Biochemical and histological effects of 26 weeks of glycyrrhizin treatment in chronic hepatitis C: a randomized phase II trial.

Abstract:

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 for 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: 6x, 3x 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.

journal_name

J Hepatol

journal_title

Journal of hepatology

authors

Orlent H,Hansen BE,Willems M,Brouwer JT,Huber R,Kullak-Ublick GA,Gerken G,Zeuzem S,Nevens F,Tielemans WC,Zondervan PE,Lagging M,Westin J,Schalm SW

doi

10.1016/j.jhep.2006.05.015

subject

Has Abstract

pub_date

2006-10-01 00:00:00

pages

539-46

issue

4

eissn

0168-8278

issn

1600-0641

pii

S0168-8278(06)00301-1

journal_volume

45

pub_type

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