Effect of Vitamin E and Alpha Lipoic Acid in Nonalcoholic Fatty Liver Disease: A Randomized, Placebo-Controlled, Open-Label, Prospective Clinical Trial (VAIN Trial)

Abstract

Objective: Antioxidants, including alpha lipoic acid (ALA) and vitamin E, are efficacious for the treatment of nonalcoholic fatty liver disease (NAFLD). The objective was to evaluate the effects of ALA and vitamin E alone or combined as therapy for patients with NAFLD and nonalcoholic steatohepatitis (NASH). Design: Placebo-controlled, open-label, prospective study in which patients with NAFLD and NASH were randomized to treatment with ALA 300 mg (n = 40), vitamin E 700 IU (n = 40), ALA 300 mg plus vitamin E 700 IU (n = 40), or placebo (n = 35) daily for 6 months. Body mass index, homeostasis model assessment scores, fibrosis and steatosis markers, and diagnostic laboratory tests were assessed at baseline and at the end of the study. Results: Treatment with ALA and vitamin E alone or in combination, improved inflammatory cytokine levels, steatosis scores, homeostasis model assessment scores, and triglyceride levels after 6 months relative to baseline. Conclusion: Alpha lipoic acid and vitamin E, either alone or in combination, were effective treatments for patients with NAFLD and NASH.

Systematic review with meta‐analysis: The effect of vitamin E supplementation in adult patients with non‐alcoholic fatty liver disease

“…Details from the risk of bias assessment are presented in Figures S1 and S2. Two 18,20 of the eight trials in our study were at high risk of bias, because of insufficient description in most of the parameters of the ROB tool. Five trials 17,21–24 were judged to be in some concerns, and finally, one trial 19 was evaluated to be at low risk of bias.…”

“…In five trials, data 17,19,21–23 were extracted by the original publications whereas in the other two 20,24 by follow‐up studies 25,26 . Data from one study 18 could not be retrieved and therefore were not included in quantitative analysis. Three trials 19,20,24 were conducted in NASH population, while the other four trials 17,21–23 included patients with NAFLD diagnosed with abdominal ultrasound regardless of the existence of elevated transaminases level, according to current guidelines 2,16 (Tables S1,S2).…”

“…In total, 1365 references were identified, 1348 from the search strategy and another 17 records from other sources. Figure 1 represents the followed steps in order to conclude in eight studies, 17–24 which met the eligibility criteria and were included in the final analysis.…”

Biochemical screen correction possibilities in patients with non-alcoholic fatty liver disease with diabetes mellitus

“…In contrast to the abovementioned study, Sanyal et al (2014) demonstrate an absence of significant liver histology changes after omega-3 PUFA therapy. In a randomized, placebo-controlled open prospective clinical trial Basu et al (2014) investigated efficacy of antioxidants in overweight and obesity patients (body mass index (BMI) 28-33 kg/m 2 ) with ultrasound liver steatosis signs. The patients walked 150 min per week (at least 100 steps per minute) and consumed less than 1600 calories daily.…”

“…Although the current recommendations (EASL-EASD-EASO, 2016; Ganesh & Rustgi, 2016) don't include indications regarding prescription of hepatoprotectors (Dajani & Abu Hammour, 2016) there are publications about their advisability as well as medicines with cytoprotective (Gonciarz et al, 1988;Gundermann et al, 2016) and antioxidant (de Oliveira et al, 2011;Basu et al, 2014) effects that constitute a pathogenetically reasonable approach in case of NAFLD. It has been proven that the function of hepatocytes correction leads to enhanced treatment effect due to indirect impact on IR degree (Dajani & Abu Hammour, 2016).…”