Combined ursodeoxycholic acid and glycyrrhizin therapy for chronic hepatitis C virus infection: a randomized controlled trial in 170 patients.
OBJECTIVE
To assess the efficacy and safety of combination therapy using ursodeoxycholic acid with glycyrrhizin for chronic hepatitis C virus infection, we conducted a prospective randomized controlled trial of glycyrrhizin (group G) compared with glycyrrhizin plus ursodeoxycholic acid (group G+U) in 170 patients.


METHODS
All patients had elevated serum aminotransferase levels over 6 months before entry into the trial. Glycyrrhizin was administered to both groups for 24 weeks, and in group G+U, ursodeoxycholic acid (600 mg/day) was administered orally as well.


RESULTS
Serum aspartate transaminase and alanine transaminase concentrations significantly decreased during treatment in both groups, but serum gamma-glutamyl transpeptidase concentrations fell significantly only in group G+U. Concentrations of all three enzymes fell significantly more in group G+U than 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 regimen, not HCV-related factors or liver histology, to the degree of serum enzyme 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, and may be an alternative to interferon in chronic hepatitis C virus infection, especially for interferon-resistant or unstable patients.
Tsubota
A
A
Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan.
Kumada
H
H
Arase
Y
Y
Chayama
K
K
Saitoh
S
S
Ikeda
K
K
Kobayashi
M
M
Suzuki
Y
Y
Murashima
N
N
D000410:Alanine Transaminase / Q000097:blood; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D002756:Cholagogues and Choleretics / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019695:Glycyrrhizic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012044:Regression Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D014766:Viremia / Q000097:blood; D005723:gamma-Glutamyltransferase / Q000097:blood
D000894:Anti-Inflammatory Agents, Non-Steroidal; D002756:Cholagogues and Choleretics; D019695:Glycyrrhizic Acid; D014580:Ursodeoxycholic Acid; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase