Background: Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial.
Objectives: To examine the evidence for treating children with hearing loss associated with OME with systemic or topical intranasal steroids.
Search strategy: We searched the Cochrane ENT Group Trials Register; CENTRAL; PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was 26 August 2010.
Selection criteria: Randomised controlled trials of oral and topical intranasal steroids, either alone or in combination with another agent such as an oral antibiotic. We excluded publications in abstract form only; uncontrolled, non-randomised or retrospective studies; and studies reporting outcomes by ears (rather than children).
Data collection and analysis: The authors independently extracted data from the published reports using standardised data extraction forms and methods. We assessed the quality of the included studies using the Cochrane 'Risk of bias' tool. We expressed dichotomous results as a risk ratio (RR) and continuous data as weighted mean difference (WMD), both with 95% confidence intervals (CI). Where feasible we pooled studies using a random-effects model and performed tests for heterogeneity between studies. In trials with a cross-over design, we did not use post cross-over treatment data.
Main results: We included 12 medium to high-quality studies with a total of 945 participants. No study documented hearing loss associated with OME prior to randomisation. The follow-up period was generally limited, with only one study of intranasal steroid reporting outcome data beyond six months. There was no evidence of benefit from steroid treatment (oral or topical) in terms of hearing loss associated with OME. Pooled data using a fixed-effect model for OME resolution at short-term follow up (< 1 month) showed a significant effect of oral steroids compared to control (RR 4.48; 95% CI 1.52 to 13.23; Chi² 2.75, df = 2, P = 0.25; I² = 27%). Oral steroids plus antibiotic also resulted in an improvement in OME resolution compared to placebo plus antibiotic at less than one month follow up, using a random-effects model (RR 1.99; 95% CI 1.14 to 3.49; five trials, 409 children). However, there was significant heterogeneity between studies (P < 0.01, I² = 69%). There was no evidence of beneficial effect on OME resolution at greater than one month follow up with oral steroids (used alone or with antibiotics) or intranasal steroids (used alone or with antibiotics) at any follow-up period. There was also no evidence of benefit from steroid treatment (oral or topical) in terms of symptoms.
Authors' conclusions: While oral steroids, especially when used in combination with an oral antibiotic, lead to a quicker resolution of OME in the short term, there is no evidence of longer-term benefit and no evidence that they relieve symptoms of hearing loss. We found no evidence of benefit from treatment of OME with topical intranasal steroids, alone or in combination with an antibiotic, either at short or longer-term follow up.