Raedsch 1993.

Methods	Randomised clinical trial.
Participants	Country: Germany. Number randomised: 28. Post‐randomisation dropouts: 8 (28.6%). Revised sample size: 20. Mean age: 54 years. Females: 20 (100%). 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.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) + colchicine (n = 8). Further details: UDCA: 10 mg/kg/day to 12 mg/kg/day for 24 months + colchicine: 1 mg/day for 24 months. Group 2: UDCA (moderate) (n = 12). Further details: UDCA: 10 mg/kg/day to 12 mg/kg/day for 24 months.
Outcomes	Adverse events.
Notes	Reasons for post‐randomisation dropouts: adverse events, lost to follow‐up.
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	Unclear risk	Comment: although a placebo used in this double‐blind trial, unclear whether the placebo was identical.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: although a placebo used in this double‐blind trial, unclear whether the placebo was identical.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias)	High risk	Comment: mortality not reported.
For‐profit bias	Unclear risk	Comment: information not available.
Other bias	Low risk	Comment: no other source of bias.