Objective: The effectiveness and safety of SAMe in the treatment of chronic liver diseases.
Main outcome measures: This study found that a combined all-cause mortality/transplantation end point fell from 30% in the placebo arm to 16% in those treated with SAMe, however, the effect did not reach statistical significance (p = 0.077) unless those with more advanced disease (Child score C) were excluded from the analysis, 29% vs. 12% (p = 0.025). No significant difference between arms in the number of patients that experienced severe complications of cirrhosis was observed during the study.
Significantly more SAMe-treated patients reported a >50% increase in general well-being (SAMe 84% vs. placebo 29%, p <0.01). These findings were supported by a subsequent Italian study. Here, 640 IHC patients were allocated to one of two different parenteral dosing schedules (500 mg/day or 800 mg/day iv) for 15 days in a non-randomised, non-placebo controlled, observational study . The majority of patients recruited had chronic viral hepatitis with or without concomitant excess alcohol consumption and approximately 60% were cirrhotic at enrolment.
In conclusion, there is strong pre-clinical evidence that SAMe has important physiological roles in health and that liver disease of various aetiologies may perturb these. Furthermore, it is apparent that hepatocellular SAMe concentration can influence diverse pathophysiological processes including tissue oxidative stress, mitochondrial function, hepatocellular apoptosis, and malignant transformation, not to mention the intriguing data suggesting that chronic viral hepatitis may modulate interferon sensitivity through SAMe. These data suggest that SAMe could offer substantial clinical benefits, however, very few large, high-quality clinical trials have been performed to prove or refute this.
Haldane Pharma’s product Ensame 400 as a supplement has shown to help replenish low levels, and may help the body resume its normal function. Healthy levels of SAMe can help maintain healthy liver function. There are more than 100 clinical studies have been conducted, it has been proven that SAMe has clear benefits in Liver health.