Shenfu injection alleviates the clinical symptoms of heart failure patients combined with conventional treatment: A protocol for systematic review and meta-analysis of randomized clinical trials.
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
16 Apr 2021
16 Apr 2021
Historique:
received:
10
11
2020
accepted:
17
11
2020
entrez:
13
4
2021
pubmed:
14
4
2021
medline:
29
4
2021
Statut:
ppublish
Résumé
Shenfu Injection (SFI) is a promising alternative treatment for heart failure (HF) in China. Many complete clinical trials have examined the efficacy of SFI combined use with conventional treatment (CT) vs CT alone. This study is to conduct a systematic review and meta-analysis of randomized clinical trials to evaluate the benefits and risks of using SFI in addition to CT for the treatment of HF. All the trials will be searched through 4 English databases (MEDLINE via PubMed, the Cochrane Library, EMBASE, Web of Science) and 4 Chinese databases (the China Science and Technology Journal Database, Chinese Biomedical Literature Database, Wan-fang Database, the China National Knowledge Infrastructure.) from October 2005 to June 2019. Conference articles or articles with incomplete data will be removed. The primary outcome was the New York Heart Association, 6-minute walk test, hospitalization or rehospitalization. Left ventricular ejection fraction percentage, left ventricular end-diastolic dimension, Cardiac index, heart rate, N-terminal pronatriuretic peptide and other indicators were also assessed. RevMan V.5.3 Software and Stata 13.0 Statistics Software were used to calculate the data synthesis and conduct meta-analysis according to the guideline of Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015. Mortality, New York Heart Association function classification, heart rate, 6-minute walk test, hospitalization or rehospitalization, Heart rate, systolic blood pressure, DBP, Cardiac minute volume, left ventricular ejection fractions percentage, left ventricular end-diastolic dimension (mm), N-terminal pronatriuretic peptide, etc. and adverse effects will be comprehensively assessed to evaluate the adjunctive effect of SFI through different aspects. We will perform a meta-analysis of each outcome with subgroup analysis based on the type of HF, treatment methods, and course of disease. Sensitivity analysis will be conducted with clinical factors, treatment methods, methodological characteristics, and statistical heterogeneity (if applicable). This study will assess the adjunctive effect of SFI and its safety on HF with clinical evidence. PROSPERO CRD42020151856.
Sections du résumé
BACKGROUND
BACKGROUND
Shenfu Injection (SFI) is a promising alternative treatment for heart failure (HF) in China. Many complete clinical trials have examined the efficacy of SFI combined use with conventional treatment (CT) vs CT alone. This study is to conduct a systematic review and meta-analysis of randomized clinical trials to evaluate the benefits and risks of using SFI in addition to CT for the treatment of HF.
METHOD
METHODS
All the trials will be searched through 4 English databases (MEDLINE via PubMed, the Cochrane Library, EMBASE, Web of Science) and 4 Chinese databases (the China Science and Technology Journal Database, Chinese Biomedical Literature Database, Wan-fang Database, the China National Knowledge Infrastructure.) from October 2005 to June 2019. Conference articles or articles with incomplete data will be removed. The primary outcome was the New York Heart Association, 6-minute walk test, hospitalization or rehospitalization. Left ventricular ejection fraction percentage, left ventricular end-diastolic dimension, Cardiac index, heart rate, N-terminal pronatriuretic peptide and other indicators were also assessed. RevMan V.5.3 Software and Stata 13.0 Statistics Software were used to calculate the data synthesis and conduct meta-analysis according to the guideline of Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015.
RESULTS
RESULTS
Mortality, New York Heart Association function classification, heart rate, 6-minute walk test, hospitalization or rehospitalization, Heart rate, systolic blood pressure, DBP, Cardiac minute volume, left ventricular ejection fractions percentage, left ventricular end-diastolic dimension (mm), N-terminal pronatriuretic peptide, etc. and adverse effects will be comprehensively assessed to evaluate the adjunctive effect of SFI through different aspects. We will perform a meta-analysis of each outcome with subgroup analysis based on the type of HF, treatment methods, and course of disease. Sensitivity analysis will be conducted with clinical factors, treatment methods, methodological characteristics, and statistical heterogeneity (if applicable).
CONCLUSION
CONCLUSIONS
This study will assess the adjunctive effect of SFI and its safety on HF with clinical evidence.
PROSPERO REGISTRATION NUMBER
UNASSIGNED
PROSPERO CRD42020151856.
Identifiants
pubmed: 33847606
doi: 10.1097/MD.0000000000023736
pii: 00005792-202104160-00002
pmc: PMC8051970
doi:
Substances chimiques
Drugs, Chinese Herbal
0
Shen-Fu
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e23736Subventions
Organisme : The College students' innovation and entrepreneurship projects
ID : 201810572081
Informations de copyright
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to disclose.
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