Steenbergen 1994.

Methods	Randomised clinical trial.
Participants	Country: Belgium. Number randomised: 14. Post‐randomisation dropouts: not stated. Revised sample size: 14. Mean age: 51 years. Females: 12 (85.7%). Symptomatic participants: not stated. AMA positive: 13 (92.9%). 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. Exclusion criteria Presence of cirrhosis. Excessive alcohol consumption. Other viral diseases. Mental disorders. Pregnancy. Chronic infection.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (low) + methotrexate (n = 8). Further details: UDCA: 500 mg/day; duration: not stated + methotrexate: 15 mg/week; duration: not stated. Group 2: control (n = 6).
Outcomes	None of the outcomes of interest reported.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Using a random number table…".
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	Unclear risk	Comment: information not available.
Selective reporting (reporting bias)	High risk	Comment: neither mortality nor adverse events reported.
For‐profit bias	Unclear risk	Comment: information not available.
Other bias	Low risk	Comment: no other source of bias.