Evidence map›Paper›PMID 34559118›Full record

Trial reportMedicine2021

Efficacy of erzhu jiedu recipe on hepatitis B cirrhosis with hyperalphafetoproteinemia: A randomized, double-blind, placebo-controlled clinical trial.

Tian-Yang Chen, Jing-Yin Mai, Ping Zhang, Jian-Hua Xue, Sheng-Li He, Jun Xi, Jian-Jie Chen, Yang Cheng

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. A Comprehensive Review ofDrug design, development and therapy · 2026
    Review
  3. 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

8 authors.

Tian-Yang ChenShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No.528 Zhangheng Road, Pudong District, Shanghai, China.ORCID 0000-0002-5905-8317
Jing-Yin MaiShanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital, No.40 Xinhua Road, Changning District, Shanghai, China.
Ping ZhangForeign Language Center of Shanghai University of Traditional Chinese Medicine, No.1200 Cailun Road, Pudong District, Shanghai, China.
Jian-Hua XueDepartment of Liver Disease, Hospital for Infectious Diseases of Pudong District, No.46 East Huaxia Road, Shanghai, China.
Sheng-Li HeMinhang Branch of Tumor Hospital Affiliated to Fudan University, No.106 Ruili Road, Minhang District, Shanghai, China.
Jun XiDepartment of Liver Disease, Hospital for Infectious Diseases of Pudong District, No.46 East Huaxia Road, Shanghai, China.
Jian-Jie ChenShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No.528 Zhangheng Road, Pudong District, Shanghai, China.
Yang ChengShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No.528 Zhangheng Road, Pudong District, Shanghai, China.

Funding

shanghai municipal science and technology commission foundation 17401935000
6 · The paper itself

Abstract

backgroundHepatitis B cirrhosis with hyperalphafetoproteinemia is the intermediate stage of liver cirrhosis progressing to hepatocellular carcinoma (HCC), there is no effective way to treat precancerous lesions of liver in modern medicine. In recent decades, clinical and experimental evidence shows that Chinese medicine (CM) has a certain beneficial effect on Hepatitis B Cirrhosis. Therefore, this trial aims to evaluate the efficacy and safety of a CM erzhu jiedu recipe (EZJDR) for the treatment of Hepatitis B Cirrhosis with Hyperalphafetoproteinemia.

methodsWe designed a randomized, double blind, placebo-controlled clinical trial. A total of 72 patients of Hepatitis B Cirrhosis with hyperalphafetoproteinemia were randomized in 2 parallel groups. Patients in the control group received placebo granules similar to the EZJDR. In the EZJDR group, patients received EZJDR twice a day, after meals, for 48 weeks. The primary efficacy measures were changes in serum alpha-fetoprotein (AFP) and alpha-fetoprotein alloplasm (AFP-L3); The secondary indicators of efficacy are changes in liver function indicators, HBV-DNA level; Liver stiffness measurement (LSM); Hepatic portal vein diameter; T lymphocyte subgroup indexes during treatment. All data will be recorded in case report forms and analyzed by Statistical Analysis System software. Adverse events will also be evaluated.

resultsThe results showed that EZJDR can significantly inhibit the levels of AFP and AFP-L3 in patients with hepatitis B cirrhosis and hyperalphafetoproteinemia and have good security. ETHICS AND DISSEMINATION: The study protocol was approved by the Medical Ethics Committee of Shuguang Hospital, affiliated with University of Traditional Chinese Medicine, Shanghai (NO.2018-579-08-01).

trial registrationThis trial was registered on Chinese Clinical Trial Center (NO.ChiCTR1800017165).

Indexed as

Chi-Square DistributionCholesterol Ester Transfer ProteinsDouble-Blind MethodFibrosisHepatitis BHumansLipid Metabolism, Inborn ErrorsMedicine, Chinese TraditionalPlacebosCholesterol Ester Transfer ProteinsPlacebos

Identifiers

PMID34559118
PMCPMC10545361

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Registered trials

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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.