TITLE: Intravenous glycyrrhizin for the treatment of chronic
hepatitis C: a double-blind, randomized, placebo-controlled phase
BACKGROUND: In Japan, glycyrrhizin therapy is widely used for
chronic hepatitis C and reportedly reduces the progression of liver
disease to hepatocellular carcinoma. The aims of this study were to
evaluate the effect of glycyrrhizin on serum alanine
aminotransferase (ALT), hepatitis C virus (HCV)-RNA and its safety
in European patients.
METHODS: Fifty-seven patients with chronic hepatitis C,
non-responders or unlikely to respond (genotype 1/cirrhosis) to
interferon therapy, were randomized to one of the four dose groups:
240, 160 or 80 mg glycyrrhizin or placebo (0 mg glycyrrhizin).
Medication was administered intravenously thrice weekly for 4
weeks; follow up also lasted for 4 weeks.
RESULTS: Within 2 days of start of therapy, serum ALT had
dropped 15% below baseline in the three dosage groups (P <
0.02). The mean ALT decrease at the end of active treatment was
26%, significantly higher than the placebo group (6%). A clear
dose-response effect was not observed (29, 26, 23% ALT decrease for
240, 160 and 80 mg, respectively). Normalization of ALT at the end
of treatment occurred in 10% (four of 41). The effect on ALT
disappeared after cessation of therapy. During treatment, viral
clearance was not observed: the mean decrease in plasma HCV-RNA
after active treatment was 4.1 x 10(6) genome equivalents/mL (95%
confidence interval, 0-8.2 x 10(6); P greater than 0.1). No major
side-effects were noted. None of the patients withdrew from the
study because of intolerance.
CONCLUSIONS: Glycyrrhizin up to 240 mg, thrice weekly, lowers
serum ALT during treatment, but has no effect on HCV-RNA levels.
The drug appears to be safe and is well tolerated. In view of the
reported long-term effect of glycyrrhizin, further controlled
investigation of the Japanese mode of administration (six times
weekly) for induction appears of interest.
AUTHOR: van Rossum TG, Vulto AG, Hop WC, Brouwer JT, Niesters
HG, Schalm SW Department of Hepatogastroenterology, Erasmus Medical
Center, Rotterdam, The Netherlands.
SOURCE: J Gastroenterol Hepatol 1999 Nov;14(11):1093-9
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