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

Chung Wah Cheng, Zhaoxiang Bian*, You Ping Li, David Moher, Tai Xiang Wu, Simon Dagenais, Jing Li, Ting Qian Li

*Corresponding author for this work

Research output: Contribution to journalEditorial

22 Citations (Scopus)


Although all Chinese materia medica (CMM) come trom nature, CMM interventions have both 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.


Original languageEnglish
Pages (from-to)881-886
Number of pages6
JournalJournal of integrative medicine
Issue number9
Publication statusPublished - 15 Sept 2008

Scopus Subject Areas

  • Complementary and alternative medicine

User-Defined Keywords

  • Chinese herbal drugs
  • Clinical research
  • Evidence-based medicine
  • Randomized controlled trials
  • Traditional Chinese medicine
  • 中医学
  • 中药
  • 临床研究
  • 随机对照试验
  • 循证医学


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