• Ian Williamson, Sarah Benge, Sheila Barton, Stavros Petrou, Louise Letley, Nicky Fasey, Mark Haggard, and Paul Little.
• Primary Medical Care, University of Southampton, Aldermoor Health Centre, Southampton SO16 5ST. igw@soton.ac.uk
• BMJ. 2009 Jan 1;339:b4984.

ObjectiveTo determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion.DesignDouble blind randomised placebo controlled trial.Setting76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007.Participants217 children aged 4-11 years who had at least one practice recorded episode of otitis media or a related ear problem in the previous 12 months, and with bilateral otitis media with effusion confirmed by a research nurse using otoscopy plus micro-tympanometry (B/B or B/C2, modified Jerger types).InterventionMometasone furoate 50 microg or placebo spray given once daily into each nostril for three months.Main Outcome MeasuresProportions of children cured of bilateral otitis media with effusion assessed with tympanometry (C1 or A type) at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms. Results 41% (39/96) of the topical steroid group and 45% (44/98) of the placebo group were cured in one or both ears at one month (difference favouring placebo 4.3% (95% confidence interval -9.3% to 18.1%). Poisson regression was done with adjustment for four pre-specified covariates (clinical severity, P=0.003; atopy, P=0.67; age, P=0.92; season, P=0.71). The adjusted relative risk at one month was 0.97 (95% confidence interval 0.74 to 1.26). At three months, 58% of the topical steroid group and 52% of the placebo group were cured (relative risk 1.23, 0.84 to 1.80). Diary symptoms did not differ between the two groups, and no significant harms were reported.ConclusionsTopical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months.Trial RegistrationCurrent Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.

16 keywords...

hide…