Van Hoogstraten 1998.

Methods	Randomised clinical trial.
Participants	Country: Netherlands. Number randomised: 61. Post‐randomisation dropouts: 2 (3.3%). Revised sample size: 59. Mean age: 57 years. Females: 55 (93.2%). Symptomatic participants: not stated. AMA positive: not stated. Responders: 0 (0%). Mean follow‐up period (for all groups): not stated. Inclusion criteria Symptom status: not stated. AMA status: not stated. Response status: non‐responders only. Exclusion criteria Decompensated liver disease.
Interventions	Participants were randomly assigned to 2 groups. Group 1: UDCA (low) (n = 32). Further details: UDCA (low): 10 mg/kg/day for 6 months. Group 2: UDCA (moderate) (n = 27). Further details: UDCA (moderate): 20 mg/kg/day for 6 months.
Outcomes	Adverse events.
Notes	Reasons for post‐randomisation dropouts: developed liver failure, lost to follow‐up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Tables with random numbers" (author's reply).
Allocation concealment (selection bias)	Low risk	Quote: "Opaque closed envelopes" (author's reply).
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "randomised open controlled trial".
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "randomised open controlled trial".
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: information not available.
Selective reporting (reporting bias)	High risk	Comment: mortality not reported.
For‐profit bias	High risk	Quote: "This study was supported in part by Zambon Nederland BV, Amersfoort, the Netherlands".
Other bias	Low risk	Comment: no other source of bias.