TY - JOUR
T1 - Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care
T2 - Double blind randomised placebo controlled trial
AU - Williamson, Ian
AU - Benge, Sarah
AU - Barton, Sheila
AU - Petrou, Stavros
AU - Letley, Louise
AU - Fasey, Nicky
AU - Haggard, Mark
AU - Little, Paul
PY - 2010/1/9
Y1 - 2010/1/9
N2 - Objective: To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion. Design: Double blind randomised placebo controlled trial. Setting: 76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007. Participants: 217 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). Intervention: Mometasone furoate 50 μg or placebo spray given once daily into each nostril for three months. Main outcome measures: Proportions 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 prespecified 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. Conclusions: Topical 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 registration: Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.
AB - Objective: To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion. Design: Double blind randomised placebo controlled trial. Setting: 76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007. Participants: 217 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). Intervention: Mometasone furoate 50 μg or placebo spray given once daily into each nostril for three months. Main outcome measures: Proportions 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 prespecified 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. Conclusions: Topical 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 registration: Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.
UR - http://www.scopus.com/inward/record.url?scp=74949091958&partnerID=8YFLogxK
U2 - 10.1136/bmj.b4984
DO - 10.1136/bmj.b4984
M3 - Article
C2 - 20015903
AN - SCOPUS:74949091958
SN - 0959-8146
VL - 339
SP - 83
JO - BMJ (Online)
JF - BMJ (Online)
M1 - b4984
ER -