[Downloaded free from http://www.ejo.eg.net on Friday, March 25, 2016, IP: 156.211.38.16] 208 Original article A comparative study of the eficacy of topical nasal steroids versus systemic steroids in the treatment of otitis media with effusion in children Mohamed Anwara, Mosaad Abdel-Aziza, Ahmad Nassara, Tamer Ismailb a Department of Otorhinolaryngology, Faculty of Medicine, Cairo University, Cairo, bHearing and Speech Institute, Cairo, Egypt Objective Correspondence to Ahmad Nassar, MD, Department of Otorhinolaryngology, Faculty of Medicine, Cairo University, Cairo, 11933, Egypt Tel: +20 122 290 3321; fax: (+202)23595174; e-mail: ahmednassar_79@hotmail.com Methods Received 08 July 2015 Accepted 28 July 2015 The Egyptian Journal of Otolaryngology 2015, 31:208–212 To evaluate the effectiveness of using topical nasal steroids versus oral steroids in the treatment of otitis media with effusion (OME) in children. One hundred (100) patients were included in the study, they were divided into two equal groups, group A received intranasal mometasone furoate spray once daily for 6 weeks, and group B received oral steroids in tapering doses for 6 weeks, plus systemic antibiotics, and nasal decongestants for both groups, tympanogram was done every 2 weeks for all patients. Results Highly signiicant improvement (P < 0.01) of OME regarding symtoms, signs, and tympanometric results, occurred in each group separately at the end of the study, with no signiicant difference (P > 0.05) in improvement between the two groups. Conclusion Both topical intranasal and oral steroids are effective medical therapy in the treatment of OME in children with no signiicant difference between the two methods. Keywords: otitis media with effusion, systemic steroids, topical nasal steroids Egypt J Otolaryngol 31:208–212 © 2015 The Egyptian Oto - Rhino - Laryngological Society 1012-5574 Introduction Otitis media with efusion (OME) or glue ear is the collection of luid behind the tympanic membrane without inlammatory signs present for 6 weeks [1]. By the age of 4 years, ~80% of children will have had an episode of OME, most of which resolve and only 10% of episodes last for a year or more [2]. he natural history of otitis media is very favorable. Combined estimates of spontaneous resolution provide a benchmark, against which new or established interventions can be evaluated. he need for surgery in children with recurrent acute otitis media (AOM) or chronic OME should be balanced against the likelihood of timely spontaneous resolution and the potential risk for learning, language, or other adverse sequelae from persistent middle ear efusion [3]. Adenoidal hypertrophy (AH) and OME are the most frequent indications for surgery in children. he current treatment options for OME include the following: elimination of the risk factors, follow-up without treatment, use of antibiotic and/or decongestant medication, maneuvers to open the Eustachian tubes, such as with nasal balloons, prophylactic antibiotic use, and, if medical treatment fails, tympanostomy tube placement with or without adenoidectomy [4,5]. Recently, a potential role of corticosteroids in the treatment of OME has emerged. he short-term use of systemic steroids provides a temporary improvement, but longterm use of systemic steroids is not appropriate in children due to severe side efects. In contrast, topical nasal steroids without systemic side efects might be used [6]. his study aimed to compare the eicacy of the use of topical intranasal steroids with oral steroids in the treatment of OME in children. Materials and methods his study was conducted on 100 patients sufering from OME. Patients were selected from those attending ENT clinics of Kasr El Eini Cairo University Hospital during the period from January This is an open access aricle distributed under the terms of the Creaive Commons Atribuion-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creaions are licensed under the idenical terms. © 2015 The Egyptian Journal of Otolaryngology | Published by Wolters Kluwer - Medknow DOI: 10.4103/1012-5574.168210 [Downloaded free from http://www.ejo.eg.net on Friday, March 25, 2016, IP: 156.211.38.16] Eficacy of topical nasal vs. systemic steroids Anwar et al. 209 2013 to September 2014. he study was approved by the scientiic and ethical committee of Kasr Alaini Hospital, Faculty of Medicine, and Cairo University. Inclusion criteria (1) Children aged 3–10 years. (2) Documented middle ear efusion by means of otoscopic examination and tympanometry (bilateral type B tympanogram) at the time of entry to the study. (3) Conductive hearing loss in pure-tone audiometry, if possible, (above the age of 6 years) supporting the diagnosis of OME. and a pure-tone audiogram (above the age of 6 years). he appropriate