Evidence map›Paper›PMID 34649610›Full record

ArticleTrials2021

YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis: study protocol for a multi-center randomized controlled trial.

Qing-Juan Wu, Wen-Liang Lv, Juan-Mei Li, Ting-Ting Zhang, Wen-Hui Zhou, Qiang Zhang, Jiu-Chong Wang, Qing-Nan Wang, Zi-Ang Yao, Rui Qiang and 8 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
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

18 authors at 2 institutions in 1 country.

Qing-Juan WuChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Wen-Liang LvChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China. wenlianglv@126.com.ORCID http://orcid.org/0000-0002-4552-919X
Juan-Mei LiChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Ting-Ting ZhangChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Wen-Hui ZhouChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Qiang ZhangChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Jiu-Chong WangChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Qing-Nan WangChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Zi-Ang YaoChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Rui QiangChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Si-Tong ChenChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Xin ZhaoChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Shuang LiuChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Zheng-Min CaoChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Lei XuChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Gao-Hui LiChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Jing ChenChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
Li WangChina Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.
China Academy of Chinese Medical Sciences · CNBeijing University of Chinese Medicine · CN

Funding

the National Key R&D Program of China 2018YFC1705700
6 · The paper itself

Abstract

introductionHepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional Chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aims to test the integrative medicine (Chinese medicine plus antiviral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis-related compensated liver cirrhosis. METHODS AND ANALYSIS: This is a multi-center randomized controlled trial, and a total of 5 hospitals and 802 patients will be involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction (YQSHD) group (n = 401) or the placebo group (n = 401). The YQSHD group receives YQSHD granule with entecavir (ETV), and the placebo group receives YQSHD placebo with ETV. The treatment period will last for 52 weeks, and the follow-up period for 52 ± 2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. The objective of this trial is "the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%." ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethics Committee of Guang'anmen Hospital, China (No.2019-006-KY), and the other centers in the trial will not begin recruiting until the local ethical approval has been obtained. Trial final results will be disseminated via publication.

trial registrationChinese Clinical Trial Registry ChiCTR1900021532 . Registered on February 26, 2019.

Indexed as

Carcinoma, HepatocellularDrugs, Chinese HerbalHepatitis BLiver NeoplasmsAntiviral AgentsDouble-Blind MethodHumansLiver CirrhosisMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntiviral AgentsDrugs, Chinese Herbal

Identifiers

PMID34649610
PMCPMC8515328
OpenAlexW3157284473

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.