 (13) 

Bronchitis 5 (5) 7 (7) 11 (11) 17 (17) 1 (2) 

Vomiting 16 (16) 13 (13) 10 (10) 13 (13) 3 (5) 

Bronchiolitis 6 (6) 7 (7) 6 (6) 10 (10) 3 (5) 

Cold hands 

8 (8) 10 (10) 1 (1) 10 (10) 1 (2) 

and feet 

Agitation 12 (12) 18 (18) 8 (8) 7 (7) 6 (11) 

Constipation 9 (9) 6 (6) 9 (9) 4 (4) 1 (2) 

Decreased 

5 (5) 3 (3) 5 (5) 1 (1) 1 (2) 

appetite 

Somnolence 6 (6) 4 (4) 1 (1) 1 (1) 1 (2) 

kg = kilogram; mg = milligram; n = number 

Placebo 

(n=55) 

Table 24 summarizes the incidence and type of adverse effects reported in case series. 

Consistent with the pharmacological action of propranolol, decreases in blood pressure and heart 

rate were the most frequently reported adverse events and were as high as 100 percent in some 

series. 168,171 However, reductions in these parameters were not always clinically significant. In 

most prospective case series, clinically important hypotension and bradycardia were not 

reported; asymptomatic changes were specifically noted in several series. 16,151-158,169,182,189,194, 

199,205 

The lack of cardiac events may be due to required cardiovascular evaluation prior to 

initiation of propranolol or discontinuation after short-term monitoring. The number of patients 

that did not qualify for propranolol therapy was not provided in any of these series. No adverse 

effects were reported in several case series, 154,156,157,196 and most studies of topical beta-blockers 

reported that no adverse events were observed, though studies typically did not describe methods 

for harms monitoring. 159,160,186 Two studies of topical applications reported recurrent itching 

associated with topical propranolol 187 in 3 percent of children and sleep disturbances in 1 percent 

of children receiving topical timolol. 161 The remaining case series reported few adverse events, 

and those reported rarely caused discontinuation of the medication. In total, 51/3810 (1.3%) 

children in case series discontinued treatment due to adverse events including sleep disturbances 

(n=13), bronchial hyperreactivity, wheezing, or asthma (n=9), and cold extremities (n=7). 

61

Table 24. Adverse effects in case series of propranolol to treat IH 

Intervention 

* Oral Propranolol 

1-1.5 mg/kg/day 

Oral Propranolol 

2-2.1 mg/kg/day 


Number of 

Studies (# 

Participants 

With 

Harm/Total 

Participants) 

Reported 

Rates 

Across 

Studies 

Decrease in heart rate and blood pressure 171 1 (89/89) 100% 

Elevation of liver enzymes (ALT, AST) 171 1 (5/89) 6% 

Hypoglycemia 171 1 (4/89) 4.5% 

Anorexia 155 1 (1/35) 3% 

Diarrhea 153,189 2 (6/114) 3%-12% 

Asymptomatic hypotension 153 1 (1/60) 2% 

Nausea 171 1 (2/89) 2% 


Restless sleep 171 1 (1/89) 1% 

**Hypotension 18,167,168,173,190,191,194,199,200,202,205 11 (89/944) 0.4%-62% 

ECG changes 167 1 (7/25) 28% 

Bradycardia 151,167,168,173,190,191,199 7 (51/577) 0.8%-38% 

Nausea/Vomiting/Diarrhea 151,153,162,175,178,179,181,190-193 12 (37/1048) 0.4%-24% 

Cold extremities 151,163,178,180,193,200,202 7 (17/626) 1%-10% 

Sleep disturbance/Light sleep 153,162,165,167,179,190-193,203 10 (88/729) 3%-29% 

Behavioral changes 162,167,175,178,193,200 6 (13/531) 0.5%-10.8% 

Respiratory 

10 (35/725) 2%-10% 

symptoms/Asthma/Dyspnea 151,162,163,165,178,180,190,192,194 

Fatigue/Somnolence 165,167,173,176,180,201 6 (15/289) 1%-25.9% 

Fever 162 1 (2/30) 7% 

Gross motor abnormalities 175 1 (13/188) 7% 

***Hypoglycemia 168,173,191,194,202 5 (14/328) 2%-6.8% 

Cutaneous symptoms/Rash 153,176,180 3 (5/172) 2%-5% 

Gastroesophageal issues 180,194 2 (3/99) 2.3%-4% 

Sweating 18,176 2 (2/85) 2%-4% 

Constipation 151,202 2 (3/186) 0.8%-3% 

Respiratory tract infection 162 1 (1/30) 3% 

Skin atrophy 156 1 (2/50) 3% 

Seizure 170 1 (1/45) 2% 

Agranulocytosis 163 1 (1/97) 1% 

Cyanotic breath-holding spells 183,184 1 (1/71) 1% 

Low body temperature 163 1 (1/97) 1% 

Stridor 183,184 1 (1/71) 1% 

Bronchospasm 168,193,203 3 (3/337) 0.4%-2.7% 

Worsening of ulceration 190 1 (4/250) 1.6% 

Peripheral cyanosis 190 1 (2/250) 0.8% 

Oral Propranolol 

† Sleep disturbances/Nightmares 158,164,166 3 (14/99) 3%-23% 

3-3.3 mg/kg/day Transient asymptomatic hypotension 158,164 2 (7/66) 3%-17% 

Daytime drowsiness 164 1 (6/35) 17% 

Benign infections 164 1 (4/35) 11% 

Digestive symptoms 164 1 (3/35) 9% 

Constipation 152 1 (2/30) 7% 

Tachypnea 152 1 (2/30) 7% 


Cold extremities 152,166 2 (2/66) 3% 

Esophageal reflux 158,166 2 (2/64) 3% 

Poor weight gain 164 1 (1/35) 3% 

Decreased appetite 164 1 (1/35) 3% 

Bradycardia 164 1 (1/35) 3% 

Hypoglycemia 152 1 (1/30) 3% 

Increased appetite 164 1 (1/35) 3% 

Shortness of breath on activity 164 1 (1/35) 3% 

62

Table 24. Adverse effects in case series of propranolol to treat IH (continued) 


Studies (# 

Intervention 


Participants 


Participants) 

Oral Propranolol 2-3 

mg/kg/day 

†† Oral Propranolol 1-4 

mg/kg/day 

Topical Propranolol 0.5-3% 

Reported 

Rates 

Across 

Studies 

Cold extremities 16,172 2 (64/206) 3%-36% 

Nocturnal restlessness 172 1 (39/174) 22% 

Daytime sleepiness/Inactivity 172 1 (28/174) 16% 

Gastrointestinal symptoms 172 1 (12/174) 7% 

Agitation 16 1 (2/32) 6% 

Insomnia 16 1 (2/32) 6% 

Restlessness/Increased daytime activity 172 1 (9/174) 5% 

Hypotension 16,172 2 (7/206) 3% 

Asthma/Wheezing 16,172 2 (18/206) 3% 

Nightmares 16 1 (1/32) 3% 

Sweating 16 1 (1/32) 3% 

Feeding difficulties 172 1 (3/174) 2% 

Ulceration (onset/worsening) 172 1 (4/174) 2% 

Breath holding spells 172 1 (2/174) 1% 

Somnolence 185,195 2 (5/83) 6%-6.7% 


Hypotension 185 1 (1/53) 2% 

Profound mottling of extremities 185 1 (1/53) 2% 

Severe bradycardia 185 1 (1/53) 2% 


Bronchospasm 195 1 (3/30) 10% 

Transaminase increase 195 1 (1/30) 3.3% 

Skin changes (redness, rash, itching, 2 (9/249) 1.96%-4% 

erosion, eczema) 197,198,204 

Ulceration 204 1 (5/148) 3% 

63

Table 24. Adverse effects in case series of propranolol to treat IH (continued) 


Studies (# 

Intervention 


Participants 


Participants) 

††† Oral Propranolol + 

Atenolol (dose not clearly 

reported) 


Sleep disturbance 188 1 (47/109) 43% 

Gastrointestinal problems 188 1 (27/109) 25% 

Fatigue 188 1 (20/109) 18% 

Coughing 188 1 (19/109) 17% 

Sweating 188 1 (16/109) 15% 

Pallor 188 1 (14/109) 13% 

Agitation/irritation 188 1 (14/109) 13% 

Dyspnea/shortness of breath 188 1 (6/109) 6% 

Increased activity 188 1 (5/109) 5% 

Skin reaction 188 1 (5/109) 5% 

Nausea/vomiting 188 1 (4/109) 4% 

Decreased appetite 188 1 (4/109) 4% 

Increased appetite 188 1 (3/109) 3% 


Syncope 188 1 (2/109) 2% 

Dizziness 188 1 (2/109) 2% 

Hair loss 188 1 (2/109) 2% 

Seizure 188 1 (1/109) 1% 

Dry mouth (xerostomia) 188 1 (1/109) 1% 

Hallucinations 188 1 (1/109) 1% 

Reported 

Rates 

Across 

Studies 

ALT = alanine aminotransferase; AST = aspartate transaminase; IH = infantile hemangioma; kg = kilogram; mg = milligram 

*One study of 1.5 mg/kg/day (not included in table) 174 reported that 23 of 109 children had adverse events (N of events not 

stated) including hypotension, insomnia, agitation, aggravation of bronchitis, cold extremities gastroesophageal issues, and dry 

skin. Four children discontinued propranolol due to aggravation of bronchitis (n=2) or gastroesophageal issues (n=2). 

** 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 

blood pressure, and 7/50 had low diastolic, systolic blood pressure and heart rate (data not factored into table). Some children in 

another study 199 were also receiving steroids (n=20/76) or timolol (n=7/76) along with propranolol. In a third study evaluating 

propranolol, 190 29 of 250 children were also receiving concurrent steroids. 

***One study 168 reported “lethargy, viral illness, and hypoglycemia” in 2/250 children (data not factored into table). 

† 

One study 164 reported discontinuation of propranolol in 4/35 children because of “insomnia, nightmares, loss of energy.” These 

data are not factored into the table. 

†† Adverse events in Blatt 2011 were considered serious by the study investigators. 185 

††† Raphael 2015 is related to de Graaf 2013, 146-148 but the extent of overlap is unclear. The case series 188 also reports harms in 3 

individual case reports: among 45 children receiving 4 mg/kg/day propranolol, 1 had multiple episodes of decreased 

consciousness, 1 had nausea, 1 had an epileptic seizure after the first propranolol dose. Among those 64 receiving 3 mg/kg/day of 

atenolol, 1 had difficulty waking and hypotonia, 1 had two episodes of loss of consciousness, 1 had three episodes of loss of 

consciousness. 

Harms Reported in Package Insert Data 

Hemangeol ® is the only medication included in this review that has an FDA approved 

indication for infantile hemangioma. The safety of Hemageol® in pediatric patients has been 

reported in the medication package insert. 206 FDA medical review packages were not available 

for this medication. The most common adverse events, occurring in greater than 10% of infants, 

were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis 

associated with cough and fever, diarrhea, and vomiting. 206 In a study of pooled safety data 

(n=424), infants (63% aged 91-150 days) were treated with Hemangeol® 1.2 mg/kg/day or 3.4 

mg/kg/day for 3 or 6 months. Treatment emergent adverse events occurring in 3% or greater in 

infants receiving the Hemangeol ® 1.2 mg/kg/day (n=200) or Hemangeol ® 3.4 mg/kg/day (n=224) 

compared to placebo were provided. Adverse events and frequencies for patients receiving 

Hemangeol® 1.2 mg/kg/day included: sleep disorders (17.5%), bronchitis (8%), peripheral 

64

coldness (8%), agitation (8.5%), diarrhea (4.5%), somnolence (5.0%), nightmare (2.0%), 

irritability (5.5%), decreased appetite (2.5%), and abdominal pain (3.5%). Adverse events and 

frequencies for patients receiving Hemangeol® 3.4 mg/kg/day (n=224) included: sleep disorders 

(16.1%), bronchitis (13.4%), peripheral coldness (6.7%), agitation (4.5%), diarrhea (6.3%), 

somnolence (0.9%), nightmare (6.3%), irritability (1.3%), decreased appetite (3.6%), and 

abdominal pain (0.4%). Additional adverse events reported in less than 1% of patients 

participating in clinical trials included: second degree atrioventricular heart block (occurring in a 

patient with underlying conduction disorder), urticaria, alopecia, decreased blood glucose, and 

decreased heart rate. 

The safety and efficacy of the oral tablet, oral capsule, and injectable formulations of 

propranolol have not been investigated in pediatric patients. 207-209 The package inserts for these 

formulations state that reports of bronchospasm and congestive heart failure have been reported 

in pediatric patients receiving propranolol. Additional adverse events revealed during postmarketing 

surveillance include agranulocytosis, hallucination, and purpura. 206 

Harms of Other Active Comparator Agents 

Harms of corticosteroids and PDL are presented in those sections; this section only includes 

medications for which harms are not presented elsewhere in this review. In a study rated poor 

quality for harms reporting, reported complications of bleomycin included febrile episode, 

superficial ulceration, and raised alkaline phosphatase. 95 The proportion of participants who 

experienced these complications is unclear. In another study, which was rated good quality for 

harms reporting, adverse effects in 20 participants using imiquimod included crusting of lesions 

(65%), superficial scars (15%), and skin pigmentation (29%). 

Key Question 3. Effectiveness and Harms of Drugs 

Administered After the Failure of Corticosteroids or Beta- 

Blockers 

We did not identify any comparative studies addressing this Key Question. 

Key Question 4. Effectiveness and Harms of Surgical 

Interventions 

Key Points 

• Studies primarily addressed different laser modalities compared with observation or other 

laser modalities. PDL was the most commonly studied laser type, but multiple variations 

in treatment protocols did not allow for demonstration of superiority of a single method 

(low SOE for difference in effects on size reduction between longer pulse PDL and other 

lasers). 

• Two small studies addressed different surgical techniques (cryotherapy, intense pulsed 

light photothermolysis, sclerosis) and reported some positive effects in reducing IH size 

or improving appearance, but their smaller size and low quality preclude conclusions 

(insufficient SOE). 

• Many studies used historical controls, based on now superseded treatment regimens. 

65

• In two RCTs reporting level of clearance, at least 40 percent of children in laser or 

observation arms had complete or near complete clearance of IH (low SOE for lack of 

difference between PDL and observation). 

• Cohort studies assessed outcomes after CO2 and Nd:YAG (neodymium yttrium 

aluminum garnet) lasers and typically reported some resolution of lesion size, but 

heterogeneity among studies limits our abilities to draw conclusions (insufficient SOE). 

• Harms associated with laser treatment included skin atrophy, bleeding, scarring, 

ulceration, purpura, and pigmentation changes. Bleeding and ulceration were observed in 

the immediate postoperative period, distinguishing these complications from the possible 

natural complications of IH themselves (moderate SOE for association of PDL with 

pigmentation changes; low for association with bleeding; and insufficient for scarring. 

Low SOE for association of Nd:YAG laser with scarring and insufficient for association 

with bleeding and pigmentation changes). 


Eleven comparative studies (three RCTs, 210-212 seven retrospective cohort studies, 213-219 and 

one prospective comparative study that used treated and untreated lesions and intervention and 

control groups 220 ) and 30 case series addressed surgical approaches. The RCTs were conducted 

in the Netherlands, 210 Japan, 211 and the UK. 212 Cohort studies were performed in the United 

States, 216,217 Greece, 218 Singapore, 213 Russia, 219 and Germany. 214,215 Two RCTs 210,212 compared 

PDL to observation; one used traditional PDL in infants aged 1 to 14 weeks, 212 and the second 

used PDL with epidermal cooling in infants aged 0 to 6 months. 210 The third RCT 211 compared 

the use of non-cooled traditional PDL to longer pulse PDL with epidermal cooling in infants 

between 1 and 3 months old. We considered RCTs to be of good 210 and fair quality. 211,212 

Cohort studies examined various comparisons between different laser types including PDL 

versus Nd:YAG, 215 Argon versus Nd:YAG, 217 short pulse PDL versus longer pulse PDL. 213 One 

compared Nd:YAG and CO2 lasers and also included a non-surgical comparison group for 

airway IH. 214 Two studies compared different skin cooling protocols with the same laser types, 

including Nd:YAG 218 and PDL. 216 One cohort study compared cryosurgery, photothermolysis 

with intense pulsed light, and photothermolysis plus sclerosis with alcohol and lidocaine. 219 We 

considered two cohort studies as fair quality, 213,218 and the rest as poor. 214-217,219 We considered 

the self-controlled comparative study (rated using the Newcastle Ottawa tool) as poor quality. 220 






complication rate than both Nd:YAG and observation. Studies addressing other surgical 

approaches (cryosurgery, intense pulsed light thermolysis) reported some improvements in IH 

but included few participants in each arm (total n = 263). 

SOE for outcomes after laser and surgical treatments ranged from insufficient to low for 

effectiveness outcomes. The evidence was limited by low sample size, and variations in the laser 

settings used including wavelength and cooling protocols. For Nd:YAG and CO2 lasers, all 

studies were limited by sample size, and SOE was insufficient for all outcome parameters. 

Thirty case series reported on harms of surgical approaches for IH (3831 children). 

Seventeen case series reported on harms from laser treatments, including 10 studies of PDL, 221- 

66

229,230 

four studies of Nd:YAG lasers, 231-234 one of combined PDL and Nd:YAG, 235 one of longpulse 

Alexandrite laser, 236 and one report of carbon dioxide laser. 237 Most studies included 

children with IH in multiple locations; one included children with only airway IH. 237 Ages of 

children in these series, where clearly reported, ranged from less than 1 month to 11 years. We 

considered one study to be of good quality for harms reporting, 223 two of fair quality, 227,230 and 

14 of poor quality. 221,222,224-226,228,229,231-237 We rated one cohort study that compared propranolol 

with concurrent PDL or followed by PDL and two comparing laser and topical timolol as poor 

quality for harms reporting and discuss harms of PDL here and harms of propranolol in the betablocker 

section of KQ2 above. 14,106,150 

Thirteen case series (840 children) reported harms from surgical procedures, typically 

excision or resection, to treat IH. 238-249 Ages ranged from 1 month to 19 years. The majority of 

studies focused on treatment of facial IH, including three studies of lip IH, 240,244,248 two series of 

periocular/periorbital IH, 242,245 two reports of various facial locations, 241,247 and one study of 

nasal tip IH. 243 All of the studies were rated as poor quality for assessment of harms as data 

collection was not predefined. 


Effectiveness of Laser Treatment 

PDL Compared With Observation 

Two RCTs compared PDL to observation. One good quality RCT 210 randomized 22 children 

with IH between 0 and 6 months of age into equal groups of observation or PDL with epidermal 

cooling. Twelve-month size change scores were used for analysis. Further, parents were asked to 

answer quality of life questionnaires at enrollment and at age 12 months. There was no statistical 

difference seen in echo depth or total surface area between the two groups; however color was 

significantly improved in the PDL group compared with control (p=0.03). Photographs reviewed 

for overall improvement also showed a “significant improvement” for the PDL group (46%) over 

the observation group (18%), but this “significant improvement” was not quantitatively defined. 

Parent-reported quality of life scales showed no difference in the severity of skin problems 

between groups. Sixty-three percent of parents in the PDL group reported improvement in the IH 

at 12 months compared with 33 percent in the observation group (p=NR). Thirteen percent of 

parents perceived the treatments to be very painful. 

The second, fair-quality RCT randomized 121 children to PDL (n=60) and observation 

(n=61) groups. 212,250 The investigators attempted to reduce bias by including a blinded panel of 

parents of non-study children to describe whether they perceived the hemangioma to be a 

problem at 1 year of age. The investigators reported no differences in the number of children 

experiencing near complete resolution (42%-44% in each group) but more children in the PDL 

group (30%) than in the control arm (5%) experienced complete resolution (p=0.001). Outcomes 

between groups were similar at the 5-year followup of 117 children (32 of 57 in the PDL arm 

had complete clearance vs. 27 of 60 in the observation arm, p=0.31 and 41 of 57 and 48 of 60 

had minimal residual signs, p=0.39). Table 25 outlines key outcomes. 

67

Table 25. Key resolution outcomes in studies comparing PDL and observation 

Author, Year 

Groups (n) 

Quality 

Age, Months 

Type 

Location 


of Resolution/ 

Response 


Kessels et al. 

2013 210 

G1: Pulsed dye 

laser (11) 

G2: 

Observation 

(11) 

Quality: Good 

Batta et al. 

2002 212 

G1: Pulsed dye 

laser (60) 

G2: 

Observation 

(61) 

Quality: Fair 

Age, median 

(range) 

G1: 3 (1.7-5.0) 

G2: 3 (1.5-4.5) 

Type 

Superficial and 

cutaneous only 

Age, median 

(range, days 

G1: 38 (10 to 

101) 

G2: 32 (5 to 

79) 

Type, n (%) 

Flat 

G1: 31 (52) 

G2: 30 (49) 

Raised 

G1: 29 (48) 

G2: 31 (51) 

G1+G2: 

multiple 

G1+G2: 

multiple 

G = group; n = number; PDL = pulsed dye laser 


• Color measured by 

reflectance 

photometer 

• Improvement scale 

evaluated by blinded 

panel 

1= no improvement 

2= moderate 

improvement 

3 = significant 

improvement 


• Primary outcome 

measure assessed by 

investigator: complete 

clearance or 

minimum residual 

signs at age 1 year 

• Blinded medical 

observer assessed 

redness (secondary 

outcome measure) 

Change in echo depth, median 

(interquartile range) 

G1: -1.21 (-1.75 to 0.15) 

G2: -1.10 (-2.00 to 0.96) 

G1 vs.G2 p= 0.69 

Change in surface, median 


G1: 0.40 (0.10 to 0.80) 

G2: 0.00 (-0.08 to 0.40) 

G1 vs.G2 p= 0.08 

Color change, median 


G1: 10.16 (5.50 to 15.41) 

G2: 4.23 (0.84 to 5.28) 

G1 vs.G2 p= 0.03 

Complete clearance or minimum 

residual signs, n (%) 

G1: 25 (42) 

G2: 27 (44) 

G1 vs.G2: p=0.92 

Complete only 

G1: 18 (30) 

G2: 3 (5) 

G1 vs.G2: p=0.001 

Comparative Effectiveness of Various PDL Modalities 

One fair quality Japanese RCT 211 randomized 52 patients to a “traditional PDL” group and a 

“long-pulse” dye laser group (pulse durations of 0.45 milliseconds vs. 10-20 milliseconds). The 

percentage of patients achieving an excellent (76-100%) clearance of the lesion did not differ 

between groups, with rates of 54 to 65 percent in each group. Time to maximal proliferation was 

significantly shorter (106 days) in the longer pulse PDL group compared with the traditional 

PDL group (177 days, p=0.01). Another fair quality cohort study comparing short and longer 

pulse PDL similarly reported no significant differences in the number of children with complete 

or near-complete resolution by age 3 to 3.5 years. 213 

In a poor quality cohort study evaluating cryogen spray cooling as an adjunct to PDL versus 

no cooling in 164 children (mean age overall= 2 years, 11 months), c 216 hildren in the cryogen 

cooling arm required fewer treatments and had greater improvements in volume and texture than 

children in the non-cooled PDL arm (p values

Table 26. Key resolution outcomes in studies comparing PDL modalities 

Author, Age, 


Year Months 

Location Measures of 


Groups (n) 


Quality Type 

Kono et al. 

2005 211 

G1: Longpulse 

dye 

laser (26) 

G2: 

Traditional 

pulsed dye 

laser(26) 

Quality: Fair 

Age, 

mean±SD, 

weeks 

G1: 11.2 

G2: 10.7 

Type, % 

Superficial 

G1+G2: 

100 

G1+G2: 

multiple 

• Serial photographs 

assessed by blinded 

medical observer 

using: Excellent: 76- 

100% 


Mild: 26-50% 

None or worse (0- 

25%) 

Complete clearance or minimal 

residual signs at 1 year, n (%) 

G1: 17 (65) 

G2: 14 (54) 

G1 vs.G2 p=0.397 

Excellent 

G1: 17 

G2: 14 

Moderate 

G1: 7 

G2: 5 

Mild 

G1: 2 

G2: 4 

Tay et al. 

2012 213 

G1: Short 

pulse 595- 

nm Pulsed 

dye laser 

(15) 

G2: Longer 

pulse 595- 

nm PDL (8) 

Quality: Fair 

Age mean 

(range) 

G1+G2: 6.5 

(2.5-19) 

Type, n 

Superficial 

G1: 7 

G2: 3 

Mixed 

G1: 8 

G2: 5 

G1+G2: 

multiple 


evaluated by 

unblinded 

dermatologist 

None or worse 

G1: 0 

G2: 3 

Number of treatments needed for 

resolution 

G1: 3-14 mean=8 median=7 

G2: 4-14 mean=9 median=7 

G1 vs.G2: p=ns 

Average number of treatments 

needed for the clearance of mixed 

IH= 4 to 5 treatments more in both 

groups 

69

Table 26. Key resolution outcomes in studies comparing PDL modalities (continued) 

Author, 

Year 

Groups (n) 

Quality 

Age, 

Months 

Type 

Location 





Chang et al. 

2001 216 

G1: Non 

cooled flash 

lamppumped 

pulsed dye 

laser (82) 

G2: Cryogen 

spray cooling 

plus flash 

lamppumped 

pulse dyed 

laser (82) 

Age, mean, 

years 

G1: 2.5 

G2: 3.4 

Type, % 

Cutaneous 

G1+G2: 

100 

G1+G2: 

multiple 


assessed by blinded 

plastic surgeons 

• Volume reduction, 

texture, color 

• Excellent: 76-100% 

improvement 

Good: 51-75% 

Fair: 26-50% 

Poor:0-25% 

Volume reduction, mean score 

G1: 3.84 

G2: 3.96 

G1 vs.G2 p=0.008 

Texture 

G1: 3.57 

G2: 3.90 

G1 vs.G2 p=0.001 

Color 

G1: 3.98 

G2: 4.00 

G1 vs.G2 p=0.155 

Quality: 

Poor 

G = group; n = number; nm = nanometer; PDL = pulsed dye laser; SD = standard deviation 

Nd:YAG Laser Compared With Other Lasers or Observation 

Three poor quality cohort studies compared Nd:YAG laser to either argon laser, 217 traditional 

PDL, 215 or CO2 laser or observation. 214 One study included 55 children with sequelae from 

hemangioma and reported similar rates of excellent clearance (defined as 90-100% clearance) 

between Nd:YAG and Argon groups and a higher rate of children attaining 50 percent or greater 

clearance in the Nd:YAG group (72% vs. 52%). 217 Lesions were also scored for size length and 

width, which showed little difference between groups. Heights of lesions were sub-analyzed, 

which showed a greater ability of Nd:YAG to treat thicker lesions, with no excellent results in 

the argon group for lesions 0.5 cm in height and greater. 

In a study comparing Nd:YAG and PDL and including 50 children, 41 percent of children 

receiving PDL and 30 percent receiving Nd:YAG had complete clearance of IH (p=NR). 215 

Similar numbers in each group had 70 to 99 percent or

had tracheostomy compared with those who had no tracheostomy, and parental worry about the 

fate of the child lessened earlier if the child did not have a tracheostomy. Table 27 outlines key 

outcomes. 

Table 27. Key resolution outcomes in comparative studies of Nd:YAG laser 

Age, 

Months 

Author, Year 

Groups (n) 

Quality 

Achauer et al. 

1989 217 

G1: Argon (30) 

G2: Nd:YAG 

(25) 

Quality: Poor 

Type 

Age 

G1+G2: 

range 2 

weeks to 5 

years 

Type 

NR 

Location 

G1+G2: multiple 


of Resolution/Response 

• % reduction in volume 

graded: 


Good: 51-89% 

Fair: 25-50% 

Poor: 0-24% 


not clear 


Volume reduction, % 

Excellent 

G1: 35 

G2: 44 

Good 

G1: 17 

G2: 28 

Fair 

G1: 21 

G2: 12 

Raulin et al. 

2001 215 

G1: Flashlight 

pumped pulsed 

dye laser (25) 

G2: Long-pulse 

Nd:YAG laser 

(25) 

Age 

NR 

Type, % 

Superficial 

G1+G2: 100 

G1+G2: multiple 


• Independent 

evaluation of 

regression rated as 

100%, 70-99%,

Nd:YAG Laser With Cooling Compared With No Cooling 

In one fair quality cohort study, 235 patients (mean age= 9 months) received the same 

Nd:YAG laser treatment but different methods of epidermal cooling (ice chips during procedure, 

n=115; ice before, during, and after treatment, n=120). 218 Children were treated until they 

received an excellent (90-100% resolution) or good (50-89% resolution) result. Patients with 

more extensive cooling required a mean 1.45 sessions of laser treatment compared to 2.11 in the 

less extensive cooling group (Table 28). 

