Herbal Faq's
TOP
Introduction
Q. Why should I use herbal
products?
Q. Are herbs safe?
Q. Are herbal supplement
products safe?
Q. Are herbal supplements
effective?
Q. How soon can I expect to notice the benefits of an herbal product?
Q. How do I know how much to use?
Q. How are herbal supplements
regulated?
Q. What about interactions with
drugs?
Q. How
can I choose the herbal product that is right for me?
Q. What are "standardized" herbs?
Q. Should I tell my
Doctor that I'm using herbs?
Q. Where can I learn more?
References
Introduction
The use of herbs and
herbal products has become broadly accepted in our contemporary culture.
Consumer surveys consistently find that nearly half of all Americans now use
herbs (1,
2) a
statistic that is particularly remarkable when we realize that today's herbal
products "industry" is just over a quarter century old. In spite of this
widespread acceptance of herbal products in individual self-care choices,
misconceptions exist as to the regulation, safety and effectiveness of herbal
products.
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Q. Why should I use herbal
products?
The decision to use
herbs for their health promoting value is, as with all health decisions, a
personal one. There are, however, many good reasons to consider herbal
products as complements to your own health care. The best reason, however, may
be the fact that herbs and herbal products, with their incredibly wide use
throughout time and place, continue to provide real health benefits while
maintaining a remarkable safety profile. Readily available natural substances
were the first medicines used by humans. Primitive and ancient civilizations
as well as contemporary cultures throughout the world have always relied on
herbs to provide the benefits that have been observed with their use. In fact,
the World Health Organization has estimated that 80% of the world's population
continues to use traditional therapies, a major part of which are derived from
plants, as their primary health care tools.
(3)
In our own time and culture, most herbs are available in the form of "herbal
supplements."
(4)
These products are found in
the form of teas, tablets, capsules, liquid extracts, and others. We now have
ready access to products that bring the herbal traditions from all over the
world in a variety of convenient forms. In addition, scientific inquiries
continue to develop our knowledge of the benefits of plants, and often
validate the observations made over the past centuries.
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Q. Are herbs safe?
Plants that enjoy broad
culinary and therapeutic usage are generally safe. We can flavor our food with
any number of herbs to make a meal more flavorful. We can appreciate a
delicious cup of peppermint leaf or ginger root tea, or benefit from the
soothing properties of marshmallow root or the bark of slippery elm. We can
take an herbal supplement containing dandelion root or saw palmetto berries,
or any number of the other herbs. Although allergies and reactions have been
recorded for a few herbs that are widely used in foods and supplements, such
individual concerns are also seen with many foods, and do not diminish the
safety profile of the many herbs that are generally recognized as safe. On the
other hand, and as everyone knows, there are any number of plants that are
highly toxic, even deadly. Every ten-year-old hiker knows to stay away from
poison ivy (Toxicodendron spp.) when walking in the woods. The death sentence
imposed on Socrates by an Athenian jury 2400 years ago was carried out with a
fatal dose of hemlock (Conium maculatum). The poison curare, a blend of
several equatorial rain forest plants (e.g., species of Chondrodendron,
Curarea and Strychnos
(5)
is used by some South American hunter cultures to make their arrows more
deadly. Just this year, in the "concrete jungle" of Los Angeles, two young
boys died from ingesting a few leaves of the ubiquitous oleander
(6)
(Nerium oleander). Federal law
(7)
and good common sense, however, prevent the use of any such highly toxic plant
in products that are readily available to consumers. The better question then,
for today's American consumer, is "Are herbal supplement products safe?"
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Q. Are herbal supplement
products safe?
