Beneficial Role of Silymarin, Alpha Lipoic Acid, N-Acetyl Cysteine and Selenium in the Management of Liver Disorders: An Observational Post-Marketing Study from India

It is a well-known fact that oxidative stress plays key role in the pathophysiology of several liver diseases which triggers hepatic damage and modulates the pathways that control normal biological functions. This study was designed to analyze 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. At the time of study, 116 patients with abnormal liver function tests received the FDC (above mentioned) twice daily for 12 weeks. LFTs were performed at baseline and at the end of 12th week and adverse events were recorded at the end of 4th, 8th and 12th week. Assessment of LFT reports at baseline and at the end of 12th week showed statistically significant difference in all LFT parameters except for serum globulin. (Total bilirubin (mean ± SEM):1.60 ± 3.72 to 0.64 ± 0.63, p<0.0069; direct bilirubin:0.82 ± 2.85 to 0.15 ± 0.31, p<0.01; Albumin:3.95 ± 0.71 to 4.2 ± 0.53, p<0.0004; Globulin:3.52 ± 0.72 to 3.48 ± 0.55, p<0.6162 Aspartate aminotransferase:151.66 ± 273.90 to 39.8 ± 46.08, p<0.0001; Alanineaminotransferase:186.17 ± 308.72 to 66.47 ± 174.04, p<0.0006; Alkaline phosphatase:150 ± 208.03 to 91.93 ± 32.81, p<0.0035; Gamma-glutamyl transferase:143.66 ± 204.29 to 51.12 ± 80.61, p<0.0001; Lactate dehydrogenase:432.64 ± 638.40 to 248.85 ± 137.48, p<0.0024). Based on findings of this study, this FDC was therapeutically effective under the circumstances of elevated oxidative stress and produces significant improvement in LFT parameters in alcoholic and viral hepatitis patients.