Complementary and Alternative Medicine
It is not unusual for an individual to use both traditional herbal medicine,
alternative treatments and Western medications at the same time. More and more Americans are using
these approaches to treat health conditions. Many people feel that
herbal/alternative products are more “natural” and
safer than conventional drugs. Unfortunately, this is not always
true and herbal products or very high doses of vitamins or minerals
can have potential side effects, just like prescription and non-prescription
(OTC) products. More than 20,000 commercial herbal products are
available in the USA. China has, perhaps, classified more herbal
medicines than any other country. Many countries have adapted their “traditional
medicines” from Traditional Chinese Medicine (TCM), including Japan (Kampo medicine)
and Korea. Herbs are typically used in combination with each other.
There has been a worldwide rush to identify the active chemicals in traditional medicines, as well
as to conduct scientifically rigorous studies to evaluate safety and efficacy.
Traditional Chinese medicine, perhaps the best known in the West,
is not the only source of alternative therapy. Native Americans,
East Indian, Pacific Islanders, Latin Americans, Inuit, and many
other cultures have developed treatments from herbs, minerals, or animal products.
Many patients using herbals/alternatives, often in addition to
Western drugs, are not familiar with the potential side effects
or possible drug-drug interactions or disease-herbal interactions
that may place them at risk for a bad reaction.
Tips to
Consider if Purchasing Herbal/Alternative Treatments:
- Is the product manufactured in the United States?
- Is the manufacturer well known and reputable? (Ask your pharmacist.)
- Does the label list the name of the herb(s), the amount of
the herb(s) in each dose in milligrams or grams, a lot number,
and an expiration date? If you choose to use products brought in from other countries,
read the label carefully with your pharmacist. Watch for names
of prescription drugs such as ephedrine and phenobarbital,
which have been found in herbal products.
- Does the label or product information list a toll free number
you can call for more information?
- Call and ask how the raw herbs are accurately identified and
how the product is tested for purity and potency. Some manufacturers
will send a copy of their analysis to you and/or your physician,
nurse or pharmacist. An independent
laboratory (ConsumerLab.com)
has tested some herbal products for purity and potency. Check
their web site and select an approved product or a manufacturer
that clearly provides quality control.
- Have you discussed the possible benefits and adverse effects
of the product with your pharmacist and/or physician?
Are herbals safe?
Unlike prescription and over-the-counter
medications, most herbal products are considered "dietary
supplements" and do not have to be proven safe or effective
before they are sold. Herbs are essentially crude drugs with
the potential for both beneficial and harmful effects.
In some cases, the herbal content of a product is considerably
more or less than the strength listed on the label. While most
herbal products are safe, some products have been found to contain
pesticides, heavy metals, toxic herbs or prescription medications.
What precautions should I take before using an herbal product?
Learn all you can about the product. Check for known side effects and interactions
with medications or food. Talk with your doctor or pharmacist
before you start taking a herbal product, especially if you
have a health condition such as heart disease, high blood pressure,
diabetes, thyroid problems, a neurological condition, or a
psychiatric problem. Children and women who are pregnant or breast
feeding should not take herbal products unless under the supervision
of a competent physician. If you plan to have surgery, ask your physician
if you should stop herbal alternative treatments before surgery.
What should I look for on the labels of herbal products?
The label should indicate the name of the herb, the form (e.g., powder
or standardized extract), and the amount of the herb per dose in
milligrams (mg) or grams (gm). A lot number and an expiration date
should be included.
Can herbal medicines have serious side effects?
Yes. For example, ma huang (ephedra) can cause high blood pressure, huperzine
A may slow the heart rate, and PC-SPES can cause blood clots. Stop
taking herbal products immediately if side effects, a rash, or
signs of an allergic reaction occur and contact your health care
provider.
Can I take herbal products with my prescription medications?
It is important to tell all your health care providers about any herbal products you take, since interactions
with prescription drugs are possible. This is true even if herbal
products are taken several hours apart from other medications.
For example, Ginkgo biloba may increase the risk of bleeding in
patients who take warfarin. Ma huang can increase the effects of
stimulants, including decongestants, diet aids, and caffeine.
It may also interact with theophylline, digoxin, antihypertensives,
MAO inhibitors, and antidiabetic drugs.
