Jm. Mato et al., S-adenosylmethionine in alcoholic liver cirrhosis: A randomized, placebo-controlled, double-blind, multicenter clinical trial, J HEPATOL, 30(6), 1999, pp. 1081-1089
Background/Aim: The efficacy of S-adenosylmethionine (AdoMet) in the treatm
ent of liver cc:ll injury has been demonstrated in several experimental mod
els. The aim of this study was to investigate the effects of AdoMet treatme
nt in human alcoholic liver cirrhosis,
Methods: A randomized, double-blind trial was performed in 123 patients tre
ated with AdoMet (1200 mg/day, orally) or placebo for 2 years, All patients
had alcoholic cirrhosis, and histologic confirmation of the diagnosis was
available in 84% of the cases. Seventy-five patients were in Child class A,
40 in class B, and 8 in class C, Sixty-two patients received AdoMet and 61
received placebo,
Results: At inclusion into the trial no significant differences were observ
ed between the two groups with respect to sex, age, previous episodes of ma
jor complications of cirrhosis, Child classification and liver function tes
ts. The overall mortality/liver transplantation at the end of the trial dec
reased from 30% in the placebo group to 16% in the AdoMet group, although t
he difference was not statistically significant (p=0.077), When patients in
Child C class were excluded from the analysis, the overall mortality/liver
transplantation was significantly greater in the placebo group than in the
AdoMet group (29% vs 12%, p=0.025), and differences between the two groups
in the 2-year survival curves (defined as the time to death or liver trans
plantation) were also statistically significant (p=0.046),
Conclusions: The present results indicate that longterm treatment with AdoM
et may improve survival or delay liver transplantation in patients with alc
oholic liver cirrhosis, especially in those with less advanced liver diseas
e.