Oral steroids for hearing loss associated with otitis media with effusion in children aged 2-8 years: the OSTRICH RCT

• Published in: Health technology assessment (Winchester, England) England), 2018-11, Vol.22 (61), p.1-114
• Main Authors: Francis, Nick A, Waldron, Cherry-Ann, Cannings-John, Rebecca, Thomas-Jones, Emma, Winfield, Thomas, Shepherd, Victoria, Harris, Debbie, Hood, Kerenza, Fitzsimmons, Deborah, Roberts, Amanda, Powell, Colin Ve, Gal, Micaela, Jones, Sarah, Butler, Christopher C
• Format: Article
• Language: English
• Subjects: Administration, Oral; Audiometry; Child; Child, Preschool; children; Cost-Benefit Analysis; cost-effectiveness; Double-Blind Method; Female; Glucocorticoids - adverse effects; Glucocorticoids - economics; Glucocorticoids - therapeutic use; Health Status; hearing loss; Hearing Loss - drug therapy; Hearing Loss - etiology; Humans; Male; middle ear; otitis media with effusion; Otitis Media with Effusion - complications; otoscopy; Prednisolone - adverse effects; Prednisolone - economics; Prednisolone - therapeutic use; primary care; Quality of Life; Quality-Adjusted Life Years; secondary care; tympanometry
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta22610

Children with hearing loss associated with otitis media with effusion (OME) are commonly managed through surgical intervention, hearing aids or watchful waiting. A safe, inexpensive, effective medical treatment would enhance treatment options. Small, poorly conducted trials have found a short-term benefit from oral steroids. To determine the clinical effectiveness and cost-effectiveness of a 7-day course of oral steroids in improving hearing at 5 weeks in children with persistent OME symptoms and current bilateral OME and hearing loss demonstrated by audiometry. Double-blind, individually randomised, placebo-controlled trial. Ear, nose and throat outpatient or paediatric audiology and audiovestibular medicine clinics in Wales and England. Children aged 2-8 years, with symptoms of hearing loss attributable to OME for at least 3 months, a diagnosis of bilateral OME made on the day of recruitment and audiometry-confirmed hearing loss. A 7-day course of oral soluble prednisolone, as a single daily dose of 20 mg for children aged 2-5 years or 30 mg for 6- to 8-year-olds, or matched placebo. Acceptable hearing at 5 weeks from randomisation. Secondary outcomes comprised acceptable hearing at 6 and 12 months, tympanometry, otoscopic findings, health-care consultations related to OME and other resource use, proportion of children who had ventilation tube (grommet) surgery at 6 and 12 months, adverse effects, symptoms, functional health status, health-related quality of life, short- and longer-term cost-effectiveness. A total of 389 children were randomised. Satisfactory hearing at 5 weeks was achieved by 39.9% and 32.8% in the oral steroid and placebo groups, respectively (absolute difference of 7.1%, 95% confidence interval -2.8% to 16.8%; number needed to treat = 14). This difference was not statistically significant. The secondary outcomes were consistent with the picture of a small or no benefit, and we found no subgroups that achieved a meaningful benefit from oral steroids. The economic analysis showed that treatment with oral steroids was more expensive and accrued fewer quality-adjusted life-years than treatment as usual. However, the differences were small and not statistically significant, and the sensitivity analyses demonstrated large variation in the results. OME in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. Discussions about watchful waiting and other interventions w