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

Leri 1994.

Methods Generation of allocation sequence: unclear (no description). 
 Allocation concealment: unclear (no description). 
 Double blinding: unclear (no description). 
 Sample size calculation: no. 
 Follow up: adequate (no drop out). 
 Intention‐to‐treat analysis: not performed.
Participants Country: Italy. 
 Type of hepatitis: chronic hepatitis C. 
 INCLUSION CRITERIA 
 ‐ anti‐HCV positive; 
 ‐ liver biopsy scoring were assessed before the treatment and showed periportal necrosis, lobular and portal inflammation, according to chronic hepatitis. 
 PARTICIPANTS 
 ‐ UDCA group (n = 12): 
 Mean age (years) 
 59.17. 
 Ratio of sex (M/F) 
 5/7. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information. 
 ‐ Placebo group (n = 10): 
 Mean age (years) 
 56.40; 
 Ratio of sex (M/F) 
 5/5. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information.
Interventions UDCA group: 
 UDCA 
 ‐ Dose: 600 mg/day; 
 ‐ Route: Orally; 
 ‐ Timing: no information; 
 ‐ Duration: six months.
Placebo group: 
 ‐ Placebo.
Outcomes ‐ Serum AST, ALT, and GGT activities at the end of treatment.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear