8 • Jan–Mar 2022 • Vol LXI • No. 3 In Focus Efficacy and Safety of Liv.52® DS in the Management of Nonalcoholic Fatty Liver Disease An excerpt of the clinical study conducted by Siregar G et al published in European Journal of Clinical and Experimental Medicine is featured here. Aim To evaluate the clinical efficacy and safety of Liv.52 DS in the management of nonalcoholic fatty liver disease (NAFLD) Materials and Methods Sixty patients (aged 48.2 ± 12.3 y; both sexes) with positive clinical and laboratory diagnoses for NAFLD were enrolled in this prospective, interventional clinical study. Alcoholic individuals; patients with severe metabolic disorders, hepatic or pancreatic carcinoma, allergies, systemic diseases; and pregnant and lactating women were excluded from the study. A detailed medical history of all patients was collected, and they were subjected to symptomatic evaluation and clinical examination for steatohepatitis with hepatomegaly. The patients were instructed to take 2 tablets of Liv.52 DS, BID, for 2 months. The patients were evaluated at baseline and at monthly intervals, for 2 months. Liver function parameters (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], γ-glutamyl transferase [GGT]), serum bilirubin and albumin levels, complete blood count, and lipid profile were monitored. Ultrasonography was performed to monitor hepatomegaly, and NAFLD score was calculated at each assessment. A subgroup analysis was performed to evaluate the role of Liv.52 DS in the management of NAFLD in patients with diabetes mellitus. NAFLD fibrosis score was calculated as follows: NAFLD score = -1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×109/L) - 0.66 × albumin (g/dL). NAFLD score was evaluated as follows: NAFLD score < -1.455 = F0-F2, NAFLD score -1.455 to 0.675 = indeterminate score and NAFLD score > 0.675 = F3-F4, where F1 to F4 are fibrosis stages. The results of liver function tests and biochemical analyses and NAFLD score were analyzed using ANOVA followed by Tukey’s multiple comparison test. The hepatomegaly ultrasound data were analyzed by repeated measures ANOVA followed by Dunnett’s multiple comparison test. Results All the enrolled patients completed the study with no clinically significant adverse events. A substantial reduction in the NAFLD fibrosis score was observed at the end of the first month, which reduced further at the end of the second month of treatment (Table 1). Table 1. Effect of Treatment With 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. NAFLD, nonalcoholic fatty liver disease. A significant decrease in the number of patients demonstrating hepatomegaly (75% of patients at baseline to 42% of patients at the end of the treatment) was observed. A significant reduction in hepatomegaly from 17.44 ± 1.9 at baseline to 15.87 ± 1.79 at the end of 2 months was observed. There was a significant reduction in ALT and AST levels (Table 2), whereas hematological and biochemical parameters were within normal limits. Conclusion The significant improvements in hepatomegaly, liver function parameters, and NAFLD score observed after the treatment with Liv.52 DS may be attributed to the synergistic action of the herbs present in the formulation. The results of this study show that Liv.52 DS is effective and safe in the treatment of NAFLD in both individuals with and without diabetes. Table 2. Effect of Treatment With Liv.52 DS on AST and ALT Parameter Baseline Month 1 Month 2 AST, IU/L 60.33 ± 13.04 56.43 ± 15.47 54.12 ± 17.26 P < .0339a ALT, IU/L 70.68 ± 18.49 64.13 ± 22.07 P < .0215a 61.9 ± 22.7 P < .0022a Statistical test: ANOVA followed by Tukey’s multiple comparison test. Significance was fixed at P < .05 Values are represented as mean ± SD. aCompared with baseline. ALT, alanine transaminase; AST, aspartate transaminase.
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