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- In
my practice, many patients say that they like Chinese Herbal
Medicine because it is natural, safe, and effective.
What concerns them the most is the insurance coverage.
“Does the insurance cover Chinese Herbal Medicine?”
became one of the most frequently asked questions.
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- Currently
in the United States, some insurance companies have begun to cover
the Acupuncture treatment. However,
no insurance company covers Chinese Herbal Medicine as an
independent treatment program.
In a few cases, some insurance companies cover Chinese Herbal
Medicine under Acupuncture only.
As a result, patients generally must pay out-of-pocket for
treatment of diseases, prevention of illnesses, and promotion of
health services when Chinese Herbal Medicine is used.
Thus, access to Chinese Herbal Medicine and practices appears
to be limited largely by the ability to pay.
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- As
mentioned above, Chinese Herbal Medicine is parallel to, is
independent of, and is approximately ten to twenty times larger than
Acupuncture. Chinese
Herbal Medicine is the main component of TCM.
Including Chinese Herbal Medicine as a subset of Acupuncture
is inappropriate. It
will not meet the great public demand for Chinese Herbal Medicine,
and is not in the best interest of American people.
Many Americans cannot benefit from TCM largely because the
insurance does not cover Chinese Herbal Medicine.
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- To
meet the great demand for Chinese Herbal Medicine in the United
States, independent insurance coverage for Chinese Herbal Medicine
is needed.
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- Currently,
many people take single herb extract in a way similar to taking
dietary supplement for disease prevention.
Thus, some people have an impression that Chinese Herbal
Medicine, similar to single herb extract, is for disease prevention
mainly. They perceive
TCM as a supporting health maintenance system (for disease
prevention) rather than a medicinal system (for disease treatment).
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- This
is a misunderstanding about TCM.
The application of a single herb (or its extract) is very
different from the practice of Chinese Herbal Medicine.
In TCM, there are monarch, minister, assistant, and guide
requirements in applying Chinese Herbal Medicine.
Therefore, it is very rare for a TCM doctor to apply a single
herb to treat diseases. Most
of the time, a TCM doctor will apply a combination of herbs to form
a formula, which can not only prevent diseases, but also treat
illnesses.
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function of a herbal formula is very different from the function of
a single herb. In TCM,
treating a disease is similar to fighting a war. A single herb is like a soldier, and a formula is like a
troop. A soldier alone
can rarely win a war, but a well-organized troop usually can.
In TCM, it is through the cooperation between different
component herbs that a formula effectively treats and cures
diseases.
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- Therefore,
there is a clear distinction between the application of single herb
and the application of Chinese Herbal Medicine.
The former may fall into the scope of nutrition dietary
supplement, which is mainly for disease prevention.
The latter falls into the scope of medicine, which is not
only for disease prevention, but also for disease treatment.
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sum, TCM is neither a nutritional program nor a dietary supplement
system. Nor is it for
prevention only. TCM is
a comprehensive, effective, and rigorous medicinal system.
It is effective not only for diseases prevention, but also
for illnesses treatment. Disease
prevention is only a small portion of TCM practice.
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- Western
herbal medicine in the United States does not have the legacy or the
diagnostic and therapeutic processes honed to provide the skill
levels that are seen in Chinese Herbal Medicine.
While the constituent based treatment process can be useful
in simple and some acute disease patterns and follows the
pharmaceutical model, it does not meet the quality of care provided
by the Chinese Herbal Medicine.
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- For
thousands of years, TCM has successfully treated and cured numerous
diseases, and saved millions or billions of peoples’ lives.
TCM is a great treasure belonging not only to the Chinese
people, but also to the whole mankind. TCM can, should, and will benefit all human beings in disease
prevention as well as disease treatment.
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- TCM
does not classify diseases the way Western medicine does.
TCM approaches diseases in a holistic way.
It stresses the relationship between different organs and
systems. For example, in TCM, an illness related to vision may be
caused by some internal organ’s problem.
The treatment might be approached from internal medicine
rather than from ophthalmology.
Also, a heart problem might be caused by other TCM organ
systems. The treatment
might cover not only cardiology, but also other systems.
Examples like this are numerous.
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- Therefore,
it is common that a TCM doctor’s practice covers a wider area of
diseases. Insurance
companies should understand this difference between TCM and Western
Medicine, and not impose Western Medicine specialties on TCM
doctors.
