Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease

Exclusion Criteria

• •Patients who have either compensated cirrhosis (biopsy proven) or a clinical picture of severe cirrhosis defined as Child's class C and/or with a recent history (within one month) of decompensated liver disease (history of ascites, encephalopathy or variceal bleeding within one month of trial entry). These patients have reduced life expectancy below one year and are most often severely coagulopathic and cannot be biopsied.
• •Patients who have severe acute alcoholic hepatitis of poor prognosis defined as a Maddrey Score \> 32. These patients have a mortality rate of 50% during their hospitalization period when untreated by either prednisone or pentoxifylline.
• •Patients who are receiving hepatotropic treatments such as colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, and pentoxifylline.
• •Patients who are receiving known hepatotoxic long-term treatments such as NSAIDs, statins, neuroleptics, certain anti-convulsive medications, or high-dose acetaminophen.
• •Patients suspected of having hepatocellular carcinoma.
• •Patients who have contra-indications to liver biopsy.
• •Patients who have a liver biopsy that does not yield sufficient specimen for analyses.
• •Patients who have untreated deficiencies of folic acid, vitamin B6 or B12.
• •Patients who have chronic active Hepatitis B or C, hemochromatosis, autoimmune hepatitis, or a cholangiopathy.
• •Patients with psychotic disorders, and in particular manic depression (contra indication to SAMe treatment).