Effect of S-adenosyl-L-methionine on liver biochemistry and quality of life in patients with primary biliary cholangitis treated with ursodeoxycholic acid. A prospective, open label pilot study

J Gastrointestin Liver Dis. 2018 Sep;27(3):273-279. doi: 10.15403/jgld.2014.1121.273.icz.


Background and aims: Chronic liver disease induces an acquired deficiency of S-adenosyl-L-methionine (SAMe) leading to impairment of detoxifying processes in the liver. Ursodeoxycholic acid (UDCA) represents the standard treatment in primary biliary cholangitis (PBC). As both compounds exert their hepatoprotective effects by different mechanisms, it is conceivable that when used together their effect might be additive. The aim of this study was to analyse the effect of SAMe supplementation on liver biochemistry and health-related quality of life (HRQoL) in patients with PBC, treated with UDCA.

Methods: In this prospective pilot, proof of the principle, non-randomized and open label study we enrolled 24 patients with PBC treated with UDCA for at least 6 months. They had received both UDCA in a standard dose of 13-15 mg/kg b.w. and SAMe in the dose of 1200 mg daily over a period of 6 months. A group of 24 patients with PBC treated with UDCA served as control for liver biochemistry (Study registered on the platform ClinicalTrials.gov under ID: NCT02557360).

Results: We observed a significant decrease of ALP, GGT and total cholesterol in non-cirrhotic patients treated with SAMe. There was also a significant improvement of fatigue and pruritus in PBC-40 questionnaire and amelioration of anxiety in STAI 2 questionnaire in the SAMe group. Treatment with SAMe neither increased sulfation capacity of the liver nor had an effect on fibroblast growth factor-19 serum levels.

Conclusions: Our pilot study demonstrates a positive effect of adding SAMe to UDCA in non-cirrhotic patients with PBC.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Alkaline Phosphatase / blood
  • Biomarkers / blood
  • Cholagogues and Choleretics / adverse effects
  • Cholagogues and Choleretics / therapeutic use*
  • Cholesterol / blood
  • Fatigue / etiology
  • Fatigue / prevention & control
  • Female
  • Humans
  • Liver / drug effects*
  • Liver / metabolism
  • Liver Cirrhosis, Biliary / blood
  • Liver Cirrhosis, Biliary / complications
  • Liver Cirrhosis, Biliary / diagnosis
  • Liver Cirrhosis, Biliary / drug therapy*
  • Middle Aged
  • Pilot Projects
  • Poland
  • Proof of Concept Study
  • Prospective Studies
  • Pruritus / etiology
  • Pruritus / prevention & control
  • Quality of Life*
  • S-Adenosylmethionine / adverse effects
  • S-Adenosylmethionine / therapeutic use*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ursodeoxycholic Acid / adverse effects
  • Ursodeoxycholic Acid / therapeutic use*
  • gamma-Glutamyltransferase / blood


  • Biomarkers
  • Cholagogues and Choleretics
  • Ursodeoxycholic Acid
  • S-Adenosylmethionine
  • Cholesterol
  • gamma-Glutamyltransferase
  • gamma-glutamyltransferase, human
  • Alkaline Phosphatase

Associated data

  • ClinicalTrials.gov/NCT02557360