PT  - JOURNAL ARTICLE
AU  - Ian Williamson
AU  - Jane Vennik
AU  - Anthony Harnden
AU  - Merryn Voysey
AU  - Rafael Perera
AU  - Sadie Kelly
AU  - Guiqing Yao
AU  - James Raftery
AU  - David Mant
AU  - Paul Little
TI  - Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial
AID  - 10.1503/cmaj.141608
DP  - 2015 Sep 22
TA  - Canadian Medical Association Journal
PG  - 961--969
VI  - 187
IP  - 13
4099  - http://www.cmaj.ca/content/187/13/961.short
4100  - http://www.cmaj.ca/content/187/13/961.full
SO  - CMAJ2015 Sep 22; 187
AB  - Background: 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.Methods: 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.Results: 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.Interpretation: 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. Trial registration: ISRCTN, No. 55208702.See also page 949 and www.cmaj.ca/lookup/doi/10.1503/cmaj.150527