Oral steroid therapy for chronic middle ear perfusion: a double-blind crossover study
Abstract
A prospective, double-blind crossover study design was used in the evaluation of the role of prednisone in the treatment of a chronic middle ear effusion. Sixty children with an effusion--of at least 2 months' duration--randomly received either prednisone or placebo for 2 weeks. One week later they were re-evaluated. If the effusion had resolved, they were followed periodically; if the effusion persisted, they were given the crossover regimen and reevaluated. Sixty percent of the patients' effusions cleared, but there was no statistical difference between the prednisone and placebo groups. The amount of hearing recovery was also the same for both treatment regimens. Subdividing the patients on the basis of effusion duration, unilateral vs. bilateral effusions, or history of ventilation tubes or antibiotics failed to identify a subgroup of individuals who might benefit from a short-term course of oral steroids.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
For Lambert 1986, 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.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, 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 Lambert 1986
For Lambert 1986, no retraction notices or expressions of concern were identified.
“No retraction notices or expressions of concern were identified”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, prospective registration was not required because the trial was published prior to 2010.
“Prospective registration was not required (trial published prior to 2010)”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, selective reporting was at unclear risk of bias.
“Selective reporting (reporting bias) Unclear risk No protocol is available.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, allocation concealment was at unclear risk of bias.
“Allocation concealment (selection bias) Unclear risk No information on how allocation was concealed.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, full follow-up is reported, but this may be plausible for short follow-up.
“Full follow-up is reported, but this may be plausible for short follow-up”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, blinding of outcome assessment was at unclear risk of bias.
“Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information is provided on how blinding was maintained when this was a single-author RCT.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, 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 Lambert 1986
For Lambert 1986, blinding of participants and personnel was at unclear risk of bias.
“Blinding of participants and personnel (performance bias) All outcomes Unclear risk The author describes this as a double-blind trial.A placebo was used, but no information is provided on whether taste/appearance differed between the interventions.This is a single-author RCT, and no information is provided on how results of randomisation were concealed from this author.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, incomplete outcome data was at low risk of bias.
“Incomplete outcome data (attrition bias) All outcomes Low risk No missing outcome data.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
For Lambert 1986, baseline characteristics cannot be compared for the 2 randomised groups, therefore the review authors cannot assess for similarity.
“Baseline characteristics cannot be compared for the 2 randomised groups, therefore we cannot assess for similarity”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Lambert 1986
Cites
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
Flagged first, then by citations
Cited by
Sorted by citations
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
- Lambert, P. R.
- Affiliations
- University of Virginia Medical Center (US)
- Corresponding author
- Lambert, Paul R.
- Venue
- Otolaryngology–Head and Neck Surgery
- Publisher
- Wiley
- Published
- 1986-09
- Volume
- 95
- Issue
- 2
- Pages
- 193-199
- ISSN
- 0161-6439 (ISSN-L)
- 0194-5998
- 1097-6817
- OpenAlex
- W2292346923
- Cited by
- 30
- References
- 1
- Citations by year
- 2023: 1 · 2020: 1
- FWCI
- 0.71
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Otolaryngology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Medicine › Oncology › Ear and Head Tumors
- Keywords
- prednisone, oral corticosteroids, otitis media with effusion, hearing recovery, children, tympanostomy tubes, antibiotic therapy
- MeSH terms
- Administration, Oral, Adolescent, Adrenal Cortex Hormones, Amoxicillin, Audiometry, Pure-Tone, Audiometry, Speech, Child, Child, Preschool, Clinical Trials as Topic, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Otitis Media with Effusion, Prednisone, Prospective Studies, Random Allocation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