Herbals
Ginkgo biloba
Ginkgo biloba is a member of the Ginkgoaceae family, the world's
oldest living tree species. Historically, ginkgo nuts and seeds
(Bai-Guo, Yin-Xing, Silver Apricot) were used to treat conditions
such as cough, asthma, and increased urine frequency.
Ginkgo leaf (Yin-Xing-Ye, Bai-Guo-Ye) is used to
treat hypertension, hyperlipidemia, and coronary heart diseases.
In Western medicine, ginkgo is receiving considerable attention
for its potential role in the treatment of memory disorders and
dementias, especially Alzheimer's disease. It may also be effective
in peripheral vascular diseases, most notably intermittent claudication
(poor circulation to the lower legs). Other uses being studied
are vertigo and tinnitus. The pharmacological effects of ginkgo
that may be responsible for its benefit in these disorders include
antioxidant activity, inhibition of platelet aggregation and vasodilation.
Ginkgo is usually administered as the standardized extract EGb
761, which is the preparation studied in most American and European
clinical trials. Use of the crude leaves or preparations containing
the nuts or seeds (which may cause an allergic reaction) is not
recommended.
Clinical Trials
Many clinical trials have suggested
that ginkgo is beneficial in the treatment of dementia and cognitive
disorders associated with aging. Unfortunately, most of these trials
were small, open label, or of poor design. One double blind, placebo-controlled
study of patients with mild to moderate Alzheimer's disease or
multi-infarct dementia was published in 1997 in the United States.
Patients treated with ginkgo extract (EGb 761) 40 mg three times
per day for 26 weeks had a small improvement in the average score
on a standard cognitive test compared to patients given placebo.
This improvement was less than that seen in similar studies comparing
donepezil, rivastigmine, or galantamine (drugs approved for the
treatment of Alzheimer's disease) to placebo. The clinicians' observations
for improvement found no difference between the ginkgo and placebo
groups. A recent analysis of 4 studies concluded that Alzheimer's
disease patients who took ginkgo extract (120-240 mg per day)
had a small but significant improvement (3%) in cognitive function
at 3 and 6 months compared to those taking placebo. Long-term,
well designed studies with doses greater than 120 mg per day
are needed to confirm the beneficial effects of ginkgo and are
currently in progress.
Adverse Effects
Ginkgo extract appears to be very well tolerated. Infrequent
side effects include mild gastrointestinal disturbances, headache,
and allergic skin reactions. Four cases of serious bleeding, including
subdural hematoma, have been reported. One case suggests an interaction
with warfarin (Coumadin®) and one an interaction with aspirin. In
one of the few studies examining a possible ginkgo-warfarin interaction,
there was found no increase in the INR (prothrombin time) when
volunteers taking warfarin were given ginkgo. Considering the
antiplatelet activity of ginkgo and the limited information available, patients
should be advised to discuss ginkgo and warfarin therapy when
used together with their physician or pharmacist.
The risks and benefits of taking ginkgo with aspirin,
clopidogrel, ticlopidine or other antiplatelet agents (including
fish oil and high dose vitamin E) must be weighed carefully and
patients should be advised of the bleeding risk.
Resources
American Botanical Council (ABC)
6200 Manor Rd.
Austin, TX 78714-4345
(800) 373-7105
International
Bibliographic Information on Dietary Supplements Database
Office of Dietary Supplements, National Institutes of Health
31 Center Drive, MSC 2086
Bethesda, MD 20892-2086
(301) 435-2920
Consumerlab.com-
Independent Tests of Herbal, Vitamin and Mineral Supplements
1 North Broadway 4th floor
White Plains, NY 10601
(914) 289-1670
Ginseng
There are at least eleven different herbs labeled "ginseng".
The most commonly used in herbal medicine are Panax ginseng (Asian
or Korean ginseng) and Panax quinquefolius (American
ginseng). Ginseng powder and extract are prepared from the roots
of these perennial herbs. Standardized ginseng extract contains
4% ginsenosides, the primary active components of P. ginseng and P. quinquefolius.
Asian ginseng has been used for many years as a stimulant
and a tonic for Qi deficiency, to treat gastrointestinal disorders
(diarrhea, vomiting) and respiratory problems, to improve stamina,
and to reduce the adverse effects of stress. Small doses are taken
daily to ward off physical or mental impairment.
Ginseng is widely used in the U.S. to
increase energy and vitality, enhance physical performance, increase
resistance to stress and improve immune function. Other uses include
lowering blood sugar and treating male impotence.
