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. 2011 May 11;2011(5):CD001935. doi: 10.1002/14651858.CD001935.pub3

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
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
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