Herbal Research: Understanding the principles of herbal formulary in Traditional Chinese Medicine

Paul L. Reller L.Ac. / Last Updated: August 03, 2017

How Do Herbal Formulas Work?

Centuries of scientific study have been conducted to understand how herbal medicines really work. Modern pharmaceutical interests would have the public believe that these herbs were found yesterday and that no scientific knowledge confirms their effects. This is patently untrue and based upon commercial rather than scientific interest. In many cases the reverse is true.

The contrast between traditional herbal medicine and modern pharmacological remedies is distinct. New pharmaceutical drugs are often being rushed to market before sufficient scientific review has determined safety and efficacy, especially with long term adverse health effects, while the safety and efficacy of traditional herbal formulas have been documented in China for centuries. Today, study done by the pharmaceutical company, or funded by the company, is highly suspect and often is found to be fraudulent and criminally misleading, as in the famous case of the Vioxx (cox2 inhibitor non-steroidal anti-inflammatory), where evidence of serious risk to patients with cardiovascular pathology was withheld from the study results submitted to the FDA. Such hidden harm and risk results in enormous court settlements for injury to patients, yet is largely ignored by the general public. Dr. Howard Brody, in his book Hooked –Ethics, the Medical Profession and the Pharmaceutical Industry, states: “Research that is driven by marketing rather than scientific aims would seem, in the end, to be low-quality research" and “Medicine has for many decades now been betraying this public trust." Even in public health research, the data has become suspect. In 2005, the National Institute of Health used an anonymous questionnaire to find that over 40 percent of their medical researchers admitted to taking pharmaceutical money to alter study findings. While research into herbal chemistry and effects may also be subjected to manipulation, it would be impossible to alter the scientific findings of thousands of years of research, and so we must revisit both the empirical, theoretical and anecdotal evidence of past centuries, and find a true foundation for current scientific research in herbal formulary. Plus, with limited profit to be made in the professional herbal industry, the temptation to alter scientific research for profit is minimal.

Twentieth century scientific study of herbal medicines is prolific, yet the modern medical industry would have us believe that it hardly exists, holding the standard of research to impossible to meet clinical trial guidelines that were set up to evaluate safety of specific chemicals, not the quantum field of chemistry that we see in herbal formula, and rarely publishing high quality research in standard Western medical journals. Herbal medicines comprised almost 100 percent of the sources of pharmaceutical chemicals before World War II, and herbal research continues to supply the pharmaceutical industry with new useful ideas in creating synthetic medicines even today. Modern scientific industry devoted much study, in modern scientific laboratories, to the study of herbal chemistry and the effects on the patient before our current system dominated by patented synthetic chemistry. The same herbs are being used today that were used throughout history, and therefore, much scientific evidence of herbal medicines must exist, yet it is often now hard to find. It has been systematically erased. Our challenge as herbal physicians is to find this information and represent it to the world. Not only the scientific facts of individual herbs, but the facts concerning combinations of herbal chemicals in formula and pairing must be again made readily available to the public. With a renewed interest in herbal medicine by the public worldwide, the insistence in standard medicine that this scientific realm is somehow invalid is absurd.

In the United States, herbal medicine, dominated by a rich and developed science of Native American Herbalism, was the most popular type of medical treatment at the turn of the 20th century, and schools of medicine even in standard Eurocentric practice touted not only this rich history of Native American Medicine, but also the importance of a Complementary and Integrative Medicine (CIM). The specialty of Eclectic Medicine, integrating European and Native American systems and treatments, was a very popular and effective school of medicine that thrived between 1825 and 1939, until laws restricting the Medical Doctor degree to University programs, and the strength of the American Medical Association, succeeded in making the practice of Eclectic, or Integrated, medicine monetarily impractical. Eclectic is a term meaning a blend of ideas from a broad and diverse range of sources, and is a historical term denoting a class of philosophers who rejected adherence to any specific formal school of thought, and were free to integrate their sources of knowledge. Eclectic Medicine, in effect Complementary and Integrative Medicine, was one of a group of schools of Reform Medicine, along with Thomsonianism, Osteopathy, Chiropractry, Homeopathy, and Natural Hygiene. Eclectic Medicine and Thomsonianism integrated Native American Herbalism to a great degree in practice. At the beginning of the 19th century there were only 4 medical schools in the United States, and the great majority of physicians apprenticed to Doctors who received their training in Europe. The rise of Heroic Medicine, a medical philosophy based on the ideas of Dr. Benjamin Rush, which carried the British school of thought centered on Galen and Paracelsus to extremes, creating new treatments that used more extreme bleeding and purging, along with imbalanced use of mercury (calomel) and other harsh commercial products that were decried by European proponents of Paracelsian Medicine, prompted a broad distrust of standard medicine, echoed in statements even from Thomas Jefferson. The French School of Empiricism, touted by such famed physicians as Dr. Elisha Bartlett and Dr. Jacob Bigelow, touted a medicine that returned to a more Hippocratic notion and true adherence to Paracelsus ideas, that the chief role of medicine is to help the body heal itself, or regain homeostasis, and a renewed emphasis on empirical evidence of efficacy, with a broader use of the herbal Materia Medica. When the medical field was deregulated by President Andrew Jackson in the mid-19th century, Dr. C.S. Rafinesque, or Constantine Samuel Rafinesque (1783-1840), primarily a professor of botany who researched the Native American Medical Flora, established a large compendium of research of Native American herbal medicines, and other integrated healing practices of the Choctaw, Chickasaw and Cherokee physicians, and 'country doctors' of the European heritage, who made up the vast majority of American doctors, and integrated this Native American Medicine, along with Samuel Thompson (1769-1843), an expert on Native American hebalism and botany, who created a Thomsonian Movement that at its height had more than 3 million followers, the successful practice of these Complementary and Integrative Medicine schools became the most popular form of medicine in the United States. The success of this traditional American CIM was based both on effectiveness and lack of adverse side effects. Unfortunately, this rich history of both European and Native American herbalism was all but erased from the history books and practice by the mid-20th century.