Federal law requires
that every food product, including herbal supplements, is free of
"adulteration" and is not "misbranded." This legal language translates into a
requirement that all foods and supplements have a reasonable expectation of
safety when offered for sale and when used as directed. So manufacturers of
soups, cereals, and supplements all have an obligation to sell only safely
made and properly labeled goods, and can find their products subject to
seizure should they fail to do so. In addition, manufacturers of herbal
products are specifically required to limit their ingredients to either those
that were already in the market prior to passage of landmark legislation in
1994 or those that a company can convincingly show, by providing information
to the Food and Drug Administration, to be safe. What that means is that any
manufacturer who wants to introduce a new herbal ingredient must first provide
FDA with information that shows that the herb will be "reasonably expected to
be safe"
(8)
Additionally, the safety of herbal products as a general class has been well
established by both their long history of traditional use worldwide and by
their broad contemporary use by a significant proportion of the population,
estimated to be nearly half of the U.S. population
(9)
There are so few credible reports of unexpected side effects due to herbal
products that most experts consider problems with herbal products to be of
only minor or occasional concern. Norman Farnsworth, Director of the WHO
Collaborating Centre for Traditional Medicine and Research Professor of
Pharmacognosy at the University of Chicago at Illinois, is generally
considered to be one of the most respected experts on the scientific research
of botanical medicines. In a 1993 article written on the subject of herbal
safety
(10),
Dr. Farnsworth concluded, "...side effects or toxic reactions associated with
herbal medicines in any form are rare. In fact, of all classes of substances
reported to cause toxicities of sufficient magnitude to be reported in the
United States, plants are the least problematic." This is not to say that
every herbal ingredient that is sold as an ingredient in a supplement is
appropriate for every consumer or in any quantity. Responsible and informed
use by consumers is essential to insure that herbal products maintain their
established safety profile. Accurate product labeling must provide consumers
with all information that is material to the use of the product, and such
disclosure is required by Federal law
(11)
To assist in assuring that herbal manufacturers provide material information
about their products, the American Herbal Products Association has developed
specific labeling guidelines for a number of botanical ingredients. Labeling
recommendations exist for products containing chaparral (Larrea tridentata);
comfrey (Symphytum spp.); ephedra (Ephedra spp.); kava (Piper methysticum);
saw palmetto (Serenoa repens); and St. John's wort (Hypericum perforatum),
among others. Botanical Safety Handbook is a wealth of information related to
established herbal safety concerns, entitled .
(12)
This reference classifies over 500 herbs with safety categories that can
assist both manufacturers in their labeling and consumers in making informed
choices in their use of herbs. A general rule for assuring responsible use of
an herbal product is to follow all of the labeled directions. If the product
bears a caution that suggests that the product is inappropriate for your use,
you should take that message seriously. More information can often be provided
by a qualified expert, and often from well-informed retail personnel.
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Q. Are herbal supplements
effective?
Botanicals have remained
a primary source of traditional medicine for millennia. They have made
contributions over the last centuries to the development of some of the most
widely used and effective modern drugs. In the last several decades, there has
been a resurgence of research in the clinical efficacy of herbs. The results
of such studies often verify that the empirical observations of the past
centuries were accurate. For example, recent studies on the effect of valerian
have produced results that led researchers to conclude that valerian root can
produce "significant improvement in sleep quality" (13)
and that valerian root extract can be "recommended for the treatment of
patients with mild psychophysiological insomnia" (14).
But can a consumer have
confidence in the claims made for the products that are available in the
market? To begin with, Federal labeling law and regulations for supplements
limit allowable claims to those for which a manufacturer "has substantiation
that such statement is truthful and not misleading" (15).
The manufacturer therefore has a legal burden to assure that the claim that is
made for their products has scientific evidence to back it up. Because there
is a greater acceptance of herbal therapies by conventional physicians in
Europe, a significant body of clinical data supporting the use of herbs has
been developed there. More recently, a number of U.S. companies have designed
clinical studies for their branded products. It is estimated that there are
over 1,000 clinical trials now being undertaken in the U.S. to increase our
knowledge about herbs. The National Institutes of Health has even set up a
center with a special focus on "alternative" medicine, and is now
concentrating much of its resources on the study of herbal products.
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Q. How soon can I expect to notice the benefits of an herbal product?
Herbs are rich mixtures
of diverse natural compounds. Although the effects of certain herbs will be
observed within a short time after consumption, others are more subtle and
provide their health promoting benefits gradually. If you have ever used
ginger root (Zingiber officinale) or peppermint leaf (Mentha × piperita) tea
to promote healthy digestion, you know that you can feel the comforting
effects of these herbs almost as you drink the soothing brew. The effect of
ephedra (Ephedra spp.) in promoting bronchodilation or better breathing is
usually felt within ten or twenty minutes of use. The sense of well-being that
results from the use of kava root (Piper methysticum) should manifest in only
a short time when using a well manufactured product. Similarly, all of the
herbs that contain anthrones, such as rhubarb root (Rheum spp.) or cascara
sagrada bark (Frangula purshiana), will produce a laxative effect within a
half a day or so.
