Evidence map›Paper›PMID 25994188›Full record

Trial reportTrials2015

Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial.

Chunxiang Liu, Yazhu Hou, Xianliang Wang, Zhiqiang Zhao, Zhi Liu, Jingbo Zhai, Jingyuan Mao, Hongcai Shang

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.0field-weighted citation impact, top 8% 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

16 citing papers in PubMed, 30 citations in OpenAlex.

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  11. Simultaneous Evaluation of the Influence ofEvidence-based complementary and alternative medicine : eCAM · 2018
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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 at 1 institution in 1 country.

Chunxiang LiuEvidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. liuchunxiangebm@foxmail.com.
Yazhu HouCardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. mreleven@163.com.
Xianliang WangCardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. xlwang1981@126.com.
Zhiqiang ZhaoCardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. quanmingzhao@126.com.
Zhi LiuEvidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. liuz_ebm@foxmail.com.
Jingbo ZhaiEvidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. zhaijingbo@foxmail.com.
Jingyuan MaoCardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Tianjin, Nankai District, Tianjin, 300193, China. jymao@126.com.
Hongcai ShangEvidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, 312 Anshan Western Road, Nankai District, Tianjin, 300193, China. shanghongcai@foxmail.com.
Tianjin University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure.

methodsThis protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee's heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure). DISCUSSION: This trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.

trial registrationThis trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857 ).

Indexed as

AdultAgedBiomarkersCardiovascular AgentsChinaChronic DiseaseClinical ProtocolsCoronary DiseaseDisease ProgressionDrugs, Chinese HerbalExercise TestExercise ToleranceFemaleHeart FailureHumansInjectionsBiomarkersCardiovascular AgentsDrugs, Chinese HerbalNatriuretic Peptide, BrainShen-Fu

Identifiers

PMID25994188
PMCPMC4446800
OpenAlexW1494964748

What OpenQuestion holds

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LicenceCC BY
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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.