Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome)
Joint Authors
Xu, Hao
Mao, Jing-Yuan
Wang, Xiaolong
Zhang, Junhua
Du, Tinghai
Liu, Chunxiang
Wang, Xian-Liang
Zhao, Zhiqiang
Chen, Yuanping
Liu, Nan
Wu, Jianguang
Li, Rong
Xu, Yong
Wang, Lei
He, Jingsong
Zhai, Jingbo
Zhao, Guoyuan
Hou, Yazhu
Wang, Shuai
Yingqiang, Zhao
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2019, Issue 2019 (31 Dec. 2019), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2019-02-25
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Background.
Shenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987.
However, the therapeutic effect of SFI has not been validated in a standard clinical study.
As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase.
Methods.
A total of 160 patients experiencing acute phase CHF were enrolled in this study and randomly assigned to receive the placebo (placebo group, 150 ml glucose (GS)) or SFI (SFI group, 50 ml SFI + 100 ml GS) in addition to their standard medications for CHF treatment.
The treatment lasted for 7 ± 1 days, and the follow-up continued for 28 ± 3 days after treatment.
The primary endpoints were New York Heart Association (NYHA) classification and Traditional Chinese Medicine (TCM) syndrome scores.
Results.
After 7±1 days of treatment, the efficacy of SFI according to improvements in NYHA and TCM syndrome scores in the SFI group (78.38% and 89.19%, respectively) was significantly higher than that in the placebo group (61.43% and 60.00%, respectively; P<0.05).
The SFI group had a longer increase in amplitude than the placebo group (113.00 m versus 82.99 m, P<0.05).
The incidence of adverse events and other safety indices showed no significant differences between the two groups.
Conclusion.
SFI combined with conventional therapy for treatment of CHF during acute symptom aggravation ameliorated the cardiac dysfunction and clinical symptoms and improved the patients’ quality of life without any significant AEs compared with the conventional therapy alone.
American Psychological Association (APA)
Wang, Xian-Liang& Zhao, Zhiqiang& Mao, Jing-Yuan& Du, Tinghai& Chen, Yuanping& Xu, Hao…[et al.]. 2019. Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome). Evidence-Based Complementary and Alternative Medicine،Vol. 2019, no. 2019, pp.1-8.
https://search.emarefa.net/detail/BIM-1151652
Modern Language Association (MLA)
Wang, Xian-Liang…[et al.]. Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome). Evidence-Based Complementary and Alternative Medicine No. 2019 (2019), pp.1-8.
https://search.emarefa.net/detail/BIM-1151652
American Medical Association (AMA)
Wang, Xian-Liang& Zhao, Zhiqiang& Mao, Jing-Yuan& Du, Tinghai& Chen, Yuanping& Xu, Hao…[et al.]. Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome). Evidence-Based Complementary and Alternative Medicine. 2019. Vol. 2019, no. 2019, pp.1-8.
https://search.emarefa.net/detail/BIM-1151652
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1151652