Other herbs are known to
produce noticeable benefits only after several days or weeks. For example,
improvement in sleep when using an extract of valerian root (Valeriana
officinalis) has been shown to be somewhat dependent on continued use
(16). With saw palmetto (Serenoa repens), the berries of which are used
to promote the health of the prostate, the full benefits have been shown in
one study to be achieved after 12 to 18 months (17).
Other herbs, such as those that are rich in antioxidants, work to improve your
health without a noticeable effect. For more information about what to expect
from an herbal product (and when to expect it), consult with the product's
manufacturer or an herbal health practitioner. You can find a regional list of
herbalists the American Herbalists Guild's professional member referral list
at http://www.healthy.net/herbalists, or your local acupuncturist at the
American Association of Oriental Medicine http://www.aaom.org.
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Q. How do I know how much to use?
Two different parts of
the Federal laws that govern dietary supplements present manufacturers with
guidelines for providing quantitative recommendations on the package of their
products. First, all supplement manufacturers are responsible for assuring
that their products do not present significant or unreasonable risks under
conditions of use recommended in labeling or under ordinary conditions of use
(18). In addition, all dietary supplements, including herbal
supplements, are required by Federal regulation to identify the "serving size"
(19). A general recommendation then, with regard to how much of an
herbal product to use: the amount recommended on the label. The idea that
"more is better" is no more relevant for an herbal supplement than for any
other food that, while it might be delicious, refreshing or nutritive in
moderation, becomes unhealthful when consumed in excess. It may also be useful
to speak with a qualified herbal expert. A regional list of herbalists is
maintained on the American Herbalists Guild's professional member referral
list at
http://www.healthy.net/herbalists. Similarly, a local acupuncturist may be
found at the American Association of Oriental Medicine at
http://www.aaom.org and
naturopathic physicians can be located through the American Association of
Naturopathic Physicians at
http://naturopathic.org.
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Q. How are herbal
supplements regulated?
All supplements,
including herbs, vitamins, minerals, etc., must conform to Federal regulations
that control their manufacture, labeling, and advertising. In order to sell an
herbal supplement, a manufacturer must meet many different Federal (and
sometimes state) regulations, and must also adhere to state and local health
and business regulations. Since supplements are legally classified as a
specifically defined type of food, all supplements are required to be
manufactured to the same high standards that are required of all foods. These
mandated good manufacturing practices (20)
establish basic guidelines to assure that supplements are manufactured under
sanitary conditions that result in properly identified products that are not
contaminated or adulterated, and that are fit for consumption. Any supplement
that does not conform to these basic guidelines is subject to regulatory
action by FDA. In addition, all supplement products are required by law to
provide certain information about their formulation.
Like foods, supplements
must provide consumers with nutritional information. Unlike foods, supplements
must state the quantity of each of the contained ingredients, or of the
"proprietary blends" that make up a product. All herbal products are required
to identify the parts used of each of the plant ingredients, and to label them
with their commonly accepted names. One of the areas of the most detailed
Federal regulation of supplements is in the area of product claims, whether on
product labels or in advertising. The Food and Drug Administration specifies
exactly what kind of claims are allowed, and prohibits the use of any
statement that would brand the product as a drug (21).
Herbal supplements are not allowed to make statements regarding prevention,
cure, mitigation or treatment of diseases. Instead, their claims are limited
to statements that are legally defined as "statements of nutritional support"
or "structure/function statements."
Unfortunately, some
uninformed writers have published statements that infer that the entire
supplement industry is unregulated. Although this unfortunate "fact" has been
broadly reported, it is absolutely false. While the details noted above
provide some response to this misrepresentation, perhaps the most compelling
refutations are in the form of statements made by Dr. Jane Henney, the current
Commissioner of FDA. In testimony before Congress last year
(22), Dr. Henney stated that "FDA has tools at its disposal to take
enforcement actions against dietary supplements found to have safety,
labeling, or other violations...," and also that she believes that current law
"...provides FDA with the necessary legal authority to protect the public
health."
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Q. What about interactions with
drugs?
Humans have been
learning about the diverse effects of ingesting plants throughout our
evolution. We have, by trial and error, found both good and bad effects that
are related to specific plants, some of which we use as food, and others that
are used for therapeutic purposes. The introduction of synthetic and highly
purified drugs is an extremely modern development. As researchers observe the
interactions that drugs have with common foods and herbs, surprises continue
to surface. For example, less than 10 years ago it was found that drinking
grapefruit juice increases the serum drug concentration when patients take
certain drugs (23). This effect, which can last
for up to (24) hours after consumption, is now
thought to inhibit specific enzymatic activities responsible for breaking down
the drugs 24. Similarly, both avocado and leafy vegetables that are high in
vitamin K can diminish the effectiveness of blood-thinning drugs
(25). These concerns are not widely known by the public, but now that
medical professionals are aware of these effects, they can routinely monitor
their patients to assure effective treatment.
Similar information has
surfaced about some of the herbs that we use. For example, we now know that
the use of an extract of St. John's wort (Hypericum perforatum) may cause
certain prescription medications to be eliminated more quickly
(26, 27), leading one researcher to caution that, "As with grapefruit
juice, a food product, physicians should also be aware of potential drug-herb
interactions" (26). In response to this new
information, the American Herbal Products Association has recommended that
products containing St. John's wort be labeled to suggest that the advice of
your prescribing physician be requested if you are taking any prescription
drugs. Speculation on the exact mechanism of St. John's wort has led to
reports that the use of this herb might affect oral contraceptives, leading to
ineffectiveness and unwanted pregnancies. To date, there have been no reports
of any such actual occurrence. Nevertheless, women taking oral contraceptives
such as ethinyl estradiol and desogestrel should be aware that, if you
experience break-through bleeding, you might experience a reduction in
protection against pregnancy.
As can be seen by the
above examples, the effect of a drug can be either increased or decreased in
the presence of other factors in the diet, including herbal use. Although it
is likely that most such factors have little or no influence on drug
metabolism, continued research will add to our knowledge of such interactions
and responsible food and supplement manufacturers will be expected to inform
their customers of any new findings. There is now an ongoing interest in other
drugs that are suspected of interacting with certain specific herbs, with most
contemporary emphasis on the use of herbs with blood-thinning drugs such as
warfarin. Although the current concerns are either conceptual or based on
isolated and inconclusive reports, it is advisable to inform your prescribing
physician or pharmacist that you are using herbs when undergoing any drug
therapy. As close monitoring of the effect of warfarin is an established
standard of medical practice, this additional information will assist your
physician in maintaining good supervision of your drug levels. In order to
understand the potential for an herbal product to interact with prescription
drugs, it may also be useful to consult with a qualified herbal expert. You
can find a regional list of herbalists the American Herbalists Guild's
professional member referral list at
http://www.healthy.net/herbalists, or your local acupuncturist at the
American Association of Oriental Medicine
http://www.aaom.org. A
similar database of naturopathic physicians is maintained by the American
Assoc. of Naturopathic Physicians at
http://naturopathic.org.
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Q. How can
I choose the herbal product that is right for me?
Single herb or
combination product? Capsule, tablet, extract or tea? Which brand?
Standardized or not? Sometimes it seems that there are just too many choices!!
Some of these choices are ultimately matters of personal choice. The issue of
product form is one example - are you attracted to the rich history of herbal
extracts and decoctions? ...or do you have trouble swallowing tablets and
capsules? Then you may want to try a liquid extract or tea product. On the
other hand, if you can't bear the taste of valerian or echinacea, or if you
like the convenience of non-liquid forms, you might choose a tablet or
capsule. Similarly, there are separate values attached to both single herb
products and to herbal formulas. You might appreciate the experience and
knowledge that many manufacturers have brought to designing combination
products, with a goal toward attaining a higher synergy for the intended use.
Multi-ingredient formulas have been the standard in Asian and Indian herbal
traditions for centuries. Then again, you might prefer the simplicity of
taking only one herb at a time, an approach that has more historical
acceptance in the West (28).
With regard to choosing
a brand, one recommendation is to only purchase products from companies who
are members of the National Wellenss Association (NWA). All of NWA's members
agree to abide by a Code of Ethics that requires adherence not only to
established regulations, but also to meaningful industry policies. Thus,
certain business practices that are not mandated by any government agency are
expected of all of these companies. It is also generally recommended that you
buy your herbal product from a reputable company. If the claims made on a
particular product are outrageous and unbelievable, especially when compared
to other products with the same or similar ingredients, that may be an
indication to try another brand. Consider the advice of your retailer, and
always feel free to contact the marketer. Those who are selling high quality
products will be happy to answer all of your questions and provide you with
the assurances that you, their customer, deserve.
Finally, if you have
purchased a product that works for you and that provides the promised
benefits, stick with it, whether it's a tablet, tincture or tea, whether a
single herb or a complex formulation of several herbs. And remember - a brand
that is remarkably less expensive than other products with the same or similar
ingredients is not always the best bargain.
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Q. What are "standardized"
herbs?
The U.S. herbal
marketplace has seen the introduction of a number of "standardized" botanical
extracts. The purpose of standardization is commonly believed to be control of
the content of one or several "marker" compounds (29),
which are perceived of as those constituents in the plant that are responsible
for its therapeutic activity. In fact, standardization - when properly
performed - entails a lot more than merely controlling the content of a
particular marker compound. Rather, standardization consists of the body of
information and manufacturing steps that ensure product consistency from one
batch to the next. As such, it comprises a wide variety of raw material and
process controls, as well as use of a consistent recipe.
The goal in
standardizing an extract is to control the complete chemical composition of
the extract, rather than one particular identified constituent or group of
constituents. The heightened interest in standardized products is due to the
belief that standardization is directly related to the potency of the extract.
This is not necessarily the case and can unfortunately lead to a "more is
better" perception. It is important to know that the use of marker compounds
is not essential to the production of quality botanical products and that many
companies market high quality and consistent herbal extracts without reference
to these. In addition, any manufacturing process that is too specifically
concentrated on maximizing one constituent may place an undue emphasis on that
single compound. On the other hand, there can be value in a manufacturing
process that implements measures to control the entire spectrum of an herb's
constituents and that also includes attention to marker compounds. Consumers
should understand that label information about markers is usually provided to
communicate product consistency and a degree of quality control rather than
potency.
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Q. Should I tell my
Doctor that I'm using herbs?
Of course you should!
And because your doctor is, ideally, your primary partner in managing your
health, you should insist that your doctor, no matter their degree of training
in herbs, receive that information respectfully. In telling your doctor of
your decision to use an herbal product, however, don't be surprised to find
that your knowledge of herbs is more advanced than theirs. You might suggest
(again, respectfully) that they expand their education by using some of the
internet resources listed below, or by purchasing and studying some of the
written references identified there. At the same time, remember that your
prescribing physician has a responsibility to safely oversee your use of any
prescription drugs. If your doctor is concerned that a pharmaceutical
substance might interact with an herbal product, it is prudent to accept such
advice.
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Q. Where can I learn more?
If you have additional
questions about the herbs you use, forward these to either of the
organizations that prepared this information, at the email addresses listed
below.
American Herbal
Products Association
8484 Georgia Avenue, Suite 370
Silver Spring, MD 20910
ph: (301) 588-1171
fax: (301) 588-1174
email: ahpa@ahpa.org
American Herbal
Pharmacopoeia
PO Box 5159 Santa Cruz, CA 95063
ph: (831) 461-6318
fax: (831) 475-6219
email: ahpadmin@got.net
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The following publications provide useful information for consumers.
McGuffin, M, C Hobbs, R
Upton & A Goldberg. 1997. Botanical Safety Handbook. Boca Raton, FL:
CRC Press.
Blumenthal, M, et al.
1998. The Complete German Commission E Monographs. Austin, TX: American
Botanical Council.
Tyler, V. 1994. Herbs
of Choice. New York: Haworth Press, Inc.
Upton, R. 1994 - 2000.
Monographs of the American Herbal Pharmacopoeia.
Wichtl, M., NG Bisset,
ed. 1994. Herbal Drugs and Phytopharmaceuticals. Boca Raton, FL: CRC
Press.
References
1 Bennett, J. and CM
Brown. 2000. Use of Herbal Remedies by Patients in a Health Maintenance
Organization. J Am Pharm Assoc 40(3):353-358.
2 Anon. 2000. Consumer
Use of Dietary Supplements. A Publication of Prevention Magazine.
