Iwasaki 2008b.

Methods	Randomised clinical trial.
Participants	Country: Japan. Number randomised: 22. Post‐randomisation dropouts: not stated. Revised sample size: 22. Mean age: 54 years. Females: 19 (86.4%). Symptomatic participants: not stated. AMA positive: not stated. Responders: 0 (0%). Mean follow‐up period (for all groups): all participants followed up for 12 months. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: non‐responders only. Exclusion criteria Cirrhosis. Advanced liver disease or decompensated cirrhosis. Renal insufficiency. Malignancy. Pregnancy. Aged < 19 years.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (low) + bezafibrate (n = 10). Further details: UDCA: 600 mg/day for 52 weeks + bezafibrate: 400 mg/day for 52 weeks. Group 2: UDCA (low) (n = 12). Further details: UDCA: 600 mg/day for 52 weeks.
Outcomes	None of the outcomes of interest reported.
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)	Low risk	Quote: "Consecutive patients from these hospitals were randomized centrally at the Kanagawa Dental University and were enrolled into the study if they met the following criteria".
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "A randomized, open study design was used because there was no suitable placebo for bezafibrate available".
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "A randomized, open study design was used because there was no suitable placebo for bezafibrate 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	Low risk	Quote: "The Ministry of Health, Labour and Welfare of Japan supported this study from 2002 to 2004 with a Health Science Research Grant on a Specific Disease (Study of Intractable Liver Diseases) to chief scientist Gotaro Toda".
Other bias	Low risk	Comment: no other bias.