Poupon 1996.

Methods	Randomised clinical trial.
Participants	Country: France. Number randomised: 74. Post‐randomisation dropouts: not stated. Revised sample size: 74. Mean age: 54 years. Females: 63 (85.1%). Symptomatic participants: not stated. AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): all participants followed up for 24 months. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: not stated. Exclusion criteria Received any of the following drugs during the previous 6 months: ursodiol, azathioprine, chlorambucil, colchicine, corticosteroids, D‐penicillamine, and ciclosporin. Serum bilirubin concentration > 150 μmol/L. Serum albumin concentration < 25 g/L. Past or active gastrointestinal bleeding from oesophageal varices. Evidence of past or present extrahepatic obstruction of the bile ducts. Excessive alcohol consumption (> 50 g/day). Other identified causes of liver or biliary diseases. Aged ≥ 75 years.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) + colchicine (n = 37). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day for 2 years + colchicine: 1 mg/day for 5 days in a week for 2 years. Group 2: UDCA (moderate) (n = 37). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day for 2 years.
Outcomes	Mortality, adverse events.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: information not available.
Allocation concealment (selection bias)	Unclear risk	Comment: information not available.
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: unclear whether all randomised participants were included for analysis.
Selective reporting (reporting bias)	Low risk	Comment: mortality and morbidity reported.
For‐profit bias	High risk	Quote: "Supported in part by Laboratoires Houde (France) and Jouveinal (Canada)".
Other bias	Low risk	Comment: no other source of bias.