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Deprecated: Implicit conversion from float 265.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 CMAJ 2015 ; 187 (13): 961-9 Nephropedia Template TP
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Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial #MMPMID26216608
Williamson I; Vennik J; Harnden A; Voysey M; Perera R; Kelly S; Yao G; Raftery J; Mant D; Little P
CMAJ 2015[Sep]; 187 (13): 961-9 PMID26216608show ga
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.