Six RCTs were included (n=367); five were fully published and one was in abstract form. Three were considered to have described an adequate method of generating the sequence of randomisation. None reported any form of blinding. Two RCTs reported using ITT analysis and the other four provided sufficient details about follow-up and dropouts to permit ITT analysis. Three of the studies scored a total of three Jadad points and three scored three points (out of a possible five). Sensitivity analysis did not alter the statistical significance of the results.
IFN plus phlebotomy versus IFN alone (six RCTs): when RCTs were pooled, SVR rates were significantly higher in the intervention group (OR 2.69, 95% CI: 1.60, 4.52), with no heterogeneity (I2=0%).
Paired liver biopsy samples were obtained in all patients in only one RCT (n=30), which reported significant histological improvement from baseline (by Knodell score) in the intervention group, but not in the control group.