Combined ursodeoxycholic acid and glycyrrhizin therapy for chronic hepatitis C virus infection: a randomized controlled trial in 170 patients

Objective and design To assess the efficacy and safety of combination thera py using ursodeoxycholic acid with glycyrrhizin for chronic hepatitis C vir us infection, we conducted a prospective randomized controlled trial of gly cyrrhizin (group G) compared with glycyrrhizin plus ursodeoxycholic acid (g roup G+U) in 170 patients. Methods All patients had elevated serum aminotransferase levels over 6 mont hs before entry into the trial. Glycyrrhizin was administered to both group s for 24 weeks, and in group G+U, ursodeoxycholic acid (600 mg/day) was adm inistered orally as well. Results Serum aspartate transaminase and alanine transaminase concentration s significantly decreased during treatment in both groups, but serum gammag lutamyl transpeptidase concentrations fell significantly only in group G+U, Concentrations of all three enzymes fell significantly more in group G+U t han in group G, and had normalized in more cases when the trial ended at 24 weeks. However, levels of HCV viraemia did not change during the trial in either group. Multiple regression analysis linked only the treatment regime n, not HCV-related factors or liver histology, to the degree of serum enzym e reduction. No adverse effects were noted in either group. Conclusions The combined therapy with ursodeoxycholic acid and glycyrrhizin is safe and effective in improving liver-specific enzyme abnormalities, an d may be an alternative to interferon in chronic hepatitis C virus infectio n, especially for interferon-resistant or unstable patients. Eur J Gastroen terol Hepatol 11 :1077 -1083 (C) 1999 Lippincott Williams & Wilkins.