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

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.

中药虽取诸天然,但亦可含对人体有害的物质,因此,近年来中药的毒副作用越来越受到关注。中药毒副作用可以分为不可预期类、使用不当类、中药“污染”类、品种混乱类和中西药物相互作用类等。使用不当类包括处方不遵从中医药理论、过量使用、炮制及制剂方法不当和配伍不当等;中药“污染”类包括重金属、农药残留及中药产品被化学药物成分“污染”。中药的毒副作用,必须明晰报告。过高或过低估计中药的毒副作用,都会误导临床医生及患者。我们建议在中医药随机对照试验报告规范中,报告副作用时,应包括以下方面：研究药物毒副作用的背景资料、针对副作用的特异性结局评估指标;毒副作用的详细内容及其诠释。