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 |