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. |
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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. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |