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

Bonnand 1996.

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 (five patients from UDCA group, four patients from control group). 
 Intention‐to‐treat analysis: no information.
Participants Country: France. 
 Type of hepatitis: chronic hepatitis C. 
 INCLUSION CRITERIA 
 ‐ anti‐HCV positive; 
 ‐ chronic hepatitis; 
 ‐ ALT activities persistently greater than two times the upper normal limit. 
 EXCLUSION CRITERIA: 
 not described. 
 PARTICIPANTS 
 ‐ UDCA plus IFN group (n = 47); 
 ‐ IFN group (n = 44). 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information.
Interventions UDCA plus IFN group: 
 UDCA 
 ‐ Dose: 13‐15 mg/kg/day; 
 ‐ Route: orally; 
 ‐ Duration: six months. 
 IFN 
 ‐ Dose: three million units three times a week; 
 ‐ Route: subcutaneously; 
 ‐ Duration: six months.
IFN group: 
 ‐ Dose: three million units three times a week; 
 ‐ Route: subcutaneously; 
 ‐ Duration: six months.
Outcomes ‐ Normalisation of ALT at the end of treatment and follow‐up. 
 ‐ Absence of serum HCV at the end of treatment and follow‐up.
Notes Follow‐up time: six months after the end of IFN treatment.
We sent letter for more information on trial methodological quality and missing data on April 17, 2001, but no response was received.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear