The Rome consensus: good clinical trials for traditional medicine

作者：Junhua Zhang, Boli Zhang, Alice Josephine Fauci, Myeong Soo Lee, L. Susan Wieland, Iman Majd, Terje Alræk, Linda L. D. Zhong, Sergio Bangrazi, Aldo Liguori, Jingqing Hu, Yanming Xie, Jianyuan Tang, Zhongqi Yang, Paolo Landini, Annalisa Bucchi, Wei-An Yuan, Kam Wa Chan, Filomena Petti, Carlo Maria Giovanardi, Jialiang He, Rui Gao, Baohe Wang, Yuhong Huang, Jia Liu, Fang Lü, Jianan Guo, Pasquale Ricci, Bo Pang · 发表于：Acupuncture and Herbal Medicine · 年份：2025 · DOI：10.1097/hm9.0000000000000167 · 被引用次数：6 · 研究领域：Health Systems, Economic Evaluations, Quality of Life、Pharmaceutical studies and practices、Complementary and Alternative Medicine Studies

Traditional Medicine (TM), particularly Traditional Chinese Medicine (TCM), is an indispensable component of the global healthcare system, offering unique insights to modern medical science. Clinical efficacy is the bedrock for the inheritance and development of TM. To meet the growing demand for high-quality healthcare, it is imperative to integrate TM with modern technology to address the issue of insufficient evidence for the efficacy of TM. To evaluate the clinical efficacy of TM, clinical trials are necessary, especially good clinical trials, which conform to the general principles of scientific research and also take into account the characteristics of traditional therapies. To promote the development of high-quality clinical trials that are in line with the features of TM, the attending experts held an in-depth discussion and reached the Rome consensus on “Good Clinical Trials for TM (GCT-TM),” at the 18th Academic Annual Meeting of the Clinical Efficacy Evaluation Committee of the World Federation of Chinese Medicine Societies and the 8th International Forum on Evidence-Based Chinese Medicine, held in Rome on June 26, 2025. Good question A sound clinical trial begins with formulating a good clinical question—that is, developing a scientific hypothesis regarding whether a traditional therapy possesses specific clinical value, and establishing the necessity and justification for a new clinical trial. The formulation of a research question should be based on human-use ex...