5 Evecare • Vol 11 • No. 2 • Sep–Dec 2023 Safety and Efficacy of Liv.52® DS in the Management of Nonalcoholic Fatty Liver Disease Aim To assess the safety and efficacy of Liv.52 DS Tablets in the management of nonalcoholic fatty liver disease (NAFLD) Materials and Methods This prospective interventional study included 60 patients of either sex (aged 18–65 y) who were diagnosed with NAFLD through clinical examination, laboratory testing, and ultrasonographic (USG) findings, and those who were willing to provide informed consent. Patients with severe metabolic disorders, hepatic or pancreatic carcinoma, allergies, systemic diseases, and genetic disorders and pregnant and lactating women were excluded from the study. A detailed medical history of all the patients was obtained, and symptom evaluation was performed at the first visit. Additionally, the patients were examined for the presence of steatohepatitis with hepatomegaly. All patients received 2 Liv.52 DS Tablets, BID, for 2 months. An excerpt of the clinical study conducted by Siregar G et al published in the European Journal of Clinical and Experimental Medicine is featured here. The patients were subjected to liver function tests (LFTs; aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, γ-glutamyl transferase, serum bilirubin, and albumin), hepatomegaly screening (using USG), and NAFLD score at baseline and at the end of months 1 and 2. The NAFLD fibrosis score was assessed at each visit to determine the severity of fibrosis due to NAFLD. Statistical analysis was performed using GraphPad Prism software version 6.07 for Windows (GraphPad Software, CA, USA). The data about LFTs, biochemical investigations, and NAFLD scores were analyzed using ANOVA followed by Tukey’s multiple comparison test. Results It was observed that there was a reduction in the liver fibrosis score at month 1, and there was a further reduction in the score by month 2. Similarly, patients with indeterminate scores also demonstrated a reduction in the fibrosis score after the treatment with Liv.52 DS. This indicates the positive effect of Liv.52 DS in reducing liver fibrosis associated with NAFLD (Table 1). Table 1. Effect of Liv.52 DS on Liver Fibrosis (NAFLD Fibrosis Score) Scale N Baseline Month 1 Month 2 NAFLD Score < - 1.455 = F0–F2 33 Mean - 2.886 - 2.911 - 2.915 SD 1.044 1.061 0.8617 NAFLD Score - 1.455 – 0.675 = Indeterminate Score 27 Mean - 0.650 - 0.684 - 0.849 SD 0.484 0.543 0.667 NAFLD Score > 0.675 = F3–F4 0 0 0 0 Statistical test: ANOVA followed by Tukey’s multiple comparison test; values are represented as mean ± SD. Formula for NAFLD Score: - 1.675 + 0.037 × age (y) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (× 109/L) - 0.66 × albumin (g/dL). NAFLD score was evaluated: NAFLD score < -1.455 = F0–F2; NAFLD score -1.455 to .675 = indeterminate score; NAFLD score > .675 = F3–F4. ALT, alanine transaminase; AST, aspartate transaminase; IFG, impaired fasting glucose; NAFLD, nonalcoholic fatty liver disease.
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