Table 28. Key resolution outcomes in comparative studies of Nd:YAG laser with cooling 

Author, Age, 

Year Months 


Location 


Groups (n) 


Quality Type 

Vlachakis et 

al. 2004 218 

G1: Nd:YAG 

laser, cooled 

with ice 

before, 

during and 

after 

irradiation 

(120) 

G2: Nd:YAG 

laser, cooled 

with ice only 

during 

irradiation 

(115) 

Age mean 

(range) 

G1+G2: 9 

(3 months 

to 4 years) 

Type, % 

Cutaneous 

G1+G2: 

100 

G1+G2: 

multiple 

• Change in size 


area reduction 

Good: 50-89% 


Poor: 0-19% 


NR 

Total resolution after session 1 

G1: 65 

G2: 39 

Total resolution after session 2 

Excellent 

G1: 55/55 

G2: 24/76 

Good 

G1: 0 

G2: 52/76 

Quality: Fair 

Abbreviations: G = group; n = number; Nd:YAG = neodymium yttrium aluminium garnet; NR = not reported 

Effectiveness of Surgical Treatments 

Photothermolysis With Intense Pulsed Light Compared With Cryosurgery 

Compared With Photothermolysis With Intense Pulsed Light Plus Sclerosis 

One retrospective cohort study compared three treatment modalities in 250 infants

Table 29. Key resolution outcomes in comparative studies of photothermolysis with intense 

pulsed light and cryosurgery 

Author, Age, 

Year Months 


Location 


Groups (n) 


Quality Type 

Ryzhevskiy 

et al. 219 

G1: Selective 

photothermol 

ysis (87) 

G2: Cyrodestruction 

with liquid 

nitrogen (79) 

G3: 

Combination 

of selective 

photothermol 

ysis and 

sclerosis(84) 

Age mean 

(range) 

G1+G2: 9 

(3 months 

to 4 years) 

Type, % 

Cutaneous 

G1+G2: 

100 

Quality: 

Poor 

G = group; NR = not reported 

G1+G2: 

multiple 

• Lesion area measured 

with graph paper. 

Change in depth 

confirmed by 

ultrasound 

• Cosmetic results after 

first treatment session: 

Good: 50% or more 

reduction in area; 

Satisfactory: 10-50% 

reduction; 

Unsatisfactory: < 10% 

or no positive 

dynamics 

• Evaluation blinding: 

NR 

Resolution after session 1, % 

Good 

G1: 35.6 

G2: 22.8 

G3: 71.4 

Satisfactory 

G1: 44.8 

G2: 46.8 

G3: 23.8 

Unsatisfactory 

G1: 19.5 

G2: 30.4 

G3: 4.8 

Cryosurgery Versus No Treatment 

One study assessed cryosurgical treatment of IH in preterm infants with multiple IH by 

treating one IH lesion and not treating another. 220 Some children had more than one pair of 

treated/untreated lesions, and the study followed infants up to age 1 or 2 years. Thirteen of 17 

treated IH and two of 17 untreated IH met the primary endpoint of intact, IH-free skin with mild 

or no pigmentation or scarring at 1 or 2 years of age (p

Table 30. Key resolution outcomes in comparative studies of cryosurgical therapy 

Author, Age, 


Year Months 

Location Measures of 


Groups (n) 


Quality Type 

Goelz et al. 

2014 220 

G1: nitrogencooled 

cryotherapy 

(13) 

G2: no 

treatment 

control (13) 

Quality: 

Poor 

Age 

NR 

(preterm 

infants) 

Type, % 

NR 

G1+G2: 

multiple 

NR 

Blinded assessment: 

NR 

Met primary endpoint, n IH (%) 

G1: 13/17 IH (76) 

G2: 2/17 (12) 

G1 vs G2: p

Table 31. Harms/adverse effects in comparative studies of lasers to treat * IH 

Intervention 


N Studies Reporting Harm 


(# Participants With 


Harm/Total Participants) 

Pulsed dye laser Purpura 215 1 (25/25) 100% 

Swelling 215 1 (25/25 100% 

Skin atrophy 212 1 (17/60) 28% 

Minimal crusting 210 1 (2/11) 18.2% 

Ulceration 212 1 (4/60) 7% 

Painful ulceration 212 1 (3/60) 5% 

Ulcer formation 211 1 (1/26) 4% 

Bleeding 212 1 (2/60) 3% 

Infection 212 1 (2/60) 3% 

** Atrophic scarring 150,215 1 (2/42) 3%-6% 

Hyperpigmentation 211,213,215 3 (12/66) 13%-20% 

Texture change 211,213 2 (8/41) 13%-23% 

Hypopigmentation 211-213,215 4 (41/126) 10%-45% 

Blistering (crusts and blisters) 213,215 2 (21/40) 13%-76% 

Longer pulse PDL Hypopigmentation 211,213 2 (4/34) 12%-12.5% 

Hyperpigmentation 211,213 2 (3/34) 8%-12.5% 

Texture change 211,213 2 (2/34) 4%-12.5% 

Nd:YAG laser *** Hypopigmentation 215 1 (2/25) 6% 

Purpura 215 1 (5/25) 20% 

Crusts and blisters 215 1 (8/25) 24% 

Swelling 215 1 (25/25 100% 

Atrophic scarring 215 1 (1/25) 3% 

Scarring 217 1 (8/26) 30.8% 

Delayed healing 217 1 (1/26) 12.5% 

Postoperative bleeding 217 1 (2/26) 7.7% 

Postoperative complications 1(35/235) 14.9% 

(including bleeding, atrophic scars 

and hypertrophic scars) 218 

Argon laser Delayed healing 217 1 (2/31) 13% 

Postoperative bleeding 217 1 (1/31) 3.2% 

Reaction to local anesthesia 1 (1/31) 3.2% 

(seizure and hospitalization) 217 

Observation Hypopigmentation 212 1 (9/61) 15% 

Skin atrophy 212 1 (5/61) 8% 

Ulceration 212 1 (4/61) 7% 

Painful ulceration 212 1 (2/61) 3% 

Bleeding 212 1 (2/61) 3% 

Infection 212 1 (4/61) 7% 

IH = infantile hemangioma; n = number; Nd:YAG = neodymium yttrium aluminum garnet; PDL = pulsed dye laser 

* One study of cryosurgery reported harms by number of IH. Scarring occurred in 4/17 treated IH and on 1 untreated IH. 220 

** 

One study reported atrophic scarring and ulceration in 1/17 children receiving PDL and concurrent propranolol. 150 One study 

(not represented in table) reported that 12.4% of the parents of 11 children receiving PDL judged that the treatment was painful. 

Another study included followup at 5 years post-PDL or observation and noted more scarring in the PDL group (49% vs 28% in 

controls, p=0.02 and more hypopigmentation (44% vs 23% in observation group, p=0.03). The number with skin atrophy was 

similar between groups. 212,250 

r*** One cohort study comparing topical timolol with PDL plus Nd:YAG laser reported crusting and hyperpigmentation in 4/30 

children. 14 Another study comparing topical timolol plus PDL to timolol alone reported that no children experienced any adverse 

effects. 106 

Ten case series reported on 1785 children who were treated with PDL (Table 32). One 

Korean study (good quality for harms reporting) treated 47 superficial or mixed IH in 40 patients 

monitored for hyper- and hypopigmentation, skin atrophy, hypertrophic scarring, and ulceration 

during treatment. 223 The only adverse event noted in this study was hyperpigmentation in two 

patients with superficial IH. The final assessment in this study was at the end of treatment so no 

75

long term follow information was available. A fair quality case series reported on PDL treatment 

for 65 children with ulcerated IH. 227 There were no cases of the predefined complications of 

hypo- or hyperpigmentation or epidermal textural changes. Some scarring occurred in an 

unknown number of patients that was comparable to scarring associated with healing of 

conservative treatment. Another fair quality case series of hand hemangiomas noted atrophy, 

pigment change, ulceration and scarring. 230 The most frequently reported harms were 

hyperpigmentation (1% to 14% in four studies 221,223-225 ) and hypopigmentation (0-25% in five 

studies 221,223-225,228 ). Ulceration was also noted in three studies. Two studies reported no adverse 

events, 222,226 and another reported no permanent side effects but cases of hyper and 

hypopigmentation. 225 

One thousand and seven children received treatment with Nd:YAG lasers reported in four 

case series. The most frequently reported adverse events from one large case series with 684 

children included skin burn (11%), infection (6.6%), and scarring (4.4%). 232 Another larger study 

with 160 participants reported complications including delayed healing, postoperative infection 

and scarring in 10 percent of their patients. 231 A single case series of 31 patients with subglottic 

IH noted one case of respiratory distress related to the ventilation system. 237 

Table 32. Adverse effects in case series of laser treatments for IH 

Number of Studies 

Intervention 


(# Participants With Reported Rates 

Harm/Total 


Participants) 

Pulsed dye laser Hyperpigmentation 221,223-225 4 (17/357) 1%-14.5% 

Hypopigmentation 221,223-225,228 5 (192/1014) 0-25.1% 

Pigment change (increase or 2 (67/700) 7-9.7% 

decrease) 228,230 

Ulceration 224,228,230 3 (7/790) 0.76-2.3% 

Blisters 221 1 (3/62) 4.8% 

Atrophy 228,230 2 (50/700) 7%-7.15% 

Scarring 228,230 2 (7/700) 0.9%-2.3% 

Granuloma telangiectaticum 229 1 (4/548) 0.7% 

Cutaneous atrophy and 

1 (22/657) 3.4% 

pigmentation 228 

Cutaneous atrophy and 

1 (32/657) 4.9% 

hypopigmentation 228 

Nd:YAG laser Scarring 232,234 2 (36/794) 4.4%-5.5% 

Hypertrophic scarring 234 1 (2/110) 1.8% 

Ulceration 232 1 (15/684) 2.2% 

Skin burn 232 1 (75/684) 11% 

Bleeding 232,234 2 (13/794) 0.9%-1.8% 

Nerve injury 232 1 (9/684) 1.3% 

Infection 232 1 (45/684) 6.6% 

Undesirable texture change 232 1 (30/684) 4.4% 

Anemia and hyperkalemia 232 1 (1/684) 0.15% 

Postoperative stenosis 233 1 (1/53) 1.9% 

CO2 laser Respiratory distress 237 1 (1/31) 3.2% 

Subglottic scarring 237 1 (1/31) 3.2% 

76

Table 32. Adverse effects in case series of laser treatments for IH (continued) 

Intervention 




(# Participants With 



Long-pulse 

Hypopigmentation 236 1 (48) 2.1% 

Alexandrite laser Blistering 236 1 99/48) 18.8% 

Marked edema and erosion 1 (1/48) 2.1% 

without residual scarring 236 

Combination (Pulsed 

Dye and ND:YAG) 

Blistering 235 1 (17/37) 45.9% 

Erosion 235 1 (1/37) 2.7% 

Scarring 235 1 (1/37) 2.7% 

CO2 = carbon dioxide; IH = infantile hemangioma; Nd:YAG = neodymium yttrium aluminum garnet 

One study 227 noted “some” scarring. One study 231 reported complications of “delayed healing, infection and/or scar formation” in 

16/160 (10%) of participants. One study 229 noted transient hypo- or hyperpigmentation in approximately 7% of cases and small 

atrophic scars in 4%. 

Table 33 outlines harms reported in surgical case series and in one comparative study of 

cryosurgery. 220 Dehiscence rates ranged from 1.4 percent to 5.5 percent in five 

studies, 238,240,246,248,251 and single cases of postoperative trauma-related wound dehiscence were 

reported in an additional three studies. 238,241,243 Postoperative infections were noted in two 

studies. 240,249 Scarring, skin necrosis, and alopecia were also noted in two reports. Other 

complications including facial paresis, permanent palsy, hematoma, intraoperative bleeding, 

cellulitis, hypopigmentation were reported in a single study each. One study reported no adverse 

events. 247 One larger series of 127 patients with lip IH treated with liquid nitrogen cryotherapy 

reported five cases of hypopigmentation and three cases of hemorrhage and ulceration. Labial 

mucoceles were noted in three children 3 years after treatment. 244 Harms reported in one study of 

cryosurgery included scarring in treated and untreated lesions. 220 

Table 33. Adverse effects in case series of surgical treatments for IH 

Intervention 


Number of Studies (# 


Participants With 



Surgery including Dehiscences 238,240,246,248,251 5 (17/357) 1.4%-5.5% 

excision and Postoperative traumatic wound 3 (3/119) 2.3%-2.8% 

resection 

dehiscence 238,241,243 

Wound infections minor or 

1 (6/44) 13.6% 

dehiscence 241 

Postoperative infection 240,249 2 (1/264) 0-2% 

Postoperative hematoma 245 1 (1/67) 1.5% 

Intraoperative bleeding 249 1 (2/50) 4% 

Skin necrosis 243,245 2 (3/106) 2.6%-3% 

Hypertrophic scarring/cheloids 249,251 2 (10/142) 4%-9.8% 

Incomplete excision with scarring 249 1 (1/50) 2% 

Facial paresis, transient postop 239 1 (4/43) 9.3% 

Permanent palsy of facial nerve 239 1 (1/43) 2.3% 

Hemorrhage and ulceration 244 1 (3/127) 2.4% 

Hypopigmentation of the skin or 1 (5/127) 3.9% 

vermillion of the lip 244 

Labial mucoceles observed 3 years 1 (3/127) 2.4% 

post- surgery 244 

Alopecia/Loss of small eyelash 2 (2/125) 1.1%-3% 

segment 242,251 

Cellulitis 251 1 (2/92) 2.2% 

Functional impairment 251 1 (2/92) 2.2% 

IH-infantile hemangioma 

No complications were noted in one study. 247 

77

Discussion 

State of the Literature 

We identified 148 unique studies (15 randomized controlled trials [RCTs], 5 prospective and 

19 retrospective cohort studies, 2 diagnostic accuracy studies, 1 study comparing pairs of treated 

and untreated infantile hemangioma (IH), and 106 case series) addressing our Key Questions. 

Forty-two comparative studies reported effectiveness outcomes (6 good quality, 22 fair quality, 

and 14 poor quality). One-hundred and forty-four studies (comparative studies and case series) 

reported harms/adverse events data (14 good quality for harms reporting, 3 fair quality, 127 poor 

quality). Eighty-one studies addressed beta-blockers (13 of which compared a beta-blocker to 

another category of intervention such as corticosteroids or laser); 26 addressed lasers; 24 

addressed steroids; 15 addressed surgical approaches; and 2 addressed diagnostic modalities. 

The literature on pharmacologic and surgical approaches for the treatment of IH is 

heterogeneous in terms of populations, interventions, comparators, and outcomes. Comparative 

studies included individuals with ages of less than one month to over 40 years (though the mean 

age in this study was below 3 years), and lesion types and locations varied across studies. Most 

studies included children with IH in multiple anatomic locations and of multiple types (e.g., 

deep, superficial) without stratifying outcomes on these characteristics. Studies typically did not 

clearly describe diagnostic criteria, and few clearly noted whether prior treatment had been 

administered (n=11/42 comparative studies). 

Studies assessed varied pharmacologic agents (corticosteroids, beta-blockers, 

immunomodulators) administered through various routes (topical, intralesional, intravenous, 

oral) at multiple doses and durations as well as varied forms of laser and surgical treatment (e.g., 

pulsed dye laser [PDL], argon laser, neodymium yttrium aluminum garnet [Nd:YAG] laser, 

cryotherapy) using varied regimens. Few (n=2) comparative studies addressed surgical treatment 

aside from laser modalities. Comparators also varied across studies and included placebo, 

observation, historical control groups, and other active interventions. Outcome measures 

similarly differed. While studies generally assessed change in lesion size or appearance, scales 

and methods varied and included visual analog scales, assessment of percentage size change, and 

more subjective assessments of good, fair, or poor response. 

Summary of Key Findings 

Key Findings From Contextual Questions 

The literature identified to answer contextual questions described a broader range of 

indications for referral of patients with IH and suggested support for a higher index of suspicion 

of extracutaneous IH in children with multiple cutaneous lesions or with facial lesions in a beard 

distribution. Studies have primarily assessed associations between cutaneous IH and hepatic IH 

and cutaneous facial IH and airway IH. 

Key Findings From Key (Comparative Effectiveness) Questions 

Until fairly recently, corticosteroids were the treatment of choice for IH. As reported in this 

review, corticosteroids demonstrate some effectiveness but are associated with clinically 

significant side effects. More recently, beta-blockers, and propranolol specifically, have been 

78

studied and recommended for use. Studies of propranolol have compared its effectiveness to 

placebo/observation, to corticosteroids and other modalities, and to other beta-blockers. Relative 

to observation or placebo arms, oral propranolol has been consistently shown to be superior in 

individual studies and in our network meta-analysis. Relative to other modalities, including 

steroids and bleomycin, we find that propranolol is generally superior with the exception of no 

significant differences in reducing lesion size in two studies comparing it to steroids. Finally, 

given that propranolol has been demonstrated to be associated with positive outcomes, the 

question of whether effectiveness is associated with propranolol specifically or beta-blockers in 

general has been studied. Although there are only three small studies available, early results are 

as positive as those noted for propranolol, and we believe that they suggest that these and 

potentially other beta-blockers may also be effective, potentially with fewer side effects. These 

findings, however, are preliminary. Studies of the beta-blocker timolol, used as a topical gel or 

solution typically to treat superficial IH, also reported greater effectiveness for timolol compared 

with placebo/observation in reducing IH lesion size, no differences in effects in one study 

comparing ophthalmic timolol and imiquimod; no differences in average overall improvement in 

another study comparing timolol and laser modalities; and greater response to timolol in 

superficial IH with greater response of mixed IH to timolol plus laser in a fourth study. 

In our network meta-analysis specifically, the expected efficacy of control arms was 

estimated to be 6 percent (95% Bayesian credible interval [BCI]=1% to 11%). All non-control 

treatments were estimated to have a larger expected clearance than control arms. The largest 

mean estimate of expected clearance was for oral propranolol (95%, 95% BCI: 88% to 99%), 

followed by timolol (62%, 95% BCI: 39% to 83%) and intralesional triamcinolone (58%, 95% 

BCI: 22% to 93%), albeit with wider confidence bounds. Oral steroids had a clearance rate of 43 

percent (95% BCI: 21% to 66%). The preponderance of available evidence used in the network 

meta-analysis was derived from studies of propranolol and corticosteroids. 

In terms of surgical interventions, only laser has been adequately studied. Most studies 

focused on PDL and generally it was found to be more effective than other types of laser, but 

effects remain unclear as studies were heterogeneous, and the role of laser vis-a-vis beta-blockers 

is not clearly described in the literature. Data are inadequate to address the role of imaging in 


We review specific findings and strength of evidence (SOE) by Key Question and provide 

more detailed results from our network meta-analysis below. 

KQ1. Effectiveness and Harms of Imaging 

Two poor quality diagnostic accuracy studies addressed imaging modalities. 68,70 Studies 

assessed IH in different anatomic locations and reported differing findings for the sensitivity of 

ultrasound and effectiveness of imaging modalities depending on location or subtype. Studies 

were limited by the size of cohorts, lack of standard processes, and lack of direct comparison at 

the same time point using the various imaging modalities. 

We considered the SOE for all imaging modalities to be insufficient given single, small 

studies addressing different approaches (Table 34) using weaker study designs and precluding a 

meta-analysis. The studies did not address harms. 

79

Table 34. Strength of evidence for effectiveness of imaging modalities 

Outcome 

Intervention 

MRI vs. 

Ultrasound 

MRI vs. 

Ultrasound 

vs. CT 

Study Design 

Quality and Number of 

Studies (N Total) 


spinal anomalies 

Cohort studies: 1 poor 68 

(48) 


liver IH 

Study 

Limitations 

Consistency Directness Precision 

Reporting 

Bias 

Finding 

Strength of Evidence Grade 

High Unknown Direct Imprecise NA Ultrasound had a sensitivity of 50% 

for identifying spinal anomalies 

including but not limited to IH and 

20% for identifying intraspinal IH 

only, compared with 100% for MRI. 

Insufficient SOE given small, single, 

poor quality study. 

High Unknown Direct Imprecise NA Ultrasound detected lesions in 42/44 

children (95% sensitivity). 


(55) 

CT = computed tomography; IH = infantile hemangioma; MRI = magnetic resonance imaging; n = number; NA = not applicable; SOE=strength of evidence 

Insufficient SOE given single small, 


80

KQ2. Effectiveness and Harms of Corticosteroids and Beta-Blockers 

Effectiveness and Harms of Corticosteroids 

We identified 24 studies (3 RCTs, 1 cohort study, and 20 case series) reporting outcomes 

and/or harms following corticosteroid use in children with IH. 40,107-129,133 In addition, seven 

studies (described in the section on beta-blockers) compared beta-blockers and steroids. 96- 

98,100,130-133 

Steroids studied varied in dose, type, and route of administration, and the ages of 

children included in comparative studies ranged widely from 1 to 72 months. Children in 

treatment arms typically had improvement in lesion size. Of the 219 children who received 

steroids in three studies 108,122,252 reporting lesion change data, 140 had a “good” or “fair” 

response to steroids. In our network meta-analysis, oral steroids had a mean estimated expected 

clearance rate of 43 percent (95% BCI: 21% to 66%). Intralesional triamcinolone had a rate of 58 

percent but with wide confidence bounds (95% BCI: 22% to 93%). 

Thus, there is adequate evidence to support a moderate strength of evidence for oral steroids 

to have a modest effect on clearance rates and low SOE for intralesional steroids to have a 

modest (albeit larger) effect relative to control with wide confidence bounds. 

However, steroids were consistently associated with clinically important harms including 

Cushingoid appearance, infection, growth retardation, hypertension, and mood changes that may 

be important in making treatment decisions. The SOE is moderate for the association of steroids 

with these clinically important harms (Table 35). 

81

Table 35. Strength of evidence for effectiveness and harms of steroids 

Outcome 

Intevention 

Oral steroids 

vs. Observation 

or Placebo 

Intralesional 

steroids vs. 

Observation or 

Placebo 

Study Design 

Quality and 


(N Total) 

Improvement in IH 




Study 

Limitations 


Reporting 

Bias 

Finding 


High Consistent Indirect Imprecise Undetected In network meta-analysis oral steroids 

had a mean expected clearance rate 

of 43% (95% BCI: 21% to 66%) 

compared with 6% (95% BCI: 1% to 

11%) for placebo/observation arms. 

Moderate SOE for greater 

effectiveness of oral steroids vs. 

placebo/observation given low 

precision and high study limitations. 

High Consistent Indirect Imprecise Undetected In network meta-analysis intralesional 

steroids had a mean expected 

clearance rate of 58% (95% BCI: 22% 

to 99%) compared with 6% (95% BCI: 

1% to 11%) for placebo/observation 

arms. 

Low SOE for greater effectiveness of 

intralesional steroids vs. 

placebo/observation given relatively 

small numbers of participants 

contributing to this comparison and low 

precision. 

82

Table 35. Strength of evidence for effectiveness and harms of steroids (continued) 

Outcome 

Intervention 

All Steroids 

Study Design 



(N Total) 

Clinically 

important harms 

(Cushingoid 

facies, growth 

retardation, mood 

changes 

/irritability, 

hypertension, 

infection) 

RCT: 2 good 98,107 

1 poor 122 (138) 

Cohort: 3 poor 40,96,97 

(179) 

Study 

Limitations 


Reporting 

Bias 

Finding 


High Consistent Direct Precise Undetected Studies consistently reported these 

adverse effects. 

Moderate SOE for the association of 

steroids with clinically important harms 

due to high study limitations. 


poor 109,110,112,113,115- 

117,120,129,133 

(2974) 

BCI = bayesian credible interval; IH = infantile hemangioma; n = number; NA = not applicable; RCT = randomized, controlled trial; SOE = strength of evidence 

83

Effectiveness and Harms of Beta-Blockers 

Eighty-one studies (25 comparative studies and 56 case series) evaluated propranolol (oral, 

topical, intralesional), oral nadolol, oral atenolol, or timolol (topical gel or ophthalmic solution). 

Beta-blockers typically demonstrated significantly greater effects on reducing lesion size or 

volume than did control or other active comparators. 

Compared with a mean estimated expected clearance rate of 6 percent (95% BCI: 1% to 

11%) in placebo or observation arms, oral propranolol had a rate of 95 percent (95% BCI: 88% 

to 99%). With adequate data and precision, we considered the SOE to be high for the effect of 

oral propranolol on lesion size relative to observation or placebo arms. Individual studies 

assessed qualitatively typically also demonstrated greater effectiveness for propranolol compared 

with other active treatments. 

Other oral beta-blockers have demonstrated promising effectiveness; we considered the SOE 

to be low for no difference in response of propranolol and nadolol or atenolol based on three 

small studies. We considered SOE to be low for greater effectiveness of topical timolol 

compared with observation or placebo (Table 36); SOE was insufficient for studies comparing 

timolol to other modalities including laser and imiquimod. Most studies of timolol included 

children with superficial lesions. 

84

Table 36. Strength of evidence for effectiveness of beta-blockers 

Outcome 

Intervention 


vs. Placebo or 

Observation 

Study Design 






RCT: 2 good, 17,92 1 

fair 99 (510) 


fair 94 (45) 

Rebound 

growth/Need for 

additional 

treatment 

RCT: 1 good 92 

(456) 


fair 94 (45) 

Study 

Limitations 


Reporting 

Bias 

Finding 


Low Consistent Indirect Precise Undetected In network meta-analysis, the mean 

expected clearance rate for oral 

propranolol was 95% (95% BCI: 88% 

to 99%) relative to 6% (95% BCI: 1% 

to 11%) for placebo/observation 

arms; greater reductions in IH size in 

propranolol arms vs. control in all 

individual studies. 

High SOE for greater effectiveness 

of oral propranolol vs. placebo or 

observation based on individual 

comparisons and the network metaanalysis. 

Low Consistent Direct Precise Undetected Fewer than 15% of children in 

treatment arms had rebound growth 

or required longer/additional 

treatment. 

Moderate SOE for low level of 

rebound growth/need for further 

treatment associated with 

propranolol given few studies 

addressing the outcome. 

85

Table 36. Strength of evidence for effectiveness of beta-blockers (continued) 

Outcome 

Intervention 


vs. Steroids 


plus prednisolone 

vs. prednisolone 

vs. propranolol 

alone 

Study Design 






RCT: 1 good 98 (19) 


fair, 2 

poor 96,97,130,132,133 

(216) 

Amblyopia 


fair 131 (43) 


RCT: 1 fair 100 (30) 

Study 

Limitations 


Reporting 

Bias 

Finding 


High Inconsistent Indirect Precise Undetected In head-to-head comparisons, 

propranolol more effective than oral 

steroids in 3 studies 96,97,132,133 ; two 

other studies reported no significant 

difference between oral or 

intralesional propranolol and oral or 

intralesional steroids. 98,130 . In a 

network meta-analysis, pooling data 

from multiple studies, propranolol 

was clearly superior to oral steroids 

(95% [95% BCI: 88% to 99%] 

clearance versus 43% [95% BCI: 

21% to 66%] clearance). 

Moderate SOE for superiority of 

propranolol over steroids at 

achieving clearance based on 

combined effects from individual 

studies and network metaanalysis,high 

study limitations, and 

inconsistency... 

High Unknown Direct Imprecise NA No significant difference in level of 

amblyopia between oral propranolol 

and intralesional triamcinolone arms. 

Insufficient SOE given single small 

study with high limitations. 

High Unknown Direct Imprecise Undetected Significant size reductions from 

baseline in propranolol and 

combined arms (p values


Outcome 

Intervention 


vs. Other betablocker 


vs. Intralesional 

bleomycin 


Placebo or 

Observation 

Study Design 





RCT: 1 fair 102 (23) 


fair, 1 poor 101,146-148 

(77) 



poor 95 (20) 



RCT: 1 good 104 (41) 


fair, 1 poor 103,144 

(147) 

Study 

Limitations 


Reporting 

Bias 

Finding 


High Consistent Indirect Imprecise Undetected In head-to-head comparisons, no 

significant differences in response 

between propranolol and atenolol in 

2 studies; better response to nadolol 

vs. propranolol in one small study. 

Low SOE for no difference in 

response with propranolol, nadolol, 

or atenolol (systemic beta-blockers) 

based on few, small studies. 

High Unknown Direct Imprecise NA No difference between agents in one 

small study. 

Insufficient SOE due to single study 

with high limitations. 

Medium Consistent Indirect Precise Undetected Timolol more effective than placebo 

or observation in three comparative 

studies. 

In network meta-analysis, the mean 

expected clearance rate for topical 

timolol was 62% (95% BCI: 39% to 

83%) relative to 6% (95% BCI: 1% to 

11%) for placebo or observation 

arms. 

Low SOE for effectiveness of timolol 

vs. placebo or observation based on 

medium study limitations and few 

studies. 

87


Outcome 

Intervention 


timolol+PDL 


PDL + Nd:YAG 

laser 

Study Design 






poor 106 (102) 


RCT: 1 fair 14 (60) 

Study 

Limitations 


Reporting 

Bias 

Finding 


High Unknown Direct Imprecise NA Timolol+PDL more effective than 

timolol alone (p=0.02). 



High Unknown Direct Imprecise Undetected Greater response to timolol among 

superficial IH and greater response 

to laser among mixed IH (p=NR). 


Topical Imiquimod 



fair 105 (38) 



High Unknown Direct Imprecise NA No significant differences in 

improvement in IH between groups. 



BCI = bayesian credible interval; IH = infantile hemangioma; N = number; Nd:YAG = neodymium yttrium aluminum garnet ; PDL = pulsed dye laser; RCT = randomized 

controlled trial; SOE = strength of evidence 

88

Harms most frequently reported with beta-blockers included hypotension, hypoglycemia, 

bradycardia, sleep disturbances, cold extremities, gastrointestinal symptoms, and bronchial 

irritation (classified as hyperreactivity, bronchospasm, bronchiolitis, cold induced wheezing). 

Harms generally were not severe enough to cause treatment discontinuation (n=75/4872 children 

receiving beta-blockers [1.5%]) in case series and comparative studies). We considered the SOE 

to be moderate for the association of propranolol with clinically important and minor harms 

(Table 37). 

89

Table 37. Strength of evidence for harms of beta-blockers 

Outcome 

Study 

Limitations 

Study Design 

Intervention 


Oral 

propranolol 



Clinically important harms 

(hypotension, bradycardia, 

bronchospasm, 

hypoglycemia) 

Reporting 

Bias 

Finding 

Strength of Evidence 

Grade 

High Consistent Direct Precise Undetected Rates of these harms with 

oral propranolol ranged 

from 0 to 100% across 

studies. 

