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

Takano 1994.

Methods Generation of allocation sequence: unclear (no description). 
 Allocation concealment: unclear (no description). 
 Double blinding: inadequate (not blinding). 
 Sample size calculation: no information. 
 Follow up: unclear (no information). 
 Intention‐to‐treat analysis: no information.
Participants Country: Japan. 
 Type of hepatitis: chronic hepatitis C. 
 INCLUSION CRITERIA 
 ‐ serum anti‐HCV antibody positive at least three times. 
 EXCLUSION CRITERIA 
 ‐ liver dysfunction was a result of other reasons (e.g., the use of hepatotoxic drugs or severe right‐sided heart failure); 
 ‐ serum ALT was normal within three months before the initiation of treatment; 
 ‐ a history of hepatic encephalopathy, bleeding oesophageal varices or ascites; 
 ‐ receiving immunomodulatory or antiviral agents within six months before the start of treatment; 
 ‐ with lesions in the liver, except benign hemangioma. 
 PARTICIPANTS 
 ‐ Low dose UDCA group (n = 21). 
 Mean age (years) 
 54.3. 
 Ratio of sex (M/F) 13/8. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information. 
 ‐ Intermediate dose UDCA group (n = 18). 
 Mean age (years) 
 57.7. 
 Ratio of sex (M/F) 9/9. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information. 
 ‐ High dose UDCA group (n = 19). 
 Mean age (years) 
 51.8. 
 Ratio of sex (M/F) 14/5. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information. 
 ‐ Control group (n = 17). 
 Mean age (years) 
 53.7. 
 Ratio of sex (M/F) 15/2. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information.
Interventions Low dose UDCA group: 
 UDCA 
 ‐ Dose: 150 mg/day; 
 ‐ Route: orally; 
 ‐ Duration: 16 weeks.
Intermediate dose UDCA group: 
 UDCA 
 ‐ Dose: 600 mg/day; 
 ‐ Route: orally; 
 ‐ Duration: 16 weeks.
High dose UDCA group: 
 UDCA 
 ‐ Dose: 900 mg/day; 
 ‐ Route: orally; 
 ‐ Duration: 16 weeks.
Control group: 
 ‐ No treatment.
Outcomes ‐ Normalisation of serum ALT at the end of treatment. 
 ‐ Adverse events at the end of treatment.
Notes 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