Leuschner 1989.

Methods	Randomised clinical trial.
Participants	Country: Germany. Number randomised: 20. Post‐randomisation dropouts: 2 (10%). Revised sample size: 18. Mean age: not stated. Females: 18 (100%). Symptomatic participants: not stated. AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): all participants followed up for 12 months. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: not stated. Exclusion criteria Decompensated liver cirrhosis. Chronic pancreatitis. Taking immunosuppressive drugs, glucocorticosteroids, or sex hormones. Taking other drugs for treatment of liver diseases or known to cause hepatotoxicity.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (low) (n = 10). Further details: UDCA: 10 mg/kg/day for 9 months. Group 2: placebo (n = 8).
Outcomes	Mortality, adverse events.
Notes	Reasons for post‐randomisation dropouts: not stated.
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 placebo was used in this double‐blind trial, unclear whether identical placebo used.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: although placebo was used in this double‐blind trial, unclear whether identical placebo used.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts.
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.