A Randomised, Prospective Parallel and Open Label Study to Compare Efficacy and Safty of Synbiotices With Tocotrienol in Non Alcholic Fatty Liver Disease

Background: Nonalcoholic fatty liver disease (NAFLD) covers spectrum of clinical entities ranging from simple steatosis to non-alcoholic steatohepatitis (NASH) to cirrhosis. Its incidence is rising worldwide, seriously endangering human health, and its pathogenesis is still unclear. Increasing evidence has shown that intestinal flora plays an important role in the occurrence and development of NAFLD. Aims and objectives: To compare the effectiveness of synbiotics and tocotrienol in NAFLD patients and to evaluate the safety and compliance of synbiotic and tocotrienol. Materials & Methods: 60 patients of NAFLD attending the OPD and IPD of a tertiary care hospital. Group A was prescribed: Tocotrienol: 200 mg Twice a day and Group B was prescribed: Synbiotic - 5 Billion Colony Forming Units (BCFU) Twice a day. Liver Function Test and Ultrasound was done and compared on day 0,30,60 and 90. Results: The mean age of NAFLD patient was 43.030±10.561 years in group A and 45.567±11.312 years in group B. Mean change in ALP (p= 0.930), GGT (p=0.132), direct bilirubin (p= 0.103) and total proteins (p= 0.564) remained statistically non-significant in both groups over 90 days of treatment. In both groups, mean change (decrease) in ALT from baseline became statistically significant (p=0.001) at 30 days and highly significant (p=0.0001) at 90 days 33% change is observed in USG scoring in Group B, 20% in Group A over 90 days of treatment. Conclusion: Group B is more efficacious than group A which is shown by improvement in ultrasound grading, with statistical significant decrease in AST in group B and non significant changes in ALP, GGT between groups A and group B. However Group A drug is better tolerated than Group B.