Puoti 1995.

Methods	Generation of allocation sequence: unclear (no description). Allocation concealment: unclear (no description). Double blinding: inadequate (not blinding). Follow up: adequate (no drop out). Sample size calculation: no information. Intention‐to‐treat analysis: not performed.
Participants	Country: Italy. Type of hepatitis: chronic hepatitis C. INCLUSION CRITERIA: ‐ positive for anti‐HCV antibodies; ‐ biopsy‐proven or biochemical and clinical evidence of chronic liver disease; ‐ serum ALT levels at least twice the upper limit of the normal range on three different occasions in the last 12 months. EXCLUSION CRITERIA: ‐ other forms of chronic liver disease; ‐ history of alcohol abuse; ‐ presence of severe liver disease and concomitant treatment with drugs which could interfere with hepatic metabolism or with bile acid absorption; ‐ previous interferon treatment; ‐ positive to HIV antibodies or HBs Ag; ‐ presence of hepatic tumours. PARTICIPANTS 101 outpatients (52 men and 49 women); mean age 45.1 years old. ‐ UDCA group (n = 49): Ratio of sex (M/F) 25/24. Proportion of patients with cholestasis: no information. Proportion of patients with cirrhosis: 13 patients. ‐ Control group (n = 52): Ratio of sex (M/F) 27/25. Proportion of patients with cholestasis: no information. Proportion of patients with cirrhosis: 14 patients.
Interventions	UDCA group: UDCA ‐ Dose: 450 mg/day; ‐ Route: orally; ‐ Timing: single bedtime dose; ‐ Duration: six months. Control group ‐ No treatment.
Outcomes	‐ Serum ALT and GGT activities at the end of treatment. ‐ Normalisation of serum ALT and GGT at the end of treatment.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear