Background/Aims： Phase I / II studies of 4 weeks duration have confirmed the ALT lowering effect of glycyrrhizin in Western chronic hepatitis C patients. Our aim was to determine the dose frequency of glycyrrhizin required to maintain the ALT response beyond 4 weeks and evaluate its effect on liver histology and quality of life.
Methods：HCV-RNA-positive patients with elevated ALT and marked fibrosis or necro-inflammation who were not eligible or interferon therapy were treated for 4 weeks with six infusions weekly of glycyrrhizin. Patients with an ALT response at week 4 were randomized to continue treatment for 22 weeks in three dose frequency groups： 6·， 3· or once weekly.
Results： 72/121 （60%） patients were randomized. At the end of treatment the ALT response was maintained in 60%， 24% and 9% of patients in the 6x， 3x， and once weekly groups， respectively （p < 0.001）. In ALT responders the necro-inflammation score improved non-significantly compared to ALT non-responders. Quality of life assessed by SF-36 increased in patients treated with the study drug， albeit unrelated to the occurrence of ALT response.
Conclusions：ALT responses induced by 4 weeks glycyrrhizin therapy can be maintained in a subset of chronic hepatitis C patients receiving at least three injections weekly. The observed ALT response did not translate in a significant histological improvement after 6 months treatment.
