• Ian Williamson, Jane Vennik, Anthony Harnden, Merryn Voysey, Rafael Perera, Sadie Kelly, Guiqing Yao, James Raftery, David Mant, and Paul Little.
• Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK igw@soton.ac.uk.
• CMAJ. 2015 Sep 22; 187 (13): 961969961-969.

BackgroundOtitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting.MethodsWe conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4-11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1-3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation.ResultsOf 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in ear-related quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score -0.42, 95% CI -0.63 to -0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups.InterpretationAutoinflation in children aged 4-11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life.Trial RegistrationISRCTN, No. 55208702.© 2015 Canadian Medical Association or its licensors.

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