Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (8): 771-775.doi: 10.3736/jcim20080801

• Editorial •     Next Articles

Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine

Zhao-xiang Bian1(), David Moher2, You-ping Li3, Tai-xiang Wu3, Simon Dangenais4, Chung-wah Cheng1, Jing Li3, Ting-qian Li3   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    3. Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    4. Division of Orthopaedic Surgery and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  • Received:2008-05-05 Online:2008-08-20 Published:2008-08-15

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

Key words: traditional Chinese medicine, Chinese herbal drugs, clinical research, randomized controlled trials, evidence-based medicine, outcome measure

CLC Number: 

  • R-3

"

论文部分和主题 项目 描述
方法
测量指标
6 根据研究目的和假设,明确定义主要和次要结局测量指标,解释其选择依据,并注明结局测量指标的测量方法(如评估人员的资历、怎样和何时进行等)和标准(如有否采用公认的金标准),及说明用于提高测量质量的方法(如多次重覆观察、评估人员培训等)。说明评估干预措施安全性的方法和终止试验的原则。
结果
描述结果和效应量估计
17 按照主要和次要结局测量指标顺序描述结果,对效应量及精确度进行描述(如95%可信区间)
结论
解释
20 针对研究假设对结果进行分析,阐述研究的潜在偏倚、不确定因素和导致多样性结果的风险,并根据研究目的和方向说明中药干预措施的疗效和安全性。
[1] Reeve-Irving Research Centre . Anatomy 101: human research.
[2] Wu TX, Li YP, Bian ZX , et al. Consolidated standards for reporting trials of traditional Chinese medicine(CONSORT for TCM)[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2007,7(8):601-605
doi: 10.3969/j.issn.1672-2531.2007.08.013
吴泰相, 李幼平, 卞兆祥 , 等. 中医药临床随机对照试验报告规范(征求意见稿)[J]. 中国循证医学杂志, 2007,7(8):601-605
doi: 10.3969/j.issn.1672-2531.2007.08.013
[3] Wu TX, Li YP, Bian ZX , et al. Consolidated standards for reporting trials of traditional Chinese medicine(CONSORT for TCM)[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2007,7(8):625-630
[4] Liu JP . Evidence-based medicine approach and traditional Chinese medicine therapeutic evaluation[J]. Shou Du Yi Ke Da Xue Xue Bao, 2007,28(2):212-215
刘建平 . 循证医学方法与中医疗效评价[J]. 首都医科大学学报, 2007,28(2):212-215
[5] Cheng CW, Bian ZX, Li YP , et al. CONSORT serial 1: How to explain the methodological rationale of randomized controlled trials of traditional Chinese medicine?[J]. Zhongguo Xun Zheng Yi Xue Za Zhi, 2008,8(3):152-154
郑颂华, 卞兆祥, 李幼平 , 等. CONSORT系列一: 中医药临床研究报告中应清晰阐述试验设计理念[J]. 中国循证医学杂志, 2008,8(3):152-154
[6] Good PI .A manager's guide to the design and conduct of clinical trials(2nd ed) [M].New Jersey: John Wiley & Sons, Inc, 2006,( 2nd ed):
[7] Ministry of Health of the People's Republic of China. Guidelines of clinical research on Chinese new herbal medicines[M]. Beijing: Medical Science and Technology Publishing House of China, 1993
中华人民共和国卫生部. 中药新药临床研究指导原则[M]. 北京: 中国医药科技出版社, 1993
[8] State Administration of Traditional Chinese Medicine. Diagnostic and therapeutic effect evaluation criteria of diseases and syndromes in traditional Chinese medicine[M]. Nanjing: Nanjing University Press, 1994
国家中医药管理局. 中医病证诊断疗效标准[M]. 南京: 南京大学出版社, 1994
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Xue-qing Yu, Shu-guang Yang, Yang Xie, Jian-sheng Li. Traditional Chinese medicine in the treatment of idiopathic pulmonary fibrosis based on syndrome differentiation: Study protocol of exploratory trial. Journal of Integrative Medicine, 2020, 18(2): 163-168.
[3] Chang-quan Ling. Traditional Chinese medicine is a resource for drug discovery against 2019 novel coronavirus (SARS-CoV-2). Journal of Integrative Medicine, 2020, 18(2): 87-88.
[4] Wen Qiang Lee, Jeremy Teoh, Pei Zheng Kenneth Lee, Zhi Xiong Gerard Low, Xueling Sim, Foong Fong Mary Chong, Norbert Ludwig Wagner. Factors influencing communication of traditional Chinese medicine use between patients and doctors: a multisite cross-sectional study. Journal of Integrative Medicine, 2019, 17(6): 396-403.
[5] Mikhail Teppone. Medicine has always been “Modern” and “Scientific” from ancient times to the present day. Journal of Integrative Medicine, 2019, 17(4): 229-237.
[6] Charles Dalcanale Tesser, Ari Ojeda Ocampo Moré, Melissa Costa Santos, Emiliana Domingues Cunha da Silva, Fátima Terezinha Pelachini Farias, Lúcio José Botelho. Auriculotherapy in primary health care: A large-scale educational experience in Brazil. Journal of Integrative Medicine, 2019, 17(4): 302-309.
