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Abstract Details
A phase II, randomized, controlled trial of S-adenosylmethionine in reducing serum alpha-fetoprotein (AFP) in patients with hepatitis C cirrhosis and elevated AFP
Morgan TR1, Osann K2, Bottiglieri T3, Pimstone N4, Hoefs JC5, Hu KQ6, Hassanein T7, Boyer T8, Kong L9, Chen WP10, Richmond E11, Gonzalez R12, Rodriguez LM13, Meyskens FL14. Cancer Prev Res (Phila). 2015 Jun 30. pii: canprevres.0029.2015. [Epub ahead of print]
Author information
1Hepatology, VA Long Beach Healthcare System timothy.morgan@va.gov.
2Department of Medicine, Epidemiology Divisio, University of California, Irvine.
3Institute of Metabolic Disease, Baylor Research Institute.
4Gastroenterology, VA Greater Los Angeles Healthcare System.
5Medicine, University of California, Irvine.
6GI Division, University of California, Irvine.
7Gastroenterology, Sharp HealthCare System.
8Gastroenterology, University of Arizona College of Medicine.
9Inpatient Pharmacy, University of California Irvine Medical Center.
10Chao Family Comprehensive Cancer Center, The University of California, Irvine.
11Division of Cancer Prevention, National Cancer Institute.
12CANCER CENTER, UC IRVINE.
13DCP, NCI.
14Chao Family Comprehensive Cancer Center, University of California Irvine.
Abstract
In animal models of hepatocellular carcinoma (HCC), deficiency of S-adenosylmethionine (SAMe) increased the risk of HCC while administration of SAMe reduced HCC. The aim of this trial was to determine whether oral SAMe administration to patients with hepatitis C cirrhosis would decrease serum AFP level, a biomarker of HCC risk in hepatitis C. This was a prospective, randomized, placebo-controlled, double-blind trial of SAMe, up to 2.4 grams/day, for 24 weeks as compared with placebo among subjects with hepatitis C cirrhosis and a mildly elevated serum AFP. Primary outcome was change in AFP between baseline and week 24. Secondary outcomes included changes in routine tests of liver function and injury, other biomarkers of HCC risk, SAMe metabolites, markers of oxidative stress, and quality of life. 110 subjects were randomized and 87 (44 SAMe and 43 placebo) completed treatment. There was no difference in the change in AFP during 24 weeks among subjects receiving SAMe as compared with placebo. Changes in markers of liver function, liver injury, and hepatitis C viral level were not significantly different between groups. Similarly, SAMe did not change markers of oxidative stress or serum glutathione level. SAMe blood level increased significantly among subjects receiving SAMe. Changes in quality of life did not differ between groups. Overall, this trial did not find that SAMe treatment improved serum AFP in subjects with advanced hepatitis C cirrhosis and a mildly elevated AFP. SAMe did not improve tests of liver function or injury, or markers of oxidative stress or antioxidant potential.