Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial

Yong-an Ye; Xiao-ke Li; Da-qiao Zhou; Xiao-ling Chi; Qin Li; Li Wang; Bing-jiu Lu; De-wen Mao; Qi-kai Wu; Xian-bo Wang; Ming-xiang Zhang; Jing-dong Xue; Yong Li; Wei Lu; Jian-chun Guo; Feng Jiang; Xin-wei Zhang; Hong-bo Du; Xian-zhao Yang; Hui Guo; Da-nan Gan; Zhi-guo Li

doi:10.1007/s11655-018-3011-5

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Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial

OriginalPaper | Updated：2021-08-27

- Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial
- Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial
- 中国结合医学杂志（英文版） 2018年24卷第9期页码：653-660
- Affiliations：
  
  1. Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine,Beijing,China
  2. Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital,Guangdong Province,Shenzhen,China
  3. Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine,Guangzhou,China
  4. Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University,Fuzhou,China
  5. Department of Hepatology, Public Health Clinical Center of Chengdu,Chengdu,China
  6. Department of Hepatology, Liaoning Hospital of Traditional Chinese Medicine,Shenyang,China
  7. Department of Hepatology, the First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning,China
  8. Department of Hepatology, the Third People’s Hospital of Shenzhen,Guangdong Province,Shenzhen,China
  9. Department of Hepatology, Beijing Ditan Hospital,Beijing,China
  10. Department of Hepatology, the Sixth People’s Hospital of Shenyang,Shenyang,China
  11. Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine,Xi’an,China
  12. Department of Hepatology, Shandong Hospital of Traditional Chinese Medicine,Jinan,China
  13. Department of Hepatology, the Second People’s Hospital of Tianjin,Tianjin,China
  14. Department of Hepatology, Xixi Hospital of Hangzhou,Hangzhou,China
  15. Department of Hepatology, Military Hospital of China,Beijing,China,302
  16. Department of Hepatology, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin,China
- Author bio：
- Funds：
  
  Supported by China National Science and Technology Major Projects 12th 5-year Plan (No.2012ZX10005004)
- DOI：10.1007/s11655-018-3011-5
  中图分类号：
- 纸质出版日期：2018，
  
  网络出版日期：2018-9-12，
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Ye, Ya., Li, Xk., Zhou, Dq. et al. Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial., Chin. J. Integr. Med. 24, 653–660 (2018). https://doi.org/10.1007/s11655-018-3011-5

Yong-an Ye, Xiao-ke Li, Da-qiao Zhou, et al. Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(9):653-660.
Ye, Ya., Li, Xk., Zhou, Dq. et al. Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial., Chin. J. Integr. Med. 24, 653–660 (2018). https://doi.org/10.1007/s11655-018-3011-5 DOI：

Yong-an Ye, Xiao-ke Li, Da-qiao Zhou, et al. Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(9):653-660. DOI： 10.1007/s11655-018-3011-5.

摘要

The domestic prevalence of chronic hepatitis B (CHB) in China is 7.18% in 2006

imposing great societal healthcare burdens. Nucleot(s)ide analogues (NUCs) anti-hepatitis B virus (HBV) therapies are widely applied despite the relatively low rate of seroconversion and high risk of drug-resistant mutation. More effective treatments for CHB deserve further explorations. Combined therapy of NUCs plus Chinese herbal medicine (CHM) is widely accepted in China

which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule (调肝益脾颗粒

TGYP) or Tiaogan-Jianpi-Jiedu Granule (调肝健脾解毒颗粒

TGJPJD) plus entecavir tablet (ETV) was superior over ETV monotherapy in enhancing HBeAg loss rate. The study was a nationwide

large-scale

multi-center

double-blind

randomized

placebo-controlled trial with a designed duration of 108 weeks. A total of 16 hospitals and 596 eligible Chinese HBeAg positive CHB patients were enrolled from November 2012 to September 2013 and randomly allocated into 2 groups in 1:1 ratio via central randomization system: experimental group (EG) and control group (CG). Subjects in EG received CM formulae (TGYP or TGJPJD

50 g per dose

twice daily) plus ETV tablet (or ETV placebo) 0.5 mg per day in the first 24 weeks (stage 1)

and CHM granule plus ETV tablet (0.5 mg per day) from week 25 to 108 (stage 2). Subjects in CG received CHM Granule placebo plus ETV tablet (0.5 mg per day) for 108 weeks throughout the trial. The assessments of primary outcomes (HBV serum markers and HBV-DNA) were conducted by a third-party College of American Pathologists (CAP) qualified laboratory. Adverse effects were observed in the hospitals of recruitment. The study was designed to compare the curative effect of CM plus ETV and ETV monotherapy in respect of HBeAg loss

which is recognized by the European Association for the Study of the Liver as “a valuable endpoint”. We believe this trial could provide a reliable status for patients’ “journey” towards durable responses after treatment discontinuation. The trial was registered before recruitment on Chinese Clinical trial registry (No. ChiCTR-TRC-12002784

Version 1.0

2015/12/23).

Abstract

The domestic prevalence of chronic hepatitis B (CHB) in China is 7.18% in 2006

which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule (调肝益脾颗粒

TGYP) or Tiaogan-Jianpi-Jiedu Granule (调肝健脾解毒颗粒

TGJPJD) plus entecavir tablet (ETV) was superior over ETV monotherapy in enhancing HBeAg loss rate. The study was a nationwide

large-scale

multi-center

double-blind

randomized

50 g per dose

twice daily) plus ETV tablet (or ETV placebo) 0.5 mg per day in the first 24 weeks (stage 1)

Version 1.0

2015/12/23).

关键词

chronic hepatitis BChinese Herbal MedicineTiaogan-Jianpi-Jiedu GranuleTiaogan- Yipi Granuleprotocolrandomized-controlled trial

Keywords

chronic hepatitis BChinese Herbal MedicineTiaogan-Jianpi-Jiedu GranuleTiaogan- Yipi Granuleprotocolrandomized-controlled trial

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