While modern pharmaceutical science has led to a focus on particular molecules and effects, the science of the many symbiotic chemicals evolved in plants may present guidance for another paradigm shift in pharmaceutical research, a sort of quantum outlook for chemistry. Already, the evolved homeostatic chemistry of the human organism has created a paradigm shift in modern pharmaceutical research toward 'biologics", or chemicals that stimulate or inhibit (agonists or antagonists) normal homeostatic biological mechanisms. Another paradigm shift may soon occur, as the science realizes that combinations of chemicals may be needed to achieve safer and more dramatic restoration of homeostatic health. Understanding the history of herbal formulary may help in this regard. This quantum field approach to medical research has already begun with the call for a 'Big Data Analytics' in medical research by a number of esteemed universities. This approach, with thorough analysis of all data sources, has already been applied to medical diagnosis and treatment design with the advent of outcome-based payment measures in healthcare reform, and may now be applied to medical research as well. Complex computer algorithms will need to be devised to analyze data from empirical data, clinical outcomes, in vivo and in vitro studies, and RCTs (randomized controlled trials with human subjects or laboratory animals), and also to analyze the effects of combined protocols, but the benefits of such research on refining care may be dramatic.

The investment in Big Data Analytic approaches in herbal medicine, also called data-driven techniques and knowledge discovery approaches, could pay big dividends for the pharmaceutical industry as well as Complementary and Integrative Medicine (CIM). Many chemical discoveries with great benefits in standard pharmacological care still come from analysis of herbal chemistry. Plants, and insects, have evolved many chemicals to achieve protective and healing effects that apply to human disease and injury, and finding the most potent of these has long been a big part of pharmacological research. In the 21st century, though, we have finally evolved scientifically to understand that there is much more potential in finding normal 'biologic' effects from medicines, restoring the homeostatic balance that keeps us healthy and functional, rather than altering that programmed biological homeostasis to fix problems. Both of these approaches are valid, but need to be integrated to achieve the best results with the fewest adverse effects. We are also finally understanding that the human organism functions in a complex and fluid quantum field of biochemical effects, not just each chemical molecule in the body acting alone to maintain or alter some biological mechanism. Most chemical mediators in the body, or cytokines, chemokines, hormones, etc. act differently when surrounded by different chemicals, in effect working as a team, or a quantum field, and not just performing one task. Actually, we now know from mapping the human genome that our genes express many different protein mediators, such as cytokines and enzymes, from the same part of the DNA, depending on not only other surrounding genes and their activities, but on the molecules surrounding the DNA, the Epigenome. The entire organism acts as a quantum field of biochemical effects, not as a static set of molecules that have a certain level or amount, and perform just one task, yet our biological sciences still teach chemistry as a set of static equations, and our research still acts like these molecules and genes can be isolated and affected without causing a field of unwanted effects. Because of this, we are creating more and more pharmaceutical medicines with larger and larger lists of unwanted adverse health effects, which we call side effects. These effects are not just on the side, though, but part of a quantum field of actual effects, which we just choose to ignore in the whole picture of healthcare.

Advances in research such as Metabolomics, where mass spectrometers and high-resolution MRI technologies are combined to analyze the quantum field of small molecules in bodily fluids and tissues, and their interactions, provide us with the ability to assess a more complex field of biological events in research. This is surely needed to actually assess the real benefits of herbal formulas, where so many chemicals act synergistically to achieve a variety of biological goals. By investing in herbal research with not only specific chemicals in an herb, but the whole interacting mix of chemicals, and the effects of mixing many chemicals in herbal formulas, we may find many new ways to better utilize herbal medicine and to integrate it with pharmacological care, enhancing both the results of Complementary and Integrative herbal medicine and enhancing the overall effectiveness of new and current pharmaceutical interventions. Big Data Analysis lets us use our developing computer sciences to develop a protocol called Observational Comparative Effectiveness Research (CER) as well. Here, instead of taking a strict binary stand, to be for or against herbal medicine, or to irrationally believe that herbal medicine either works or it doesn't work, we actually put the objective data together in a big field of facts and use Big Data Analysis to find what works in combinations of therapies for individuals or subsets of the patient population, to achieve the best outcome effects, with the fewest risks and adverse effects. Instead of using Big Data Analysis and CER to promote only standard medicine, which is surely what we will see happen for the most part, our healthcare research could instead open these research devices to integrate herbal and nutrient medicine into the overall treatment strategy. While the present system of reimbursement in healthcare discourages these integrative researches and treatment protocols by establishing reimbursement and profit based on the most expensive set of individual treatments, healthcare is now moving towards reimbursement based on outcome measures, which will favor the inclusion of Complementary and Integrative Medicine and low-cost and risk-free Traditional Chinese Medicine (CIM/TCM). A great leap forward could be achieved with this new attitude toward healthcare and health research, and the patients would be the beneficiaries. It is time for the public to finally exert some controlling influence on this vital arena of healthcare, instead of meekly going along with whatever the business authorities present. As we start to utilize these systems of Big Data Analysis and Observational Comparative Effectiveness Research (CER) in herbal research, the field of herbal medicine, and especially Chinese Herbal Medicine, will be able to further refine this complex field of treatment.

A Brief History of Chinese Herbal Formulary

The most systematic of the herbal systems is from China, where continuity of research has never faltered. China was the first culture to systematically organize herbs according to chemical content, effects on the organ systems, and therapeutic actions. This was achieved before microscopic analysis was possible, by determining that predominance of certain chemicals produced consistent properties of taste, color, aroma, warming or cooling action, and levels of toxicity.