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- Most
Chinese herbs are very safe, fall into FDA’s food category, and
need not be regulated.
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- However,
there have been reports of adverse side effects when certain Chinese
herbs have been applied. As
a result, a few herbs are regarded as “dangerous” and are
restricted by the FDA.
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- Actually,
there are significant differences between the adverse side effects
of chemical drugs and the adverse side effects of Chinese herbs.
The adverse side effects of a chemical drug exist no matter
whether the drug is applied appropriately or not.
In other words, the adverse side effects of the chemical drug
are unconditional:
they exist no matter if the chemical drug is applied appropriately
or not. On the
contrary, most adverse side effects of Chinese Herbal Medicine arise
from the inappropriate application of herbs.
In other words, the adverse side effects of Chinese herbs are
conditional:
they generally exist only when applied inappropriately.
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- The
inappropriate applications of Chinese Herbal Medicine include:
- (1)
Wrong diagnosis;
- (2)
Inappropriate selection of herbs;
- (3)
Inappropriate combination of herbs;
- (4) Inappropriate
processing of herbs;
- (5)
Inappropriate methods of taking herbs;
- (6)
Inappropriately high dosage;
- (7) Inappropriately long
application;
- (8)
Inappropriately taking with other drugs, etc.
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- Any
one or more of above inappropriate applications will lead to adverse
herbal side effects. Because
only qualified TCM doctors are capable of avoiding above situations,
the public is not recommended to take Chinese herbs by their own
decision. Otherwise,
the adverse herbal side effect is unavoidable.
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- For
thousands years, clinic practices proved that when applied
appropriately, most adverse side effects of Chinese herbs (including
most of those being restricted) could be reduced, avoided, and did
not exist.
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- Currently,
due to the FDA restriction on importing certain Chinese herbs, it is
very difficult to get them in practice.
These few herbs are very important in treating certain
illnesses. They are an
integral part of Chinese Medicine.
Without them, Chinese Medicine will not be complete.
Complete herbal availability is necessary for the full
application and development of Chinese Herbal Medicine in the United
States.
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appears that the FDA needs to balance between the safety assurance
for the public on one hand, and the herbal availability assurance
for qualified TCM practitioners on the other hand.
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fact, this situation is not new to Chinese Medicine.
In Western Medicine, most prescription drugs are dangerous
and will cause serious adverse side effects if applied
inappropriately. However,
the FDA has not banned them simply based on their
“dangerousness”. Because
the prescription drugs are useful to treat certain diseases when
applied appropriately, the FDA allows these drugs to be prescribed
by qualified MDs.
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- Similarly,
the few “dangerous” herbs should not be banned.
They should be regulated following the manner of prescription
drugs. Like
prescription drugs, these herbs are “dangerous” in the hands of
public or unqualified doctors, but are useful in the hands of
qualified TCM doctors.
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- Because
there is no complete, systematic, and rigorous study of these herbs,
it is too early to conclude that they are absolutely dangerous.
Because these few herbs have been applied to treat many
diseases for thousands of years, and there were not many side
effects documented in the literature, recent increase of reports on
their side effects may be caused by inappropriate applications.
At this stage, these few herbs should be regulated following
the way of prescription drugs. Let well-trained, qualified TCM doctors apply these few
“dangerous” herbs. In
this sense, these few herbs may be called “prescription herbs”.
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course, only a few herbs fall into this category.
Most Chinese herbs, generally speaking, are still safe and
should not be regulated.
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- Recent
increase of reports on herbal side effect is probably related to the
following causes:
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- (1)
Herb popularity.
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- Chinese
herbs are becoming more and more popular, and enjoy a reputation of
being natural, safe, and effective.
Thus, many people take Chinese herbs by themselves without
obtaining qualified TCM doctor’s direction.
This leads to an increase of inappropriate application of
Chinese herbs.
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have heard many people saying that Chinese herbs are safe and do not
have side effects. This is a misunderstanding about TCM. Chinese herbs are safe only when applied appropriately.
Chinese herbs will cause side effects too if applied
inappropriately. Due to
this reason, it is not advised for patients to take Chinese herbs by
themselves because it is impossible for patients to have enough
knowledge and expertise on TCM.
Even in China, although many people are very familiar with
Chinese herbs, patients still rely on qualified TCM doctors to
prescribe Chinese formulas for disease treatments.
People there are aware that Chinese Herbal Medicine is a
medicinal system, and the public does not have the education,
training, and experience to decide what herbs to take.
