Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial

Abstract

SummaryBackgroundChildren 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.MethodsIn 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.FindingsBetween 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 [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.InterpretationOtitis 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.FundingNational Institute for Health Research (NIHR) Health Technology Assessment programme.

The effect of ventilation tube insertion on quality of life in children with persistent otitis media with effusion

“…Ethical approval for the OSTRICH trial was obtained from an NHS research ethics committee, recognised by the UK Ethics Committee Authority (UKECA), the National Research Ethics Service Research Ethics Committee for Wales on 29 February 2013 (reference number 13/WA/0004). The trial protocol was reviewed and approved by the Wales Research Ethics Committee 3, recognised by the UKECA.…”

“…This was a secondary analysis of data from the Oral STteroids for the Resolution of OME In CHildren (OSTRICH) trial, a double-blind randomised controlled trial of the effect of a one-week course oral steroids on hearing at five weeks. 18 Trial participants were aged 2-8 years with at least three months of hearing loss secondary to bilateral OME and were recruited from ear, nose and throat (ENT) outpatients or paediatric audiology and audiovestibular medicine (AVM) departments across Wales and England. For further details of the OSTRICH trial study design, see the published study protocol.…”

Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study

“…All the prior RCTs investigating systemic steroid use in community-acquired pneumonia recruited hospitalized patients; among them, steroids as adjuvant therapy to proper antibiotics were shown to reduce mortality and morbidity only in patients with severe pneumonia but not for those with nonsevere pneumonia, casting doubt on generalizing the effectiveness to the ambulatory settings [26]. There were very limited RCT data in steroid use in common cold (only intranasal steroids were studied, which was shown to be ineffective [5]) and otitis media (only pediatric population was studied, which was found to be ineffective [6]). With questionable benefits and substantial risks [9,10], treating ARTI with systemic steroids has not been recommended by clinical guidelines [1].…”

“…Data from randomized control trials (RCTs) show that systemic steroids are ineffective in the treatment of lower respiratory tract infections [4]. Similar-albeit more limited-data also show the lack of effectiveness of steroid use in the common cold [5] and otitis media [6]. Studies have shown mixed results on whether systemic steroids lead to faster symptom relief in pharyngitis [7], and possibly also in sinusitis [8].…”

Oral steroids for persistent otitis media with effusion

“…A Cochrane review suggested that the addition of oral steroids to antibiotics was beneficial for chronic OME, although studies were mostly of poor quality . A large UK randomised controlled trial compared 7 days of oral steroids with a placebo in children aged 2–8 years with at least 3 months of OME with bilateral hearing loss . The primary outcome, hearing at 5 weeks, was acceptable in 73 (40%) of 183 recipients in the steroid group and 59 (33%) of 180 placebo recipients.…”