Verpoorte, Rob

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dJournal of Ethnopharmacology 140 (2012) 455– 457
Contents lists available at SciVerse ScienceDirect
Journal  of  Ethnopharmacology
journa l h o me  page: www.elsev ier .com/ locate / je thpharmditorial
ood  Practices:  The  basis  for  evidence-based  medicinesIn the past years the journal has emphasized the importance
f setting standards for studies of medicinal plants (e.g. Cos et al.,
006; Gertsch, 2009). Standards are required for studies to be con-
idered as valid evidence for safe and effective use of traditional
edicines, and thus may  contribute to an ofﬁcial registration with
overnmental agencies, like FDA or EMA, as evidence based drugs.
t present there is a window of opportunity for such studies, among
thers because of the changing global economic scene.
With 30,000–70,000 plant species being used somewhere in
his world as a medicine there is an enormous potential for the
evelopment of novel products. But that requires making choices.
ecause with superﬁcial studies, e.g. studying one plant species
fter another in a simple pharmacological model at a single dose, we
nd up with an enormous amount of information, but little data for
vidence-based use of any plant. What is needed is a clear strategy
bout what should be considered as active in terms of the required
ose and to address from the very beginning adverse effects and
oxicity.
Development of evidence-based traditional medicines is the
nly valid argument to convince skeptic Western medical doctors of
he application of such medicines. Experimental evidence is needed
nd not only historical evidence of safe use since ancient times.
herefore our major challenge in the coming years is to come to
vidence-based traditional medicines. If we fail in this task, the
resent window of opportunity will be closed and the support for
uch research will diminish, and worse, the old knowledge will be
ost including an important gateway to novel discoveries for drug
evelopment.
Traditional medical knowledge has two potential values, one
s an easy accessible and low-cost source of medicines for pri-
ary health care, the other as the source for ﬁnding novel leads
nd/or targets for drug development. Based on the paradigm
f “single compound single target”, pharmaceutical industry has
eveloped good drugs for most targets. However, present day drug
evelopment using these known targets has more or less stalled.
ovel approaches are needed that might lead to novel drugs. In
he past 50–60 years Western medicines have to a great extend
een developed on the basis of compounds that originate from
editerranean-European traditional medicines. Poppy, belladonna
nd digitalis are examples of plants that stand at the basis of essen-
ial modern drugs. Traditional medicine might thus be the start for
uch novel approaches.A novel approach is the use of multicomponent drugs. The suc-
essful treatment of HIV-patients with mixtures of compounds is a
lear example. The cause of many diseases is multifactorial, the use
378-8741 © 2012 Elsevier Ireland Ltd.  
oi:10.1016/j.jep.2012.02.033
Open access under CC BY-NC-ND license.of combinations of drugs rather than single compounds thus makes
sense. The same applies to drugs for which resistance is built up,
e.g. antibiotics and antitumor medicines. The problem of such an
approach in rational drug design is the modeling of the effect of a
combination of drugs, as at any moment there will be a different
ratio of active compounds in the system. That is where traditional
medicine comes into the picture.
In traditional medicine often mixtures are applied, in which
the individual ingredients are said to play a different role. That
means that mixtures of active compounds are used, which may
have some sort of synergism, such as acting on different targets,
affecting bioavailablity, suppressing adverse side effects, and alter-
ing drug metabolism and excretion. Such traditional formulations
can be further explored, which may  lead to novel insights in human
diseases and pharmacology. The omics applied in a systems biol-
ogy type of approach offer excellent novel tools for such studies
(Verpoorte et al., 2005; Wang et al., 2005).
Traditional medicine is often based on personalized medicine.
Personalized medicine is the dream of modern pharmacy with the
ultimate goal of human genetics based tailor made pharmacother-
apy. About 90% of the present western drugs is estimated not to
work in about 60% of the patients using them (Editorial, 2012),
therefore the concept of personalized medicine in traditional Chi-
nese medicine might be worth some further study.
Many aspects of traditional medicine might thus be good
sources of inspiration for research. The outcome could be novel sin-
gle leads for drug discovery, combination preparations, new targets
or modes of action. But in all cases it will lead to a safe and effective
use of traditional medicines.
With all these great perspectives it is an absolute must to get
our act together in the ﬁeld of ethnopharmacology and related
areas in order to be successful in obtaining applications. Obviously
research should be of high quality. Statistics, proper controls and
reproducibility are among the keywords for “Good Practices” in
performing experiments. Of course there are generally accepted
rules for experimental work in drug development. But studies of
traditional medicine have some special problems, such as how to
translate traditional diagnosis to western medicine (Lu and Chan,
2012), naming of the materials (Chan et al., 2012), how to deal with
complex mixtures of variable quality and personalized medicine
(Buriani et al., 2012; Chan et al., 2012; Pelkonen et al., 2012;
Sheridan et al., 2012). For example the general set-up of clinical
trials does not suit the idea of personalized medicine.
In this issue of the journal the conclusions and recommenda-
tions from three years of intensive discussions among experts from
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f56 Editorial / Journal of Ethnop
he relevant disciplines united in the EU-project “Good Practices in
raditional Chinese Medicine in the Post-genomic Era” (GP-TCM)
re summarized. The goal was to deﬁne “Good Practices” in the var-
ous types of studies that are needed to document the safety and
fﬁcacy of the traditional medicines, and thus may  be part of reg-
stration ﬁles. That means in designing, performing and reporting
tudies on traditional medicines the goal is not a publication in itself
ut the contribution to evidence-based medicine. That requires in-
epth studies on the pharmacology and toxicology, and a proper
ssessment of the ﬁndings.
The overall conclusions from the survey made by the GP-
CM network (Uzuner et al., 2012) are in line with this analysis.
nterestingly, the clariﬁcation of standards from the side of the
egulatory authorities comes out as an important item as well.
ecause of the complexity and the importance of the registration
f evidence-based traditional medicine, an intensive collaboration
nd discussion between all stakeholders is of great importance and
hould help to develop a model for studies in traditional medicine.
he inventory of the regulations concerning herbal medicine in
ifferent countries all over the world shows that there is still a
ong way to go to achieve some sort of global rules (Fan et al.,
012).
A major item will be the development and validation of novel
pproaches to deal with the complexity of the problem. As can be
een from the outcome from the survey (Uzuner et al., 2012), par-
icipants of the project recognized the importance of the omics.
hereas respondents outside the project did not mark omics as a
igh priority. Whether this is based on extensive experience in the
se of omics or the opposite is not clear, at least the two groups
iffer in their professional background. But the positive attitude
owards the omics that is reﬂected in earlier publications on this
opic (e.g. Verpoorte et al., 2005; Wang et al., 2005) and in the
resent issue shows that the appreciation of these methods in a
ystems biology approach is growing exponentially.
Metabolomics in combination with multivariate data analysis
s an excellent tool for quality control of botanicals and complex
ormulations (Buriani et al., 2012; Pelkonen et al., 2012; Sheridan
t al., 2012). In combination with biological testing of different
ccessions, extracts or fractions from a plant one may  be able to
nd the active compound(s), including prodrugs and synergy, by
eans of multivariate analysis of all data (Buriani et al., 2012;
elkonen et al., 2012; Sheridan et al., 2012; Taketa et al., 2008;
uliana et al., 2011). Such an approach using metabolomics on
he animal/human side as well as on the plant side are now
ecoming common practice in pharmacology and in pharmacog-
osy (Barlow et al., 2012; Buriani et al., 2012; Pelkonen et al.,
012; Sheridan et al., 2012). This approach also holds promise for
tudying the effect of other TCM such as acupuncture (Jia et al.,
012).
Besides the omics, also other research tools are needed. Tools
hat cover the whole chain from the production of the plant (Booker
t al., 2012; Zhao et al., 2012) to the formulation of the medicine
Luo et al., 2012), to the pharmacology and toxicology, includ-
ng animal experiments (Garcia et al., 2012; Liu and Yung-Chi
heng, 2012) and to clinical trials (Luo et al., 2012; Robinson
t al., 2012). Once evidence-based traditional medicines are on
he market pharmacovigilance studies are required, that means
onitoring for possible adverse effects and toxicity (Shaw et al.,
012).
Now this issue is published I look back to a period of enjoyable
nd intense discussions in the GP-TCM European project, and I look
orward to further discussions in this ﬁeld with the authors, review-
rs and editorial board members of the journal to implement the
ecommendations in our work.
This special issue is an important step towards deﬁning rules
or the “Good Practices” in our research, and setting standardscology 140 (2012) 455– 457
for evidence-based traditional medicines. But these rules, these
standards should all the time be subject of further discussion, to
continue our efforts to improve our research to the beneﬁt of all
people’s healthcare. It is amazing to see how few publications are
recognized as valid in meta studies assessing efﬁcacy of medicines.
Our goal should be that any study done on traditional medicine
counts for the assessment of safety and efﬁcacy of traditional
medicine, if not, it means that we  have wasted our precious time
and money. That also means that we must be honest in our conclu-
sions, one should dare to write that there is no or only weak activity.
Too many of the presently submitted papers give the impression
that another wonder drug has been found, e.g. making a ubiquitous
compound like sitosterol to a real panacea.
Here I should like to thank all the authors, reviewers and
the guest editors for their great efforts to get this special issue
published. Also I want to acknowledge the great vision of EU-
commission that recognized the need for high quality studies in the
ﬁeld of traditional medicine, resulting in the grant for the GP-TCM
project. This resulted, among others, in this special issue, which will
be a very important landmark for the future research in the ﬁeld
of traditional medicine. A ﬁeld asking for extensive global collab-
orations: east-west and north-south, all to the beneﬁt of human
health.
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Editor-in-Chief
Rob Verpoorte
Natural Products Laboratory, IBL, Leiden University,
Leiden, The NetherlandsE-mail address: Verpoort@LACDR.Leidenuniv.nl
16 February 2012
Available online 24 February 2012


Good Practices: The basis for evidence-based medicines 

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Good Practices: The basis for evidence-based medicines

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