The first known text to define herbs this way was written in the first century A.D. and based on centuries of oral tradition. Before this, alchemists had achieved much knowledge of the mineral contents of herbs and mineral medicines and the ways to chemically transform and alter mineral chemistry and the effects on the biological organism. Alchemical and protochemical study had started to identify more than the known minerals by the first century A.D. though, and interest in classifying the chemistry in combinations of plant and mineral medicinals reached a height. A text from the 220 A.D. titled Treatise on Cold Disease Damage (Shang Han Lun) is the oldest preserved complete clinical textbook on herbal formulary in world history and outlines the theories of herbal combination and preparation (Pao zhi) into formulas. Shang han is also a term used for Typhoid fever and febrile diseases in general, or endemic disease, but in Daoist theory, the 5 types of disease caused by the element of Cold in Nature dominated this theoretical discussion of endemic disease in China. One naturally asks why febrile diseases are classified as Cold. When interpreting these elemental Daoist terms, we have to see the term for what it meant in context, not what it means in our common experience. For instance, Cold as an element refers to less energetic characteristics, deficient function, slowed circulation, less caloric heat, etc. The 5 types of damage from Cold disease explained in the Nan Jing, question 58, are strokes, colds, inflammatory swellings, febrile diseases, and mental suffering, or depression. We see from this answer that all of these damages from elemental Cold imply damage to functional systems, the nervous system, the immune system, the inflammatory system, etc. The Shang Han Lun dealt with herbal formulas individualized from a template for endemic febrile disease, and a system for this individualized herbal formulation. Formulas in Chinese medicine utilize a group of supporting herbs to increase effect, counter toxicity or side-effects, balance the effects on the organ systems, and produce therapeutic effects that support the main goal. One goal of formulas is to promote general health while achieving a therapeutic goal. This is in a sense opposite to modern allopathic pharmacology, which most often seeks to alter body chemistry in a specific way while disregarding the effects on general health, and hence produces many adverse side effects. Modern pharmaceutical practice could benefit greatly from integrating a broader and synergistic approach to counter toxic adverse effects of pharmaceuticals with integration of complement herbal medicine, and the only real reason this is not being adopted is the fact that herbal medicine cannot be patented and is thought to compete monetarily with patented drugs.

In the preface to the Shang Han Lun, the author, or authors, explain that when endemic disease strikes, the public panics, and resort to all sorts of dramatic cures, but fails to adhere to what is sensible, namely, supporting their vitality even as they fight the disease. They "surrender their willpower and bend their integrity", having been given this life of 100 years of productivity and learning, they panic and give it up to achieve a dramatic cure. The authors talk in general of civilization giving up their natural integrity with utter disregard, creating a society where they are now threatened by serious health threats and depend on a narrow branch of medical marvels to keep saving them, rather than to adhere to natural healthy principles and maintain a balanced homeostasis and health aging, or longevity (yang shen), and "inclined to the mundane, compete in a chase for superficial glory, but fail to secure the root. They forget the body (mind and soul) in pursuit of external things, and place themselves at risk, as if (treading on) ice in a (deep) gorge." The author or authors of the Shang Han Lun, namely Zhang Zhonjing and/or Wang Shuhe, state that faced with this shortcoming in societal attitude, and with the failure to rescue their patients from such a disastrous attitude to health, that they sought out historical texts to refine the methods for herbal formulary, choosing the Su Wen, the Ling Shu (books of the Huang Di de Nei Jing), the Yin Yang Da Lun (Grand Treatise on Yin and Yang), the Tai Lu Yao Lu, and the Ping Mai Bian Zheng (Differentiation of Signs in Normal Pulses) to compose this example of how to create herbal formulas that both cure the immediate disease and maintain the root vitality (the 'branch and the root'). The author or authors, namely write in the preface: "When I look at today's doctors, they do not study and ponder the meaning of the classics in order to advance what they know. Each has inherited his family's skills and from beginning to end merely follows along in the old ways. In examining the illness and inquiring after the disease, their service is limited to fancy words, and after just an instant of face-to-face interaction, they prescribe decoctions and medicines... In such a short time period, they are unable to know a determined diagnosis and they have never had anything resembling the nine indicators... This is what I call looking through a narrow tube of bamboo and that is all!" How amazing that this criticism of standard medicine from about 220 AD still applies today!

The rich history of Chinese herbal formulary is rooted in the text now entitled the Ben Cao Jing, attributed to the historical sovereign of herbal medical theory, Shen Nong. Depending on the version of history in Chinese civilization, Shen Nong was one of the 3 Sovereigns and 5 Emperors of modern Chinese civilization, beginning in approximately 2800 BCE, and differing versions of the origins of Chinese civilization include Shen Nong, Fu Xi, Nu Wa, Sui Ren, Zhu Rong, Gong Gong, Huang Di, and the mythical Earthly, Human and Heavenly Sovereigns. No matter how the story was told, Shen Nong was credited with organization of knowledge of agricultural and medicinal plants. The modern version of the Shen Nong Ben Cao Jing is divided into 3 sections, describing the basic Materia Medica of non-toxic herbs and tonics, mildly toxic herbs to clear pathogenic properties, and stronger herbs and minerals that are more toxic and need to be prepared to reduce toxicity and combined with other mollifying herbs. The actual Shen Nong, whose full title is Yan Di Shen Nong Shi (Fire Emperor Divine Farmer and Master), lived in the Western province now known as Sha An Xi, near the ancient capital of Xian, near the Hua Shan mountain range. Shen Nong is said to have helped this civilization develop a plant-based diet, cultivate grains as staple foods, and organize herbal medicines. The earliest preserved mention of the Shen Nong Ben Cao Jing, though, dates to about 220 AD, suggesting its modern form originating in the Han Dynasty after the purge of books by the Qin Emperor. The actual origins of the text and science must be pieced together historically. This present form of the herbal classic was printed by Tao Hongjing in about 500 AD, and the organization of the text may be largely attributed to the interpretations of a number of great physicians from this time. Before the printing press in about 250 AD and the typeset ceramic press in about 1000 AD, these texts were largely handwritten and varied in content, and the materials used for the books have largely deteriorated in their original forms.

