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History of Herbal Medicine
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Early humans recognized their dependence on nature in both health and illness. Led by instinct, taste, and experience, primitive men and women treated illness by using plants, animal parts, and minerals that were not part of their usual diet. Physical evidence of use of herbal remedies goes back some 60,000 years to a burial site of a Neanderthal man uncovered in 1960 (Solecki, 1975). In a cave in northern Iraq, scientists found what appeared to be ordinary human bones. An analysis of the soil around the bones revealed extraordinary quantities of plant pollen that could not have been introduced accidentally at the burial site. Someone in the small cave community had consciously gathered eight species of plants to surround the dead man. Seven of these are medicinal plants still used throughout the herbal world (Bensky and Gamble, 1993). All cultures have long folk medicine histories that include the use of plants. Even in ancient cultures, people methodically and scientifically collected information on herbs and developed well-defined herbal pharmacopoeias. Indeed, well into the 20th century much of the pharmacopoeia of scientific medicine was derived from the herbal lore of native peoples. Many drugs, including strychnine, aspirin, vincristine, ~taxol, curare, and ergot, are of herbal origin. About one-quarter of the prescription drugs dispensed by community pharmacies in the United States contain at least one active ingredient derived from plant material (Farnsworth and Morris, 1976).
Middle East medicine. The invention of writing was a focus around which herbal knowledge could accumulate and grow. The first written records detailing the use of herbs in the treatment of illness are the Mesopotamian clay tablet writings and the Egyptian papyrus. About 2000 B.C., King Assurbanipal of Sumeria ordered the compilation of the first known materia medica--an ancient form of today's United States Pharmacopoeia--containing 250 herbal drugs (including garlic, still a favorite of herbal doctors). The Ebers Papyrus, the most important of the preserved Egyptian manuscripts, was written around 1500 B.C. and includes much earlier information. It contains 876 prescriptions made up of more than 500 different substances, including many herbs (Ackerknecht, 1973).
Greece and Rome. One of the earliest materia medica was the Rhizotomikon, written by Diocles of Caryotos, a pupil of Aristotle. Unfortunately, the book is now lost. Other Greek ~and Roman compilations followed, but none was as important or influential as that written by Dioscorides in the 1st century A.D., better known by its Latin name De Materia Medica. This text contains 950 curative substances, of which 600 are plant products and the rest are of animal or mineral origin (Ackerknecht, 1973). Each entry includes a drawing, a description of the plant, an account of its medicinal qualities and method of preparation, and warnings about undesirable effects.
Muslim world. The Arabs preserved and built on the body of knowledge of the Greco-Roman period as they learned of new remedies from remote places. They even introduced to the West the Chinese technique of chemically preparing minerals. The principal storehouse of the Muslim materia medica is the text of Jami of Ibn Baiar (died 1248 A.D.), which lists more than 2,000 substances, including many plant products (Ackerknecht, 1973). Eventually this entire body of knowledge was reintroduced to Europe by Christian doctors traveling with the Crusaders. Indeed, during the Middle Ages, trade in herbs became a vast international commerce.
~East India. India, located between China and the West, underwent a similar process in the development of its medicine. The healing that took place before India's Ayurvedic medical corpus was similar to that of ancient Egypt or China (i.e., sickness was viewed as a punishment from the gods for a particular sin). Ayurvedic medicine emerged during the rise of the philosophies of the Upanishads, Buddhism, and other schools of thought in India. Herbs played an important role in Ayurvedic medicine. The principal Ayurvedic book on internal medicine, the Characka Samhita, describes 582 herbs (Majno, 1975). The main book on surgery, the Sushruta Samhita, lists some 600 herbal remedies. Most experts agree that these books are at least 2,000 years old.
China and Japan. The earliest written evidence of the medicinal use of herbs in China consists of a corpus of 11 medical works recovered from a burial site in Hunan province. The burial itself is dated 168 B.C., and the texts (written on silk) appear to have been composed before the end of the 3rd century B.C. Some of the texts discuss exercise, diet, and channel therapy (in the form of moxibustion--see the "Alternative Systems of Medical Practice" chapter). The largest, clearest, and most important of these manuscripts, called by ~its discoverers Prescriptions for Fifty-Two Ailments, is predominantly a pharmacological work. More than 250 medicinal substances are named. Most are substances derived from herbs and wood; grains, legumes, fruits, vegetables, and animal parts are also mentioned. Underlying this entire text is the view that disease is the manifestation of evil spirits, ghosts, and demons that must be repelled by incantation, rituals, and spells in addition to herbal remedies.
