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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (9): 881-886.doi: 10.3736/jcim20080901

• Editorial •     Next Articles

Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials

Chung-wah Cheng1, Zhao-xiang Bian1(), You-ping Li2, David Moher3, Tai-xiang Wu2, Simon Dagenais4, Jing Li2, Ting-qian Li2   

  1. 1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China
    2. Department of Clinical Epidemiology, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China
    3. Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada
    4. Division of Orthopaedic Surgery and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  • Received:2008-05-05 Online:2008-09-20 Published:2018-10-19

Although all Chinese materia medica (CMM) come from nature, CMM interventions have therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

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

CLC Number: 

  • R-3

"

内容 条目 描述
背景 2 描述中药干预措施中每一种药物及其复方的已知及可能的副作用,并基于中西医理论予以解释。
目的 3 如果研究的目的是为了评估安全性和疗效,则应在研究目的中予以说明。
干预措施 5 清晰列明干预措施中为减少毒副作用发生所采取的方法,说明是否具有安全评估资料,如急性毒性试验、长期毒性试验或药材的质量控制方法等。
结局指标 6 列明有关安全性评估的指标,包括其定义、测量方法及其参考标准;列明研究终止的原则(如适用)。
统计学方法 12 列明用于统计毒副作用的统计分析方法。
流程图 13 列明每一研究组别中由于安全问题流失的病例数或减少剂量的病例数。
结局指标及其估计值 17 描述每一研究组别中的安全性指标的测量结果,包括估值及其精确度(95%可信区间)。
辅助性分析 18 描述有关安全性的亚组分析结果。
毒副作用 19 详细报告每一研究组的毒副作用,包括定义、发生时间、程度、性质和频率等,如果没有副作用发生,亦应予以说明。
解释 20 以中医及西医理论解释发生的毒副作用,确定发生的可能原因,如可行,确定是否与其他治疗方法(措施)有相互作用;提出进一步研究的建议。
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