RCT: 2 good, 1 poor 17,92,98 

(515) 

Cohort studies: 3 poor 94,97,147 

(213) 

Moderate SOE for 

association of propranolol 

with these harms based on 

high study limitations. 

Case series: 1 good, 15 

poor 16,153,171,172,185,190,191,193- 

195,199,200,202,203,205 

(1249) 

Minor harms (cold 

extremities, diarrhea, sleep 

changes) 

RCT: 1 good, 3 poor 17,92,98,100 

(545) 


poor 94,96,131,132,145,147 (270) 

High Consistent Direct Precise Undetected Rates of these harms with 

propranolol ranged from 

1% to 50% across studies. 

Moderate SOE for 

association of propranolol 

with these harms given 

relatively low numbers of 

participants in studies. 

Case series: 1 good, 12 

poor 16,171,172,185,189- 

191,193,195,200,202,203 

(1140) 

90

Table 37. Strength of evidence for harms of beta-blockers (continued) 

Intervention 

Timolol 

Outcome 

Study Design 



Lack of harms 

RCT: 1 good, 1 poor 14,104 

(71) 

Cohort studies: 1 good, 3 

poor 103,105,106,144 (287) 

Study 

Limitations 


Reporting 

Bias 

Finding 


Grade 

Medium Unknown Direct Imprecise Undetected No harms observed with 

timolol in 5 comparative 

studies and 1 case series. 

Shortness of breath and 

insomnia observed in 1 of 

30 children in one 

comparative study. 14 

Nadolol 

Case series: 1 poor 159 (25) 

Clinically important harms 

(hypotension, bradycardia, 

bronchospasm, 

hypoglycemia) 


(19) 



changes) 

Cohort studies: 1 poor 101 (19) 

Low SOE for lack of 

association of timolol with 

harms based on few 

studies. 

High Unknown Direct Imprecise NA Harms of nadolol reported 

in 10%-20% of children. 

Insufficient SOE for 

association with clinically 

important harms given 

single, small poor quality 

cohort study. 

High Unknown Direct Imprecise NA Harms of nadolol reported 

in 10%-50% of children. 


association with minor 

harms given single, small 


91

Table 37. Strength of evidence for harms of beta-blockers (continued) 

Intervention 

Atenolol 

Outcome 

Study Design 



Hypotension 




changes) 

RCT: 1 poor 102 (23) 


Study 

Limitations 


Reporting 

Bias 

Finding 


Grade 

High Unknown Direct Imprecise NA Hypotension reported in 

3% of children in one 

study. 


association with 

hypotension given only a 

single, small poor quality 

study. 

High Consistent direct Imprecise Undetected Minor hams occurred in 

7%-27% of children. 

IH = infantile hemangioma; n = number; NA = not applicable; RCT = randomized, controlled trial; SOE = strength of evidence 

Low SOE for the lack of 

association with minor 

harms given two small 

studies with high 

limitations. 

92

KQ3. Effectiveness and Harms of Second-Line Drugs 

We did not identify any studies addressing this question. 

KQ4. Effectiveness and Harms of Surgical Interventions 

Effectiveness and Harms of Laser and Surgical Treatment 

Eleven comparative studies (three RCTs, 210-212 seven retrospective cohort studies, 213-219 and 

one study that compared cryotherapy-treated and untreated IH pairs in individual children 220 ) 

addressed surgical approaches. In addition, one RCT and one cohort study (described in KQ2 

above) compared topical timolol and laser modalities, 14,106 and 28 case series addressed surgical 

approaches. 221-228,230-249 Most comparative studies were small (≤55 participants), but one RCT and 

three retrospective cohort studies included more than 120 children. Lasers varied across studies 

in type, pulse width, or cooling materials. Most studies assessed variations of PDL (n=7) and 

examined heterogeneous endpoints. Most studies reported on treatment of cutaneous lesions. 






complication rate than both Nd:YAG and observation. 

Two comparative studies addressed surgical approaches (cryotherapy, intense pulsed light 

photothermolysis, sclerosis) and reported some positive effects in reducing IH size or improving 

appearance, but their smaller size and low quality preclude conclusions (insufficient SOE). 

Strength of evidence for outcomes after surgical treatments ranged from insufficient to low for 

effectiveness outcomes. The evidence was limited by low sample size, lack of comparisons of 

the same modalities, and variations in the laser settings used including wavelength and cooling 

protocols. For Nd:YAG and CO2 lasers, cryotherapy, and intense pulsed light photothermolysis, 

all studies were severely limited by sample size, and SOE was determined to be insufficient in all 

outcome parameters (Table 38). 

93

Table 38. Strength of evidence for effectiveness of laser modalities 

Outcome 

Intervention 

Longer pulse 

PDL vs. other 

laser types 

and protocols 

Study Design 

Quality and Number 

of Studies (N Total) 


RCT: 1 fair 211 (52) 


poor 215,216 (212) 

Study 

Limitations 


Reporting 

Bias 

Finding 


Medium Inconsistent Direct Imprecise Undetected In 1 RCT, resolution outcomes 

similar between laser types; greater 

clearance in PDL +cooling arm in 

one cohort study, 216 and more 

children in PDL arm had complete 

regression than in Nd:YAG in 

another 215 ; typically more than 50% 

of children receiving any laser had 

at least 50% clearance. 

PDL vs. 

Observation 


RCT: 1 good, 1 

fair 210,212 (143) 

Low SOE for no difference in 

effects on size reduction between 

longer pulse PDL and various other 

lasers given few studies, medium 

limitations, and inconsistent and 

imprecise findings. 

Low Consistent Direct Imprecise Suspected No significant difference in 

measured volume or proportion of 

clearance between groups in either 

study when considering complete 

and near complete clearance; 

greater observer-ratings of 

improvement for PDL arm vs. 

observation in one study. 210 

Low SOE for lack of difference 

between PDL treatment and 

observation in reducing lesion size 

due to lack of precision, few 

studies. 

94

Table 38. Strength of evidence for effectiveness of laser modalities (continued) 

Intervention 

PDL vs. 

Observation 

Outcome 

Study Design 



Quality of life 

RCT: 1 good, 1 

fair 210,212 (143) 

Study 

Limitations 


Reporting 

Bias 

Finding 


Medium Inconsistent Indirect Imprecise Undetected No significant differences in parent 

ratings of QoL in one study; more 

parents of children in PDL arm in 

another considered appearance 

improved than in observation arm. 

Nd:YAG with 

extended 

cooling vs. 

Nd:YAG with 

standard 

cooling 

Nd:YAG vs. 

CO2 laser vs. 

Tracheostomy 



fair 218 (290) 

Speech 


poor 214 (46) 

Low SOE for lack of difference in 

QoL with PDL compared with 

observation due to lack of 

consistency and precision, few 

studies. 

Medium Unknown Direct Imprecise NA Improved resolution with extended 

cooling protocol vs. traditional. 

Insufficient SOE given single study 

with medium limitations. 

High Unknown Indirect Imprecise NA 75% of children with tracheostomy 

had delayed speech vs. 0 with no 

tracheostomy in the laser treatment 

era. 

Insufficient SOE given small, single 

study. 

95

Table 38. Strength of evidence for effectiveness of laser modalities (continued) 

Intervention 

Cryotherapy 

vs. 

Observation 

Photothermolysis 

with Intense 

Pulsed Light 

With or 

Without 

Sclerosis vs. 

Cryotherapy 

Outcome 

Study Design 




Comparative study 

with treated/untreated 

IH per child: 1 poor 220 

(13) 



poor 219 (250) 

Study 

Limitations 


Reporting 

Bias 

Finding 


High Unknown Direct Imprecise NA 76% of IH in treated arm vs. 12% in 

untreated resolved without scarring. 

Insufficient SOE given single, small 

study with high limitations. 

High Unknown Direct Imprecise NA More children had ≥50% reduction 

in IH size in the combined therapy 

arm than in other arms (p=NR). 

Insufficient SOE given single study 


CO2 = carbon dioxide; IH = infantile hemangioma; NA = not applicable; NR = not reported; Nd:YAG = neodymium yttrium aluminum garnet; PDL= pulse dye laser; QoL = 

quality of life; RCT = randomized controlled trial 

96

For harms, a moderate strength of evidence was noted for pigmentation changes with PDL, 

which was most frequently hypopigmentation. Low SOE was noted for bleeding in the 

immediate postoperative period. Due to low sample size and limitations in reporting, pain and 

scarring were found to have insufficient SOE. For Nd:YAG lasers, evaluation for scarring was 

most frequently reported, and there was low SOE to support no difference in scarring between 

Nd:YAG and observation. Evidence was deemed insufficient to comment on pigmentation 

changes and bleeding for children treated with Nd:YAG and scarring after cryotherapy. 

Most surgical case series (n=13) were retrospective and included a total of 838 children. We 

considered all to be poor quality for harms reporting. Frequently reported harms included 

scarring and wound dehiscence. SOE was insufficient for the association of surgical approaches 

with harms given the small numbers of harms reported (Table 39). 

97

Table 39. Strength of evidence for harms of laser modalities 

Outcome 

Intervention 

PDL 

Study Design 



Pigmentation changes 

RCT: 1 good, 1 poor 211,212 

(173) 

Study 

Limitations 


Reporting 

Bias 

Finding 


Low Consistent Direct Precise Undetected Hypo- or hyper-pigmentation 

consistently reported, with 

hypopigmentation reported more 

frequently. 


poor 213,215 (73) 

Case series: 1 fair, 4 

poor 221,224,225,228,230 (1017) 

Bleeding 

RCT: 1 good 212 (121) 

Pain 

RCT: 1 good 212 (121) 

Scarring 

Cohort studies: 1 good 215 

(50) 

Case series: 2 fair, 1 

poor 227,228,230 (769) 

Moderate SOE for association of 

PDL with skin pigmentation 

complications based on relatively 

few participants in studies. 

Low Unknown Direct Imprecise Undetected No significant difference in 

bleeding between short pulse 

PDL and observation groups. 

Low SOE for association of 

bleeding with PDL based on one 

study with low limitations, 

unknown consistency, and 

imprecision. 

Low Unknown Indirect Imprecise Undetected 13% of parents reported pain for 

their children after PDL. 

Insufficient SOE for pain 

following PDL given few 

occurrences of outcome. Pain is 

also difficult to assess in infant 

population. 

Medium Inconsistent Direct Imprecise NA 1/25 children receiving PDL in 

one study 7/769 children in case 

series had scarring. 

Insufficient SOE due to few 

occurrences of the outcome 

reported in studies. 

98

Table 39. Strength of evidence for harms of laser modalities (continued) 

Intervention 

Nd:YAG 

Cryotherapy 

vs. 

Observation 

Outcome 

Study Design 



Pigmentation changes 

Cohort studies: 1 good 215 

(50) 

Scarring 


poor 214,215,218 (386) 


poor 231,232,234 (954) 

Bleeding 

Case series: 2 poor 232,234 

(794) 

Scarring 

Comparative study with 

treated/untreated IH per 

child: 1 poor 220 (13) 

Study 

Limitations 


Reporting 

Bias 

Finding 


Low Unknown Direct Imprecise NA 2/25 children receiving Nd:YAG 

in one study had scarring. 



reported. 

Medium Consistent Direct Precise NA Most studies reported scarring in 

≤5% of children. 

Low SOE for association of 

scarring with Nd:YAG treatment 

due to few occurrences of the 

outcome reported. 

High Unknown Direct Precise Undetected Bleeding noted in 13/794 

children. 




High Unknown Direct Imprecise NA Scarring in 4 of 17 IH treated with 

cryotherapy. 

Insufficient SOE due to single, 

small study. 

99

Table 39. Strength of evidence for harms of laser modalities (continued) 

Intervention 

Surgical 

Excision or 

Resection 

Outcome 

Study Design 



Scarring 

Case series: 2 poor 249,251 

(142) 

Study 

Limitations 


Reporting 

Bias 

Finding 


High Consistent Direct Imprecise NA Scarring in 11/192 children. 




Wound dehisecence 


poor 238,240,241,243,246,248,251 

(483) 

High Consistent Direct Imprecise NA Dehiscences in 20/483 children. 



reported in studies with high 

limitations. 

IH = infantile hemangioma; n = number; NA = not applicable; Nd:YAG = neodymium yttrium aluminium garnet; QoL = quality of life; PDL = pulse dye laser; 

RCT = randomized, controlled trial; SOE = strength of evidence 

100

Findings in Relation to What is Already Known 

We identified ten recent (2010-present) systematic review or meta-analyses assessing 

interventions for IH. 91,253-261 Most reviews addressed propranolol or beta-blockers: three 

addressed propranolol generally; 258,259,261 two examined effectiveness specifically for airway 

IH; 91,260 one for periocular IH; 262 and two compared beta-blockers and steroids. 253,254 One 

Cochrane review assessed multiple interventions, 257 and two additional reviews examined 

intralesional steroids 256 and laser treatment. 255 

Across reviews, investigators commented on small sample sizes, disparate outcome 

measures, and typically low to moderate quality studies. Most reviews noted the promise of 

propranolol for reducing IH lesion size but also a need for additional, larger studies with longer 

term followup. Overall, our findings related to the effectiveness of propranolol in most children 

and limited effectiveness of steroids for cutaneous IH align with findings in prior reviews. One 

review and meta-analysis of 10 comparative studies (six considered high quality, four of 

moderate quality) of children with cutaneous IH meta-analyzed data related to adverse events 

and reported no differences in the rate of adverse events between propranolol and corticosteroids 

(18 events in propranolol studies and 19 in steroid, p=0.73, 95% CI: 0.56 to 1.50). 253 

Only one prior review addressed laser treatments (two IH studies) and concluded that, despite 

favorable results, the evidence is weak to support the use of lasers in IH treatment (level 3b on 

the Oxford Centre of Evidence-based Medicine scale). 255 

Applicability 

We set inclusion criteria intended to identify studies with applicability to children with IH 

between the ages of 0 and 18 years. Studies differed in terms of study population and outcome 

measures. Most studies included children with IH in multiple anatomic locations and did not 

report effectiveness by lesion site or type. Most studies were non-comparative, and lack of direct 

comparisons of treatment options and few studies addressing the same interventions and 

comparators further hinder our ability to understand what findings will best extrapolate to 

children at specific ages, with specific lesion types, or in specific anatomic locations. Further, 

most comparative studies were conducted in larger medical centers or referral centers, which is 

in line with typical treatment as most children with IH are referred to specialists from general 

practitioners. 

Overall the available data on the effectiveness and harms of beta-blockers and corticosteroids 

are largely applicable to the general population of children with IH. Most studies included a 

majority of females, in line with the female predominance of IH, and ages in comparative studies 

generally ranged from 1 month to 9 years. One cohort study included individuals between 1 

month and 43 years of age, with a mean age of 2 years and 11 months. 216 

Few studies addressed imaging modalities, and those that did evaluated modalities to assess 

hepatic or intraspinal IH. Studies compared ultrasound, magnetic resonance imaging, computed 

tomography, and angiography. Imaging was sometimes not conducted at the same time, which 

limits comparability, and potentially the applicability of findings. Studies were also completed 

prior to 2010, so imaging techniques and practices may have changed. 

Studies addressing steroids compared various routes of steroid administration (oral, topical, 

and intralesional) and various agents (methylprednisolone, triamcinolone, mometasone furoate) 

in children with ages ranging from less than 1 to 72 months. Studies likely included children 

with IH in the proliferative and involution phase, which may limit applicability to younger or 

101

older children. One comparative study was conducted in Canada and the others in Turkey, 

Pakistan, and India. Applicability may be limited given differences in the systems of care in 

these lower resource countries. Comparative studies were also published between 2001 and 2014 

and may not fully represent evolutions in standards of care. 

Studies of beta-blockers typically included infants of both sexes ages 1 to 12 months of age 

(range: 1 month - 9 years) with superficial, deep, and mixed lesions primarily involving the head 

and neck and occurring as focal or segmental lesions. Studies of topical or ophthalmic timolol 

typically included children with superficial lesions, though two of six comparative studies 

included children with superficial and deep lesions. Children were treated with a variety of betablockers 

including propranolol at various doses and administrations (oral, intralesional, or 

topical), timolol (topical or ophthalmic), atenolol (oral), or nadolol (oral), most commonly for up 

to 6 months duration. These agents and dosage forms are typically easily available in the United 

States and not universally available. Dosage amounts ranged from 1 to 4 mg/kg/day. Doses over 

2 mg/kg/day are not typically administered and may limit applicability of findings of two studies 

of propranolol. 92,97 

Surgical studies, conducted in the United States, the United Kingdom, the Netherlands, 

Germany, Greece, Japan and Singapore, included infants of both sexes with a preponderance of 

females (age range: 1 week to 43 years of age) with superficial and cutaneous infantile 

hemangiomas in varied locations. One study reported laser use for subglottic IH and one 

evaluated photothermolysis with intense pulsed light and cryosurgery in children of maxillary 

IH. Most comparative studies evaluated laser treatments including short-pulse and longer pulse 

PDL, Nd:YAG, and argon. Two studies evaluated cryotherapy, one of which compared it to 

photothermolysis with intense pulsed light with or without concomitant sclerosis. Applicability 

of many of these studies is limited by historical changes in care and technology. 

Newer lasers and adjunctive features such as dynamic cooling have resulted in older lasers 

being out of date, thus limiting the applicability of studies conducted with those models. Most 

laser studies evaluated lasers as first-line treatment, which is currently less common in practice 

since the advent of beta-blocker treatment in countries, like the United States, where such 

treatments are readily available, as beta-blockers have generally superseded other treatments as 

first-line management of IH. Additionally, most comparative literature evaluated PDL, which is 

typically used only for the treatment of superficial lesions. Appendix G contains full applicability 

tables. 

Implications for Clinical and Policy Decisionmaking 

This review provides evidence for use in clinical care of children who present with IH. It 

particularly demonstrates that there are moderate benefits with steroid treatment and significantly 

greater improvements with beta-blockers, with propranolol being the agent most commonly 

studied. When a decision to treat is made, our review provides qualitative and quantitative 

evidence that beta-blockers are associated with substantial improvement in IH size/volume 

(mean expected clearance rates of 95% for oral propranolol [95% BCI: 88% to 99%] and 62% 

for topical timolol [95% BCI: 39% to 83%], compared with 6% for observation/placebo arms 

[95% BCI: 1% to 11%]). 

Steroids were associated with mean expected clearance rates of 43 percent (95% BCI: 21% to 

66%) for oral steroids and 58 percent (95% BCI: 22% to 99%) for intralesional triamcinolone in 

our network meta-analysis, but side effects are clinically significant, and clinicians and families 

will need to weigh the benefits and harms. 

102

It is important for clinicians to know that the literature summarized here typically examines 

children with problematic or complicated IH and thus may not apply to all children, particularly 

those with minor IH. In one large trial evaluating active treatment with propranolol for children 

without problematic IH, propranolol was associated with complete resolution or near complete 

resolution in 60 percent of cases (vs. 4% in placebo arm). 92 In addition, studies typically reported 

outcomes only in the short term (generally ≤12 months followup); thus, our understanding of the 

longer term effects of these medications is lacking. Further, though the literature demonstrates a 

strong shift towards beta-blocker therapy, uncertainty still remains about the most effective 

agent, dosage, and duration of treatment, and the need for pre-treatment evaluation and 

monitoring while on beta-blockers. 

Limited research is available to guide decision-making about the use of lasers as the initial 

intervention. Historically, lasers provided a fair benefit in primary management of IH, which was 

comparable in many cases series to steroid treatment, and generally was superior to observation. 

The advent of propranolol, however, has largely relegated laser treatment to secondary 

management. There is little comparative data between lasers and beta-blockers, but the success 

rates for complete or near complete resolution in historical laser studies are notably lower than 

those in more recent propranolol studies. Under current treatment paradigms, PDL with 

epidermal cooling is most often used for residual cutaneous changes after the completion of the 

proliferative growth phase and with incomplete resolution after pharmacologic management, 

while Nd:YAG laser is most often used intralesionally for medically refractory lesions. A variety 

of other lasers are used for intralesional treatment or resection, though no conclusions can be 

drawn regarding the superiority of any of these modalities over any other. 

The literature identified to answer contextual questions describes a broader range of 

indications for referral of patients with IH and suggests that indications for referral include large 

size; segmental type; risk for complications including bleeding, ulceration, and pain; 

involvement of critical structures; and risk factors for occult lesions (numerous cutaneous 

lesions, beard distribution). Further, the potential for psychosocial concerns may support referral 

for patients with uncomplicated lesions in highly visible areas on a case-by-case basis. 

Given the lack of long-term data on harms of interventions, clinicians and families must 

balance the potential of both short- and long-term harms with the benefits of potential resolution 

or size reduction of lesions. 

Limitations of the Comparative Effectiveness Review 

Process 

We included studies published in English only and did not seek or include unpublished data. 

In our scan of the non-English language literature published since 1982 and located via our 

MEDLINE search, we determined that the majority would not meet our review criteria. Given 

the high percentage of non-eligible items in this scan, we feel that excluding non-English studies 

did not introduce significant bias into the review. 

We also required that studies reporting on “second-line” treatments such as imiquimod, 

bleomycin, or alpha interferon address such treatments after a trial of beta-blockers or 

corticosteroids, and we did not identify any such studies. While this undoubtedly means that 

some treatment outcomes are not included in this review, these drugs are not frequently used 

since the advent of beta-blocker treatment for IH in the opinion of our clinical experts. 

We also used only comparative studies to address questions of effectiveness and case series 

with at least 25 participants to provide harms data. These requirements eliminated some smaller 

103

case series reporting on rarer presentations of IH (e.g., liver IH). We were also dependent upon 

the characterization of IH as presented in each study. Given changes in nomenclature and 

variations in the way IH are described, it may be that some studies included non-IH lesions. 

However, our clinical experts carefully reviewed studies to attempt to ascertain that included 

studies were reporting on true IH. We also note that other approaches to meta-analysis could be 

used, but that our estimates of a high anticipated response to propranolol largely align with those 

in other reviews of propranolol. 254,258,259,261 

Limitations of the Evidence Base 

The evidence base for IH treatment is limited by a small number of comparative studies 

including a limited number of participants. While cohort studies compared at least two different 

interventions, few presented truly comparative data. A number of studies reported only absolute 

differences in resolution or other outcomes, with no statistical comparison, in part likely due to 

their small sample sizes. Similarly, few studies reported baseline characteristics of the lesion, so 

understanding the magnitude of change reported is challenging. Most studies included children 

with problematic IH, so change was likely substantial, and parents and children may value any 

lessening of lesion size or change in color or texture. 

A growing number of studies address beta-blockers, but current studies are limited by a 

general lack of long-term followup and analyses to explore differences in response among 

subgroups. Studies may also have used compounded forms of beta-blockers, which may add to 

the complexity of interpreting dosage amounts. Few comparative studies addressed steroids, and 

indications for steroid treatment compared with beta-blockers are unclear. Few comparative 

studies addressed surgical approaches besides laser modalities, and those addressing lasers used 

different interventions and comparators, limiting comparisons across studies. Technological 

advances have also changed the indications for treatment, and a historical trend towards treating 

smaller, less severe lesions, similarly make analyses difficult because of changing indications for 

and expectations of treatment. 

Studies are also limited by the use of multiple and variable outcome measures to assess 

resolution of lesions. As no objective lab value or other measures exist to determine size 

changes, investigators have developed multiple techniques, and studies did not always report 

scales or other approaches clearly. The variety of scales (e.g., percentage change, mean change, 

VAS, HAS) makes combining outcomes challenging. Similarly, studies typically included 

multiple lesion types in multiple locations, which complicates determining potential differences 

in response, and treatment approaches varied across studies (e.g., doses and dosage forms, level 

of patient monitoring, timing of treatment and followup). 

The most important deficiency in the reported outcomes across studies is the tendency for the 

reporting of discretized outcomes, when the underlying outcome is a continuous variable. 

Specifically, though outcomes are likely recorded as a continuous measure (i.e., the proportion of 

an existing lesion that is cleared or reduced in size following treatment), authors often chose an 

arbitrary cutoff proportion (or a small number of bins) and reported only the numbers in each of 

the resulting categories. This results in an immediate and unrecoverable loss in power for any 

quantitative meta-analyses. Researchers should be encouraged to report outcome variables as 

they were recorded, without transforming them in such a way that information is lost. In 

addition, methods for measurement of outcomes such as rebound growth are not clearly reported; 

thus, our understanding of the magnitude of regrowth is limited. 

104

Research Gaps and Areas for Future Research 

While a growing number of comparative studies address treatments for IH, a number of 

research gaps exist. These gaps include a lack of information on: 

• Indications, optimal timing, and optimal modalities for imaging and diagnostic 

approaches. Few studies in the literature we reviewed reported imaging or diagnostic 

techniques, and data on optimal approaches for each are lacking in the current research 

base. In general, imaging is infrequently used to differentiate accurately an IH from other 

vascular lesions. When a diagnosis is in question, a tissue biopsy is the most accurate 

method to determine the diagnosis. Future studies should use imaging modalities at the 

same point in the IH course to allow direct comparison. Studies should also report 

adverse effects of imaging, which are not addressed in the literature meeting criteria for 

this review. 

• Indications for treatment and treatment referral. While it is likely that non-placebocontrolled 

studies reviewed here included mostly children with problematic IH (e.g., 

lesions that are vision-threatening or disfiguring, ulcerated lesions, airway/lifethreatening 

lesions), studies did not always clearly report indications for treatment or 

referral for treatment. Children may be referred for life-, functional-, or visionthreatening 

reasons, but in the beta-blocker era, potential disfigurement is likely a cause 

for referral. 

• Appropriate dosing for propranolol and timing of treatment. The largest RCT to 

date 92 used doses of either 1 mg/kg or 3 mg/kg, but other studies typically used doses of 

2-2.5 mg/kg, and ages of children and number, severity, and type of lesions varied among 

study populations. Existing studies do not provide data to determine optimal dosing. 

Similarly, few studies reported on resolution outcomes by phase (i.e., proliferative, 

involution). Studies likely included mostly children in the proliferative phase, but the 

effectiveness of propranolol during the involution phase is not clear. Similarly, because 

proliferation may occur up to and after 12 months of age, the effectiveness of starting 

beta-blockers in older children is not clear. 

• Optimal duration of beta-blocker use. Duration of propranolol treatment ranged from 3 

to 13 months in comparative studies, but the optimal duration of treatment is not clear. 

Studies generally treated children for 6 months, potentially so that effects observed were 

likely drug-related and not the result of natural involution. However, current studies have 

not addressed the question of optimal timing to achieve maximal benefit. 

• Long-term outcomes and harms of beta-blockers. While harms reported in studies of 

beta-blockers were typically not severe, only one comparative study 144 had greater than 6 

months followup after the end of treatment. Longer term effects on cardiovascular and 

metabolic parameters known to be affected by beta-blocker use as well as effects on 

cognition, memory, and the central nervous system are not well-understood in the 

population of very young children receiving beta-blockers for IH. 263 

• Treatment choice for specific lesion types and locations. Characteristics, such as lesion 

size, location, and persistence, as well as modifiers such as patient age, functional impact, 

and IH subtype influence whether children are treated with pharmacologic agents or 

surgically. Lesion characteristics also influence the choice of specific pharmacologic 

agents. Most studies included multiple lesion types and in multiple locations, and few 

included specific modifier analyses or reported outcomes by lesion characteristics. 

Research to improve understanding of which lesions are likely to respond best to specific 

105

agents is critical, especially as understanding of the effectiveness of beta-blockers in the 

involution phase is limited. Optimal treatment in the proliferative phase may be key to 

maximal resolution of IH. 

• Assessment of methods for assessing rebound growth. A number of studies reported 

regrowth of lesions but typically did not indicate what constituted rebound growth. 

Greater clarity in reporting this outcome would help to clarify our understanding of 

effectiveness. 

• Characteristics that may influence response to beta-blockers. Studies of beta-blockers 

were typically not powered to provide information on subgroups, but a percentage of 

children did not respond or responded minimally to propranolol. In 10 comparative 

studies of beta-blockers reporting these data, 17,93,94,98,103,104,130,144,146,147,150 20 percent of 

children (n=63/314) had a limited or no response to the agent. We lack data to assess 

whether improvement in lesions or promotion of involution is affected by child age or 

number, severity, type, or anatomic location of lesions. Similarly, understanding the 

mechanisms of growth of IH will promote our understanding of response to treatments 

and treatment safety. 

• Use of beta-blockers other than propranolol. Small cohort studies of oral atenolol and 

nadolol and topical or ophthalmic timolol showed positive effects on IH resolution with 

few side effects. Additional RCTs of these agents, with clear reporting of lesion 

parameters and child characteristics, would increase our understanding of their 

effectiveness and comparative effectiveness versus propranolol. 

• Treatments for hepatic IH. Few treatment studies explicitly reported if children had 

hepatic IH. Most studies included children with IH in multiple locations, so children 

could have had hepatic IH as well; however, the applicability of findings to children with 

visceral IH is not clear. 

• Use of steroids and laser treatments in the beta-blocker era. Clinical practice in the 

United States is moving toward use of a beta-blocker as the first-line treatment for IH; 15 

however, a number of recent studies report use of steroids and laser treatments in younger 

children with lesions in the proliferative stage. Given the side effect profile of steroids, 

understanding of whether or when to use such agents in the absence of life-threatening 

lesions or contraindications to beta-blockers is needed. Current literature does not provide 

sufficient data to address these questions. 

• Interventions to follow beta-blockers or corticosteroids if such treatments fail. We 

did not identify any studies that clearly reported data on this question. While most 

children receiving beta-blockers in the studies reviewed here responded to the 

medication, some had no or minimal response. 

• Standardization of scoring tools to assess change in IH. IH outcomes are necessarily 

assessed using subjective measures, and investigators typically reported grading scales 

used to assess change in IH size or appearance. Few studies, however, commented on 

interrater reliability of instruments. Research to improve standardization among tools and 

the development of uniform scoring systems and measurements would improve our 

ability to combine outcomes across studies. 

• Standardization of nomenclature. Data extraction and comparisons in the review were 

limited by inconsistent naming conventions. Agreement and adherence to a standard 

classification of lesions would improve the ability of researchers to focus on individual 

lesion types and determine optimal treatment regimens for specific lesions. 

106

Conclusions 

Corticosteroids demonstrate some effectiveness at reducing IH size/volume, but may be 

associated with clinically important side effects. Propranolol is effective at reducing the size of 

IH, with high strength of evidence for effects on reducing lesion size, and compared with 

placebo, observation, and other treatment methods including steroids in most, but not all, studies. 

In a network meta-analysis, the largest mean estimate of expected clearance was for oral 

propranolol (95%, 95% BCI: 88% to 99%), followed by timolol (62%, 95% BCI: 39% to 83%) 

and triamcinolone (58%, 95% BCI: 22% to 93%). The mean rate was 43 percent for oral steroids 

(95% BCI: 21% to 66%). With fairly wide confidence bounds and limited data in some areas, the 

relative differences among these estimates are of greater importance than the absolute effects. 

The estimates provide a relative ranking of anticipated rates of lesion clearance among treatment 



as patient/family preferences. Evidence pointed to substantial side effects for corticosteroids; 

harms were also noted with beta-blockers, but overall, these were well tolerated in the short term. 

Few studies have assessed potential long-term harms associated with beta-blocker use in infants 

and children. Laser studies generally found PDL more effective than other types of laser, but 

effects remain unclear as studies are heterogeneous and the role of laser vis-a-vis beta-blockers is 

not clearly described in the literature. Data are inadequate to address the role of imaging in 


107

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117

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121

Abbreviations and Acronyms Used in This Report 

AHRQ 

BCI 

CER 

CI 

cm 

CO2 

CT 

CQ 

EPC 

G 

HAS 

HR 

IH 

IQR 

IV 

kg 

KQ 

LUMBAR 

mg 

mL 

Mm 

MRI 

n 

NA 

Nd:YAG 

NR 

NS 

OR 

OSD 

PDL 

PELVIS 

PHACES 

PICOTS 

QoL 

RCT 

SD 

SOE 

TEP 

TSA 


Bayesian Credible Interval 


Confidence Interval 

Centimeters 

Carbon Dioxide 

Computed Tomography 

Contextual Questions 

Evidence-based Practice Center 

Group 

Hemangioma Activity Score 

Hazard Ratio 

Infantile Hemangioma 

Interquartile Range 

Intravenous 

Kilograms 

Key Questions 

Lower-body hemangioma and other cutaneous defects, Urogenital 

anomalies, Ulceration, Myelopathy, Bony deformities, Anorectal 

malformations, Arterial anomalies, and Renal anomalies 

Milligrams 

Milliliters 

Millimeters 

Magnetic Resonance Imaging 

Number 

Not Applicable 

Neodymium Yttrium Aluminum Garnet 

Not Reported 

Not Significant 

Odds ratio 

Occult Spinal Dysraphism 

Pulsed Dye Laser 

Perineal hemangioma, External genitalia malformations, 

Lipomyelomeningocele, Vesicorenal abnormalities, Imperforate anus, and 

Skin tag 

Posterior fossa malformations, Hemangiomas, Arterial anomalies, Cardiac 

defects, Eye abnormalities, Sternal cleft and supraumbilical raphe 

Population, Interventions, Outcomes, Timing, and Setting 

Quality of Life 

Randomized, Controlled Trial 

Standard Deviation 


Technical Expert Panel 

Total Surface Area 

122

US 

VAS 

Ultrasound 

Visual Analog Scale 

123

Appendix A. Search Strategies 

Searches for Contextual Questions 

Table A-1. MEDLINE (PubMed) 

Search Terms 

Search Results 

#1 hemangioma[mh] OR hemangioma, capillary infantile[nm] OR infantile 

33,062 

hemangioma*[tiab] OR infantile haemangioma*[tiab] OR capillary hemangioma*[tiab] 

OR capillary haemangioma*[tiab] OR congenital hemangioma*[tiab] OR congenital 

haemangioma*[tiab] OR IH[tiab] 

#2 infant[mh] OR infant[tiab] OR infants[tiab] OR infantile[tiab] OR child[mh] OR 

2,235,431 

Children[tiab] OR youth[tiab] OR pediatric[tiab] OR neonat*[tiab] 

#3 #1 AND #2 10,049 

#4 #3 AND eng[la] 7,297 

#5 #4 AND (review[pt] OR historical article[pt] OR practice guideline[pt] OR metaanalysis[pt]) 

897 

#6 #5 AND Humans[mh] 892 

#7 #6 AND (Therapeutics[mh] OR therapy[sh] OR Treatment Outcome[mh] OR 

630 

therapy[tiab] OR therapies[tiab] OR therapeutic[tiab] OR therapeutics[tiab] OR 

outcome[tiab] OR outcomes[tiab] OR surgical[tiab] OR surgery[sh] OR surgery[tiab] 

OR Embolization, Therapeutic[mh] OR embolization[tiab] OR embolization[tiab] OR 

cryotherapy[mh] OR cryotherapy[tiab] OR Catheter Ablation[mh] OR radiofrequency 

ablation[tiab ]OR Laser, dye [mh] OR Laser, Gas/therapeutic use[mh] OR Laser 

Therapy[mh] OR “carbon dioxide laser”[tiab] OR “carbon dioxide lasers”[tiab] OR 

CO2 laser[tiab] OR CO2 lasers[tiab] OR “fractionated laser”[tiab] OR “fractionated 

lasers”[tiab] OR argon[tiab] OR Lasers, Solid-State[mh] OR Neodymium YAG[tiab] 

OR YAG[tiab] OR Erbium[tiab] OR Propranolol[mh] OR propranolol[tiab] OR 

Timolol[mh] OR timolol[tiab] OR Imiquimod[NM] OR angiotensin OR Adrenergic 

beta-Antagonists[mh] OR Angiotensin-converting enzyme inhibitors[mh] OR 

Immunosuppressive agents[mh] OR Angiogenesis Inhibitors[mh] OR Bleomycin[mh] 

OR bleomycin[tiab] OR Antineoplastic agents[mh] OR Vincristine[mh] OR 

vincristine[tiab] OR corticosteroids[tiab] OR beta-blockers[tiab] OR beta blockers[tiab] 

OR beta blocker[tiab] OR beta-blockers[tiab] OR angiotensin[tiab] OR intralesional 

interferon[tiab]) 

Key: [mh] medical subject heading; [nm] supplementary concept; [tiab] keyword in title or abstract; [la] language; [pt] 

publication type; [sh] subheading 

Table A-2. CINAHL search strategies (EBSCO Host interface) 

Search Terms 


#1 (MH “Hemangioma”) OR (MH “Hemangioma, Cavernous”) OR “infantile 1,164 

hemangioma” OR “infantile hemangiomas” OR “infantile haemangiomas” OR 

“infantile haemangiomas” OR “IH” 

#2 (MH “ Infant, Newborn, Diseases”) OR (MH “Infant”) OR (MH “Infant, Newborn”) 377,138 

OR (MH “Child”) OR “infant” OR “infants” OR “infantile” OR “newborn” OR 

“child” OR “children” OR “pediatric” or “neonat*” 

#3 S1 AND S2 452 

#4 S3 AND limiters: English language 449 

#5 S4 AND limiters: Exclude MEDLINE records 90 

Key: MH CINAHL medical subject heading; MW CINAHL subheading 

A-1

Table A-3. EMBASE search strategies (OvidSP interface) 

Search Terms 

#1 Capillary hemangioma / or infantile hemangioma.tw. or infantile 

hemangiomas.tw. or infantile haemangioma.tw. or infantile haemangiomas.tw. 

or haemangioma.tw. or hemangiomas.tw. or IH.tw. 

#2 Infant/ or child/ or newborn/ or congenital disorder/ or infant*.tw. or infantile.tw. 

or child.tw. or children.tw. or newborn.tw. or newborns.tw. 


15,518 

2,257,155 

#3 1 AND 2 4658 

#4 Limit 3 to English 3782 

#5 Limit 4 to human 3392 

#6 5 not (editorial.pt. or letter.pt. or note.pt. or short survey.pt. or conference 3155 

paper.pt.) 

#7 Limit 6 to exclude MEDLINE journals 236 

Key: / Emtree heading; .tw. abstract, title and drug trade name; /cn congenital; .fs. subheading; si.fs. side effects 

subheading; th.fs. therapy subheading; su.fs. surgery subheading; co.fs. complications subheading; pt. publication 

type 

A-2

Searches for Comparative Effectiveness Questions 

Table A-4. MEDLINE (PubMed) 

Search Terms 


#1 hemangioma[mh] OR hemangioma, capillary infantile[nm] OR infantile 

hemangioma*[tiab] OR infantile haemangioma*[tiab] OR capillary hemangioma*[tiab] 

OR capillary haemangioma*[tiab] OR congenital hemangioma*[tiab] OR congenital 

haemangioma*[tiab] OR IH[tiab] 

#2 infant[mh] OR infant[tiab] OR infants[tiab] OR infantile[tiab] OR pediatric[tiab] OR 

neonat*[tiab] OR child[mh] OR children[tiab] OR youth[tiab] 

33,062 

2,335,431 

#3 Therapeutics[mh] OR therapy[sh] OR Treatment Outcome[mh] OR therapy[tiab] OR 10,334,120 

therapies[tiab] OR therapeutic[tiab] OR therapeutics[tiab] OR outcome[tiab] OR 

outcomes[tiab] OR surgical[tiab] OR surgery[sh] OR surgery[tiab] OR Embolization, 

Therapeutic[mh] OR embolization[tiab] OR embolization[tiab] OR cryotherapy[mh] 

OR cryotherapy[tiab] OR Catheter Ablation[mh] OR radiofrequency ablation[tiab ]OR 

Laser, dye [mh] OR Laser, Gas/therapeutic use[mh] OR Laser Therapy[mh] OR 

“carbon dioxide laser”[tiab] OR “carbon dioxide lasers”[tiab] OR CO2 laser[tiab] OR 

CO2 lasers[tiab] OR “fractionated laser”[tiab] OR “fractionated lasers”[tiab] OR 

argon[tiab] OR Lasers, Solid-State[mh] OR Neodymium YAG[tiab] OR YAG[tiab] OR 

Erbium[tiab] OR Propranolol[mh] OR propranolol[tiab] OR Timolol[mh] OR 

timolol[tiab] OR Imiquimod[NM] OR Adrenergic beta-Antagonists[mh] OR 

Angiotensin-converting enzyme inhibitors[mh] OR Immunosuppressive agents[mh] 

OR Angiogenesis Inhibitors[mh] OR Bleomycin[mh] OR bleomycin[tiab] OR 

Antineoplastic agents[mh] OR Vincristine[mh] OR vincristine[tiab] OR 

corticosteroids[tiab] OR beta-blockers[tiab] OR beta blockers[tiab] OR beta 

blocker[tiab] OR beta-blockers[tiab] OR angiotensin[tiab] OR intralesional 

interferon[tiab] OR “adverse effects"[Subheading] OR unsafe[tiab] OR safety[tiab] 

OR harm[tiab] OR harms[tiab] OR harmful[tiab] OR complication[tiab] OR 

complications[tiab] OR side-effect[tiab] OR "side-effects"[tiab] OR 

Undesirable effect[tiab] OR undesirable effects[tiab] OR undesirable reaction[tiab] 

OR undesirable reactions[tiab] OR undesirable event[tiab] OR undesirable 

events[tiab] OR undesirable outcome[tiab] OR undesirable outcomes[tiab] OR 

adverse effect[tiab] OR adverse effects[tiab] OR adverse reaction[tiab] OR adverse 

reactions[tiab] OR adverse event[tiab] OR adverse events[tiab] OR adverse 

outcome[tiab] OR adverse outcomes[tiab] OR "Postoperative Complications"[Mesh] 

OR postoperative complication[tiab] OR postoperative complications[tiab] OR post 

operative complication[tiab] OR post operative complications[tiab] OR surgical 

complication[tiab] OR surgical complications[tiab] OR postsurgical complication[tiab] 

OR postsurgical complications[tiab] OR post surgical complication[tiab] OR post 

surgical complications[tiab] OR adverse effects[Subheading] OR 

complications[Subheading] OR contraindications[Subheading] OR bleeding[tiab] OR 

Hemorrhage[mh] OR scarring[tiab] OR scars[tiab] OR residual hemangiomas[tiab] 

OR residual hemangioma[tiab] OR residual haemangioma[tiab] OR residual 

haemangiomas[tiab] OR pain[mh] OR pain[tiab] OR “Skin atrophy”[tiab] OR venous 

prominence[tiab] OR facial injuries[mh] OR skin ulcer[mh] OR ulceration[tiab] OR 

“surgical wound infection”[mh] OR wound infection[mh] OR infection[tiab] 

#4 #1 AND #2 AND #3 7392 

#5 #4 AND eng[la] 5441 

#6 #5 AND Humans[mh] 5203 

#7 #6 AND ("1982/01/01"[Date - Publication] : "3000"[Date - Publication]) 4358 

#8 #7 NOT (editorial[pt] OR letter[pt] OR comment[pt] OR review[pt] OR news[pt] OR 3409 

historical article[pt] OR practice guideline[pt] OR meta-analysis[pt]) 

Key: [mh] medical subject heading; [nm] supplementary concept; [tiab] keyword in title or abstract; [la] language; [pt] 

publication type; [sh] subheading 

A-3

Table A-5. CINAHL search strategies (EBSCO Host interface) 

Search Terms 

#1 (MH “Hemangioma”) OR (MH “Hemangioma, Cavernous”) OR “infantile 

hemangioma” OR “infantile hemangiomas” OR “infantile haemangiomas” OR 

“infantile haemangiomas” OR “IH” 

#2 (MH “ Infant, Newborn, Diseases”) OR (MH “Infant”) OR (MH “Infant, Newborn”) 

OR “infant” OR “infants” OR “infantile” OR “newborn” OR “pediatric” OR 

“neonat*” OR (MH “Child”) OR “child” OR “children” 

#3 S1 AND S2 452 

#4 S3 AND limiters: English language 449 

#5 S4 AND limiters: 1982- 448 

#6 S5 AND limiters: Exclude MEDLINE records 90 

Key: MH CINAHL medical subject heading; MW CINAHL subheading 


1,163 

376,639 

Table A-6. EMBASE search strategies (OvidSP interface) 

Search Terms 


#1 Capillary hemangioma / or infantile hemangioma.tw. or infantile 

15,410 

hemangiomas.tw. or infantile haemangioma.tw. or infantile haemangiomas.tw. 

or haemangioma.tw. or hemangiomas.tw. or IH.tw. 

#2 Infant/ or child/ or newborn/ or congenital disorder/ or infant*.tw. or infantile.tw. 2,316,140 

or child.tw. or children.tw. or newborn.tw. or newborns.tw. or neonat*.tw 

#3 1 AND 2 4,615 

#4 Limit 3 to English 3,756 

#5 Limit 4 to human 3,343 

#6 5 not (review.pt. or editorial.pt. or letter.pt. or note.pt. or short survey.pt. or 2,699 

conference paper.pt. or meta analysis/ or practice guideline/ or systematic 

review/) 

#7 Limit 6 to 1982- 2645 

#8 Limit 7 to exclude MEDLINE journals 207 

Key: / Emtree heading; .tw. abstract, title and drug trade name; /cn congenital; .fs. subheading; si.fs. side effects 

subheading; th.fs. therapy subheading; su.fs. surgery subheading; co.fs. complications subheading; pt. publication 

type 

A-4

Appendix B. Screening and Quality Assessment 

Forms 

Infantile Hemangioma Abstract Review Form 

1. Does this reference include an abstract? 

□ Yes □ No □ Cannot Determine 

2. Does this study include newborns, infants or children (ages 0-18) with diagnosis of 

infantile hemangioma (or suspected hemangioma)? 

(Do not include hemangioblastomas, hemangioendothelioma, cavernous 

hemangiomas/lesions/malformation, non-involuting congenital hemangiomas (NICH), rapid 

involuting congenital hemangiomas (RICH), vascular malformations, choroidal hemangiomas, 

diffuse hemangiomatosis, angiomas, verrucous hemangiomas) 


3. Is this study original research (e.g., not commentaries, literature reviews, or systematic 

reviews, letters to the editor, editorials, case reports)? 


4. Does this study address the effectiveness or harms of a diagnostic modality or surgical, 

laser or pharmacological intervention for infantile hemangioma? 


Diagnostic modality/workup evaluation Including but not limited to: 

Diagnostic imaging including MRI, CT, MRA, Echo, Ultrasound 

Surgical interventions Including but not limited to: cryotherapy, resection, embolization, 

radiofrequency ablation therapy, incisional biopsy 

Laser treatment Including but not limited to: 

Pulsed dye, fractionated, argon, carbon dioxide, neodymium (Nd): YAG, Erbium lasers 

Pharmacologic interventions Including but not limited to: 

Beta-blockers (e.g., systemic propranolol, topical timolol); corticosteroids (topical, intralesional, 

systemic); sirolimus, imiquimod, interferon, bleomycin, vincristine, ACE inhibitors, 

antiangiogenic agents 

5. Does this article address contextual questions including natural history, adverse 

outcomes of untreated infantile hemangioma, characteristics of the hemangioma that 

indicate risk of significant medical complications that would prompt immediate medical or 

surgical intervention, or evidence for the association of multiple cutaneous hemangiomas 

and increased risk of occult hemangiomas? 


Retain for: 

□ Background/Discussion □ Review of References □ Other: ____________________ 

Comments: 

B-1

Infantile Hemangioma Full Text Review Form 

1. Eligible study design: 

□ RCT 

□ Cohort study with comparison group 

□ Case-control 

□ Case series reporting harms and including at least 25 children with IH 

□ Case series with

Harms Risk of Bias Assessment Form 

RefID: __________________ 

Reviewer:____________________ 

Question Yes No Unclear Comments 

1. Are any important harms 

or adverse events that 

may be a consequence 

of the 

intervention/exposure 

missing from the results? 

(RTI cohort) 

2. Were the harms 

predefined using 

standardized or precise 

definitions? (mcharms) 

Pre-defined indicates that the harms 

that were expected are explicitly 

defined prior to the collection of these 

expected events. For example, if 

bleeding is listed as a harmful event, 

the criteria by which they determine 

the bleeding (i.e. body location, type, 

or amount of blood loss that counts 

as an event, etc) should be specified. 

Standardized classification of harms 

can be derived from any of the 

following: 

1) reference to standard terminology 

or classifications of harms from a 

recognized external 

organization(s)(such as government 

regulatory or health agencies. 

Examples of standardized 

terminology for harms includes, 

WHO-ART, MEDra, HTA report on 

the Measurement and Monitoring of 

Surgical Adverse Events) 

2) previously explicitly defined 

classifications of harms in the 

literature, or 

3) based on pre-specified clinical 

criteria, or 

4) pre-specified laboratory test (may 

not need to have a specific cut-off 

level specified in all cases) 

In some instances only 

some of the harms identified 

in a study will be precisely 

defined. In this case, there 

must be some judgement if 

the nature of the harms not 

pre-defined. 

3. Are all pre-specified 

harms reported? (RTI 

case series) 

4. Did the author(s) use 

STANDARD scale(s) or 

checklist(s) for harms 

collection? (mcharms) 

IF #2 is 

NO, this is 

unclear 

B-3

Standard scales or checklists are 

those that have at least one of the 

following: 

-Established reliability and validity 

(specified in the text); 

-Are very widely used within the 

discipline (may have to check the 

reference list for the scale) 

In the instance where the 

methods indicate that a 

NEW scale or checklist was 

developed for the study 

specifically, the author(s) 

must explicitly specify the 

CONTENT of the new scale 

or checklist in sufficient 

detail (for example, the body 

systems evaluated, or the 

specific tests or questions 

included.) 

5. Are the statistical 

methods used to assess 

the main harm or adverse 

event outcomes 

adequate? (RTI cohort) 

Note: This form derived from questions from the RTI Item bank and McHarms tool. 

Good= 4-5 “yes”; Fair=3 “yes” out of 5; Poor=2 “yes” or less 

B-4

QUADAS Diagnostic Accuracy Rating Tool – For Diagnosis studies Form 

1 Was the spectrum of patients representative of 

the patients who will receive the test in 

practice? 

Yes No Unclear Comments 

2 Were selection criteria clearly described? 

3 Is the reference standard likely to correctly 

classify the target condition? 

4 Is the time period between reference standard 

and index test short enough to be reasonably 

sure that the target condition did not change 

between the two tests? 

5 Did the whole sample or a random selection of 

the sample, receive verification using a 

reference standard of diagnosis? 

6 Did patients receive the same reference 

standard regardless of the index test result? 

7 Was the reference standard independent of 

the index test (i.e. the index test did not form 

part of the reference standard)? 

8 Was the execution of the index test described 

in sufficient detail to permit replication of the 

test? 

9 Was the execution of the reference standard 

described in sufficient detail to permit its 

replication? 

10 Were the index test results interpreted without 

knowledge of the results of the reference 

standard? 

11 Were the reference standard results 

interpreted without knowledge of the results of 

the index test? 

12 Were the same clinical data available when 

test results were interpreted as would be 

available when the test is used in practice? 

13 Were uninterpretable/ intermediate test results 

reported? 

14 Were withdrawals from the study explained? 

B-5

Newcastle-Ottawa Quality Assessment Form for Cohort Studies Form 

Note: A study can be given a maximum of one star for each numbered item within the Selection and Outcome 

categories. A maximum of two stars can be given for Comparability. 

REFID:___________________ 

Reviewer:________________ 

Selection 

1) Representativeness of the exposed cohort: 

a) Truly representative (one star) 

b) Somewhat representative (one star) 

c) Selected group 

d) No description of the derivation of the cohort 

2) Selection of the non-exposed cohort 

a) Drawn from the same community as the exposed cohort (one star) 

b) Drawn from a different source 

c) No description of the derivation of the non exposed cohort 

3) Ascertainment of exposure: 

a) Secure record (e.g., surgical record) (one star) 

b) Structured interview (one star) 

c) Written self report 

d) No description 

e) Other 

4) Demonstration that outcome of interest was not present at start of study: 

a) Yes (one star) 

b) No 

Comparability 

5) Comparability of cohorts on the basis of the design or analysis controlled for confounders: 

a) The study controls for age (one star) 

b) Study controls for other factors (list) _________________________________(one star) 

c) Cohorts are not comparable on the basis of the design or analysis controlled for confounders 

Outcome 

6) Assessment of outcome: 

a) Independent blind assessment (one star) 

b) Record linkage (one star) 

c) Self report 

d) No description 

e) Other 

7) Was follow-up long enough for outcomes to occur: 

a) Yes (one star) 

b) No 

Indicate the median duration of follow-up and a brief rationale for the assessment 

above:____________________ 

8) Adequacy of follow-up of cohorts: 

a) Complete follow up- all subject accounted for (one star) 

b) Subjects lost to follow up unlikely to introduce bias- number lost less than or equal to 20% or description of 

those lost suggested no different from those followed. (one star) 

c) Follow up rate greater than 80% and no description of those lost 

d) No statement 

9) Would answers to any of these questions vary based on the specific outcome assessed? If yes, please explain: 

_____________________________________________________________________________________________ 

_____________________________________________________________________________________________ 

B-6

Infantile Hemangioma CER: Risk of Bias for RCTs Form 

Reviewer Initials: _____ Ref ID: __________ 

Risk of 

Bias 

Selection 

bias 

Performa 

nce bias 

Attrition 

bias 

Detection 

bias 

Criterion Yes No Unclear COMMENTS 

Was the allocation sequence generated adequately (e.g., random number table, 

computer-generated randomization)? 

Was the allocation of treatment adequately concealed (e.g., pharmacycontrolled 

randomization or use of sequentially numbered sealed envelopes)? 

Were participants analyzed within the groups they were originally assigned to? 

Does the design or analysis control account for important confounding and 

modifying variables through matching, stratification, multivariable analysis, or 

other approaches? 

Did researchers rule out any impact from a concurrent intervention or an 

unintended exposure that might bias results? 

Did the study maintain fidelity to the intervention protocol? 

If attrition (overall or differential nonresponse, dropout, loss to follow-up, or 

exclusion of participants) was a concern, were missing data handled 

appropriately (e.g., intention-to-treat analysis and imputation)? 

Was the length of follow-up different between the groups? 

Were the outcome assessors blinded to the intervention or exposure status of 

participants? 

Reporting 

bias 

Other 

Were interventions/exposures assessed/defined using clearly defined measures, 

implemented consistently across all study participants? 

Were outcomes assessed using clearly defined measures, implemented 

consistently across all study participants? 

Were the potential outcomes prespecified by the researchers? 

Are all prespecified outcomes reported? 

List outcomes of interest assessed: 

______________________________________________________________ 

Would answers to any of these questions vary by the specific outcome 

assessed? If yes, please explain in Comments box. 

OUTCOMES OF INTEREST FOR REVIEW 

Imaging: Ability to identify presence, number, and extent of hemangiomas and associated structural anomalies (sensitivity and specificity) 

Treatment: Size / volume of hemangioma; Impact on vision; Aesthetic appearance as assessed by clinician or parent; Degree of ulceration; Quality of life 

B-7

Appendix C. Excluded Studies 

Reasons for Exclusion 

X-1 Does not include children with infantile hemangioma 

X-2 Not original research 

X-3 Does not address interventions/outcomes of interest 

X-4 Ineligible study design 

X-5 Not obtainable 

X-6 Not in English 

1. Argenta LC, Bishop E, Cho KJ, et al. Complete 

resolution of life-threatening hemangioma by 

embolization and corticosteroids. Plast Reconstr 

Surg. 1982 Dec;70(6):739-44. PMID: 6890694; 

X-1, X-2 

2. Bardelli AM, Lasorella G. Primary and 

secondary ocular tumors in children. J Neurosurg 

Sci. 1982 Jan-Mar;26(1):11-6. PMID: 6815311; 

X-1 

3. Biller HF, Krespi YP, Som PM. Combined 

therapy for vascular lesions of the head and neck 

with intra-arterial embolization and surgical 

excision. Otolaryngol Head Neck Surg. 1982 

Jan-Feb;90(1):37-47. PMID: 6806755; X-1, X-2 

4. Bloom DA, Scardino PT, Ehrlich RM, et al. The 

significance of lymph nodal involvement in renal 

angiomyolipoma. J Urol. 1982 Dec;128(6):1292- 

5. PMID: 7154190; X-1 

5. Bookstein JJ, Cho KJ, Davis GB, et al. 

Arterioportal communications: observations and 

hypotheses concerning transsinusoidal and 

transvasal types. Radiology. 1982 

Mar;142(3):581-90. PMID: 7063671; X-1 

6. Bradley PJ, Singh SD. Congenital nasal masses: 

diagnosis and management. Clin Otolaryngol 

Allied Sci. 1982 Apr;7(2):87-97. PMID: 

7094387; X-1 

7. Brooks BS, El Gammal T, Beveridge WD. 

Erosion of vertebral pedicles by unusual vascular 

causes. Report of three cases. Neuroradiology. 

1982;23(2):107-12. PMID: 7078720; X-1 

8. Brown BZ, Huffaker G. Local injection of 

steroids for juvenile hemangiomas which disturb 

the visual axis. Ophthalmic Surg. 1982 

Aug;13(8):630-3. PMID: 7133606; X-2 

9. Carruth JA. The argon laser in he treatment of 

vascular naevi. Br J Dermatol. 1982 

Sep;107(3):365-8. PMID: 7115616; X-1 

10. Carruth JA, McKenzie AL. The argon laser in 

dermatology: safety aspects. Clin Exp Dermatol. 

1982 May;7(3):247-53. PMID: 7105476; X-1 

11. de Tribolet N, Kaech D, Perentes E. Cerebellar 

haematoma due to a cavernous angioma in a 

child. Acta Neurochir (Wien). 1982;60(1-2):37- 

43. PMID: 7058698; X-1 

12. Demakas JJ, Sonntag VK, Kaplan AM, et al. 

Surgical management of pineal area tumors in 

early childhood. Surg Neurol. 1982 

Jun;17(6):435-40. PMID: 7112375; X-1 

13. Di Trapani G, Di Rocco C, Abbamondi AL, et 

al. Light microscopy and ultrastructural studies 

of Sturge-Weber disease. Childs Brain. 

1982;9(1):23-36. PMID: 6460599; X-1 

14. Edgerton MT. Vascular hamartomas and 

hemangiomas: classification and treatment. 

South Med J. 1982 Dec;75(12):1541-7. PMID: 

7146992; X-1, X-2 

15. Fabian JT, Rose AG. Tumours of the heart. A 

study of 89 cases. S Afr Med J. 1982 Jan 

16;61(3):71-7. PMID: 6277017; X-1 

16. Felder KS, Brockhurst RJ. Neovascular fundus 

abnormalities in peripheral uveitis. Arch 

Ophthalmol. 1982 May;100(5):750-4. PMID: 

6177305; X-1 

17. Fischer EG, Sotrel A, Welch K. Cerebral 

hemangioma with glial neoplasia 

(angioglioma?). Report of two cases. J 

Neurosurg. 1982 Mar;56(3):430-4. PMID: 

7057243; X-1 

18. Gilchrest BA, Rosen S, Noe JM. Chilling port 

wine stains improves the response to argon laser 

therapy. Plast Reconstr Surg. 1982 

Feb;69(2):278-83. PMID: 7054797; X-1 

19. Gresty MA, Ell JJ, Findley LJ. Acquired 

pendular nystagmus: its characteristics, 

localising value and pathophysiology. J Neurol 

Neurosurg Psychiatry. 1982 May;45(5):431-9. 

