Kanda 2003.

Methods	Randomised clinical trial.
Participants	Country: Japan. Number randomised: 22. Post‐randomisation dropouts: 0 (0%). Revised sample size: 22. Mean age: 56 years. Females: 19 (86.4%). Symptomatic participants: not stated. AMA positive: not stated. Responders: 0 (0%). Mean follow‐up period (for all groups): minimum 7 months. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: non‐responders only. Other inclusion criteria Treatment with UDCA for ≥ 6 months prior the study. Prior compliance with UDCA therapy. Exclusion criteria Other chronic liver diseases or decompensated liver disease. Previous colchicine, corticosteroid, or immunosuppressive treatment. Thyroid or renal dysfunction.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (low) + bezafibrate (n = 11). Further details: UDCA: 600 mg/day for 6 months + bezafibrate: 400 mg/day for 52 weeks. Group 2: UDCA (low) (n = 11). Further details: UDCA: 600 mg/day for 6 months.
Outcomes	Adverse events.
Notes
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: information not available.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: information not available.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no post‐randomisation dropouts.
Selective reporting (reporting bias)	High risk	Comment: mortality was not reported.
For‐profit bias	Unclear risk	Comment: information not available.
Other bias	Low risk	Comment: no other bias.