method of using the intranasal steroid spray was demonstrated at the baseline visit to the children’s parents. he parent’s use of the spray was observed and assessed. his was intended to produce maximal local anti-inlammatory efects on the posterior nasal airway. At the follow-up visits (every 2 weeks), subjective improvement in the symptoms, otoscopic examination indings, and the tympanometry evaluation were recorded. Exclusion criteria (1) Children who have taken systemic or topical intranasal steroids in the previous 3 months. (2) Children who previously underwent operative procedures for treatment of their OME. All patients were subjected to the following diagnostic workup: Full medical history including diminution of hearing, tinnitus, earache, or any associated complaint, and full clinical examination including general examination and otoscopic examination. Basic audiological evaluation to diagnose otitis media with effusion (1) Tympanometry: using low frequency probe tone 226 Hz for pressure applied to the external canal between +300 and −300 daPa. (2) Pure-tone audiometry (if possible) was carried out in children older than 6 years to diagnose the degree of hearing loss. Children meeting the inclusion criteria were divided into two equal groups: Group A (50 children) received 50 µg (one puf ) of topical intranasal mometasone furoate, once a day for 6 weeks in each nostril (total daily dose of 100 µg). Group B (50 children) received oral prednisolone in syrup form at a dose of 1 mg/kg/day in divided doses in tapering doses for 6 weeks. In addition, both groups received systemic antibiotic (amoxicillin) for 10 days and nasal decongestants (xylometazoline) for 5 days. Outcome of the study (1) Resolution or cure of bilateral glue ear was deined as complete bilateral clearance (A tympanogram) at any stage. (2) Partial improvement was deined by C tympanogram. (3) No improvement was deined by persistence of B tympanogram. Results he present study included 100 patients (children) between 3 and 10 years of age (65% male and 35% female patients). he patients were divided into two equal groups (group A and group B) for a comparative study between the use of oral steroids and topical nasal steroids in the treatment of OME. Group A received intranasal mometasone furoate monohydrate at a dose of 100 µg/day, one spray in each nostril once a day for 6 weeks. Group B received oral prednisolone in tapering doses for 6 weeks. A highly signiicant improvement in OME as regards symptoms, signs, and tympanometric results occurred within each group at the end of the study, with no signiicant diference in improvement between the two groups. here was no signiicant diference between group A and group B as regards improvement in hearing impairment at all stages of the study, but a highly signiicant diference between the two groups was found at stage 2 (after 4 weeks) (Table 1). A highly signiicant improvement in hearing occurred within each group separately at the end of the study, with no signiicant improvement in group A after 2 weeks and after 6 weeks in group B (Fig. 1). All patients were evaluated at 0, 2, 4, and 6 weeks The assessment of each patient included history taking, otoscopic examination, a tympanogram, As regards earache, there was no signiicant diference between group A and group B at all stages of the [Downloaded free from http://www.ejo.eg.net on Friday, March 25, 2016, IP: 156.211.38.16] 210 The Egyptian Journal of Otolaryngology B after 4 weeks and in both groups after 6 weeks. Overall, there was a highly signiicant improvement in tympanic membrane appearance within each group separately. Figure 1 As regards the tympanogram results, there was no signiicant diference between group A and group B at all stages of the study. Within each group separately, there was a highly signiicant improvement in tympanometric results in both groups at all stages of the study except at the irst stage (after 2 weeks), when there was a signiicant improvement in group A. Improvement in hearing impairment with time within each group separately. Table 1 Comparison between the two groups as regards hearing impairment at different time points Hearing impairment at Start of treatment Positive Negative After 2 weeks Positive Negative After 4 weeks Positive Negative After 6 weeks Positive Negative Group A [N (%)] Group B [N (%)] χ2 P value 50 (100.0) 0 (0.0) 50 (100.0) 0 (0.0) 0 1.0 NS 47 (94.0) 3 (6.0) 42 (84.0) 8 (16.0) 2.6 0.2 NS 36 (72.0) 14 (28.0) 21 (42.0) 29 (58.0) 9.2 0.004 HS 24 (48.0) 26 (52.0) 20 (40.0) 30 (60.0) 0.6 0.5 NS HS, highly signiicant (P < 0.01); NS, nonsigniicant (P > 0.05); S, signiicant (P = 0.05–0.01). study. Within each group separately, there was a highly signiicant improvement after 2 weeks in both groups. Overall, there