Kawata 1994.
Methods | Generation of allocation sequence: unclear (no description). Allocation concealment: unclear (no description). Double blinding: unclear (no information). Withdrawal: unclear (no information). Sample size calculation: no information. Intention‐to‐treat analysis: no information. | |
Participants | Country: Japan. Type of hepatitis: chronic hepatitis C. INCLUSION CRITERIA ‐ anti‐HCV positive; ‐ chronic hepatitis; ‐ ALT levels persistently greater than two times the upper normal limit. PARTICIPANTS UDCA plus IFN group (n = 35). IFN group (n = 35). Proportion of patients with cholestasis: no information. Proportion of patients with cirrhosis: no information. | |
Interventions | UDCA plus IFN group:
UDCA
‐ Dose: 600 mg/day;
‐ Route: orally;
‐ Duration: 48 weeks.
IFN
‐ IFN alpha 2a six million units a day for two weeks then thrice weekly for 22 weeks. IFN group: ‐ IFN alpha 2a six million units a day for two weeks then thrice weekly for 22 weeks. |
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Outcomes | ‐ Normalisation of serum ALT at the end of treatment and follow‐up. ‐ Absence of serum HCV RNA 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 |