The Shen Nong Ben Cao Jing, though, is the first printed text that outlines the theories of protochemistry in herbal medicine, using taste, color, and other properties to define herbs into protochemical categories, that correspond to modern chemical constituents. A number of systems in the text outline a variety of methods of protochemical organization and formulary, creating a rich template for future work. The 3 categories of herbal medicines in the Shen Nong Ben Cao Jing also imply that many herbs may be used to prevent disease and improve health, others to cure disease and relieve symptoms, as well as promote healthy aging and cognitive, or psychic improvement, and then a third lower, or cruder, class of herbs may be used to alter homeostasis, an allopathic approach, with caution concerning adverse side effects and hence limiting the dosage and course of treatment. The benefits of these approaches would be debated for centuries in China, Europe and around the planet. Eventually, the stronger allopathic approach was chosen as a preferred medical approach, mainly because it produce dramatic results that impressed both physicians and patients. The gentler class of herbal medicines perhaps did the most good, but often these results were hard to see, as preventive medicine produced effects that were not especially certain to the immediate view, but depended more on a higher knowledge of what might have been if you didn't take these medicines. Over time, these herbal medicines were referred to in Europe as simple folk remedies and derided. Great physicians such as Paracelsus tried to bring back a focus on these preventive medicines, incorporating them into European medicine, but he was eventually ridiculed in history, despite his obvious brilliance and contribution to many aspects of modern medicine and chemistry. A one-size-fits-all mentality triumphed time and time again. Today, the struggle to integrate these concepts into medical practice continues, and is still fought fiercely, sides are taken, and a failure to come to a sensible holistic conclusion is thwarted time and time again. Complementary and Integrative Medicine continues to attempt integrating all of these concepts into medical practice.

The height of study of herbal formulary development in China occurred perhaps in the Ming Dynasty with Li Shi-zhen (1518-1593) and the Ben Cao Gang Mu, or Great Compendium of the Herbal Materia Medica, considered the most complete and comprehensive medical text ever written, and completely integrated with what is now considered the Complementary Medicine specialty of Traditional Chinese Medicine. The first draft of the Ben Cao Gang Mu was completed in 1578, roughly along the timeline of the development of Philosophical Medicine by Paracelsus, and Helmontian Medicine, both of which tried to integrate the holistic and traditional medicines with a focus on a new scientific methodology. Li Shi-zhen also tried to clarify the pathology of disease based on objective scientific observation and study, but to integrate philosophical medicine and traditional approaches. This important extent medical text was quickly translated into Latin, French, German, English, Russian, Japanese and Korean, and became an important clinical guide for the whole of Eurasia, describing 11,096 prescriptions for treating many hundreds of illnesses, and describing 1892 drugs, herbal preparations and formulas. The comprehensive text filled 52 volumes and took 38 years to write. This text sought to clarify herbal formulas by better identifying the specific ingredients in terms of the actual product and place of origin, the chemical substance, and procedures of preparation, and then the therapeutic approach to utilization of the formulas for a set of diseases. The size of this text has limited its availability in modern English translation, as well as the difficulty in accurately translating the terminology. A 4 volume dictionary of the terminology was published and released in 2015 by the University of California Press, edited by Zhang Zhibin and Paul U. Unschuld. Dr. Unschuld presents his own view of the meaning of many of the traditional terms, though, and has stuck to a Eurocentric translation in many cases. A 6 volume hardcover version was introduced in 2006, edited and translated by Li Shizhen, but comes at a cost of nearly $1200. This work represents the modern attempts to objectively refine the science of herbal formulary in a complex manner that is analogous to the present attempts at again re-introducing herbal formulary into modern evidence-based medicine in a more useful way. Such institutions as the Centre for Chinese Medicine Research and Development at The Hong Kong University of Science and Technology are devoted to bringing TCM formulary into this accepted realm as standard medicine.

The historical practice of Chinese herbal formulary was never separated from nutrient medicine, though, but integrated to complete the effects of the formulas. The famous book of the Nei Jing, the Su Wen, states that ancient xi'an, or Daoist sages, lived out their long lives with great health mainly because they "apprehended the Dao (the Way of Nature) and took yin and yang as their pattern, harmonized themselves through the regularities of (life sustaining) techniques (shu shu), moderated their diets, lived in a regular way, and did not exhaust themselves through undisciplined activities." While historians refer to these sages as "the immortals" (xi'an), it is clear from the numerous writings that these texts merely advised a sensible diet and lifestyle to maintain health within the allotted time span of 100 years. So too, with the taking of medicines to cure disease, the Su Wen stated that "toxic drugs attack agents of disease; and the 5 (types of) cereals provide nutriment (to supplement the drug); the 5 (types of) fruits assist them, the 5 (types of) meats aid them, and the 5 (types of) vegetables reinforce therm. Thus they are ingested in a way that balances the (Ying) Qi and the Wei (Qi), so as to replenish the Jing and the Qi." Future physicians expanded on this idea that nutrient medicine was integral to herbal medicines, suggesting that the science of diet and nutrients could be twice as effective as medicines, especially as patients were often reluctant to take medicines, but always enjoyed food. Herbal formulas were important, but the importance of educating the public to the medicinal characteristics of the food they ate were perhaps even more important, and the two strategies should always be used together.

