Abstract
Siliphos-selenium-methionine-alpha lipoic acid (SSMAL) has been used to treat chronic hepatic diseases, although formal evaluation of this mixture with clinical trials is lacking. We conduct this pilot study to investigate the safety and effectiveness of SSMAL in patients with non-alcoholic fatty liver disease (NAFLD). Forty NAFLD patients were randomized into two groups. All patients received metformin 1500 mg q.a.d. added to nutritional and exercise advice. Twenty patients received selenium (15 mcg) – methionine (3 mg)-alpha lipoic acid (200 mg) group. After 24 weeks, basal versus final biochemical and image studies were compared. Patients from SSMAL group, had a decrease in steatosis graded by ultrasound 70% vs. 15% (p<0.001) and showed lower rates of liver enzymes than control group. Pro-inflammatory cytokines profile and the reduced antioxidant status noted in NAFLD patients showed improvement with this therapy. Adiponectin was significantly increased in both groups and it changed with active therapy. No serious adverse reactions were reported. This is the first study to systematically assess SSMAL in NAFLD patients. Treatment for 6 months may protect against worsening steatosis and improve the inflammatory profile. These findings warrant further investigation. (NTC01650181)
Highlights
Hepatic diseases and, non-alcoholic fatty liver disease (NAFLD) have become a significant worldwide public health issue [1]
We evaluated the proportion of patients achieving at least 1 grade improvement in steatosis degree from baseline to 24 weeks as measured by ecosonographyc score
Patients randomized to Siliphos-selenium-methionine-alpha lipoic acid (SSMAL) group, had a clinical and statistical decrease in steatosis graded by ultrasound (p < 0.001)
Summary
Non-alcoholic fatty liver disease (NAFLD) have become a significant worldwide public health issue [1]. NAFLD is a condition that ranges from single fat accumulation in the liver (steatosis) and hepatic inflammation (steatohepatitis), fibrosis, cirrhosis and even hepatic cancer. Oxidative stress, and inflammatory cascade may play a role in the pathogenesis and progression of fatty liver [2]. Selenium-methionine-alpha lipoic acid (SSMAL) theoretically has a powerful anti- oxidant activity [3]. SSMAL has been used in the treatment of chronic hepatic diseases, including NAFLD. The rationality behind its use in the treatment of NAFLD is its antioxidant activity and virtually nonexistent side effects. To date, no clinical trials have been evaluated to see SSMAL efficacy and safety in the treatment of NAFLD
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