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

Fabbri 2000.

Methods Generation of allocation sequence: unclear (no description). 
 Allocation concealment: unclear (no description). 
 Double blinding: inadequate (not blinding). 
 Follow up: adequate (no drop out). 
 Sample size calculation: no information. 
 Intention‐to‐treat analysis: no information.
Participants Country: Italy. 
 Type of hepatitis: chronic hepatitis C. 
 INCLUSION CRITERIA 
 ‐ serum HCV RNA positive; 
 ‐ liver biopsy findings of chronic hepatitis; 
 ‐ no response to alpha IFN treatment for four consecutive months; 
 ‐ persistent elevations of serum ALT levels (at least 1.5‐fold the upper normal limit). 
 EXCLUSION CRITERIA: 
 ‐ HBV or HIV co‐infection; 
 ‐ genetic liver disease; 
 ‐ evidence of auto‐immune disorder (auto‐antibody titre greater than 1:40); 
 ‐ malignancy, or renal, haematological, cardiac or pulmonary diseases, or was consuming alcohol. 
 PARTICIPANTS 
 ‐ UDCA plus IFN group (n = 53): 
 Mean age (years +/‐ SD) 
 52.6 +/‐ 1.8. 
 Ratio of sex (M/F) 
 34/19. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information. 
 ‐ IFN group (n = 50): 
 Mean age 
 (years +/‐ SD) 
 45.8 +/‐ 1.8. 
 Ratio of sex (M/F) 
 26/24. 
 Proportion of patients with cholestasis: no information. 
 Proportion of patients with cirrhosis: no information.
Interventions Alpha IFN 2b was administered to all patients at a dose of three million units three times weekly for four months firstly.
UDCA plus IFN group: 
 UDCA 
 ‐ Dose: 600 mg/day; 
 ‐ Route: orally; 
 ‐ Timing: two times a day; 
 ‐ Duration: 14 months. 
 IFN 
 Alpha IFN 2b 
 ‐ Dose: three million units three times a week; 
 ‐ Route: subcutaneously; 
 ‐ Duration: eight months.
IFN group: 
 Alpha IFN 2b 
 ‐ Dose: three million units three times a week; 
 ‐ Route: subcutaneously; 
 ‐ Duration: eight months.
Outcomes ‐ Normalization of serum ALT at the end of treatment. 
 ‐ Absence of serum HCV RNA at the end of treatment. 
 ‐ Liver histology changes.
Notes Follow‐up time is six months after the end of treatment.
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