Recommendationon Chinese Medicine in The

Recommendation on Chinese Medicine in the United States of America (Primary)

TO: White House Commission on Complementary and Alternative Medicine Policy FROM: Bob Xu RE: Recommendation DATE: December 4, 2001

Dear Sir or Madam:

As a doctor of Chinese Medicine practicing in the United States, I have met some issues relating to patients’ care and the profession of Chinese Medicine. I have discussed these issues with representatives at the American Association of Oriental Medicine (AAOM). They have generally agreed with me on these issues, and felt that these issues are important to address in order for the American public to receive the reliable, safe, and effective system of Chinese Medicine. They suggested I send my recommendation to the White House Commission on Complementary and Alternative Medicine Policy.

Because English is my second language, and I am writing this recommendation in a short time, I am presented with many challenges. Yet I hope to call to your attention to issues that will benefit both the American public and the profession of Chinese Medicine.

Thank you.

Sincerely,

Bob Xu, CMD, MS Director Center for Holistic and Herbal Therapy

1 Recommendation on Chinese Medicine in the United States of America

1. Inappropriate Status of Chinese Herbal Medicine

Traditional Chinese Medicine (TCM), or Chinese Medicine, is composed of two parts: Acupuncture and Chinese Herbal Medicine. Acupuncture first drew the American public's attention, partly attributed to the media, during President Nixon's historic visit to China in the early 70s. Chinese Herbal Medicine arrived in US later than Acupuncture, and is not as well known as Acupuncture.

The less well-known status of Chinese Herbal Medicine does not mean that it is less important. On the contrary, it is the most important component of TCM. In all TCM hospitals in China, there is only one Acupuncture Department, but there are normally between ten and twenty Departments of Chinese Herbal Medicine. In China, students at TCM medical schools are trained in both Acupuncture and Chinese Herbal Medicine. After graduation, they will focus in their practice on either Acupuncture or Chinese Herbal Medicine (although some of them focus on both). For thousand years, more TCM doctors have focused on Chinese Herbal Medicine than on Acupuncture. Above facts show that Chinese Herbal Medicine is more than a dozen times larger than Acupuncture, and is the major component of TCM.

Despite this fact, in the United States many agencies and insurance companies regard Chinese Herbal Medicine as a sub-category of Acupuncture, and include Chinese Herbal Medicine into Acupuncture. This relationship between Acupuncture and Chinese Herbal Medicine is inappropriate, and will block the development of TCM in the United States. TCM cannot be fully developed in the US, and the American public will not enjoy the full benefit of TCM if Chinese Herbal Medicine is bound to Acupuncture. The American public will get more benefits once Chinese Herbal Medicine has obtained the status and recognition it deserves.

2. Scientific Basis of TCM

For thousands of years, TCM has been proven clinically safe and effective when applied appropriately. However, because TCM diagnoses and treats diseases in a way different from Western medicine, many people question its scientific basis.

I had a chance to study physics before entering TCM medical school. The interdisciplinary background provides me with an opportunity to view TCM from a physics viewpoint. To my surprise, many TCM principles, methods, processes, and

2 mechanisms have their basis in physics. TCM relates to theoretical mechanics, aeromechanics, fluid mechanics, thermodynamics, statistical physics, control theory, system theory, information theory, etc. For example, the mechanisms of many diseases in pulmonary system relate to aeromechanics, and the mechanisms of many cardiovascular diseases relate to fluid mechanics.

According to TCM, a healthy state is a yin-yang balanced state, and a diseased state is a yin-yang imbalanced state. From the physics viewpoint, the human body is a complex system in dynamic equilibriums. There are constant flows of matter, energy, and information which are in dynamic equilibriums inside the body. Therefore, the balance is not a static balance, but a dynamic equilibrium. Any deviation from these equilibriums, no matter if it is due to internal factors or external factors, will lead to a diseased state. The goal of TCM’s treatment is to reestablish the dynamic equilibriums with the appropriate application of Chinese herbs and other modalities of Oriental Medicine.

Although more studies are needed to clarify these relationships, it is reasonable to say that TCM is compatible with physics, and it is scientific. The relationship between physics and TCM is not a coincidence. Because the human body is also a physical system, all physiological and pathological processes should obey physical laws.

3. Controversy on TCM

As a scientific field, TCM should have a high degree of reproducibility and consistency. Unfortunately, TCM enjoys a varied reputation in the United States at this time. Some patients say that TCM is excellent and superior to Western medicine. They believe TCM is natural, safe, and effective. Others say it is ineffective, or even has adverse side effects.

The controversy arises mainly from the fact that the Chinese Herbal Medicine is not regulated in the United States.

