Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China
Xiaoke Li,
Ludan Zhang,
Mei Qiu,
Yi Huang,
Huanming Xiao,
Bingjiu Lu,
Yuyong Jiang,
Fuli Long,
Hui Lin,
Jinyu He,
Qikai Wu,
Mingxiang Zhang,
Li Wang,
Xiaoning Zhu,
Man Gong,
Xuehua Sun,
Jianguang Sun,
Fengxia Sun,
Wei Lu,
Weihua Xu,
Guang Chen,
Zhiguo Li,
Danan Gan,
Xianzhao Yang,
Hongbo Du,
Yong’an Ye
Affiliations
Xiaoke Li
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Ludan Zhang
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Mei Qiu
Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital
Yi Huang
Department of Hepatology, Chongqing Traditional Chinese Medicine Hospital
Huanming Xiao
Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine
Bingjiu Lu
Department of Hepatology, Liaoning Hospital of Traditional Chinese Medicine
Yuyong Jiang
Department of Hepatology, Beijing Ditan Hospital
Fuli Long
Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine
Hui Lin
Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University
Jinyu He
Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine
Qikai Wu
Department of Hepatology, The Third People’s Hospital of Shenzhen
Mingxiang Zhang
Department of Hepatology, The Sixth People’s Hospital of Shenyang
Li Wang
Department of Hepatology, Public Health Clinical Center of Chengdu
Xiaoning Zhu
Department of Hepatology, Affiliated traditional Chinese Medicine Hospital of Southwest Medical University
Man Gong
Department of Hepatology, 302 Military Hospital of China
Xuehua Sun
Department of Hepatology, Shanghai Shuguang Hospital
Jianguang Sun
Department of Hepatology, Shandong Hospital of Traditional Chinese Medicine
Fengxia Sun
Department of Hepatology, Beijing Chinese Medicine Hospital
Wei Lu
Department of Hepatology, The Second People’s Hospital of Tianjin
Weihua Xu
Department of Gastroenterology, The Second Hospital of Shandong University
Guang Chen
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Zhiguo Li
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Danan Gan
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Xianzhao Yang
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Hongbo Du
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Yong’an Ye
Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Abstract Background Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal. Methods/design The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial. Conclusion This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population. Trial registration Chinese Clinical Trial Registry No. ChiCTR1900021232 . Registered on February 2, 2019