Evidence map›Paper›PMID 33128206›Full record

Trial reportHepatology international2020

Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial.

Xiaoke Li, Daqiao Zhou, Xiaoling Chi, Qin Li, Li Wang, Bingjiu Lu, Dewen Mao, Qikai Wu, Xianbo Wang, Mingxiang Zhang and 15 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.7field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Review
  3. Journal of pharmaceutical analysis · 2024
    Article
  4. Hepatitis B: Model Systems and Therapeutic Approaches.Journal of immunology research · 2024
    Review
  5. Article
  6. Network pharmacology andFrontiers in pharmacology · 2022
    Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 15 institutions in 1 country.

Xiaoke LiDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
Daqiao ZhouDepartment of Hepatology, Shenzhen TCM Hospital, No. 1 Fuhua Road, Futian District, Shenzhen, 518033, China.
Xiaoling ChiDepartment of Hepatology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Dade Road 111, Guangzhou, 510120, Guangdong, China.
Qin LiDepartment of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, No. 312 Xihong road, Gulou District, Fujian, 350025, Fuzhou, China.
Li WangDepartment of Hepatology, Public Health Clinical Center of Chengdu, No. 377 Jingming Road, Jinjiang District, Chengdu, 610066, Sichuan, China.
Bingjiu LuDepartment of Hepatology, Liaoning Hospital of TCM, Huanggu District, No. 33, Beiling Street, Shenyang, 110032, Liaoning, China.
Dewen MaoDepartment of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, No. 89-9, Dongge road, Nanning, 530023, Guangxi, China.
Qikai WuDepartment of Hepatology, The Third People's Hospital of Shenzhen, No. 29 Bujibulan Road, Longgang District, Shenzhen, 518112, China.
Xianbo WangDepartment of Hepatology, Beijing Ditan Hospital, No. 8 Jingshun East Road, Chaoyang District, Beijing, 100015, China.
Mingxiang ZhangDepartment of Hepatology, The Sixth People's Hospital of Shenyang, No. 85 Heping south road, Heping District, Shenyang, 110006, Liaoning, China.
Jingdong XueDepartment of Hepatology, Shaanxi Hospital of TCM, No. 4 Xihuamen, Lianhu District, Xi'an, 710003, Shaanxi, China.
Yong LiDepartment of Hepatology, The Affiliated Hospital of Shandong University of TCM, No. 42 Wenhua West Road, Jinan, 250011, Shandong, China.
Wei LuDepartment of Hepatology, Tianjin Second People's Hospital, No.7 Sudi South Road, Nankai District, Tianjin, 300192, China.
Jianchun GuoDepartment of Hepatology, Xixi Hospital of Hangzhou, No. 2 Hengbu road, Liuxiazhen, Xihu District, Hangzhou, 310023, Zhejiang, China.
Feng JiangDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
Xinwei ZhangDepartment of Liver Disease, Fifth Medical Center of Chinese PLA General Hospital, No.100 West Fourth Ring Road, Beijing, 100039, China.
Zhiguo LiDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
Xianzhao YangDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
Hui GuoDepartment of Hepatology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 An Shan Xi Road, Nan Kai District, Tianjin, 300193, China.
Danan GanDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
Liyun HeInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences, No. 16, Dongzhimen South Street, Dongcheng District, Beijing, 100700, China.
Lin LuoInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences, No. 16, Dongzhimen South Street, Dongcheng District, Beijing, 100700, China.
Ludan ZhangDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China.
Hongbo DuDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China. duhongbo@bucm.edu.cn.
Yong'an YeDepartment of Gastroenterology, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (BUCM), Institute of Liver Diseases, BUCM, No. 5 Haiyuncang road, Dongcheng District, Beijing, 100700, China. yeyongan@vip.163.com.ORCID http://orcid.org/0000-0002-0924-5835
Beijing University of Chinese Medicine · CNChina Academy of Chinese Medical Sciences · CNAffiliated Hospital of Liaoning University of Traditional Chinese Medicine · CNBeijing Ditan Hospital · CNChinese PLA General Hospital · CNFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine · CNFujian Medical University · CNGuangxi University · CNGuangzhou University of Chinese Medicine · CNHangzhou Xixi hospital · CNPublic Health Clinical Center of Chengdu · CNShandong University · CNShenzhen Bao'an District People's Hospital · CNShenzhen Third People’s Hospital · CNThe Sixth People's Hospital of Shenyang · CN

Funding

China National Science and Technology major projects 12th 5-year plan 2012ZX10005004
6 · The paper itself

Abstract

BACKGROUND AND

aimTraditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients.

methods596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108.

resultsThe combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9-43.2%) in the experiment group and 27.21% (95% CI 22.0-32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4-12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week.

conclusionCombining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile. CLINICAL TRIAL NUMBER: ChiCTR-TRC-12002784 (Chinese Clinical Trial Registry).

Indexed as

Hepatitis B, ChronicAntiviral AgentsDNA, ViralDrug CombinationsDrugs, Chinese HerbalGuanineHepatitis B e AntigensHepatitis B virusHumansTreatment OutcomeAntiviral AgentsDNA, ViralDrug CombinationsDrugs, Chinese HerbalentecavirGuanineHepatitis B e AntigensChronic hepatitis BTiao-gan-jian-pi-jie-du granuleTiao-gan-yi-pi granuleTraditional Chinese medicine

Identifiers

PMID33128206
OpenAlexW3094881921

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.