By the Later Han Dynasty (25-220 A.D.), medicine had changed dramatically in China. People grew more confident of their ability to observe and understand the natural world and believed that health and disease were subject to the principles of natural order. However, herbs still played an important part in successive systems of medicine. The Classic of the Materia Medica, compiled no earlier than the 1st century A.D. by unknown authors, was the first Chinese book to focus on the description of individual herbs. It includes 252 botanical substances, 45 mineral substances, and 67 animal-derived substances. For each herb there is a description of its medicinal effect, usually in terms of symptoms. Reference is made to the proper method of preparation, and toxicities are noted (Bensky and Gamble, 1993).~Since the writing of the Classic of the Materia Medica almost 2,000 years ago, the traditional Chinese materia medica have been steadily increasing in number. This increase has resulted from the integration into the official tradition of substances from China's folk medicine as well as from other parts of the world. Many substances now used in traditional Chinese medicine originate in places such as Southeast Asia, India, the Middle East, and the Americas. The most recent compilation of Chinese materia medica was published in 1977. The Encyclopedia of Traditional Chinese Medicine Substances (Zhong yao da ci dian), the culmination of a 25-year research project conducted by the Jiangsu College of New Medicine, contains 5,767 entries and is the most definitive compilation of China's herbal tradition to date (Bensky and Gamble, 1993).
Traditional Chinese medicine was brought to Japan via Korea, and Chinese-influenced Korean medicine was adapted by the Japanese during the reign of Emperor Ingyo (411-453 A.D.). Medical envoys continued to arrive from Korea throughout the next century, and by the time of the Empress Suiko (592-628 A.D.), Japanese envoys were being sent directly to China to study medicine. Toward the end of the Muromachi period (1333-1573 A.D.) the ~Japanese began to develop their own form of traditional oriental medicine, called kampo medicine. As traditional Chinese medicine was modified and integrated into kampo medicine, herbal medicine was markedly simplified.
In North America, early explorers traded knowledge with the Native American Indians. The tribes taught them which herbs to use to sharpen their senses for hunting, to build endurance, and to bait their traps. In 1716, French explorer Lafitau found a species of ginseng, Panax quinquefolius L., growing in Iroquois territory in the New World. This American ginseng soon became an important item in world herb commerce (Duke, 1989). The Jesuits dug up the plentiful American ginseng, sold it to the Chinese, and used the money to build schools and churches. Even today, American ginseng is a sizable crude U.S. export.
As medicine evolved in the United States, plants continued as a mainstay of country medicine. Approaches to plant healing passed from physician to physician, family to family. ~Even in America's recent past, most families used home herbal remedies to control small medical emergencies and to keep minor ailments from turning into chronic problems. During this period there was a partnership between home folk medicine and the family doctor (Buchman, 1980). Physicians often used plant and herbal preparations to treat common ills. Until the 1940s, textbooks of pharmacognosy--books that characterize plants as proven-by-use prescription medicines--contained hundreds of medically useful comments on barks, roots, berries, leaves, resins, twigs, and flowers.
As 20th-century technology advanced and created a growing admiration for technology and technologists, simple plant-and-water remedies were gradually discarded. Today, many Americans have lost touch with their herbal heritage. Few Americans realize that many over-the-counter (OTC) and prescription drugs have their origins in medicinal herbs. Cough drops that contain menthol, mint, horehound, or lemon are herbal preparations; chamomile and mint teas taken for digestion or a nervous stomach are time-honored herbal remedies; and many simple but effective OTC ache-and pain-relieving preparations on every druggist's and grocer's shelf contain oils of camphor, menthol, or eucalyptus. Millions of Americans ~greet the morning with their favorite herbal stimulant--coffee.
Despite the importance of plant discoveries in the evolution of medicine, some regulatory bodies such as the U.S. Food and Drug Administration (FDA)--the main U.S. regulatory agency for food and drugs--consider herbal remedies to be worthless or potentially dangerous (Snider, 1991). Indeed, today in the United States, herbal products can be marketed only as food supplements. If a manufacturer or distributor makes specific health claims about a herbal product (i.e., indicates on the label the ailment or ailments for which the product might be used) without FDA approval, the product can be pulled from store shelves.
