EFFECTS OF omega-3 POLYUNSATURATED FATTY ACIDS (PUFA) FROM FISH AND FLAXSEED OILS ON NONALCOHOLIC STEATOHEPATITIS (NASH)

Abstract

Introduction: There are very few intervention strategies that have been proven in non-alcoholic fatty liver disease (NAFLD). Omega-3 polyunsaturated fatty acids (PUFA) seem to be efficacious on NAFLD treatment from experimental models, but few randomized trails have been realized. The aim of this study was to evaluate prospectively the efficacy of Omega-3 PUFA derived from fish and flaxseed in non-alcoholic steatohepatitis (NASH) patients. Methods: Sixty patients with biopsy proven NASH were included in the randomized placebo controlled trial. The patients were randomized into two groups. Omega-3 group (n=30) received capsules containing 945mg of Omega-3 PUFA [α linolenic acid/64%, eicosapentaenoic acid (EPA)/16% and docosahexaenoic acid (DHA)/21%], in 3 capsules/day. Placebo Group (n=30), received 3 placebo capsules containing mineral oil. The intervention was carried out for 6 months, when patients were re-submitted for new liver biopsy. Primary endpoint was liver histology according to the NASH activity score (NAS) at baseline and 6 months. Second endpoints were evaluated by analysis of serum aminotransferases, fasting lipid profile, serum glucose, anthropometric parameters and serum levels of cytokines at 0, 3 and 6 months. Results: These 60 patients enrolled, 10 were not finished the study (5 in Omega-3 group and 5 in the Placebo group). Concerning the primary endpoint, the NAS activity improved by 57% in the placebo group and 67% in the omega-3 group, however, no significant difference was seen (p=0.33), the hepatocellular ballooning reduced 22% in the placebo group and 33% in the omega-3 group, also with no difference between groups (p=0.28). Omega-3 did not reduce steatosis, lobular inflammation and fibrosis. Serum aminotransferases, fasting lipid profile, serum glucose, anthropometric parameters and serum levels of IL-6 and TNF-α were not altered with the treatment. Conclusion: Our results indicate that Omega-3 PUFA from fish and flaxseed oil compound cannot improve, after 6 months, the liver histology, biochemical parameters and serum levels of IL-6 and TNF-α. The limitations of this study were the small number of patients enrolled and the composition of Omega-3 compound that was enriched with linolenic acid (64%) than EPA/DHA. Further study is needed to confirm these results.