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. 2013 Jan 31;2013(1):CD003617. doi: 10.1002/14651858.CD003617.pub2
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.
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.
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.