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- Title
Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial.
- Authors
Williamson, Ian; Vennik, Jane; Harnden, Anthony; Voysey, Merryn; Perera, Rafael; Kelly, Sadie; Guiqing Yao; Raftery, James; Mant, David; Little, Paul; Yao, Guiqing
- Abstract
<bold>Background: </bold>Otitis 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.<bold>Methods: </bold>We 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.<bold>Results: </bold>Of 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.<bold>Interpretation: </bold>Autoinflation 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.<bold>Trial Registration: </bold>ISRCTN, No. 55208702.
- Subjects
OTITIS media with effusion; COMPARATIVE studies; FAMILY medicine; PRIMARY health care; QUALITY of life; RESEARCH funding; STATISTICAL sampling; LOGISTIC regression analysis; RANDOMIZED controlled trials; TREATMENT effectiveness; THERAPEUTICS
- Publication
Canadian Medical Association Journal (CMAJ), 2015, Vol 187, Issue 13, p961
- Publication type
journal article
- DOI
10.1503/cmaj.141608