Despite FDA's skepticism about herbal remedies, a growing number of Americans are again becoming interested in herbal preparations. This surge in interest is fueled by factors that include the following:
• Traditional European and North American herbs are sold in most U.S. health food ~stores. The same is true for Chinese and, to a lesser extent, Japanese herbal medicinals. Ayurvedic herbals are available in most large U.S. cities, as are culinary and medicinal herb shops called botanicas that sell herbs from Central and South America and Mexico. The reemergence of Native American Indian cultural influences has increased interest in Native American Indian herbal medicines.
• Pharmaceutical drugs are seen increasingly as overprescribed, expensive, even dangerous. Herbal remedies are seen as less expensive and less toxic.
• Exposure to exotic foreign foods prepared with non-European culinary herbs has led many Euroethnic Americans to examine and often consider using medicinal herbs that were brought to the United States along with ethnic culinary herbs.
• People increasingly are willing to "self-doctor" their medical needs by investigating and using herbs and herbal preparations. Many Americans--especially those with chronic illnesses such as arthritis, diabetes, cancer, and AIDS--are turning to herbs as adjuncts to ~other treatments.
The next section discusses the regulatory status of herbal medicine in various countries around the world, particularly in Europe and Asia, as well as in less developed countries. It is followed by an overview of promising European and Asian herbal medicine research and recommendations for making herbal medicine a more viable health care alternative in this country.
The World Health Organization (WHO) estimates that 4 billion people--80 percent of the world population--use herbal medicine for some aspect of primary health care (Farnsworth et al., 1985). Herbal medicine is a major component in all indigenous peoples' traditional medicine and is a common element in Ayurvedic, homeopathic, naturopathic, traditional oriental, and Native American Indian medicine (see the "Alternative Systems of Medical Practice" chapter).~The sophistication of herbal remedies used around the world varies with the technological advancement of countries that produce and use them. These remedies range from medicinal teas and crude tablets used in traditional medicine to concentrated, standardized extracts produced in modern pharmaceutical facilities and used in modern medical systems under a physician's supervision.
Drug approval considerations for phytomedicines (medicines from plants) in Europe are the same as those for new drugs in the United States, where drugs are documented for safety, effectiveness, and quality. But two features of European drug regulation make that market more hospitable to natural remedies. First, in Europe it costs less and takes less time to approve medicines as safe and effective. This is especially true of substances that have a long history of use and can be approved under the "doctrine of reasonable certainty." According to this principle, once a remedy is shown to be safe, regulatory officials use a standard of evidence to decide with reasonable certainty that the drug will be effective. This ~procedure dramatically reduces the cost of approving drugs without compromising safety. Second, Europeans have no inherent prejudice against molecularly complex plant substances; rather, they regard them as single substances.
The European Economic Community (EEC), recognizing the need to standardize approval of herbal medicines, developed a series of guidelines, The Quality of Herbal Remedies (EEC Directive, undated). These guidelines outline standards for quality, quantity, and production of herbal remedies and provide labeling requirements that member countries must meet. The EEC guidelines are based on the principles of the WHO's Guidelines for the Assessment of Herbal Medicines (1991). According to these guidelines, a substance's historical use is a valid way to document safety and efficacy in the absence of scientific evidence to the contrary. (App. C contains the complete WHO guidelines.) The guidelines suggest the following as a basis for determining product safety:
A guiding principle should be that if the product has been traditionally used without demonstrated harm, no specific restrictive regulatory action should be undertaken unless ~new evidence demands a revised risk-benefit assessment. . . . Prolonged and apparently uneventful use of a substance usually offers testimony of its safety.
With regard to efficacy, the guidelines state the following:
For treatment of minor disorders and for nonspecific indications, some relaxation is justified in the requirements for proof of efficacy, taking into account the extent of traditional use; the same considerations may apply to prophylactic use (WHO, 1991).
The WHO guidelines give further advice for basing approval on existing monographs:
If a pharmacopoeia monograph exists it should be sufficient to make reference to this monograph. If no such monograph is available, a monograph must be supplied and should be set out in the same way as in an official pharmacopoeia.
To further the standardization effort and to increase European scientific support, the ~phytotherapy societies of Belgium, France, Germany, Switzerland, and the United Kingdom founded the European Societies' Cooperative of Phytotherapy (ESCOP). ESCOP's approach to eliminating problems of differing quality and therapeutic use within EEC is to build on the German scientific monograph system (below) to create "European" monographs.
