Dai Liang, Cheng Chung-Wah, Tian Ran, Zhong Linda Ld, Li You-Ping, Lyu Ai-Ping, Chan An-Wen, Shang Hong-Cai, Bian Zhao-Xiang
Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Chin J Integr Med. 2019 Jan;25(1):71-79. doi: 10.1007/s11655-018-2999-x. Epub 2018 Nov 27.
Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
传统中医（TCM）是最古老的医学体系之一。中医的应用越来越受到关注，但中医临床试验质量参差不齐阻碍了其被广泛接受。《标准方案条目：干预性试验建议》（SPIRIT）2013声明为设计临床试验制定了指南，以确保试验结果准确可靠。然而，由于中医独特的理论和干预特点，将SPIRIT 2013声明应用于中医试验存在困难。因此开发了原始SPIRIT的扩展版，以确保中医试验设计的质量。由于中药配方、针灸和艾灸是中医实践中常见且具有代表性的干预措施，执行工作组决定SPIRIT-TCM扩展版聚焦于这三种干预措施。扩展版通过启动、三轮德尔菲共识调查和最终专家会议而制定。对SPIRIT 2013声明中的七个条目进行了修改，即“标题”“背景和原理”“目标”“纳入标准”“干预措施”“结局”和“数据收集方法”。该扩展版包括引入中医证型的概念和三种主要的中医干预措施，并配有实例和解释。《SPIRIT-TCM扩展版2018》为研究者设计高质量的中医临床试验提供了建议。预计该扩展版的广泛传播和应用将确保全球中医试验质量不断提高。
