Primary Biliary Cirrhosis Clinical Trial
Official title:
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disorder which may lead to
several symptoms such as intractable pruritus or chronic fatigue, significantly impairing
patients quality of life. Recent studies show, that chronic liver diseases are associated
with an acquired deficiency of S-adenosyl-L-methionine (SAMe) synthetase, responsible for
the synthesis of SAMe from methionine. SAMe deficiency is associated with impaired
detoxification and hepatoprotection and exacerbate liver injury. Supplementation with SAMe
has proven useful in several liver diseases.
The study group will include 20 patients with PBC diagnosed with European Association for
the Study of the Liver (EASL) criteria, who have been already treated with ursodeoxycholic
acid (UDCA). They will receive SAMe in the dose of 1600 mg bd over the period of 6 months.
Both clinical and laboratory aspects will be analyzed: liver serum biochemistry, serum and
urine bile acids metabolites, transient elastography and health related quality of life.
Background: Primary biliary cirrhosis is a chronic cholestatic liver disorder which may lead
to end stage liver disease causing death or requiring liver transplantation. Additionally, a
significant proportion of patients suffers from complications related to impaired bile
secretion such as intractable pruritus, chronic fatigue, osteoporosis or lipid disturbance.
They all have a significant consequence for patients well being, quality of life and
economical aspects of health care systems. Pathogenesis of PBC remains to be fully
elucidated. Recent studies show,that chronic liver diseases are associated with an acquired
deficiency of S-adenosyl-L-methionine synthetase, an enzyme responsible for the synthesis of
SAMe from methionine. SAMe initiates two very important protective metabolic pathways:
transmethylation and transsulphuration. As a result of the later, glutathione, taurine and
sulphate group are synthesized. Thus SAMe deficiency is associated with impaired
detoxification and hepatoprotection and exacerbate liver injury. Supplementation with SAMe
has proven useful in alcoholic liver disease, obstetric cholestasis and elimination of
hepatitis C virus (HCV). The investigators' studies on experimental models where cholestasis
was induced in vitro with lithocholic acid and 17-beta estradiol glucuronide showed that
supplementation with SAMe exerts a significant anticholestatic effect. Interestingly,
simultaneous administration of SAMe and ursodeoxycholic acid (UDCA) exerts an additive
effect.
Methods: The study group will include 20 patients PBC diagnosed with EASL criteria, who have
been already treated with UDCA. They will receive UDCA in the dose of 13 - 15mg/kg bw plus
SAMe in the dose of 1600 mg bd over the period of 6 months.
The key aim of the project is to analyze the effect of SAMe on the health related quality of
life and liver biochemistry. Blood and urine samples (from 24hr urine collection) will be
collected for liver biochemistry and metabolites of bile acids. Additionally transient
elastography will be performed before and after 6 months SAMe treatment.
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