Trial reportBMJ (Clinical research ed.)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.
Trial report in BMJ (Clinical research ed.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Topical and oral steroids for otitis media with effusion (OME) in children.The Cochrane database of systematic reviews · 2023Pooled it
- Otitis media with effusion in children.BMJ clinical evidence · 2011Pooled it
- Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children.The Cochrane database of systematic reviews · 2010Pooled it
- Trial
- Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2015Trial
- Allergy in pathogenesis of Eustachian Tube Dysfunction.The World Allergy Organization journal · 2024Review
- Cochlear Implantation in Deaf Children with Coexisting Otitis Media with Effusion: A comparative study.Sultan Qaboos University medical journal · 2023Article
- Availability and Affordability of Primary Health Care Among Vulnerable Populations in Urban Kumasi Metropolis: Family Health Perspective.Health equity · 2022Article
- Role of Allergy in Eustachian Tube Dysfunction.Current allergy and asthma reports · 2020Review
- International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.International forum of allergy & rhinology · 2018Article
- Curcumin suppresses NTHi-induced CXCL5 expression via inhibition of positive IKKβ pathway and up-regulation of negative MKP-1 pathway.Scientific reports · 2016Article
- The Efficacy of Nasal Steroids in Treatment of Otitis Media with Effusion: A Comparative Study.International archives of otorhinolaryngology · 2015Article
- Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews.BMJ open · 2014Article
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 1 country.
Funding
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.