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 |