Therefore, the public should not run risk of taking herbs by
their own choice.
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- TCM
is a medicinal system rather than a nutritional program.
Chinese herbs should be prescribed by qualified TCM doctors
only. Otherwise, it will endanger both the public and the TCM
profession. This is the
first cause leading to recent increase of reports on herbal side
effect.
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Lack of TCM regulation.
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- Because
TCM is a medicinal system, only qualified TCM doctors can provide
patients with safe and effective TCM treatments.
In the past, it was those qualified TCM doctors who help TCM
win the good reputation of being safe and effective.
It was based on this good reputation that many governments
have made decision of not regulating TCM.
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- Unfortunately,
the decision of not regulating TCM itself in turn destroys TCM’s
good reputation. Being
unregulated, many unqualified practitioners entered into the TCM
profession, lowered the TCM standards, and ruined the TCM’s
reputation. By deciding
not to regulate TCM, many governments have actually sent a wrong
signal to the public telling them that Chinese Herbal Medicine is as
safe as food and dietary supplement.
Thus, many people take Chinese herbs by their own choice
without obtaining TCM medical direction.
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- This
brings many dangers to both the public and the TCM profession. The public and TCM profession are threatened not by TCM
itself. Instead, they
are endangered by the inappropriate application of TCM through
unqualified practitioners and the public.
This is the second cause contributing to the recent increase
in the adverse side effects reports on TCM.
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- From
the timing (the increase of TCM popularity in public, the increase
of unqualified practitioners entering into TCM, and the increase of
reports on herbal side effects), it is reasonable to believe that
many reported side effects were probably caused by inappropriate
applications of these herbs.
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fact, if applied inappropriately, most “safe” things will become
dangerous and can cause side effects.
For example, most people will agree that water is safe.
But it will cause side effects if one drinks too much water.
Drinking an over dose of water will damage the spleen-stomach
system and the kidney-urinary bladder system in TCM and cause a
series of adverse side effects.
In the extreme case, too much water (as in a swimming pool)
can obstruct the normal function of respiratory system and cause
drowning. Water is very
dangerous in these cases, but the FDA does not restrict or ban the
water. This is because
above dangers are caused by inappropriate application of water only.
The water will be very safe if it is taken appropriately.
Examples like this are numerous.
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- Similarly,
all foods, vegetables, and herbs can cause adverse side effects if
one takes them inappropriately (e.g. take too much at one time).
There is no absolutely safe thing, and there is no absolutely
dangerous thing either. It
all depends on how we apply them.
Many things are safe if applied appropriately, just as many
things are dangerous if applied inappropriately.
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fact, all things differ only in the range of safety dosage, duration
of application, combination, applicable cases, etc.
Some have larger safety range (e.g. water), and others have
smaller safety range (e.g. the few “dangerous” herbs).
If applied appropriately within their safety range, the few
“dangerous” herbs might be safe and will not cause side effect.
If applied inappropriately, anything (including water) is
dangerous. The Chinese
Herbal Medicine is no exception.
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- There
is one issue that has not yet been addressed.
Because TCM has been practiced empirically for thousands of
years, it lacks rigorous scientific study on the dosage, duration,
combination, and applicable cases of herbs. Continual refinement by trial and error over thousands of
years’ practices has resulted in a highly reliable system. Still, we cannot completely exclude the possibility that some
of these few “dangerous” herbs might have too narrow safety
ranges to be applied in practice.
However, conclusions should be drawn based on sound
scientific studies rather than on separate, sporadic media reports.
It is very important to have a complete investigation and
study on all the reported side effect cases (including the Belgium
case that lead to FDA’s restriction on many Chinese herbs), and
find out the original cause of the side effect.
It will also be helpful to conduct complete, systematic, and
rigorous studies on the few possibly “dangerous” herbs as to
their safe dosage, processing, duration, combination, applicable
cases, etc. These
studies will provide practitioners with clear guidelines to follow
in practice, help improve therapeutic outcomes, and reduce possible
side effects.
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sum, everything has potential to be both safe and dangerous.
As to the safety of TCM, the key is how to establish a
mechanism to ensure the appropriate application of Chinese herbs
rather than how to restrict or ban them.
