Lambert 1986.
Methods | Randomised, placebo‐controlled trial (patients who failed to respond at 2 weeks crossed over to alternative treatment) | |
Participants | 60 children aged from 2 to 15 years completed the study. Participants were recruited from the otolaryngology clinic. Effusion present for at least 2 months Diagnosis: 1A, 2C 72% bilateral |
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Interventions | Antibiotic (amoxycillin) plus prednisone 1.5 mg/kg daily in tapering doses (n = 32) versus antibiotic plus placebo (n = 28) for 2 weeks | |
Outcomes | Resolution defined by otoscopy and tympanometry Improvement defined by better hearing on pure tone audiometry Not clear if resolution referred to clearing of both ears when bilateral OME at entry Measured 7 to 10 days after completion of treatment Audiometry data used ear as unit of analysis and present outcomes as ears resolving with each treatment |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not stated |
Allocation concealment (selection bias) | Unclear risk | Although the study was (double‐blind) placebo‐controlled it is not clear if the person enrolling patients was blind to treatment allocation and control truly indistinguishable from intervention Quote: "placebo, which consisted of a cherry‐flavoured lactose syrup, was given in the same manner" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Unclear if outcome assessors were blind, but study reported as double‐blind |
Incomplete outcome data (attrition bias) < 1 month | Unclear risk | 60 participants included in analysis, but not clear if more were randomised |
Incomplete outcome data (attrition bias) 1 to 6 months | Unclear risk | — |
Selective reporting (reporting bias) | Unclear risk | Poor reporting of results |
Other bias | Low risk | — |