Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2020; 26(30): 4501-4522
Published online Aug 14, 2020. doi: 10.3748/wjg.v26.i30.4501
Efficacy of a Chinese herbal formula on hepatitis B e antigen-positive chronic hepatitis B patients
Yu-Feng Xing, Chun-Shan Wei, Tian-Ran Zhou, Dan-Ping Huang, Wei-Chao Zhong, Bin Chen, Hua Jin, Xiao-Yu Hu, Zhi-Yun Yang, Qing He, Kai-Ping Jiang, Jun-Min Jiang, Zhen-Bin Hu, Xin Deng, Fan Yang, Feng-Yi Li, Gang Zhao, Li-Chun Wang, Yu-Qiang Mi, Zuo-Jiong Gong, Peng Guo, Jian-Hua Wu, Wei-Qun Shi, Hong-Zhi Yang, Da-Qiao Zhou, Guang-Dong Tong
Yu-Feng Xing, Chun-Shan Wei, Tian-Ran Zhou, Dan-Ping Huang, Wei-Chao Zhong, Da-Qiao Zhou, Guang-Dong Tong, Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen 518033, Guangdong Province, China
Bin Chen, Department of Hepatology, The First Hospital of Hunan University of Chinese Medicine, Changsha 410007, Hunan Province, China
Hua Jin, Department of Integrated Traditional and Western Medicine on Liver Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
Xiao-Yu Hu, Department of Infectious Disease, The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610032, Sichuan Province, China
Zhi-Yun Yang, Department of Integrated Traditional and Western Medicine on Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
Qing He, The First Department of Hepatology, Shenzhen No. 3 People’s Hospital, Shenzhen 518100, Guangdong Province, China
Kai-Ping Jiang, Department of Hepatology, Foshan Hospital of Traditional Chinese Medicine, Foshan 528000, Guangdong Province, China
Jun-Min Jiang, Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou 510006, Guangdong Province, China
Zhen-Bin Hu, Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning 530012, Guangxi Province, China
Xin Deng, Department of Hepatology, Ruikang Hospital, Guangxi University of Chinese Medicine, Nanning 530012, Guangxi Province, China
Fan Yang, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430060, Hubei Province, China
Feng-Yi Li, Treatment and Research Center of Infectious Disease, 302 Military Hospital of China, Beijing 100039, China
Gang Zhao, Department of Hepatology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201204, China
Li-Chun Wang, Center of Infectious Disease, Huaxi Hospital, Sichuan University, Chengdu 610044, Sichuan Province, China
Yu-Qiang Mi, Department of Infectious Disease, Tianjin Infectious Disease Hospital, Tianjin 300192, China
Zuo-Jiong Gong, Department of Infectious Disease, Hubei People’s Hospital, Wuhan 430060, Hubei Province, China
Peng Guo, Department of Hepatology, Xiyuan Hospital, China Academy of Chinese Medical Science, Beijing 100080, China
Jian-Hua Wu, Center of Hepatology, Xiamen Hospital of Traditional Chinese Medicine, Xiamen 361009, Fujian Province, China
Wei-Qun Shi, Department of Hepatology, Xinhua Hospital, Zhejiang University of Traditional Chinese Medicine, Hangzhou 310005, Zhejiang Province, China
Hong-Zhi Yang, Department of Traditional Chinese Medicine, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510620, Guangdong Province, China
Author contributions: Tong GD, Xing YF and Wei CS conceived the experiment; Zhou TR analyzed the results; Huang DP and Zhong WC wrote the original draft; Chen B, Jin H, Hu XY, Yang ZY, He Q, Jiang KP, Jiang JM, Hu ZB, Deng X, Yang F, Li FY, Zhao G, Wang LC, Mi YQ, Gong ZJ, Guo P, Wu JH, Shi WQ, Yang HZ and Zhou DQ conducted the experiment; all the authors revised the manuscript and approved the final version.
Supported by the National Natural Science Foundation of China, No. 81174263; National Science and Technology Major Project during the 12th Five-year Plan Period, No. 2012ZX1005006; Sanming Project of Medicine in Shenzhen, Guangdong Province, China, No. SZSM201612074; and Science and Technology Planning Project of Guangdong Province, China, No. 2017A020213016.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine.
Clinical trial registration statement: This study was registered at Chinese Clinical Trial Registry. The registration identification number is ChiCTR-IPR-17011944 (11/07/2017) (http://www.chictr.org.cn/index.aspx).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Guang-Dong Tong, MD, Professor, Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, No. 1 Fuhua Road, Futian District, Shenzhen 518033, Guangdong Province, China. tgd755@163.com
Received: March 25, 2020
Peer-review started: March 25, 2020
First decision: April 25, 2020
Revised: May 29, 2020
Accepted: July 22, 2020
Article in press: July 22, 2020
Published online: August 14, 2020
Processing time: 142 Days and 2.9 Hours
Core Tip

Core tip: Hepatitis B e antigen-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus DNA viral load may progress to cirrhosis or hepatocellular carcinoma. However, no guideline recommends antiviral therapy for it because of poor efficacy. In the present study we report the feasibility and safety profiles of a Chinese herbal formula as a therapeutic option for chronic hepatitis B virus infection.