4. FROM SINGLE-HERB REMEDY TO FORMULATED HERBALISM
4.1. 平衡之藝術 THE ART OF BALANCE
The Four Essentials:
Monarch, Minister, Adjuvant & Dispatcher
1. 君：主葯 Principal Herbs: Presidential Cabinet (Head)
2. 臣：輔葯 Assistant Herbs: Democratic Party (Left Arm)
3. 佐：製藥 Adjuvant Herbs: Republican Party (Right Arm)
4. 使：引葯 Dispatcher Herbs: News Media (Legs)
Example 1: 麻黃湯 Ma Huang Tang
Ephedra Decoction F010201
1. Principal Herb: 麻黃(ma huang) Ephedra sinica 12g
2. Assistant Herb: 桂枝(gui zhi) Cassia twig 9g
3. Adjuvant Herb: 杏仁(xing ren) Apricot kernel 15g
4. Dispatcher Herb: 甘草(gan cao) Glycyrrhiza glabra 6g
Example 2: 四君子湯 Si Jun Zi Tang
The Four Gentlemen Decoction F080101
1. Principal Herb: 人蔘(ren shen) Panax quinqueflium 12g
2. Assistant Herb: 白朮(bai shu) Atractylodes rhizome 9g
3. Adjuvant Herb: 茯苓(fu ling) Poria cocos 30g
4. Dispatcher Herb: 甘草(gan cao) Glycyrrhiza glabra 6g
Systematic Herbalism Principle 5:
The Golden Law of Balance and Harmony:
The effect of an unbalanced herbal
formula yields a tyranny of the dictatorial herb which might kill;
while the balanced formula provides a liberty of the democratic herbs which could heal.
A Hot Topic on a TCM Classroom Discussion
SHOULD FDA BAN ALL EPHEDRA CONTAINING PRODUCTS?
Published on Oracle20/20 Magazine, Volume 14 Issue 2, December 2003
Dr. J. J. L.:
Professor of
the H112 (Chinese Herbal Formulation I)
The lecture topic for today is The Art of Herbal Formula Design. In general speaking, there are four essential parts for a balanced herbal formula. The Four Essentials include the Principal, the Assistant, the Adjuvant, and the Dispatcher. In ancient China, medicine people traditionally described the Principal as an Emperor, the Assistant as a Minister, the Adjuvant as a Bishop, and the Dispatcher as an Ambassador. Well, it may be too difficult to understand this archetype of the old Chinese feudalist society; therefore let us now adopt a new model from the current American government system: the Principal as the Presidential Cabinet (head), the Assistant as the Republican Party (right arm), the Adjuvant as the Democratic Party (left arm), and the Dispatcher as the congress members (legs). Political parties always whistling each other create democracy, and democracy makes America strong. This similar philosophy can also be applied to the Four Essential Concept of the formula design. Compounding a variety of herbs with different, or even opposite characteristics, makes a more efficient, balanced, and safer formula. A Principal herb takes a place of leading effects in treating the main syndrome of a disease. An Assistant herb enhances the effects of the Principal herb. An Adjuvant herb assists both the Principal and the Assistant herbs by strengthening their main therapeutic effects, treating side symptoms, and eliminating the toxicity and the drastic actions that the principal or the Assistant herbs might have. A Dispatcher herb coordinates the various ingredients into the affected meridian sites.
Let us take the Ephedra Decoction (F010105) as an example: (1). Ephedra, as the Principal Herb, acting on the lung and urinary bladder meridians, is pungent in flavor and warm in property, and relieves the exterior cold or asthma syndrome. (2). Cinnamon twigs, as the Assistant Herb, also acting on the lung and urinary bladder meridians, is pungent and sweet in flavor and warm in property, reinforces Yang and promotes the flow of Qi. (3). Apricot kernel, as the Adjuvant Herb, acting on the lung and colon meridians, is bitter in flavor and warm in property, and reduces the adverse flow of Qi to relieve asthma. (4). Licorice root, as the Dispatcher Herb, acting on the lung meridian, harmonizes the dry and drastic reactions of both the Principal and the Assistant Herbs, and prevents the impairment of the genuine Qi. The compounding of the four herbs shows clearly their respective effects, primary and secondary, supplementing each other. Only in such a way, a more efficient, balanced, and safer herbal prescription is thus formulated. The effect of an unbalanced herbal formula yields a tyranny of the dictatorial herb which might kill; while the balanced one provides a liberty of the democratic herbs which could heal. Indeed, It was this Golden Law of Balance and Harmony that had also certainly lit Dr. Zhongshan Sun (Dr. Sun, Yet-Saint, originally a TCMD from the South) to lead the Chinese revolutionary people and successfully overthrow the last Mandarin Emperor of the Qing Dynasty, and then to be honored and remembered as the greatest National Founding Father of the United Republic of China.
Homework: After studying the concept of The Four Essentials, please present your opinion by email to me on the matter of whether the FDA should ban all Ephedra containing products.
Mr. S. B.:
Student of the H112 (Chinese Herbal Formulation I)
MT National Board Certified
I do not think the FDA should ban all Ephedra containing products. There is a problem with people using Ephedra for the wrong reasons, in unbalanced formulas, and without proper knowledge of its purpose. From the first article: 「the functions (of Ephedra) are to induce sweat, soothe breathing, and promote the excretion of urine. It is traditionally prescribed for typhoid fever, bad colds, fevers without sweat, pain over the body, pain in the joints, coughing, shortness of breath, and swelling of the ankles.」 In the cases where people blamed Ephedra for having negative effects, they were using it as a pep pill or as a diet supplement. These are not the intended uses for Ephedra. It seems to me that Ephedra, like anything we eat, has the potential to be harmful. It also seems like, for thousands of years, it has helped people with asthma and other problems.
The mission statement of the FDA is: 「The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our national food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public to get the accurate, science-based information they need to use medicines and foods to improve their health.」
My opinion is that the FDA should: (1) Require Ephedra only is sold by someone who has passed the National Board for Chinese Herbs. Even a formula that is balanced, such as Ephedra Decoction, can be harmful if used too long, or not followed by a clearing formula such as the Four Gentlemen Decoction. Each patient is different, and many patients will need to have their formula altered to have the proper effect. Without the knowledge that comes from being properly educated in Chinese Herbal Medicine, more people will be hurt by Ephedra in the Unites States. (2) Limit the uses to the original uses, until more research can be done on using it for energy or weight loss. Any herb needs to be balanced in a formula using the Four Essentials (Principal, Assistant, Adjuvant, and Dispatcher). Only someone trained in Chinese herbs would know this. (3) Put warning labels for amount of time the herb should be taken. Any herb should only be taken for a certain amount of time. Only someone trained in Chinese herbs would know this. Allowing people to use Ephedra as a stimulant or diet pill in the form now available is dangerous. Outlawing Ephedra is not a good solution because it is an effective herb for treating many conditions when used properly. Regulating Ephedra so as to ensure that people use the herb in a balanced formula may help this society to accept the Chinese medicinal methods.
Miss. W. L.:
Student of the H112 (Chinese Herbal Formulation I)
ARCB National Board Certified
The four essentials are principal herbs which are the main ingredients for the primary symptoms. Assistant Herbs are to help the principal herbs. Adjuvant Herbs are to help the principal and the Assistant Herbs and to tonify or counteract their toxic effects. Dispatcher Herbs can be a mediator of all other herbs or be a vehicle to the meridians.
In the Western world, the modern high-tech made it easy to isolate single ingredients from plants to make it into pills. However, Traditional Chinese Medicine was not intended to work in this way. Our formulation consists of four parts: he principal herbs, the assistant herbs, the adjuvant herbs and the dispatcher herbs. Make it easier to understand, principal herbs are just like the Presidential Cabinet, assistant herb is the Republican Party, adjuvant herb is the Democratic Party and dispatcher Herb is the Congressmen. As a whole group all work together to run the country to maintain balance of power. It is the same as our formulation. For example, ephedra decoction which contains ephedra, cassia twig, apricot kernel, and roasted licorice. This classic formula is for relieving exterior cold. Ephedra is the main herb to disperse the lung for relieve. Cassia twig is the assistant to dispel the cold while warming the meridian and activate the defensive Qi. Apricot kernel soothes the lung and roasted licorice mediates the drastic effect of ephedra. This is the way the Asian use the herbs. Therefore, if somebody taking the Ephedra Formula in pill form would not accumulate enough to harm.
The disputes of Mahuang (Ephedra) on the modern days actually happened in ancient China thousand s of years ago. The case was about a young man fell ill with profuse perspiration. A young herbalist prescribed Mahuang in large doses with the intention to produce quick results. Unexpectedly, the patient perspired even more that his arms and legs became as cold as ice. His entire body was shivering with cold. People brought him to his master. He gave him Mahuang again. This time, he was cured. Since then Mahuang had been under investigation. They found out that the leaves of Mahuang actually induce perspiration yet the root produces the opposite effect. The judgment is this herb would be marked as troublesome to remind people this accident and the valuable findings should be included in all herbal scripts. From then onwards, all Chinese herbal medicine books had a mark on using the herbs intermittently, particularly in chronic asthma. In addition, it is marked that this herb can also excite the cerebral cortex, which may lead to nervousness and insomnia. Ephedrine, I believe, is found in the leaves and pseudo-ephedrine is found in the root.
