Conducting traditional Chinese medicine trials that achieve global credibility

Researchers have published a paper discussing the key requirements that traditional Chinese medicine trials should meet to gain global credibility.

 

This paper was published in the journal Evidence-Based Chinese Medicine and Technology Assessment on September 2, 2026.

 

For generations, traditional Chinese medicine has operated based on the teachings of ancient clinicians and centuries of accumulated clinical experience with the knowledge summarized from historical practice and handed down through classical literature and master-apprentice mentorship. By contrast, Western medicine has operated based on a framework of evidence-based medicine that evaluates the effectiveness of health care interventions, patient prognosis, and diagnostic accuracy.

 

“Success in bringing traditional Chinese medicine to the West requires high-quality randomized controlled trials that rigorously evaluate its effects. This paper outlines the key requirements that traditional Chinese medicine trials should meet to gain global credibility,” said Professor Ying Wang from the University of Chinese Medicine, Beijing, China.

 

The traditional Chinese medicine randomized controlled trials will need to be exemplary in their content and design. This involves choosing clinical questions that are important and prevalent in both China and the West. The team should consist of experienced trialists, statisticians and data mangers conducting the randomized controlled trials. Several thousand patients should be included in the trial samples.

 

For Western doctors and patients to have confidence in the trials, the research team suggests that the trials take place at multiple hospital locations, including Western hospitals. Although this multicenter approach is more costly and challenging logistically, it is necessary to build confidence among Western doctors and patients.

 

There are some challenges specific to traditional Chinese medicine. In disease diagnosis, traditional Chinese medicine uses “patterns” while Western medicine uses “disease” classification. With pattern diagnosis, doctors base their diagnosis on a comprehensive analysis of symptoms and then select treatment based on the patterns. For example, the same disease in different patients, or even in the same patient at different stages, may represent different underlying patterns that call for different treatments. For traditional Chinese medicine to gain acceptance in the West, adopting the Western disease classification for eligibility criteria in the trials and then conduct subgroup analysis by patterns would be ideal.

 

A second challenge specific to acupuncture trials is blinding. It is difficult to construct a sham acupuncture control that is indistinguishable from true acupuncture and physiologically inert. Researchers are still searching for successful ways to conduct acupuncture randomized controlled trials.

 

The third challenge specific to traditional Chinese medicine relates to Chinese herbal medicine trials. Traditional Chinese medicines typically prescribe Chinese herbal medicine as a blend of multiple herbs tailored to each patient’s specific needs. This level of personalization is nearly impossible to replicate in Western settings. Standardized finished dosage forms, such as pills, granules, and tablets, known as proprietary Chinese medicines, are needed for conducting trials in Western countries.

 

“For traditional Chinese medicine to gain global acceptance, researchers should embrace evidence-based medicine principles and conduct high-quality randomized controlled trials that meet international standards, with appropriate clinical questions, experienced trialists, adequate sample sizes, low risk of bias, multicenter participation including Western centers, and pragmatic designs,” said Wang. “Beyond these general requirements, researchers must also address challenges specific to traditional Chinese medicine.”

 

In their paper, the research team provides guidance on conducting high-quality randomized controlled trials to evaluate the effects of traditional Chinese medicine and generate credible evidence. Traditional Chinese medicine practitioners must prove that their practices work using general scientific and global research methods, if they want to be successfully accepted globally. “Demonstrating the benefits of traditional Chinese medicine by high-quality randomized trials could promote its international acceptance and use,” said Professor Gordon Guyatt.

 

The researchers include Ying Wang, Beijing University of Chinese Medicine, Beijing, China, and Gordon Guyatt, McMaster University, Ontario, Canada. Professor Guyatt is also a visiting professor at Beijing University of Chinese Medicine.  This work was funded by Research and Development for Evidence-Based Chinese Medicine Program, Ministry of Education and Ministry of Science and Technology of the People’s Republic of China.

 

 

DOI Link:

https://doi.org/10.26599/eCMTA.2026.9570044

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