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Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial.

ABSTRACT: BACKGROUND:Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. OBJECTIVE:To compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran. METHODS:This randomized controlled trial was done on 2- to 6-year-old children attending Koodakan Hospital in Bandar Abbas, southern Iran, in 2014. Patients were divided into three groups of montelukast, mometasone, and control group. Audiometry was done for all patients at baseline and four weeks after treatment. Patients were compared for treatment results. Data were analyzed using SPSS 21.0 software. RESULTS:A total of 143 children were included in the study. Mean age of the participants were 44.64 ± 18.03 months. There was no significant difference in treatment results in different treatment groups (p>0.05). CONCLUSION:Mometasone and montelukast are not effective and not recommended in treatment of otitis media with effusion in children. More studies are needed in this regard. TRIAL REGISTRATION:This study is registered at ClinicalTrials.gov with ClinicalTrials.gov Identifier: NCT02541760. FUNDING:The authors received financial support for this research from Hormozgan University of Medical Sciences.

SUBMITTER: Rahmati MB

PROVIDER: S-EPMC5587009 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial.

Rahmati Mohammad Bagher MB Safdarian Fatemeh F Shiroui Babak B Zare Shahram S Sadeghi Naser N

Electronic physician 20170725 7

<h4>Background</h4>Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue.<h4>Objective</h4>To compare the effectiveness of montelukast and mometasone nasal spray in treatmen ...[more]

PMID: 28894551

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Project description:BackgroundChildren with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.MethodsIn this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2-8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431.FindingsBetween March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40%) children in the oral steroid group and in 59 (33%) in the placebo group (absolute difference 7% [95% CI -3 to 17], number needed to treat 14; adjusted odds ratio 1·36 [95% CI 0·88-2·11]; p=0·16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.InterpretationOtitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2-8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence.FundingNational Institute for Health Research (NIHR) Health Technology Assessment programme.

Project description:Different guidelines are adopted in clinics and countries to assess pure tone hearing sensitivity in children with otitis media with effusion (OME). Some guidelines specify a broad range of audiometric frequencies that must be tested and from which average thresholds determined, while others leave test frequencies unspecified. For guidelines that suggest specific frequencies there are various pure tone frequencies and frequency ranges given. The present study investigated whether (1) a full range of audiometric frequencies is required to evaluate hearing loss caused by OME in children, or if neighboring frequencies provide essentially the same threshold information, and (2) if different combinations of test frequency pure tone averaging calculations may affect decision criteria for surgical treatment. In a retrospective cohort study, right and left ear air conduction pure tone threshold data were obtained, from 125 Hz to 8 kHz, for 96 children with OME aged 4 to 12 years. Paired t-tests, correlation tests (Pearson's r, Cronbach's alpha, intraclass correlation) and absolute differences were used to examine the relationships among pure tone audiometric (PTA) frequencies for all ears with hearing loss. 168 ears were found to have OME-related hearing loss. Only the 125 Hz-250 Hz comparison showed no statistically significant difference between neighboring thresholds. However, only the 4 kHz and 8 kHz comparison showed a clinically significant mean difference of ≥ 10 dB. When viewing individual differences, comparison between 250 Hz and 500 Hz, 125 Hz and 500 Hz, and 4 kHz and 8 kHz, showed a large number of ears with clinically significant differences between test frequencies. Comparisons among low frequency 3 PTA average (500 Hz, 1 kHz, 2 kHz), high frequency 3 PTA average (1 kHz, 2 kHz, 4 kHz), and 4 frequency PTA average (500 Hz, 1 kHz, 2 kHz, 4 kHz) showed no statistically significant differences, with very strong correlations for all comparisons. In addition, for all the combinations of PTA averages, no clinically significant differences were found for the various comparisons or among individual results. Clinically, testing hearing sensitivity in the 125 Hz to 8 kHz range is worthwhile in evaluating hearing sensitivity in children with OME due to large individual variability across audiometric frequencies. However, frequencies tested for criterion averages for surgical treatments of children with OME may be restricted to 3 frequency PTA averages, either an average of 500 Hz, 1 kHz, 2 kHz or an average of 1 kHz, 2 kHz, 4 kHz, as no clinically significant differences were found using these or a 4 frequency averaging technique. For research purposes, 250 Hz can proxy for hearing thresholds at 125 Hz; and the low frequency 3 PTA average, high frequency 3 PTA average and 4 frequency PTA average may be used interchangeably, as no statistically significant differences were found among these measures.

Dataset Information

Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial.

Publications

Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial.

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