Another factor is cultural difference. The general public in the East understand the short term use of herbs to relieve symptoms and the long term use of herbs to tonify the body. In the West, people tend to relieve symptom fast without tonify the body. In order to get a rapid result, large doses should be administered. This would lead to harmful effects of the body like weakening the defensive Qi. As people do not have the concept of tonifying the body, the use of single herbs is very dangerous. In China, it is a common knowledge that ephedra is not for long term use, as people only know a little bit about this herb. Culture trains them to stop using the herbs if the body experience differently. However in the West, people are not instructed in understanding levels of Qi, Yin, and Yang. Without this background, they cannot be aware of the danger of long term use of single herbs.
Another difference in the culture is the consumption of coffee. Asian people do not drink as much coffee as westerners. The caffeine in coffee will boost up the effect of ephedra by 20%. Other medication that contains stimulants or recreational drugs will add up to the danger of using any counter drugs or dietary supplement that contains ephedra. The problem of ephedra arises from its use in weight loss products. These products contain a safe amount of ephedra. It is the long period use of the product that leads to the danger. In addition, the general public have no idea of intermittently use of herbs, of tonify the body and the huge consumption of other medication or drugs complicated the problem.
Ephedra is commonly use in the weight loss product. It is good because one can see the result in the first week because of the thermogenic effect. This rapid change explains why the herb is so popular. However, losing weight should be done through proper diet and exercise. There is no point of eating and resting a lot, then take ephedra to burn the extra fat. When things go wrong, the ephedra is labeled as the criminal.
If we banned the use of ephedra, it would push it into the black market and became a new form of drug. This would bring more harm than good to the public. Besides, people who need the benefits cannot get it. Ephedra itself is not harmful; it is harmful only because people abuse the use of herbs. The banning of this herb will lead to another question, what will be the next? Sooner or later the legal herbs will be limited, and then illegal drug business will flourish.
What about the herbs only are dispensed by licensed people? It is unlikely to be only those herbalists or natural healers. It would probably the medical doctors. However they have limited training in herbs. Furthermore, it is not hard to get these products from other countries or through the Internet. So this is a fruitless act.
The law means to protect the public. In my opinion, I think the package of any product containing ephedra should include a warning label just like cigarettes. It should have information on the side effect if combined with other stimulants as well as advisement on the rest period and to consult the doctor if there is any doubt. The manufacturer should be the one liable to the abusive use of the herbs.
As in modern language, if the presidential cabinet is in power and we only let the president to rule, without his own party to help and the other party to counteract or help, the government will easily become a dictator. Even worse without the congressmen to mediate, the country is in chaos situation. A good president needs his party support, the opposite part to watch out and the congressmen to deliver the order. Just like the formulation, it needs all herbs to work together.
Traditional Chinese Medicine is an art, and does not encourage a 「one size fits all」 mentality. The formulation varies with people, season, gender and the nature of the illness itself. The proper use of it will benefit us. Through this event I hope a fair judgment will pass down for ephedra.
I disagree to ban all ephedrine containing products. Our ancestor already handed down their wise judgment that lead to the use of this herb for thousand years.
Mr. A. J. G.:
Student of the H112 (Chinese Herbal Formulation I)
Reiki Master
In my opinion, the product Tylenol is more dangerous than Ephedra even when the Tylenol is used as instructed. Each and every argument that I read did not give enough clinical evidence for such strong action as a total ban on the use of this product. To date there has been one state legislature to ban the use of the drug state wide. I smell money; this herb is too valuable to the public to have is ban at the State or National government.
The company that was at the forefront of the Ephedra controversy is Metabolite, a multilevel marketing company. Money is all this type of organization is concerned with. How much research do you believe a company like that is going to perform before going public with the product and they prompted it as a weight lose product which is not what is should be used for?
Then the question of side effects, I have seen commercials on television for people who suffer for allergies that have side effects that are worse than Ephedra. An Example is Zola to lower cholesterol; the side effects are: increased blood pressure, diarrhea, and in certain cases can cause heart problems. It is fine for the medical establishment to prescribe this form of death. It is all about money and as soon as the big drug companies can package Ephedra it will be on back on the market without any concern. Like the case where a high school football player uses the herb and dies: this incident is sad, yet Ephedra is not the only drug that will kill you if not use it properly. Certain street drugs can be produce using this herb, but this particular street drug is already being produced with the aid of Ephedra, and therefore this argument has no basis for a ban.