Currently, there is no mechanism to ensure a consistently high quality of TCM practitioners. The lack of TCM regulations has, in some cases, allowed unqualified people to practice TCM. As a result, people with limited knowledge about TCM can practice Chinese Medicine. Some of them have only several months to two years of TCM study, and have not received a recognized TCM degree. They lack systematic study and rigorous training in TCM, and are therefore unable to provide patients with safe and effective TCM treatments, thus giving TCM this undeserved mixed reputation.

3 When patients have complained that Chinese Medicine did not work, it was not that Chinese Medicine did not work, it was because the practitioner was not qualified to practice Chinese Medicine. Low standards and quality not only harm the public, but also seriously damage the reputation of TCM.

I had the opportunity to witness several Nationally Outstanding TCM Doctors honored by the State Department and the Ministry of Health, P. R. China (I studied under these master TCM doctors). If these TCM master doctors were allowed to practice in America, most Americans would believe that Chinese Medicine is wonderful and excellent. They practice the same TCM, but reach different results from those unqualified practitioners. It is because these master doctors are qualified to provide the public with the best and most consistent high quality of Chinese Medicine.

The government’s decision of not regulating TCM probably has sent a wrong message to the public. Because the FDA classifies the herb into food category, many people think it is safe to take Chinese herbs by their own decisions. This has lead to many inappropriate takings of Chinese herbs by the public. In the end, many people say that Chinese herbs are ineffective or have side effects.

Actually, the public is not supposed to take Chinese herbs by their own choices. Even in China where everyone know TCM, the public still seek TCM doctors’ prescription for Chinese herbs rather than take herbs by their own decision. Recently, the public’s inappropriate uses of Chinese herbs have increased the number of ineffectiveness or side effects of Chinese Herbal Medicine in US and other countries.

Because TCM is new to many countries, many governments do not have adequate information or preparation on how to regulate it. Thus, they decide not to regulate it based on partial information. The decision of not regulating TCM is a misunderstanding about Chinese Herbal Medicine. In fact, this decision has played an important role in increasing reports of side effects on TCM. We will discuss the herbal side effects later in details.

4. Regulation of the TCM Profession

To ensure high quality of TCM and to protect the public interests, the TCM profession needs to be regulated in a similar manner to the one that Western medical doctors are. The purpose of TCM professional regulation is to:

4  Ensure that all TCM practitioners have adequate education, training, and experience in order to practice TCM safely and effectively;  Prevent unqualified practitioners from harming the public and damaging the profession of Chinese Medicine. In China, there are two types of medical schools: Western medical schools and TCM medical schools. TCM medical schools are independent of, and parallel to, Western medical schools. It takes 5 years to obtain a Doctor of Chinese Medicine (CMD) degree for practicing TCM. The length and workload of the curriculum at TCM medical schools is the same as those at Western medical schools. It is impossible to become a Doctor of Chinese Medicine in less time. Even after obtaining the CMD degree, there is still a long way to go to become a good TCM doctor.

In the United States, the criteria for a practitioner to be a qualified TCM doctor should be 4 to 5 years study and training at an accredited TCM Medical School, either in China or the US. Anyone without adequate TCM Medical School study and training should not be allowed to practice Chinese Medicine.

Currently in many states in the United States, an MD, DO, DC, ND, or other healthcare practitioner is automatically allowed to practice Chinese Medicine (e.g. Acupuncture and/or Chinese Herbal Medicine) no matter how little education or training he or she has in TCM. This is another area that lowers the standards of Chinese Medicine and do harm to the public. If an MD, DO, DC, ND, or other healthcare practitioner has received adequate training (has met above criteria of 4 to 5 years formal study and training at a TCM Medical School), he or she is qualified to practice Chinese Medicine. However, if the MD, DO, DC, ND, or other healthcare practitioner has not met above criteria, he or she is unqualified to practice Chinese Medicine.

In China, generally speaking, a graduate from Western medical schools is an MD who is qualified to practice Western medicine only, and the MD is not allowed to practice Chinese Medicine. A graduate from TCM medical schools is a Doctor of Chinese Medicine (CMD) who is qualified to practice TCM only, and the CMD is not allowed to practice Western medicine. This is because the trainings at Western medical schools and TCM medical schools are completely different. Both types of medical schools take 5 years of study and training. It is impossible for an MD graduated from a Western medical school to have adequate education, training, and knowledge in Chinese Medicine, and vice versa.

Therefore, to ensure the high quality of Chinese Medicine and to protect the public interests in the United States, an MD, DO, DC, ND, or other healthcare practitioner

5 should not automatically be qualified to practice Chinese Medicine unless he or she has met the criteria to practice TCM.

5. Insurance coverage

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.

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.

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.

To meet the great demand for Chinese Herbal Medicine in the United States, independent insurance coverage for Chinese Herbal Medicine is needed.

