P071 Silymarin-choline combination versus ursodeoxycholic acid in non-alcoholic fatty liver disease: a randomised double-blind clinical trial

IntroductionPrevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) is 20%–30% and 5%–18% in Western countries and Asia respectively.1 Currently there is no evidence-based standard of care. Since an oxidative stress and dietary deficiency of choline have been implicated in the pathophysiology of hepatic insult, the use of natural compounds like Silymarin, Choline and Ursodeoxycholic acid (UDCA) represents an extremely popular therapeutic option for the treatment of NAFLD.2 ObjectiveTo compare the efficacy, safety profile and adherence of Silymarin-Choline combination vis – a – vis UDCA in patients with NAFLDMethodThe study was a double blind parallel arm trial where 88 NAFLD diagnosed patients, abiding by the inclusion and exclusion criteria, were randomised to receive either Tablet Silymarin (140 mg) - Choline bitartrate (450 mg) 1 tablet thrice daily or UDCA (300 mg) 1 tablet twice daily for 6 months. Lifestyle modification was advised. Participants were monitored for weight, liver function test, lipid profile parameters, HOMA-IR, liver stiffness measurement and liver biopsy at baseline and 6 months of medication. Monitoring of associated adverse events and adherence were done. Results were tabulated and statistically analyzed for any significant inter or intra group differences using standard statistical software.ResultsA total of 39 patients received tablet Silymarin - Choline bitartrate (group A) as compared to 40 who received UDCA (group B). Both the groups were comparable at baseline with regard to age (mean±SD) [39.33±9.39 vs 40.63±10.63], weight (mean±SD) [72.80±4.24 vs 72.95±4.22] Kg, BMI (mean±SD) [29.11±1.02 vs 29.32±2.07] Kg/m2, LFT (Alanine aminotransferase, median±IQR) [86.00±18.00 vs 87.00±19.00] IU/L, Lipid Parameters, HOMA-IR (mean±SD) [1.42±0.53 vs 1.27±0.71], transient elastography (mean±SD) [7.67±0.97 vs 7.61±0.66] and tolerability. At 2nd visit, significant individual intra-group reduction in weight, liver and lipid parameters, improvement in transient elastography, liver biopsy, HOMA IR score was noted. Notably, independent T test suggests significant decrease (p