The rich history of Chinese herbal formulary is thus holistic with diet and lifestyle. Today, this system of herbal formulary needs to be integrated with modern evidence-based medicine, but to do so is a daunting task. Scientific studies to evaluate medical treatment relies mainly on the system set up to judge safety of pharmaceutical medicine, not efficacy. A system of determining the level of safety in many new pharmacological treatments involving toxicity and adverse health effects was devised that judged the efficacy, or effectiveness of the treatment, to compare to the relative risk, called the risk versus benefit value. Eventually, this type of determination of benefit was used to judge both acupuncture and herbal medicine, as well as nutrient medicine to some extent. This system ignored that fact that acupuncture and herbal medicine was set up to present only treatments without health risk as standard treatment, and ignored that fact that manual therapies, such as acupuncture stimulation, physiotherapies, and surgeries were not routinely held to this type of evaluation strategy set up to determine the efficacy of pharmaceuticals compared to the most important consideration, the health risk. Surgeries and physiotherapies are never subjected to this system of double-blinded placebo-controlled human clinical trials to prove safety and compare it to efficacy. Acupuncture and herbal medicine are held to this difficult system, yet it does not really apply to these treatment modalities. They have no adverse health effects in standard care. Nevertherless, herbal medicine does need to now adhere to this evaluation system. To do this, we need to assess not just isolated single chemicals, as in pharmacological treatments, but literally hundreds of active chemicals, if not thousands, in herbal formulas, and devise a complicated system that assesses the safety, efficacy and activities in a field of data related to the study outcome, or disease. To devise a system that uses the rich history of Chinese formulary, comparing the effects and safety of individual herbs in formulas designed to mollify any toxicity with 'minister' herbs, and create a holistic approach to treatment with these 'minister' herbs, as well as 'courier' herbs added to guide the herbal effects to a particular system in the body, now combined with a modern system that catalogues all of the active chemicals in these herbs, catalogues the chemical interactions, and perhaps even uses data in assessment that catalogues herbal formula effects within a specific holistic treatment, such as acupuncture stimulation and dietary or nutrient medicine.

Such a system will not be easy, and thus there are very few studies to date that evaluate herbal formulas and are published in standard Western medical journals. This does not mean that there is no evidence that these formulas work, though. Decades of studies with human clinical trials of specific herbs, and specific chemicals in these herbs, have created a database of evidence. To fully evaluate these effects, though, we need to study the effects on patients when utilizing more than just a single herbal chemical, obviously. In Traditional Chinese Medicine patients are very rarely, if ever, treated with just a single herbal chemical, or a single herb. This system of modern evaluation is taking decades to achieve, simply because the data of holistic treatment is enormous.


Why do plant chemicals work on the human body?

Susan L Lingquist, a famous biologist and former director of the Whitehead Institute for Biomedical Research at MIT, states in a N.Y. Times interview: “As biology has moved forward, we've come to realize that the same rules apply to all living things. If there's a defect in cell biology, it might be shared by other cells (from other organisms)." She used strains of yeast to study how to alter cellular mechanisms with exposure to a variety of chemicals to find a group of chemicals that could correct the problems in human brain cells related to Parkinsons.

This theory was expounded centuries ago in China, as early Daoist scientists realized that all living things evolved with similar patterns of biological mechanism, and that plant chemistry developed to correct problems of biological disease and injury in similar ways that animal biology responded. Animals survived challenges of disease and injury by evolving biochemical means of utilizing plant chemicals from foods to correct these biochemical problems in disease and injury. The same chemicals that the plant used to fight the ill effects of bacteria and viruses in their physiology were useful to the animal. In fact, a general rule of likeness was found. Aerial parts of the plants were most useful in effecting the surface, or membrane pathology in the human, while root parts were most useful in effecting the deep organ pathologies.

Modern research has revealed much in the way that plants and animals are alike in their utilization of bacteria and other microorganisms to evolve complex systems of biology. Both plants and animals developed circulatory systems, immune systems, digestive systems etc. that are surprisingly similar, as well as cellular biology that is common to both plants and animals. The book Microcosmos by Dorion Sagan & Lynn Margulis, professor of Geoscience at Amherst, University of Massachusetts, outlines the common origins of plant and animal biology. What separates plant and animal is not the biochemical processes and systems, but rather the development of complex communication between body cells in the animal organism that is not found in the other kingdoms of bacteria, protests, fungi and plants. These authors show how “Human beings are not particularly special, apart, or alone" in their biology. The large number of chemicals found in certain plant species have evolved to work symbiotically to achieve certain cellular and biochemical effects that are useful to the human organism.

Modern research in herbal pharmaceuticals has blossomed in Europe as well as in Asia, and the European Union has mandated the payment for Complementary and Integrative Medicine (CIM) by the governments and insurance industry. Researchers there at first utilized increased amounts or standardized active ingredients in their herbal pharmaceuticals, but found that side effects were less likely when the whole plant chemistry was kept intact in the original balance. The theory is that plant's evolved a variety of chemicals to insure that biochemical processes caused little harm to the organism. This is why proper use of holistic plant extracts in formula have little harmful effect on the human organism. Advertisers frequently claim that herbal medicines are harmless because they are 'natural'. This is not true. Herbal formulas have very little risk of harm because of the science of proper plant and mineral selection, extraction methods, and combinations. Improper herbal formulary may produce products that are toxic, ineffective, and have problems of risk. This is a subject that is thoroughly studied and dealt with by professional herbalists, especially those that have graduated from a medical college specializing in herbal medicine. Proper professional use of herbal medicines have shown to create virtually no harm, while amateur use of herbs account for a relatively small number of deaths and injuries each year in the United States, much less than the use of chemical pharmaceuticals, but a concern nonetheless. It is vital the we start the new era of herbal formulary with Big Data Analysis and CER based on the centuries of study of safety in formulary, using combinations of herbs and preparation techniques to eliminate toxic effects. Research in China is taking this strategy to heart.