There is also the problem of nationalism. The herb can be grown both in the United States and China and we are not talking about placing the ban on Ephedra shipped into this country from China. So if we go out west and gather the same plant and make the herb teas it will be legal, but if we use the Chinese』s herb we are breaking the law.
Without thinking about the laws that may or may not be passed, the only active compounds in Ephedra are alkaloids, ephedrine, and pseudoephedrine. There are indications that this herb can help individuals with are cold and flu, headache, nasal congestion under Traditional Chinese Medicine and on the Western terms it is considered to have diuretic, central nervous system, stimulating and anti-asthmatic effects.
After reading the article and doing some research about Ephedra (Ma-Huang in Chinese), it is my opinion that the drug should not be banned by the FDA. But because of the potential danger of the use of Ephedra it should be controlled and dispenses only by professionally qualified individuals, who have qualified by testing and have met other state or national requirements before being licensed to dispense the herb.
Therefore, in my opinion, the herb should be treated like medications only those who are licensed can dispense the herb.
Dr. C. G. J.:
Student of the H112 (Chinese Herbal Formulation I)
MD
The Four Essentials are a way in which to think about herbal therapy formulations. Each herb or set of herbs would have a principal ingredient, otherwise nicknamed the 「Monarch」. An herb assisting the principal herbal therapeutic action is nicknamed, the 「Minister」. An herb assisting the principal herb and balancing the effects of the 「Minister」 herb is nicknamed, the 「Adjuvant」. An herb in the formulation that makes the whole formulation move into action, so to speak, is nicknamed, the 「Dispatcher」.
An FDA ban on ALL ephedra products makes sense only in regard to protecting users from unscrupulous manufacturing and from improper use arising from ignorance or wishful thinking. A ban on ephedra would have the untoward effect of taking a therapeutic agent with a long history of relatively safe use out of the American formulary. Fundamentally, the question rests on whether the FDA has a statutory or moral obligation to protect citizens from predatory marketers and from their own ignorance. We know that caffeine is not banned, yet it too can cause hypertensive crisis or stroke when it is abused in the concentrated tablet form that is available at any truck stop. Similarly, ephedra products are also available at truck stops where they are promoted by predatory marketers making fantastically appealing claims. Medically speaking is ephedra abuse more likely to result in hypertension or stroke or cardiac arrhythmia than caffeine? This is probably so, especially when the ephedra is improperly prepared. Are vulnerable citizens likely to abuse ephedra? Some no doubt have done so, which is why we have the black cloud hanging over this herb, although when used in a classic Chinese herb formulation it may be harmless, or in fact be one of the Four Essential portions for that formulation to be effective.
In an unregulated market where the buyer must beware, any herb or pharmaceutical product is potentially just as harmful as ephedra to uneducated consumers. Antibiotics and heart medications are sold over-the-counter in countries without a central regulating body. Undoubtedly, some consumers have died as a result of improper use of these medications. Supposedly, the United States market is under FDA protection, which also relies on physicians to be gatekeepers and educators for the use of potentially harmful (and potentially helpful) medications. A new day is dawning. As a result of internet commerce, formerly regulated medications are now widely available to interested consumers. For example, vicodin, an addictive narcotic pain killer, can be ordered over the internet without physician, pharmacy or FDA scrutiny, just as addictive, illegal, non-pharmaceutical drugs continue to be bought and sold without regulation. If the buyer is now in charge, then with or without FDA action, that buyer must beware.
FDA regulation of manufacturing, quality control, truth in advertising, packaging and consumer warnings would make all herbal products more acceptable to an American public that is wary. Without knowledge of herbal products use and misuse, with no control over manufacturing processes, and with little knowledge of medication interactions, many Americans simply shy away from all Chinese herb formulations, much less from those containing ephedra. Abusive and predatory practices by some Chinese herb manufacturers, who have in some instances included prednisone or theophylline in their products, or have allowed pollutants and pesticides into them, makes Americans suspicious. They are used to some degree of protection afforded by FDA supervision. Although an FDA ban would be an extreme step, some cooperation between the FDA and herb formulae manufacturers would encourage more Americans to try Chinese herbs that may contribute significantly to illness prevention as well as treatment. A voluntary effort by herb manufacturers cooperating with the FDA may allow removal of predatory ephedra containing products from the market, and correspondingly permit a wider good perception of Chinese herbs in general. Doing so would also allow the continued use of ephedra when a formulation requires its presence to be safe and effective.
