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. 2007 Oct 17;2007(4):CD003181. doi: 10.1002/14651858.CD003181.pub2

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