Systemic steroid for chronic otitis media with effusion in children
Abstract
Objective To determine the efficacy of a short course of an adrenocorticosteroid agent (prednisolone) given with amoxicillin as compared with that of amoxicillin alone for the treatment of chronic middle ear effusion (MEE). The efficacy of 2 weeks versus 4 weeks of amoxicillin with and without steroid was also assessed. Methods In a double-blind, randomized trial, children who were 1 to 9 years of age and had MEE of at least 2 months' duration were assigned to 1 of 4 treatment arms: 1) steroid + amoxicillin for 14 days, then amoxicillin for 14 more days; 2) steroid + amoxicillin for 14 days, then placebo for amoxicillin for 14 more days; 3) placebo (for steroid) + amoxicillin for 14 days, then amoxicillin for 14 more days; or 4) placebo (for steroid) + amoxicillin for 14 days, then placebo for amoxicillin for 14 more days. Children were examined by otoscopy, tympanometry, and audiometry at entry and 2 and 4 weeks after entry; those without MEE at the 4-week visit returned monthly for up to 3 more visits or until recurrence of effusion. Serum immunoglobulin (Ig) G, IgM, IgA, and varicella titers were obtained at entry, and allergy skin testing was performed at the 4-week visit. Results A total of 144 children was entered; 135 children (94%) returned for the 2-week visit, and 132 (92%) were seen for the 4-week visit. At the 2-week visit, 33.3% of children in the steroid + amoxicillin group had no MEE compared with 16.7% in the placebo + amoxicillin group (95% confidence interva…
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In Mandel 2002, no evidence of a difference in effect size was found between children with allergies versus those without, or between children aged <4 versus ≥4 years.
“However, we did not find evidence of a difference between these subgroups.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Mandel 2002
For Mandel 2002, 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 Mandel 2002
For Mandel 2002, allocation concealment was at unclear risk of bias.
“Allocation concealment (selection bias) Unclear risk No information regarding concealment of allocation.The use of non-permuted blocks of 4, at a group allocation ratio of 1:1:1:1 could be predictable.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Mandel 2002
For Mandel 2002, baseline characteristics are not excessively similar between the groups.
“Baseline characteristics are not excessively similar between the groups”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Mandel 2002
For Mandel 2002, prospective registration was not required because the trial was performed before 2010.
“This trial was performed 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 Mandel 2002
For Mandel 2002, 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 Mandel 2002
For Mandel 2002, different numbers were randomised to each group.
“Different numbers were randomised to each group”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Mandel 2002
For Mandel 2002, 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 Mandel 2002
Cites
Some Methods for Strengthening the Common χ 2 Tests
Cochran, W. G. (1954) · Biometrics · doi:10.2307/3001616 · Cited by 3,718 · see citing works
Epidemiology of Physician-Diagnosed Allergic Rhinitis in Childhood
Wright, A. L., Holberg, C. J., Halonen, M., Martinez, F. D., Morgan, W., & Taussig, L. M. (1994) · Pediatrics · doi:10.1542/peds.94.6.895 · Cited by 441 · see citing works
Systemic steroids for otitis media with effusion in children
Rosenfeld, R. M., Mandel, E. M., & Bluestone, C. D. (1991) · Archives of Otolaryngology - Head and Neck Surgery · doi:10.1001/archotol.1991.01870210056008 · Cited by 99 · see citing works
Self-citationBernstein, J. M., Lee, J., Conboy, K., Ellis, E., & Li, P. (1985) · Otolaryngology–Head and Neck Surgery · doi:10.1177/019459988509300508 · Cited by 79 · see citing works
Oral dexamethasone for treatment of persistent middle ear effusion
Macknin, M. L., & Jones, P. K. (1985) · Pediatrics · doi:10.1542/peds.75.2.329 · Cited by 48 · see citing works
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Simpson, S. A., Lewis, R., van der Voort, J., & Butler, C. C. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001935.pub3 · Cited by 184 · see citing works
Topical and oral steroids for otitis media with effusion (OME) in children
Mulvaney, C. A., Galbraith, K., Webster, K. E., Rana, M., Connolly, R., Tudor-Green, B., Marom, T., Daniel, M., Venekamp, R. P., Schilder, A. G., et al. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015255.pub2 · Cited by 18 · see citing works
- Authors
- Mandel, E. M., Casselbrant, M. L., Rockette, H. E., Fireman, P., Kurs-Lasky, M., & Bluestone, C. D.
- Affiliations
- University of Pittsburgh (US)
- Children's Hospital of Pittsburgh (US)
- Department of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
- ORCID
- Mandel, Ellen M.
- Venue
- Pediatrics
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2002-12-01
- Volume
- 110
- Issue
- 6
- Pages
- 1071-1080
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W2011611411
- Cited by
- 51
- References
- 5
- Citations by year
- 2024: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2017: 3 · 2016: 2 · 2015: 4 · 2014: 1 · 2013: 3 · 2012: 2
- FWCI
- 4.79
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5r01dc001693-03)
- National Institute on Deafness and Other Communication Disorders (DC01693)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Medicine › Infectious Diseases › Otolaryngology and Infectious Diseases
- Keywords
- chronic otitis media with effusion, middle ear effusion, prednisolone, adrenal cortex hormones, amoxicillin, children, treatment efficacy, serum immunoglobulins, allergen skin testing, tympanometry, audiometry, otoscopy, tympanostomy tubes, adenoidectomy
- MeSH terms
- Acoustic Impedance Tests, Amoxicillin, Audiometry, Child, Child, Preschool, Chronic Disease, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Follow-Up Studies, Hearing Tests, Humans, Infant, Otitis Media with Effusion, Patient Compliance, Prednisolone, Prognosis, Recurrence, Treatment Outcome
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