PMID- 30407310
OWN - NLM
STAT- MEDLINE
DCOM- 20181119
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 45
DP  - 2018 Nov
TI  - Qishen Yiqi dripping pills for ischemic heart failure: A protocol for a 
      prospective cohort study.
PG  - e13085
LID - 10.1097/MD.0000000000013085 [doi]
LID - e13085
AB  - BACKGROUND: The prognosis of ischemic heart failure (IHF) is worse than non-IHM. 
      Improving the management of IHF remains an urgent demand. In recent years, Qishen 
      Yiqi dripping pills (QSYQ), a type of Chinese herbal medicine (CHM), has been 
      popular for IHF combined with standard western medicine. However, relevant 
      scientific evidence from the real clinical practice still is insufficient. The 
      prospective cohort study aims to assess the effectiveness and safety of QSYQ plus 
      standard western medicine for IHF in the real clinical practice. METHODS: It is a 
      multicenter, prospective, observational cohort study. A total of 1200 patients 
      with IHF recruited from 84 hospitals in China will be assigned to exposure group 
      (patients with QSYQ treatment) or non-exposed group (patients without QSYQ 
      treatment) mainly according to patients' preference in real clinical situation. 
      The primary outcomes include New York Heart Association (NYHA) cardiac functional 
      classification and Minnesota Living with Heart Failure Questionnaire (MLHFQ). The 
      secondary outcomes include composite outcomes (all-cause mortality, frequency of 
      re-admission or emergency due to cardiovascular events), left ventricular 
      ejection fraction and cardiothoracic ratio, symptoms and signs obtained by the 4 
      Tradiational Chinese Medicine (TCM) diagnostic methods. Assessments will be 
      performed at baseline, 1st and 3rd month after enrollment. DISCUSSION: It will 
      provide new evidence on QSYQ for IHF in real clinical practice. STUDY 
      REGISTRATION: This study has been registered on the Chinese Clinical Trial 
      Registry (No: ChiCTR-ONRC-14004407).
FAU - Zhao, Zhiqiang
AU  - Zhao Z
AD  - Cardiovascular Department of First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine.
FAU - Wang, Xianliang
AU  - Wang X
AD  - Cardiovascular Department of First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine.
FAU - Hou, Yazhu
AU  - Hou Y
AD  - Cardiovascular Department of First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine.
FAU - Wang, Shuai
AU  - Wang S
AD  - Cardiovascular Department of First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine.
FAU - Zhai, Jingbo
AU  - Zhai J
AD  - Tianjin University of Traditional Chinese Medicine, Tianjin, China.
FAU - Wang, Cong
AU  - Wang C
AD  - Cardiovascular Department of First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine.
FAU - Mao, Jingyuan
AU  - Mao J
AD  - Cardiovascular Department of First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine.
FAU - Zhang, Boli
AU  - Zhang B
AD  - Tianjin University of Traditional Chinese Medicine, Tianjin, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (qishen yiqi)
SB  - IM
MH  - Aged
MH  - Clinical Protocols
MH  - Drugs, Chinese Herbal/*administration & dosage
MH  - Female
MH  - Heart Failure/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Ischemia/*drug therapy
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC6250437
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2018/11/09 06:00
MHDA- 2018/11/20 06:00
PMCR- 2018/11/09
CRDT- 2018/11/09 06:00
PHST- 2018/11/09 06:00 [entrez]
PHST- 2018/11/09 06:00 [pubmed]
PHST- 2018/11/20 06:00 [medline]
PHST- 2018/11/09 00:00 [pmc-release]
AID - 00005792-201811090-00033 [pii]
AID - MD-D-18-07199 [pii]
AID - 10.1097/MD.0000000000013085 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Nov;97(45):e13085. doi: 10.1097/MD.0000000000013085.