was a highly signiicant improvement within each group separately. No signiicant diference was found between group A and group B as regards tympanic membrane appearance at all stages of treatment. Within each group separately, there was no signiicant improvement in both groups after 2 weeks and in group A after 4 weeks, but a highly signiicant improvement occurred in group B after 4 weeks and in both groups after 6 weeks. Overall, there was a highly signiicant improvement in tympanic membrane appearance within each group separately. No signiicant diference was found between group A and group B as regards improvement in tympanic membrane retraction at all stages of the treatment. Within each group separately, there was no signiicant improvement in both groups after 2 weeks and in group A after 4 weeks, but a highly signiicant improvement occurred in group Discussion OME has been deined as the presence of luid in the middle ear without signs or symptoms of acute ear infection [7]. Epidemiological studies of OME reveal that it afects 50–80% of children by the age of 5 [8,9]. Without efective intervention, severe OME can cause signiicant hearing loss, which may result in linguistic, developmental, behavioral, motor, and social impairment [10]. Although many OME cases resolve spontaneously, referral rates from primary care remain high, with ∼1–5/1000 children in the general population undergoing surgery (grommets) each year [11]. OME in children is a global health problem due to its negative impact on quality of life. It is one of the most common causes of treatable conductive hearing loss. Many patients remain undiagnosed especially in developing countries, which can lead to poor performance in school and afect the overall development of the child. In recent years, the diagnosis and method of treatment of OME have emerged. Many studies have conduced however that the usefulness of steroid spray in patients with OME is debatable. he mechanism of action of steroids in this context is still unclear. Mometasone furoate has been shown to help in the recovery of transport function of ciliary epithelium helping in appreciable clinical efect [12]. A high level of expression of the human glucocorticoid receptor-a (vs. b) in the adenoids and tonsils of patients who have obstructive sleep apnea versus recurrent throat infections suggested a possible chance for these patients to respond to topical steroid therapy [13]. he current treatment options for OME include elimination of the risk factors, follow-up without treatment, use of antibiotic and/or decongestant medication, maneuvers to open the Eustachian tubes, such as with nasal balloons, prophylactic antibiotic use, and, if medical treatment fails, tympanostomy tube placement with or without adenoidectomy [4,5]. [Downloaded free from http://www.ejo.eg.net on Friday, March 25, 2016, IP: 156.211.38.16] Eficacy of topical nasal vs. systemic steroids Anwar et al. 211 Systemic corticosteroids produce a prompt, temporary decrease in adenoid size and resolution in middle ear efusion, but signiicant side efects cause avoidance of its chronic use in children [14]. Compared with systemic steroids, topical nasal steroids have limited systemic efects and would be expected to exert their antiinlammatory efects locally on the nose, nasopharynx, and Eustachian tube [15]. Although systemic steroids have been extensively studied, the topical nasal steroids as the sole treatment of OME and adenoid hypertrophy have not been adequately evaluated. he present study included 100 patients (children) divided into two equal groups (group A and group B) in a comparative study between the use of oral steroids and topical nasal steroids in the treatment of OME within 6 weeks. Group A received intranasal mometasone furoate at a dose of 100 µg/day, one spray in each nostril once a day for 6 weeks, and group B received oral prednisolone in tapering doses for 6 weeks. In addition, both groups received systemic antibiotic (amoxicillin) for 10 days and nasal decongestant (xylometazoline) for 5 days. A highly signiicant improvement (P < 0.01) in OME as regards symptoms, signs, and tympanometric results occurred within each group at the end of the study, with no signiicant diference (P > 0.05) in improvement between the two groups. Cengel and Akyo conducted a prospective, controlled, randomized, clinical study on a total of 122 children (3–15-year-old) who were on the waiting list for adenoidectomy and/or ventilation tube placement; they were enrolled into the study and control groups. he study group (67 patients with AH, 34 of them with OME) received intranasal mometasone furoate monohydrate at a dose of 100 µg/day, one spray in each nostril once a day for 6 weeks. he control group (55 patients with AH, 29 