Oral dexamethasone for treatment of persistent middle ear effusion
Abstract
A double-blind controlled study of oral dexamethasone (in a 2-week tapering dose from .15 mg/kg/d) v placebo in 49 pediatric patients (mean age 3.7 years) with persistent asymptomatic middle ear effusion of three or more weeks duration was conducted. Middle ear effusion resolution was determined by a myringotomy-validated algorithm that combined pneumatic otoscopy and tympanometry. Four weeks after completing treatment, 1/26 (4%) patients receiving dexamethasone and 2/23 (9%) patients receiving placebo had completely cleared their middle ear effusion (95% confidence interval -0.05 +/- 0.14). Five of 26 (19%) patients receiving dexamethasone and 6/23 (26%) patients receiving placebo had improved their hearing in all affected ears by 10 dB or more (95% confidence interval -0.07 +/- 0.23). Oral dexamethasone as used in this study was not effective in treating persistent middle ear effusion in children.
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For Macknin 1985, incomplete outcome data was at unclear risk of bias.
“Incomplete outcome data (attrition bias) All outcomes Unclear risk It is unclear how many children were recruited to the study; data are reported on 49 participants.A further 12 children, approximately, did not complete the study as planned.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, numbers allocated to each group are different.
“Numbers allocated to each group are different”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, other bias was at high risk of bias.
“Other bias High risk High risk of bias for short-term follow-up as there is insufficient time to detect a difference between the groups.Study was terminated early due to very low cure rate in the first 49 recruited patients.A sample size calculation found that 81 children were needed per group (total of 162).”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, no implausible results were identified.
“No implausible results were identified”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, plausible loss to follow-up was reported.
“Plausible loss to follow-up was reported”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, baseline characteristics of the groups are not excessively similar.
“Baseline characteristics of the groups are not excessively similar”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, prospective registration was not required because the trial was published before 2010.
“Trial was published before 2010, therefore prospective registration was not required”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, selective reporting was at unclear risk of bias.
“Selective reporting (reporting bias) Unclear risk No protocol was found.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
For Macknin 1985, no retractions or expressions of concern were identified.
“No retractions or expressions of concern were identified”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
In the sensitivity analysis for persistence of OME (short-term) with persistence in all affected ears (Macknin 1985), the risk ratio was 0.78 (95% CI 0.47 to 1.30) across 3 studies with 211 participants.
“1.15 Sensitivity analysis: persistence of OME (short-term); persistence in all affected ears (Macknin 1985) 3 211 Risk Ratio (M-H, Random, 95% CI) 0.78 [0.47, 1.30]”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Macknin 1985
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- Authors
- Macknin, M. L., & Jones, P. K.
- Affiliations
- Case Western Reserve University (US)
- Venue
- Pediatrics
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 1985-02-01
- Volume
- 75
- Issue
- 2
- Pages
- 329-335
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W1505741973
- Cited by
- 48
- References
- 0
- Citations by year
- 2023: 1 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 1 · 2013: 1
- FWCI
- 3.81
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (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
- dexamethasone, middle ear effusion, otitis media with effusion, pediatric patients, corticosteroid therapy, hearing improvement, tympanometry, myringotomy
- MeSH terms
- Acute Disease, Administration, Oral, Adolescent, Child, Child, Preschool, Dexamethasone, Double-Blind Method, Female, Follow-Up Studies, Hearing, Humans, Infant, Male, Otitis Media, Otitis Media with Effusion, Patient Compliance, Time Factors
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