Efficacy and tolerability of fixed dose combination of silymarin, alpha lipoic acid, N-acetyl cysteine and selenium in the management of some liver disorders

ABSTRACT

Globally liver disorders are major cause of illness death and death. Oxidative stress plays a critical role in the progression of alcoholic and nonalcoholic related diseases. The aim of the present study was to evaluate the efficacy and tolerability of fixed dose combination (FDC) of silymarin, alpha lipoic acid, N-acetyl cysteine and selenium in the management of liver disorders. This was an observational, non-randomized, open label, non-comparative, multi-centric post-marketing surveillance study. The above mentioned FDC was administered to 15 patients diagnosed with alcoholic or viral hepatitis for three months. Evaluation of liver function tests (LFT) were carried out at baseline and at the end of 3rd month of the treatment. Significant changes were observed in the LFT parameters at the end of three months of this study. aspartate aminotransferase (AST) (Mean ± SEM) 369.9 ± 128.0 to 97.00 ± 34.27 U/L, (p < 0.0001); alanine aminotransferase (ALT) 652.93 ± 214.57 to 194.40 ± 82.51 U/L, (p < 0.03); Alkaline phosphatase 197.47 ± 25.57 to 151.60 ± 17.92 U/L, (p < 0.0059); Gamma glutamyl transferase 156.67 ± 49.80 to 87.33 ± 22.94 U/L, (p < 0.0490); Total bilirubin 3.44 ± 0.76 to 1.66 ± 0.57 mg/dL, (p < 0.0192) and bilirubin direct 2.13 ± 0.58 to 1.00 ± 0.50 mg/dL, (p < 0.0273). Two patients reported mild gastrointestinal adverse events (nausea, bloating). This FDC was therapeutically effective under the circumstances of elevated oxidative stress and produces significant reduction in LFT parameters in alcoholic and viral hepatitis patients.