of them with OME) was followed up without any treatment. No other medication was allowed during the study in either group. Resolution of OME in the study group (42.2%) was signiicantly higher than that in the control group (14.5%). Forty-ive patients (67.2%) with adenoid hypertrophy in the study group showed signiicant decreases in adenoid size according to the endoscopic evaluation compared with the control group. A signiicant improvement in obstructive symptoms was seen in the treatment group. hese results indicated that nasal mometasone furoate monohydrate treatment can signiicantly reduce adenoid hypertrophy and obstructive symptoms and is a useful alternative to surgery, at least in the short term, for OME [6]. Williamson and colleagues reported a randomized, placebo-controlled trial on 217 children aged 4–11 years presenting with one or more episodes of otitis media or ear-related problems in the previous 12 months and with bilateral OME who were enrolled into two groups. he study group received topical nasal steroid mometasone furoate (50 µg) in each nostril, and the placebo group received topical nasal steroid mometasone furoate once daily for 3 months. An overall 41% of the topical steroid group and 45% of the placebo group were cured in one or both ears at 1 month. At 3 months, 58% of the topical steroid group and 52% of the placebo group were cured. However, they concluded that topical steroids are unlikely to be an efective treatment for OME in general practice [16]. In our study, both topical and systemic steroids gave a highly signiicant improvement as regards symptoms, signs, and tympanometric results in OME at the end of the study (after 6 weeks). hus, both topical intranasal and systemic steroid administration are considered efective treatments of OME in children; however, complications of systemic steroids can be avoided using topical steroids. Conclusion Both topical intranasal and oral steroids are efective adjunctive treatment for OME in children in the short term. In our study, 100 children who fulilled the inclusion criteria were divided into two equal groups: group A received topical intranasal steroids and group B received oral steroids. he results showed improvement in the average tympanogram results in 17 patients from group A and in 21 patients from group B after treatment. From these indings, it can be concluded that both topical intranasal and systemic steroids are efective in the treatment of OME in children, without signiicant diference between the two methods, and thus oral steroid complications could be avoided using local steroid spray. Financial support and sponsorship Nil. Conlicts of interest here are no conlicts of interest. References 1 Stool SE, Berg AO, Berman S, et al. Otitis media with effusion in young children. Agency for Health Care Policy and Research. Clin Pract Guideline 1994; 12:1–13. 2 Williamson IG, Dunleavey J, Bain J, Robinson D. The natural history of otitis media with effusion — a three-year study of the incidence and prevalence of abnormal tympanograms in four South West Hampshire infant and irst schools. J Laryngol Otol 1994; 108:930–934. [Downloaded free from http://www.ejo.eg.net on Friday, March 25, 2016, IP: 156.211.38.16] 212 The Egyptian Journal of Otolaryngology 3 Rosenfeld RM, Kay D. Natural history of untreated otitis media. The laryngoscope. Lippincott Williams & Wilkins; 2003; 113:1645–1657. 4 American Academy of Family Physicians, American Academy Of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics 2004; 113:1412–1429. 11 Petrou S, Dakin H, Abangma G, Benge S, Williamson I. Cost–utility analysis of topical intranasal steroids for otitis media with effusion based on evidence from the GNOMETrial. Value Health 2010; 13:543–551. 5 Rosenfeld RM, Bluestone CD. Evidence-based otitis media. Hamilton, Canada: BC Decker Inc; 1999. 12 Poliakova SD, Popova EA. Effectiveness criteria for the topical application of glucocorticosteroids to the treatment of exudative otitis media associated with allergic rhinitis. Arch Otolaryngol Head Neck Surg 2011; 137:449–455. 6 Cengel S, Akyol MU. The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy. Int J Pediatr Otorhinolaryngol 2006; 70:639–645. 13 Goldbart AD, Veling MC, Goldman JL, Li RC, Brittian KR, Gozal D. Glucocorticoid receptor subunit expression in adenotonsillar tissue of children with obstructive sleep apnea. Pediatr Res 2005; 57:232–236. 7 Stool SE, Berg AO, Berman S, et al. Otitis media with effusion in children. Guideline Technical Report. No 12. AHCPR. Pub No.95-0621. Rockville, MD: US Department of Health and Human Services; 1994. 14 Laliberte F, Laliberte MF, Lecart S, Bousquet J, Klossec JM, Mounedji N. Clinical and pathologic methods to assess the long-term safety of nasal corticosteroids. French Triamcinolone Acetonide Study Group. Allergy 2000; 55:718–722. 