PMID: 7086456; X-1 

C-1

20. Grundfest-Broniatowski S, Carey WD, Sivak 

MV, Jr., et al. Klippel-Trenaunay-Weber 

syndrome with visceral involvement and portal 

hypertension. Cleve Clin Q. 1982 

Winter;49(4):239-47. PMID: 6301708; X-1 

21. Hayman LA, Evans RA, Ferrell RE, et al. 

Familial cavernous angiomas: natural history and 

genetic study over a 5-year period. Am J Med 

Genet. 1982 Feb;11(2):147-60. PMID: 6950664; 

X-1 

22. Hurvitz CH, Greenberg SH, Song CH, et al. 

Hemangiomatosis of the pleura with hemorrhage 

and disseminated intravascular coagulation. J 

Pediatr Surg. 1982 Feb;17(1):73-5. PMID: 

7077482; X-1, X-2 

23. Ilbawi M, DeLeon S, Riggs T, et al. Primary 

vascular tumors of the heart in infancy. Report of 

a case with successful surgical management. 

Chest. 1982 Apr;81(4):511-2. PMID: 7067518; 

X-1 

24. Kaibara N, Mitsuyasu M, Katsuki I, et al. 

Generalized enchondromatosis with unusual 

complications of soft tissue calcifications and 

hemangiomas. Follow-up for over a twelve-year 

period. Skeletal Radiol. 1982;8(1):43-6. PMID: 

7079783; X-1 

25. Kalicinski ZH, Joszt W, Perdzynski W, et al. 

Hemangioma of the superior caval vein. J Pediatr 

Surg. 1982 Apr;17(2):178-9. PMID: 7077501; 

X-2 

26. Kobus K, Licznerski A, Stepniewski J, et al. 

The surgical treatment of vascular tumours of the 

face. J Maxillofac Surg. 1982 May;10(2):99-112. 

PMID: 7047664; X-3, X-4 

27. Kushner BJ. Intralesional corticosteroid 

injection for infantile adnexal hemangioma. Am 

J Ophthalmol. 1982 Apr;93(4):496-506. PMID: 

7072814; X-4 

28. Kveton JF, Pillsbury HC. Conservative 

treatment of infantile subglottic hemangioma 

with corticosteroids. Arch Otolaryngol. 1982 

Feb;108(2):117-9. PMID: 7059313; X-2 

29. Ladurner G, Fritsch G, Sager WD, et al. 

Computer tomography in children with stroke. 

Eur Neurol. 1982;21(4):235-41. PMID: 

7117310; X-1 

30. Liberski PP, Alwasiak J, Wegrzyn Z, et al. 

Sturge-Weber syndrome with a unilateral 

developmental anomaly of the cerebral 

hemisphere. Neuropatol Pol. 1982;20(3-4):505- 

10. PMID: 7183945; X-1 

31. McCarthy JC, Goldberg MJ, Zimbler S. 

Orthopaedic dysfunction in the blue rubber-bleb 

nevus syndrome. J Bone Joint Surg Am. 1982 

Feb;64(2):280-3. PMID: 7056783; X-1 

32. Mencke HJ, Zilkens J, Bigalke KH, et al. The 

problem of intramuscular haemangioma. Arch 

Orthop Trauma Surg. 1982;100(4):243-7. PMID: 

7159196; X-1 

33. Moazam F, Talbert JL, Rodgers BM. Primary 

tumors of the liver in infancy and childhood. J 

Fla Med Assoc. 1982 Dec;69(12):991-6. PMID: 

6296270; X-2 

34. Moss LA, Stueber K, Hafiz MA. Congenital 

hemangioendothelioma of the hand--case report. 

J Hand Surg Am. 1982 Jan;7(1):53-6. PMID: 

7061809; X-1 

35. Nguyen L, Shandling B, Ein S, et al. Hepatic 

hemangioma in childhood: medical management 

or surgical management? J Pediatr Surg. 1982 

Oct;17(5):576-9. PMID: 7175647; X-1 

36. Niechajev IA, Karlsson S. Angiomatosis 

osteohypotrophica. Scand J Plast Reconstr Surg. 

1982;16(1):77-85. PMID: 7112039; X-1 

37. Niechajev IA, Karlsson S. Vascular tumours of 

the hand. Scand J Plast Reconstr Surg. 

1982;16(1):67-75. PMID: 7112038; X-1 

38. Norins AL, Treadwell PA. The management of 

persistent pediatric skin problems. Pediatr Clin 

North Am. 1982 Feb;29(1):37-53. PMID: 

6460218; X-1, X-2 

39. Ogawa Y, Inoue K. Electrothrombosis as a 

treatment of cirsoid angioma in the face and 

scalp and varicosis of the leg. Plast Reconstr 

Surg. 1982 Sep;70(3):310-8. PMID: 7111485; 

X-1 

40. Pereyra R, Andrassy RJ, Mahour GH. 

Management of massive hepatic hemangiomas in 

infants and children: a review of 13 cases. 

Pediatrics. 1982 Aug;70(2):254-8. PMID: 

7099792; X-3, X-4 

41. Polus K. Skin haemangioma: treatment by 

cryosurgery. Acta Paediatr Acad Sci Hung. 

1982;23(2):167-70. PMID: 7136598; X-3, X-4 

42. Pretorius HT, Katikineni M, Kinsella TJ, et al. 

Thyroid nodules after high-dose external 

radiotherapy. Fine-needle aspiration cytology in 

diagnosis and management. Jama. 1982 Jun 

18;247(23):3217-20. PMID: 7087060; X-1, X-2 

C-2

43. Price JB, Jr., Schullinger JN, Santulli TV. 

Major hepatic resections for neoplasia in 

children. Arch Surg. 1982 Sep;117(9):1139-41. 

PMID: 6287966; X-1 

44. Ramming KP, Holmes EC, Zarem HA, et al. 

Surgical management and reconstruction of 

extensive chest wall malignancies. Am J Surg. 

1982 Jul;144(1):146-52. PMID: 6953769; X-1 

45. Randall PA. Vascular mass. Preoperative 

occlusion of feeding vessel. N Y State J Med. 

1982 Feb;82(2):189-91. PMID: 6952084; X-1, 

X-2 

46. Ricketts RR, Stryker S, Raffensperger JG. 

Ventral fasciotomy in the management of hepatic 

hemangioendothelioma. J Pediatr Surg. 1982 

Apr;17(2):187-8. PMID: 6210769; X-1 

47. Sadan N, Sade J, Grunebaum M. The treatment 

of subglottic hemangiomas of infants with 

prednisone. Int J Pediatr Otorhinolaryngol. 1982 

Mar;4(1):7-14. PMID: 7095995; X-4 

48. Sanborn GE, Augsburger JJ, Shields JA. 

Treatment of circumscribed choroidal 

hemangiomas. Ophthalmology. 1982 

Dec;89(12):1374-80. PMID: 6891765; X-1 

49. Schneeweiss A, Blieden LC, Shem-Tov A, et al. 

Coarctation of the aorta with congenital 

hemangioma of the face and neck and aneurysm 

or dilatation of a subclavian or innominate 

artery. A new syndrome? Chest. 1982 

Aug;82(2):186-7. PMID: 7047095; X-1 

50. Shannon K, Buchanan GR, Votteler TP. 

Multiple hepatic hemangiomas: failure of 

corticosteroid therapy and successful hepatic 

artery ligation. Am J Dis Child. 1982 

Mar;136(3):275-6. PMID: 7064957; X-2 

51. Starzl TE, Iwatsuki S, Shaw BW, Jr., et al. Left 

hepatic trisegmentectomy. Surg Gynecol Obstet. 

1982 Jul;155(1):21-7. PMID: 6283687; X-1 

52. Verity CM, Strauss EH, Moyes PD, et al. Longterm 

follow-up after cerebral hemispherectomy: 

neurophysiologic, radiologic, and psychological 

findings. Neurology. 1982 Jun;32(6):629-39. 

PMID: 7201093; X-1 

53. Abad JM, Alvarez F, Manrique M, et al. 

Cerebral arteriovenous malformations. 

Comparative results of surgical vs conservative 

treatment in 112 cases. J Neurosurg Sci. 1983 

Jul-Sep;27(3):203-10. PMID: 6663354; X-1 

54. Bart RS, Kopf AW. Tumor conference #50. 

Untreated massive hemangioma with satisfactory 

outcome. J Dermatol Surg Oncol. 1983 

Nov;9(11):875-7. PMID: 6630701; X-2 

55. Becht EW, Rumpelt HJ, Frohneberg D, et al. 

Angioma-like pseudometamorphosis in Wilms' 

tumors subjected to preoperative radio- and 

chemotherapy. Pathol Res Pract. 1983 

Jun;177(1):22-31. PMID: 6312438; X-1 

56. Bendl BJ, Bashir R, Dowling AD. Sturge- 

Weber syndrome. Cutis. 1983 Mar;31(3):286-94. 

PMID: 6839805; X-1 

57. Benjamin B, Carter P. Congenital laryngeal 

hemangioma. Ann Otol Rhinol Laryngol. 1983 

Sep-Oct;92(5 Pt 1):448-55. PMID: 6625442; X- 

2 

58. Bernhard LM, Brant RG, Bakst MJ, et al. 

Hypertrophic hemangioma vs. 

hemangiopericytoma. J Foot Surg. 1983 

Winter;22(4):308-13. PMID: 6643939; X-1 

59. Bouwman DL, Walt AJ. Current status of 

resection for hepatic neoplasms. Semin Liver 

Dis. 1983 Aug;3(3):193-202. PMID: 6623102; 

X-1 

60. Browne AF, Katz S, Miser J, et al. Blue Rubber 

Bleb Nevi as a cause of intussusception. J 

Pediatr Surg. 1983 Feb;18(1):7-9. PMID: 

6834229; X-1 

61. Charboneau JW, Hattery RR, Ernst EC, 3rd, et 

al. Spectrum of sonographic findings in 125 

renal masses other than benign simple cyst. AJR 

Am J Roentgenol. 1983 Jan;140(1):87-94. 

PMID: 6295123; X-1 

62. Chew E, Morin JD. Glaucoma in children. 

Pediatr Clin North Am. 1983 Dec;30(6):1043- 

60. PMID: 6646864; X-1 

63. Corbella F, Arico M, Podesta AF, et al. Infantile 

hepatic hemangioendothelioma treated by 

radiotherapy. Pediatr Radiol. 1983;13(5):297- 

300. PMID: 6622093; X-1 

64. Crow J, Gibbs DA, Cozens W, et al. 

Biochemical and histopathological studies on 

patients with mucopolysaccharidoses, two of 

whom had been treated by fibroblast 

transplantation. J Clin Pathol. 1983 

Apr;36(4):415-30. PMID: 6403596; X-1 

C-3

65. Dachman AH, Lichtenstein JE, Friedman AC, 

et al. Infantile hemangioendothelioma of the 

liver: a radiologic-pathologic-clinical correlation. 

AJR Am J Roentgenol. 1983 Jun;140(6):1091-6. 

PMID: 6602472; X-1 

66. David TJ, Evans DI, Stevens RF. Haemangioma 

with thrombocytopenia (Kasabach-Merritt 

syndrome). Arch Dis Child. 1983 

Dec;58(12):1022-3. PMID: 6660888; X-1 

67. Edmondson HA, Peters RL. Tumors of the 

liver: pathologic features. Semin Roentgenol. 

1983 Apr;18(2):75-83. PMID: 6306841; X-1, X- 

2 

68. Ehren H, Mahour GH, Isaacs H, Jr. Benign liver 

tumors in infancy and childhood. Report of 48 

cases. Am J Surg. 1983 Mar;145(3):325-9. 

PMID: 6837854; X-3, X-4 

69. Esterly NB. Kasabach-Merritt syndrome in 

infants. J Am Acad Dermatol. 1983 

Apr;8(4):504-13. PMID: 6853783; X-1 

70. Ford CN. Serial excision and advancement flaps 

in the management of facial lesions. Otolaryngol 

Head Neck Surg. 1983 Apr;91(2):156-64. PMID: 

6408572; X-1 

71. Gibbs DA, Spellacy E, Tompkins R, et al. A 

clinical trial of fibroblast transplantation for the 

treatment of mucopolysaccharidoses. J Inherit 

Metab Dis. 1983;6(2):62-81. PMID: 6410119; 

X-1 

72. Gonzalez DG, Breur K. Clinical data from 

irradiated growing long bones in children. Int J 

Radiat Oncol Biol Phys. 1983 Jun;9(6):841-6. 

PMID: 6863057; X-1 

73. Gu BK. 10 cases of cavernous hemangioma 

treated with injection of "Xiao Zhi Ling" 

solution. J Tradit Chin Med. 1983 Dec;3(4):289- 

90. PMID: 6325829; X-1 

74. Haik BG, Clancy P, Ellsworth RM, et al. Ocular 

manifestations in diffuse neonatal 

hemangiomatosis. J Pediatr Ophthalmol 

Strabismus. 1983 May-Jun;20(3):101-5. PMID: 

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141. Ikegami N, Nishijima K. Hemangioma of the 

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151. Lyon AJ, Johnson J. Non immune hydrops 

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179. Schmidt RP, Lentle BC. Hemangioma with 

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Interhemispheric approach through the lamina 

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226. McIntosh WA, Lownie JF, Berezowski BM. 

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227. Miller JH, Greenspan BS. Integrated imaging 

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231. Nem-Yun B, Zulkiflee Laidin A. Giant 

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232. Ogata S, Mizoguchi H, Arita M, et al. A case 

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233. O'Sullivan TJ, Healy GB. Complications of 

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256. Yu DT, Sheth KJ. Cystic renal involvement in 

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261. Beran M, Petruson B. Changes in the nasal 

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265. Carruth JA, Shakespeare P. Toward the ideal 

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275. Ehrlich MG, Zaleske DJ. Pediatric orthopedic 

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281. Goldberg NS, Hebert AA, Esterly NB. Sacral 

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292. Maeda M, Yamashiro Y. Diagnostic red blood 

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308. Shikhani AH, Shehadi SI. Surgical treatment 

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309. Shorr N, Seiff SR. Central retinal artery 

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317. Stiller AG, Skafish PR. Placental 

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791. Troughton AH, Paxton RM. Direct puncture 

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794. Vedung S, Atterhem H. Argon laser treatment 

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796. White WL, Mumma JV, Tomasovic JJ. 

Congenital oculomotor nerve palsy, cerebellar 

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797. Wirth T, Rauch G, Ruschoff J, et al. Synovial 

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798. Zide BM, Karp NS. Maximizing gain from 

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Nigerian infant with strawberry naevus. Trop 

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Sturge-Weber syndrome: management of 

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802. Alter GJ, Trengove-Jones G, Horton CE, Jr. 

Hemangioma of penis and scrotum. Urology. 

1993 Aug;42(2):205-8. PMID: 8367930; X-2 

803. Apfelberg DB, Smoller B. Preliminary 

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804. Armstrong AL, Finch RG, Bailie FB. Serious 

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806. Atebara NH, Shields JA. Capillary 

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807. Awad IA, Robinson JR, Jr., Mohanty S, et al. 

Mixed vascular malformations of the brain: 

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808. Baker LL, Dillon WP, Hieshima GB, et al. 

Hemangiomas and vascular malformations of the 

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809. Baronia AK, Pandey CK, Kaushik S. Diffuse 

oral facial cavernous hemangioma causing 

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810. Benedikt RA, Brown DC, Walker R, et al. 

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812. Blei F, Orlow SJ, Geronemus RG. 

Supraumbilical midabdominal raphe, sternal 

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of hemangioma to laser and interferon alfa-2a. 

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813. Bloom PA, Laidlaw A, Easty DL. 

Spontaneous development of retinal ischaemia 

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Use of Ethibloc in the treatment of cystic and 

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816. Burton BK, Schulz CJ, Burd LI. Spectrum of 

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817. Carrington PR, Rowley MJ, Fowler M, et al. 

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818. de Vathaire F, Fragu P, Francois P, et al. 

Long-term effects on the thyroid of irradiation 

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819. Devaney K, Vinh TN, Sweet DE. Synovial 

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820. Diaz-Landaeta L, Kerdel FA. Hyperhidrotic, 

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Intraventricular haemorrhage caused by 

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825. Fiore F, Califano L, Cortese A, et al. 

Hemangiomas of the maxillofacial area. 

Usefulness of 99Tcm-labelled red cell 

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826. Fornage BD, McGavran MH, Duvic M, et al. 

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827. Fox MW, Onofrio BM. The natural history 

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832. Garden JM, Bakus AD. Clinical efficacy of the 

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833. Gelb AB, Van Meter SH, Billingham ME, et 

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835. Goh WH, Lo R. A new 3C syndrome: 

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Treatment of port-wine stains (capillary 

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Successful management of an infant with a giant 

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Kasabach-Merritt syndrome with alphainterferon. 

J Pediatr Surg. 1993 

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838. Henley JD, Danielson CF, Rothenberger SS, et 

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839. Huang JF, Li GS, Chen BX. An improved 

technique for bloodless hepatic resection on in 

situ cold perfused liver. Chin Med J (Engl). 1993 

May;106(5):385-9. PMID: 8404283; X-1 

840. Jabra AA, Taylor GA. MRI evaluation of 

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841. Jackson IT, Carreno R, Potparic Z, et al. 

Hemangiomas, vascular malformations, and 

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methods of treatment. Plast Reconstr Surg. 1993 

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842. Jarrett F. Cavernous hemangioma of the 

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843. Jimenez-Cruz JF, Osca JM. Laser treatment of 

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844. Kawagishi J, Suzuki M, Kayama T, et al. Huge 

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845. Kennedy WA, 2nd, Hensle TW, Giella J, et al. 

Potassium thiophosphate laser treatment of 

genitourinary hemangioma in the pediatric 

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846. Kojima Y, Kuwana N. Progressive diffuse 

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847. Kulkarni ML, Kumar CS, George VG, et al. 

Oral steroids in the treatment of periorbital 

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848. Kumar A, Aggarwal S, Willinsky R, et al. 

Posterior fossa surgery: an unusual cause of 

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849. Kurtz SN, Melamed S, Blumenthal M. 

Cataract and intraocular lens implantation after 

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850. Lee C, Dineen TE, Brack M, et al. The 

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1993 Nov-Dec;14(6):1285-92. PMID: 8279321; 

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851. Levine MR, Kellis A, Lash R. Nasal glioma 

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Ophthal Plast Reconstr Surg. 1993 Jun;9(2):132- 

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852. Lim RY. Nd:YAG laser surgery of venous 

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853. Lindquist C, Guo WY, Karlsson B, et al. 

Radiosurgery for venous angiomas. J Neurosurg. 

1993 Apr;78(4):531-6. PMID: 8110208; X-1 

854. Lupret V, Negovetic L, Smiljanic D, et al. 

Cerebral venous angiomas: surgery as a mode of 

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855. MacArthur CJ, Gliklich R, McGill TJ, et al. 

Sinus complications in mucopolysaccharidosis 

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856. Mantravadi J, Roth LM, Kafrawy AH. 

Vascular neoplasms of the parotid gland. Parotid 

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857. Matsumoto T, Okano R, Sakura N, et al. 

Hypergalactosaemia in a patient with portalhepatic 

venous and hepatic arterio-venous shunts 

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858. Mazzocchi A, Foschini MP, Marconi F, et al. 

Kasabach-Merritt syndrome associated to 

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859. McCarthy RE, Lytle JO, Van Devanter S. The 

use of total circulatory arrest in the surgery of 

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1993 Apr(289):237-42. PMID: 8386070; X-1, 

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860. McDaniel DH. Clinical usefulness of the 

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1993 Apr;19(4):312-9. PMID: 8478470; X-1 

861. Miyagi Y, Mannoji H, Akaboshi K, et al. 

Intraventricular cavernous malformation 

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Neurosurgery. 1993 Mar;32(3):461-4; discussion 

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862. Mizuguchi M, Kano H, Narita M, et al. Weber 

syndrome caused by intracerebral hemorrhage in 

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863. Mordon S, Rotteleur G, Brunetaud JM, et al. 

Rationale for automatic scanners in laser 

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1993;13(1):113-23. PMID: 8426518; X-1 

864. Morelli JG, Huff JC, Weston WL. Treatment 

of congenital telangiectatic vascular 

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Hemangioma of the upper arm associated with 

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1993;23(3):273-6. PMID: 8467182; X-1, X-2 

866. Neumann RA, Leonhartsberger H, Bohler- 

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869. Phillips WG, Marsden JR. Kasabach-Merritt 

syndrome exacerbated by platelet transfusion. J 

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870. Radke M, Waldschmidt J, Stolpe HJ, et al. 

Blue rubber-bleb-nevus syndrome with 

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871. Ramadwar RH, Deshmukh SS, Oak SN, et al. 

Infantile hemangioendothelioma of the liver in a 

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872. Ramon F, Degryse H, De Schepper A. 

Intramuscular haemangioma. J Belge Radiol. 

1993 Dec;76(6):406. PMID: 8163449; X-1 

873. Reese V, Frieden IJ, Paller AS, et al. 

Association of facial hemangiomas with Dandy- 

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J Pediatr. 1993 Mar;122(3):379-84. PMID: 

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874. Renfro L, Geronemus RG. Anatomical 

differences of port-wine stains in response to 

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875. Robinson JR, Jr., Awad IA, Masaryk TJ, et al. 

Pathological heterogeneity of angiographically 

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876. Rogalski R, Hensinger R, Loder R. Vascular 

abnormalities of the extremities: clinical findings 

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877. Rossiter JL, Hendrix RA, Tom LW, et al. 

Intramuscular hemangioma of the head and neck. 


Jan;108(1):18-26. PMID: 8437870; X-2 

878. Ruttum MS, Abrams GW, Harris GJ, et al. 

Bilateral retinal embolization associated with 

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879. Schulman A. Intrahepatic biliary stones: 

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880. Schulman SR, Jones BR, Slotnick N, et al. 

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881. Schwartz MZ, Silver H, Schulman S. 

Maintenance of the placental circulation to 

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882. Seo W, Kishimoto M, Minato T, et al. 

Submandibular hemangioma as the initial 

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J Pediatr Otorhinolaryngol. 1993 Jan;25(1- 

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883. Serna MJ, Vazquez-Doval J, Vanaclocha V, et 

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884. Sexton J, O'Hare D. Simplified treatment of 

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885. Sheehan-Dare RA. Laser treatment of port 

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886. Smith TP, Koci T, Mehringer CM, et al. 

Transarterial embolization of vertebral 

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887. Stenninger E, Schollin J. Diffuse neonatal 

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888. Stoltenberg L, Rootwelt T, Oyasaeter S, et al. 

Hypoxanthine, xanthine, and uric acid 

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889. Taccone A, Tortori Donati P, Marzoli A, et al. 

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890. Takato T, Komuro Y, Yonehara Y. Giant 

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891. Tawfik OW, Moral LA, Richardson WP, et al. 

Multicentric bilateral renal cell carcinomas and a 

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1993 May-Jun;13(3):289-98. PMID: 8516223; 

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892. Taylor MB. Can early therapy make a 

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893. Teillac-Hamel D, De Prost Y, Bodemer C, et 

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894. Telander RL, Ahlquist D, Blaufuss MC. Rectal 

mucosectomy: a definitive approach to extensive 

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896. Tiacci C, D'Alessandro P, Cantisani TA, et al. 

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897. Tsao CY, Sommer A, Hamoudi AB. Aicardi 

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898. Velez A, Herrera M, Del Rio E, et al. 

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Management of children on interferon therapy. 

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900. Walton JM, Rubin SZ, Soucy P, et al. Fetal 

tumors associated with hydrops: the role of the 

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3044. Annamalai A, Puri V, Mehta S. Radium 

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3050. Barros A, Freitas AC, Cabral AJ, et al. Giant 

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Randomized crossover trial of kangaroo care to 

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3090. El-Badrawy A, Elzaafarany M, Youssef TF, 

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3977. Vivas-Colmenares GV, Bernabeu-Wittel J, 

Alonso-Arroyo V, et al. Effectiveness of 

Propranolol in the Treatment of Infantile 

Hemangioma Beyond the Proliferation Phase. 

Pediatr Dermatol. 2015 Feb 26PMID: 25721095; 

X-4 

3978. Wang G, Zhong J, Li J, et al. Computer-aided 

three-dimensional reconstruction of main vessels 

in hemangiomas. International Journal of 

Clinical and Experimental Medicine. 2015 28 

Feb;8(2):1747-54. PMID: X-1 

3979. Wygnanski-Jaffe T, Spierer A, Melamed S, et 

al. The effect of oral propranolol on intraocular 

pressure in infants with Sturge-Weber syndrome 

glaucoma. Eur J Ophthalmol. 2015 Mar- 

Apr;25(2):134-6. PMID: 25044138; X-1 

C-188

Appendix D. Methods for Network Meta-Analysis 

Using data extracted by the systematic review, we conducted a multi-intervention (network) 

meta-analysis to estimate the effectiveness of several corticosteroids and beta-blockers for the 

treatment of infantile hemangioma. Of particular interest was the estimation of the efficacy of 

propranolol, a beta-blocker that was used in a large number of studies in the review. To this end, 

we estimated the expected clearance of IH following intervention based on outcomes from 17 

unique studies obtained from the systematic review. This set included outcomes for 4 different 

non-control pharmacologic interventions: propranolol, timolol, triamcinolone, and oral steroids. 

A challenge for meta-analyzing these outcomes is the diversity in outcome reporting among 

the constituent studies. Though most used some measure of the reduction in the original IH at 

end of treatment, typically results were reported as counts of subjects achieving some arbitrary 

minimum clearance threshold, such as 50% or 75%. An approach to analyzing outcomes 

reported in this way is via a binomial model. For this model, the response variable is the number 

of individuals in study j under intervention k that achieve the clearance threshold: 

nn jjjj 

yy jjjj = II ii (aaaaaaaaaa cccccccccccccccccc tthrrrrrrhoooooo) 

ii=1 

where I is the indicator function, returning 1 if the argument is true, or 0 otherwise. This outcome 

can then modeled as a binomial response: 

yy jjjj ~ BBBBBB(nn jjjj , ππ jjjj ) 

where ππ jjjj is the probability of a positive response for study j under intervention k. To allow for 

heterogeneity in this probability across studies, we can specify it as a random effect: 

llllllllllππ jjjj = θθ jjjj 

θθ jjjj ~NNNNNNNNNNll(μμ kk , σσ kk ) 

where μμ kk , σσ kk are the parameters of a normal distribution (which, inverse logit-transformed, 

models quantities on the [0,1] interval). 

However, the use of an arbitrary cutoff value as a threshold of success is an unsatisfactory 

modeling choice because there is an inherent loss of information in the dichotomization or 

discretization of continuous variables, and this loss is magnified here by having to discard data 

from studies that use a different response threshold than the adopted value (e.g. 75%). Since the 

clearance rate is a continuous measure, one can hypothesize a latent, continuous probability 

distribution that each study reports relative to specific quantiles: 50%, 75%, etc. If there is 

sufficient information, one may use a Bayesian approach to attempt to reconstruct this latent 

distribution, which would allow for more of the available information to be used in the metaanalytic 

procedure. 

Under treatment k, one can consider a notional distribution of hemangioma clearance rates, 

from no effect (0) to complete clearance (1)—for our purposes, we will not consider IH 

enlargement, other than assigning it a “no effect” outcome. As a matter of convenience in a 

particular study j, researchers chose a clearance threshold cj, only reporting whether a particular 

subject occupied one side or the other of this threshold. We can characterize the true, latent 

response distribution by estimating the parameters via the following identity: 

ππ jjjj = 1 − ΦΦ(cc jj |μμ kk , σσ kk ) 

D-1

where ΦΦ(xx) is the cumulative distribution function of the normal distribution (our latent 

ditribution) under parameters evaluated at x. The resulting probability is the same as specified 

above, and can be used in the same binomial likelihood: 

yy jjjj ~ BBBBBB(nn jjjj , ππ jjjj ) 

This can be readily generalized to studies that report multiple thresholds, simply by dividing the 

distribution of ππ jjjj into regions corresponding to each threshold. This corresponds to a 

multinomial, rather than binomial, likelihood. 

In principle, one may incorporate covariates to improve the prediction of intervention 

effectiveness. For example, the mode of delivery (oral, intralesional, topical), dose, or the 

hemangioma location may be predictive of intervention effectiveness. In this work, only 

propanolol had a sufficient number of studies to estimate covariate effects; we included an 

indicator variable for intralesional mode of delivery, relative to the oral mode that was used as a 

baseline. The logit-expected value of treatment k from study j was modeled as: 

θθ jjjj = μμ + ββ kk + ψψzz jj + εε jj 

where μμ is the baseline (control) clearance rate, ββ kk is the relative effect of treatment k, zj is an 

indicator for the use of intralesional propranolol, and ψψ the associated relative intralesional 

effect. Finally, εε jj is a study random effect that is assigned to all treatment arms of study j, which 

accounts for the lack of independence within-study. This random effect was assumed to be 

normally distributed with zero mean and variance σσ 2 that was estimated from the data. 

A handful of studies, rather than reporting threshold counts, reported summary statistics of 

VAS scores for each study arm. Using the latent variable framework described above under a 

Bayesian estimation approach, this information can also be brought to bear on the estimation of 

the model parameters. This required the transformation of the reported outcomes from the VAS 

scale (0-100) to values on the real line (i.e. a logit transformation), including the reported 

standard deviation, which was transformed using the delta method. The resulting transformed 

values can then be used to inform the expected outcome for the corresponding intervention via a 

normal likelihood: 

llllllllllVVVVSS jjjj ∼ NN(θθ kk , ss jjjj δδ ) 

where ss jj δδ is the transformed standard deviation for the outcome. 

