PMID- 28685712
OWN - NLM
STAT- MEDLINE
DCOM- 20180417
LR  - 20220321
IS  - 2542-5641 (Electronic)
IS  - 0366-6999 (Print)
IS  - 0366-6999 (Linking)
VI  - 130
IP  - 14
DP  - 2017 Jul 20
TI  - Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm 
      and Function in Congestive Heart Failure Patients with Frequent Ventricular 
      Premature Complexes: A Randomized, Double-blind, Multicenter Clinical Trial.
PG  - 1639-1647
LID - 10.4103/0366-6999.209906 [doi]
AB  - BACKGROUND: Pharmacological therapy for congestive heart failure (CHF) with 
      ventricular arrhythmia is limited. In the study, our aim was to evaluate the 
      effects of Chinese traditional medicine Shensong Yangxin capsules (SSYX) on heart 
      rhythm and function in CHF patients with frequent ventricular premature complexes 
      (VPCs). METHODS: This double-blind, placebo-controlled, multicenter study 
      randomized 465 CHF patients with frequent VPCs to the SSYX (n = 232) and placebo 
      groups (n = 233) for 12 weeks of treatment. The primary endpoint was the VPCs 
      monitored by a 24-h ambulatory electrocardiogram. The secondary endpoints 
      included the left ventricular ejection fraction (LVEF), left ventricular 
      end-diastolic diameter, N-terminal pro-brain natriuretic peptide (NT-proBNP), New 
      York Heart Association (NYHA) classification, 6-min walking distance (6MWD), 
      Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores, and composite 
      cardiac events (CCEs). RESULTS: The clinical characteristics were similar at 
      baseline. SSYX caused a significantly greater decline in the total number of VPCs 
      than the placebo did (-2145 +/- 2848 vs. -841 +/- 3411, P < 0.05). The secondary 
      endpoints of the LVEF, NYHA classification, NT-proBNP, 6MWD, and MLHFQ scores 
      showed a greater improvements in the SSYX group than in the placebo group (DeltaLVEF 
      at 12th week: 4.75 +/- 7.13 vs. 3.30 +/- 6.53; NYHA improvement rate at the 8th and 
      12th week: 32.6% vs. 21.8%, 40.5% vs. 25.7%; mean level of NT-proBNP in patients 
      with NT-proBNP >/=125 pg/ml at 12th week: -122 [Q1, Q3: -524, 0] vs. -75 [Q1, Q3: 
      -245, 0]; Delta6MWD at 12th week: 35.1 +/- 38.6 vs. 17.2 +/- 45.6; DeltaMLHFQ at the 4th, 
      8th, and 12th week: -4.24 +/- 6.15 vs. -2.31 +/- 6.96, -8.19 +/- 8.41 vs. -3.25 +/- 9.40, 
      -10.60 +/- 9.41 vs. -4.83 +/- 11.23, all P < 0.05). CCEs were not different between 
      the groups during the study period. CONCLUSIONS: In this 12-week pilot study, 
      SSYX was demonstrated to have the benefits of VPCs suppression and cardiac 
      function improvement with good compliance on a background of standard treatment 
      for CHF. TRIAL REGISTRATION: www.chictr.org.cn, ChiCTR-TRC-12002061 
      (http://www.chictr.org.cn/showproj.aspx?proj=7487) and Clinicaltrials.gov, 
      NCT01612260 (https://clinicaltrials.gov/ct2/show/NCT01612260).
FAU - Wang, Xi
AU  - Wang X
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
FAU - Hu, Dan
AU  - Hu D
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China; Department of 
      Experimental Cardiology, Masonic Medical Research Laboratory, Utica, NY 13501, 
      USA.
FAU - Dang, Song
AU  - Dang S
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
FAU - Huang, He
AU  - Huang H
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
FAU - Huang, Cong-Xin
AU  - Huang CX
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
FAU - Yuan, Ming-Jie
AU  - Yuan MJ
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
FAU - Tang, Yan-Hong
AU  - Tang YH
AD  - Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of 
      Wuhan University, Wuhan University, Wuhan, Hubei 430060, China.
FAU - Zheng, Qing-Shan
AU  - Zheng QS
AD  - Center for Drug Clinical Research, Shanghai University of Traditional Chinese 
      Medicine, Shanghai 201203, China.
FAU - Yin, Fang
AU  - Yin F
AD  - Center for Drug Clinical Research, Shanghai University of Traditional Chinese 
      Medicine, Shanghai 201203, China.
FAU - Zhang, Shu
AU  - Zhang S
AD  - National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of 
      Medical Sciences and Peking Union Medical College, Beijing 100037, China.
FAU - Zhang, Bo-Li
AU  - Zhang BL
AD  - State Key Laboratory of Modern Chinese Medicine, College of Traditional Chinese 
      Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, 
      China.
FAU - Gao, Run-Lin
AU  - Gao RL
AD  - National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of 
      Medical Sciences and Peking Union Medical College, Beijing 100037, China.
CN  - Efficacy and Safety of Shensong Yangxin Capsules for Frequent VPCs in Congestive 
      Heart Failure Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01612260
PT  - Journal Article
PT  - Multicenter Study
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Drugs, Chinese Herbal/therapeutic use
MH  - Female
MH  - Heart Failure/*drug therapy/metabolism
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Male
MH  - Medicine, Chinese Traditional/*methods
MH  - Middle Aged
MH  - Ventricular Function, Left/drug effects
MH  - Ventricular Premature Complexes/*drug therapy/metabolism
MH  - Young Adult
PMC - PMC5520549
COIS- Shijiazhuang Yiling Pharmaceutical Co., Ltd., (Shijiazhuang, China) provided the 
      Shensong Yangxin capsules.
EDAT- 2017/07/08 06:00
MHDA- 2018/04/18 06:00
PMCR- 2017/07/20
CRDT- 2017/07/08 06:00
PHST- 2017/07/08 06:00 [entrez]
PHST- 2017/07/08 06:00 [pubmed]
PHST- 2018/04/18 06:00 [medline]
PHST- 2017/07/20 00:00 [pmc-release]
AID - ChinMedJ_2017_130_14_1639_209906 [pii]
AID - CMJ-130-1639 [pii]
AID - 10.4103/0366-6999.209906 [doi]
PST - ppublish
SO  - Chin Med J (Engl). 2017 Jul 20;130(14):1639-1647. doi: 10.4103/0366-6999.209906.