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Global Translational Medicine Evidence-based approach for TCM development

Table 1. Fundamental differences between a WM and a TCM
Aspect WM TCM
Principal ingredients Singular active ingredient focus Combination of several ingredients
Dosage flexibility Standardized dosage Tailored dosage according to individual needs
Diagnostic approach Empirical, based on validated tools Holistic, often based on the practitioner’s observation
Outcome measures Established clinical outcomes Emphasis on subjective outcomes, less standardized
Therapeutic target Specific organs or systems Restoring overall body harmony and balance
Foundation Empirical evidence and scientific research Centuries of tradition and empirical experiences
Analysis perspective Population-based, emphasizing generalizability Individual-centric, emphasizing customization
Approach to medicine Precision medicine: minimize intersubjective variability Personalized medicine: minimize intrasubject variability
Abbreviations: TCM: Traditional Chinese medicine; WM: Western medicine.
from centuries of tradition and empirical experiences, approaches inherent to TCM. The 2004 guidelines marked
emphasizing the interconnectedness of the body’s systems a significant step toward clarifying the regulatory landscape
and the importance of maintaining equilibrium. for CAM products, emphasizing the need for scientific
validation within a framework traditionally oriented
2.4. Analysis perspective and approach to medicine toward synthetic, single-agent pharmaceuticals.
WM adopts a population-based analysis perspective, The progression toward the 2016 regulations highlighted
emphasizing the generalizability of treatment outcomes the FDA’s commitment to adapting its regulatory framework
across large groups of patients. This approach aligns to better accommodate the unique aspects of TCM. The
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with the principles of precision medicine, which aims to updated guidelines provided more explicit guidance on
minimize intersubjective variability by developing targeted the pre-market evaluation process for botanical drugs,
therapies based on an individual’s genetic profile and other facilitating the integration of TCM products into the US
biomarkers. Conversely, TCM takes an individual-centric health-care system. These regulations underscored the
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approach, emphasizing the customization of treatment importance of rigorous clinical trials, quality control,
plans to address the unique needs of each patient. This
aligns with the principles of personalized medicine, which and manufacturing standards while also addressing the
seeks to minimize intrasubject variability by tailoring challenge of standardizing TCM formulations. The 2016
treatments to the individual’s specific constitution and guidelines represented a nuanced approach to TCM
imbalances. 7 regulation, acknowledging the need for a balance between
ensuring public safety and preserving the traditional
3. Westernization of TCM practices and philosophies that define TCM.
The integration of TCM into the Western healthcare The FDA’s regulatory frameworks for TCM have played
system has been significantly influenced by the a crucial role in its Westernization, enabling TCM products
regulatory frameworks established by the Food and to gain legitimacy and acceptance within the Western
Drug Administration (FDA) in the US (US). The FDA’s medical community. However, the adaptation of TCM to
approach to botanical and biologically based TCM meet Western scientific and regulatory standards has also
products – categorized based on their intended use as sparked concerns about the potential erosion of traditional
drugs, dietary supplements, or foods – reflects a broader knowledge and methodologies. The focus on scientific
global trend toward the acceptance and standardization of validation and the standardization of TCM formulations
complementary and alternative medicines (CAM). 12 may not fully capture the holistic and individualized nature
of TCM practices.
In 2004, the FDA addressed the increasing incorporation
of CAM, including TCM, into the US health-care For instance, the demand for evidence-based outcomes
market. The guidelines established aimed to ensure that through clinical trials may not always align with TCM’s
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TCM products intended for use as drugs met safety and individualized treatment approach, which is based on
efficacy standards comparable to those for conventional personalized diagnoses and natural, complex herbal
pharmaceuticals. This required applying Western clinical formulations rather than single, isolated active ingredients.
research methodologies to demonstrate the safety and In addiion, the financial and logistical challenges associated
effectiveness of TCM products – a challenging task due with conducting Western-style clinical trials pose
to the complex mixtures and individualized treatment significant barriers to TCM practitioners and researchers,

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