Finally, one study (Qiu 2013) reported individual patient data in the form of VAS scores. 

This data was integrated into the study via the same method as for the summarized VAS score 

output outlined above, except that the delta transformation was not necessary, since the data were 

used directly. 

This model was implemented in the PyMC package for Bayesian analysis in Python (Patil et 

al. 2010). Parameter estimates were obtained using Markov chain Monte Carlo (MCMC, Brooks 

et al. 2011) methods. Sampling was carried out for 100,000 iterations, with the first 90,000 

conservatively discarded as burn-in to ensure convergence of the sampler. In order to evaluate 

convergence using the Gelman-Rubin diagnostic (Gelman and Rubin 1992), a second chain was 

sampled of identical size. The complete analysis is available is an open-access GitHub repository 

(https://github.com/fonnesbeck/IH_meta-analysis), including an IPython Notebook containing 

the model described above (https://github.com/fonnesbeck/IH_metaanalysis/blob/master/Infantile%20Hemangioma%20Meta-analysis.ipynb). 

D-2

Model Results 

The expected efficacy of control arms was estimated to be 0.06 (95% Bayesian credible 

interval = [0.01, 0.11]). All non-control treatments were estimated to have a larger expected 

clearance than control (Figure D-1). The largest mean estimate was oral propranolol (0.95, 95% 

BCI = [0.88, 0.99]), followed by timolol (0.62, 95% BCI = [0.39, 0.83]) and triamcinolone (0.58, 

95% BCI = [0.22, 0.93]). Oral steroids had a mean clearance estimate of 0.43(95% BCI = [0.21, 

0.66]). 

We calculated the probability that each of the non-control interventions is the best treatment, 

based on expected clearance rate. This was estimated from the MCMC simulation that tallied the 

number of iterations that each intervention had the highest expected value, and calculating the 

proportion for each intervention as an estimate of the probability of being best. Oral propranolol 

had the highest probability (99%), followed by triamcinolone (1%); all others had probabilities 

less than 1% combined. To better account for the uncertainty in the estimated treatment effects, 

we also calculated the surface under the cumulative ranking curve (SUCRA) for each treatment, 

which provides a probabilistic summary of the rankings of the treatments (Figure D-3). Oral 

propranolol had the highest SUCRA score (0.902), intralesional propanolol the lowest (0.119), 

with the other treatments intermediate. 

Propanolol was estimated to have the largest variability in clearance rate (Figure D-2, σ=2.5, 

95% BCI = [2.1, 2.9]) with timolol (σ=1.5, 95% BCI: 1.4 to 1.6), intralesional triamcinolone 

(σ=1.8, 95% BCI: 1.3 to 2.3), and oral steroids (σ=1.3, 95% BCI: 1.1 to 1.6) yielding similar, 

lower estimates. With the exception of Timolol, interventions with larger effect sizes tended to 

have larger effect size variance. 

Table D-1. Posterior estimates of effect size 

Mean SE 95% Credible interval 

Oral propranolol 6.0 0.7 [4.6 7.5] 

Timolol 3.5 0.5 [2.4 4.6] 

Triamcinolone 3.3 0.8 [1.7 4.9] 

Oral steroid 2.6 0.5 [1.8 3.6] 

Note: Posterior estimates of effect size, on logit scale, relative to control, along with standard error and 95% credible interval. 

Positive values indicate increased clearance relative to control, negative indicate decreased clearance. 

D-3

Figure D-1. Estimates of expected IH clearance 

Note: Estimates of expected IH clearance (expressed as percent clearance relative to initial condition) for each treatment, along 


D-4

Figure D-2. Estimates of the variation of each treatment 

Note: Estimates of the variation of each treatment, expressed as standard deviation, along with associated posterior interquartile 

range (thick lines) and 95% credible interval (thin lines). 

D-5

Figure D-3. Posterior SUCRA estimates for each treatment 

To give an overview of the expected distribution of clearance rates across treatments, Figure 

D-4 plots estimated probability distribution functions based on the posterior clearance rates and 

standard deviations of four treatments. For each of 100 iterations, a sample was drawn from the 

posterior distributions of both the mean and standard deviation for oral propranolol, timolol, 

triamcinolone, and oral steroid. Inverse-logit transforming the normal probability distribution 

function resulted in plots that integrate the residual uncertainty of the parameters with the 

sampling variability of the model. 

D-6

Figure D-4. 100 posterior samples of distribution of clearance rates under oral propranolol, 

timolol, triamcinolone, and oral steroid 

The network diagram in Figure D-5 illustrates the relative numbers of direct comparisons 

between intervention types. The largest number (thickest line) is four comparisons. 

D-7

Figure D-5. Network diagram of comparisons 

D-8

References 

1. Patil A, Huard D, Fonnesbeck CJ. PyMC: Bayesian Stochastic Modelling in Python. J Stat Softw. 2010;35(4):1- 

81. 

2. Brooks S, Gelman A, Jones G, Meng X-L. Handbook of Markov Chain Monte Carlo. CRC Press; 2011. 

3. Gelman A, Rubin DB. Inference from iterative simulation using multiple sequences. Statist Sci. 1992:457-472. 

4. Salanti G, Ades AE, Ioannidis JPA. Graphical methods and numerical summaries for presenting results from 

multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011;64(2):163-171. 

doi:10.1016/j.jclinepi.2010.03.016. 

D-9

Appendix E. Study Design Classification Algorithm 

Figure E-1. Study design algorithm 

E-1

Appendix F. Quality/Risk of Bias Ratings 

Table F-1. Quality assessment of randomized controlled trials 

Author, Year 

Leaute- 

Labreze 2015 1 

Allocation Sequence 

Generated Adequately 

Allocation Treatment 

Adequately Concealed 

Participants Analyzed In 

Groups Originally 

Assigned 

Design Account for 

Confounding 

Rule Out Impact from 

Concurrent Intervention 

or Unintended Exposure 

Fidelity Maintained to 

Intervention Protocol 

If Attrition, Were 

Missing Data Handled 

Appropriately 

Difference in Length of 

Follow-up Between 

Groups 

Outcome Assessors 

Blinded 

Interventions/ 

Exposures Assessed 

Clearly 

Outcomes Assessed 

Clearly 

Potential Outcomes 

Prespecified 

All Prespecified 

Outcomes Reported 

Risk of Bias 

Rating for 

Outcome 

Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Good 

Tawfik 2015 2 Unclear Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Fair 

Abarzua-Araya 

2014 3 

Unclear Unclear Yes No No Unclear Yes No Yes Yes Yes Yes Yes Fair 

Bauman 2014 4 Yes Yes Yes Yes Yes Yes Unclear No Yes Yes Yes Yes Yes Good 

Chan 2013 5 Yes Yes Yes Yes Unclear Yes Yes No Yes Yes Yes Yes Yes Good 

Kessels 2013 6 Yes Yes Yes Yes Yes Yes Yes No Yes Yes No Yes Yes Good 

Leaute- 

Labreze 2013 7 

Yes Unclear Yes No Unclear Yes Yes No Yes Yes Yes Yes Yes Fair 

Malik 2013 8 Yes Unclear Yes No Yes Yes Unclear No Yes Yes Yes Yes Yes Fair 

Zaher 2013 9 Unclear Unclear yes No Yes Yes Yes Unclear Unclear Yes Yes Yes Yes Fair 

F-1

Author, Year 

Hogeling 

2011 10 

Allocation Sequence 

Generated Adequately 

Allocation Treatment 

Adequately Concealed 

Participants Analyzed In 

Groups Originally 

Assigned 

Design Account for 

Confounding 

Rule Out Impact from 

Concurrent Intervention 

or Unintended Exposure 

Fidelity Maintained to 

Intervention Protocol 

If Attrition, Were 

Missing Data Handled 

Appropriately 

Difference in Length of 

Follow-up Between 

Groups 

Outcome Assessors 

Blinded 

Interventions/ 

Exposures Assessed 

Clearly 

Outcomes Assessed 

Clearly 

Potential Outcomes 

Prespecified 

All Prespecified 

Outcomes Reported 

Risk of Bias 

Rating for 

Outcome 

Yes Yes Yes Yes No Yes Yes No Yes Yes Unclear Yes Yes Good 

Pandey 2010 11 Unclear Unclear Yes Yes Unclear Unclear Yes No Unclear Yes Yes Yes Yes Fair 

Pope 2007 12 Yes Yes Yes Yes Unclear No Yes No Yes Yes Yes Yes Yes Good 

Jalil 2006 13 Unclear No Yes Unclear Unclear Unclear Yes No Unclear Yes Yes Yes Yes Poor 

Kono 2006 14 Unclear Unclear Yes Yes Yes Unclear Yes No Yes Yes No Yes Yes Fair 

Batta 2002 15 Yes Yes Yes Yes Unclear No Yes No No Yes Yes Yes Yes Fair 

F-2

Table F-2. Quality assessment of cohort studies 

Author, Year 

Representativeness 


exposed cohort 

Selection of 

non-exposed 

cohort 

Goelz 2014 16 Selected group Drawn from 

same 

community 

Hoornweg 

2014 17 

Park 2014 18 

Perkins 

2014 19 

Ryzhevskiy 

2014 20 

de Graaf 

2013 21-23 

Pope 2013 24 

Qiu 2013 25 

Reddy 2013 26 

Sondhi 

2013 27 

Truly 

representative 

Somewhat 


Truly 


Truly 


Somewhat 


Truly 


Truly 


Somewhat 


Truly 


Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Ascertainment 

of exposure 

Outcome of 

interest not 

present at 

start of 

study 

Comparability 

of cohorts 

No description Yes Cohorts not 

comparable 

Assessment 

of outcome 

No 

description 

Secure record Yes Controls for age Record 

linkage 

Secure record Yes Cohorts not 

comparable 

Record 

linkage 


linkage 


comparable 

No 

description 

Secure record Yes Controls for age Independent 

blind 

assessment 

Secure record Yes Controls for 

other factors 


other factors 


other factors 


comparable 

Independent 

blind 

assessment 

Record 

linkage 

Independent 

blind 

assessment 

Independent 

blind 

assessment 

Followup 

long 

enough 

Yes 

Yes 

Yes 

Yes 

Yes 

Yes 

Adequacy of 

follow-up of 

cohorts 

Complete 

follow-up 

Follow up 

rate less than 

80% and no 

description of 

those lost 

Complete 

follow-up 

Complete 

follow-up 

Complete 

follow-up 

Complete 

follow-up 

Quality 

Rating 

Poor 

Fair 

Poor 

Fair 

Poor 

Good 

No No statement Poor 

Yes 

Yes 

Yes 

Complete 

follow-up 

Complete 

follow-up 

Subjects lost 

to follow up 

unlikely to 

introduce 

bias 

Fair 

Fair 

Fair 

F-3

Author, Year 





non-exposed 

cohort 

Ascertainment 



interest not 

present at 


study 

Comparability 


Assessment 


Followup 

long 

enough 



cohorts 

Quality 

Rating 

Yu 2013 28 

Truly 


Drawn from 

same 

community 

No description Yes Controls for age No 

description 

Yes 

Complete 

follow-up 

Poor 

Chambers 

2012 29 

Somewhat 


Drawn from 

same 

community 


blind 

assessment 

Yes 

Complete 

follow-up 

Fair 

Pope 2012 24 

Truly 


Drawn from 

same 

community 


other factors 

Independent 

blind 

assessment 

No No statement Poor 

Rossler 

201230, 31 

Tay 2012 32 

Thayal 2012 33 

No description of 

the derivation of 

cohort 

Truly 


Somewhat 


No description 

of derivation of 

non-exposed 

cohort 

Drawn from 

same 

community 

No description 

of derivation of 

non-exposed 

cohort 


comparable 

Record 

linkage 


linkage 


comparable 

Record 

linkage 

No 

Yes 

Yes 

Complete 

follow-up 

Complete 

follow-up 

Subjects lost 

to follow up 

unlikely to 

introduce 

bias 

Poor 

Fair 

Poor 

Awadein 

2011 34 

Truly 


Drawn from 

same 

community 

Structured 

interview 

Yes Controls for age Independent 

blind 

assessment 

No 

Complete 

follow-up 

Fair 

Bertrand 

2011 35 

Truly 


Drawn from 

same 

community 


blind 

assessment 

Yes 

Complete 

follow-up 

Fair 

Hermans 

2011 36 

Truly 


Drawn from 

same 

community 


other factors 

Record 

linkage 

Yes 

Complete 

follow-up 

Fair 

Price 2011 37 

Somewhat 


Drawn from 

same 

community 


other factors 

Record 

linkage 

Yes 

Complete 

follow-up 

Fair 

F-4

Author, Year 





non-exposed 

cohort 

Ascertainment 



interest not 

present at 


study 

Comparability 


Assessment 


Followup 

long 

enough 



cohorts 

Quality 

Rating 

Nicolai 2005 38 

Vlachakis 

2004 39 

Akyuz 2001 40 

Chang 2001 41 

Raulin 2001 42 

Truly 


Truly 


Truly 




cohort 



cohort 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 

Drawn from 

same 

community 


comparable 


comparable 

Self report Yes Subjects lost 

to follow up 

unlikely to 

introduce 

bias 

Record 

linkage 


linkage 


comparable 


comparable 

Independent 

blind 

assessment 

Record 

linkage 

Yes 

Yes 

Yes 

Yes 

Complete 

follow-up 

Complete 

follow-up 

Complete 

follow-up 

Subjects lost 

to follow up 

unlikely to 

introduce 

bias 

Poor 

Fair 

Fair 

Poor 

Poor 

Achauer 

1997 43 

Truly 


Drawn from 

same 

community 


comparable 

Record 

linkage 

No 

Complete 

follow-up 

Poor 

Achauer 

1989 44 

Selected group 

Drawn from 

same 

community 


comparable 

Record 

linkage 

Yes 

Subjects lost 

to follow up 

unlikely to 

introduce 

bias 

Poor 

Table F-3. Quality assessment of studies reporting harms 

F-5

Author, Year 

Were the harms 



definitions? 

Were all pre-specified 

harms reported? 

Did the author(s) use 



collection? 

Were the statistical 




adequate? 

Rating 

Chen 2015 45 

Chen 2015 46 

Leaute-Labreze 2015 1 

Raphael 2015 47 

Tawfik 2015 2 

Xu 2015 48 

Abarzua-Araya 2014 3 

Andersen 2014 49 

Bauman 2014 4 

Chai 2014 50 

Chen 2014 51 

Chu 2014 52 

Couto 2014 53 

El Ezzi 2014 54 

Partial Unclear Partial Yes Poor 

No Unclear Unclear Yes Poor 

Yes Yes Yes Yes Good 



Partial Unclear Partial No Poor 


Unclear Unclear Unclear Yes Poor 



Yes Yes Unclear Yes Fair 


No Unclear No No Poor 


F-6

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Giachetti 2014 55 

Goelz 2014 16 

Hassan 2014 56 

Hoornweg 2014 17 

Jian 2014 57 

Kaune 2014 58 

Ke 2014 59 

Kwon 2014 60 

Lynch 2014 61 

Martinez Roca 2014 62 

May 2014 63 

Muzaffar 2014 64 

Park 2014 18 

Park 2014 65 


No Unclear No Yes Poor 


Partial Unclear Unclear Yes Poor 

Partial Unclear No Yes Poor 

Yes Unclear Unclear Yes Poor 

No Unclear Unclear No Poor 


Partial Unclear Unclear No Poor 






F-7

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Sagi 2014 66 

Schneider 2014 67 

Schneider 2014 68 

Solman 2014 69 

Su 2014 70 

Szychta 2014 71 

Bonifazi 2013 72 

Chan 2013 5 

de Graaf 2013 21-23 

Gan 2013 73 

Hermans 2013 74 

Hong 2013 75 

Kessels 2013 6 

Leaute-Labreze 2013 7 















F-8

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Liu 2013 76 

Ma 2013 77 

Malik 2013 8 

Puttgen 2013 78 

Qiu 2013 25 

Reddy 2013 26 

Sadykov 201379, 80 

Semkova 2013 81 

Sondhi 2013 27 

Vercellino 2013 82 

Xiao 2013 83 

Yu 2013 28 

Yuan 2013 84 

Zaher 2013 9 















F-9

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Balma-Mena 2012 85 

Bertrand 2012 86 

Celik 2012 87 




Chakkittakandiyil 

2012 88 No Unclear Unclear Yes Poor 

Chambers 2012 29 

Georgountzou 2012 89 

Janmohamed 2012 90 

Kunzi-Rapp 2012 91 

Lv 2012 92 

Phillips 2012 93 

Pope 2012 24 

Samimi 2012 94 

Talaat 2012 95 

Tay 2012 32 











F-10

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Thayal 2012 33 

Wang 2012 96 

Xu 2012 97 

Zegpi-Trueba 2012 98 

Awadein 2011 34 

Bertrand 2011 35 

Blatt 2011 99 

Chang 2011 100 

Cushing 2011 101 

Daramola 2011 102 

Di Maio 2011 103 

Fuchsmann 2011 104 

Greene 2011 105 

Hermans 2011 36 

Partial Unclear Partial Unclear Poor 








Yes Yes Yes Unclear Fair 


Yes Yes Yes No Fair 




F-11

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Hogeling 2011 10 

Holmes 2011 106 

Kulbersh 2011 107 

Li 2011 108 

Price 2011 37 

Rossler 201130, 31 

Saint-Jean 2011 109 

Schiestl 2011 110 

Schupp 2011 111 

Snir 2011 112 

Zaher 2011 113 

Zvulunov 2011 114 

Arneja 2010 115 

Hamou 2010 116 















F-12

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Li 2010 117 

Manunza 2010 118 

Pandey 2010 11 

Chen 2009 119 

Pandey 2009 120 

Rizzo 2009 121 

Saleh 2009 122 

Sans 2009 123 

Wu 2009 124 










Chantharatanapiboon 

2008 125 No Unclear Unclear Yes Poor 

Chen 2008 126 

Claude 2008 127 

Baraldini 2007 128 

Pope 2007 12 





F-13

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Jalil 2006 13 

Kono 2006 14 

Garzon 2005 129 

McHeik 2005 130 

Nicolai 2005 38 

Waldschmidt 2005 131 

Vlachakis 2004 39 

David 2003 132 

Vlachakis 2003 133 

Batta 2002 15 

Akyuz 2001 40 

Chang 2001 41 

Demiri 2001 134 

Hohenleutner 2001 135 







No Unclear Unclear Unclear Poor 







Unclear Unclear Unclear No Poor 

F-14

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Raulin 2001 42 

Chen 2000 136 

Poetke 2000 137 

Blei 1999 138 

Boon 1999 139 

Zide 1997 140 

Gangopadhyay 1996 141 

Sadan 1996 142 

Chowdri 1994 143 

Morelli 1994 144 

Preeyanont 1994 145 

Morrell 1991 146 

Kushner 1990 147 

Achauer 1989 44 















F-15

Author, Year 




definitions? 






collection? 





adequate? 

Rating 

Sloan 1989 148 

Kushner 1985 149 

Healy 1984 150 

Sharma 1983 151 





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F-16

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132. David LR, Malek MM, Argenta LC. Efficacy of pulse dye laser therapy for the treatment of ulcerated haemangiomas: a review of 78 patients. Br J Plast 

Surg 2003 Jun;56(4):317-27. PMID: 12873458. 

133. Vlachakis I, Gardikis S, Michailoudi E, et al. Treatment of hemangiomas in children using a Nd:YAG laser in conjunction with ice cooling of the epidermis: 

techniques and results. BMC Pediatr 2003 Apr 12;3:2. PMID: 12697072. 

134. Demiri EC, Pelissier P, Genin-Etcheberry T, et al. Treatment of facial haemangiomas: the present status of surgery. Br J Plast Surg 2001 Dec;54(8):665-74. 

PMID: 11728108. 

135. Hohenleutner S, Badur-Ganter E, Landthaler M, et al. Long-term results in the treatment of childhood hemangioma with the flashlamp-pumped pulsed dye 

laser: an evaluation of 617 cases. Lasers Surg Med 2001;28(3):273-7. PMID: 11295764. 

136. Chen MT, Yeong EK, Horng SY. Intralesional corticosteroid therapy in proliferating head and neck hemangiomas: a review of 155 cases. J Pediatr Surg 

2000 Mar;35(3):420-3. PMID: 10726680. 

F-24

137. Poetke M, Philipp C, Berlien HP. Flashlamp-pumped pulsed dye laser for hemangiomas in infancy: treatment of superficial vs mixed hemangiomas. Arch 

Dermatol 2000 May;136(5):628-32. PMID: 10815856. 

138. Blei F, & Chianese, J. Corticosteroid toxicity in infants treated for endangering hemangiomas: experience and guidelines for monitoring. International 

Pediatrics 1999;14:146-53. 

139. Boon LM, MacDonald DM, Mulliken JB. Complications of systemic corticosteroid therapy for problematic hemangioma. Plast Reconstr Surg 1999 

Nov;104(6):1616-23. PMID: 10541160. 

140. Zide BM, Glat PM, Stile FL, et al. Vascular lip enlargement: Part I. Hemangiomas--tenets of therapy. Plast Reconstr Surg 1997 Dec;100(7):1664-73. PMID: 

9393462. 

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. 

142. Sadan N, Wolach B. Treatment of hemangiomas of infants with high doses of prednisone. J Pediatr 1996 Jan;128(1):141-6. PMID: 8551406. 

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. 

PMID: 7944196. 

144. Morelli JG, Tan OT, Yohn JJ, et al. Treatment of ulcerated hemangiomas infancy. Arch Pediatr Adolesc Med 1994 Oct;148(10):1104-5. PMID: 7921107. 

145. Preeyanont P, Nimsakul N. The Nd:YAG laser treatment of hemangioma. J Clin Laser Med Surg 1994 Aug;12(4):225-9. PMID: 10147482. 

146. Morrell AJ, Willshaw HE. Normalisation of refractive error after steroid injection for adnexal haemangiomas. Br J Ophthalmol 1991 May;75(5):301-5. 

PMID: 2036349. 

147. Kushner BJ. Infantile orbital hemangiomas. International Pediatrics 1990;5(3):249-57. 

148. Sloan GM, Reinisch JF, Nichter LS, et al. Intralesional corticosteroid therapy for infantile hemangiomas. Plast Reconstr Surg 1989 Mar;83(3):459-67. 

PMID: 2919200. 

149. Kushner BJ. The treatment of periorbital infantile hemangioma with intralesional corticosteroid. Plast Reconstr Surg 1985 Oct;76(4):517-26. PMID: 

4034770. 

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. 

PMID: 6431866. 

151. Sharma LK, Dalal SS. Corticosteroid therapy in the treatment of cutaneous hemangioma of infancy and childhood. Indian J Pediatr 1983 Mar- 

Apr;50(403):153-6. PMID: 6618575. 

F-25

Appendix G. Applicability Tables 

Table G-1. Applicability of studies assessing imaging modalities 

Domain Description of applicability of evidence 

Population 

Intervention 

Comparator 

s 

Outcomes 

Setting 

Infants with hemangiomas (with mean ages of 30 days and 34 weeks). Fair distribution of male 

and female patients. 

Radiologic evaluation of hepatic hemangioma to determine which lesions required intervention and 

radiologic evaluation of lumbosacral cutaneous hemangiomas to evaluate which were associated 

with occult spinal dysraphism 

Comparators included ultrasound, magnetic resonance imaging, computed tomography and 

angiography. If different modalities were utilized on the same patient, it was sometimes not at the 

same time point making comparison between methods difficult. 

Studies assessed imaging and clinical findings and with need for intervention for hepatic 

hemangiomas and the second study reviewed incidence of occult spinal dysraphism found in 

patients with lumbosacral hemangioma 

Studies were conducted in the US, Canada and Spain at tertiary care centers with referral 

programs for hemangiomas / vascular malformations 

Table G-2. Applicability of studies assessing steroids 


Population 

Intervention 

Comparator 

s 

Outcomes 

Setting 


Infants and children with IH (ages ranging from less than one to 72 months). Typically more 

females. 

Corticosteroids including topical, intralesional, intravenous, and oral forms. 

Comparators included another steroid or observation. 

Studies generally assessed change in lesion size and/or appearance and rebound growth. Two 

studies assessed vision outcomes. Comparative studies and case series also reported harms. 

One comparative study was conducted in Canada and the others in the Netherlands, Germany, 

Turkey, Pakistan, and India. Applicability of some findings may be limited given differences in the 

systems of care in lower resource countries. Several comparative studies were also published 

between 2001 and 2010 and may not reflect current standards of care. 

Table G-3. Applicability of studies assessing beta-blockers 


Population Studies typically included infants of both sexes ages 1 to 12 months of age (range: 1 month to 9 

years of age) with infantile hemangiomas which included superficial, deep, and mixed lesions 

primarily involving the head and neck and occurring as focal or segmental lesions. 

Intervention Patients were treated with a variety of beta-blockers including propranolol at various doses and 

administrations (oral, intralesional, or topical), timolol (topical), atenolol (oral), or nadolol (oral) for a 

variety of treatment durations most commonly up to 6 months duration. 

Comparator 

s 

Outcomes 

Setting 

Comparators included other formulations of the same beta-blocker, other beta-blockers, untreated 

historical controls, treated historical controls, and non-beta-blocker comparators (topical imiquimod, 

oral and intralesional steroids, laser, and intralesional bleomycin). 

Studies commonly assessed final response based on size, volume, and/or coloration of IH, 

resolution of ulceration if present at initiation of therapy, and visual acuity or resolution of ptosis for 

periocular lesions. Assessments were obtained throughout therapy but final outcome assessments 

were typically performed following 24 weeks of treatment. Additional assessments for serious 

harms including bronchial hyperreactivity, hypoglycemia, bradycardia, and hypotension and less 

severe harms including sleep disturbances, cold extremities, and gastrointestinal complaints were 

monitored in the majority of studies. 

Studies were conducted globally, often in speciality referral centers. 

G-1


Table G-4. Applicability of studies assessing surgical and laser studies 


Population Studies typically included infants of both sexes, with preponderance of females ages 1 week to 43 

years of age with superficial and cutaneous infantile hemangiomas in varied locations. 

Intervention 

Comparator 

s 

Outcomes 

Setting 


Patients were treated with a variety of lasers including pulse dyed, Nd:YAG, argon, cryotherapy, 

and intense pulsed light photothermolysis; in most cases, lasers were used as first-line treatment, 

which is not general, current clinical practice. Some studies used laser in combination with a betablocker 

like timolol or propranolol or combined laser modalities. 

Comparators included other lasers, different pulse lengths, different cooling regimens, and 

observation. 

Studies commonly assessed final response based on size, volume, and/or coloration of IH. Harms 

associated with laser treatment included skin atrophy, bleeding, scarring, ulceration and pigment 

changes. 

Studies were conducted in the United States, United Kingdom, Netherlands, Germany, Greece, 

Japan and Singapore, typically in referral centers. 

G-2

Appendix H. Harms Reported in Package Insert Data and Other Sources 

Infantile Hemangioma Package Insert and FDA Harms Data 

The harms data provided in this section were gathered from analyzing available gray literature (i.e., package inserts and FDA 

review packages). FDA approval packages were limited to those available on the FDA website that contained a “Medical Review” 

section of the document. Many of the review packages did not contain pediatric data and therefore the adult data was used. Table 1 

includes the relevant indications for pediatric medications referenced in the clinical studies included in this review. Medications that 

have not been approved as safe and effective in pediatric patients and therefore are only FDA approved in adults are referenced in 

Table 2. Notable contraindications and warnings/precautions that would be relevant to consider in the pediatric population were 

included in the tables (drug interactions were not included). As a result, the data provided in this chart is not an all-inclusive list of 

these package insert sections. For complete data please see the corresponding package insert. 

Table H-1: FDA Approved Pediatric Medications Included in Literature Review 

Drug 

Dosage 

Form 

FDA Approved Indication Contraindications Warnings/ Precautions 

Hemangeol 

® 

(propranolol 

hydrochlorid 

e) 1 

Oral 

solution 

Beta-adrenergic blocker 

indicated for the treatment 

of proliferating infantile 

hemangioma requiring 

systemic therapy 

• Premature infants with 

corrected age

Orapred 

ODT 

(prednisolon 

e sodium 

phosphate) 3 

Rayos® 

(prednisone) 

4 

ODT tablet 

Delayed 

release 

tablet 

conventional treatment in 

adults and pediatric 

populations with: 

o Atopic dermatitis 

o Drug hypersensitivity 

reactions 

o Seasonal or perennial 

allergic rhinitis 

o Serum sickness 

• Dermatologic Diseases 

o Bullous dermatitis 

herpetiformis 

o Contact dermatitis 

o Exfoliative 

erythroderma 

o Mycosis fungoides 

o Pemphigus 

o Severe erythema 

multiforme (Stevens- 

Johnson syndrome) 

• Endocrine Conditions 

o Congenital adrenal 

hyperplasia 

o Hypercalcemia of 

malignancy 

o Nonsuppurative 

thyroiditis 

o Primary or secondary 

adrenocortical 

insufficiency: 

hydrocortisone or 

cortisone is the first 

choice: synthetic 

analogs may be used 

in conjunction with 

mineralocorticoids 

where applicable 

• Gastrointestinal Diseases: 

During acute episodes in: 

o Crohn's Disease 

o Ulcerative colitis 

• Hematologic Diseases 

• Infections: Increased susceptibility to new infection and increased 

risk of exacerbation, dissemination, or reactivation of latent 

infection. Signs and symptoms of infection may be masked 

• Elevated blood pressure, salt and water retention and hypokalemia: 

Monitor blood pressure and sodium, potassium serum levels 

• GI perforation: increased risk in patients with certain GI disorders. 

