S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.

Inclusion Criteria: * primary sclerosing cholangitis fulfilling EASL criteria; * age: 18 - 75 years; * treatment with ursodeoxycholic acid (UDCA) in a dose of 13-15mg/kg b.w. for at least 6 months. Exclusion Criteria: * inability to give informed consent; * patients with other forms of chronic liver diseases; * decompensated liver cirrhosis (Child-Pugh class B-C); * patients with PSC who underwent stenting of their biliary tree within 6 months; * other diseases or states that can affect quality of life and mood: decompensated diabetes mellitus, renal insufficiency requiring dialyses, malignancy, heart failure ≥ New York Heart Association (NYHA) II, organ transplantation, known HIV infection, rheumatoid arthritis, asthma, psychiatric disorders; * treatment with: steroids, statins, rifampicin, antidepressants; * pregnant or breastfeeding women; * history of hypersensitivity reactions to S-adenosylmethionine; * any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study.