Lack of efficacy of middle-ear inflation: treatment of otitis media with effusion in children
Abstract
A randomized controlled trial was conducted to evaluate the efficacy of autoinflation of the middle ear in the treatment of otitis media with effusion. Forty-one children with middle ear effusion not responsive to antimicrobial therapy enrolled in the study. Of these subjects, 75 percent had effusion duration over 3 months. A system consisting of a disposable anesthesia mask attached to a flowmeter was used to teach children to perform autoinflation based on a modified Valsalva technique. Subjects were stratified according to their ability to achieve tubal opening as assessed by tympanometry and tubosonometry. Subjects were randomly assigned to either treatment or observation group and were followed weekly for 2 weeks; subjects in the treatment group attempted inflation three times each day for 2 weeks. Of the 19 subjects who were in the autoinflation group, only one (5.3 percent) was effusion-free at the two-week endpoint and of the 21 subjects in the control, only two (9.5 percent) were without middle-ear effusion. Autoinflation was ineffective for treatment of children with otitis media with effusion in our study.
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No retraction notices or expressions of concern were identified for the Chan 1989 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 Chan 1989
No protocol was identified for the Chan 1989 trial.
“No protocol was identified.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
The groups in the Chan 1989 trial did not include equal numbers of participants.
“The groups did not include equal numbers of participants”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
No information on concealment of allocation was provided for the Chan 1989 trial.
“No information on concealment of allocation.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
Only 1 participant was missing from follow-up in the Chan 1989 trial.
“Only 1 participant was missing from follow-up.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
The Chan 1989 trial used a set of random numbers to randomly assign subjects to either autoinflation or control within each stratification.
“Comment: random numbers were used for randomisation.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
Some loss to follow-up was reported in the Chan 1989 trial (1 participant) and the trial lasted for only 2 weeks, so this is plausible.
“Some loss to follow-up was reported (1 participant) and the trial lasted for only 2 weeks, so this is plausible”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
No implausible results were reported in the Chan 1989 trial.
“No implausible results were reported”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
Baseline characteristics of the groups in the Chan 1989 trial were not excessively similar.
“Baseline characteristics of the groups were not excessively similar”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
The Chan 1989 trial was published prior to 2010, therefore prospective registration is not applicable.
“The trial was published prior to 2010, therefore prospective registration is not applicable”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
Follow-up of 2 weeks is insufficient time for follow-up of no treatment in the Chan 1989 trial.
“Follow-up is 2 weeks and therefore this is insufficient time for follow-up of no treatment.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
Outcome assessors were likely unblinded in the Chan 1989 trial.
“It is likely that they were unblinded.”
From Autoinflation for otitis media with effusion (OME) in children (2023) · cites this paper as Chan 1989
It is not possible to blind participants and personnel in the Chan 1989 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 Chan 1989
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Basagoudanavar, S. H., & Gadwal, D. S. (2025) · International Journal of Otorhinolaryngology and Head and Neck Surgery · doi:10.18203/issn.2454-5929.ijohns20252989
- Authors
- Chan, K. H., & Bluestone, C. D.
- Affiliations
- University of Pittsburgh (US)
- Corresponding author
- Chan, Kenny H.
- ORCID
- Chan, Kenny H.
- Venue
- Otolaryngology–Head and Neck Surgery
- Publisher
- Wiley
- Published
- 1989-04
- Volume
- 100
- Issue
- 4
- Pages
- 317-323
- ISSN
- 0161-6439 (ISSN-L)
- 0194-5998
- 1097-6817
- OpenAlex
- W55325783
- Cited by
- 40
- References
- 20
- Citations by year
- 2025: 1 · 2023: 1 · 2020: 1 · 2015: 1 · 2013: 1
- FWCI
- 2.53
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Otolaryngology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (NS 16337, NS 07270)
- 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, middle ear effusion, children, treatment efficacy, tympanometry, middle ear ventilation
- MeSH terms
- Adolescent, Child, Child, Preschool, Clinical Trials as Topic, Humans, Middle Ear Ventilation, Otitis Media with Effusion, Random Allocation, Time Factors, Valsalva Maneuver
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