Ferri 1993.

Methods	Randomised clinical trial.
Participants	Country: Italy. Number randomised: 30. Post‐randomisation dropouts: 0 (0%). Revised sample size: 30. Mean age: 53 years. Females: 27 (90%). Symptomatic participants: not stated. AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): all participants followed up for 6 months. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: not stated. Exclusion criteria People with decompensated cirrhosis. Extrahepatic biliary obstruction. Severe kidney or heart disease. Neoplasms. Pregnancy or breastfeeding. Excessive alcohol consumption.
Interventions	Participants were randomly assigned to 2 groups. Group 1: TUDCA (moderate) (n = 15). Further details: TUDCA: 13 mg/day to 15 mg/day for 6 months. Group 2: UDCA (moderate) (n = 15). Further details: UDCA: 13 mg/day to 15 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: adverse events, the only outcome of interest reported in this study were available from all randomised participants.
Selective reporting (reporting bias)	High risk	Comment: mortality not reported.
For‐profit bias	Unclear risk	Comment: information not available.
Other bias	Low risk	Comment: no other source of bias.