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

Schwartz 1980.

Methods Randomised, placebo‐controlled trial (patients who failed to respond at 1 week crossed over to alternative treatment)
Participants 41 children aged 1.2 to 10 years seen by 2 paediatricians in separate private clinics
Effusions present for at least 3 weeks despite previous antibiotics and/or decongestants
Diagnosis: 1B, 2C
48% bilateral
Interventions Antibiotic (sulfisoxazole) plus prednisone 1 mg/kg/day tapering over 7 days (n = 24) versus antibiotic plus placebo (n = 17)
Outcomes Tympanometry and pneumo‐otoscopy clearing of effusions
Follow up at 1 week after entry (data for the period after participants cross‐over have not been included)
Not clear whether 'cleared' refers to clearing in all affected ears
Notes Not clear why numbers in treatment groups unbalanced. Small sample size therefore likely due to chance, but the number of participants enrolled and randomised not stated.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not state
Allocation concealment (selection bias) Low risk Quote: "Pulverized prednisone tables or lactose powder packed in unmarked gelatin capsules and placed in identical coded vials by a registered pharmacist"; patients are assumed to have been enrolled in the clinic
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 41 participants included in study, but not clear if only 41 were randomised
Incomplete outcome data (attrition bias) 
 1 to 6 months Unclear risk
Selective reporting (reporting bias) Unclear risk Poor reporting
Other bias Unclear risk Baseline characteristics not reported