Papatheodoridis 2002.

Methods	Randomised clinical trial with parallel group design (two interventions groups). Trial duration: 92 months. Follow‐up: no patients lost to follow‐up.
Participants	Country: Greece. Number of patients randomised: 86, mean age 54 years (89% females). Inclusion criteria: ‐ liver histology compatible with PBC; ‐ positive antimitochondrial antibodies; ‐ alkaline phosphatase levels more than twice the upper limit of normal. Exclusion criteria: ‐ extrahepatic biliary obstruction or other cause of liver disease; ‐ patients aged > 70 years; ‐ patients treated with any immunosuppressive agent within the 12 months before entry; ‐ patients with decompensated cirrhosis (Child class B or C); ‐ baseline bilirubin levels ≥ 3 mg/dl.
Interventions	Patients were randomly assigned to receive: Intervention group 1: ursodeoxycholic acid 12 to 15 mg/kg/day, n = 43; Intervention group 2: no intervention, n = 43.
Outcomes	Liver decompensation. Mortality or liver transplantation. Symptoms. Liver biochemistry. Liver histology.
Notes	14/43 control patients were crossed‐over to ursodeoxycholic acid at their own request at a median of 3.5 years (range 2 to 8 years) after entry in the trial. Mean follow‐up was 7.3 ± 3.0 years in the ursodeoxycholic acid group and 8.1 ± 3.1 years in the control group. The authors did both intention‐to‐treat analysis and treatment‐as‐received analysis. Data for the following outcomes were extracted from graphs from Hadziyannis 1990 (Papatheodoridis 2002): ‐ serum bilirubin; ‐ serum alanine aminotransferase.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generation was achieved using random number table.
Allocation concealment (selection bias)	Low risk	Allocation was controlled by serially numbered sealed envelopes.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	The trial did not address this component and it was likely unblinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	It was specified that there were no dropouts or withdrawals.
Selective reporting (reporting bias)	Low risk	Pre‐defined, or clinically relevant and reasonably expected outcomes are reported on.
Other bias	Unclear risk	The trial reported a grant from the pharmaceutical company Galenica Hellas.