New R&D Paradigm Needed for TCM

Traditional Chinese medicine (TCM), with a history of thousands of years, is facing significant opportunities and challenges in its modernization.

Compared to the new drugs developed by international pharmaceutical giants, new TCM-based drugs still lag behind in terms of innovation and market scale. According to recent data, over 500 TCM products have annual sales surpassing 100 million RMB, but fewer than 10 reached sales of over five billion RMB.

Due to the lack of internationally recognized diagnostic and clinical evidence, the efficacy and mechanisms of TCM have long been referred to as a "black box." So it is necessary to explore a new R&D paradigm for modern TCM.

A new evaluation system

TCM modernization has been underway for nearly 30 years, yet challenges remain, particularly in gaining international approval for TCM products, for instance, from the U.S. Food and Drug Administration. Besides, clinical trials often face difficulties in quantifying specific TCM syndromes, leading to ineffective evaluations.

"There is a growing consensus that the current Western medical efficacy evaluation methods are not suitable for TCM," said Professor Li Jiansheng from the Henan University of Chinese Medicine. He thinks a comprehensive evaluation system and methodology should be developed based on the scientific application of Western evaluation methods, specifically tailored to highlight the unique advantages of TCM.

In 2019, China issued a document on facilitating the inheritance, innovation and development of TCM, for the first time proposing a "three-combined" evaluation system should be established for TCM. This system combines TCM theories, human use experience and clinical trials to provide a more holistic approach to evaluating TCM efficacy.

According to Zhang Boli, an academician of the Chinese Academy of Engineering, it is important to clarify what data can be considered as human use experience. It cannot simply be a collection of clinical data, but should have relevant guidelines and standards. Building a "three-combined" evaluation system is a key issue to address in the future development of TCM, especially in developing compound medicines.

Integrating AI with TCM

With the rapid advancements of AI large models, embracing AI has become an inevitable step in the modernization of TCM.

Experts point out that the theoretical system and diagnostic methods of TCM are primarily based on extensive experience and observation. In many ways, the accumulation of such experiential knowledge parallels the large-scale data training process in machine learning. These parallels open up possibilities for the deep integration of AI with TCM.

The Institute of Medicinal Plant Development at the Chinese Academy of Medical Sciences has developed a precise and efficient compound efficacy screening model, using AI to assist in drug discovery, with eight new TCM drugs already commercialized.

Using deep learning and other AI algorithms, Professor Li Shao from the Department of Automation at Tsinghua University built a "navigation system" within the "black box" of TCM's effect, which has resulted in a new discipline —AI-driven network pharmacology.

Researchers are also using AI to analyze thousands of images of patients' tongues, whose examination is an essential element of TCM. The application of AI also includes intelligent wearable devices for TCM diagnosis, herbal medicine quality identification, as well as the digital preservation and transmission of classical literature and the clinical wisdom of experienced TCM practitioners.

However, integrating TCM with AI is not an easy task. Whether AI can truly "understand" the traditional theories of TCM, how to prevent and address the ethical risks of AI's involvement in diagnosis and treatment, and whether over-reliance on technology will lead to a decline in the number of skilled TCM practitioners are issues that deserve careful thought and attention.

TCM requires innovation. Although the process is complex, the prospects are bright. This is not only due to people's trust in the unique value and efficacy of TCM, but also because of the confidence in integrating modern technology with ancient wisdom, as well as expectations for researchers to explore and apply TCM resources to safeguard public health.

Source: Science and Technology Daily