Ikeda 1996.

Methods	Randomised clinical trial.
Participants	Country: Japan. Number randomised: 22. Post‐randomisation dropouts: 0 (0%). Revised sample size: 22. Mean age: 61 years. Females: 19 (86.4%). Symptomatic participants: 7 (31.8%). AMA positive: 22 (100%). Responders: not stated. Mean follow‐up period (for all groups): all participants followed up for 24 months. Inclusion criteria Symptom status: symptomatic and asymptomatic participants. AMA status: AMA‐positive participants only. Response status: not stated. Exclusion criteria Other liver diseases. No immunosuppressants or hepatotoxic drugs in the previous 6 months. Alcohol or drug abuse.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) + colchicine (n = 10). Further details: UDCA: 9 mg/kg/day to 15 mg/kg/day for 2 years + colchicine: 1 mg/day for 2 years. Group 2: UDCA (moderate) (n = 12). Further details: UDCA: 9 mg/kg/day to 15 mg/kg/day for 2 years.
Outcomes	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	Unclear risk	Comment: information not available.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: information not available.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no post‐randomisation dropouts.
Selective reporting (reporting bias)	High risk	Comment: mortality not reported.
For‐profit bias	Unclear risk	Quote: "Part of the present study was supported by a grant from the Intractable Liver Diseases Research Committee, the Ministry of Health and Welfare, Japan". Comment: unclear how the remaining part of the funds were obtained.
Other bias	High risk	Comment: dose range for UDCA was very wide.