【Pharmacology & 方剂学】Traditional Chinese Medicine (TCM) – Does its contemporary business booming and globalization really reconfirm its medical efficacy & safety?

Traditional Chinese Medicine (TCM) – Does its contemporary business booming and globalization really reconfirm its medical efficacy & safety? 笔记

1. Introduction

有几个国家同意中医

Promoting the globalization of TCM, Traditional Chinese medicine has been spread to 183 countries and regions around the world. 

According to the World Health Organization, 

• 103 member states have given approvalto the practice of acupuncture and moxibustion
• 29 have enacted special statutes on traditional medicine
• 18 have included acupuncture and moxibustion treatment in their medical insurance provisions 

2. What's in the TCM bottle?

The philosophy behind Chinese medicine is a melding of tenets from Buddhism, Confucianism, and the combined religious and philosophical ideas of Taoism. 

TCM is based on the concept that illness occurs when a person's “internal Qi” falls out of balance. 

• Qi: the word the Chinese use to describe the un-measurable energies that theoretically permeate everything in the universe. 

The herbal remedies, acupuncture, massage, breathing exercises, dietary therapy, moxibustion (burning of dried herbs above the patient's skin), and other traditional Chinese healing techniques are presumed to work by rebalancing the Qi that flows through the invisible channels of the body called a “Meridians”.

Conceptually TCM is based on an understanding of health and illness which differs substantially from that in modern medicine. 

TCM is based on holistic principles and emphasizes harmony with the universe. 

It has roots in 

• Chinese philosophy of Negative (Yin)– Positive (Yang) 
• Five Elements and its basic theory includes five - (Zang) organs and six-(Fu) organs
• qi (vital energy), blood, and meridians. 

Clinical phenomena were interpreted by reference to systems based on theories of bodily function and syndromes are differentiated according to the 4 pairs of contradictory principles 

• Negative (yin), positive (yang)
• exterior, interior
• cold, heat 
• deficiency (xu) and excess (shi)

These systems are interpreted within a more holistic observational diagnostic framework.

TCM: phenomenological (interpretive) paradigm

contemporary western medical system: reductionist (normative) paradigm 

3. The driving factors for TCM growth

目前获得GMP，也发展了许多剂型

To expand the market of TCM so as to promote the economic growth in China, the State Food Drug Administration (SFDA) has continuously deregulated the restrictions on TCM drug sales. 

The government began to classify prescription and OTC drugs in 1999. 

To date, 60,000 TCM and ethnic minority medical drugs have been approved

• 2088 pharmaceutical enterprises that have been approved by the Good Manufacturing Practice (GMP) of Medical Products are manufacturing Chinese patent medicines. 

The dosage forms of TCM medicines have increased from a traditionally limited number of forms such as 

• pills
• powders
• ointments
• pellets 

into more than 40, including 

• dropping pills
• tablets
• pods
• capsules, 

indicating marked improvement in the technological level of Chinese medicinal drug production, and 

initial establishment of a modern Chinese medicine industry based on the production of medicinal materials and industrial production and tied together by commerce. 

TCM has always been regarded as a symbol of Chinese civilization

With a history of 5000 years, TCM has been considered to be superior to the western modern medicine by those supporters

4. Traditional Chinese Medicine's efficacy – trick or treatment

相信的原因：历史悠久、副作用小

• Chinese people believe in TCM because of its long history of usage, traditions, faith, popularity, and related anecdotes. 
• Most Chinese people prefer traditional Chinese remedies to Western remedies because they believe TCM have fewer side effects and a recuperative effect on the body. 

科学上无法解释

• However, in scientific points, most of TCM practices have seldom been verified by randomized controlled trials (RCT). 
• The critical puzzles are these aspects of TCM's concepts on the human body, health. 
• Its concept about diseases cannot be explained by modern medical theory. 
• For example:
• it is difficult to prove the concepts of Yin (Negative) and Yang (Positive), Qi (Gas or Energy), Six Exogenous Pathogenic Factors (Six Yin). 
• The concepts of Five Elements, Chinese 5 - (Zangs) Organs and Chinese 6 - (Fu) organs, Xue (Blood), Qi (energy). 
• Meridians have not been confirmed easily. 

所有科学认证的都需要实验，因此中医必须做科学研究

All these concepts could be ancient people's philosophical thinking or imagination, which seem to be “right” but cannot be testified by any scientific approach.

In modern science field, any concept, which is the basic component of hypotheses is strictly defined and the hypothesis should be thoroughly and rigorously tested by experiments. 

Once the hypothesis has been proven, it becomes a theory accepted by the majority of scientists and could be applied and deduced in its specified situation. 

Honestly speaking, the concepts of TCM were not tested by experiments. Therefore, there is an urgent need to evaluate TCM and TCM practices.

5. Is TCM clinical effective?

TCM therapy largely consists of 

    1. Chinese Herbal Medicine (CHM)

    2. Acupuncture

    3. Dietary therapy

    4. TuiNa (massage)

    5. Cupping

    6. Guasha, etc.

The above item 3 to 6 can be explained easily, 

• since they are not different from that in any other country. 
• may be used as alternative methods (or self health practices) for helping some patients with minor uncomfortable conditions
• cannot be used as standard treatments for any specific disease.
• In literatures, much of the scientific research on TCM has been done on acupuncture, but the effectiveness of acupuncture remains controversial in the scientific community. 

争议：针灸有无有效

The 1997 NIH Conference Statement on acupuncture concluded: …promising results have emerged, 

for example, showing efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. 显示针灸对成人术后和化疗恶心和呕吐以及术后牙痛的疗效。

There are other situations such as 

• addiction
• stroke rehabilitation
• headache
• menstrual cramps
• tennis elbow
• fibromyalgia
• myofascial pain
• osteoarthritis
• low back pain
• carpal tunnel syndrome
• asthma
• in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program 

But in 2008, Singh and Ernst, after reviewing Acupuncture papers, concluded that there was 

• no scientific basis for the concept of meridians
• no high-quality evidence testifying to the benefits of acupuncture beyond a placebo effect.
•  found the absence of an appropriate control for acupuncture in early clinical trials
• cited recent trials in which it was found that several types of sham or unconventional acupuncture (using unconventional points or telescoping needles) were as effective as traditional acupuncture for the relief of pain

有些公司为了卖中药，编造文章

Historically in China, the herbal industry was not required to conduct any research rigorously in randomized controlled trials (RCT). 

Some experts such as Dr. Jinling Tang advocates applying RCT and reliable data to assess TCM, yet herb medicine companies argued that it was difficult to do herb medicine studies because of numerous reasons they can list (personalized treatment, no way to have control group, etc.). 

However, in order to promote their products, companies had sponsored socalled clinical trials, claimed that positive results of the clinical trials on herbal products were reported in recent years. Vickers A, 

Goyal N etc. found that published clinical trials conducted in China almost never reported an experimental treatment to be equal or inferior to control

实验发现中药没有像历史那样有效

但中医是辨证论治的，所以实验不能进行

There are a few important studies showed some herb medicines,

which were thought to be useful, were not effective as history data described. 

For example, Dr. Kapil K. Soni and his team studied 

• Black cohosh 
• [Actaea racemosa L., formerly Cimicifuga racemosa (L.) Nutt.],
• herbal medicine that has been used in the United States for over 100 years for the treatment of many conditions, including menopausal symptoms. 
• unresolved issues include quality, safety, and efficacy. 

conclusion: unless these issues are solved, the use of black cohosh products shall not be recommended.

However, TCM practitioners and herb traders praise highly of treatment based on syndrome differentiation

even if patients have the same syndrome and clinical manifestation in modern medicine, TCM practitioners will give them different remedies as TCM treatment is individual, 

Under such circumstances, randomized controlled trials cannot be undertaken as RCT requires patients with similar disease who apply similar treatments

中医理论的矛盾：

一些慢性疾病可通过良好的习惯而改善

有安慰剂的效果

如果每个人都是特别的，那怎么有basic 治疗？

These arguments sound plausible but actually are full of inconsistencies. 

• Firstly, diseases have their own development process, and some chronic diseases can be controlled well with healthy diet, appropriate exercises and positive attitude. 
• Secondly, Patient will feel better if his doctor pays more attention on him even no effective remedy used. That is why placebo will also take effect in some patients. 
• Finally, Dr. Austin B. Hill challenged individual traditional treatment 60 years ago: “The most frequent and the most foolish criticism of the statistical approach in medicine is that human beings are too variable to allow of the contrasts inherent in a controlled trial of a remedy. If each patient is unique, how can a basis for treatment be found in the past observations of other patients?” .

中药提取物造成的事端

As TCM has booming in China, the ignorance of the importance of RCT in TCM assessment resulted in some painful incidences. 

Recently, the innovative herb-extracts injections have resulted in many medical incidents in China. 

For example, on October 6, 2008, SFDA (State Food and Drug Administration) received 6 patients' serious adverse reaction report from Yunnan Provincial SFDA. 

