Cadranel 2003.
Methods | Generation of allocation sequence: unclear (no description). Allocation concealment: unclear (no description). Double blinding: adequate (identical placebo). Sample size calculation: no information. Follow up: adequate. Intention‐to‐treat analysis: yes. | |
Participants | Country: France. Type of hepatitis: chronic viral hepatitis. INCLUSION CRITERIA ‐ heart transplanted patients; ‐ biopsy proven chronic viral hepatitis; PARTICIPANTS ‐ UDCA group (n = 30). Proportion of patients with cholestasis: no information. Proportion of patients with cirrhosis: no information. ‐ Placebo group (n = 30). Proportion of patients with cholestasis: no information. Proportion of patients with cirrhosis: no information. | |
Interventions | UDCA group: UDCA ‐ Dose: 800 mg/day; ‐ Route: orally; ‐ Duration: 12 months. Placebo group: ‐ Identical placebo for 12 months. | |
Outcomes | ‐ Normalisation of serum ALT at the end of treatment. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | D ‐ Not used |