1. Lancet. 2018 Aug 18;392(10147):557-568. doi: 10.1016/S0140-6736(18)31490-9. Epub 
2018 Aug 16.

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

Francis NA(1), Cannings-John R(2), Waldron CA(2), Thomas-Jones E(2), Winfield
T(3), Shepherd V(2), Harris D(2), Hood K(2), Fitzsimmons D(3), Roberts A(4),
Powell C(5), Gal M(6), Butler CC(7).

Author information: 
(1)Division of Population Medicine, School of Medicine, Cardiff University,
Neuadd Meirionnydd, Heath Park, Cardiff, UK. Electronic address:
francisna@cardiff.ac.uk.
(2)Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff
University, Neuadd Meirionnydd, Heath Park, Cardiff, UK.
(3)Swansea Centre for Health Economics, College of Human Health Sciences, Swansea
University, Singleton Park, Swansea, UK.
(4)Cardiff and Vale University Health Board, Child Health Directorate, St David's
Children Centre, Cowbridge Road East, Cardiff, UK.
(5)Department of General Paediatrics, Children's Hospital for Wales, Heath Park, 
Cardiff, UK.
(6)Division of Population Medicine, School of Medicine, Cardiff University,
Neuadd Meirionnydd, Heath Park, Cardiff, UK.
(7)Nuffield Department of Primary Care Health Sciences, University of Oxford,
Radcliffe Observatory Quarter, Oxford, UK.

Comment in
    Lancet. 2018 Aug 18;392(10147):533-534.

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 [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.
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.
FUNDING: National Institute for Health Research (NIHR) Health Technology
Assessment programme.

Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access
article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights
reserved.

DOI: 10.1016/S0140-6736(18)31490-9 
PMCID: PMC6099122
PMID: 30152390  [Indexed for MEDLINE]