It is wise to consult a professional herbalist who utilizes herbs and patent herbal medicines from professional companies with a proven track record of safety and quality. Buying herbal medicines off the shelf, or from a doctor untrained in herbal medicine, is still a crap shoot for the patient, no matter how knowledgeable of a doctor the prescriber is in other specialties. This is apparent by the wide prescription of Phen-fen, an herbal weight reduction formula that caused many deaths in the United States and resulted in a ban on the use of ephedrine derivatives in all supplements and medicines not prescribed by a professional herbalist. Now, ephedrine is a slightly different chemical than any of the 3 amphetamine derivatives in Fen-Phen, and hence, the cynical tactic to placing an FDA ban on Ephedra, or Ma huang, yet still allowing Phentermine to be the predominant pharmaceutical for obesity and weight loss is dramatically cynical, yet seems to be still completely lost on the public, health professionals, and even Licensed Acupuncturists and herbalists. Studies in Canada and New York in 2014 revealed another cynical tactic, with a majority of randomly chosen herbal and nutrient products from major drugstores having none or little of the main ingredient listed, and a sizable percent having unlisted pharmaceuticals in the product! The result in the media is surely the impression that professional herbal medicine is not to be trusted, which is the opposite of what this reveals.


Documentation of the Scientific Facts in Herbal Medicine

Present standards of evidence to confirm safety and efficacy of medical practices with double-blinded placebo-controlled human clinical trials that were designed purely for pharmaceutical medicines will not be easy to apply to herbal formulas. This system, which was cynically applied to the manual medicine of acupuncture needle stimulation, but not to the many other types of manual medicine, such as surgery, in modern medicine, is also demanded of the practice of herbal medicine, but by its very nature and rules makes the design of such studies almost impossible. Randomized controlled clinical trials (RCTs) need to clearly narrow the focus of the study to a single, or small set, of variables, to achieve high quality. Obviously, this is easy for a synthetic molecule with a designed primary activity. For an herbal extract, the number of active chemicals in the medicine may number 50 or more, and each of these chemicals may have 50 known biological activities. The variables are too great for the present standards of RCTs, and the effect of the herbal chemistry is usually symbiotic, with chemicals that evolved in the plant acting in a quantum field of activities to achieve a set of biological goals for the health of the organism. With herbal formulas, this task of narrowing the variables to achieve an acceptable high quality of drug trial is even more daunting. Thus, we have almost no proof of the efficacy for herbal formulas based on the standards of the pharmaceutical RCTs. We do have many scientific facts that can be totaled in evaluation to deduce that the herbal formula will achieve the desired goals in treatment, and we do have centuries of empirical evidence that they work and are safe. For modern medicine, though, this is all discounted and the herbal medicines are declared to have no proof of effectiveness, based upon the standards of pharmaceutical RCTs, which the herbal formulas will never be able to meet. Why this is not seen for what it is, a cynical approach to evidence of efficacy and safety that at its core will always deny this type of proof, is the question.

There are new approaches that will be applied to evidence of herbal formulary safety and efficacy, though, and more complex study designs, using Rational Design Techniques that utilize Big Data Approaches to calculate more complex results in algorithms of effects, collecting data on the field of biological functions affected by the array of chemicals in the herbal formula, and the resulting chemical metabolism and its biological functions that result, will be eventually devised. Of course, until there is motivation and money to conduct this research, the progress will be slow. At present, the money resides in delaying this type of evidence, because the present system does not allow the patenting of natural chemistry and products, and hence, any increase in the acceptance of herbal medicine will decrease the profits generated by the patented synthetic medicines. Until there is a realization by the public and the field of medicine that there are plenty of profits in the field of medicine, and the bottom line should not be just the most profits, but rather the greatest quality of the effects of medical care, of integrated medical care, then we are not going to achieve this goal of evidence-based acceptance of herbal formulas by the present standards. Our perspective and our goals in medicine will have to be broadened. Other means of analysis of large fields of chemicals are being devised in research as well, with attention to a quantum field of biological effects, using such means as the measure of quantum chromodynamics and alchemical free energy. Pure research is motivated to achieve methods to answer questions that are now difficult to answer, but big business is not, unless it presents more profit. In the meantime, we do have abundant evidence with scientific facts concerning the many specific chemicals evolved in medicinal herbs and foods, and abundant evidence with empirical science as to the efficacy and safety of herbal formulas. Whether we can convince the patient population that these are enough, is the question.

There are large databases available to review the chemical constituents and activities of these chemicals in herbs and foods. There are also a large number of studies around the world and throughout modern history to review to determine the actual efficacy of specific herbs and formulas. The common textbooks of modern herbology used in the teaching of Traditional Chinese Medicine are based in part on scientific studies and documented in this way. There are also a number of English texts recording the pharmacology of herbs and the scientific study of their effects. Some of these published studies are found on the public database PubMed, but most scientific magazines that publish medical studies refuse to publish most studies on herbal medicines, and so these studies often do not show up in databases of scientific publications of studies. Why does this happen. It is because these scientific journals are funded by the pharmaceutical industry, either directly through grants or indirectly through advertisement. There is no end to how big money can alter the “scientific proof" in the United States. Only a professional herbalist has easy access to text books documenting these scientific studies. So called “Scientific Proof" in the United States is based on published articles related to these scientific studies, and these published articles are controlled by the industry. The professional herbalist, on the other hand, in order to avoid malpractice, studies the subject of herbal safety and biochemistry thoroughly, and does not rely on articles in the Journal of American Medicine, an AMA sponsored publication, or other medical journals invested in a business doctrine that excludes herbal scientific research religiously. It is obvious to everyone that the pharmaceutical interests are closely tied with the AMA and that medical doctors are thus very biased commercially and professionally against the practice of herbal medicine.

