20 • Probe •Vol LXII • No. 4 • Sep–Dec 2023 Safety and Efficacy of Liv.52® DS in the Management of Nonalcoholic Fatty Liver Disease Gontar Siregar1, Rangesh Paramesh2, Rajesh Kumawat2, Palaniyamma D2, Srikrishna HA2 Eur J Clin Exp Med. 2021;19(2):129–136. Authors’ Affiliations 1Division of Gastroenterology-Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Sumatera Utara, Medan, Indonesia 2Himalaya Wellness Company, Makali, Bengaluru, India 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 both sexes (aged 18–65 y) who were diagnosed with NAFLD through clinical examination, laboratory testing, and ultrasound findings, and those who were willing to provide informed consent. A detailed medical history and symptom evaluation were 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. The patients were subjected to liver function tests (LFTs) including aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma-glutamyl transferase, serum bilirubin, and albumin; ultrasonic evaluation for hepatomegaly analysis; and NAFLD score assessment to determine the severity of fibrosis due to NAFLD, at baseline and at the end of months 1 and 2. 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 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. 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 treatment with Liv.52 DS. This indicates the positive effect of Liv.52 DS in reducing NAFLD-associated liver fibrosis (Table 1). At baseline, 75% of the patients exhibited hepatomegaly (liver size > 16 cm), and 25% of the patients showed no hepatomegaly (liver size
RkJQdWJsaXNoZXIy MjAwNDg=