[7] Rachael Farrington, Ian F.Musgrave, Roger W.Byard. Evidence for the efficacy and safety of herbal weight loss preparations. Journal of Integrative Medicine, 2019, 17(2): 87-92.
[8] Fung-Kei Cheng. An overview of the contribution of acupuncture to thyroid disorders. Journal of Integrative Medicine, 2018, 16(6): 375-383.
[9] Chang-quan Ling, Jia Fan, Hong-sheng Lin, Feng Shen, Zhen-ye Xu, Li-zhu Lin, Shu-kui Qin, Wei-ping Zhou, Xiao-feng Zhai, Bai Li, Qing-hui Zhou, on behalf of the Chinese Integrative Therapy of Primary Liver Cancer Working Group. Clinical practice guidelines for the treatment of primary liver cancer with integrative traditional Chinese and Western medicine. Journal of Integrative Medicine, 2018, 16(4): 236-248.
[10] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[11] Qing Ji, Yun-quan Luo, Wen-hai Wang, Xuan Liu, Qi Li, Shi-bing Su. Research advances in traditional Chinese medicine syndromes in cancer patients. Journal of Integrative Medicine, 2016, 14(1): 12-21.
[12] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[13] Bing He, Ge Zhang, Ai-ping Lu. Integrative network analysis: Bridging the gap between Western medicine and traditional Chinese medicine. Journal of Integrative Medicine, 2015, 13(3): 133-135.
[14] Zhao-guo Li, Xi-ru Liu. Comparative study on WHO Western Pacific Region and World Federation of Chinese Medicine Societies international standard terminologies on traditional medicine: Diseases of Paediatrics (Part 3). Journal of Integrative Medicine, 2015, 13(3): 201-204.
[15] Xiao Ye, Jing Wang. On English translation of infant Tuina points in traditional Chinese medicine. Journal of Integrative Medicine, 2015, 13(3): 205-207.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Ying Xu , Chang-chun Zeng , Xiu-yu Cai , Rong-ping Guo , Guang Nie , Ying Jin. Chromaticity and optical spectrum colorimetry of the tongue color in different syndromes of primary hepatic carcinoma. Journal of Chinese Integrative Medicine, 2012, 10(11): 1263-1271
[2] Ji Chen, Qin Pan, Li-shuang Ye, Jia-ling Huang. English translation of cultural aspects of the titles of traditional Chinese medicine classics based on the skopos theory. Journal of Chinese Integrative Medicine, 2012, 10(11): 1316-1320
[3] Li-fang Wang, Jin-feng Wang, Wei-fang Jin, Hong-fu Wang, Shao-fen Zhang, Jian-jun Gao. Effects of daidzein on steroid receptor coactivator-1 expression in MC3T3-E1 cells and the mechanism. Journal of Chinese Integrative Medicine, 2011, 9(11): 1248-1253
[4] Le-qin Xu, Xiao-feng Li , You-wei Zhang , Bing Shu , Qi Shi, Yong-jun Wang, Chong-jian Zhou. Effects of Chinese herbal medicine Yiqi Huayu Recipe on apoptosis of dorsal root ganglion neurons and expression of caspase-3 in rats with lumbar nerve root compression. Journal of Chinese Integrative Medicine, 2010, 8(12): 1174-1179
[5] Liang-ping Hu, Xiao-lei Bao, Xue Guan, Shi-guo Zhou. Estimation of sample size and testing power (Part 3). Journal of Chinese Integrative Medicine, 2011, 9(12): 1307-1311
[6] Jian-sheng Li, Su-yun Li, Xue-qing Yu, Yang Xie. Bufei Yishen Granule combined with acupoint-sticking therapy in patients with stable chronic obstructive pulmonary disease: Study protocol of a multicenter, randomized, double-blind, active-controlled trial. Journal of Chinese Integrative Medicine, 2011, 9(12): 1312-1318
[7] Wei Zhang, Hai-yu Liu. Variabilities of the impacts of cold pathogen and cold-dampness pathogen on fractalkine mRNA expression in lung tissues of rats. Journal of Chinese Integrative Medicine, 2008, 6(2): 171-174
[8] Yong-hong Li, Zong-wen Huang, Ping Xue, Jia Guo, Fu-qian He, Zheng You, Zheng-rong Wang. Effects of Chaiqin Chengqi Decoction on activation of nuclear factor-κB in pancreas of rats with acute necrotizing pancreatitis. Journal of Chinese Integrative Medicine, 2008, 6(2): 180-184
[9] Hong Zhang, Xiao-guang Xu, Jun Gu. Impact of the method of cooling blood to remove stasis on tumor necrosis factor-alpha and interleukin-10 mRNA expressions in peripheral blood mononuclear cells of rats with experimental autoimmune thyroiditis. Journal of Chinese Integrative Medicine, 2008, 6(2): 190-193
[10] Vamsi Reddy, Arvind Sridhar, Roberto F. Machado, Jiwang Chen. High sodium causes hypertension: Evidence from clinical trials and animal experiments. Journal of Integrative Medicine, 2015, 13(1): 1-8