To reduce the incidence of adverse herbal side effects and
protect the public from being harmed by herbal side effects, the
following measures should be taken:
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Regulate the TCM profession;
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Send a clear message to the public
that TCM is a medicinal system rather than a nutritional program. Chinese herbs are not foods either. Chinese herbs should be taken under the prescription of
qualified TCM doctors only. The
public should not take Chinese herbs by their own decision.
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- For
thousands of years, TCM has been practiced as a black-box system,
and developed mainly by the trial and error and clinical
experiences. The
thousands of years’ clinic experiences are very precious, and have
enabled TCM to become one of the most outstanding traditional
medicines in the world.
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- Despite
all achievements, TCM has some aspects that could be improved.
One of them is the inconsistency between different studies.
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- The
two fundamental principles in TCM are (1) Concept of holism; and (2)
Bian Zheng Lun Zhi (Diagnosis and treatment based on overall
analysis of signs and symptoms, the cause, nature, and location of
the illness and the patient’s physical condition according to the
basic theories of TCM). Different
practitioners apply Bian Zheng Lun Zhi in a different way,
and reach different outcomes. When
applied appropriately, it enables TCM to be very effective.
However, when applied inappropriately, it makes TCM
ineffective, or even causes side effects.
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main cause leading to the inconsistency between different studies is
that systematic study on Chinese Herbal Medicine is rare.
For more reliable, accurate, and consistent outcomes of TCM
practice, modern scientific methods should be introduced into TCM
research. Complete,
systematic, and rigorous studies on the efficacy and safety of
Chinese Herbal Medicine should be conducted.
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- However,
there are problems and difficulties in this approach.
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- 10.1
Problems
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- Currently,
most studies on Chinese Herbal Medicine have the following problems:
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- (1)
They
are subjective and oversimplified;
- (2)
They
are incomplete, unsystematic, and non-rigorous.
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- There
are two types of variables involved in the study of Chinese Herbal
Medicine: component herbs and ingredients (i.e. chemical ingredients
in the herbal formula). Most
studies of Chinese Herbal Medicine control the variables of
component herbs rather than ingredients because the latter is much
more complicated than the former.
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- In
most studies, usually only one or a few variable settings (e.g. the
amount of each component herbs) are chosen, and the formula’s
efficacy and safety are studied under these few settings only.
Each study concludes that under the chosen variable setting,
the Chinese herbal formula has certain efficacy and safety.
Thus, the conclusion is applicable to the chosen setting
only. No systematic
study is carried out, and there is no comparison study on the
formula’s efficacy and safety under all settings. Different researchers try different settings by trial and
error based on their experiences.
Therefore, it is impossible to know what is the optimum
setting with the highest efficacy and safety.
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- As
a result, current studies on Chinese Herbal Medicine appear more
like an art rather than a science.
The determination of variable settings is subjective,
incomplete, and non-rigorous. It
is very difficult to find the best variable setting following this
study method.
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- We
have discussed earlier that TCM is a scientific field.
Then what causes above problems?
The answer for this question is very complicated, and many
issues have not been solved yet.
Following is an attempt to address the problems noted above.
We hope to see more opinions and suggestions on how to
improve TCM research.
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- 10.2
Theoretical Difficulty
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- A
chemical drug usually contains one or a few active ingredients.
Models studying chemical drugs belong to a linear system or
single body, non-linear system.
Differential equations for pharmacokinetics of these systems
are solvable. Therefore,
it is possible to control and analyze the chemical drug’s process
analytically and accurately in Western medicine’s pharmaceutical
research.
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- However,
a single Chinese herb usually contains many ingredients.
A formula consisting of many herbs contains many more
ingredients. During
decocting (a process of boiling the herbs together in a liquid such
as water), there are cross-reactions between these ingredients,
which make the decoction even more complicated.
In vivo, the pharmacokinetics of herbal medicine usually
involves many ingredients, some of them may act together and couple
each other. As a
result, models for TCM study may fall into multi-body, non-linear
systems. Currently,
differential equations for multi-body, non-linear systems cannot be
solved accurately. Approximations
are necessary in TCM study. Therefore,
there is no mathematical tool to study TCM pharmacokinetic process
in vivo analytically and accurately.
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- When
applying modeling and other pharmaceutical study methods to Chinese
Herbal Medicine, some studies make assumptions and approximate the
TCM system into a linear system or single body, non-linear system.
These assumptions may not reflect the true process involved
in the TCM pharmacokinetics. If
the multi-body, non-linear property is not essential to the normal
function of the system, a linear approximation is acceptable.
