PMID- 30930952
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 1741-427X (Print)
IS  - 1741-4288 (Electronic)
IS  - 1741-427X (Linking)
VI  - 2019
DP  - 2019
TI  - 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).
PG  - 9297163
LID - 10.1155/2019/9297163 [doi]
LID - 9297163
AB  - 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.
FAU - Wang, Xianliang
AU  - Wang X
AD  - First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 
      (TCM), Tianjin, 300193, China.
FAU - Zhao, Zhiqiang
AU  - Zhao Z
AD  - First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 
      (TCM), Tianjin, 300193, China.
FAU - Mao, Jingyuan
AU  - Mao J
AUID- ORCID: 0000-0002-9882-7406
AD  - First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 
      (TCM), Tianjin, 300193, China.
FAU - Du, Tinghai
AU  - Du T
AD  - The First Affiliated Hospital of Henan University of T.C.M., Henan, 450000, 
      China.
FAU - Chen, Yuanping
AU  - Chen Y
AD  - The First Affiliated Hospital of Guangxi University of Chinese Medicine, Guangxi, 
      530000, China.
FAU - Xu, Hao
AU  - Xu H
AUID- ORCID: 0000-0002-3139-4087
AD  - Xiyuan Hospital, China Academy of Chinese Medical Sciences (CACMS), Beijing, 
      100091, China.
FAU - Liu, Nan
AU  - Liu N
AD  - The First Affiliated Hospital of Guangzhou University of T.C.M, Guangzhou, 
      510450, China.
FAU - Wang, Xiaolong
AU  - Wang X
AD  - Department of Cardiovascular, Shuguang Hospital Affiliated to Shanghai University 
      of Traditional Chinese Medicine, Shanghai, 201203, China.
FAU - Wu, Jianguang
AU  - Wu J
AD  - Affiliated Hospital of Jiangxi University of T.C.M., Jiangxi, 330000, China.
FAU - Li, Rong
AU  - Li R
AD  - The First Affiliated Hospital of Guangzhou University of T.C.M, Guangzhou, 
      510450, China.
FAU - Xu, Yong
AU  - Xu Y
AD  - Teaching Hospital of Chengdu University of T.C.M., Chengdu, 610000, China.
FAU - Zhao, Yingqiang
AU  - Zhao Y
AD  - Second Affiliated Hospital of Tianjin University of T.C.M., Tianjin, 300143, 
      China.
FAU - Wang, Lei
AU  - Wang L
AD  - West China Hospital of Sichuan University, Sichuan, 610000, China.
FAU - He, Jingsong
AU  - He J
AD  - Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Guangxi, 
      530000, China.
FAU - Zhang, Junhua
AU  - Zhang J
AUID- ORCID: 0000-0003-4043-1967
AD  - Evidence-Based Medicine Center, Tianjin University of Traditional Chinese 
      Medicine, Tianjin 300193, China.
FAU - Zhai, Jingbo
AU  - Zhai J
AD  - Evidence-Based Medicine Center, Tianjin University of Traditional Chinese 
      Medicine, Tianjin 300193, China.
FAU - Zhao, Guoyuan
AU  - Zhao G
AD  - First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 
      (TCM), Tianjin, 300193, China.
FAU - Hou, Yazhu
AU  - Hou Y
AD  - First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 
      (TCM), Tianjin, 300193, China.
FAU - Wang, Shuai
AU  - Wang S
AD  - First Teaching Hospital of Tianjin University of Traditional Chinese Medicine 
      (TCM), Tianjin, 300193, China.
FAU - Liu, Chunxiang
AU  - Liu C
AUID- ORCID: 0000-0003-4063-3729
AD  - Evidence-Based Medicine Center, Tianjin University of Traditional Chinese 
      Medicine, Tianjin 300193, China.
LA  - eng
PT  - Journal Article
DEP - 20190225
PL  - United States
TA  - Evid Based Complement Alternat Med
JT  - Evidence-based complementary and alternative medicine : eCAM
JID - 101215021
PMC - PMC6413379
EDAT- 2019/04/02 06:00
MHDA- 2019/04/02 06:01
PMCR- 2019/02/25
CRDT- 2019/04/02 06:00
PHST- 2018/06/16 00:00 [received]
PHST- 2019/01/02 00:00 [revised]
PHST- 2019/01/20 00:00 [accepted]
PHST- 2019/04/02 06:00 [entrez]
PHST- 2019/04/02 06:00 [pubmed]
PHST- 2019/04/02 06:01 [medline]
PHST- 2019/02/25 00:00 [pmc-release]
AID - 10.1155/2019/9297163 [doi]
PST - epublish
SO  - Evid Based Complement Alternat Med. 2019 Feb 25;2019:9297163. doi: 
      10.1155/2019/9297163. eCollection 2019.