Where do physicians and patients then turn to access the rich wealth of scientific studies not published in standard medical journals and not listed in the medical databases? This is the question in the United States, where once we had many established medical schools touting the science of herbal medicine and formulary, the last being the Eclectics, but now these medical schools have been replaced by University Medical Schools that adhere to a strict code, and exclude herbal chemistry and medicine, as well as nutrient medicine to a great extent. The texts still accessible online from these past medical schools and institutions researching herbal and nutrient chemistry and medicine are just a superficial part of the whole. Hopefully, researchers will eventually find copies and again make this research accessible. Chinese herbal texts too are hard to find in English translation. We have only the tip of the iceberg in English, and hence, even a professional education depends on a limited base of evidence. Professional herbalists must spend the time in the United States to uncover and study these past texts, and to support current scientific research fully.

Thankfully, the U.S. database of the National Institutes of Health (NIH), entitled PubMed, now publishes more and more of the important research concerning herbal and nutrient medicine. Much of this research is found on this website in sections of articles entitled Additional Information and Information Resources, with links to the studies. With so much study only being published in the West in the last decade, though, the progress in integration of evidence-based herbal and nutrient medicine, and the even more difficult changing of the mindset of the patient public, will be slow. Decades of denial of efficacy is being reversed, but the damage is done, and while herbal medicine may seem now popular, the utilization of professional herbal medicine and physicians with herbal treatment in their scope of practice and study, such as Licensed Acupuncturists and herbalists, and Naturopathic Doctors, is still scarce and does not support this profession. As herbal and nutrient medicine gains acceptance, we see a cynical approach in business and government as well, though, with alarming studies in the United States and Canada revealing that a great percentage of herbal and nutrient medicines, largely unregulated, that are bought off the shelf of drugstores or online, are not what they say they are, and many do not even have the main ingredients listed in the product, with many of these products having unlisted pharmaceutical chemicals in the product. The penalty for such public harm is almost nothing at present. You may go to the article on this website entitled Herbal and Nutrient Medicine: Quality Assurance, to see documentation of this. The way to insure effective results with herbal formulary is to utilize the professional physician and professional products.

Summary

Herbal medicine has accumulated centuries of scientific documentation through empirical evidence of clinical effects, chemical study, systems of extraction, selection and formulary to insure greatest effect and safety, and proper prescription. Commercial interests and the medpharm industry are unlikely sources of safe and effective herbal medicines, and in fact this industry has been found to both manipulate research studies and put a large number of herbal medicines on the market that are of poor quality, do not contain what is listed on the label, and often contain a synthetic drug (see the article on the website entitled Herbal and Nutrient Medicine: : Quality Assurance). The chemicals in medicinal plants and foods are complex and require a complex approach to utilize effectively. This approach should utilize a variety of experts devoted to the proper harvesting, growing, analysis, distribution, extraction methods and the proper diagnostics in relation to prescription. Self-prescription and commercial products, as well as prescription by professionals without a specialized herbal background in their education should not be trusted. To be safe, and find the herbal formulas and food supplements that work to cure, consult a professional. In the end, this system of herbal medicine is designed to work within a framework that is holistic, combining an array of synergistic therapies, and thousands of years of development that has achieved a system that relies on herbal formulas that avoid toxicity and utilize the safest herbal medicines and dosages, which is able to work effectively when put in the context of a more complex holistic treatment. This system is very different from what we are used to receive from standard medicine in modern times, and a perspective has to be developed to utilize and appreciate this holistic approach. The standard of evidence of modern medicine is not designed for such a broad holistic treatment strategy, and to judge holistic medicine by the current system of evidence is not realistic. Thankfully, human adapt to change, though, and herbal science is adapting Big Data Analysis and Comparative Effectiveness Research to finally achieve a fair system of evidence-based evaluation in holistic medicine and herbal formulary.


Additional Information and Links to Research Studies:

Sources:

NY Times, A Conversation with Susan L. Lindquist, April 24, 2007, Science Times

Microcosmos, California Press, Magulis and Sagan, pg 195

Science and Civilisation in China by Joseph Needham, Vol. 3 Origins of Alchemy and Chemistry and Vol. 6 Biology and Biological Technology

