Background: Kampo medicine has been shown to be useful for reducing the adverse effects of pegylated interferon (PEG-IFN) α-2b plus ribavirin (RBV). The study was done to determine if Kampo would have a synergistic effect with PEG-IFNα-2b plus RBV that would improve their effectiveness in the treatment of chronic hepatitis C. Methods: From a total of 51 chronic hepatitis C virus (HCV) patients, 26 received PEG-IFNα-2b plus RBV treatment combined with Kampo medicine (group A) and 25 received only the standard treatment (group B). Group B patients were prescribed a mixture of shimbuto and ninjinto extract to be taken three times a day before meals. Results: The early virological response (EVR) and sustained virological response (SVR) rates were significantly higher in group A than in group B (EVR: 84.6%, 22 of 26 vs 56.0%, 14 of 25, P=0.034: SVR: 76.9%, 20 of 26 vs 48.0%, 12 of 25, P=0.033). 22 of 26 patients in group A (84.6%) and 18 of 25 patients in group B (72.0%) received at least the minimum acceptable dosage (at least 80% or more of the target PEG-IFNα-2b and 60% or more of RBV) during treatment, with no significant between group difference in the rate of SVR. The discontinuation rate was significantly lower in group A, in which no patients discontinued, than in group B (20.0%, 5 of 25) (P=0.023). Conclusions: A mixture of shimbuto and ninjinto reduced the discontinuation rate and improved the treatment efficacy of patients with chronic HCV treated with PEG-IFNα-2b plus RBV.
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