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
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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2020-08-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04417-9 |
| _version_ | 1819277901389889536 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Xiaoke Li |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-24T00:03:28Z |
| format | Article |
| id | doaj.art-4877a011b28341079a065ce27e05da54 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-24T00:03:28Z |
| publishDate | 2020-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4877a011b28341079a065ce27e05da542022-12-21T17:25:04ZengBMCTrials1745-62152020-08-012111910.1186/s13063-020-04417-9Chinese 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 ChinaXiaoke Li0Ludan Zhang1Mei Qiu2Yi Huang3Huanming Xiao4Bingjiu Lu5Yuyong Jiang6Fuli Long7Hui Lin8Jinyu He9Qikai Wu10Mingxiang Zhang11Li Wang12Xiaoning Zhu13Man Gong14Xuehua Sun15Jianguang Sun16Fengxia Sun17Wei Lu18Weihua Xu19Guang Chen20Zhiguo Li21Danan Gan22Xianzhao Yang23Hongbo Du24Yong’an Ye25Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineDepartment of Hepatology, Shenzhen Traditional Chinese Medicine HospitalDepartment of Hepatology, Chongqing Traditional Chinese Medicine HospitalDepartment of Hepatology, Guangdong Hospital of Traditional Chinese MedicineDepartment of Hepatology, Liaoning Hospital of Traditional Chinese MedicineDepartment of Hepatology, Beijing Ditan HospitalDepartment of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese MedicineDepartment of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical UniversityDepartment of Hepatology, Shaanxi Hospital of Traditional Chinese MedicineDepartment of Hepatology, The Third People’s Hospital of ShenzhenDepartment of Hepatology, The Sixth People’s Hospital of ShenyangDepartment of Hepatology, Public Health Clinical Center of ChengduDepartment of Hepatology, Affiliated traditional Chinese Medicine Hospital of Southwest Medical UniversityDepartment of Hepatology, 302 Military Hospital of ChinaDepartment of Hepatology, Shanghai Shuguang HospitalDepartment of Hepatology, Shandong Hospital of Traditional Chinese MedicineDepartment of Hepatology, Beijing Chinese Medicine HospitalDepartment of Hepatology, The Second People’s Hospital of TianjinDepartment of Gastroenterology, The Second Hospital of Shandong UniversityInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineInstitute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese MedicineAbstract 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, 2019http://link.springer.com/article/10.1186/s13063-020-04417-9Chronic hepatitis BChinese herbal medicine formulaProtocolRandomized-controlled trial |
| spellingShingle | 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 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 Trials Chronic hepatitis B Chinese herbal medicine formula Protocol Randomized-controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Chronic hepatitis B Chinese herbal medicine formula Protocol Randomized-controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-020-04417-9 |
| work_keys_str_mv | AT xiaokeli chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT ludanzhang chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT meiqiu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT yihuang chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT huanmingxiao chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT bingjiulu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT yuyongjiang chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT fulilong chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT huilin chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT jinyuhe chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT qikaiwu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT mingxiangzhang chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT liwang chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT xiaoningzhu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT mangong chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT xuehuasun chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT jianguangsun chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT fengxiasun chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT weilu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT weihuaxu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT guangchen chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT zhiguoli chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT danangan chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT xianzhaoyang chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT hongbodu chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina AT yonganye chineseherbalmedicinecombinedwithentecavirtoreducetheofftherapyrecurrenceriskinhbeagpositivechronichepatitisbpatientsamulticenerdoubleblindrandomizedcontrolledtrialinchina |