A Randomised Open Label Clinical Trial With Oral Alpha Lipoic Acid and Vitamin E In Non Alcoholic Fatty Liver Disease

Abstract

Purpose: NAFLD may progress to end-stage liver disease and hepatocellular carcinoma over time. Free fatty acid influx in the liver causes oxidative stress and generates free radicals and reactive oxygen species that trigger inflammatory pathways and also activate stellate cells leading to the development of fibrosis. Alfa Lipoic Acid (ALA) is a pan-antioxidant that blocks the cascade of free radicals preventing lipid peroxidation and apoptosis. We evaluated the effect of ALA versus vitamin E in NAFLD. Methods: Forty obese patients (mean age, 39 years; male: female, 2:1; mean BMI-32) with NAFLD were randomized to ALA 200 mg (n=20) and vitamin E 700 IU (n=20) orally once daily for 24 weeks. Diet and alcohol consumption were restricted to 1600 Kcal/day and 20 grams/day, respectively. Patients using phenytoin, amiodarone, valproate, highly active anti-retroviral therapy for human immunodeficiency virus infection and those with chronic liver disease from other causes were excluded. Laboratory (Quest Diagnostics, Teterboro, New Jersey, USA) and clinical parameters are shown in the Table.TableResults: Overall, ALA was tolerated well. Seventeen (85%) and 11 (55%) patients normalized ALT in the ALA arm and vitamin E arm, respectively, with no change in fasting and fed free fatty acids. Other results are shown in Table. Conclusion: Oral ALA had better efficacy compared to vitamin E in normalizing ALT, increasing HDL and reducing HOMA-IR(Homeostasis Model Assessment-Insulin Resistance) score, leptin, LDL, triglycerides, TNF(Tumor Necrosis Factor)-alpha, and diastolic blood pressure in NAFLD. ALA may be a therapeutic option for NAFLD. Larger randomized, controlled studies with paired liver biopsies are required to determine if these preliminary findings can be confirmed.