Kaplan 1999.

Methods	Randomised clinical trial.
Participants	Country: USA. Number randomised: 87. Post‐randomisation dropouts: 2 (2.3%). Revised sample size: 85. Mean age: 51 years. Females: 82 (96.5%). Symptomatic participants: 71 (83.5%). AMA positive: 77 (90.6%). Responders: not stated. Mean follow‐up period (for all groups): minimum 24 months. Inclusion criteria Symptom status: symptomatic and asymptomatic participants. AMA status: AMA‐positive and AMA‐negative participants. Response status: not stated. Exclusion criteria End‐stage liver failure. History of alcohol abuse. Administration of drugs associated with chronic liver disease. Contemplation of pregnancy. Other serious medical illnesses such as renal or heart disease that may cause liver dysfunction or shorten life expectancy. Hypersplenism.
Interventions	Participants were randomly assigned to 2 groups. Group 1: colchicine (n = 43). Further details: colchicine: 0.6 mg BD for 2 years. Group 2: methotrexate (n = 42). Further details: methotrexate: 15 mg/week orally.
Outcomes	None of the outcomes of interest reported.
Notes	Reasons for post‐randomisation dropouts: withdrawal from study.
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	Quote: "Both the patients and investigators were blinded to the treatment assignments".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Both the patients and investigators were blinded to the treatment assignments". Comment: authors stated that this was a double‐blind trial and used a placebo; however, they did not state whether the placebo was identical.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts.
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 bias.