Study on the evaluation of the clinical effects of traditional chinese medicine in heart failure by complex intervention: protocol of SECETCM-HF.
BACKGROUND
Experts in Traditional Chinese Medicine (TCM) have studied the TCM subject of the pathogenesis of heart failure (HF) for several decades. As a result, the general idea is ben deficiency and biao excess. However, the clinical evaluation system which combined the TCM and western medicine in HF has not been developed yet. The objective is to establish the evaluation index system for the integration of TCM and western medicine. The evaluation indexes which include TCM items will specify the research design and methods.


METHODS
Nine medical centers in different cities in China will participate in the trial. A population of 340 patients with HF will be enrolled through a central randomized system for different test groups. Group A will be treated with only western medicine, while group B with western and Chinese medicine together. The study will last for 12 months from the date of enrollment. The cardiovascular death will be the primary outcome.


CONCLUSIONS
By putting the protocol into practice, the clinical effects of TCM for HF will be identified scientifically, objectively as well as rationally. The proper index system which built in the study will be helpful for the clinical effect expression of HF by integrated medicine in future.


BACKGROUND
ChiCTR-TRC-00000059.
Mao
Jingyuan
J
Cardiovascular Department of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 314 Anshan Western Road, Nankai District, Tianjin, China. jymao@126.com
Hou
Yazhu
Y
Shang
Hongcai
H
Wang
Henghe
H
Wang
Xianliang
X
Zhao
Yingqiang
Y
Niu
Tianfu
T
Cui
Jinrong
J
Li
Guangping
G
Lin
Qian
Q
Shi
Le
L
Jia
Xiuli
X
Fan
Ruihong
R
Wang
Baohe
B
Wang
Hongwu
H
Ruan
Jishou
J
D002681:China; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008516:Medicine, Chinese Traditional; D011788:Quality of Life; D019366:Western World