In Europe, herbal remedies fall into three categories. The most rigorously controlled are prescription drugs, which include injectable forms of phytomedicines and those used to treat life-threatening diseases. The second category is OTC phytomedicines, similar to American OTC drugs. The third category is traditional herbal remedies, products that typically have not undergone extensive clinical testing but are judged safe on the basis of generations of use without serious incident.
The following brief overviews of phytomedicine's regulatory status in France, Germany, and England are representative of the regulatory status of herbal medicine in Europe.
~France, where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. These products are distinguished from approved pharmaceutical drugs by labels stating "Traditionally used for . . ." Consumers understand this to mean that indications are based on historical evidence and have not necessarily been confirmed by modern scientific experimentation (Artiges, 1991).
Germany considers whole herbal products as a single active ingredient; this makes it simpler to define and approve the product. The German Federal Health Office regulates such products as ginkgo and milk thistle extracts by using a monograph system that results in products whose potency and manufacturing processes are standardized. The monographs are compiled from scientific literature on a particular herb in a single report and are produced under the auspices of the Ministry of Health Committee for Herbal Remedies (Kommission E). Approval of such remedies requires more scientific documentation than traditional remedies, but less than new pharmaceutical drug approvals (Keller, 1991).
~In Germany there is a further distinction between "prescription-only drugs" and "normal prescription drugs." The former are available only by prescription. The latter are covered by national health insurance if prescribed by a physician, but they can be purchased over the counter without a prescription if consumers want to pay the cost themselves (Keller, 1991). OTC phytomedicines--used for self-diagnosed, self-limiting conditions such as the common cold, or for simple symptomatic relief of chronic conditions--are not covered by the national health insurance plan.
England generally follows the rule of prior use, which says that hundreds of years of use with apparent positive effects and no evidence of detrimental side effects are enough evidence--in lieu of other scientific data--that the product is safe. To promote the safe use of herbal remedies, the Ministry of Agriculture, Fisheries, and Food and the Department of Health jointly established a database of adverse effects of nonconventional medicines at the National Poisons Unit.
Asia~In more developed Asian countries such as Japan, China, and India, "patent" herbal remedies are composed of dried and powdered whole herbs or herb extracts in liquid or tablet form. Liquid herb extracts are used directly in the form of medicinal syrups, tinctures, cordials, and wines.
In China, traditional herbal remedies are still the backbone of medicine. Use varies with region, but most herbs are available throughout China. Until 1984 there was virtually no regulation of pharmaceuticals or herbal preparations. In 1984, the People's Republic implemented the Drug Administration Law, which said that traditional herbal preparations were generally considered "old drugs" and, except for new uses, were exempt from testing for efficacy or side effects. The Chinese Ministry of Public Health would oversee the administration of new herbal products (Gilhooley, 1989).
Traditional Japanese medicine, called kampo, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese folklore. Kampo declined when Western medicine was introduced between 1868 and 1912, but by 1928 it had begun ~to revive. Today 42.7 percent of Japan's Western-trained medical practitioners prescribe kampo medicines (Tsumura, 1991), and Japanese national health insurance pays for these medicines. In 1988, the Japanese herbal medicine industry established regulations to manufacture and control the quality of extract products in kampo medicine. Those regulations comply with the Japanese government's Regulations for Manufacturing Control and Quality Control of Drugs.
Herbal medicines are the staple of medical treatment in many developing countries. Herbal preparations are used for virtually all minor ailments. Visits to Western-trained doctors or prescription pharmacists are reserved for life-threatening or hard-to-treat disorders.
Individual herbal medicines in developing regions vary considerably; healers in each region have learned over centuries which local herbs have medicinal worth. Although trade brings a few important herbs from other regions, these healers rely mainly on indigenous herbs. Some ~have extensive herbal materia medica. A few regions, such as Southeast Asia, import large amounts of Chinese herbal preparations. But the method and form of herb use are common to developing regions.
In the developing world, herbs used for medicinal purposes are "crude drugs." These are unprocessed herbs--plants or plant parts, dried and used in whole or cut form. Herbs are prepared as teas (sometimes as pills or capsules) for internal use and as salves and poultices for external use. Most developing countries have minimal regulation and oversight.