TY - JOUR
T1 - Silymarin in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid
AU - Angulo, Paul
AU - Patel, Tushar
AU - Jorgensen, Roberta A.
AU - Therneau, Terry M.
AU - Lindor, Keith D.
N1 - Funding Information:
Abbreviations: PBC, primary biliary cirrhosis; UDCA, ursodeoxycholic acid; AST, aspartate transaminase. From the 1Division of Gastroenterology and Hepatology and the 2Department of Health Science Research, Mayo Clinic and Foundation, Rochester, MN. Received June 12, 2000; accepted August 7, 2000. Presented in part during the annual meeting of the American Gastroenterological Association, San Diego, CA, May 2000. Drs. Angulo and Patel share the principal authorship of this article. Address reprint requests to: Keith D. Lindor, M.D., Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, 200 First Street SW, Rochester, MN 55905.
PY - 2000
Y1 - 2000
N2 - Ursodeoxycholic acid (UDCA) is a safe and effective medical therapy for most patients with primary biliary cirrhosis (PBC), but some patients show an incomplete response. Silymarin is a potent antioxidant with immunomodulatory and antifibrotic properties. The aim of this study was to evaluate the safety and assess the efficacy of silymarin in patients with PBC who had shown a suboptimal response to UDCA. Twenty-seven patients with PBC who had been on UDCA (13-15 mg/kg/day) therapy for 7 to 221 months and had shown a persistent elevation of alkaline phosphatase activity at least 2 times the upper limit of normal for more than 6 months were enrolled. Oral silymarin, 140 mg 3 times daily was given for 1 year, and patients continued on the same dosage of UDCA. No significant changes in serum alkaline phosphatase activity (897 ± 84 vs. 876 ± 95, P = .5), total bilirubin (0.9 ± 0.1 vs. 1 ± 0.1, P = .07), aspartate transaminase (AST) (58 ± 5 vs. 56 ± 6, P = .4), albumin (4.0 ± .06 vs. 4.1 ± .06, P = .4), or Mayo risk score (3.82 ± 0.2 vs. 3.88 ± 0.2, P = .4) were noted after 1 year of treatment with combination therapy. Transitory gastrointestinal adverse events occurred in 2 patients. In conclusion, although silymarin was well tolerated, this medication did not provide benefit to patients with PBC responding suboptimally to UDCA. The results of this pilot study would seem to discourage further controlled trials of silymarin in patients with PBC.
AB - Ursodeoxycholic acid (UDCA) is a safe and effective medical therapy for most patients with primary biliary cirrhosis (PBC), but some patients show an incomplete response. Silymarin is a potent antioxidant with immunomodulatory and antifibrotic properties. The aim of this study was to evaluate the safety and assess the efficacy of silymarin in patients with PBC who had shown a suboptimal response to UDCA. Twenty-seven patients with PBC who had been on UDCA (13-15 mg/kg/day) therapy for 7 to 221 months and had shown a persistent elevation of alkaline phosphatase activity at least 2 times the upper limit of normal for more than 6 months were enrolled. Oral silymarin, 140 mg 3 times daily was given for 1 year, and patients continued on the same dosage of UDCA. No significant changes in serum alkaline phosphatase activity (897 ± 84 vs. 876 ± 95, P = .5), total bilirubin (0.9 ± 0.1 vs. 1 ± 0.1, P = .07), aspartate transaminase (AST) (58 ± 5 vs. 56 ± 6, P = .4), albumin (4.0 ± .06 vs. 4.1 ± .06, P = .4), or Mayo risk score (3.82 ± 0.2 vs. 3.88 ± 0.2, P = .4) were noted after 1 year of treatment with combination therapy. Transitory gastrointestinal adverse events occurred in 2 patients. In conclusion, although silymarin was well tolerated, this medication did not provide benefit to patients with PBC responding suboptimally to UDCA. The results of this pilot study would seem to discourage further controlled trials of silymarin in patients with PBC.
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U2 - 10.1053/jhep.2000.18663
DO - 10.1053/jhep.2000.18663
M3 - Article
C2 - 11050036
AN - SCOPUS:0033754697
SN - 0270-9139
VL - 32
SP - 897
EP - 900
JO - Hepatology
JF - Hepatology
IS - 5
ER -