Effect of telmisartan and vitamin E on liver histopathology with non‐alcoholic steatohepatitis: A randomized, open‐label, noninferiority trial
Shahinul Alam, Mushfiqul Abrar, Saiful Islam, Mohammad Amjad Kamal, Mohammad Jahid Hasan, Md. Abdullah Saeed Khan, Nooruddin Ahmad
Abstract
Abstract Background and Aim To compare the effect of telmisartan and vitamin E on liver histopathology of non‐alcoholic steatohepatitis (NASH) patients. Methods This noninferiority clinical trial was conducted for 1 year. Fatty liver patients with non‐alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 5 (in liver biopsy) were selected. All methods were in accordance with the Declaration of Helsinki. Patients who received telmisartan and vitamin E were denoted as Group‐T and Group‐E, respectively. Forty patients >18 years old were assigned and divided into two groups (20 in each group). Histological improvements were primary outcome measures. Results Significant improvement in NAS score was noted in both groups (Group E [GE]: 6 ± 0.8 to 4.36 ± 1.4; P = 0.00 and Group T [GT]: 5.6 ± 0.7to 4.9 ± 1.2; P = 0.03). Fibrosis score improved from 1.6 ± 0.5 to 1.5 ± 0.5 in GE and from 1.7 ± 0.9 to 1.5 ± 0.7 in GT ( P = 0.67 and 0.42, respectively). Steatosis improved in GE from 2.07 ± 0.6 to 1.14 ± 0.66 ( P = 0.00) and in GT from 1.94 ± 0.57 to 1.56 ± 0.8 ( P = 0.05). Lobular inflammation improved from 2.0 ± 0.4 to 1.6 ± 0.5 in GE ( P = 0.02) and from 1.9 ± 0.3 to 1.8 ± 0.4 in GT ( P = 0.58). Ballooning score in GE decreased from 1.9 ± 0.3 to 1.7 ± 0.5 ( P = 0.03), and in GT, it reduced from 1.9 ± 0.1 to 1.5 ± 0.5 ( P = 0.19). NAS improvement was similar in GE (1.6 ± 1.2) and GT (0.6 ± 1.1; P = 0.07) when controlled for weight reduction. Conclusion Telmisartan was similar to vitamin E in improving the histology of NASH patients.