4 • Probe •Vol LXII • No. 3 • May–Aug 2023 Clinical Evidence 2 Liv.52® DS in the Management of Nonalcoholic Steatohepatitis Aim To evaluate the efficacy and safety of Liv.52 DS in the management of nonalcoholic steatohepatitis (NASH) Materials and Methods This open clinical study enrolled 50 patients (21 male and 29 female patients; mean age 48.28 ± 9.92 y) suffering from steatohepatitis, characterized by elevated liver enzyme levels and hepatomegaly with pain and discomfort in the right upper abdomen. Patients with severe metabolic disorders, carcinoma of the liver or the pancreas, preexisting systemic disease that requires long-term medications, genetic and endocrinal disorders, and pregnant and lactating women were excluded from the study. At the initial visit, a detailed family and medical history was collected from all the patients. A thorough systemic examination and hematological and biochemical tests including liver function tests, ultrasonography (USG), and a noninvasive nonalcoholic fatty liver disease (NAFLD) scoring were performed to grade the severity of liver fibrosis. The patients were instructed to take Liv.52 DS tablet at a dosage of 2 tablets, BID, for 3 months. All the adverse events, either reported or observed by the patients, were recorded as either unrelated, possible, or probable. All the patients were followed up at monthly intervals for 3 months. Clinical assessment scores were recorded using a 5-point scale on each visit as follows: 5, good improvement/no complaints; 4, considerable improvement; 3, improvement; 2, no change; 1, worsening. The USG findings were recorded using a scale of 0 to 3, where 0, no fatty liver; 1, mild fatty liver; 2, moderate fatty liver; 3, severe fatty liver. The 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. NAFLD fibrosis score was calculated using the following formula: − 1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m2) + 1.13 × impaired fasting glucose/diabetes (yes = 1, no = 0) + 0.99 × aspartate aminotransferase/alanine aminotransferase ratio − 0.013 × platelet count (× 109/L) − 0.66 × albumin. The overall clinical efficacy was assessed using a 6-point scale as follows: 6, symptoms became worse; 5, no change; 4, slight improvement; 3, moderate improvement; 2, marked improvement; and 1, cured. Improvement in liver function parameters after the administration of Liv.52 DS tablet and the incidence of adverse events and overall compliance to the therapy were considered the predefined primary and secondary end points, respectively. Statistical analysis was performed using repeated measure of ANOVA followed by Friedman test and Dunn’s multiple comparisons test for between-thegroup analyses followed by the paired t test. Results Significant improvements in abdominal discomfort due to hepatomegaly, fatigue, weakness, body weight, and recurrent infections were observed at the first month, and further improvement was seen by the end of the treatment period (Table 1). After the treatment with Liv.52 DS tablet, gradual improvements in the hematological and biochemical parameters were observed at the end of the
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