title: Study on the evaluation of the clinical effects of traditional chinese medicine in heart failure by complex intervention: protocol of SECETCM-HF.
abstract: 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.
authors.affiliation: 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
authors.forename: Jingyuan
authors.initials: J
authors.lastname: Mao
authors.forename: Yazhu
authors.initials: Y
authors.lastname: Hou
authors.forename: Hongcai
authors.initials: H
authors.lastname: Shang
authors.forename: Henghe
authors.initials: H
authors.lastname: Wang
authors.forename: Xianliang
authors.initials: X
authors.lastname: Wang
authors.forename: Yingqiang
authors.initials: Y
authors.lastname: Zhao
authors.forename: Tianfu
authors.initials: T
authors.lastname: Niu
authors.forename: Jinrong
authors.initials: J
authors.lastname: Cui
authors.forename: Guangping
authors.initials: G
authors.lastname: Li
authors.forename: Qian
authors.initials: Q
authors.lastname: Lin
authors.forename: Le
authors.initials: L
authors.lastname: Shi
authors.forename: Xiuli
authors.initials: X
authors.lastname: Jia
authors.forename: Ruihong
authors.initials: R
authors.lastname: Fan
authors.forename: Baohe
authors.initials: B
authors.lastname: Wang
authors.forename: Hongwu
authors.initials: H
authors.lastname: Wang
authors.forename: Jishou
authors.initials: J
authors.lastname: Ruan
mesh_terms: 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