A short course of oral steroid (prednisolone) might help in the attainment of acceptable hearing in children experiencing persistent hearing loss due to otitis media with effusion, according to a new study published in the journal Lancet.
Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options.
Nick A. Francis, Division of Population Medicine, School of Medicine, Cardiff University, and colleagues conducted the study to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.
For this OSTRICH, a randomized, parallel, double-blinded, placebo-controlled trial, the researchers recruited children aged 2–8 years with symptoms attributable to otitis media with effusion for at least 3 months and with a confirmed bilateral hearing loss. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child’s age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat.
Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomized. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 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], number needed to treat 14; adjusted odds ratio 1·36 [95% CI 0·88–2·11]; p=0·16).
- There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.
“Otitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2–8 years with persistent otitis media with effusion but is well tolerated. One in 14 children might achieve improved hearing but not the quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence,” conclude the authors.