Methods | Randomized four‐groups trial comparing different doses and type of interferon with no treated control group Intention‐to‐treat analysis: yes Sample size calculation: no. |
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Participants | Country: Italy Nonresponders (n = 112) ‐ Previous nonresponse: biochemical ‐ Groups (interferon/interferon/interferon/C): ‐ Excluded: 0/0/0/0 ‐ Mean age (y): 47/48/45/46 ‐ Male (%): 64/57/61/54 ‐ Transfusion (%): 32/29/29/25 ‐ Drug abuse (%): N/A ‐ Genotype 1 (%): N/A ‐ Cirrhosis (%): 0/0 Inclusion criteria: Chronic hepatitis (clinical, serological and histological data), alanine transaminase levels at least twice the ULN, positive Anti‐HCV, lack of response to previous interferon‐alfa (3 MU three times per week x 24 wk). Exclusion criteria: Consumption of > 40 g/d of alcohol, drug‐induced liver disease, HBV, HDV, HIV, metabolic disorders, autoimmune factors and histological diagnosis of cirrhosis. |
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Interventions | ‐ Schedule: Experimental 1: Interferon alfa 3 MU three times per week x 24 wk Experimental 2: Interferon alfa 6 MU three times per week x 24 wk Experimental 3: LYMPH interferon alfa 3 MU three times per week x 24 wk Control: no treatment ‐ Follow‐up (F/U): 24 wk. | |
Outcomes | ‐ Biochemical end of treatment response. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear. |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
Blinding (performance bias and detection bias) Objective outcomes (Biochemical or virologic response) | Low risk | The review authors consider that knowledge of the group to which the patient belongs to, will not increase the bias as these outcomes are objective. |
Blinding (performance bias and detection bias) Subjective outcomes (Clinical events other than mortality, Histology) | High risk | Not reported. |
Blinding (performance bias and detection bias) Adverse effects | High risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients discontinued the therapy for adverse events. |
Selective reporting (reporting bias) | Unclear risk | While it may be that no clinical events occurred in the 24 weeks of the trial, this was not specified in the paper. |
Other bias | Unclear risk | Unclear. |