Page 66 - GTM-3-3

Global Translational Medicine Evidence-based approach for TCM development

its integration with WM. Modernizing TCM clinical directly to the TCM. However, this Westernization process
3
development is a crucial step in this process, aiming to may not be feasible due to some fundamental differences
apply rigorous scientific methods to evaluate the safety and between WM and TCM, which are summarized in Table 1.
efficacy of TCM treatments while preserving their unique These fundamental differences are briefly described below:
characteristics and holistic approach. 4
2.1. Principal ingredients and dosage flexibility
However, the direct application of well-established
Western processes to TCM clinical development may not One of the most striking differences between WM and TCM
be feasible due to fundamental differences between WM lies in their approach to medicinal ingredients and dosage.
and TCM. These differences span various aspects, including WM typically focuses on a singular active ingredient,
the use of singular active ingredients versus combinations with standardized dosages for each patient. In contrast,
of ingredients, standardized versus tailored dosages, TCM often employs a combination of several ingredients,
empirical versus holistic diagnostic approaches, and a tailoring the dosage according to individual needs. This
focus on specific organs or systems versus restoring overall personalized approach allows TCM practitioners to
body harmony and balance. Furthermore, WM and TCM address the unique constitution and specific imbalances of
5
differ in their foundational principles, with WM relying on each patient. 7
empirical evidence and scientific research, while TCM is 2.2. Diagnostic approach and outcome measures
based on centuries of tradition and empirical experiences. 6
WM relies on empirical evidence and validated diagnostic
The modernization of TCM clinical development tools, focusing on established clinical outcomes and
requires a thoughtful and innovative approach that objective measures such as imaging, blood tests, and
considers these fundamental differences. This process standardized protocols to assess a patient’s condition.
8
involves creating objective, evidence-based methods to This approach is grounded in identifying specific
evaluate the safety and efficacy of TCM treatments while pathophysiological processes, emphasizing quantifiable
acknowledging the unique characteristics and holistic data to guide diagnosis and treatment.
nature of TCM. Key considerations include establishing
standards for diagnostic procedures, evaluation, and In contrast, TCM is rooted in ancient theories like
regulatory review, as well as validating TCM instruments Yin and Yang, which represent the dualistic nature of all
against well-established Western standards. things – Yin being the passive, cooling, and nurturing
aspect, and Yang being the active, warming, and driving
This article aims to explore the challenges and opportunities force. These concepts, along with the theory of Qi (vital
9
associated with modernizing TCM clinical development. energy), form the foundation of TCM diagnosis. Qi is
The subsequent sections will: (i) discuss the fundamental considered the life force that flows through the body, and
differences between WM and TCM, highlighting key aspects its balance and harmony are essential for health. TCM
10
to consider in the modernization process. (ii) Examine the practitioners assess the balance of Yin and Yang and the
Westernization of TCM, its limitations, and focus on the flow of Qi through observations and the patient’s subjective
modernization of TCM development, including clinical experiences, such as their emotional state and overall well-
investigation, establishment of standards, and validation being. Instead of relying on standardized measures, TCM
against Western standards. (iii) Introduce innovative evaluates treatment effectiveness through improvements
approaches for TCM modernization, such as demonstrating in Qi balance, the restoration of harmony between Yin
“not unsafe” and “not ineffectiveness,” using composite and Yang, and the alleviation of symptoms as perceived by
hypotheses for safety and efficacy, and incorporating the patient. This holistic approach often involves practices
real-world data (RWD) and real-world evidence (RWE) such as acupuncture, herbal medicine, and Qigong,
in regulatory submissions. (iv) Address practical and aiming to harmonize the body’s internal energies with the
challenging issues in TCM modernization, including the surrounding forces of heaven and earth. 10
preparation of matching placebos, development of clinical
endpoints, and the development, validation, and calibration 2.3. Therapeutic target and foundation
of instruments. (v) Conclude with remarks on the future While WM aims to target specific organs or systems
direction of TCM modernization. affected by a disease, TCM focuses on restoring
7
2. Fundamental differences between WM overall body harmony and balance. This difference in
and TCM therapeutic targets stems from the distinct foundations
of each medical system. WM is grounded in empirical
For the modernization of TCM clinical development, one evidence and scientific research, constantly evolving
may consider applying well-established Western processes as new discoveries are made. In contrast, TCM draws

Volume 3 Issue 3 (2024) 2 doi: 10.36922/gtm.4190