Papatheodoridis 2002.

Methods	Randomised clinical trial.
Participants	Country: Greece. Number randomised: 92. Post‐randomisation dropouts: 6 (6.5%). Revised sample size: 86. Mean age: 54 years. Females: 77 (89.5%). Symptomatic participants: 86 (100%). AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): 89 months. Inclusion criteria Symptom status: symptomatic participants only. AMA status: not stated. Response status: not stated. Exclusion criteria Extrahepatic biliary obstruction. Other liver diseases. Aged > 70 years. Immunosuppression within previous 12 months. Advanced or decompensated liver disease.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) (n = 43). Further details: UDCA: 12 mg/kg//day to 15 mg/kg//day for ≥ 2 years. Group 2: control (n = 43).
Outcomes	Mortality, liver transplantation, decompensated liver disease.
Notes	Reasons for post‐randomisation dropouts: not stated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was carried out by serially numbered sealed envelopes containing random table numbers 14 patients crossed over from placebo to UDCA".
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was carried out by serially numbered sealed envelopes containing random table numbers 14 patients crossed over from placebo to UDCA".
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Patients and healthcare providers were not blinded" (author's reply).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "The outcome assessors were not blinded" (author's reply).
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were post‐randomisation dropouts in the initial report.
Selective reporting (reporting bias)	High risk	Comment: adverse events not reported.
For‐profit bias	High risk	Quote: "Support for this work was provided during the first 2 years of the study by a research grant the pharmaceutical company Galenica Hellas and by the Greek Ministry of Health and Welfare".
Other bias	High risk	Comment: 14 participants crossed over from placebo to UDCA.