Evidence map›Paper›PMID 32437567›Full record

Trial reportThe Journal of infectious diseases2022

Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients With Chronic Hepatitis B Treated With Entecavir: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Guanghua Rong, Yongping Chen, Zujiang Yu, Qin Li, Jingfeng Bi, Lin Tan, Dedong Xiang, Qinghua Shang, Chunliang Lei, Liang Chen and 12 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01965418 (A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 9% 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.

NCT01965418 phase4unknown statusnot on this map

A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial

TypeinterventionalSponsorBeijing 302 HospitalRan2013Enrolled1,000ConditionsLiver Fibrosis, Chronic Hepatitis BArmsFufang Biejia Ruangan Tablet, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. [Chinese guidelines for clinical diagnosis, treatment, and management of cirrhosis (2025)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Guideline
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. [Exploring the advantages of traditional Chinese medicine and dual-anti therapy for liver cirrhosis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Article
  11. Article
  12. Article
  13. Protective effects ofCytotechnology · 2025
    Article
  14. Chinese Guidelines on the Management of Hepatic Encephalopathy in Cirrhosis (2024).Journal of clinical and translational hepatology · 2025
    Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. [Chinese guidelines on the management of hepatic encephalopathy in cirrhosis (2024)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    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

22 authors at 17 institutions in 4 countries.

Guanghua RongDepartment of Liver Diseases & the Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China.
Yongping ChenDepartment of Infectious and Liver Diseases, Liver Research Center, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.
Zujiang YuDepartment of Infectious Disease, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
Qin LiFuzhou Infectious Diseases Hospital, Fuzhou, Fujian Province, China.
Jingfeng BiDepartment of Clinical and Translational Medicine, Fifth Medical Center of Chinese People's Liberation Army General Hospital, Beijing, China.
Lin TanLiver Disease Department, Fuyang Second People's Hospital, Fuyang, Anhui Province, China.
Dedong XiangDepartment of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China.
Qinghua ShangTherapeutic Center for Liver Disease, 88th Hospital of People's Liberation Army, Taian, Shandong Province, China.
Chunliang LeiGuangzhou Eighth People's Hospital, Guangzhou, Guangdong Province, China.
Liang ChenDepartment of Hepatic Diseases, Shanghai Public Health Clinical Center, Shanghai, China.
Xiaoyu HuNational Integrative Medicine Clinical Base for Infectious Diseases and Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
Jing WangAffiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan Province, China.
Huabao LiuTraditional Chinese Medicine Hospital of Chongqing, Chongqing, China.
Wei LuTianjin Second People's Hospital, Tianjin Institute of Hepatology, Tianjin, China.
Yan ChenDepartment of Liver Diseases & the Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China.
Zheng DongDepartment of Liver Diseases & the Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China.
Wenlin BaiDepartment of Liver Diseases & the Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China.
Eric M YoshidaDivision of Gastroenterology, Vancouver General Hospital, Vancouver, British Columbia, Canada.
Nahum Mendez-SanchezLiver Research Unit Medica Sur Clinic and Foundation, Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico.
Ke-Qin HuDivision of Gastroenterology and Hepatology, School of Medicine, University of California, Irvine, Orange, California, USA.
Xingshun QiDepartment of Gastroenterology, General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, China.ORCID 0000-0002-9448-6739
Yongping YangDepartment of Liver Diseases & the Fifth Medical Center of the Chinese People's Liberation Army General Hospital, Beijing, China.
Chinese People's Liberation Army · CNWenzhou Medical University · CNArmy Medical University · CNChengdu University of Traditional Chinese Medicine · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst People's Hospital of Chongqing · CNFuyang Second People's Hospital · CNFuzhou Pulmonary Hospital of Fujian · CNGeneral Hospital of Shenyang Military Region · CNGuangzhou Eighth People's Hospital · CNHospital Médica Sur · MXPeople's Liberation Army 401 Hospital · CNShanghai Public Health Clinical Center · CNSouthwest Medical University · CNTianjin People's Hospital · CNUniversity of California, Irvine · USVancouver General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLong-term nucleos(t)ide analogue (NA) treatment can reverse liver fibrosis in chronic hepatitis B (CHB), but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an antifibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs.

methodsCHB patients with histologically confirmed advanced fibrosis or cirrhosis were randomly assigned to receive entecavir (ETV) (0.5 mg per day) plus BR (2 g 3 times a day) or placebo for 72 weeks. Liver fibrosis regression was defined as a reduction of ≥ 1 point by the Ishak fibrosis stage (IFS).

resultsOverall, 500 patients were enrolled in each group as the intention-to-treat population. The rate of fibrosis regression after 72 weeks of treatment was significantly higher in the ETV + BR group (40% vs 31.8%; P = .0069). Among 388 patients with cirrhosis (ie, IFS ≥ 5) at baseline, the rate of cirrhosis reversal (ie, IFS ≤ 4) was significantly higher in the ETV + BR group (41.5% vs 30.7%; P = .0103).

conclusionsAddition of BR to the current standard treatment with NAs in CHB patients with advanced fibrosis or cirrhosis can improve liver fibrosis regression. CLINICAL TRIALS REGISTRATION: NCT01965418.

Indexed as

Hepatitis B, ChronicAntiviral AgentsGuanineHumansLiver CirrhosisTreatment OutcomeAntiviral AgentsentecavirGuanineentecavirhepatitis Bliver cirrhosisliver fibrosistraditional Chinese medicine

Identifiers

PMID32437567
PMCPMC8921993
OpenAlexW3026573246

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.