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

Senturk 1997.

Methods Generation of allocation sequence: unclear (no description). 
 Allocation concealment: unclear (no description). 
 Double blinding: inadequate (not blinding). 
 Follow up: adequate (six patients from UDCA plus IFN group; 
 four patients from IFN group). 
 Sample size calculation: no information. 
 Intention‐to‐treat analysis: not performed.
Participants Country: Turkey. 
 Type of hepatitis: chronic hepatitis C. 
 INCLUSION CRITERIA 
 ‐ persistent serum ALT elevation of two times or more of the upper normal limit for at least six months preceding treatment; 
 ‐ serum anti‐HCV and HCV RNA positive; 
 ‐ absence of HBsAg; 
 ‐ liver biopsy findings of chronic hepatitis. 
 EXCLUSION CRITERIA 
 ‐ patients with signs of decompensated cirrhosis such as ascites, oesophageal varices, and hepatic encephalopathy. PARTICIPANTS 
 ‐ UDCA plus IFN group (n =45): 
 Mean age (years) 
 50 (19‐69). 
 Ratio of sex (M/F) 22/23. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information. 
 ‐ IFN group: 
 Mean age (years) 
 46 (23‐73). 
 Ratio of sex (M/F) 23/26.
Interventions UDCA plus IFN group: 
 UDCA 
 ‐ Dose: 500 mg/day; 
 ‐ Route: orally; 
 ‐ Timing: two times per day; 
 ‐ Duration: six months. 
 Alpha IFN 
 ‐ Dose: three million units; 
 ‐ Route: no described; 
 ‐ Timing: three times per week; 
 ‐ Duration: six months.
IFN group: 
 Alpha IFN 
 ‐ Dose: three million units; 
 ‐ Route: no described; 
 ‐ Timing: three times per week; 
 ‐ Duration: six months.
Outcomes ‐ Normalisation of serum ALT at the end of six months treatment.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear