Chinese Medicine, 2011, 2, 186-190
doi:10.4236/cm.2011.24029 Published Online December 2011 (http://www.SciRP.org/journal/cm)
Translational Chinese Medicine: A Way for
Development of Traditional Chinese Medicine
Xuegang Sun1, Donglan Lin1, Weikang Wu2*, Zhiping Lv1*
1The Key Laboratory of Molecula r Biology, State Administration of Traditional Chinese Medicine,
School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, China
2The Institute of Integrated Traditional Chinese and Western Medicine, Sun Yat-sen University, Guangzhou, China
Received October 22, 2011; revised November 23, 2011 ; accepted December 3, 2011
Abstract
Translational Chinese medicine is one of the latest developing fields in traditional Chinese medicine. In this
paper, we discuss the “3 w” namely, “what is”, “why to advance”, “how to carry out” and the significance of
translational Chinese medicine. To overcome the innate drawbacks of traditional Chinese medicine (TCM),
the basic theory of TCM had better be refreshed. The safety and efficacy of classic formulae and therapy ex-
perience of TCM should be evaluated based on strict quality control and reaffirmed with evidence based
medicine. The significance of translational Chinese medicine is to transform Chinese medicine into a balan-
ced, personalized medicine with sound safety, good efficacy and strict quality control.
Keywords: Translational Medicine, Traditional Chinese Medicine, Quality Control, Efficacy, Safety
1. Introduction
TCM, which is the quintessence of the Chinese cultural
heritage, has made an everlasting contribution to the sur-
vival, propagation and prosperity of all ethnic groups in
China, thereby enhancing the fertility and prosperity of
the nation. In 2008, the Ministry of Science and Techno-
logy jointed together by other fifteen Ministries, include-
ing Ministry of Health, State Administration of Traditio-
nal Chinese Medicine, and State Food and Drug Admini-
stration, etc, collectively issued the “Outline of Tradi-
tional Chinese Medicine Innovation and Development
Plan (2006-2020)”. The outline explicitly pointed out that
inheritance, innovation, modernization, and internation-
alization of TCM would be the four basic tasks for a con-
siderable period of time. Thereby, combination and inte-
gration of classic heritage of TCM with innovations of life
science would be the necessary avenue to develop TCM.
The essence of the avenue is to translate the ancient kn-
owledge of Chinese medicine into clinical effectiveness.
Therefore, we propose a new research model translatio-
nal Chinese medicine, to utilize global scientific and tech-
nological resources, to provide evidence and to facilitate
Chinese medicine globalization.
2. What Is Translational Chinese Med ici ne ?
“Translational medicine” is a trendy term being increase-
ingly used to describe the wishing of biomedical resear-
chers to ultimately help patients [1]. It is the link betw-
een “bench and bedside” and a scientific approach that
bridges laboratory experiments through clinical trials, to
actual health-care applications.
“Translational medicine” (or “translational research”)
describes a uni-directional effort to test in humans novel
therapeutic strategies developed through experimentation.
“Translational Chinese medicine” is a two-way street: one
way is going from the bedside to the labo ratory with ob-
servations made in clinical practices of TCM and another
way is driving back to bedside to cure and collect Data of
evidence-based medicine. The former might be more
constructive, focusing scientific thinking and providing
more practical information [1]. The evidence from the
latter is more objective. So, the first step is to fill up the
gap between the empiricism of Chinese medicine and
molecular models of life science. The second step is to
bridge up the safety, effectiveness of Chinese medicine
to bedside and community.
3. Why Translational Chinese Medicine?
The safety, efficacy, quality, availability, preservation, and
further development of TCM are often questioned, be-
cause of its seemingly under developed scientific know-
ledge of TCM. So, some translational work need be done

187 X. G. SUN ET AL.
to improve the scientific contents of TCM.
3.1. The Transcendental Basic Theory Needs
Translational Renovation
Influenced by the idea of natural philosophy and cogni-
tive theory of “analogy based classification” and “deduc-
tive reasoning”, the basic theory of TCM has natural phi-
losophy neuclear under a transcendental robe. The five
zang-organs theory is an example in that it includes char-
acters of intangibility, formality and ideality. For exam-
ple, brain is the most important organ, however, it is incl-
uded among the “the oddly Fu organs”. Pancreas and
testicles are not even listed in zang-organ system at all.
The tongue is supplemented to eyes, ears, mouth, and
nose to be the five orifices. The long summer is fabrica-
ted to cater the five seasons. The five elements theory is
the promodial model to promulgate the “natural law” for
zang-organs. The formation of zangfu-organs theory is a
process that changes th e big notes of general proposition
into small coins [2]. This kind of exchange could be fini-
shed overnight and the result theory could neither be
verified nor be it falsifiable. Therefore, altho ugh the the-
ory of five elements occupies a lot of space in the text-
book, nearly no progression was made over thousands of
years [3]. So, some new knowledge, such as crosstalks
between signal transduction network, had better to fuse
into holism idea of TCM and make it progress with the
advance of live science.
3.2. The Safety and Efficacy of TCM
Prescription Need Translational Evaluation
In 2000, World health organization (WHO) formulated
the “General Guidelines for Methodologies on Research
and Evaluation of Traditional Medicine” and also warned
that “with the tremendous increase in the use of tradi-
tional medicines worldwide, the safety, efficacy, and qu-
ality control of herbal medicines and traditional proce-
dure-based therapies has become an important concern
for both healthcare authorities and the public”. Ten years
later, traditional herbal medicinal products directive (TH-
MPD) declared that the sale of all Chinese herbal medici-
nes has been banned within the European Union (EU)
from 1st April 2011 as a result that not a single Chinese
herbal medicine has been approved and licensed in the
EU. The aim of THMPD is to ensure the safety and effi-
cacy of herbal medicines and prescriptions in EU. The
underlying word is that although the efficacy of TCM has
been “field-tested” by tens of thousands of people for hun-
dreds of years, it do es no t necessarily mean th at it is real-
ly safe and it indeed works. So, what we need today is to
find solid data to repeat what the TCM prescription
claimed to be safe and effective for therapeutic practice.
It is only on this basis that further scientific studies can
be done. For example, meta-analyses showed that there
was insufficient evidence of good quality in proving the
efficacy of traditional Chinese patent medicines used for
treating ischemic stroke [4]. Moreover , this is a common
phenomenon in most TCM research. Therefore, high
quality TCM researches with adequate information and
solid data on safety and efficacy evaluation are crucial.
Translational Chinese medicine is the way to bring about
high level evidence-based resources.
3.3. The Empiricism in Clinical Practices Needs
Translational Validation
Theory of TCM is a pragmatic tool to explain the results
of clinic practices [5]. It is also the carrier of clinical ex-
periences sedimented generation after generation. For ex-
ample, syndrome differentiation is the landmark of Chi-
nese medicine clinical practice. However, as the diagno-
sis tools in TCM are less tangible, the TCM practitioner
depends more on experience, technique, intuition and
insight. Thus, the gradual development of Chinese medi-
cine is based on constant accumulation and summary of
experience in clinical practice [6]. Therefore, syndrome
differentiation has always been lying in expirism even
after thousands of years of evolution. The practitioner
can only make a fuzzy, holistic, and black box evaluation
on the syndrome. So, more work should be done to
document the experience with the language of life sci-
ence and could be recogn ized and permitted by the inter-
national soci ety.
4. How to Carry out Translational Chinese
Medicine
4.1. Refreshing the Basic Theory of TCM
The natural philosophy confers basic theory of TCM with
clear-cut humanities features and philo sophical meaning s
that put a strangle hold on its progression with the deve-
lopment of modern life science. For example, the five-
element theory is no longer adequate to explain the func-
tionality and relationship of five zang-organs. However,
if the five-element theory were specifically depleted fr-
om TCM, some TCM experts would say that it is no
longer TCM anymore. So, the rational crux of basic the-
ory of TCM should be reserved. It had better to be re-
freshed by absorbing the essence from the fast develop-
ment of contemporary medical science but not recon-
struct it to be Chinese medicine without tradition. For
instance, it is a well-documented fact that the dysfunc-
tion of hypothalamic-pituitary-adrenal (HPA) axis and

X. G. SUN ET AL.
188
locus coeruleus-norepinephine (LC-NE) system plays an
important role in chronic stress-induced depression [7].
In TCM, the corresponding dipiction is that the failure of
liver-organ to dominate conveyance and dispersion re-
sults in liver-stagnancy syndrome. We can therefore es-
tablish the relationship between liver and brain. The hy-
peractive liver-Qi might be related with the dysfunction
of certain nucleus. It is therefore understandable that
liver-soothing and Qi-dispersing herbs or formulae could
be prescribed to cure depression.
4.2. Reassure Safety and Efficacy of TCM
Prescrition with Strict Quality Control
In the United States, a Phase I study of PHY906 in com-
bination with capecitabine was conducted in patients wi-
th advanced pancreatic cancer [8] and a similar Phase I/II
study of PHY906 in combination with capecitabine in
advanced hepatocellular carcinoma (HCC) were conduct-
ed [9]. Phytomics quality control is a characteristic meth-
odology adopted, which combines chemical analysis,
bioresponse analysis, and animal pharmacology to deter-
mine batch-to-batch reproducibility [9]. Formula is the
major method and final carrier for TCM pricription. The
safety of formula is a case involving human life and thus
should to be treated with the utmost care. So, we propose
a new concept “formulomics”, a strategy similar to phy-
tomics with strict quality control and established clinical
efficacy. It is a unified platform integrating: 1) standard
extraction process with fixed material basis; 2) exact
treatment effects with information-rich bioresponse fin-
gerprints; 3) clear target based on absorbed bioactive
compound (ABC) [10] and regulatory mechanism based
on statistical pattern comparisons; and 4) compatibility
mechanism of major ingredients based on immunoaffin-
ity Chromatography [11,12]. The research model is diff-
erent from phytomics that it includes all classic TCM
formulae; not only phyto-derived formulae and it would
study the compatib ility mechanism. Thos e classic formu-
lae, especially formulae from “Treatise on Febrile Disea-
ses” and “Synopsis of Golden Chamber”, are of choice
for formulomics research. It is an open platform and a
translational medicine strategy to translate the classic
formulae of TCM into new clinical drugs. It focuses on
quality control and efficacy evaluation for it’s the most
important factors for the standardization of TCM [13].
4.3. Reaffirm the Efficacy of TCM with EBM
Although the history of trad itional Chinese medicine can
give people more confidence in terms of “evidence based
practice”, their efficacy are still be queried by the inter-
national society. To make the efficacy of TCM meet the
modern criterion, a commonly accepted standard of TC-
M syndrome had better to be established in the pattern of
combining diseases with syndrome differentiation of their
syndromes. At the same time, the good practices of TCM
clinical guidelines and clinical pathways and a grading
system for TCM evidence had been developing [14]. As
the Chinese EBM Centre has taken the responsibility to
promote the modernization of TCM in 2007, it is time to
combine these standards with EBM to reaffirm the effi-
cacy of TCM. Furthermore, widely accepted animal mo-
dels that could mimic the pathogenesis of diseases with
syndrome differentiation for evaluation efficacy of TCM
are a must. Objective evaluation criterion and reverse ve-
rification by classic Chinese formula are also needed. For
example, chronic unpredictable mild stress model is a
widely accepted model for depression and also for liver
-Qi stagnation. Forced swimming test, sucrose preference
test, and open field test would be performed, and xiao-
yaosan could be chosen as the reverse verification medi-
cine. The unified system would reduce the co nfusion and
chaos in TCM efficacy research.
5. Significance of Translational Chinese
Medicine
5.1. To Translate Chinese Medicine to Balanced
Medicine
The persue of translational Chinese medicine is to be ba-
lanced medicine: balance between maximizing safety,
effectiveness, long term value, and minimizing the risk
of side-effects. Translational clinical practice system
(TCPS) [15] is of choice to strike the balance. The aim of
TCPS is to facilitate the practitioners’ skills in translating
the multifaceted inter-relationship of scientific evidence,
patient preferences and values, practitioner experience
and judgment, clinically relevant outcomes, and ethical
practice parameters into substantial healthcare improve-
ments for their patients [16]. To accomplish TCPS in T-
CM, The first stage is to ensure the safety of herbal me-
dicines with strich quality control. Then EBM with the
pattern of combining diseases with differentiations of
their syndromes is the second stage to ensure its efficacy
and patient preference.
5.2. To Translate Chinese medicine to
Personalized Medicine
Chinese medicine is patient-cen tered in all ages. Syndro-
me differentiation is the promodial form of personalized
medicine. Translational medicine is synonymous with
“molecular medicine” or “personalized medicine” as all of
them refer to the process of applying molecular insight

189 X. G. SUN ET AL.
into the clinical care of the patients [17]. Provided that
large-scale data sets from genomics, proteomics, popula-
tion genetics, and imaging drives research at an un-
precedented pace, translational Chinese medicine is to
integrate these data with the safety and efficacy of TCM
to take deeper insights into syndrome differentiation and
formulae [18]. The gene studies pertaining to pharmaco-
genetical variations in response to Chinese medicine re-
sponse, optimum dose for adequate response, patho-
physiology changes of a particular formula, patient
population predisposition to adverse effects would pro-
vide the pharmacogenetic basis of drug effect variations
in patients. In the long run, the application of pharmaco-
genetics in Chinese medicine will significantly contrib-
ute to the individualization of drug therapy, known as
personalized Chinese medicine.
As the science matures, the empiricism of medical
practice is replaced by mechanism-based targeted dia-
gnostics and therapeutics. Molecular sciences, including
the evolving science of biomarkers, have catalyzed the
development of diagnostic and therapeu tic platforms tail-
ored to the individual patient profiles, paving the way for
the deployment of personalized Chinese medicine. There-
fore, it is time to advance the concept of translational
Chinese medicine to make Chinese medicine a personal-
ized and balanced medicine, with sound safety, good ef-
ficacy and strict quality control.
6. Acknowledgements
This Project was supported by grants from the National
Natural Sciences Foundation of China (No. 81173168,
30973699).
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