Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A Cochrane review indicated that oral steroids might provide some short term benefit, but the studies included were underpowered and poor quality. The present randomised trial was undertaken to determine whether oral steroids improved hearing in children with hearing loss from otitis media with effusion.
Eligible children were those aged 2–8 years with symptoms of hearing loss attributable to otitis media with effusion for at least 3 months. The trial was double-blind with children randomised 1:1 to either a one week course of oral prednisolone or matching placebo. The primary outcome was acceptable hearing at 5 weeks with further follow-up at 6 and 12 months. Secondary outcomes included adverse events and quality of life. All analyses were intention to treat.
A total of 1,018 children were assessed for eligibility and of these 389 (38%) from 20 sites were randomly assigned. The majority of those excluded did not meet the inclusion criteria. After randomisation, a further 9 children were excluded (6 of them due to the hearing test result not meeting the pre-specified threshold and in a further 3 where consent was withdrawn). A total of 380 children (193 children in the steroid group and 187 in the placebo group) were included in the analyses.
Hearing at 5 weeks was assessed in 183 children in the oral steroid group and 180 in the placebo group. Acceptable hearing was observed in 73 (40%) children in the oral steroid group and in 59 (33%) in the placebo group (absolute difference 7% [95% CI −3 to 17]; the adjusted odds ratio was 1·36 [95% CI 0·88–2·11]; p=0·16). No significant differences were also observed in secondary outcomes for adverse events and for quality of life.
The authors conclude that a short course of oral steroids for otitis media with effusion is unlikely to be effective for most children aged 2–8 years.
The full report is available here.