Evidence map›Paper›PMID 32481305›Full record

Trial reportMedicine2020

A multi-center, randomized, double-blind, placebo-parallel controlled trial for the efficacy and safety of shenfuqiangxin pills in the treatment of chronic heart failure (Heart-Kidney yang deficiency syndrome).

Lijun Guo, Hui Yuan, Dawu Zhang, Jian Zhang, Qi Hua, Xiaochang Ma, Keji Chen

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.2field-weighted citation impact, top 19% 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

10 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. The Challenges of Ethical Review in Clinical Research of Traditional Chinese Medicine.Evidence-based complementary and alternative medicine : eCAM · 2021
    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

7 authors at 3 institutions in 2 countries.

Lijun GuoNational Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Hui YuanNational Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Dawu ZhangNational Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Jian ZhangNational priority R & D programmes (2018YFC1707410-02), Fuwai Hospital of Chinese Academy of Medical Sciences.
Qi HuaNational Priority R & D Programmes (2018YFC1707410-02), Xuanwu Hospital Capital Medical University, Beijing, China.
Xiaochang MaNational Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Keji ChenNational Priority R & D Programmes (2018YFC1707410-02), Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Dana (United States) · USXiyuan Hospital · CNChina Academy of Chinese Medical Sciences · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHeart failure (HF) is the final stage of various cardiac diseases with poor prognosis. The integrated traditional Chinese medicine (TCM) and western medicine therapy has been considered as a prospective therapeutic strategy for chronic heart failure (CHF). There have been small clinical trials and experimental studies to demonstrate the efficacy of Shenfu Qiangxin Pills (SFQX) for treating CHF, however, there is still a lack of further high-quality trial. This paper describes the protocol for the clinical assessment of SFQX in CHF (heart-kidney Yang deficiency syndrome) patients.

methodsA randomized, double-blind, parallel-group, placebo-controlled, multi-center trial will assess the efficacy and safety of SFQX in the treatment of CHF. 352 patients with CHF (heart-kidney Yang deficiency syndrome) from 22 hospitals in China will be enrolled. Besides their standardized western medicine, patients will be randomized to receive treatment of either SFQX or placebo for 12 weeks. The primary outcome is the plasma N-terminal pro-B-type natriuretic peptide levels, which will be measured uniformly by the central laboratory. The secondary outcomes include composite endpoint events (hospitalization due to worsening HF, all-cause mortality, other serious cardiovascular events), echocardiography indicators, grades of the New York Heart Association (NYHA) functional classification, the 6-minute walk test (6MWT) results, Minnesota Living With Heart Failure Questionnaire and TCM syndrome scores. DISCUSSION: The integrated TCM and western medicine therapy has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of SFQX in the treatment of CHF.

trial registrationChinese Clinical Trial Registry: ChiCTR2000028777 (registered on January 3, 2020).

Indexed as

Case-Control StudiesChinaChronic DiseaseDouble-Blind MethodDrugs, Chinese HerbalEchocardiographyHeartHeart FailureHospitalizationHumansMedicine, Chinese TraditionalNatriuretic Peptide, BrainPeptide FragmentsPlacebosSafetyTreatment OutcomeDrugs, Chinese HerbalNatriuretic Peptide, BrainPeptide FragmentsPlacebospro-brain natriuretic peptide (1-76)qiangxinShen-Fu

Identifiers

PMID32481305
PMCPMC7249903
OpenAlexW3031886501

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.