8 Zielhuis GA, Rach GH, Broek PV. Screening for otitis media with effusion in preschool children. Lancet 1989; 1:311–314. 9 Casselbrant ML, Brostoff LM, Cantekin EI, Flaherty MR, Doyle WJ, Bluestone CD, Fria TJ. Otitis media with effusion in preschool children. Laryngoscope 1985; 95:428–436. 10 Haggard M, Hughes E. Screening children’s hearing: a review of the literature and implications of otitis media. London, UK: HMSO; 1991. 15 Szeler SJ. Pharmacokinetics of intranasal corticosteroids. J Allergy Clin Immunol 2001; 108:26–31. 16 Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. Topical intranasal corticosteroids in 4–11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial. BMJ 2009; 339:b4984. [Downloaded free from http://www.ejo.eg.net on Friday, March 25, 2016, IP: 156.211.38.16] Original article 213 The role of intranasal prelacrimal recess approach in complete removal of anterior maxillary sinus lesions Mohammed A. Al Ayadi, Sherif A. Raafat, Khalid A. Ateya, Fadi M. Gharib, Abdullah M. Al Murtada Department of Otorhinolaryngology, Suez Canal University, Thamar University, Dhamar, Yemen Correspondence to Fadi Mahmoud Gharib, MD, 7 Khaleefa Al Motee St., 7th District, Nasr City, Cairo, 11471, Egypt Tel: +20 122 581 9057; e-mail: fadigharib@hotmail.com Received 24 April 2015 Accepted 30 June 2015 The Egyptian Journal of Otolaryngology 2015, 31:213–218 Objective The aim of the study was to assess the role of the intranasal prelacrimal recess approach (PLRA) in complete removal of anterior maxillary lesions. Study design This was a prospective study in which 20 patients were recruited between July 2013 and September 2014 from the Otorhinolaryngology outpatient clinic, Cairo University. Patients and methods Patients with anterior maxillary sinus (MS) lesions underwent endoscopic sinus surgery and had their lesions removed through the maxillary ostium. The PLRA was then performed to assess the presence of any anterior maxillary remnants, which were then removed. Results The intranasal pathologies included sinonasal polyposis (four patients), recurrent sinonasal polyposis (four patients), antrochoanal polyps (four patients), allergic fungal sinusitis (ive patients), inverted papilloma (one patient), lymphoma (one patient), and cancer maxilla (one patient). After the PLRA 45% of the patients showed remnants. These included antrochoanal polyp (two patients), recurrent sinonasal polyposis (one patient), allergic fungal sinusitis (three patients), inverted papilloma (one patient), lymphoma (one patient), and cancer maxilla (one patient). Conclusion Our preliminary study demonstrated that without the PLRA 45% of the cases will have remnants missed in hidden areas of the MS. The PLRA is a minimally invasive technique to deal with anterior MS lesions. Keywords: maxillary sinus, nasal endoscope, nasolacrimal duct Egypt J Otolaryngol 31:213–218 © 2015 The Egyptian Oto - Rhino - Laryngological Society 1012-5574 Introduction Functional endoscopic sinus surgery is the gold standard surgical treatment in patients with chronic rhinosinusitis. It has an 80–90% success rate in primary surgeries [1]. However, the success rate drops to 50–70% in revision surgeries. The approach to the severely diseased sinus, especially the maxillary sinus (MS), is still controversial. Because of the anatomy of the MS and the characteristics of diseases originating in it, as assessed with multiangled telescopes, there are still some areas that cannot be viewed and handled [2]. Although a good visualization is provided for complete excision of the lesion, from the viewpoint of minimal invasion, a drawback still exists in both external and intranasal surgical procedures. Compromise of the inferior turbinate (IT) and nasolacrimal duct (NLD) is often unavoidable [3]. he endonasal endoscopic prelacrimal recess approach (PLRA) provides a clear view. It enables us to accurately, mini-invade and completely remove benign MS lesions. It is a physiological and functional surgery, and has great advantages in treating the diseases of the nasal cavity [4]. Prelacrimal recess is a concavity in the medial, anterosuperior part of the MS. It is located in front of the eminence of the lacrimal passages on the medial sinus wall (Fig. 1) [2]. As reaching hidden areas in the MS is still problematic, this study was conducted to assess the role of the PLRA in dealing with anterior lesions of the MS. This is an open access aricle distributed under the terms of the Creaive Commons Atribuion-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creaions are licensed under the idenical terms. © 2015 The Egyptian Journal of Otolaryngology | Published by Wolters Kluwer - Medknow DOI: 10.4103/1012-5574.168211