Combes 1995a.

Methods	Randomised clinical trial.
Participants	Country: USA. Number randomised: 151. Post‐randomisation dropouts: 0 (0%). Revised sample size: 151. Mean age: 49 years. Females: 134 (88.7%). 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: AMA‐positive and AMA‐negative participants. Response status: not stated. Other exclusion criteria Recurrent bleeds from oesophagogastric varices, spontaneous encephalopathy, or diuretic‐resistant ascites. Serum bilirubin ≥ 20 mg/dL. Pregnancy. Aged < 19 years. Findings of other causes of liver disease.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) (n = 77). Further details: UDCA: 10 mg/kg/day to 12 mg/kg/day for 2 years. Group 2: placebo (n = 74).
Outcomes	Decompensated liver disease.
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 double‐blind trial.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: identical placebo used in double‐blind trial.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no post‐randomisation dropouts.
Selective reporting (reporting bias)	High risk	Comment: neither mortality nor adverse events reported.
For‐profit bias	High risk	Quote: "Supported in part by a research grant from Ciba‐Geigy".
Other bias	Low risk	Comment: no other risk of bias.