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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

Warnes 1987.

Methods Randomised clinical trial.
Participants Country: UK.
Number randomised: 64.
Post‐randomisation dropouts: not stated.
Revised sample size: 64.
Mean age: not stated.
Females: not stated.
Symptomatic participants: not stated.
AMA positive: 64 (100%).
Responders: not stated.
Median follow‐up period (for all groups): 19 months.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: AMA‐positive participants only.

  • Response status: not stated.

Interventions Participants were randomly assigned to 2 groups.
Group 1: colchicine (n = 34).
Further details: colchicine: 0.5 mg BD; duration: not stated.
Group 2: placebo (n = 30).
Outcomes Mortality, adverse events.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "To ensure that treatment groups were comparable, patients were stratified according to serum bilirubin level at entry (A, < 19/µmol/1; B, 20‐34/ µmol/L; C, 35‐102/µmol/L; D, >102/µmol/1). The first patient in any pair was allocated by the staff pharmacist to the treatment or placebo group by reference to random tables. The pair was completed when another patient, in the same bilirubin group and with an age within 5 years of the first patient, was entered into the study. The second member of the pair was allocated to the alternative treatment group. The study was double‐blind".
 Comment: minimisation method used.
Allocation concealment (selection bias) Low risk Quote: "To ensure that treatment groups were comparable, patients were stratified according to serum bilirubin level at entry (A, < 19/µmol/1; B, 20‐34/ µmol/L; C, 35‐102/µmol/L; D, >102/µmol/1). The first patient in any pair was allocated by the staff pharmacist to the treatment or placebo group by reference to random tables. The pair was completed when another patient, in the same bilirubin group and with an age within 5 years of the first patient, was entered into the study. The second member of the pair was allocated to the alternative treatment group. The study was double‐blind".
 Comment: minimisation method used.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: identical placebo used in this double‐blind trial.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: identical placebo used in this double‐blind trial.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available.
Selective reporting (reporting bias) Low risk Comment: mortality and morbidity reported.
For‐profit bias Unclear risk Comment: information not available.
Other bias Low risk Comment: no other source of bias.