Skip to main content
. 2004 Apr 19;2004(2):CD002904. doi: 10.1002/14651858.CD002904.pub2

Dammacco 1994.

Methods Generation of the allocation sequence: unclear (not reported). 
 Allocation concealment: 
 unclear (not reported). 
 Blinding: no blinding. 
 Follow‐up: adequate. Median follow‐up was 13 months after treatment. They specified that all patients completed the study.
Participants 52 patients from Italy with type 2 mixed cryoglobulinaemia and with positive anti‐HCV and HCV‐RNA.
Inclusion criteria: 
 diagnosed cryoglobulinaemia characterised by detectable serum cryoglobulins for at least one year associated with the triad purpura‐weakness‐arthralgias and positive anti‐HCV.
Exclusion criteria: 
 Interferon or immunosuppressive therapy within the previous six months, pregnancy, concomitant illness, ascites, bleeding oesophageal varices, hepatic encephalopathy, bilirubin greater than three mg/dL, albumin less than three g/dL, prothrombin time greater than three seconds longer than the control, leukocyte count less than 3000/µL, platelet count less than 10 g/dL, and positive test for hepatitis B surface antigen.
Characteristics (including patients without positive anti‐HCV): 
 Interferon group: 
 Male/Female: 6/9. 
 Age (mean ± SD): 59.2 ± 7.1. 
 ALT (IU/L): 54.1 ± 32.2. 
 Gamma‐globulin (g/L): 2.01 ± 0.6. 
 Anti‐HCV: 12. 
 HCV RNA: 12. 
 Cirrhosis: 3.
Prednisolone group: 
 Male/Female: 8/10. 
 Age (mean ± SD): 49.2 ± 16.7. 
 ALT (IU/L): 56.1 ± 47.2. 
 Gamma‐globulin (g/L): 1.9 ± 0.8. 
 Anti‐HCV: 15. 
 HCV RNA: 15. 
 Cirrhosis: 5.
Interferon plus prednisolone group: 
 Male/Female: 8/9. 
 Age (mean ± SD): 56.3 ± 3.3. 
 ALT (IU/L): 49.4 ± 41.0. 
 Gamma‐globulin (g/L): 1.9 ± 0.5. 
 Anti‐HCV: 11. 
 HCV RNA: 11. 
 Cirrhosis: 6.
Control group: 
 Male/Female: 7/8. 
 Age (mean ± SD): 51.4 ± 5.0. 
 ALT (IU/L): 62.0± 18.0. 
 Gamma‐globulin (g/L): 1.8 ± 0.7. 
 Anti‐HCV: 11. 
 HCV RNA: 11. 
 Cirrhosis: 4.
Interventions Prednisolone group: 
 all patients received prednisolone (16 mg/day) for 48 weeks.
Interferon plus prednisolone group: 
 Same as the interferon group plus prednisolone on non‐interferon days.
Interferon group: 
 all patients received three million units of lymphoblastoid interferon alpha‐n1 three times/week for 48 weeks.
Control group: 
 received no intervention.
Outcomes IgM, rheumatoid factor activity, ALT, HCV‐RNA and adverse events. The authors defined complete response as having a negative (non‐detectable) HCV‐RNA level.
Notes Thirteen patients were not anti‐HCV positive. They were excluded from our meta‐analysis. 
 No information on health economics was provided.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear