Jennifer Jacobs, M.D.--Cochair
John Reed, M.D.--Cochair
Michael Balick, Ph.D.
Gerald Bodeker, Ed.D.
Carlo Calabrese, N.D.
Edward Chapman, M.D.
Deepak Chopra, M.D.
Effie Chow, Ph.D.
Patricia D. Culliton, M.A. Dipl.Ac.
Peter Hindebergh, M.D.
Tori Hudson, N.D.
Fredi Kronenberg, Ph.D.
Nancy Lonsdorf, M.D.
Michael Balick, Ph.D.
James Duke, Ph.D.
Robert S. McCaleb, Ph.D.
John Reed, M.D.
James P. Swyers, M.A.
History of Herbal Medicine
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
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
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
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.
Herbal Medicine in the United States
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.
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
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
* 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
Regulatory Status of Herbal Medicine Worldwide
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
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
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
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.
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
The professional literature of Europe and Asia
abounds with efficacy and safety studies of many herbal
medicines. It is beyond this report's resources to investigate
the validity of this vast literature. The following is an
overview of some of the more promising research on herbal
remedies around the world.
European phytomedicines, researched in leading
European universities and hospitals, are among the world's best
studied medicines. In some cases they have been in clinical use
under medical supervision for more than 10 years, with tens of
millions of documented cases. This form of botanical medicine
most closely resembles American medicine. European phytomedicines
are produced under strict quality control in sophisticated
pharmaceutical factories, packaged and labeled like American
medicines, and used in tablets or capsules.
Examples of well-studied European
phytomedicines include Silybum marianum (milk thistle), Ginkgo
biloba (ginkgo), Vaccinium myrtillus (bilberry extract), and Ilex
guayusa (guayusa). Their efficacy is well documented. Herbs of
American origin, such as Echinacea (purple coneflower) and
Serenoa repens (saw palmetto), are better studied and marketed in
Europe than in the United States. Below is an overview of recent
research on these phytomedicines and American herbs.
* Milk thistle (Silybum marianum). Milk thistle
has been used as a liver remedy for 2,000 years. In 1970s
studies, seed extracts protected against liver damage and helped
regenerate liver cells damaged by toxins (alcohol) and by
diseases such as hepatitis (Bode et al., 1977) and cirrhosis
(Ferenci et al., 1989). More recently, a 6-month treatment of
milk thistle significantly improved liver function in 36 patients
with alcohol-induced liver disease (Feher et al., 1990). Animal
studies show that it may protect against radiation damage caused
by x rays (Flemming, 1971), and it gave "complete
protection" to rats against brain damage caused by the
potent nerve toxin triethyltin sulfate (Varkonyi et al., 1971).
European hospital emergency rooms use intravenous milk thistle
extract to counteract cases of liver poisoning from toxins such
as those in the Amanita phalloides mushroom.
* Bilberry extract (Vaccinium myrtillus).
Bilberry extract is believed to help prevent or treat fragile
capillaries. Capillary fragility can cause fluid or blood to leak
into the tissues, causing hemorrhage, stroke, heart attack, or
blindness. Less serious effects include a tendency to bruise
easily, varicose veins, poor night vision, coldness, numbing, and
leg cramping. Bilberry extract may protect capillaries and other
small blood vessels by increasing the flexibility of red blood
cell membranes. This action allows capillaries to stretch,
increasing blood flow, and red blood cells can deform into a
shape that eases their way through narrow capillaries.
European clinical trials have shown the
effectiveness of bilberry extract for venous insufficiency of the
lower limbs in 18-to 75-year-old subjects (Corsi, 1987; Guerrini,
1987). It has been used to treat varicose veins in the legs,
where it significantly improved symptoms of varicose syndrome
such as cramps, heaviness, calf and ankle swelling, and numbness
(Gatta, 1982). These trials revealed no significant side effects,
even at 50 percent over the normal dose. In two clinical trials,
a standardized bilberry extract was given to 115 women with
venous insufficiency and hemorrhoids following pregnancy. Both
studies documented improvements of symptoms, including pain,
burning, and pruritus, all of which disappeared in most cases
(Baisi, 1987; Teglio et al., 1987).
* Ginkgo biloba extract. Though this oriental
herb has a different traditional use in Asia, Ginkgo biloba is
one of Europe's most lucrative phytomedicines (Duke, 1988). In
Europe, ginkgo is used mainly against symptoms of aging. It is
believed to stimulate circulation and oxygen flow to the brain,
which can improve problem solving and memory. It was shown to
increase the brain's tolerance for oxygen deficiency and to
increase blood flow in patients with cerebrovascular disease
(Haas, 1981). No other known circulatory stimulant, natural or
synthetic, has selectively increased blood flow to
disease-damaged brain areas. In a French study, "the results
confirmed the efficacy of [ginkgo extract] in cerebral disorders
due to aging" (Taillandier et al., 1988). In another
experiment, those given ginkgo showed consistent and significant
improvement over the control group on all tests, including
mobility, orientation, communication, mental alertness, recent
memory, and other factors (Weitbrecht and Jansen, 1985). A
"digit copying test" and a computerized classification
test confirmed the improved cognitive function related to use of
this herb (Rai et al., 1991).
Ginkgo extracts also stimulate circulation in
the limbs, reducing coldness, numbness, and cramping. In elderly
people, ginkgo improved pain-free walking distance by 30 percent
to 100 percent (Foster, 1990). It also lowered high cholesterol
levels in 86 percent of cases tested and prevented oxygen
deprivation of the heart (Schaffler and Reeh, 1985). The extract
seems to affect neurons directly, as shown by a recent French
study (Yabe et al., 1992). Another French study proved protection
against cell damage, this time by ultraviolet light (Dumont et
A German study documented benefits of long-term
ginkgo use in reducing cardiovascular risks, including those
associated with coronary heart disease, hypertension,
hypercholesterolemia, and diabetes mellitus (Witte et al., 1992).
By maintaining blood flow to the retina, ginkgo extracts
inhibited deteriorating vision in the elderly. An adequate amount
of extract may reverse damage from lengthy oxygen deprivation of
the retina. The assessment by doctors and patients of the
patients' general condition showed a significant improvement
after therapy. These results show that visual field damage from
chronic lack of blood flow is reversible (Raabe et al., 1991).
* Ilex guayusa (guayusa). In animal studies, a
concentrated aqueous herbal preparation from guayusa leaves
significantly reduced uncontrolled appetite, excessive thirst,
and weight loss associated with diabetes (Swanston-Flatt et al.,
1989). Although guayusa's active principles are not established,
guayusa contains guanidine, a known hypoglycemic (blood
sugar-lowering) substance (Duke, 1992b).
* Echinacea (purple coneflower). The subject of
more than 350 scientific studies, most conducted in Europe,
Echinacea seems to stimulate the immune system nonspecifically
rather than against specific organisms. In laboratory tests,
Echinacea increased the number of immune system cells and
developing cells in bone marrow and lymphatic tissue, and it
seemed to speed their development into immunocompetent cells
(cells that can react to pathogens). It speeds their release into
circulation, so more are present in blood and lymph, and
increases their phagocytosis rate--the rate at which they can
digest foreign bodies. Echinacea also inhibits the enzyme
hyaluronidase, which bacteria use to enter tissues and cause
infection. This inhibition helps wounds to heal by stimulating
new tissue formation.
Echinacea exhibits interferonlike antiviral
activity documented through extensive experiments in Germany. For
example, in a double-blind, placebo-controlled study of 180
volunteers, Echinacea's therapeutic effectiveness for treating
flu-like symptoms was "good to very good" (Braunig et
al., 1992). Another study showed that orally administered
Echinacea extracts significantly enhanced phagocytosis in mice
(Bauer et al., 1988). Water-soluble Echinacea components strongly
activated macrophages (Stimpel et al., 1984), enhanced immune
system cell motility, and increased these cells' ability to kill
bacteria. Other immune system cells were stimulated to secrete
the disease-fighting tumor necrosis factor and interleukins 1 and
6 (Roesler et al., 1991). Another study showed that Echinacea
polysaccharides increased the number of immunocompetent cells in
the spleen and bone marrow and the migration of those cells into
the circulatory system. The authors said these effects resulted
in excellent protection of mice against consequences of lethal
listeria and candida infections (Coeugniet and Elek, 1987).
* Saw palmetto (Serenoa repens). These berries
have been used to treat benign prostatic hypertrophy (BPH). The
standardized extract was clinically evaluated as effective, has
no observed side effects, and costs 30 percent less than the main
prescription drug marketed in the United States for BPH
(Champpault et al., 1984).
Another effective herbal drug for treating BPH
is made from Prunus africanum and is widely prescribed in France.
It is interesting to note that the U.S. government is funding a
multicenter study on BPH treatment to find the most
cost-effective criteria for surgical versus medical treatment.
However, because the study includes neither saw palmetto nor
Prunus africanum, it may not reflect the "state of the
art" in clinical medicine worldwide.
Since the early 19th century, attempts have
been made to understand the actions and properties of traditional
Chinese medicine through scientific research. Nearly all of this
work has been conducted during the past 60 years, primarily in
laboratories in China, Korea, Japan, Russia, and Germany. It was
also during this time that most of the drugs used in modern
biomedicine were developed. It is therefore not surprising that
most of the biomedical research into the effects and uses of
traditional Chinese medicinal substances has attempted to isolate
their active ingredients and to understand their effects on body
Several institutions and laboratories at the
forefront of medicinal plant research in China are working to
identify and study the active ingredients in traditional Chinese
herbal remedies. Researchers at the Institute of Materia Medica
in Beijing study the use of herbal remedies to prevent and treat
the common cold, bronchitis, cancer, and cardiovascular disease
and to prevent conception. The institute has isolated compounds
such as bergenin from Ardisia japonica, traditionally used to
treat chronic bronchitis, and monocrotaline from Crotalaria
sessiliflora, used in folk medicine to treat skin cancer. Most of
China's 5,000 medicinal plant species are represented in the
institute's herbarium. Other Chinese research organizations with
major programs on medicinal herbs are the Institute of Chinese
Medicine, Beijing; the Institute of Materia Medica, Shanghai; the
Institute of Organic Chemistry, Shanghai; the Municipal Hospital
of Chinese Traditional Medicine, Beijing; the College of
Pharmacy, Nanking; and the Department of Organic Chemistry and
Biochemistry, Beijing University (Duke and Ayensu, 1985).
Many herbs in China have been extensively
studied by using methods acceptable from a Western perspective.
For example, a 1992 article in the Journal of Ethnopharmacology
reported that during the preceding 10 years more than 300
original papers on Panax ginseng had been published in Chinese
and English (Liu and Xiao, 1992). Ginseng is one of the world's
most thoroughly researched herbs. Following is an overview of
recent research on ginseng and other herbs in China. Unless
otherwise indicated, the data on specific herbs are taken from
Chinese Herbal Medicine: Materia Medica, revised edition,
compiled and translated by Dan Bensky and Andrew Gamble (1993).
* Ginseng root (Panax ginseng [ren shen]). The
Chinese first used oriental ginseng (Panax ginseng) more than
3,000 years ago as a tonic, a restorative, and a specific
treatment for several ailments. By the 10th century, oriental
ginseng had traveled the Silk Road to the Arabic countries (Kao,
1992), and during the next 4 centuries it spread to Europe, where
the French, among others, used it to treat asthma and stomach
troubles (Vogel, 1970).
In modern times, ginseng has been extensively
studied in China, Japan, and Korea and, to a lesser degree, in
the United States. In its various forms, ginseng or its compounds
have various physiological effects. These include antistress
capabilities (Cheng et al., 1986; Yuan et al., 1988), antihypoxia
effects (Cheng et al., 1988; Han et al., 1979; Qu et al., 1988),
alteration of circadian rhythms by modifying neurotransmitters
(Lu et al., 1988; Zhang and Chen, 1987), cardiac performance
effects (Chen et al., 1982), protection against myocardial
infarction in animals (Chen, 1983; Fang et al., 1986), histamine
response effects (Zhang et al., 1988), inhibition of platelet
aggregation (Shen et al., 1987; Yang et al., 1988), alteration of
circadian variation of plasma corticosterone (Li et al., 1988),
modulation of immune functions (Qian et al., 1987; Wang et al.,
1980), and delay of the effects of aging (Tong and Chao, 1980;
* Fresh ginger rhizome (Zingiber officinale
[sheng jiang]). In one study, preparations of sheng jiang and
brown sugar were used to treat 50 patients with acute bacillary
dysentery. A cure rate of 70 percent was achieved in 7 days.
Abdominal pain and tenesmus (an urgent but ineffectual attempt to
urinate or defecate) disappeared in 5 days, stool frequency
returned to normal in 5 days, and stool cultures were negative
within 4 days, with no side effects.
In another study, 6 to 10 thin pieces of sheng
jiang placed over the testes were used to treat acute orchitis
(inflammation of the testicles). The ginger was changed daily or
every other day. All participants felt a hot-to-numbing sensation
in the scrotum, while a few reported local erythema and edema.
Among 24 patients in the study, average cure time was 3 days. In
a control group of four patients, average healing time was 8.5
days. This technique is not recommended for patients with scrotum
* Chinese foxglove root (Rehmannia glutinosa
[sheng di huang]). A preparation of this herb and Radix
glycyrrhiza uralensis (gan cao) was used to treat 50 cases of
hepatitis in various stages. Within 10 days, 41 cases showed
improved symptoms, reduced liver and spleen size, and improved
liver function tests. Experiments from the 1930s seemed to show
that sheng di huang, given to rats via gastric lavage or
injection, lowered serum glucose levels. Later studies of this
problem showed variable results. Work in Japan showed that the
herb is useful in treating experimental hyperglycemia in rats. In
other studies, decoctions of sheng di huang have been used to
treat rheumatoid arthritis in adults and children. In one
uncontrolled study, 12 subjects all showed reduced joint pain and
swelling, increased function, improved nodules and rash, and
lowered temperature. Followup over 3 to 6 months showed only one
relapse, which was treated successfully with the same
* Baical skullcap root (Scutellaria baicalensis
[huang qin]). Huang qin was shown to inhibit the skin reaction of
guinea pigs to passive allergic and histamine tests. It has been
shown to be effective in treating guinea pigs with allergic
asthma. Huang qin also prevented pulmonary hemorrhage in mice
subjected to very low pressure. Huang qin has an inhibitory
effect against many kinds of bacteria in vitro, including
Staphylococcus aureus, Corynebacterium diphtheriae, Pseudomonas
aeruginosa, Streptococcus pneumoniae, and Neisseria meningitidis.
In one report, one strain of bacteria (Staph. aureus) that was
resistant to penicillin remained sensitive to this herb.
According to one study, 100 patients with bacillary dysentery
received a prescription composed mainly of huang qin. Mean
recovery times were 2.5 days until symptoms disappeared, 3.3 days
until normal stool examination, and 4.3 days until negative stool
* Coptis rhizome, or yellow links (Coptis
chinensis [huang lian]). Huang lian and one of its active
ingredients, berberine, have broad effects in vitro against many
microbes. It strongly inhibits many bacteria that cause
dysentery; it is more effective than sulfa drugs but less
effective than streptomycin or chloramphenicol. Decoctions of
huang lian have been effective against some bacteria that
developed resistance to streptomycin and other antibiotics. The
herb's antimicrobial ingredient is generally considered to be
berberine. Experiments on chicken embryos show that huang lian
has an inhibitory effect against flu viruses and the Newcastle
Huang lian preparations have a strong
inhibitory effect in vitro against many pathogenic fungi.
Capsules of powdered huang lian were given to patients with
typhoid fever, with good results. In one report, two cases that
were resistant to antimicrobials responded to this herb. In
another study, 30 cases of pulmonary tuberculosis were treated
with huang lian for 3 months; all improved.
A 10-percent solution of huang lian also was
used to treat 44 cases of scarlet fever. It was as effective as
penicillin or a combination of penicillin and a sulfa drug. Huang
lian also has been successfully used to treat diphtheria; in one
study, the fever subsided in 1 to 3 days. Huang lian ointments or
solutions promoted healing and reduced infections in first-and
second-degree burns. It also has positive effects on blood
pressure, smooth muscle, lipid metabolism, and the central
nervous system; is effective as an anti-inflammatory; and has
been used successfully in gynecology, ophthalmology, and
* Woad leaf (Isatis tinctoria [da qing ye]). Da
qing ye kills some kinds of bacteria, including some strains
resistant to sulfa drugs. It was reported effective in hundreds
of cases of encephalitis B, with cure rates of 93 percent to 98
percent. In most cases the fever subsided in 1 to 4 days, and
symptoms disappeared 3 to 5 days later. Da qing ye has been
effective by itself in mild and moderate cases; other herbs,
acupuncture, and Western drugs should be added in severe cases.
In a study of 100 subjects, only 10 percent of
the group given a da qing ye decoction twice daily had upper
respiratory infections during the study period versus 24 percent
of the control group. When a mixture of decoctions of da qing ye
and Herba taraxaci mongolici cum radice (pu gong ying) was given
to 150 children with measles, signs and symptoms disappeared in 4
to 5 days. In 68 of 100 cases, da qing ye was used successfully
to treat infectious hepatitis.
* Wild chrysanthemum flower (Chrysanthemum
indicum [ye ju hua]). Ye ju hua has been used to treat
hypertension, either alone as an infusion or with Elos lonicerae
japonicae (jin yin hua) and Herba taraxaci mongolici cum radice
(pu gong ying) in a decoction. Ye ju hua preparations have an
inhibitory effect in vitro against some bacteria and viruses.
Preparations given orally or as injections lowered blood
pressure. Preparations made from the whole plant had more
toxicity and less efficacy than those made from the flower alone.
One study was performed with 1,000 subjects to
see whether ye ju hua would prevent colds. The subjects were
compared with their own histories and against a matched set of
261 controls. A ye ju hua decoction was taken once a month by
people with histories of infrequent colds, twice a month by those
with three to five colds a year, and weekly by those with
frequent colds. Comparison with their own histories showed a
13.2-percent reduction in frequency, but a greater frequency in
comparison with the controls. At the same time, another clinical
series of 119 cases of chronic bronchitis was observed. Using the
same preparation, this group experienced a 38-percent reduction
in acute attacks in comparison with their seasonally adjusted
rate for the previous year.
* Bletilla rhizome (Bletilla striata [bai ji]).
Bai ji, in powdered form or in a powder made from starch and a
decoction of bai ji, helped control bleeding in seven of eight
cases of surgical wounds to dogs' livers. Pure starch was much
less effective. Similar results have been achieved with sponges
soaked in a sterile water-extraction solution of the herb. In
anesthetized dogs with 1-mm-diameter stomach perforations,
washing the perforations with 9 g of powdered bai ji through a
tube closed the perforations in 15 minutes. Eight hours after the
procedure the abdomens were opened, and no trace of gastric
contents was found. When the dogs' stomachs were full or the
perforations were larger, powdered bai ji had no effect.
In another study, powdered bai ji was used to
treat 69 cases of bleeding ulcers, and in all cases the bleeding
stopped within 6.5 days. In another series of 29 perforated ulcer
cases, the powdered herb was successful in 23 cases, 1 required
surgery, and the other 4 died (1 went into hemorrhagic shock
while under treatment, and the other 3 were in precarious
condition on admission).
In other studies, powdered bai ji was given to
60 chronic tuberculosis patients who had not responded to normal
therapy. After taking the herb for 3 months, 42 were clinically
cured, 13 significantly improved, and 2 showed no change. A
sterile ointment made from decocted bai ji and petroleum jelly
was used in a local application to treat 48 cases of burns and
trauma (less than 11 percent of total body area). Dressings were
changed every 5 to 7 days, and all patients recovered within 1 to
* Salvia, or cinnabar root (Salvia miltiorrhiza
[dan shen]). Dan shen caused coronary arteries to dilate in
guinea pig and rabbit heart specimens. In one study of 323
patients given a dan shen preparation for 1 to 9 months, there
was marked improvement in 20.3 percent of clinical cases and
general improvement in 62 percent of cases. Results were best
when patients had coronary artery disease and no history of
myocardial infarction. In a clinical series of more than 300
patients with angina pectoris, a combination of dan shen and
Lignum dalbergiae odoriferae (jiang xiang) given intramuscularly
or intravenously improved symptoms in 82 percent and
electrocardiograms in 50 percent of cases.
* Corydalis rhizome (Corydalis yanhusuo [yan hu
suo]). Yan hu suo is widely used to treat pain. Powdered yan hu
suo is a very strong analgesic, about 1 percent the strength of
opium. In one clinical study of 44 patients with painful or
difficult menstruation, 50 mg of the yan hu suo active
ingredient, dihydrocorydaline, given 3 times a day brought
significant relief in 14 cases and reduced pain in another 18
cases. Side effects included reductions in menstrual flow,
headaches, and fatigue.
* Root of Szechuan aconite (Aconitum
carmichaeli [fu zi]). Fu zi's toxicity has always been a major
concern. It is usually prepared with salt to reduce its toxicity.
Anesthetized dogs or cats given fu zi preparations showed a sharp
drop in blood pressure. In another experiment, fu zi caused blood
vessels to dilate in lower extremities and coronary vessels. In
normal dosage for humans, fu zi slightly lowers blood pressure,
while a large overdose can cause rapid heartbeat or ventricular
fibrillation. This herb seems to have some cardiotonic function
and a regulatory effect on heart rhythm. Administered with herbs
such as Cortex cinnamomi cassiae (rou gui), Panax ginseng (ren
shen), Rhizoma zingiberis officinalis (gan jiang), and Radix
glycyrrhiza uralensis (gan cao), fu zi raised blood pressure in
animals with acute hemorrhage. In one study, patients with
congestive heart failure were treated by intramuscular injections
of a fu zi preparation. In all cases, including one of
cardiogenic shock, the result was increased cardiac output as
well as decreased breathing difficulty, liver swelling, and
general edema. A few cases showed temporary side effects of
flushing and slight tremors.
* Licorice root (Glycyrrhiza uralensis [gan
cao]). Gan cao preparations have been used with common
antituberculosis drugs in many large clinical studies among
patients who did not respond to standard treatment. In most
cases, symptoms improved or disappeared and x rays improved
markedly. In many clinical studies using gan cao for ulcers with
groups of 50 to 200 subjects, effectiveness was around 90
percent. It was especially useful to treat the pain, which
disappeared or improved within 1 to 3 weeks. The more recent the
onset of disease, the better the results. In almost all cases the
powdered herb was most effective.
In rats with experimentally induced
atherosclerosis, gan cao lowered cholesterol levels and stopped
progression of lesions. In several experiments, the herb reduced
the toxicity of some substances, including cocaine, and
moderately reduced the toxicity of others, including caffeine and
nicotine. When decocted with fu zi, it sharply reduced fu zi's
* Dryopteris root, or shield fern (Dryopteris
crassirhizoma [guan zhong]). Dryopteris crassirhizoma is called
dong bei guan zhong because it is found in northeastern (dong
bei) China. In recent times this herb has been prescribed as a
preventive measure during influenza epidemics. Guan zhong
preparations strongly inhibit the flu virus in vitro. In one
clinical trial, 306 people took twice-weekly doses of guan zhong
and 340 served as controls. In the treatment group, 12 percent
became ill versus 33 percent of the controls. Local versions of
guan zhong from Guangdong, Hunan, and Jiangxi provinces have
mildly inhibitory effects in vitro against many pathogenic
bacteria. Guan zhong also is effective against pig roundworms in
vitro, and it expels tapeworms and liver flukes in cattle.
In other studies, decoctions and alcohol
extracts of dong bei guan zhong strongly stimulated the uterus of
guinea pigs and rabbits. It increased the frequency and strength
of contractions. Intramuscular injections of dong bei guan zhong
preparations were used with more than 91-percent success to treat
postpartum, postmiscarriage, and postsurgical bleeding.
* Garlic bulb (Allium sativum [da suan]). Da
suan preparations have a strong inhibitory effect in vitro
against amebae. In one study, concentrated da suan decoctions
were used to treat 100 cases of amebic dysentery. The cure rate
was 88 percent, and the average hospital stay was 7 days. In this
clinical study, purple-skinned bulbs were more effective than
white-skinned bulbs. Patients were discharged on a regimen that
included purple-skinned da suan in the daily diet.
When used with Chinese leek seeds, da suan
juice and decoctions have a strong inhibitory effect in vitro
against many pathogenic bacteria. Da suan can be effective
against bacteria that resist penicillin, streptomycin, and
chloramphenicol. In one clinical study, 130 patients with
bacillary dysentery were given da suan enemas. Of the followup
colonoscopies, 126 showed that pathological changes were resolved
within 6.3 days. In other studies with hundreds of patients, da
suan's effectiveness against bacillary dysentery was more than 95
percent. Again, purple-skinned garlic seemed more effective than
white-skinned, and fresh bulbs were more effective than old ones.
In one clinical study, 17 cases of encephalitis B were treated
with an intravenous drip of da suan preparations and supportive
care. Except for one fatality, all other cases recovered.
Ayurveda, the oldest existing medical system,
is recognized by WHO and is widely practiced. The word comes from
two Sanskrit roots: ayus means life or span; veda means knowledge
or science. India recently increased research on traditional
Ayurvedic herbal medicines after observations that they are
effective for conditions to which they have traditionally been
applied. For example, the ancient Sanskrit text on Ayurveda, the
Sushruta Samhita, noted that Commiphora mukul was useful in
treating obesity and conditions equivalent to hyperlipidemia, or
increased concentrations of cholesterol in the body. The plant
has been used by Ayurveda practitioners for at least 200 years
and may have been in use since the writing of the Sushruta
Samhita more than 2,000 years ago. In a recent study, the crude
gum from Commiphora mukul significantly lowered serum cholesterol
in rabbits with high cholesterol levels. The plant substance also
protected rabbits from cholesterol-induced atherosclerosis
(hardening of the arteries). This finding led to pharmacological
and toxicological studies that showed this herbal remedy to be
effective in humans, with no adverse side effects. Approval was
obtained from the national regulatory authority in India for
further clinical trials (Verma and Bordia, 1988). The drug is
marketed in India and other countries for treatment of
hyperlipidemia (Chaudhury, 1992).
The following other Ayurvedic herbs have
recently been studied in India under modern scientific
* Eclipta alba. In Ayurvedic medicine, Eclipta
alba is said to be the best drug for treating liver cirrhosis and
infectious hepatitis. Eclipta alba and Wedelia calendulacea are
widely used in India for jaundice and other liver and gall
bladder ailments. One recent study showed that a liquid extract
from fresh Eclipta leaves was effective in vivo in preventing
acute carbon tetrachloride-induced liver damage in guinea pigs.
Clinically, the powdered drug is effective against jaundice in
children (Wagner et al., 1986).
* Common teak tree (Tectona grandis). Trunk
wood and bark of the common teak tree are described in Ayurvedic
medicine as a cure for chronic dyspepsia (indigestion) associated
with burning pain. Teak bark forms an ingredient of several
Ayurvedic preparations used to treat peptic ulcer. Pandey et al.
(1982) experimentally screened teak bark and its effect on
gastric secretory function and ulcers in albino rats and guinea
pigs. The solution reduced gastric ulcers in restrained albino
rats and significantly inhibited gastric and duodenal ulcers in
* Indian gooseberry (Emblica officinalis
[amla]). Jacob et al. (1988) studied the effect of total serum
cholesterol by using amla to supplement the diets of normal and
hypercholesterolemic men aged 35-55. The supplement was given for
28 days in raw form. Normal and hypercholesterolemic subjects
showed decreased cholesterol levels. Two weeks after the
supplement was withdrawn, total serum cholesterol levels of the
hypercholesterolemic subjects rose almost to initial levels.
* Picrorhiza kurroa. P. kurroa rhizomes are
main ingredients of a bitter tonic used in fever and dyspepsia
(indigestion). This drug occupies a prestigious position in
Ayurveda. It often substitutes for Gentiana kurroo, the Indian
gentian. Powdered rhizomes also are used as a remedy for asthma,
bronchitis, and liver diseases. Other researchers have reported
that a P. kurroa-derived mixture called kutkin exhibits
hepatoprotective activity; that P. kurroa acts as a bile
enhancer; that it has antiasthmatic effects in patients with
chronic asthma; and that it has immunomodulating activity in
cell-mediated and humoral immunity. Another study (Bedi et al.,
1989) shows that P. kurroa works to boost the immune system as a
supplement to other treatments in patients with vitiligo, a skin
disease that causes discolored spots.
* Articulin-F. This herbomineral formula
contains roots of Withania somnifera, stem of Boswellia serrata,
rhizomes of Curcuma longa, and a zinc complex. Kulkarni et al.
(1991) performed a randomized, double-blind, placebo-controlled
crossover study of articulin-F to treat osteoarthritis, a common
progressive rheumatic disease characterized by degeneration and
eventual loss of articular cartilage. Articulin-F treatment
produced a significant drop in pain severity and disability
score, whereas radiological assessment showed no significant
* Abortifacient plants. Nath et al. (1992)
organized a survey program in Lucknow and Farrukhabad, two towns
in Uttar Pradesh, India, from March to July 1987. During the
survey, they recorded the common folk medicine used by women and
consulted Ayurvedic and Unani drug encyclopedias for the
antireproductive potential of the following medicinal plants:
leaves of Adhatoda vasica, leaves of Moringa oleifera, seeds of
Butea monosperma, seeds of Trachyspermum ammai, flowers of
Hibiscus sinensis, seeds of Abrus precatorius, seeds of Apium
petroselinium, buds of Bambusa arundensis, leaves of Aloe
barbadensis, seeds of Anethum sowa, seeds of Lepidium sativum,
seeds of Raphanus sativus, seeds of Mucuna pruriens, seeds of
Sida cordifolia, seeds of Blepharis edulis, flowers of Acacia
arabica, and seeds of Mesua ferrea. Plant materials were
collected, authenticated, chopped into small pieces, air dried in
shade, and then ground to a 60-mesh powder. During the survey,
female rats were given aqueous or 90-percent ethanol extracts of
the plants orally for 10 days after insemination by males, with
special attention to effects on fetal development. Leaf extracts
of Moringa oleifera and Adhatoda vasica were 100-percent abortive
at doses equivalent to 175 mg/kg of starting dry material.
* Neem (Azadiractica indica) and turmeric
(Curcuma longa). In the Ayurveda and Sidha systems of medicine,
neem and turmeric are used to heal chronic ulcers and scabies.
Charles and Charles (1991) used neem and turmeric as a paste to
treat scabies in 814 people. Ninety-seven percent of cases were
cured within 3 to 15 days. The researchers found this to be a
cheap, easily available, effective, acceptable mode of treatment
for villagers in developing countries, with no adverse reactions.
* Trikatu. Trikatu is an Ayurvedic preparation
containing black pepper, long pepper, and ginger. It is
prescribed routinely for several diseases as part of a multidrug
prescription. These herbs, along with piperine (alkaloid of
peppers), have biological effects in mammals, including
enhancement of other medicaments. Of 370 compounds listed in the
Handbook of Domestic Medicines and Common Ayurvedic Remedies
(Handbook, 1979), 210 contain trikatu or its ingredients. Trikatu
is a major decoction used to restore the imbalance of kapha,
vata, and pitta, the body's three humors (see the
"Alternative Systems of Medical Practice" chapter).
Piper species are used internally to treat fevers, gastric and
abdominal disorders, and urinary difficulties. Externally they
are used to treat rheumatism, neuralgia, and boils. P. longum and
P. nigrum are folklore remedies for asthma, bronchitis,
dysentery, pyrexia, and insomnia (Akamasu, 1970; Chopra and
Chopra, 1959; Perry, 1980; Youngken, 1950). In Chinese folklore,
P. nigrum is mentioned as a treatment for epilepsy (Pei, 1983).
The efficacy of P. longum fruits in reducing asthma in adults
(Upadhyaya et al., 1982) and children has been reported
(Dahanukar et al., 1984). P. nigrum promoted digestive juice
secretion (Shukla, 1984) and increased appetite (Sumathikutty et
al., 1979). P. longum was reported useful in patients with
gastric disorders accompanied by clinical symptoms of
achlorhydria (Kishore et al., 1990).
Native American Indian Herbal Medicine
In 1977 and 1978, Croom (see Kirkland et al.,
1992) spent 2 years documenting plant remedies among the Lumbee
Indians, the largest group of Native American Indians east of the
Mississippi River. Following are some often-used medicinal plant
remedies of the Lumbee:
* Rabbit tobacco (Gnaphalium obtusifolium).
These annual herbs reach a height of 1 to 3 feet and have erect
stems with brown, shriveled leaves persisting into winter and
stems covered with feltlike hairs in summer. The leaves are 1 to
3 inches long, and alternate. The flowers, minute in whitish
heads, appear in late summer to fall. Fields, pastures, and
disturbed areas are the sites of this common native plant of the
eastern United States. It is used to treat colds, flu, neuritis,
asthma, coughs, and pneumonia. This is one of the most popular
plants used by the Lumbee. The decoction is drunk hot, like most
medicinal teas, and is said to cause profuse sweating.
* Poke (Phytolacca americana). Also a common
native plant of the eastern United States, poke is a robust,
perennial herb that reaches a height of 9 feet. It has a large
white root; a green, red, or purple stem; alternate leaves up to
1 foot long; and white flowers in a drooping raceme. The fruit is
a dark purple to black berry, round, soft, and juicy. Poke is
found in waste areas, road sides, disturbed habitats, fields, and
pastures. It is used to treat asthma, spring tonic, boils
(risings), sores, intestinal worms in people or chickens, cramps,
and stomach ulcers. Poke is said to inhibit gram-positive and
gram-negative bacteria and is listed as a parasiticide in the
British Herbal Pharmacopoeia.
* Pine (Pinus echinata, P. palustris, P.
virginiana). Pines are resinous evergreen trees with needlelike
foliage leaves in bundles of two to five. The male and female
reproductive structures are in separate cones on the same tree;
the female cone matures to a large woody cone with winged seeds;
pollen sheds in the spring. Pine is used to treat colds, flu,
pneumonia, fever, heartburn, arthritis, neuritis, and kidney
* Oak (Quercus laevis, Q. phellos). These
deciduous trees have alternate, unlobed, or variously lobed
leaves and minute flowers; the fruit is an acorn. Oak is used to
treat kidney problems (including Bright's disease), bladder
problems, virus, menstrual bleeding, diarrhea, sores, sprains,
and swellings. It is also used as a booster for other remedies.
* Sassafras (Sassafras albidum). These
deciduous, aromatic, small trees or shrubs have green twigs
and--when mature--thick, furrowed bark. The leaves are 2.5 to 5
inches long; alternate; and either unlobed, lobed on one side, or
three-lobed. Flowers are small and yellow in clusters at the end
of twigs. The fruit is a dark blue, fleshy drupe on a bright red
stalk and cup. This common native plant of fencerows, woodland
borders, and old fields of the eastern United States is used to
treat measles, chicken pox, colds, flu, and fever. It is also
used as a "shotgun heart remedy," a blood purifier, and
a spring tonic.
According to the Handbook of Northeastern
Indian Medicinal Plants Native American Indians used about 25
percent of the flora of Maryland for medicinal purposes (Duke,
1986). A few examples of medicinal plant species in Maryland are
* Sweetflag or calamus (Acorus). The root has
been used to treat flatulence, colds, coughs, heart disease,
bowel problems, colic, cholera, suppressed menses, dropsy,
gravel, headache, sore throat, spasms, swellings, and yellowish
urine. Some tribes considered the root a panacea; others thought
it had mystic powers.
* Bloodroot (Sanguinaria). This very poisonous
plant is emetic, laxative, and emmenagogue. It has been used to
treat chronic bronchitis, diphtheria, sore throat, uterine and
other cancers, tetterworm, deafness, and dyspepsia; it has also
been used as a pain reliever and sedative. In Appalachia it is
carried as a charm to ward off evil spirits.
* Yellowdock. Contains anthraquinones of value
in the treatment of ringworm and some types of psoriasis. Rumicin
from the roots reportedly destroys skin parasites. The
anthraquinones are proven laxatives.
* Coneflower (Echinacea, Rudbeckia). Echinacea
(purple coneflower) reportedly increases resistance to infection,
bad coughs, dyspepsia, venereal disease, insect bites, fever, and
* Witch hazel. A proven astringent and hemostat
(to stop bleeding).
* Lobelia (Lobelia cardinalis). Cardinal flower
was used to indurate ulcers and to treat stomachache, syphilis,
and worms. The leaf tea was used for cold, croup, epistaxis
(nosebleed), fever, headache, rheumatism, and syphilis. Lobelia
inflata (Indian tobacco) yields lobeline sulfate, used in
antitobacco therapy. It is used as an antiasthmatic, an
expectorant, and a stimulant for bronchitis; it also is used to
treat aches, asthma, boils, croup, colic, sore throat, stiff
neck, and tuberculosis of the lungs. Some smoked the herb to
break a tobacco habit.
* Mayapple (Podophyllum peltatum). Early Native
American Indians used the roots as a strong purgative, liver
cleanser, emetic, and worm expellant. A resin made from the plant
has been used to treat venereal warts and exhibits antitumor
activity; it also is used for snakebite and as an insecticide for
* Wild cherry (Prunus virginiana). The bark has
been used to treat sores and wounds, diarrhea, cold and cough,
tuberculosis, hemoptysis, scrofula, sore throat, stomach cramps,
and piles. Native American Indians treated snow blindness by
leaning over a kettle of boiling bark "tea." Some
smoked the bark for headache and head cold.
* White willow (Salix alba). The bark is
astringent, expectorant, hemostatic, and tonic. It is used to
treat calluses, cancers, corns, tumors, and warts. Salicylic acid
(used to make aspirin) is found in white willow. Leaves and bark
of different willows are used in a tea to break a fever. Some
Native American Indians burned willow stems and used the ashes to
treat sore eyes.
Barriers to Herbal Medicine Research in the United States
The regulatory lockout of natural remedies has
crippled natural products research in U.S. universities and
hospitals. There is no dedicated level of support by the Federal
Government for herbal medicine research. Herbalists may apply
under existing guidelines for approval of new pharmaceutical
drugs, but this burden is unrealistic because the total cost of
bringing a new pharmaceutical drug to market in the United States
is an estimated $140 million to $500 million (Wall Street
Journal, 1993). Because botanicals are not patentable (although
they can be patented for use), an herbal medicine manufacturer
could never recover this expenditure. Therefore, herbal remedies
are not viable candidates for the existing drug approval process:
pharmaceutical companies will not risk a loss of this magnitude,
and herb companies lack the financial resources even to consider
Another major barrier is that the academic
infrastructure necessary for proper study of ethnomedical systems
has seriously eroded in recent decades and must be reinvigorated
to accommodate the newly recognized need for preserving
traditional medical systems and biological diversity.
Pharmacognosy and other academic studies of medicinal plants have
declined alarmingly in the United States. North American
scientists, once at the forefront of this research, lag behind
their European and Japanese colleagues, reducing the likelihood
that they will discover useful new medicines from plants. This
problem is exacerbated by the fact that much of the discipline of
botany has moved away from field studies and into molecular and
laboratory approaches. Today only a handful of active full-time
ethnobotanists are trained to catalog information on the
medicinal properties of plants.
In contrast to the United States, many European
and Asian countries have taken a more holistic approach to
researching the efficacy of herbal remedies. In Germany, France,
and Japan, the past 20 years have seen a rapid increase in
research into and use of standardized, semipurified (still
containing multiple individual chemicals) herbal extracts called
phytomedicines. In Europe and Japan, phytomedicines treat
conditions ranging from serious, life-threatening diseases such
as heart disease and cancer to simple symptomatic relief of
colds, aches and pains, and other conditions treated by OTC drugs
in the United States. Phytomedicines include preventive
medicines, an often-neglected area of medicine in the United
States. The FDA has approved many plant-derived
"heroic" cures, but never a plant-derived preventive
Research Needs and Opportunities
Much modern-day medicine is directly or
indirectly derived from plant sources, so it would be foolish to
conclude that plants offer no further potential for the treatment
or cure of major diseases. Worldwide, the botanical pharmacopoeia
contains tens of thousands of plants used for medicinal purposes.
Hundreds, perhaps thousands, of definitive texts, monographs, and
tomes on herbal remedies exist. But most of this information is
outside current databases and remains unavailable to physicians,
researchers, and consumers.
Globally, herbal remedies have been researched
under rigorous controls and have been approved by the governments
of technologically advanced nations. The scientific validation is
good to excellent, and the history of clinical use is even
stronger. Many phytomedicines have been used by thousands of
physicians in their practices and are consumed under medical
supervision by tens of millions of people.
A great deal of literature exists on the use of
phytomedicines in Europe and within native medical systems in
China, Japan, India, and North America. Much of this literature
can be found in a unique database developed and maintained by the
University of Illinois at Chicago, College of Pharmacy. The
database, NAPRALERT (Natural Products Alert), holds references
for more than 100,000 scientific articles and books on natural
products (plant, microbial, and animal extracts). NAPRALERT
includes considerable data on the chemistry and pharmacology
(including human studies) of secondary metabolites of known
structure, derived from natural sources. About 80 percent of the
references are from post-1975 literature, the rest from pre-1975
literature (see the "Research Databases" chapter for
more information on NAPRALERT).
In 1981 the U.S. Department of Agriculture
(USDA), in conjunction with the National Cancer Institute,
concluded a 25-year study of plants with possible anticancer
properties. One result is published in the Handbook of Medicinal
Herbs (Duke and Ayensu, 1985). This work lists 365 folk medicinal
species and identifies more than 1,000 pharmacologically active
phytochemicals. Toxicity estimates are given for many of these
biologically active compounds. More recently, Dr. James Duke of
USDA published databases on biologically active compounds of more
than 1,000 species of plants with potential medicinal uses (Duke,
1992a, 1992b). Duke proposed to FDA a computer-calculated
toxicity index to parallel the Ames Human Exposure Rodent Potency
(HERP) index for carcinogenicity. He calls his index the Better
Understanding of Relative Potency (BURP) index.
Much of the literature on traditional Chinese
and other Asian countries' herbal medicine is only now beginning
to be translated into English. While much of this information is
in the form of folklore, there is a growing body of data from
scientifically valid literature on herbal medicine research in
China as well as India and Japan. In 1986, the book Chinese
Herbal Medicine: Materia Medica was published by Dan Bensky and
Andrew Gamble, both of whom are fluent in Chinese dialects and
studied herbal medicine in Asia. Revised in 1993 (Bensky and
Gamble, 1993), it presents an indepth study of 470 herbs used in
traditional Chinese medicine. Each entry details the traditional
properties, actions and indications, principal combinations,
dosage, and contraindications of the herbs, as well as summaries
of abstracts regarding pharmacological and clinical research
conducted in Asia. The revised edition also provides a brief
description of the appearance of each herb.
Although very little laboratory or clinical
research has been performed on Native American Indian herbal
remedies, extensive listings of herbs and their uses have been
compiled by ethnobotanists for several tribes. One source,
American Indian Medicine (Vogel, 1970), cites references in the
professional ethnobotanical literature on herbal medicines for
the following tribes: Alabama-Koasati, Arakara, Algonquian,
Arapaho, Aztec, Catawba, Cheyenne, Chickasaw, Choctaw, Comanche,
Congaree, Creek, Dakota, Delaware, Hoh, Hopi, Houma, Huron,
Illinois-Miami, Iroquois, Kwakiutl, Lake St. John Montagnais,
Mayan, Menomini, Mescalero Apache, Malecite, Meswaki, Michigan,
Mohawk, Mohegan, Natchez, Navajo, Nebraska, Oglala Sioux, Ojibwa,
Omaka, Pawnee, Penobscot, Ponca, Potawatomi, Quileute,
Rappahannock, San Carlos Apache, Seminole, Sioux, White Mountain
Apache, Ute, Winnebago, Yuma, and Zuni. Moerman's database
(Moerman, 1982) lists more than 2,000 species of Native American
Indian medicinal plants, and Duke (1986) lists more than 700
These sources--the NAPRALERT database, USDA
laboratory research, the Bensky and Gamble book, and the Native
American Indian herbal medicinal books--are the foundation on
which the U.S. Government, particularly the National Institutes
of Health (NIH), can begin substantial research into herbal
Much unwritten knowledge resides in the hands
of healers in many societies where oral transmission of
information is the rule. Unfortunately, in many regions this
information is endangered because there are no young apprentices
to whom elderly healers can pass on their unwritten wisdom; the
knowledge that has been refined over thousands of years of
experimentation with herbal medicine is being lost. A major
research opportunity in this area would be to catalog information
on herbal medicines from thousands of traditional healers in
cultures where these skills are normally transmitted through an
apprentice system. Some organizations have recently increased
their efforts to catalog endangered herbal knowledge from
traditional medical systems in Latin America, such as those
practiced in the rain forests of Belize (Arvigo and Balick, 1993)
and Peru (Duke and Martinez, in press).
Basic Research Priorities
Basic research into characterizing these plant
products and compounds in terms of standardized content and
potential toxicity is needed to allow safe and replicable
research to document clinical efficacy. Basic science research
should be conducted to evaluate research on the biochemical
effects of traditional herbal prescriptions from Western,
Ayurvedic, oriental, and other traditions (see the
"Alternative Systems of Medical Practice" chapter).
Clinical Research Priorities
Research in phytomedicines in the United States
could follow on the results of existing high-quality European and
Asian research on plant medicines and should focus on replicating
results of key studies or addressing weaknesses in those studies.
Reviews of foreign literature and translations of non-English
literature would be helpful. Current widespread use of herbal
medications as "food supplements" in the United States
provides a ready base of users, producers, and practitioners for
clinical research in traditional and modern applications of
Key Research Issues
Before a comprehensive research agenda is
developed, several key issues must be addressed, including the
following: the impending loss of knowledge about traditional
healing in many societies; the impending loss of large numbers of
plant species of potential medicinal value; impediments to the
use of herbal remedies outside the cultures in which they
originated; and determination of the conditions under which
herbal medicines are most appropriate, safe, and effective.
Additionally, several regulatory issues hamper research into
Loss of Knowledge
The knowledge of traditional healers in remote
Amazonian or Central American regions may have the potential to
make a significant contribution to Western society. But few, if
any, practitioners of these lesser known medical systems practice
outside their native range, and those who still practice within
these regions are elderly and often have not found younger
Loss of Plant Species of Potential Medicinal Value
This loss of knowledge from traditional healers
comes at a time when native flora in many areas, especially
tropical regions, are being destroyed at an alarming pace. In the
United States alone, an estimated 10 percent of all species of
flowering plants will be extinct by the year 2000, including an
estimated 16 species of medicinally useful plants (Farnsworth et
One hopeful sign is that the U.S. Government
recently formed a cooperative biodiversity group including
representatives from NIH, the National Institute of Mental
Health, the National Science Foundation (NSF), and the U.S.
Agency for International Development. This group intends to fund
research to locate and catalog medicinally active substances that
can be analyzed and used for new pharmaceutical drug development,
while working to preserve biological diversity in developing
Use in Practice
Basic to the use of medicinal herbs in many
societies is the practice of using whole, unrefined plant
material. The material may be leaves, buds, flowers, bark, or
roots, separately or in combination. In some cases an herbal
remedy is a complex mixture of many plants. There is an age-old
belief that whole-plant medicines have fewer dangerous side
effects and provide a more balanced physiological action than
plant-derived pharmaceutical drugs whose single ingredient has
been isolated, concentrated, and packaged as a pill or liquid.
Herbs and herbal preparations generally are
self-administered. Often they are purchased through native
herbalists who prescribe one or more herbs or preparations on the
basis of medical and health approaches that often include
concepts of attaining balance in the client's body, psychology,
and spirit (see the "Community-Based Medical Practices"
section of the "Alternative Systems of Medical
Practice" chapter). Consequently, it is often difficult to
assess the relative value of herbal remedies versus prescription
drugs on a one-to-one basis.
Indeed, herbal remedies of all types, including
those from China, are composed of a multitude of ingredients
whose interactions with the body are exceedingly complex. A high
level of sophistication of research methodology is necessary to
describe the interaction between the human body and substances as
complex as those contained in many herbal remedies. Only recently
has such a rigorous methodology begun to be developed. For
example, the Chinese herb Herba hedyotidis diffusae (bai hua she
she cao) has been shown clinically effective in the prevention
and treatment of a variety of infectious diseases. However, it
has not been demonstrated to have a significant inhibitory effect
in vitro against any major pathogen. Only as techniques became
available to test the immunological system did it become apparent
that at least part of the herb's effect was due to its
enhancement of the body's immune response (Bensky and Gamble,
Another complicating factor in researching
traditional Chinese herbal medicine is the fact that Chinese
medicine characteristically tries to treat the whole body to
alleviate disease stemming from one body organ. Therefore, it
rarely relies on a single herb to treat an illness. Instead,
formulas usually contain 4 to 12 different herbs (Duke and
Beyond the problem of trying to test herbal
preparations that may contain many active ingredients is the
question of whether the research eventually will lead to the
isolation of single active ingredients that can be packaged and
sold separately. Intense debate surrounds the issue of how to
conduct clinical trials of herbal medicines according to Western
pharmaceutical clinical standards. Critics say there is an
inherent problem with the single-active-ingredient approach
preferred by pharmaceutical companies that are actively involved
in herbal medicine research. The problem, they say, is that
isolating a single compound may not be the most appropriate
approach in situations where a plant's activity decreases on
further fractionation (separation of active ingredients by using
solvents) or where the plant contains two or three active
ingredients that must be taken together to produce the full
effect (Chaudhury, 1992). Beckstrom-Sternberg and Duke (1994)
have documented several cases where synergy has been lost by
using the single-ingredient approach to developing drugs from
A good example of this single-active-ingredient
versus whole-plant debate is illustrated by intense interest
among pharmaceutical companies in the compound called genistein.
Genistein is part of a class of compounds called flavonoids that
occur naturally in plants such as kudzu, licorice, and red
clover. Soybeans contain high concentrations of genistein, and
lima beans reportedly are even higher in genistein than soybeans
(Duke, 1993). There is increasing evidence that genistein may
inhibit the growth of cancers of the stomach (Yanagihara et al.,
1993), pancreas (Ura et al., 1993), liver (Mousavi and
Adlercreutz, 1993), and prostate (Peterson and Barnes, 1993).
Genistein is believed to inhibit the growth of cancers because of
its antiangiogenetic properties (i.e., it prevents the growth of
new blood vessels--a process known as angiogenesis--to tumors).
Genistein is being intensely studied as a
possible preventive or treatment for breast cancer, which kills
an estimated 44,000 women in the United States each year (Duke,
1993). Studies indicate a correlation between a high intake of
foods containing genistein (soy products) and a low incidence of
hormone-dependent cancers such as breast cancer (Hirayama, 1986)
and prostate cancer (Baker, 1992). The growth of certain cancers,
especially breast cancers, has been shown to depend on the female
sex hormone estrogen. Genistein exhibits estrogenlike activity in
plants and is often called a phytoestrogen. In humans it binds to
estrogen receptors (Baker, 1992). It has been suggested that
these phytoestrogens may compete with endogenous estrogen on the
cellular level, further reducing the cellular proliferation and
the potentially carcinogenic effects of estrogen (Tang and Adams,
1981). Thus, it may prevent the growth of estrogen-dependent
cancer by competing for estrogen sites on the tumor cells.
If genistein is developed as an isolated
pharmaceutical drug, it may have some action against cancer, but
the purified compound may not be as potent as genistein in its
natural state, and trials may give misleading results. The reason
is that all plant species containing genistein also contain other
flavonoid compounds, which may have synergistic effects when
ingested with genistein. Formononetin--a precursor of equol,
which also occurs with genistein--is said to be more active
estrogenically than genistein (Spanu et al., 1993). Although
genistein clearly inhibits angiogenesis, several other compounds
are pseudoestrogens. With this in mind, the question arises: Is a
mixture of genistein, formononetin, and other flavonoids, as
occurs in many plants, more estrogenic (and antiangiogenic) than
an equivalent quantity of any one of these components? If so, the
herbal or dietary approach may make more sense than a genistein
"silver bullet" approach.
Safety, Efficacy, and Appropriateness
Opinions about the safety, efficacy, and
appropriateness of medicinal herbs vary widely among medical and
health professionals in countries where herbal remedies are used.
Some countries' professionals accept historical, empirical
evidence as the only necessary criterion for herbal medicine's
efficacy. Others would ban all herbal remedies as dangerous or of
The problem is further complicated by the fact
that many "patent medicines" available in world trade
often are sold as herbal medicinal preparations when they include
nonherbal substances. These nonherbal additives often include
toxic metals (cinnabar, i.e., mercury) (Kang-Yum and Oransky,
1992), poisonous substances (powdered scorpion), or refined
prescription drugs (Catlin et al., 1993). Usually labeled
"Chinese herbal medicine," many of these products are
manufactured in Thailand, Taiwan, or Hong Kong and exported to
the United States, where they are sold in retail outlets. The
California Department of Health Services, in conjunction with the
Oriental Herbal Association, recently published a list of 20
popular Asian patent medicines (see app. E) that contain toxic
The increased use of plant medicines has
potential for improving public health and lowering health care
costs. Phytomedicines, if combined with the preventive model of
medical practice, could be among the most cost-effective,
practical ways to shift the focus of modern health care from
disease treatment to prevention. But drug regulatory policy
prevents the United States from taking advantage of these
phytomedicines for two reasons. The first is the exorbitant
expense involved in investigating each chemical compound in a
given plant extract before it can be tested for clinical
usefulness. Hence there is an urgent need to rework current
research guidelines to allow the whole plant material or
combination mixture (an herbal remedy containing more than one
plant) to be evaluated instead of requiring separate evaluations
of each chemical component of the therapeutic ingredients.
The second reason is that regulatory
requirements for proof of safety and efficacy constitute an
economic disincentive for private industry to conduct additional
scientific studies. Relaxing regulatory requirements for efficacy
for herbal products might make it economically feasible for more
private companies to pursue research into issues of safety and
quality control. Even with such regulatory change, some public
funding of research is needed to confirm the remedies' validity.
Public funds are needed because private industry has no incentive
to develop an herbal product that might displace a patented drug
from an approved treatment regime.
The Panel on Herbal Medicine recommends the
* OAM should hold a research organizational
conference to facilitate planning in herbal medicine research.
The conference would help to identify state-of-the-art questions
in ethnomedical research, existing databases, and research
personnel needed to support basic and clinical research needs in
* Federal funding agencies such as NSF and NIH
must begin to support the training of
ethnobotanists--specifically in the field of ethnomedicine--and
to offer funding opportunities to foster the rebirth of this
field at U.S. universities and research institutions. This is a
critical priority because much traditional knowledge in herbal
remedies is in danger of disappearing, as are the plant species
used in these systems of medicine.
* The bias against plant medicines must be
eliminated by restructuring the requirements for proof of
efficacy and concentrating on safety, and by removing the need
for extensive analyses of chemically complex natural product
medicines (thus eliminating the "monosubstance bias").
Several international regulatory models exist to guide the United
States in this direction. For example, the German
"Kommission E" (expert committee for herbal remedies)
monographs give a good example of how the United States might
simplify the approval of natural products without sacrificing
safety or quality standards. (The "doctrine of reasonable
certainty" that influences the approval of drugs under this
system was previously mentioned.)
Adopting a more realistic standard of evidence
for established plant medicines would eliminate much of the
expense required for approval of new and unknown chemical drugs.
Doing so would be similar to having standardized the crude drug
senna leaf, used in the United States as an OTC laxative and
documented for safety, effectiveness, and quality.
Another option might be to require
pharmaceutical companies that are testing a plant-derived,
single-ingredient pharmaceutical on a specific condition to
demonstrate that it is more effective than the natural product.
For example, before a patent could be issued to a pharmaceutical
company for an isolated compound such as genistein, the company
would first have to prove that the isolated compound is more
effective than genistein consumed in context (as a food). But
some market incentive, such as exclusive prescriptive marketing
rights, might be needed to allow the pharmaceutical company to
recoup its research costs.
* Legislative action may be required to restate
FDA's mandate with respect to herbal products and traditional
medications. The current regulatory mandate puts FDA in a
difficult position. It is expected to "protect the
public" but has no expertise or resources to evaluate the
global herbal medicine inventory. If a crisis such as the
contaminated tryptophan affair (see the "Diet and
Nutrition" chapter) were to occur with a popular herbal
product, FDA might attempt to prohibit the sale of medicinal
herbs altogether. Instead of expecting FDA to be an omnipotent
protector, Congress should legislate a more educational,
With respect to herbs used in popular health
care, a proactive FDA role in establishing quality and safety
standards would benefit the public and industry. A certification
system for herbal content and potency of marketed products could
be set up by FDA with USDA and the herbal industry. Such a system
could draw on the existing global database and other countries'
regulatory experiences. Participation in a voluntary product
certification system would be a marketing advantage for ethical
producers, allowing them, for example, to make a statement such
as "This product meets U.S. government purity and potency
standards." New statutory authority also would be necessary
to establish a category that would allow traditional usages to be
listed on labels according to criteria similar to WHO guidelines.
Finally, if herbal remedy producers were given
the option to apply for specific health condition label
indications based on new FDA phytomedicine standards, the United
States would have the same three-tiered regulatory system adopted
by other developed countries. Such a voluntary system would let
consumers make intelligent personal choices about the use of
medicinal herb products while mandating safety standards
consistent with existing OTC practices for potentially toxic
drugs such as aspirin and ibuprofen.
* OAM should review the TRAMIL approach, in
which distinguished Caribbean botanists, chemists, ethnologists,
and physicians review promising herbs and label them as
reasonably safe and effective for people who cannot afford the
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