主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

JOURNAL OF BEIJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE ›› 2020, Vol. 43 ›› Issue (7): 606-616.doi: 10.3969/j.issn.1006-2157.2020.07.013

• Clinical Studies • Previous Articles    

Analysis of outcomes used in RCTs of traditional Chinese medicine on stable angina pectoris in the past 3 years*

Li Huimin1, Xiong Xingjiang2, Zhao Hui3, Hu Ruixue1, Shang Hongcai4, Yang Wei1, Liao Xing1#   

  1. 1 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2 Guang'anmen Hospital, China Academy of Chinese Medical Sciences;
    3 China Center for Evidence Based Traditional Chinese Medicine, China Academy of Chinese Medical Sciences;
    4 Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100070, China
  • Received:2019-12-20 Published:2020-08-11
  • Contact: Dr. Liao Xing,Doctoral Supervisor. 16 Dongzhimennei Nanxiaojie, Dongcheng District, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. E-mail: okfrom2008@hotmail.com
  • Supported by:
    National Key Research and Development Plan (No.2017YFC1700400,No.2017YFC1700406-2); National Natural Science Foundation of China (No. 81774159);the Fundamental Research Funds for the Central public welfare research institutes(No.ZZ13-YQ-075,No.Z065)

Abstract: Objective To evaluate the outcomes used in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of stable angina pectoris, and to provide a basis for the study of the core outcome set of TCM in the treatment of stable angina pectoris. Methods We searched RCTs of TCM in the treatment of stable angina pectoris in the databases of PubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP from January 2016 to August 2019. Two reviewers independently screened all the records, extracted the data and evaluated the risk of bias for the included trials. A qualitative analysis was conducted to describe the outcomes of the included studies. Results 6349 papers were searched and screened. 24 papers (3 English papers) were included in the final analysis. Outcomes used in these 24 studies were mainly divided into six categories, namely clinical efficacy of angina pectoris, electrocardiogram (ECG), Quality of life (QoL) scale, blood biochemistry panel, safety profiles (including adverse reactions and adverse events), and other parameters. Blood biochemical parameters topped the list, followed by angina pectoris. 14 of the 24 studies used TCM syndrome scores as an indicator of outcome. Conclusion There are existing problems in the outcomes used in RCTs of TCM treatment of stable angina pectoris. We should establish core outcome set for TCM studies on the basis of combining the international standardized core outcome set with the characteristics and laws of diagnosis and treatment of traditional Chinese medicine.

Key words: traditional Chinese medicine, stable angina pectoris, randomized controlled trial, outcome measurements

CLC Number: 

  • R2-031