6. Disease Prevention vs Disease Treatment

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).

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

6 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.

The 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.

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.

In 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.

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.

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.

7. Scope of TCM

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.

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.

8. Regulation on Certain Chinese Herbs

Most Chinese herbs are very safe, fall into FDA’s food category, and need not be regulated.

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.

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.

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.

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.

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.

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.

It 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.

In 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.

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.

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”.

Of course, only a few herbs fall into this category. Most Chinese herbs, generally speaking, are still safe and should not be regulated.

9. On Herbal Side Effects

Recent increase of reports on herbal side effect is probably related to the following causes:

(1) Herb popularity.

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.

I 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.

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.

(2) Lack of TCM regulation.

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.

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.

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

10 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.

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.

In 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.

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.

In 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.

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

11 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.

In 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:

(1) Regulate the TCM profession; (2) 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.

10. Research on Chinese Herbal Medicine

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.

Despite all achievements, TCM has some aspects that could be improved. One of them is the inconsistency between different studies.

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.

The 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

12 introduced into TCM research. Complete, systematic, and rigorous studies on the efficacy and safety of Chinese Herbal Medicine should be conducted.

However, there are problems and difficulties in this approach.

10.1 Problems

Currently, most studies on Chinese Herbal Medicine have the following problems:

(1) They are subjective and oversimplified; (2) They are incomplete, unsystematic, and non-rigorous.

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.

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.

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.

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.

10.2 Theoretical Difficulty

13 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.

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.

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.

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.

Therefore, when the non-linear property is essential to the normal function of the multi-body system, linear approximation is inappropriate. Without linear

14 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.

10.3 Experimental Difficulty

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.

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.

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.

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.

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,

15 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.

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.

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.

Thus, we have many challenges: how to make approximations, what assumptions should be made, will the assumptions break the system’s nature, and how to conduct a complete, systematic, and rigorous study on a Chinese herbal formula. All these questions are very important in studying the pharmacokinetic mechanisms as well as the efficacy and safety of Chinese Herbal Medicine. They should be addressed in the design of a scientific TCM research. Simply copying the pharmaceutical study methods is inappropriate or impractical.

It is probably helpful to establish a set of standards for TCM research. These standards should reflect the characteristics of TCM on one hand, and incorporate modern scientific methods on the other hand. With the advancement of mathematics and other scientific methods for multi-body, non-linear systems, TCM mechanisms and processes will be understood and controlled more accurately.

Acknowledgements

I would like to thank Dr. David Malony, Executive Director of the American Association of Oriental Medicine (AAOM) and Dr. Mingming Pan, Associate

16 Director of AAOM, for suggesting and supporting me to initiate this recommendation. Thanks to Mr. David Niles of American Health Care Alliance (AHCA) for his understanding, suggestions, and support on many issues in the recommendation. Dr. Albert Ito of Fermi Lab deserves thanks for discussion on some issues in mathematics and physics. Thank Dr. Yumi Dong of College of Pharmacy, University of Illinois at Chicago for discussing some issues on pharmaceutical research and Chinese Medicine. Thanks also to Dr. Chun-Su Yuan, the Director, and Dr. Jing-Tian Xie of Tang Center for Herbal Medicine Research, Department of Anesthesia and Clinical Care, University of Chicago Medical Center for providing their publications and discussing some issues on pharmaceutical research and Chinese herbal study. Likewise, thanks to my neighbor Ms. Maylene Landi and Mr. Edward C. Spengler II, Service Core of Retired Executives (SCORE) Counselor for supporting the project and correcting grammatical errors and writing problems in the draft. Especially, I would like to thank Coordinator Bonnie J. McLaren of the Small Business Development Center at College of DuPage for hours of enlightening discussion and various supports, from literature search and documentation to writing, on this and other projects. After finishing the recommendation, I have received many valuable feedbacks. I apologize for being unable to mention everyone here, and appreciate all encouragements and supports for TCM and this recommendation.

Recommendation on Chinese Medicine in the

United States of America

(Supplement)

TO: White House Commission on Complementary and

Alternative Medicine Policy

FROM: Bob Xu

RE: Recommendation (Supplement)

DATE: February 20, 2002

17 Dear Sir or Madam:

I submitted a recommendation to WHCCAMP on December 4, 2001. Since then, some issues not covered in that recommendation have drawn our attention. We deem it appropriate to provide a supplement to the recommendation to elucidate the new issues.

Hope the March final report could take into consideration of these issues.

Thank you.

Sincerely,

Bob Xu, CMD, MS

Director

Center for Holistic and Herbal Therapy

1. Classification of Herbs

Herbal Medicine in general, and Chinese Herbal Medicine in particular, have met many challenges in the United States. Many issues mentioned in previous recommendation relate to another fundamental issue ---- the classification of herbs. Without a clear, appropriate, and scientific classification of herbs, it may be very difficult to solve other issues.

