Hendrickse 1999.

Methods	Randomised clinical trial.
Participants	Country: UK. Number randomised: 60. Post‐randomisation dropouts: not stated. Revised sample size: 60. Mean age: 57 years. Females: 55 (91.7%). Symptomatic participants: 57 (95%). AMA positive: 51 (85%). Responders: not stated. Mean follow‐up period (for all groups): minimum 68 months. Inclusion criteria Symptom status: symptomatic and asymptomatic participants. AMA status: AMA‐positive and AMA‐negative participants. Response status: not stated. Exclusion criteria Advanced liver disease. Continuing or recent alcohol abuse. Immunosuppressive drugs in the previous 6 months. Contemplation of pregnancy. Haematological abnormalities. Other serious medical illness that might cause liver dysfunction or limit life expectancy.
Interventions	Participants were randomly assigned to 2 groups. Group 1: methotrexate (n = 30). Further details: methotrexate: 2.5 mg 3 times weekly for 6 years. Group 2: placebo (n = 30). Further details: placebo: 3 times weekly for 6 years.
Outcomes	Mortality, liver transplantation.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomized in groups of 10 by a random‐number technique, operated by the hospital pharmacy, to receive 2.5 mg MTX [methotrexate] or identical placebo tablets, both supplied by Lederle Laboratories, on Friday, Saturday, and Sunday of each week for up to 6 years".
Allocation concealment (selection bias)	Low risk	Quote: "Patients were randomized in groups of 10 by a random‐number technique, operated by the hospital pharmacy, to receive 2.5 mg MTX or identical placebo tablets, both supplied by Lederle Laboratories, on Friday, Saturday, and Sunday of each week for up to 6 years".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: placebo used in this double‐blind trial; however, the authors did not state whether the placebo was identical.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: placebo used in this double‐blind trial; however, the authors did not state whether the placebo was identical.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: information not available.
Selective reporting (reporting bias)	High risk	Comment: neither mortality nor morbidity reported.
For‐profit bias	Unclear risk	Comment: information not available.
Other bias	Low risk	Comment: no other source of bias.