4 | Himalaya Livline | Vol 6 | No. 4 | May–Aug 2023 Research at Himalaya Effect of Liv.52® DS on Various Liver Parameters in Nonalcoholic Fatty Liver Disease: A Cumulative Analysis Abstract Nonalcoholic fatty liver disease (NAFLD) is a clinical condition where excess fat accumulates within the liver and culminates in steatohepatitis, l iver failure, or hepatocellular carcinoma. A cumulative efficacy analysis of 4 clinical studies (2 controlled/comparative studies and 2 single-arm studies) that evaluated individuals with NAFLD post-Liv.52 DS administration was performed. A dosage of 2 tablets, BID, was recommended across the 4 studies. Treatment duration was 3 months in 3 studies and 2 months in 1 study. Improvements in clinical signs and symptoms, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT ) levels, hepatomegaly, NAFLD fibrosis scores (NFS), aspartate aminotransferase to platelet ratio index (APRI), and fibrosis-4 (FIB-4) scores were considered for analysis. Reduced hepatomegaly and significant improvements in symptoms, levels of SGPT and SGOT, NFS, APRI, and FIB-4 scores were observed. Thus, the cumulative efficacy analysis confirmed that the recommended dosage of Liv.52 DS tablets was well-tolerated and showed beneficial improvement trends in individuals with NAFLD. An excerpt of the study conducted by Shah SC et al that was published in the International Journal of Pharmaceutical and Clinical Research is featured here. Aim To evaluate the effect of Liv.52 DS tablets on various liver parameters in NAFLD Materials and Methods Four clinical studies comprising 155 patients (aged 18–75 y; both sexes) who received 2 Liv.52 DS tablets, BID, orally, were considered for the cumulative efficacy analysis. Of the 4 studies, 2 were comparative, controlled clinical studies performed for 3 months (Liv.52 DS vs ursodeoxycholic acid and Liv.52 DS vs placebo, respectively), and the other 2 studies were single-arm clinical studies performed for 2 and 3 months, respectively, with Liv.52 DS alone. Clinical data specifically related to the Liv.52 DS arm of the studies were considered for the cumulative analysis. The studies’ outcomes were evaluated based on the improvement in the following parameters: NAFLD clinical signs and symptoms, hepatomegaly assessed using ultrasonography, SGOT and SGPT levels, NAFLD fibrosis scores, APRI, and fibrosis-4 score. Data were presented as mean ± standard deviation for quantitative variables, and as proportions and percentages for categorical variables. Comparisons of continuous variables within groups were performed using the paired t test. Comparisons of different categorical variables were performed using the c2 or Fisher’s exact tests. Results The cumulative analysis showed a significant reduction in SGPT (P < .0001) and SGOT (P < .0001) levels by the end of the study in 153 patients, compared with the baseline values (Figure 1). The ultrasonography results revealed a significantly improving trend in fatty liver grades by the end of the study in 90 patients. By the end of the study, 38% of the patients had grade 0, 60% had grade 1, 2% had grade 2, and no patients were reported with grade 3 fatty liver (Figure 2). The percentage of patients with hepatomegaly had reduced from 90% to 61.33%. A significant improvement
RkJQdWJsaXNoZXIy MjAwNDg=