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2015 ; 187
(13
): 961-969
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English Wikipedia
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
): 961-969
PMID26216608
show 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.