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
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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). |
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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. |