Currently, herbs are classified as food dietary supplements. Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet [1].

“To supplement the diet” may be appropriate for vitamins, minerals, amino acids, enzymes, etc. However, it is inappropriate for herbs. Herbs are much more complicated and have far more functions than simply “To supplement the diet”.

18 Then, what category should herbs be classified? Following, we try to discuss this issue from several viewpoints:

(1) Dietary Supplement Viewpoint

For thousands of years, millions or billions of clinic practices and studies prove that herbs can effectively prevent, treat, and cure diseases rather than to simply supplement the diet. Therefore, it is inappropriate to classify herbs as dietary supplements.

(2) Efficacy Viewpoint

From the efficacy point of view, Herbal Medicine (as a generative or constructive medicine) is very effective in preventing, treating, and curing diseases. This therapeutic function is similar to the Western Medicine.

Generally speaking, Herbal Medicine takes effect slower but the results last longer than Western Medicine in treating diseases (There are, however, some cases in which Herbal Medicine works faster than Western Medicine). For acute diseases, Western Medicine usually works faster and more effectively in controlling the signs and symptoms. For chronic diseases, however, Herbal Medicine usually works more effectively than Western Medicine in treating the root cause of a disease.

Therefore, herbs should be classified as a category of products for medicinal use rather than as dietary supplements.

(3) Safety Viewpoint

From the safety point of view, herbs are usually safer than chemical drugs. Herbs are very different from chemical drugs in causing adverse side effects (Please refer to the previous recommendation). Therefore, herbs should not be classified into the category of chemical drugs.

Comparing with dietary supplements, however, herbs usually can be more dangerous if the herbs are prescribed inappropriately. Many situations may lead to herbal side effects (Please refer to the previous recommendation). Therefore, herbs should not be classified as dietary supplements.

Based on above discussion, herbs should be classified as a category:

(a) different from dietary supplements;

(b) for medicinal use;

(c) different from chemical drugs.

Due to above reasons, it is appropriate and necessary to establish a new category for herbs. This herbal category should be independent of, and between dietary supplements and chemical drugs. The definition of herbs in this category should contain the following characteristics:

(1) Efficacy: Herbs can prevent, treat, and cure diseases;

(2) Safety: Herbs are generally safer than chemical drugs, but may be more dangerous than dietary supplements;

(3) Mechanism, Rules, and Principles: The mechanism of Herbal Medicine does exist, but it is more complicated than Western Medicine. Herbal Medicine works under a set of rules and principles different from Western Medicine. Some holistic and module approach may be needed in elucidating the mechanism of Herbal Medicine.

This new classification of herbs will have the following functions:

(a) Send a clear message to the public that herbs are not dietary supplements. Herbs can be very dangerous if taken inappropriately. The public is not advised to take herbs at their own discretion. This will reduce the herbal side effects caused through inappropriate self-administration of herbs by the public.

(b) As a medicinal field, the profession of Herbal Medicine should be regulated. This will reduce the herbal side effects caused through administration of herbal remedies by unqualified practitioners of Herbal Medicine.

(c) With the decrease of herbal side effects and the increase of herbal therapeutic effects, insurance companies may be willing to pay for herbal treatments. As a result, more Americans will benefit from the natural, safe, and effective Herbal Medicine.

20 (d) The regulated and judicious use of herbal remedies will very likely provide solutions for some problems facing the American health care system today.

2. TCM vs Acupuncture

Currently, many people in America have an impression that “Traditional Chinese Medicine (TCM) is acupuncture, and acupuncture is TCM”.

This is, in fact, a misunderstanding about Chinese Medicine. As mentioned in the previous recommendation, TCM is composed of two parts: Herbal Medicine and Acupuncture (the Herbal Medicine is about ten to twenty times larger than the Acupuncture). To equal TCM to Acupuncture is to equal the whole (TCM) to a part (a smaller part: Acupuncture).

Above misunderstanding could actually obstruct the development of TCM in particular, and Complementary and Alternative Medicine (CAM) in general in the United States. If this situation continues, the American public will be unable to receive the vast amount of benefits that Chinese Herbal Medicine could offer. The profession of Chinese Medicine deeply believes that without Herbal Medicine (which is the main component of TCM), TCM could never be complete.

Reference

[1] FDA Overview of Dietary Supplements, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, January 3, 2001.

Acknowledgements

I would like to thank Dr. Stephen Groft, Executive Director of the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP), for calling me discussing the previous recommendation. Most thoughts in this supplement were triggered and developed from that conversation. Thanks also to Coordinator Bonnie J. McLaren of the Small Business Development Center at the College of DuPage for reviewing, editing, and commenting this and other projects.