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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
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Williamson, I. (Ian), Dr., Benge, Sarah, Barton, S., Petrou, Stavros, Letley, L., Fasey, N., Haggard, M. P. and Little, P. (2009) 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, Vol.339 (No.b4984 ). doi:10.1136/bmj.b4984 ISSN 0959-8138.
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Official URL: http://dx.doi.org/10.1136/bmj.b4984
Abstract
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 ยตg 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 โ9.3% 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.
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.
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > RF Otorhinolaryngology R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Otitis media with effusion in children -- Treatment, Adrenocortical hormones, Intranasal medication, Placebos (Medicine), Clinical trials | ||||
| Journal or Publication Title: | BMJ | ||||
| Publisher: | B M J Group | ||||
| ISSN: | 0959-8138 | ||||
| Official Date: | 16 December 2009 | ||||
| Dates: |
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| Volume: | Vol.339 | ||||
| Number: | No.b4984 | ||||
| DOI: | 10.1136/bmj.b4984 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||
| Funder: | NIHR Health Technology Assessment Programme (Great Britain) (NIHR HTA) |
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