Signs and symptoms may be masked 

• Behavioral and mood disturbances: May Include euphoria, 

insomnia, mood swings, personality changes, severe depression, 

and psychosis. Existing conditions may be aggravated. 

• Decreases in bone density: Monitor bone density in patients 

receiving long-term corticosteroid therapy. 

• Ophthalmic effects: May include cataracts, infections and 

glaucoma. Monitor intraocular pressure if corticosteroid therapy is 

continued for more than 6 weeks. 

• Live or live attenuated vaccines: Do not administer to patients 

receiving immunosuppressive doses of corticosteroids. 

• Negative effects on growth and development: Monitor pediatric 

patients on long-term corticosteroid therapy. 

• Kaposi's sarcoma has been reported to occur in patients receiving 

corticosteroid therapy, most often for chronic conditions. 

Discontinuation of corticosteroids may result in clinical 

improvement. 

• Although controlled clinical trials have shown corticosteroids to be 

effective in speeding the resolution of acute exacerbations of 

multiple sclerosis, they do not show that corticosteroids affect the 

ultimate outcome or natural history of the disease. The studies do 

show that relatively high doses of corticosteroids are necessary to 

demonstrate a significant effect. 

• An acute myopathy has been observed with the use of high doses 

of corticosteroids, most often occurring in patients with disorders of 

neuromuscular transmission (e.g., myasthenia gravis), or in 

patients receiving concomitant therapy with neuromuscular 

blocking drugs (e.g., pancuronium). This acute myopathy is 

generalized, may involve ocular and respiratory muscles, and may 

result in quadriparesis. Elevation of creatinine kinase may occur. 

Clinical improvement or recovery after stopping corticosteroids may 

require weeks to years. 

H-2

o Acquired 

(autoimmune) 

hemolytic anemia 

o Diamond-Blackfan 

anemia 

o Pure red cell aplasia 

• Neoplastic Conditions: 

o Acute leukemia 

o Aggressive 

lymphomas 

• Nervous System 

Conditions 

o Acute exacerbations of 

multiple sclerosis 

o Cerebral edema 


primary or metastatic 

brain tumor, 

craniotomy or head 

injury 

• Ophthalmic Conditions 

o Sympathetic 

ophthalmia 

o Uveitis and ocular 

inflammatory 

conditions 

unresponsive to 

topical steroids 

• Conditions Related to 

Organ Transplantation 

o Acute or chronic solid 

organ rejection 

• Pulmonary Diseases 

o Allergic 

bronchopulmonary 

aspergillosis 

o Aspiration pneumonitis 

o Asthma 

o Fulminating or 

disseminated 

pulmonary 

tuberculosis when 

used concurrently with 

H-3

appropriate 

chemotherapy 

o Hypersensitivity 

pneumonitis 

o Idiopathic bronchiolitis 

obliterans with 

organizing pneumonia 

o Idiopathic eosinophilic 

pneumonias 

o Idiopathic pulmonary 

fibrosis 

o Pneumocystis carinii 

pneumonia (PCP) 


hypoxemia occurring 

in an HIV(+) individual 

who is also under 

treatment with 

appropriate anti-PCP 

antibiotics. 

o Symptomatic 

sarcoidosis 

• Renal Conditions 

o To induce a diuresis or 

remission of 

proteinuria in nephrotic 

syndrome, without 

uremia, of the 

idiopathic type or that 

due to lupus 

erythematosus 

• Rheumatologic 

Conditions: As 

adjunctive therapy for 

short-term administration 

(to tide the patient over 

an acute episode or 

exacerbation) in: 

o Acute gouty arthritis 

• During an exacerbation 

or as maintenance 

therapy in selected 

cases of: 

H-4

o Ankylosing spondylitis 

o Dermatomyositis/poly 

myositis 

o Polymyalgia 

rheumatica 

o Psoriatic arthritis 

o Relapsing 

polychondritis 

o Rheumatoid arthritis, 

including juvenile 

rheumatoid arthritis 

(selected cases may 

require low dose 

maintenance therapy) 

o Systemic lupus 

erythematosus 

o Vasculitis 

• Specific Infectious 

Diseases 

o Trichinosis with 

neurologic or 

myocardial 

involvement. 

o Tuberculous 

meningitis with 

subarachnoid block or 

impending block used 

concurrently with 

appropriate 

antituberculous 

chemotherapy. 

Medrol® 

(methylpred 

nisolone) 5 

Depo- 

Medrol® 

(methylpred 

nisolone 

acetate) 6 

Oral tablet 

Intramuscul 

ar injection 

• Similar Indications as 

listed in the prednisolone 

row with the following 

additional: 

o Acute and subacute 

bursitis 

o Synovitis of 

osteoarthritis 

o Acute nonspecific 

tenosynovitis 

• Systemic fungal 

infections 

• Injectable 

formulation: NOT 

FOR USE IN 

NEWBORNS 

Similar Warnings/Precautions the prednisolone with the following 

additional: 

• In patients on corticosteroid therapy subjected to unusual stress, 

increased dosage of rapidly acting corticosteroids before, during, 

and after the stressful situation is indicated. 

• The use of methylprednisolone tablets in active tuberculosis should 

be restricted to those cases of fulminating or disseminated 

tuberculosis in which the corticosteroid is used for the management 

of the disease in conjunction with an appropriate antituberculous 

regimen. 

H-5

Solu- 

Medrol® 

(methylpred 

nisolone 

sodium 

succinate) 7 

Intravenou 

s or 

intramuscul 

ar injection 

o Post-traumatic 

osteoarthritis 

o Epicondylitis 

o Severe seborrheic 

dermatitis 

o Severe psoriasis 

o Allergic corneal 

marginal ulcers 

o Herpes zoster 

ophthalmicus 

o Loeffler's syndrome 

not manageable by 

other means 

o Erythroblastopenia 

• Not indicated for: 

o Crohn’s Disease 

o Transfusion reactions 

o Pure red cell aplasia 

o Vasculitis 

o Allergic 

bronchopulmonary 

aspergillosis 

o Aspiration pneumonitis 

o Hypersensitivity 

pneumonitis 

o Idiopathic bronchiolitis 

obliterans with 

organizing pneumonia 

o Idiopathic pulmonary 

fibrosis 

o Pneumocystis carinii 

pneumonia (PCP) 


hypoxemia occurring 

in an HIV(+) individual 

who is also under 

treatment with 

appropriate anti-PCP 

antibiotics. 

o Polymyalgia 

rheumatica 

o Relapsing 

polychondritis 

• If corticosteroids are indicated in patients with latent tuberculosis or 

tuberculin reactivity, close observation is necessary as reactivation 

of the disease may occur. During prolonged corticosteroid therapy, 

these patients should receive chemoprophylaxis. 

• Persons who are on drugs which suppress the immune system are 

more susceptible to infections than healthy individuals. Druginduced 

secondary adrenocortical insufficiency may be minimized 

by gradual reduction of dosage. This type of relative insufficiency 

may persist for months after discontinuation of therapy; therefore, 

in any situation of stress occurring during that period, hormone 

therapy should be reinstituted. Since mineralocorticoid secretion 

may be impaired, salt and/or a mineralocorticoid should be 

administered concurrently. 

• There is an enhanced effect of corticosteroids on patients with 

hypothyroidism and in those with cirrhosis. 

• Corticosteroids should be used cautiously in patients with ocular 

herpes simplex because of possible corneal perforation. 

• The lowest possible dose of corticosteroid should be used to 

control the condition under treatment, and when reduction in 

dosage is possiathyble, the reduction should be gradual. 

• Steroids should be used with caution in nonspecific ulcerative 

colitis, if there is a probability of impending perforation, abscess or 

other pyogenic infection; diverticulitis; fresh intestinal anastomoses; 

active or latent peptic ulcer; renal insufficiency; hypertension; 

osteoporosis; and myasthenia gravis. 

• Since complications of treatment with glucocorticoids are 

dependent on the size of the dose and the duration of treatment, a 

risk/benefit decision must be made in each individual case as to 

dose and duration of treatment and as to whether daily or 

intermittent therapy should be used. 

Injection Specific: 

• This product contains benzyl alcohol. Benzyl alcohol has been 

associated with a fatal “Gasping Syndrome” in premature infants 

and infants of low birth weight. Exposure to excessive amounts of 

benzyl alcohol has been associated with toxicity (hypotension, 

metabolic acidosis), particularly in neonates, and an increased 

incidence of kernicterus, particularly in small preterm infants. There 

have been rare reports of deaths, primarily in preterm infants, 

associated with exposure to excessive amounts of benzyl alcohol. 

• Rare instances of anaphylactoid reactions have occurred in 

patients receiving corticosteroid therapy 

H-6

H-7 

• Increased dosage of rapidly acting corticosteroids is indicated in 

patients on corticosteroid therapy subjected to any unusual stress 

before, during, and after the stressful situation. 

• Literature reports suggest an apparent association between use of 

corticosteroids and left ventricular free wall rupture after a recent 

myocardial infarction; therefore, therapy with corticosteroids should 

be used with great caution in these patients. 

• Metabolic clearance of corticosteroids is decreased in hypothyroid 

patients and increased in hyperthyroid patients. Changes in thyroid 

status of the patient may necessitate adjustment in dosage. 

• Fungal Infections: Corticosteroids may exacerbate systemic fungal 

infections and therefore should not be used in the presence of such 

infections unless they are needed to control drug reactions. 

Corticosteroids should not be used in cerebral malaria. 

• Latent disease may be activated or there may be an exacerbation 

of intercurrent infections due to pathogens, including those caused 

by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, 

Pneumocystis, and Toxoplasma. 

• Tuberculosis: If corticosteroids are indicated in patients with latent 

tuberculosis or tuberculin reactivity, close observation is necessary 

as reactivation of the disease may occur. During prolonged 

corticosteroid therapy, these patients should receive 

chemoprophylaxis. 

• Viral Infections: Chicken pox and measles can have a more serious 

or even fatal course in pediatric and adult patients on 

corticosteroids 

• This product, like many other steroid formulations, is sensitive to 

heat. Therefore, it should not be autoclaved when it is desirable to 

sterilize the exterior of the vial. 

• The lowest possible dose of corticosteroid should be used to 

control the condition under treatment. When reduction in dosage is 

possible, the reduction must be gradual. 

• Cardio-renal: As sodium retention with resultant edema and 

potassium loss may occur in patients receiving corticosteroids, 

these agents should be used with caution in patients with 

congestive heart failure, hypertension, or renal insufficiency. 

• Endocrine: Drug-induced secondary adrenocortical insufficiency 

may be minimized by gradual reduction of dosage. 

• Although controlled clinical trials have shown corticosteroids to be 

effective in speeding the resolution of acute exacerbations of 

multiple sclerosis, they do not show that they affect the ultimate 

outcome or natural history of the disease.

• An acute myopathy has been observed with the use of high doses 

of corticosteroids, most often occurring in patients with disorders of 

neuromuscular transmission (e.g., myasthenia gravis), or in 

patients receiving concomitant therapy with neuromuscular 

blocking drugs (e.g., pancuronium). 

• Corticosteroids may suppress reactions to skin tests. 

• Vaccines: Patients on prolonged corticosteroid therapy may exhibit 

a diminished response to toxoids and live or inactivated vaccines 

due to inhibition of antibody response. Corticosteroids may also 

potentiate the replication of some organisms contained in live 

attenuated vaccines. Routine administration of vaccines or toxoids 

should be deferred until corticosteroid therapy is discontinued if 

possible 

Aristospan® 

(triamcinolon 

e 

hexacetonid 

e) 8 

Kenalog- 

10® 

(triamcinolon 

e 

acetonide) 9 

Intralesiona 

l injection 

The intralesional 

administration of 

triamcinolone hexacetonide 

injectable suspension is 

indicated for: 

• alopecia areata 

• discoid lupus 

erythematosus 

• keloids 

• localized hypertrophic 

• infiltrated 

• inflammatory lesions of 

granuloma annulare 

• lichen planus 

• lichen simplex chronicus 

(neurodermatitis) 

• psoriatic plaques 

• necrobiosis lipoidica 

diabeticorum 

• cystic tumors of an 

aponeurosis or tendon 

(ganglia) 

NOT FOR USE IN 

NEWBORNS 

Similar Warnings/Precautions the prednisolone with injection specific 

warnings in the methylprednisolone row. 

Celestone 

Soluspan® 

(betamethas 

one) 10 

Intralesiona 

l injection 

Intralesional injection has 

similar indications as listed 

in the triamcinolone row. 

NOT FOR USE IN 

NEWBORNS 

Similar Warnings/Precautions the prednisolone with injection specific 

warnings in the methylprednisolone row. 

H-8

Elocon® 

(mometason 

e furoate) 11 

Topical 

cream 

Corticosteroid indicated for 

the relief of the inflammatory 

and pruritic manifestations 

of corticosteroid-responsive 

dermatoses in patients 2 

years of age or older 

--- • Reversible HPA axis suppression with the potential for 

glucocorticosteroid insufficiency after withdrawal of treatment, 

Cushing's syndrome, and hyperglycemia may occur due to 

systemic absorption. Patients applying a topical steroid to a large 

surface area or to areas under occlusion should be evaluated 

periodically for evidence of HPA axis suppression. Modify use 

should HPA axis suppression develop. 

• Pediatric patients may be more susceptible to systemic toxicity. 

• Allergic Contact Dermatitis: If irritation develops, mometasone 

furoate should be discontinued and appropriate therapy instituted. 

• Concomitant Skin Infections: If concomitant skin infections are 

present or develop, an appropriate antifungal or antibacterial agent 

should be used. If a favorable response does not occur promptly, 

mometasone furoate use of should be discontinued until the 

infection has been adequately controlled. 

Zyclara® 

(imiquimod) 1 

2 

Aldara® 

(imiquimod) 1 

3 

2.5% to 

3.75% 

Topical 

cream 

5% Topical 

cream 

Indicated for the treatment 

of external genital and 

perianal warts 

(EGW)/condyloma 

acuminata in patients 12 

years or older. 

--- • Local Skin Reactions: Intense local skin reactions including skin 

weeping or erosion can occur after a few applications and may 

require an interruption of dosing. Imiquimod has the potential to 

exacerbate inflammatory conditions of the skin, including chronic 

graft versus host disease. 

Severe local inflammatory reactions of the female external genitalia 

can lead to severe vulvar swelling. Severe vulvar swelling can lead 

to urinary retention. Dosing should be interrupted or discontinued 

for severe vulvar swelling. 

Administration of imiquimod is not recommended until the skin is 

healed from any previous drug or surgical treatment. 

• Systemic Reactions Flu-like signs and symptoms may accompany, 

or even precede, local skin reactions and may include fatigue, 

nausea, fever, myalgias, arthralgias, malaise and chills. 

• Ultraviolet Light Exposure Risks: Exposure to sunlight (including 

sunlamps) should be avoided or minimized during use of 

imiquimod. 

• Increased Risk of Adverse Reactions with Concomitant Imiquimod 

Use 

• Immune Cell Activation in Autoimmune Disease: Imiquimod should 

be used with caution in patients with pre-existing autoimmune 

conditions because imiquimod activates immune cells 

H-9

Table H-2: FDA Approved Adult Medications (Prescribed Off-Label in Pediatric Patients) Included in Literature Review 

Drug 

Dosage 

Form 

FDA Approved Indication Contraindications Warnings/ Precautions 

Tenormin® 

(atenolol) 14 

Oral tablet 

• Treatment of 

hypertension, to lower 

blood pressure 

• Long-term management 

of patients with angina 

pectoris. 

• Management of 

hemodynamically stable 

patients with definite or 

suspected acute 

myocardial infarction to 

reduce cardiovascular 

mortality 

• Sinus bradycardia 

• Heart block greater 

than first degree 

• Cardiogenic shock 

• Overt cardiac failure 

• Cardiac Failure: Sympathetic stimulation is necessary in supporting 

circulatory function in congestive heart failure, and beta blockade 

carries the potential hazard of further depressing myocardial 

contractility and precipitating more severe failure. 

• In Patients Without a History of Cardiac Failure: Continued 

depression of the myocardium with beta-blocking agents over a 

period of time can, in some cases, lead to cardiac failure 

• Cessation of Therapy with Atenolol: Patients with coronary artery 

disease, who are being treated with atenolol, should be advised 

against abrupt discontinuation of therapy. 

• Concomitant Use of Calcium Channel Blockers: Bradycardia and 

heart block can occur and the left ventricular end diastolic pressure 

can rise when beta-blockers are administered with verapamil or 

diltiazem. Patients with pre-existing conduction abnormalities or left 

ventricular dysfunction are particularly susceptible. 

• Bronchospastic Diseases: Patients with bronchospastic disease 

should, in general, not receive beta blockers. Because of its relative 

beta1 selectivity, however, atenolol may be used with caution in 

patients with bronchospastic disease who do not respond to, or 

cannot tolerate, other antihypertensive treatment. 

• Major Surgery: Chronically administered beta-blocking therapy 

should not be routinely withdrawn prior to major surgery, however 

the impaired ability of the heart to respond to reflex adrenergic 

stimuli may augment the risks of general anesthesia and surgical 

procedures. 

• Diabetes and Hypoglycemia: atenolol should be used with caution 

in diabetic patients if a beta-blocking agent is required. Beta 

blockers may mask tachycardia occurring with hypoglycemia, but 

other manifestations such as dizziness and sweating may not be 

significantly affected. 

• Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical 

signs (eg, tachycardia) of hyperthyroidism. Abrupt withdrawal of 

beta blockade might precipitate a thyroid storm; therefore, patients 

suspected of developing thyrotoxicosis from whom atenolol therapy 

is to be withdrawn should be monitored closely. 

• Untreated Pheochromocytoma: atenolol should not be given to 

patients with untreated pheochromocytoma. 

H-10

Timoptic® 

(timolol 

maleate) 15 

Timoptic- 

XE® (timolol 

maleate) 16 

Betimol® 

(timolol) 17 

Ophthalmic 

Solution 

Treatment of elevated 

intraocular pressure in 

patients with ocular 

hypertension or open-angle 

glaucoma. 

• Bronchial asthma 

• A history of bronchial 

asthma 

• Severe chronic 

obstructive 

pulmonary disease 

• Sinus bradycardia 

• Second or third 

degree 

atrioventricular block 

• Overt cardiac failure 

• Cardiogenic shock 

. 

• Cardiac Failure: sympathetic stimulation may be essential for 

support of the circulation in individuals with diminished myocardial 

contractility, and its inhibition of beta-adrenergic receptor blockade 

may precipitate more severe failure. 

• In Patients Without a History of Cardiac Failure: continued 

depression of the myocardium with beta-blocking agents over a 

period of time can, in some cases, lead to cardiac failure. At the 

first sign or symptom of cardiac failure, timolol should be 

discontinued. 

• Major Surgery: Beta-adrenergic receptor blockade impairs the 

ability of the heart to respond to beta-adrenergically mediated reflex 

stimuli. This may augment the risk of general anesthesia in surgical 

procedures. In patients undergoing elective surgery, some 

authorities recommend gradual withdrawal of beta-adrenergic 

receptor blocking agents. 

• Diabetes Mellitus: Beta-adrenergic blocking agents should be 

administered with caution in patients subject to spontaneous 

hypoglycemia or to diabetic patients (especially those with labile 

diabetes) who are receiving insulin or oral hypoglycemic agents. 

Beta-adrenergic receptor blocking agents may mask the signs and 

symptoms of acute hypoglycemia. 

• Thyrotoxicosis: Beta-adrenergic blocking agents may mask certain 

clinical signs (e.g., tachycardia) of hyperthyroidism.: 

• Because of potential effects of beta-adrenergic blocking agents on 

blood pressure and pulse, these agents should be used with 

caution in patients with cerebrovascular insufficiency 

• There have been reports of bacterial keratitis associated with the 

use of multiple-dose containers of topical ophthalmic products. 

• Choroidal detachment after filtration procedures has been reported 

with the administration of aqueous suppressant therapy (e.g. 

timolol). 

• Angle-closure glaucoma: In patients with angle-closure glaucoma, 

the immediate objective of treatment is to reopen the angle. This 

requires constricting the pupil. Timolol maleate has little or no effect 

on the pupil. Timolol should not be used alone in the treatment of 

angle-closure glaucoma. 

• Anaphylaxis: While taking beta-blockers, patients with a history of 

atopy or a history of severe anaphylactic reactions to a variety of 

allergens may be more reactive to repeated accidental, diagnostic, 

or therapeutic challenge with such allergens. 

• Muscle Weakness: Beta-adrenergic blockade has been reported to 

potentiate muscle weakness consistent with certain myasthenic 

symptoms (e.g., diplopia, ptosis, and generalized weakness). 

H-11

H-12 

Timolol has been reported rarely to increase muscle weakness in 

some patients with myasthenia gravis or myasthenic symptoms.

Harms Data for Medications Included in the Analysis 

The following sections provide an overview of the common and notable adverse events of 

each medication. When possible, adverse event data specific for pediatric patients have been 

included. It is important to note that the information provided in this section is not an allinclusive 

list of adverse events. Consult the corresponding package insert for complete 

information. Many of the adverse events reported are from various clinical trials used in support 

of the medication’s FDA approval. As a result, these trials many have been conducted under 

varying conditions and the adverse event rates may not reflect what is observed in clinical 

practice. In addition, these rates may not necessarily be able to be compared to the rates observed 

in the clinical trials of different drugs. Post-marketing adverse events are reported on a voluntary 

basis and therefore do not represent complete patient data. 

Hemangeol® (propranolol hydrochloride) 

Hemangeol® is the only medication included in this review that has an FDA approved 

indication for infantile hemangioma. The safety of Hemageol® in pediatric patients has been 

reported in the medication package insert. 1 FDA medical review packages were not available for 

this medication. 

The most common adverse events, occurring in greater than 10% of infants, were sleep 

disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated 

with cough and fever, diarrhea, and vomiting. 1 In a study of pooled safety data (n=424), infants 

(63% aged 91-150 days) were treated with Hemangeol® 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 

6 months. Treatment emergent adverse events occurring in 3% or greater in infants receiving the 

Hemangeol® 1.2 mg/kg/day (n=200) or Hemangeol® 3.4 mg/kg/day (n=224) compared to 

placebo were provided. Adverse events and frequencies for patients receiving Hemangeol® 1.2 

mg/kg/day included: sleep disorders (17.5%), bronchitis (8%), peripheral coldness (8%), 

agitation (8.5%), diarrhea (4.5%), somnolence (5.0%), nightmare (2.0%), irritability (5.5%), 

decreased appetite (2.5%), and abdominal pain (3.5%). Adverse events and frequencies for 

patients receiving Hemangeol® 3.4 mg/kg/day (n=224) included: sleep disorders (16.1%), 

bronchitis (13.4%), peripheral coldness (6.7%), agitation (4.5%), diarrhea (6.3%), somnolence 

(0.9%), nightmare (6.3%), irritability (1.3%), decreased appetite (3.6%), and abdominal pain 

(0.4%). Additional adverse events reported in less than 1% of patients participating in clinical 

trials included: second degree atrioventricular heart block (occurring in a patient with underlying 

conduction disorder), urticaria, alopecia, decreased blood glucose, and decreased heart rate. 

Additional Formulations 

The safety and efficacy of the oral tablet, oral capsule, and injectable formulations of 

propranolol have not been investigated in pediatric patients. 18-20 The package inserts for these 

formulations state that reports of bronchospasm and congestive heart failure have been reported 

in pediatric patients receiving propranolol. 

Post-marketing Adverse Events 

Additional adverse events revealed during post-marketing surveillance include: 

agranulocytosis, hallucination and purpura. 1 

H-13


The safety and efficacy of pediatric use of corticosteroids has been studied in the literature 

for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and 

leukemias (>1 month of age). 2-4,6,7,10 It has been reported that the adverse events identified in 

pediatric patients were similar to the events experienced in adults. Monitoring pediatric patients 

for blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence 

of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and 

osteoporosis is recommended. Specifically, pediatric patients may have a decrease in growth 

velocity after taking corticosteroids by any route of administration. Therefore, children should be 

titrated to the lowest effective dose. 

Common adverse events of corticosteroids include: fluid retention, alteration in glucose 

tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and 

weight gain. 2-10 Additional adverse events include: anaphylactoid reaction, anaphylaxis, 

angioedema, bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory 

collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in 

premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, 

syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, acne, allergic dermatitis, 

cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or 

hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, 

rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp 

hair, urticaria, abnormal fat deposits, decreased carbohydrate tolerance, development of 

Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements 

for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon faces, 

secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in 

trauma, surgery or illness), suppression of growth in children, potassium loss, hypokalemic 

alkalosis, sodium retention, abdominal distention, elevation in serum liver enzymes levels 

(usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis, 

peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis, osteonecrosis of 

femoral and humeral heads, charcot-like arthropathy, loss of muscle mass, muscle weakness, 

osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral 

compression fractures, arachnoiditis, convulsions, depression, emotional instability, euphoria, 

headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually 

following discontinuation of treatment, insomnia, meningitis, mood swings, neuritis, neuropathy, 

paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo, 

exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, 

alteration in motility and number of spermatozoa. 

Flo-pred® (prednisolone acetate), Orapred ODT (prednisolone sodium phosphate) 

The adverse events reported for Flo-pred® and Orapred ODT® in adult patients has been 

compiled from the package insert and the original FDA approval package assessing the safety of 

adult patients with rheumatoid arthritis. 2,3,21 Common adverse events for Flo-pred and Orapred 

ODT have been reported in the common adverse events for corticosteroids in general (see 

above). 2,3 Bioequivalence studies conducted in healthy volunteers assessing prednisolone oral 

suspension, prednisolone syrup, and prednisolone tablet were reported in the Flo-pred® original 

FDA approval document. 21 The following adverse events were reported across 3 of these studies 

(see table 3). 

H-14

Table H-3: Adverse Events from Flo-pred® Bioequivalence Studies 21 

Study # 

Dosage form 

1 1 1 2 2 2 3 3 3 

Suspension 

(n=24) 

Syrup 

(n=24) 

Arthralgia 0 0 

Tablet 

(n=24) 

1 

(4%) 

Suspension 

(n=24) 

Headache 1 (4%) 0 0 3 (13%) 

Somnolence 0 

Dyspepsia 1 (4%) 

1 

(4%) 

1 

(4%) 

Syrup 

(n=23) 

0 0 

1 

(4%) 

Tablet 

(n=24) 

1 

(4%) 

6 

(25%) 

Suspension 

(n=24) 

Syrup 

(n=23) 

0 0 

1 (4%) 

1 

(4%) 

0 1 (4%) 0 0 0 0 

1 

(4%) 

1 (4%) 

1 

(4%) 

Fatigue 1 (4%) 0 0 1 (4%) 0 

Tablet 

(n=23) 

1 

(4%) 

1 

(4%) 

1 

(4%) 

0 --- --- --- 

1 

(4%) 

--- --- --- 

1 

1 

Hot Flash 0 

0 1 (4%) 

0 --- --- -- 

(4%) 

(4%) 

Venipuncture site 

1 

1 

1 (4%) 0 

0 

0 --- --- --- 

pain 

(4%) 

(4%) 

Lymphocyte count 

2 2 

1 1 

2 (8%) 

1 (4%) 

--- --- --- 

increased 

(8%) (8%) 

(4%) (4%) 

Neutrophil count 

1 1 

2 2 

1 (4%) 

--- --- --- 2 (8%) 

decreased 

(4%) (4%) 

(9%) (9%) 

Ocular 

1 

1 

--- --- --- 1 (4%) 0 

0 0 

hyperaemia 

(4%) 

(4%) 

1 

1 

Lip dry --- --- --- 1 (4%) 

0 0 0 

(4%) 

(4%) 

1 1 

Nausea --- --- --- 2 (8%) 

1 (4%) 0 0 

(4%) (4%) 

1 

1 

Dizziness --- --- --- 1 (4%) 

0 0 

0 

(4%) 

(4%) 

Venipuncture site 

1 (4%) 0 0 --- --- --- --- --- --- 

swelling 

Blood Bilirubin 

1 1 

1 (4%) 

--- --- --- --- --- --- 

increase 

(4%) (4%) 

1 

Increased appetite 0 0 

--- --- --- --- --- --- 

(4%) 

Pharyngolaryngeal 

1 

0 0 

--- --- --- --- --- --- 

Pain 

(4%) 

Blister 1 (4%) 0 0 

Abdominal 

1 

--- --- --- 0 0 

--- --- --- 

distension 

(4%) 

1 

Abdominal pain --- --- --- 0 0 

--- --- --- 

(4%) 

Upper abdominal 

1 

--- --- --- 0 0 

--- --- --- 

pain 

(4%) 

1 

Diarrhea --- --- --- 0 0 

--- --- -- 

(4%) 

Dry mouth --- --- --- 1 (4%) 0 0 --- --- --- 

Flatulence --- --- --- 1 (4%) 0 0 --- --- --- 

1 

Vomiting --- --- --- 1 (4%) 0 

--- --- --- 

(4%) 

Vessel puncture 

site bruise 

--- --- --- 1 (4%) 0 0 --- --- --- 

Tremor --- --- --- 1 (4%) 0 0 --- --- --- 

Metrorrhagia --- --- --- 1 (4%) 0 0 --- --- --- 

Nasal congestion --- --- --- 0 0 

1 

(4%) 

--- --- --- 

Rhinorrhea --- --- --- 0 0 

1 

(4%) 

--- --- --- 

H-15

Fixed eruption --- --- --- 1 (4%) 0 0 --- --- --- 

Catheter site pain --- --- --- --- --- --- 1 (4%) 0 0 

Catheter site 

reaction 

--- --- --- --- --- --- 1 (4%) 0 0 

Shivering --- --- --- --- --- --- 1 (4%) 0 0 

Blood potassium --- --- --- --- --- --- 1 (4%) 

1 

(4%) 

Hypoaesthesia --- --- --- --- --- --- 0 

1 

(4%) 

0 

Bioavailability studies were also conducted for Orapred ODT® in 24 health patients each 

receiving Orapred ODT® 30mg tablet, Pediapred® oral solution 30mg and Orapred® oral 

solution 30mg. Adverse events reported in patients taking Oprapred ODT® included: face 

edema/swelling face, pharyngolaryngeal pain, blood in stool, eye irritation, and eyelid edema. 

