Page 71 - GTM-3-3

Global Translational Medicine Evidence-based approach for TCM development

The Western
way
Test R
The Chinese way
All subjects
are screened
the Chinese R
way
The Western
way
Control R
The Chinese way
All subjects R
The Western
way
Test R
All subjects The Chinese way
are screened
the Western R
way
The Western
way
Control R
The Chinese way

Figure 2. Design for integrating Western medicine and traditional Chinese medicine clinical trials: A comparison of Western and Chinese approaches 22
6. Practical/challenging issues in TCM or clinicians might reveal treatment assignments if they
modernization break the capsules. To ensure the success of the blinding
process, it is essential to establish standard operating
For the modernization of TCM clinical development, procedures that prevent capsule breakage by both patients
clinical trials evaluating the safety and efficacy of the TCM and clinicians.
under investigation must be conducted under a valid study
design. When conducting TCM clinical trials, practitioners 6.2. Development of clinical endpoint
inevitably encounter several practical and challenging
issues, which are briefly outlined below. The selection of appropriate clinical endpoints is crucial
in TCM clinical trials to accurately assess the safety and
6.1. Preparation of matching placebo efficacy of the treatment under investigation. Unlike WM,
which often relies on well-established and widely accepted
In TCM clinical trials, preparing a matching placebo is clinical endpoints, TCM may require the development
essential to maintain blinding integrity and minimize
potential biases that may arise from knowledge of treatment of novel endpoints that capture the holistic nature of the
24
assignment. Creating a quality-matching placebo that treatment and align with the principles of TCM theory.
mirrors the test drug in physical form, sensory perception, These endpoints should be clinically meaningful, reliable,
packaging, and labeling, while having no pharmaceutical and sensitive to treatment effects.
activity, is challenging but crucial. Collaboration between TCM practitioners and Western
Fai et al. developed a satisfactory placebo capsule that clinicians is essential to developing clinical endpoints that
23
matched an herbal medicine in terms of its physical form, are both relevant to TCM and acceptable to the scientific
chemical nature, appearance, packaging, and labeling. community. This process should involve a thorough
They concluded that a matching placebo could be created understanding of TCM principles and the specific
for an RCT involving herbal medicine and discussed the condition being treated, as well as a critical evaluation
means to acquire a patent for the developed placebo. of the existing endpoints used in WM. The developed
endpoints should be validated in pilot studies to ensure
However, maintaining blinding integrity and avoiding their reliability and sensitivity before being implemented
operational biases due to knowledge of treatment in large-scale clinical trials.
assignments remains a major challenge. In TCM clinical
trials, oral capsules are often used to prepare a matching Moreover, the selection of clinical endpoints should
placebo, as they can mask the strong smell and taste of consider the stage of the disease and the expected outcomes
herbal medicines. Nonetheless, there is a risk that patients of the TCM treatment. For example, in chronic conditions,

Volume 3 Issue 3 (2024) 7 doi: 10.36922/gtm.4190