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Oral natural vitamin E is safe and effective for steatohepatitis

2022-8-22 13:00/ 发布者: Jay/ 查看: 565/ 评论: 0

——The first international registered randomized controlled trial (RCT) VENS research results of liver histology evaluation in mainland China were released

The world's first internationally registered RCT (VENS study) targeting fatty liver patients in mainland China was released in Beijing. The data show that taking moderate dose of natural vitamin E orally is a safe and effective basic treatment for Chinese patients with nonalcoholic steatohepatitis (NASH).
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On August 21, 2022, at the academic exchange meeting on fatty liver sponsored by the China Liver Health, Zhuang Hui, academician of Peking University Medical Department, Shang Yongfeng, academician of Hangzhou Normal University, Dr. Chen Zhongdan, representative office of the World Health Organization in China, Wu Jing, director of China Chronic Heart Disease Management Center for Disease Control, Professor Shi Junping, chief research expert of the VENS program, and member of the Fatty Liver and Alcoholic Liver Group of the Hepatology Branch of the Chinese Medical Association, And experts from the field of chronic liver disease all over the country witnessed the release of this academic achievement.

Professor Wei Lai, honorary chairman of the Hepatology Branch of the Chinese Medical Association and head of the Fatty Liver and Alcoholic Liver Study Group, said that the VENS study was the first time to obtain the clinical trial data of natural vitamin E for the treatment of Chinese people with steatohepatitis. Its achievements are of industry milestone significance and will help the diagnosis and treatment of fatty liver in China to a new level. In clinical practice, when patients progress from fatty liver disease to steatohepatitis (NASH), they can be treated with natural vitamin E. Of course, all the treatment methods of fatty liver and lifestyle interventions such as weight loss are very necessary.

Group photo of the conference


Professor Shi Junping, the main research expert of the project, released the research results of VENS

Professor Wei Lai presided over the conference

Dr. Chen Zhongdan from the WHO Representative Office in China delivered a speech

Wu Jing, Director of Chronic Disease Center of China CDC, interpreted China's chronic disease prevention and control policy

Professor Xu Xiaoyuan, Chairman of Hepatology Branch of Chinese Medical Association, delivered a speech

Academician Shang Yongfeng delivered a speech on behalf of Hangzhou Normal University, the main research unit of the VENS project

Professor Fan Jiangao of Shanghai Xinhua Hospital explains the harm of fatty liver.

Li Mingyang, Director of the China Liver Health, presided over the meeting

VENS (Vitamin E Versus Placebo for the Treatment of Non-Diabetic Patients with Nonalcoholic steatohepatitis) is a national multicenter, large sample, randomized, double-blind clinical study on vitamin E in the treatment of non-diabetic nonalcoholic steatohepatitis as a control placebo to investigate the liver histology improvement rate of subjects after treatment with natural vitamin E capsules.


Professor Shi Junping, a member of the Fatty Liver and Alcoholic Liver Group of the Hepatology Branch of the Chinese Medical Association, and the Vice Dean of the Affiliated Hospital of Hangzhou Normal University, led the study of VENS, and cooperated with Professor Wang Bingyuan, Professor Chi Xiaoling, Professor Sheng Huiping, Professor Yang Yongfeng, Professor Zheng Minghua and other top domestic experts and professors from 15 research centers in the southeast and northwest of China, Professor Xiao Shuyuan of the University of Chicago, Professor Zhao Jingming of the Fifth Medical Center of the PLA General Hospital Professor Yang Wenjun of the Affiliated Hospital of Hangzhou Normal University and other well-known international and domestic fatty liver pathologists read the film intensively and evaluated the efficacy using the latest international pathological evaluation method.


This five-year multidisciplinary evidence-based research project included 124 subjects from different nationalities. The drug group selected the natural vitamin E (Zhejiang Medicine, Laiyi ), The medium dose of 300mg/day was administered orally for 96 weeks, followed up for 24 weeks. The data showed that the effective rates of liver histology improvement in the treatment group and placebo control group of NASH patients confirmed by biopsy were 43.59% and 23.53% respectively, P=0.0436, with significant statistical significance between the two groups. There was no safety report significantly related to the drug during the whole experiment. It is concluded that taking moderate dose of natural vitamin E orally is a safe and effective basic treatment for Chinese patients with NASH.


Epidemiological data in recent years show that nonalcoholic fatty liver disease (NAFLD, referred to as "fatty liver") has become the chronic liver disease with the largest number of patients in China. The prevalence rate in mainland China is as high as 30%, and the total number of people exceeds 300 million. Without timely intervention, a large number of people in China will progress from simple fatty liver in the early stage to nonalcoholic steatohepatitis (NASH), and even to liver fibrosis, cirrhosis and liver cancer, which will cause heavy medical burden to social families and individuals. At present, the number of NASH patients in China has exceeded 33 million.


In the past decade, the international clinical trials related to fatty liver have been surging, but at present, no drug has been approved to be marketed in the world for the treatment of NASH. It is an internationally recognized method to treat NASH patients with natural vitamin E. For example, the PIVENS study published in the New England Journal of Medicine in 2010 showed that the use of natural vitamin E with a daily therapeutic dose of 800 IU (i.e., 534 mg) could effectively treat nondiabetic NASH patients confirmed by biopsy. This famous study and another TONIC test results have proved that vitamin E has an exact effect on the treatment of NASH inflammation. Vitamin E treatment has been recommended as Class A evidence by the American Society of Hepatology (AASLD), the European Society for the Study of Liver (EASL), the Chinese Society of Hepatology and the Chinese Endocrine Society and other authoritative guidelines and consensus. However, due to the huge differences in population race and lifestyle, foreign data has limited reference significance for Chinese patients, and whether the relevant administration methods and treatment doses are applicable to Chinese people has not been verified by data.


In order to explore and verify the clinical solutions applicable to Chinese NASH patients, the academic team of the VENS project optimized the design of the study of "oral medium dose natural vitamin E treatment of Chinese NASH patients" on the basis of PIVENS research. It is the first RCT in mainland China that uses "two previous liver biopsies" as the evaluation means, and has carried out international registration, obtaining evidence-based evidence for Chinese mainland people for the first time in the world.


The VENS results are of great significance for guiding doctors to diagnose and treat Chinese NASH patients. Compared with PIVENS clinical trial (all the enrolled patients are European and American) using high dose (534mg/day) of natural vitamin E, VENS verified that the medium dose (300mg/day) of natural vitamin E can be used as the basic treatment drug for NASH with good safety. In the oral natural vitamin E group, the inflammation of NASH patients was significantly improved, and even the liver fibrosis was also improved to some extent.


Experts attending the meeting said that they expected NASH achievements to help Chinese liver doctors and fatty liver patients better cope with the common enemy of steatohepatitis, timely detection, standardized treatment and regular follow-up, and jointly promote the construction of a healthy China.


Experts of chronic liver diseases from 15 research centers of the VENS project and relevant medical institutions nationwide attended the event. Fan Jiangao, Yuan Pingge, Xiao Shuyuan, Rao Huiying, Li Jie, Zhao Jingming, Ding Huiguo, Li Jie, Qi Xiaolong, Feng Bo, Zhang Jing, Xie Wen, Li Hai, Xin Yongning, Xu Jinghang and other experts made academic reports or presided over and participated in relevant links.

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