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

Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial
Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial
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.
0820-3946
961-969
Williamson, I.
12381296-edbf-4ac5-969b-dcb559c22f27
Vennik, J.
6ee78166-5a7a-433b-87fc-018771f20b19
Harnden, A.
3de28dd6-bc3e-404e-a03f-fe1a276a7ef4
Voysey, M.
b756c6a6-9514-4a42-b7dc-2a41f9e6171e
Perera, R.
d0b24f7a-0794-4563-92b9-3e624d725378
Kelly, S.
d40522b8-1037-4711-823d-50015e04f238
Yao, G.
d777f84c-cf3d-4fad-bbc1-ea01dec01695
Raftery, J.
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Mant, D.
10e94981-cd2c-4e56-8a11-54d9fc107117
Little, P.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Williamson, I.
12381296-edbf-4ac5-969b-dcb559c22f27
Vennik, J.
6ee78166-5a7a-433b-87fc-018771f20b19
Harnden, A.
3de28dd6-bc3e-404e-a03f-fe1a276a7ef4
Voysey, M.
b756c6a6-9514-4a42-b7dc-2a41f9e6171e
Perera, R.
d0b24f7a-0794-4563-92b9-3e624d725378
Kelly, S.
d40522b8-1037-4711-823d-50015e04f238
Yao, G.
d777f84c-cf3d-4fad-bbc1-ea01dec01695
Raftery, J.
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Mant, D.
10e94981-cd2c-4e56-8a11-54d9fc107117
Little, P.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777

Williamson, I., Vennik, J., Harnden, A., Voysey, M., Perera, R., Kelly, S., Yao, G., Raftery, J., Mant, D. and Little, P. (2015) Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial. Canadian Medical Association Journal, 187 (13), 961-969. (doi:10.1503/cmaj.141608). (PMID:26216608)

Record type: Article

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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More information

Accepted/In Press date: 10 June 2015
e-pub ahead of print date: 27 July 2015
Published date: 22 September 2015
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 390166
URI: http://eprints.soton.ac.uk/id/eprint/390166
ISSN: 0820-3946
PURE UUID: 06d9f694-d3cf-49c7-81b9-498e406ebc70
ORCID for J. Vennik: ORCID iD orcid.org/0000-0003-4602-9805

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Date deposited: 21 Mar 2016 15:13
Last modified: 15 Mar 2024 03:58

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Contributors

Author: I. Williamson
Author: J. Vennik ORCID iD
Author: A. Harnden
Author: M. Voysey
Author: R. Perera
Author: S. Kelly
Author: G. Yao
Author: J. Raftery
Author: D. Mant
Author: P. Little

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