Autoinflation as a treatment of secretory otitis media. A randomized controlled study
Abstract
This study was undertaken to evaluate the effect of a new method of autoinflation as an alternative treatment of secretory otitis media. Up to 80% of all children experience one or more episodes of eustachian tube dysfunction and secretory otitis media before school age. Common treatment of this condition is insertion of a ventilation tube in the tympanic membrane. Because of the very high incidence of secretory otitis media in childhood, insertion of ventilation tubes is the most frequently performed operation under general anesthesia in children. In addition to possible anesthetic complications, insertion of ventilation tubes may be associated with purulent suppuration, pathologic findings in the eardrum, and hearing impairment. One hundred children were consecutively randomized to undergo either autoinflation, using a new device, or placed in a control group. The children were between 3 and 10 years of age and were entered into the study after having had secretory otitis media for at least 3 months, as verified by tympanometric findings. Tympanometry was repeated at 2 weeks and at 1, 2, and 3 months after the children were entered into the study. After 2 weeks of autoinflation, the tympanometric conditions were improved in 64% of ears, unchanged in 34%, and deteriorated in the remaining 2%. In the control group, tympanometric findings were improved in 15% of ears, unchanged in 71%, and deteriorated in the remaining 14%.
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It is not possible to blind participants and personnel in the Stangerup 1992 trial.
“It is not possible to blind participants and personnel.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
Some loss to follow-up was reported in the Stangerup 1992 trial.
“Some loss to follow-up was reported”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
No retraction notices or expressions of concern were identified for the Stangerup 1992 trial.
“No retraction notices or expressions of concern were identified”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
No protocol or trial registration was found for the Stangerup 1992 trial.
“No protocol or trial registration was found.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
Outcome assessors were unlikely to be blind to treatment allocation in the Stangerup 1992 trial.
“It is unlikely that outcome assessors were blind to treatment allocation.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
No information on how allocation was concealed was provided for the Stangerup 1992 trial.
“no information on how allocation was concealed.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
Prospective trial registration was not required for the Stangerup 1992 trial, as it was published prior to 2010.
“Prospective trial registration was not required, as this study was published prior to 2010”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
Very few characteristics were reported for the individual groups in the Stangerup 1992 trial, but different numbers of male and female children were enrolled in each group.
“Very few characteristics were reported for the individual groups, but different numbers of male and female children were enrolled in each group”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
No implausible results were reported in the Stangerup 1992 trial.
“No implausible results were reported”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
No information on how the random sequence was generated was provided for the Stangerup 1992 trial.
“no information on how the random sequence was generated.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
No concerns regarding other bias were identified for the Stangerup 1992 trial.
“No concerns.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
The number randomised to each group in the Stangerup 1992 trial is unclear, but assumed to be 50 in each group.
“The number randomised to each group is unclear, but assumed to be 50 in each group”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Stangerup 1992
Cited by
Sorted by citations
Autoinflation for hearing loss associated with otitis media with effusion
Perera, R., Glasziou, P. P., Heneghan, C. J., McLellan, J., & Williamson, I. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006285.pub2 · Cited by 109 · see citing works
Autoinflation for otitis media with effusion (OME) in children
Webster, K. E., Mulvaney, C. A., Galbraith, K., Rana, M., Marom, T., Daniel, M., Venekamp, R. P., Schilder, A. G., & MacKeith, S. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015253.pub2 · Cited by 21 · see citing works
- Authors
- Stangerup, S. E., Sederberg-Olsen, J., & Balle, V.
- ORCID
- Sederberg-Olsen, J.
- Venue
- Archives of Otolaryngology - Head and Neck Surgery
- Publisher
- American Medical Association (AMA)
- Published
- 1992-02-01
- Volume
- 118
- Issue
- 2
- Pages
- 149-152
- ISSN
- 0886-4470 (ISSN-L)
- OpenAlex
- W2005305626
- Cited by
- 75
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 1 · 2019: 1 · 2018: 1 · 2016: 1 · 2015: 7 · 2014: 1 · 2013: 2 · 2012: 1
- FWCI
- 4.93
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Otolaryngology - Head and Neck Surgery (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
- Health Sciences › Medicine › Oncology › Ear and Head Tumors
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Keywords
- otitis media with effusion, Eustachian tube dysfunction, tympanometry, ventilation tube insertion, children, conservative treatment, tympanic membrane
- MeSH terms
- Acoustic Impedance Tests, Child, Child, Preschool, Equipment Design, Female, Humans, Male, Middle Ear Ventilation, Otitis Media with Effusion, Self Care
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