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Randomized Controlled Trial
. 2015 Sep 22;187(13):961-969.
doi: 10.1503/cmaj.141608. Epub 2015 Jul 27.

Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial

Ian Williamson  1 , Jane Vennik  2 , Anthony Harnden  2 , Merryn Voysey  2 , Rafael Perera  2 , Sadie Kelly  2 , Guiqing Yao  2 , James Raftery  2 , David Mant  2 , Paul Little  2
Affiliations
Randomized Controlled Trial

Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial

Ian Williamson et al. CMAJ. .

Abstract

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.

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Figures

Figure 1:
Figure 1:
(A) Child demonstrating use of the Otovent device. Reproduced with permission. (B) Illustration of otitis media with effusion and the mechanism of autoinflation.
Figure 2:
Figure 2:
Enrolment, allocation and follow-up of patients. Note: ITT = intention-to-treat, OME = otitis media with effusion, R = randomization.
Figure 3:
Figure 3:
Standardized total scores on the OMQ-14 (an ear-related measure of quality of life) at baseline and at 3 months. Lower scores represent improvement.
See this image and copyright information in PMC

Comment in

References

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