A search of the literature for adverse events associated with prednisolone was conducted by 

Taro Pharmaceuticals and reported in the FDA review package. 21 The most common adverse 

events reported in 4 pediatric studies (mean age 2% of 

patients participating in phase 3 clinical studies. 23 These patients were treated with prednisone 

extended release (XL) (n=375) and prednisone immediate release tablets (IR) (n=144). Adverse 

events included: abdominal pain upper: XL=6 (

(

An additional clinical trial assessing the safety of prednisone extended release was conducted 

in Germany and included 2676 patients in the safety analysis. 23 Serious adverse events reported 

included: gastrointestinal disorders (5 events,

thromboembolism, thrombophlebitis, vasculitis, acne, cutaneous and subcutaneous atrophy, dry 

scalp, edema, hyper or hypopigmentation, sterile abscess, striae, thinning scalp hair, hirsutism, 

moon faces, hepatomegaly, hiccups, malaise, nausea, charcot-like arthropathy, arachnoiditis, 

depression, emotional instability, euphoria, insomnia, meningitis, neuritis, neuropathy, 

paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, and alteration in 

motility/number of spermatozoa. 

Warnings for the use of Depo-Medrol® and Solu-Medrol® in pediatric patients due to the 

presence of benzyl alcohol have been described above (see table 1). 6,7 

Adverse events for Depo-Medrol® and Solu-Medrol® were similar to those listed in general 

for corticosteroids (see above) with the addition of: dry scaly skin, glycosuria, hypertrichosis, 

negative nitrogen balance due to protein catabolism, injection site infections following nonsterile 

administration, postinjection flare (following intra-articular use), temporary/permanent 

visual impairment including blindness associated with periocular injections and decreased 

resistance to infection. 6,7 

Depo-Medrol® has unique adverse events reported in addition to those listed above: 

calcinosis (following intra-articular or intra-lesional use), seizures, ocular and periocular 

inflammation including allergic reactions, and residue or slough at injection site. 6 

Additional adverse events reported for Solu-Medrol® included: rhinitis and burning or 

tingling (especially in the perineal area after intravenous injection). 7 

Aristospan® (triamcinolone hexacetonide), Kenalog-10® (triamcinolone 

acetonide) 

Aristospan® (triamcinolone hexacetonide), Kenalog-10® (triamcinolone acetonide) includes 

pediatric dosing in the FDA approved labeling. 8,9 FDA review packages were not available for 

this medication. Warnings for the use of Aristospan® and Kenalog-10® in pediatric patients due 

to the presence of benzyl alcohol have been described above (see table 1). 

Adverse events for Aristospan® and Kenalog-10® were similar to those listed in general for 

corticosteroids (see above) with the addition of: dry scaly skin, glucosuria, hypertrichosis, 

negative nitrogen balance due to protein catabolism, calcinosis (following intra-articular or 

intralesional use), postinjection flare (following intra-articular use), rare instances of blindness 

associated with periocular injections, and decreased resistance to infection. 8,9 FDA medical 

review packages were not available for these medications. 

Celestone Soluspan® (betamethasone) 

Adverse event data for Celestone Soluspan® was gathered from the package insert. 10 FDA 

approval packages were not available for review. 

Adverse events for Celestone Soluspan® were similar to those listed in general for 

corticosteroids (see above) with the addition of: dry scaly skin, glucosuria, hypertrichosis, 

negative nitrogen balance due to protein catabolism, calcinosis (following intra-articular or 

intralesional use), postinjection flare (following intra-articular use), rare instances of blindness 

associated with periocular injections, and decreased resistance to infection. 10 The following 

adverse events have been reported for general corticosteroids but were NOT included as adverse 

events for Celestone Soluspan®: manifestations of latent diabetes mellitus and menstrual 

irregularities. 

H-19

Elocon® (mometasone furoate) 

The use of this medication in pediatric patients (>2 years) is recommended for less than 3 

weeks. 11 This medication is administered topically and pediatric patients will have an increase in 

the skin surface area to body mass ratio. As a result, adverse events such as HPA axis 

suppression, Cushing’s syndrome, adrenal insufficiency upon withdraw, skin atrophy, striae, 

linear growth retardation, delayed weight gain, and intracranial hypertension are more likely to 

occur in pediatric patients. 

The adverse event data for Elocon® was obtained from the package insert. 11 FDA approval 

packages were not available for this medication. The package insert notes that rates of adverse 

events may differ in clinical practice because clinical trials for Elocon® were conducted under 

variable conditions. In pediatric studies (n=74), 7% of patients experienced adverse events 

including: stinging, pruritus, and furunculosis. In a pediatric trial, 24 patients (age 6 to 23 

months) used Elcon® cream for 3 weeks covering a mean body surface area of 41%. Sixteen 

percent of patients reported HPA axis suppression after treatment. Additional adverse events 

reported in pediatric (age 6 months to 2 years) trials (n=182) included: decreased glucocorticoid 

levels (2), paresthesia (2), folliculitis (1) moniliasis (1), bacterial infection (1), skin 

depigmentation (1). Ninety seven patients, participating in a clinical trial, experienced skin 

atrophy including: shininess (4), telangiectasia (1), loss of elasticity (4), loss of normal skin 

markings (4), thinness (1), and bruising (1). Adverse events that have been reported for topical 

corticosteroids in general include: irritation, dryness, folliculitis, hypertrichosis, acneiform 

eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, 

striae, and miliaria. 

Aldara® (imiquimod), Zyclara® (imiquimod) 

Package inserts and original FDA approval packages were utilized to gather safety 

information for these medications. 12,13,24 

It has been reported that the pediatric patients applying Aldara® for molluscum contagiosum 

experienced application site reactions most often. 12,13,25 Additional adverse events reported in 

these trials were similar to those reported in adult patient with the addition of: otitis media (5%) 

and conjunctivitis (3%). Local skin reactions reported in pediatric patients and considered severe 

include: erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion 

(2%) and weeping/exudate (2%). 

The Aldara® package insert notes that rates of adverse events may differ in clinical practice 

because clinical trials were conducted under variable conditions. 13 The following adverse events 

were reported in >1% of adult patients applying Aldara® to the face or scalp 2 times a week for 

16 weeks for actinic keratosis (n=215): application site reaction: 71 (33%), upper respiratory 

tract infection: 33 (15%), sinusitis: 16 (7%), headache: 11 (5%), carcinoma squamous: 8 (4%), 

diarrhea: 6 (3%), eczema: 4 (2%), back pain: 3 (1%), fatigue: 3 (1%), atrial fibrillation: 3 (1%), 

viral infection: 3 (1%), dizziness: 3 (1%), vomiting: 3 (1%), UTI: 3 (1%), fever: 3 (1%), rigors: 3 

(1%), and alopecia: 3 (1%). Specific application site reactions that were reported in >1% of 

adult patients taking Aldara® for actinic keratosis (n=215) included: itching: 44 (20%), burning: 

13 (6%), bleeding: 7 (3%), stinging: 6 (3%), pain: 6 (3%), induration: 5 (2%), tenderness: 4 

(2%), and irritation: 4 (2%). The following local skin reactions have been reported in adult 

patients applying Aldara® for actinic keratosis (n=215): erythema (all grades): 209 (97%), 

erythema (severe): 38 (18%), flaking/scaling/dryness (all grades): 199 (93%), 

flaking/scaling/dryness (severe): 16 (7%), scabbing/crusting (all grades): 169 (79%), 

scabbing/crusting (severe): 18 (8%), edema (all grades): 106 (49%), erosion/ulceration (all 

H-20

grades): 103 (48%), erosion/ulceration (severe): 5 (2%), weeping/exudate (all grades): 45 (22%), 

and vesicles (all grades): 19 (9%). Increased scarring scores were reported in 2.9% (6/206) 

patients with a baseline and 8-week post treatment scarring assessment. 

In patients applying Aldara® for genital warts, female patients reported severe skin reactions 

including: erythema (3%), ulceration (2%), and edema (1%); and for males, erosion (2%), and 

erythema (1%), edema (1%), induration (1%), and excoriation/flaking (1%). 13 The following 

adverse reactions were reported by >1% of patients: burning, hypopigmentation, irritation, 

itching, pain, rash, sensitivity, soreness, stinging, tenderness, bleeding, burning, itching, pain, 

tenderness, tinea cruris, fatigue, fever, influenza-like symptoms, headache, diarrhea and myalgia. 

Aldara® was studied in male and female patients (n=784) aged 15-77 (mean age 31.5) with 

genital warts. Patients applied Aldara® three times a week for 16 weeks. 25 Some patients were 

treated for up to 32 weeks if their warts were not cleared after the initial 16 week treatment. 

Common adverse events reported in >2% of patients included: application site reactions 26.7%, 

infection 3.8%, upper respiratory infection 3.3%, headache 2.5%, fatigue 2.1%, nausea 2.1%, 

herpes simplex 2.1%, and myalgia 2.0%. In a similar study of male and female patients (n=943) 

age 16-78 (mean 31.2) with genital warts, adverse events reported in >2% of patients included: 

application site reactions 27.7%, infection 4.5%, headache 2.9%, respiratory infection 2.1%, and 

myalgia 2%. 

Similar to the Aldara® package insert, Zyclara® adverse events may differ in clinical 

practice because clinical trials were conducted under variable conditions. 12 Adult patients with 

actinic keratosis completing clinical trials applied Zyclara® daily for 2 weeks to their entire face 

or blading scalp. Treatment cycles were separated by 2 weeks of no treatment. Adverse reactions 

reported in clinical trials are listed below (see table 5). In addition to the adverse events included 

in the chart, the following events have been reported: application site bleeding, application site 

swelling, chills, dermatitis, herpes zoster, insomnia, lethargy, myalgia, pancytopenia, pruritus, 

squamous cell carcinoma, and vomiting. 

Table H-5: Zyclara® Adverse Event Data 

Zyclara® 2.5% 

(n=160) 


(n=160) 

Adverse Events reported in >2% of Patients 

Headache 3(2%) 10(6%) 

Application site pruritus 6(4%) 7(4%) 

Fatigue 2(1%) 7(4%) 

Nausea 1(1%) 6(4%) 

Influenza like illness 6(4%) 1(

(mild, moderate or severe) 

Severe scabbing/crusting 9% 14% 

Edema 

63% 75% 


Severe edema 4% 6% 

Erosion/Ulceration 

52% 62% 


Severe erosion/ulceration 9% 11% 

Exudate 

39% 51% 


Severe Exudate 1% 6% 

Flaking/Scaling/Dryness (mild, moderate or 

88% 91% 

severe): 

Severe Flaking/Scaling/Dryness 4% 8% 

An additional database review of Zyclara® (n=779) across two clinical trials, revealed the 

following adverse events reported in >1% of patients (see table 6). 25 

Tablet H-6: Common Adverse Events Reported in >1% of Patients 


(n=400) 


(n=379) 

Application site pain 28 (7.0%) 20 (5.3%) 

Application site irritation 24 (6.0%) 13 (3.4%) 

Nasopharyngitis 16 (4.0%) 21 (5.5%) 

Upper respiratory tract infection 12 (3.0%) 7 (1.8%) 

Application site pruritus 11 (2.8%) 17 (4.5%) 

Headache 9 (2.3%) 8 (2.1%) 

Vaginitis bacterial 8 (2.0%) 6 (1.6%) 

Nausea 7 (1.8%) 4 (1.1%) 

Back pain 7 (1.8%) 4 (1.1%) 

Urinary tract infection 6 (1.5%) 6 (1.6%) 

Sinusitis 6 (1.5%) 4 (1.1%) 

Sinus congestion 6 (1.5%) 1 (0.3%) 

Cough 5 (1.3%) 5 (1.3%) 

Rash 5 (1.3%) 2 (0.5%) 

Vomiting 5 (1.3%) 1 (0.3%) 

Skin laceration 5 (1.3%) 1 (0.3%) 

In patients applying Zyclara® 3.75% for genital warts (n=400) for up to 8 weeks, adverse 

events occurring in greater than >2% included: application site pain: 28 (7%), application site 

irritation: 24 (6%), application site pruritus: 11 (3%), vaginitis bacterial: 6/216 (3%), and 

headache: 6(2%). Additional local skin reactions that required medical attention, caused patients 

to discontinue the study or extended beyond the treatment area included: erythema (mild, 

moderate or severe): 70%, severe erythema: 9%, edema (mild, moderate or severe): 41%, severe 

edema: 2%, erosion/ulceration (mild, moderate or severe): 36%, severe erosion/ulceration: 11%, 

exudate (mild, moderate or severe): 34%, and severe exudate: 2%. In addition to the adverse 

events included above, these events have been reported: rash, back pain, application site rash, 

application site cellulitis, application site excoriation, application site bleeding, scrotal pain, 

scrotal erythema, scrotal ulcer, scrotal edema, sinusitis, nausea, pyrexia, and influenza-like 

symptoms. 

Adverse events reported for Zyclara® from the sponsor’s clinical trial safety database 

include: anginal pain (angia pectoris, prinzmetal angina): 3 (Rate=0.035%), arrhythmia: 15 

(Rate=0.177%), ventricular arrthythmia: 2 (Rate=0.024%), cardiac arrest: 1 (Rate=0.012%), 

cardiac failure: 7 (Rate=0.083%), chest pain: 12 (Rate=0.142%), dizziness: 66 (Rate=0.780%), 

dyspnea: 2 (Rate=0.024%), fibrillation atrial: 12 (Rate=0.142%), hypotension: 2 (Rate=0.024%), 

H-22

acute myocardial infarction: 3 (Rate=0.035%), palpitation: 9 (Rate=0.106%), pulmonary edema: 

1 (Rate=0.012%), syncope: 7 (Rate=0.083%), tachycardia: 8 (Rate=0.095%), presyncope: 1 

(Rate=0.012%), and tachycardia ventricular: 2 (Rate=0.024%). 24 It is important to note that the 

original FDA approval document only contains data for adult patients. Across five clinical trials, 

patients applying the medication for 2 to 3 week cycles (n=665) experienced the following 

adverse events most often: headache, local site reactions, fatigue and nausea. Patients using the 

higher dose (3.75%) of Zyclara experienced local cite reactions more often. 

Two clinical trials assessing the use of Zyclara® 2.5% and 3.75% in adult patients with 

actinic keratosis were submitted in the original FDA approval document. 24 Patients age 36 to 90 

applied the medication using one of two treatment cycles: 1) 3 weeks of treatment followed by 3 

weeks of rest, 2) 3 weeks of treatment followed by 8 weeks of rest. Adverse events reported most 

often in patients applying Zyclara® included: application site adverse events, fatigue, headache, 

lymphadenopathy and influenza like illness. 

Serious Adverse Events 



treated for up to 32 weeks if their warts were not cleared after the initial 16 weeks. Serious 

adverse events reported in this study included: acute appendicititis (1), skull fracture (1), 

increased depression/suicide attempt (1), suicide attempt/drug overdose (1), inferior mypcardial 

infarction (1), pyelonephritis (1), pacemaker generator exchange (1), pancreatitis (1), cervical 

cancer (1), exacerbation of depression (1), incomplete abortion (1), possible infection of GI tract 

(1), and heroin addiction (1). In a similar study of male and female patients (n=943) age 16-78 

(mean 31.2) with genital warts, 14 patients experienced serious adverse events including: 

alteration in speech and sensation of spaciness (1), fracture of left clavicle (1); exacerbation of 

eczema at non-wart site (1), rectal pain due to internal warts-remote site (1), nephrotic syndrome 

(1), carcinoma of vulva (1), vulval pain (with anorexia and fatigue) (1), depression (1), 

lymphangitis due to dog bite (1), axillary abscess (1), laryngeal cancer (1), vomiting and 

abdominal pain (1), cholecystectomy (1), flu (1), tonsil abscess (1), metrorrhagia (1), and act 

fetal distress (1). 

The first clinical trial reviewed in the original FDA approval document for Zyclara® (GW01- 

0702) had 227 patients complete the study. 24 Severe adverse events reported in patients applying 

the 3.75% cream included: cerebrovascular accident, gout, and atrial fibrillation. Severe adverse 

events reported in patients applying the 2.5% cream included: oral herpes, sinusitis, pneumonia, 

application site infection, bacterial pneumonia, application site irritation, pruritic rash, procedural 

pain, and cartilage injury. The second clinical trial (GW01-704) reported the following severe 

adverse events in patients applying the 3.75% cream: influenza-like illness, chest pain, diarrhea, 

vascular graft, and anxiety. Severe adverse events reported in patients applying the 2.75% cream 

included: bronchiectasis, influenza-like illness twice, cheilitis, lymphadenopathy twice, angina 

pectoris, atrial fibrillation, and arteriosclerosis. 

Serious Adverse events reported across trials (n=160) of adult patients (mean age 64.4) 

applying Zyclara® 2.5% cream for 2 weeks included: atrial fibrillation (1), chest pain (1), 

pneumonia (2), acute myocardial infarction (1), non-cardiac chest pain (1), and ventricular 

tachycardia (1). 24 Events reported in adult patients (n=160) applying Zyclara® 3.75% cream for 

2 weeks included: cerebrovascular accident (1), atrial fibrillation (1), small intestine obstruction 

(1), chest pain (1), anxiety (1), and diarrhea (1). 

H-23

Serious Adverse events reported across trials (n=160) of adult patients (mean age 64.7) 

applying Zyclara® 2.5% cream for 3 weeks included: chest pain (1), pneumonia (1), aortic valve 

stenosis (1), syncope (1), and bronchitis (1). 24 Events reported in adult patients (n=160) applying 

Zyclara® 3.75% cream for 3 weeks included: pneumonia (1), breast cancer (1), surgery (1), 

dyspnea (1), hip fracture (1), arthralgia (1), wound infection (1), coronary artery disease (1), Non 

Hodgkin lymphoma (1), and pancytopenia (1). 

An additional database review of Zyclara® (n=779) across two clinical trials revealed the 

following severe adverse events (see table 7). 25 

Table H-7: Severe Adverse Events Reported in Patients Applying Zyclara® 


(n=400) 


(n=379) 

Application site pain 6 (1.5%) 5 (1.3%) 

Application site irritation 2 (0.5%) 3 (0.8%) 

Application site reaction 1 (0.3%) 3 (0.8%) 

Application site pruritus 1 (0.3%) 2 (0.5%) 

Application site rash 2 (0.5%) 0 

Application site dermatitis 0 1 (0.3%) 

Application site erythema 0 1 (0.3%) 

Application site ulcer 0 1 (0.3%) 

Application site vesicles 1 (0.3%) 0 

Chest pain 1 (0.3%) 0 

Influenza like illness 1 (0.3%) 0 

Pelvic mass 1 (0.3%) 0 

Infections and infestation 3 (0.8%) 3 (1.1%) 

Nasopharyngitis 1 (0.3%) 1 (0.3%) 

Application site infection 0 1 (0.3%) 

Bronchitis 0 1 (0.3%) 

Influenza 1 (0.3%) 0 

Pharyngitis streptococcal 0 1 (0.3%) 

Vaginal infection 1 (0.3%) 0 

Gastrointestinal disorders 3 (0.8%) 2 (0.5%) 

Acute abdomen 1 (0.3%) 0 

Diarrhea 0 1 (0.3%) 

Haemorrhoidal haemorrhage 1 (0.3%) 0 

Haemorrhoids 0 1 (0.3%) 

Proctalgia 1 (0.3%) 0 

Reproductive system and breast disorders 4 (1.0%) 2 (0.5%) 

Scrotal erythema 2 (0.5%) 1 (0.3%) 

Dysmenorrhea 2 (0.5%) 0 

Vulval ulceration 0 1 (0.3%) 

Injury, poisoning and procedural complications 1 (0.3%) 1 (0.3%) 

Gunshot wound 1 (0.3%) 0 

Upper limb fracture 0 1 (0.3%) 

Musculoskeletal and connective tissue disorders 0 1 (0.3%) 

Groin pain 0 1 (0.3%) 

Nervous system disorders 1 (0.3%) 1 (0.3%) 

Headache 1 (0.3%) 0 

Migraine 0 1 (0.3%) 

Respiratory, thoracic and mediastinal disorders 1 (0.3%) 0 

Dyspnea 1 (0.3%) 0 

Iron deficiency anemia 0 1 (0.3%) 

Tooth extraction 1 (0.3) 0 

H-24

Discontinuations 

Patients utilizing Aldara® for actinic keratosis withdrew from studies or initialed rest periods 

most often due to application site reactions and local skin reactions. 13 Specifically, 2% (5/215) of 

patients discontinued from clinical trials due to local skin/application site reactions. Rest periods 

occurred in 16% (35/215), 11% (17/160), and 7% (11/160) of patients using Aldara®, Zyclara® 

3.75% and Zyclara® 2.5% cream respectively. 12,13 Four out of 327 (1.2%) patients applying 

Aldara® and 3 out of 400 (1%) patients applying Zyclara® for genital warts reported 

discontinuing due to local skin/application reactions. 12,13 Thirty-two percent (126/400) of 

patients taking Zyclara® temporarily discontinued treatment due to local skin reactions. 12 



treated for up to 32 weeks if their warts were not cleared after the initial 16 weeks. Patients 

discontinued due to the following adverse events: intolerable local skin reactions: burning, 

tenderness, itching, pain (31); flu-like symptoms (2); fatigue (1); bacterial infection at the wart 

site (1); urethral irritation (1); and intraepithelial vulvar neoplasia (1). In a similar study of male 

and female patients (n=943) age 16-78 (mean 31.2) with genital warts, 105 patients discontinued 

due to an adverse event including: local site reaction: burning, tenderness, itching, and pain (89); 

flu-like symptoms (8); headache, chills and fever (3); worsening of psoriasis (1); generalized 

itching (1); diarrhea (1); vaginal candidiasis (1); and fatigue (1). 

Out of the 227 patients applying Zyclara® and completed the GW01-0702 trial, two 

withdrew from the treatment due to safety reasons: tachycardia, chest pain, hypertension, and 

increased tremors. 24 

Postmarking Adverse Events 

Additional adverse events identified after Aldara® and Zyclara® were brought to the market 

include: tingling at the application site, angioedema, capillary leak syndrome, cardiac failure, 

cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations), 

chest pain, ischemia, myocardial infarction, syncope, thyroiditis, abdominal pain, decreases in 

red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), 

lymphoma, abnormal liver function, herpes simplex, arthralgia, agitation, cerebrovascular 

accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis 

aggravation, paresis, suicide, dyspnea, proteinuria, dysuria, urinary retention, exfoliative 

dermatitis, erythema multiforme, hyper/hypo pigmentation, hypertrophic scar, and Henoch- 

Schönlein purpura syndrome. 12,13 Post-marketing data was gathered by the sponsor in 2004 and 

was included in the Zyclara® original FDA approval document. 24 Adverse reported include: 

chest pain (2), angina (1), myocardial infarction (1), tachycardia (2), syncope (2), palpitation (1), 

sudden death (1) (potentially due to arrhythmia), atrial fibrillation (1). 

Tenormin® (atenolol) 

Tenormin® is not FDA approved for use in pediatric patients and therefore safety data in this 

population is not available. 14 The adverse event data provided below was gathered from the 

Tenormin® package insert and is specific for adult hypertensive patients. Adverse events 

specific for patients using this medication for acute myocardial infarction was not included in 

this analysis. 

Controlled studies in conducted in the United States and in unspecified foreign countries 

revealed the following adverse events associated with atenolol (n=399): bradycardia (3%), cold 

extremities (12%), postural hypotension (4%), leg pain (3%), dizziness (13%), vertigo (2%), 

H-25

light-headedness (3%), tiredness (26%); fatigue (6%), lethargy (3%), drowsiness (2%), 

depression (12%); dreaming (3%), diarrhea (3%), nausea (3%), wheeziness (3%), and dyspnea 

(6%). 14 

Adverse events reported for beta-adrengeric blocking agents in general include: 

agranulocytosis; fever, combined with aching and sore throat, laryngospasm, and respiratory 

distress; reversible mental depression progressing to catatonia; acute reversible syndrome 

characterized by disorientation of time and place; short-term memory loss; emotional lability 

with slightly clouded sensorium; decreased performance on neuropsychometrics; mesenteric 

arterial thrombosis, ischemic colitis, erythematous rash; skin rashes and/or dry eyes. 14 

Post-marketing Adverse Events 

Additional adverse events revealed during post-marketing surveillance include: dry mouth, 

headache, elevated liver enzymes and/or bilirubin, hallucinations, impotence, purpura, reversible 

alopecia, Peyronie's disease, postural hypotension which may be associated with syncope, 

psoriasiform rash or exacerbation of psoriasis, psychoses, thrombocytopenia, visual disturbance, 

sick sinus syndrome, development of antinuclear antibodies (ANA), lupus syndrome, and 

Raynaud’s phenomenon. 14 

Timoptic® (timolol maleate), Timoptic-XE® (timolol maleate), Betimol® (timolol) 

Timoptic®, Timoptic-XE®, and Betimol® are not FDA approved for use in pediatric 

patients and therefore safety data in this population is not available. 15-17 The adverse event data 

provided below is gathered from the package inserts for these medications and is specific for 

adult patients. These medications are ophthalmic preparations and therefore many of the 

common adverse events are associated with the ophthalmic route of administration. One in eight 

patients reported stinging and burning after administration of all three of these medications. 15-17 

In patients taking Timoptic-XE®, one in three patients, in clinical trials, experienced blurred 

vision upon drop administration lasting 30 seconds to 5 minutes. 16 One in eight patients reported 

stinging and burning after use. Additional adverse events reported in 1-5% of patients included: 

pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching and tearing, 

headache, dizziness, and upper respiratory infections. 

In patients taking Betimol® 0.25% or 0.5%, adverse events that occurred more than 5% in 

two controlled clinical studies (n=184 patients) included: dry eyes, itching, foreign body 

sensation, discomfort in the eye, eyelid erythema, conjunctival injection, and headache. 17 

Adverse events occurring at a frequency of 1-5% included: eye pain, epiphora, photophobia, 

blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis and cataract, 

allergic reaction, asthenia, common cold and pain in extremities, hypertension, nausea, 

peripheral edema, dizziness, dry mouth, respiratory infection and sinusitis. Additional adverse 

events reported in ophthalmic use of beta-blockers include: blepharoptosis, retinal vascular 

disorder, bronchospasm. 

The following adverse events were reported in the package inserts of both Timpotic® and 

Timoptic-XE®: headache; asthenia/fatigue; arrhythmia; hypertension; worsening of angina 

pectoris; pulmonary edema; edema; claudication; Raynaud's phenomenon; cold hands and feet; 

nausea; dyspepsia; anorexia; dry mouth; systemic lupus erythematosus; dizziness; somnolence; 

insomnia; nightmares; behavioral changes and psychic disturbances including confusion, 

hallucinations, anxiety, disorientation, nervousness, and memory loss; alopecia and psoriasiform 

rash or exacerbation of psoriasis; signs and symptoms of systemic allergic reactions, including 

anaphylaxis, and angioedema; cough and upper respiratory infections; signs and symptoms of 

H-26

ocular irritation including blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign 

body sensation, itching and tearing, and dry eyes; ptosis; cystoid macular edema; visual 

disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal 

detachment following filtration surgery; tinnitus; retroperitoneal fibrosis; decreased libido; and 

Peyronie's disease. 15,16 

Adverse events reported for Betimol®, Timpotic®, Timoptic-XE® included: conjunctivitis, 

decreased corneal sensitivity, visual disturbances including refractive changes and diplopia, chest 

pain, arrhythmia, palpitation, bradycardia, hypotension, syncope, heart block, cerebral vascular 

accident, cerebral ischemia, cardiac failure, cardiac arrest, masked symptoms of hypoglycemia in 

diabetic patients, diarrhea, depression, impotence, increase in signs and symptoms of myasthenia 

gravis and paresthesia, dyspnea, bronchospasm (predominantly in patients with preexisting 

bronchospastic disease), respiratory failure, nasal congestion; alopecia, urticaria, and 

localized/generalized rash. 15-17 

Adverse events reported for oral timolol and oral beta-blocking agents that could be 

considered potential adverse events for ophthalmic timolol include: erythematous rash; fever 

combined with aching and sore throat; laryngospasm with respiratory distress; extremity pain; 

decreased exercise tolerance; weight loss; worsening of arterial insufficiency; vasodilatation; 

gastrointestinal pain; hepatomegaly; vomiting; mesenteric arterial thrombosis; ischemic colitis; 

nonthrombocytopenic purpura; thrombocytopenic purpura; agranulocytosis; hyperglycemia; 

hypoglycemia; pruritus; skin irritation; increased pigmentation; sweating; arthralgia; vertigo; 

local weakness; diminished concentration; reversible mental depression progressing to catatonia; 

an acute reversible syndrome characterized by disorientation for time and place; emotional 

lability; slightly clouded sensorium; and decreased performance on neuropsychometrics; rales; 

bronchial obstruction; urination difficulties. 15,16 

H-27

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25. Zyclara Medical Review - Original 




H-28

Diagnosis and Management of Infantile Hemangioma

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