• Three out of the 6 patients died. 
• The good thing now is that China government has required to reevaluate all TCM injectable formulations since 2010 

6. There is a Chinese saying TCM's efficacy is for chronic diseases, is it true?

慢性疾病患者通常需要心理安慰

• In China, when a patient suffered acute discomfort, if the patient got a confirmed diagnosis and the disease can be cured immediately by modern medicine. 
• The patient will be happy and just go to modern hospital, never go to see TCM doctors. 
• With increasing number of aging people, there are more severe diseases among the aging patients, while some of chronic diseases are not curable easily. 
• For these incurable patients, they may try both modern medicine and TCM. 
• In China, the modern hospitals are located in big cities, and there was no good system which patients can make appointments with doctors, so the hospitals were very crowded. 
• The doctors' average enquiry time for patients would be only several minutes, while patients must spend several hours waiting to see a doctor in these big hospitals. 
• Because of no immediate modern medicine's efficacy for most of chronic diseases, patients are not happy with the big hospitals' treatment. 
• In fact, as to the patients with Chronic diseases, their psychological and spiritual supporting needs are neglected by modern medicine practitioners because of doctors' no time to consul to these patients. 
• The patients lose confidence on modern doctors.

All these factors make the patients with chronic diseases go to see traditional medicine practitioners. 

中医私人诊所会花较多时间跟病人交流，久而久之中医成为治疗慢性疾病

• Whereas, traditional medicine practitioners in private clinics with few patients are able to spend much more time in communicating with and comforting their patients and thus keep much closer relationships with patients. 
• The patients, especially the aged and chronic disease sufferers, will get great psychological and spiritual satisfaction from the traditional medicine practitioners and then they will have an illusion of symptom abatement by psychological implication. 
• In that case, a good patient-doctor relationship has been established, as well as the confidence on TCM.
• Based on the above analysis, it is believed that Chinese modern doctors focused on the diseases of patients, not for the patients' needs & feeling. 
• When the patients did not get immediate effective treatment, they will go to TCM doctors. 
• As the time goes on, most lay Chinese people believe that the modern medicines are for acute diseases, TCM for chronic diseases.

Taking examples, patients with cancer, or organ failure, or dementia will have to live a low quality of life for their rest years. 

For these kinds of patients, besides relieving physical illness, patients' psychological, social and spiritual needs play more and more important roles in patients' satisfaction. A modern drug's treatment for his/her disease maybe not effective enough to his needs, which drives patients to find other alternative TCM ways. 

Any patient will feel better if his doctors pay more attention to him/her even no effective remedy was used for his/ her disease

7. Will TCM be for health improvement or for diseases treatment?

作者认为中医需要管制

In the field of diseases treatment market, TCM should have some regulatory guidelines like Directive 2004/24/EC

8. The combination of TCM with modern scientific system

中药成就：青蒿素

• There is no doubt that TCM itself has the huge potential to be explored for different diseases. 
• The biggest success is the discovery of artemisinin (Qinghaosu) from Chinese herb, which is used against a life-threatening disease Malaria caused by Plasmodium falciparum.
• Currently, artemisinin has been developed into a class of drugs and a standard treatment for P. falciparum, which saves millions of patients suffering from the malaria.

作者认为中西结合使得青蒿素成功

中药需要更多研究

但如果成功研究，中药显着促进针对目前不治之症的治疗方法的发展

• Therefore, the author believed that the combination of Chinese herb with modern scientific system is the genuine reason that thousands of patients with malaria every year can be treated with effective drugs. 
• It is indicated that concluded experience from TCM is valuable that can help scientists research the new drugs. 
• However, the current understanding about Chinese herbs, especially about their natural component and mechanism, is still little. 
• In other words, the research of a new candidate needs to be carefully validated step by step likewhat artemisinin experienced. TCM dose have many years of history in China and saved countless lives but it does not mean that it is special enough to jump
• the scientific validation into clinic. 
• On the contrary, as if TCM validated by right system, it can significantly promote the development of treatments for those currently incurable diseases.
  

9. Summary

国际化的方向：科学化，EU管制中药品质，中医师要良好的教育

• The main properties of a world-view are coherence and fidelity to experience. 
• If TCM would be accepted internationally, it must be faithful to the real experience and it cannot contradict rational knowledge. 
• No matter how important now TCM may be, we are not satisfied with merely knowing it.
• We need to understand it, gain insight into it and explain it.
• Thousand years' experience on practice is not a rationale to use TCM, we must keep the quality up and unveil its mystery. 
• To guarantee the quality of Chinese herb medicine, the EU regulatory framework of herbal medicine products should be a good example for China to learn from. 
• It is critical to develop China's monographs and list entries in future for all TCM usage so that we can throw the rubbish away.
• It is also important to make the practitioner's registration system
• function well in China. Health care management is a big market. Considering its special demand, it is important to have it developed in a scientific way, the priority of which is that practitioners are prepared with well education and high moral standard. 
• TCM booming in China does not imply its good efficacy and well safety.