3 Akerele, O. 1992. WHO
Guidelines for the Assessment of Herbal Medicines. Fitoterapia 63(2):99-104.
4 The broad category of
"dietary supplements" was legally defined in 1994 by Congress' unanimous
passage of a law called the Dietary Supplement Health and Education Act, or
DSHEA.
5 Schultes, RE and RF
Raffauf. 1990. The Healing Forest.
6 Garrison, J. Two
Toddlers Died from Oleander Poisoning, Coroner Says. Los Angeles Times: July
26, 2000.
7 Federal Food, Drug &
Cosmetic Act, Section 301(a).
8 Federal Food, Drug &
Cosmetic Act, Section 350b(a)(2).
9 Bennett, J. and CM
Brown. 2000. Use of Herbal Remedies by Patients in a Health Maintenance
Organization. Journal of the American Pharmaceutical Association
40(3):353-358.
10 Farnsworth, NR. 1993.
Relative Safety of Herbal Medicines. Herbalgram 29.
11 Federal Food, Drug &
Cosmetic Act, Section 201(n).
12 McGuffin, M., C.
Hobbs, R. Upton, and A. Goldberg. 1997. Botanical Safety Handbook. Boca Raton,
FL: CRC Press. Available from AHPA.
13 Leathwood, PD, et al.
1982. Aqueous extract of valerian root (Valeriana officinalis L) improves
sleep quality in man. Pharmacol Biochem Behav 17(1):65-71.
14 Donath, F, et al.
2000. Critical evaluation of the effect of valerian extract on sleep structure
and sleep quality. Pharmacopsychiatry 33(2):47-53.
15 DSHEA
16 Donath, F., et al.
2000. Critical evaluation of the effect of valerian extract on sleep structure
and sleep quality. Pharmacopsychiatry 33(2):47-53.
17 Bach, D. and L.
Ebeling. 1996. Long-term drug treatment of benign prostatic hyperplasia -
results of a prospective 3-year multicenter study using Sabal extract IDS 89.
Phytomedicine 3(2):105-111.
18 Federal Food, Drug &
Cosmetic Act, Section 402(f).
19 Government Printing
Office. 2000. Title 21 Code of Federal Regulation, Section 101.36. There are
exemptions to the requirement for labeled "Supplement Facts," which includes a
statement of serving size, for specifically identified small businesses and
for foods in small packages. Exempt manufacturers nevertheless generally
provide information about recommended serving.
20 Government Printing
Office. 2000. Title 21 Code of Federal Regulation, Section 110. "Current good
manufacturing practice in manufacturing, packing, or holding human food."
21 Government Printing
Office. Revised Feb. 7, 2000. Title 21 Code of Federal Regulation, Section
101.93. "Certain types of statements for dietary supplements."
22 Henney, J. Statement
By Jane E. Henney, M.D., Commissioner, Food And Drug Administration,
Department Of Health And Human Services, Before The Committee On Government
Reform, U.S. House Of Representatives. March 25, 1999.
23 Bailey DG, et al.
1991. Interaction of citrus juices with felodipine and nifedipine. Lancet
337(8736):268-9.
24 Bailey DG, et al.
1998. Grapefruit juice-drug interactions. Br J Clin Pharmacol 46(2):101-10
25 Wells, PS, et al.
1994. Interactions of warfarin with drugs and food. Ann Intern Med
121(9):676-83.
26 Johne A, et al. 1999.
Pharmacokinetic interaction of digoxin with an herbal extract from St John's
wort (Hypericum perforatum). Clin Pharmacol Ther 66(4):338-45.
27 Piscitelli SC, et al.
2000. Indinavir concentrations and St John's wort [letter].
Lancet 355(9203):547-8.
28 Some concern has been
stated regarding a conceptual danger in "unknown" herbal combinations. This
point of view is apparently uninformed about the historic acceptance of herbal
formulas, and is no more relevant to herbal ingredients combined in a
supplement product than it would be to the creation of an innovative recipe in
your kitchen.
29 Indeed, there is a
common misconception in the U.S. that standardization is equivalent to adding
purified compounds to an herb in order to achieve a desired level of the
marker compound. In fact, nothing could be further from the truth. The
addition of purified compounds in order to achieve "standardization" actually
defeats the purpose of standardization.
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