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
Williamson, Ian, Benge, Sarah, Barton, Sheila, Petrou, Stavros, Letley, Louise, Fasey, Nicky, Haggard, Mark and Little, Paul (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. British Medical Journal, 339:b4984 (doi:10.1136/bmj.b4984).
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Description/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 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 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: | Article |
|---|---|
| ISSNs: | 0959-8138 (print) |
| Related URLs: | |
| Subjects: | R Medicine > RJ Pediatrics |
| Divisions: | University Structure - Pre August 2011 > School of Medicine > Community Clinical Sciences |
| Item ID: | 73273 |
| Date Deposited: | 04 Mar 2010 |
| Last Modified: | 02 Mar 2012 12:54 |
| Contributors: | Williamson, Ian (Author) Benge, Sarah (Author) Barton, Sheila (Author) Petrou, Stavros (Author) Letley, Louise (Author) Fasey, Nicky (Author) Haggard, Mark (Author) Little, Paul (Author) |
| Date: | 16 December 2009 |
| Status: | Published |
| Contact Email Address: | igw@soton.ac.uk |
| URI: | http://eprints.soton.ac.uk/id/eprint/73273 |
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