Real World Evidence of Safety and Effectiveness of Combination of Vitamin E and <i>Fraxinus excelsior</i>in Treatment of Indian Patients with Nonalcoholic Fatty Liver Disease  

作　　者：Virukalpatti Gopalratnam Mohan Prasad[1] Prashant Rahate[1] Husain Bohri[1] Jyoti Ranjan Mahapatra[1] Ashish Mungantiwar[1] Priyanka Srivastava[1] Nirali Bhatt[1] Dhavalkumar Patel[1] Soumen Roy[1] Amit Qamra[1] 

出　　处：《Open Journal of Gastroenterology》2020年第1期14-22,共9页肠胃病学期刊（英文）

摘　　要：Introduction: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease ranging from liver steatosis to nonalcoholic steatohepatitis (NASH). Besides lifestyle modifications, Vitamin E (800 IU/day) is generally recommended for NASH. Vitamin E monotherapy is not sufficient for the multifaceted disease like NALFD. The combination of Vitamin E 400IU and Fraxinus excelsior 500 mg twice daily was found to be better than vitamin E 400 IU twice daily in improving the lipid profile and liver function parameters in patients with NAFLD. We conducted a study to assess safety and effectiveness of Vitamin E plus Fraxinus excelsior in Indian patients with NAFLD in real-world settings. Patients and Methods: This was a non-interventional study in NAFLD patients with varying grades of steatosis conducted by 234 physicians across India from January 2018 to August 2018. Patients received combination of Vitamin E (400 IU) and Fraxinus excelsior (500 mg) soft gelatin capsules twice daily after meals for 12 weeks. Effectiveness of the treatment was assessed at visit 2 (6 weeks) and visit 3 (12 weeks, end of study) from baseline. The parameters for assessment included severity of liver steatosis, liver function parameters and the global assessment of safety and effectiveness. Results: A total of 1114 patients were included in the study. At baseline, majority of the patients (71.18%) had Grade II liver steatosis followed by 21.01% and 7.81% patients who had Grade III and Grade I liver steatosis, respectively. After 12 weeks of treatment with vitamin E and Fraxinus excelsior combination, 21% patients had no steatosis, 58.79% patients were in Grade 1 steatosis, 19.57% in grade II steatosis and only 0.63% patients in Grade III steatosis. The mean percentage reduction in aspartate aminotransferase (AST) level at week 6 and week 12 from baseline was 24.92% and 43.79%, respectively. Similarly, the mean percentage reduction in alanine aminotransferase (ALT) level at week 6 and week 12 from baseline was 24.37% and 44.05% respectively. Introduction: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease ranging from liver steatosis to nonalcoholic steatohepatitis (NASH). Besides lifestyle modifications, Vitamin E (800 IU/day) is generally recommended for NASH. Vitamin E monotherapy is not sufficient for the multifaceted disease like NALFD. The combination of Vitamin E 400IU and Fraxinus excelsior 500 mg twice daily was found to be better than vitamin E 400 IU twice daily in improving the lipid profile and liver function parameters in patients with NAFLD. We conducted a study to assess safety and effectiveness of Vitamin E plus Fraxinus excelsior in Indian patients with NAFLD in real-world settings. Patients and Methods: This was a non-interventional study in NAFLD patients with varying grades of steatosis conducted by 234 physicians across India from January 2018 to August 2018. Patients received combination of Vitamin E (400 IU) and Fraxinus excelsior (500 mg) soft gelatin capsules twice daily after meals for 12 weeks. Effectiveness of the treatment was assessed at visit 2 (6 weeks) and visit 3 (12 weeks, end of study) from baseline. The parameters for assessment included severity of liver steatosis, liver function parameters and the global assessment of safety and effectiveness. Results: A total of 1114 patients were included in the study. At baseline, majority of the patients (71.18%) had Grade II liver steatosis followed by 21.01% and 7.81% patients who had Grade III and Grade I liver steatosis, respectively. After 12 weeks of treatment with vitamin E and Fraxinus excelsior combination, 21% patients had no steatosis, 58.79% patients were in Grade 1 steatosis, 19.57% in grade II steatosis and only 0.63% patients in Grade III steatosis. The mean percentage reduction in aspartate aminotransferase (AST) level at week 6 and week 12 from baseline was 24.92% and 43.79%, respectively. Similarly, the mean percentage reduction in alanine aminotransferase (ALT) level at week 6 and week 12 from baseline was 24.37% and 44.05% respectively.

关 键 词：NAFLD NASH VITAMIN E FRAXINUS excelsior Real Life India 

分 类 号：R57[医药卫生—消化系统]