However, if this multi-body, non-linear property is essential
to the normal function of the system, the approximation should not
violate the nature of the multi-body, non-linear system.
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- For
example, an ingredient in Chinese herbs may be toxic in a linear or
single body, non-linear system.
However, its toxicity may be reduced or suppressed through
coupling in a multi-body, non-linear system.
This might happen in some heavy metal studies.
In an isolated state, a heavy metal may be toxic.
However, in an herbal formula, the heavy metal may couple
with other ingredients to form a less toxic or non-toxic compound.
Thus, its toxicity may be reduced or suppressed.
It is inappropriate to apply the conclusions from studies of
an isolated state (a linear or single body, non-linear system) to
the TCM system, which may be a multi-body, non-linear system.
In addition, the heavy metal may be crucial to the normal
function of the herbal formula.
Thus, taking away the heavy metal may lead to a reduction of
the normal function of the herbal formula.
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- Therefore,
when the non-linear property is essential to the normal function of
the multi-body system, linear approximation is inappropriate.
Without linear approximation, it is very difficult to solve
the differential equations of multi-body, non-linear system.
This is the theoretical difficulty underlying modern
scientific study on Chinese Herbal Medicine.
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- 10.3
Experimental Difficulty
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- Experimentally,
it is important to study each individual ingredient of an herb.
However, due to the system difference, it is inappropriate to
apply the conclusion of the study of an individual ingredient (a
single body, linear system) to a formula (a multi-body, non-linear
system). Therefore, for
the efficacy and safety of an herbal formula, it is necessary to
study the original herbal formula in its formula state directly.
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- The
experimental difficulty in conducting a systematic and rigorous TCM
research is the control of variable settings.
Because conclusions from an isolated ingredient study may be
different from those in a formula study, it is inappropriate to draw
a conclusion based on isolated ingredient study.
Thus, it may be inappropriate to conclude which ingredient is
active, and which is not, simply based on the study of isolated
ingredients. A
complete, rigorous research on a formula demands full study of all
variable settings in the formula state.
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- Because
the ingredient variable is more accurate than the herb variable, the
study should concentrate on the variable of ingredient.
However, this is sometimes very difficult to implement.
For example, if a formula consists of 50 ingredients (this is
a conservative estimate), and each variable (ingredient) takes on 10
different values (e.g. ten different “strengths”) during the
control study, there will be an astronomical number of variable
settings to study. There
is no time and fund to support these studies.
Thus, simply copying pharmaceutical study methods to TCM
study will not work. This
is why it is very rare (if it ever exists) to see a complete,
systematic, and rigorous study (controlling and comparing all
variable settings) on a Chinese herbal formula.
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- To
simplify the situation, some studies simply assume many ingredients
to be inactive based on conclusions of studies under their isolated
states. This leads to
the control study on a few assumed "active" ingredients.
However, it runs risk of making inappropriate and subjective
assumptions.
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- Many
other studies concentrate on the control of single component herbs
rather than on ingredients in an herbal formula.
This greatly reduces the number of variables, but it actually
goes back to the traditional way of TCM study.
Even for the control of component herbal variables, there are
still many variable settings for a complete, systematic, and
rigorous study. Most
studies simply choose one or a few variable settings (based on
researchers’ experience or literature) to conduct studies.
These fixed-setting studies provide conclusions for these
settings only. They do
not provide information on the optimum setting.
Neither do they provide information on the “dangerous”
settings. Due to these reasons, TCM study appears to be an art rather
than a science.
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- One
distinction should be made here.
What appears to be an art is the TCM study method.
It is the current TCM study method that is incomplete,
unsystematic, and non-rigorous.
As to the TCM itself, it is a complete, systematic, and
rigorous medicinal system.
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- From
above discussion one may conclude that TCM is a science.
It obeys all mathematical and physical laws.
The problems and difficulties are caused by the high
complexity of TCM. TCM
is a very rigorous science that is, in many aspects, beyond the
capability of contemporary scientific theory and methods to explain
it in precise terms. More
scientific research should be conducted on TCM.
However, it may take intensive effort to have a complete,
systematic, and rigorous study on TCM.
In the interim, well-educated, trained and qualified TCM
doctors will carefully research, administer herbal formulas, and add
their own observations of the herbal treatments to the literature,
as has been the tradition for thousands of years.
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- Thus,
we have many challenges: how to make approximations, what
assumptions should be made, will the assumptions break the
system’s
