Topical intranasal steroids do not benefit children with persistent middle ear effusion
Article Outline
- Question
- Design
- Setting
- Participants
- Intervention
- Outcomes
- Main Results
- Conclusions
- Commentary
- References
- Copyright
Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. 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 2009;339:b4984.
Question
Among children with bilateral otitis media with effusion, does the use of topical intranasal corticosteroids result in more rapid resolution of the effusion?
Design
Double-blind randomized placebo controlled trial.
Setting
Seventy-six general practices in the United Kingdom, between 2004 and 2007.
Participants
Two hundred seventeen children, aged 4-11 years, who had at least one 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.
Intervention
Mometasone furoate 50 μg or placebo spray given once daily into each nostril for three months.
Outcomes
Proportion of children cured of bilateral otitis media with effusion assessed with tympanometry at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms.
Main Results
Forty-one percent (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 favoring placebo 4.3% (95% confidence interval −9.3% to 18.1%). After adjustment for four prespecified covariates (clinical severity, atopy, age, and season), the 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.
Commentary
The best approach for otitis media with effusion in primary care is active observation. The effusion often resolves spontaneously within three months. Several treatment options have been studied in the past for this period of active observation. Antibiotics have shown only very little effect and are not recommended. Another option is the use of intranasal corticosteroids, which relieve a range of allergic inflammatory symptoms. Current evidence on the effects of steroids on otitis media with effusion is conflicting.1, 2 Williamson et al show that treatment with topical nasal steroids is ineffective in primary care. The resolution rate of about 50% in both groups is high, so it could be argued that only the less severe cases were included. However, the rates are consistent with other studies performed in primary care.3 Furthermore, the authors show that the severity of disease was comparable with that seen in studies in secondary care. Again, it has been shown that the natural course of otitis media with effusion is favorable, and the use of intranasal corticosteroids have no effect on this course. As clinicians we should bear in mind that the resolution of the effusion should not be our first goal, but the amount of hearing loss. Also, when effusion persists, the hearing level should be the main indication for further surgical treatment.
References
- . Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2006;(3):CD001935
- . The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy. Int J Pediatr Otorhinolaryngol. 2006;70:639–645
- . Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice. Lancet. 1996;348:713–716
PII: S0022-3476(10)00405-1
doi:10.1016/j.jpeds.2010.05.009
© 2010 Mosby, Inc. All rights reserved.