  1. A 2014 multicenter article reviewing the vast subject of the history and present state of herbal medicines and resources, by experts at Beijing University of Chinese Medicine, and Hong Kong University, in China, the Medical University of Graz, in Austria, the University of South Florida, and the American Academy of Natural Medicine, in the U.S.A., provides a thorough overview of herbal formulary and Chinese Herbal Medicine (CHM). The fact that 85 percent of the world population still depends on traditional herbal medicine to some extent, and obviously because it works, is often overlooked in modern civilization: http://www.hindawi.com/journals/ecam/2014/525340/
  2. A thorough synopsis of the rich history of herbal medicine in the United States is presented here by Dr. Douglas Schar, a doctor, journalist, researcher, and author who lives and practices near Washington DC, and along with many famed botanists, herbalists, researchers and physicians, such as Christopher Hobbs in California, who are still largely ignored and shunned by standard medicine, offer much to the public in the realm of tangible evidence and a safer and more integrated medical practice: http://doctorschar.com/archives/eclectic-school-of-medicine/
  3. The Institute for Traditional Medicine in Portland, Oregon, USA provides a succinct history of the text we call Shen Nong Ben Cao Jing: http://www.itmonline.org/arts/shennong.htm
  4. An excellent translation of the preface to the Shang Han Lun by the sublime Sabine Wilms: http://static1.squarespace.com/static/537fb379e4b0fe1778d0f178/t/54937bdbe4b044a934686273/1418951643290/%E5%82%B7%E5%AF%92%E8%AB%96%E5%BA%8F_translation.pdf
  5. An excellent synopsis of the uncertain actual history of the text we now call the Shang Han Lun, by Yaron Seidman DAOM, in California, reveals the difficulties in the United States of obtaining the information to really explore these concepts of herbal formulary. The Chinese teachers in medical schools have taken an attitude that the Americans cannot really understand these historical Daoist concepts, and that we must just accept such texts as the rule, and not even try to really understand the concepts. Here, the basic history of the modern printed version of this ancient text, of which many private versions existed before the printing press, is explained: http://chineseclassics.org/j/index.php?option=com_content&view=article&id=268&Itemid=1
  6. The 'seismic shift' in medical research and protocol involves use of Big Data Analytics, or algorithmic use of all available data, both in research and individualized treatment design. Experts at Stanford University feel that this approach will make the standard so-called 'scientific method' obsolete. It will also allow easy inclusion of complex data on Complementary and Integrative protocols to enhance the therapeutic outcomes: http://blogs.kqed.org/science/audio/how-big-data-is-changing-medicine/
  7. Dr. Martin E. Feder of the University of Chicago Department of Organismal Biology and Anatomy provides a thorough history and discussion of the science of likeness between plant and animal physiology in the context of medicine: http://icb.oxfordjournals.org/content/42/3/409.full
  8. The Herb Med database collection provides physicians and patients with access to a number of research database sites in herbal medicine. PubMed and the Phytochemical and Ethnobotanical Databases of David Duke and ARS GRIN are especially useful: http://www.herbmed.org/links.html
  9. Integrative databases of Chinese herbs and formulas are finally becoming available, allowing the physician to research specific biochemical effects to enhance treatment outcomes within the TCM traditional framework. This is one example:http://pubs.acs.org/doi/abs/10.1021/ci600288m
  10. A free source database of in vivo study data of Chinese Herbal Medicine is now set up by this Chinese institution, allowing for access to complex data on studied biochemical effects of herbal chemistry: http://www.jcheminf.com/content/5/1/28
  11. A 2009 report on the current models of research in Chinese Herbal Medicine, by the Shanghai University of Traditional Chinese Medicine, in Shanghai, China, outlines the development of research models that combine a Traditional study of the whole and component combination effects of herbal chemistry in formula with the modern approach of studying herbal components in simple combination. Using new "Big Data" research methods, component chemical combinations evaluation can be integrated with optimal composition methods of traditional formula design, which have concentrated on empirical clinical evaluation of 7 compatible relations between 3 classes of herbs in formula design, the main herbal 'sovereign', with herbs to assist the desired activities of the formula and mollify any adverse effects, called 'ministers', and the addition of herbs that help target the formula to specific biologic systems in the body, called 'couriers'. The separation of the traditional and modern study approaches to herbal formula research has hampered the modern clarification and development of proven herbal medicines, and it is hoped that this new analytic model can create a clear proof of the array of biochemical effects and mechanisms in herbal formulas to meet modern evidence-based standards: http://www.ncbi.nlm.nih.gov/pubmed/19615311
  12. Medical Universities in China are now creating herbal formulary databases with access to scientific study of herbal medicines that includes the research on pharmaceutical applications and investigations and brings together a diverse array of Big Data: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4001360/
  13. The U.S. Agency for Healthcare Research and Quality (AHRQ) provides an overview of a new direction in healthcare research with Big Data Analysis and Observational Comparative Effectiveness Research (CER) guiding treatment design in the future: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?productid=1166&pageaction=displayproduct
  14. A 2013 paper on healthcare outcome measurement from experts at Cambridge University in Massachusetts, U.S.A. and the Johns Hopkins Bloomberg School of Public Health, in Baltimore, Maryland, U.S.A. outlines a new model for healthcare guidelines that may turn out to be inclusive of Complementary and Integrative Medicine and Traditional Chinese Medicine (CIM/TCM): http://www.ncbi.nlm.nih.gov/books/NBK126186/
  15. A 2012 proposal for new research guidelines for study of Chinese Herbal Medicine and formulas to further the advance of such research to accepted standards of randomized controlled human clinical trials was presented by experts at Southamptom University in the UK, Charite' University, University of Bonn, and Rheinishce Frederick-Wilhelms University, in Germany, and the Beijing University of Chinese Medicine, in Beijing, China. This comprehensive proposal suggests that this research should start with evidence of Chinese herbal medicine at the clinical level, and be inclusive at times of a holistic synergistic array of treatments, combining acupuncture with Chinese herbal formula and herbal specifics in the randomized controlled human clinical trials as a single intervention. Of course, this method will need a "Big Data Analysis" to assess the whole range of activities and effects: http://www.sciencedirect.com/science/article/pii/S0378874111008956
  16. A proposal for guidelines for randomized controlled human clinical trials (RCTs) of herbal medicine and formulas was presented in 2012 by experts at Southampton University, in the UK, Charite' University School of Medicine, in Germany, Beijing University, in China, and the Rheinische Friedrich-Wilhelms University of Bonn, in Germay, attempting to devise a fair system of trial designs that finally allows the inclusion of Chinese Herbal Medicine. Current standards show that more than 17,000 RCTs have been published in the Chinese database system by 2012, but less than 5 percent of these meet the unrealistic standards of RCTs designed to evaluate pharmaceuticals. The conclusion was that an inclusion of evidence from clinical experience, and appropriate research methodologies for herbal medicine, are needed to fully form evidence-based treatment guidelines in herbal medicine: http://www.sciencedirect.com/science/article/pii/S0378874111008956
  17. An example of new guidelines for herbal formulary that meet standards of evidence-based medicine is presented here from a collaboration of the Capital Medical University and Centre for Evidence-Based Medicine at Beijing University of Chinese Medicine in Beijing, and various hospitals in China. Here we see guidelines based on current standards of evidence for herbal formulas used to treat psoriasis, with a consideration of the traditional typing of patients in TCM: http://www.sciencedirect.com/science/article/pii/S1876382014000110