Almasio 2000.

Methods	Randomised clinical trial.
Participants	Country: Italy. Number randomised: 90. Post‐randomisation dropouts: 6 (6.7%). Revised sample size: 84. Mean age: 54 years. Females: 81 (96.4%). Symptomatic participants: 84 (100%). AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): not stated. Inclusion criteria Symptom status: symptomatic participants only. AMA status: not stated. Response status: not stated. Exclusion criteria People with biliary obstruction. Anticipated requirement for liver transplantation in 1 year. Pregnancy. Aged < 18 years or > 70 years. Coexisting liver disease. Anticipated life expectancy < 3 years.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (low) + colchicine (n = 42). Further details: UDCA: 250 mg BD for 3 years + colchicine: 1 mg/day for 3 years. Group 2: UDCA (low) (n = 42). Further details: UDCA: 250 mg BD for 3 years.
Outcomes	Mortality, decompensated liver disease.
Notes	Reasons for post‐randomisation dropouts: adverse effects and low compliance.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Colchicine, 1 mg daily, or an indistinguishable placebo were randomly assigned to patients according to a computer‐generated list developed separately for each centre".
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was performed by a central study unit…".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: identical placebo used and authors stated double‐blind.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: identical placebo used and authors stated double‐blind.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias)	High risk	Comment: adverse events not reported.
For‐profit bias	Low risk	Comment: no money received for the trial; the drug was provided by Abc Farmaceutici S.p.a (author's reply).
Other bias	Low risk	Comment: no other bias noted.