NIHR | November 2018 | Oral steroids do not help hearing for children with glue ear
An NIHR-funded trial demonstrates that oral steroids do not improve hearing, symptoms, or quality of life in children with glue ear. This NIHR-funded trial compared oral steroids with placebo for 389 children with otitis media with effusion, and found no significant effect on those outcomes.
The study shows that many children will improve spontaneously, even after three months of glue ear and confirms that steroids are not useful, even though they are well tolerated. Surgery to place ventilation tubes known as grommets is an option for children with persistent glue ear in and hearing loss in both ears. This evidence supports more informed discussions with parents about watchful waiting and the surgical options available.
Background: 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. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.
Methods: In this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2-8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. 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. This trial is registered with the ISRCTN Registry, number ISRCTN49798431.
Findings: Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 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. There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.
Interpretation: 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 quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence.
Full reference: Francis, N. A., et al | 2018| Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial | Lancet | 392 | 10147| 10.3310/signal-000674
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