The Research Question Otitis media with effusion OME

The Research Question • Otitis media with effusion (OME) is the main cause of hearing loss and the commonest reason to have an operation requiring anesthesia in children. • Systematic reviews report benefits in resolution of OME from oral steroids. However, no rigorous trials use hearing and condition specific quality of life (Qo. L) as outcomes. • The researchers set out to determine whether a short course of oral steroids improved hearing in children with bilateral OME and hearing loss for ≥ three months.

What the Researchers Did • Conducted a randomized controlled trial with 389 children randomized to oral steroid (prednisolone) or matched placebo for one week. • Assessed hearing loss after five weeks (primary outcome), as well as symptoms, Qo. L, surgery and other healthcare use, and hearing loss at five weeks, six months and 12 months.

What the Researchers Found • 33% of children in the control arm and 40% in the steroid arm went from having prolonged significant hearing loss to ‘acceptable hearing’ five weeks after randomization. • The difference was not statistically significant (adjusted OR 1. 36, 95%CI 0. 88 to 2. 11). • No differences in quality of life at any point over one year.

What This Means for Clinical Practice • Spontaneous resolution of OME is common, even in children with bilateral disease and significant hearing loss for at least three months. • Oral steroids are unlikely to result in clinically meaningful benefits for children with OME, although we cannot exclude small benefits and they were well tolerated.