Clinical Trials
A review of randomized, controlled trials evaluating
ginseng for a number of uses (enhancement of physical
and intellectual performance, stimulation of the immune system,
treatment of type 2 diabetes and herpes infection)
concluded that efficacy has not been established for any of these
indications. Recently, a small study found that American ginseng
taken 40 minutes before a meal decreases the post-meal rise in
blood glucose in both nondiabetic patients and those with type 2 diabetes.
Adverse Effects
To date, serious adverse effects have not been
reported with American ginseng. Side effects reported with Asian
ginseng include insomnia, diarrhea and skin eruptions.
There is some evidence that both American and Asian ginseng may
lower blood glucose levels. Until more data is available, ginseng
products should be used with caution in patients with diabetes
because the risk of hypoglycemia may be increased. Individuals
with or without diabetes should probably take ginseng with meals.
One case report suggests that ginseng may decrease the anticoagulant
effect of warfarin (decrease the INR). One small study found no
change in the INR, however, when patients stabilized on warfarin
were given a two week course of ginseng. Two cases involving a
possible interaction with phenelzine have been reported. One patient
experienced headache and tremor and another developed mania. Further
study is needed to establish the effectiveness of ginseng for any
indication.
Quality & Labeling
Ginseng root varies in quality, with the
highest quality being very expensive. Adulteration is common and
significant variation can occur between the actual ginseng content
in a product and the content stated on the label. In April and
May 2000 an independent laboratory, ConsumerLab.com (see Resources
inset page 5), evaluated the purity and potency of 22 brands of
Asian and American ginseng products. Eight products contained excessive
amounts of pesticides, two contained excessive lead, and seven
had less than the minimum concentration of ginsenosides (2%). Only
10 products met or exceeded the claimed ginsenoside concentration
on their labels.
Huperzine A
A herbal medicine called Qian Ceng Ta that
is prepared from Chinese club moss (Huperzia serrata) has
been used for centuries in China to treat colds, fever, inflammation,
pain, and irregular menstrual cycles. Huperzine A, an alkaloid
isolated from Chinese club moss, has recently been used for treating
dementia and myasthenia gravis in China. It is available in the
U.S. in supplements promoted as memory enhancers.
Clinical Trials
A number of animal studies have documented that
huperzine A is a long acting acetylcholinesterase inhibitor with
greater potency than tacrine or donepezil, two cholinesterase inhibitors
approved for the treatment of Alzheimer's disease (AD). Huperzine
A also appears to decrease neuronal cell death in the brain. Well
designed human trials with huperzine A have not been published
in the Western medical literature. Four clinical trials have been
published in China, where it has been approved for treating dementia
for many years. One of these studies was an 8 week, double-blind,
placebo controlled trial of 103 patients with AD. Among patients
who took 200 mcg of huperzine A twice daily, 58% improved in memory,
cognition, behavior and function, compared to 36% of patients who
took placebo. A derivative of huperzine A, huprine X, is also currently
of interest for the treatment of AD.
Adverse Effects
No serious side effects have been reported with
huperzine A. As a result of greater selectivity for central acetylcholinesterase,
huperzine A may cause fewer cholinergic side effects (e.g., nausea,
vomiting, diarrhea, anorexia) than tacrine, donepezil or rivastigmine.
Bradycardia was reported in one clinical trial. Individuals with
heart conditions should not use huperzine A without guidance from
a physician. Possible contraindications include sick sinus syndrome
and bradycardia. As an acetylcholinesterase inhibitor, huperzine
A can be expected to interact with cholinergic agonists, anticholinergic
drugs, and the muscle relaxant, succinylcholine.
Dosage
Usual doses of huperzine A, which is extracted and purified
in China, range from 50 mcg to 200 mcg twice daily. A dose for
huperzine A has not been established in domestic clinical trials.
Conclusion
If animal studies and the findings reported in the
Chinese medical literature are confirmed in domestic clinical trials,
huperzine A may offer a significant benefit in reducing the damage
caused by AD, with fewer side effects than currently available
agents.
Ma Huang
(banned by the FDA, but may be
found in some products manufactured outside the US and imported
illegally or purchased while traveling abroad)
Ma huang uses include the treatment of upper respiratory diseases,
fever, headache, edema and arthritis. Ma huang has been used in
the West as a stimulant and an appetite suppressant ("herbal
fen-phen"). Ma huang contains ephedrine, pseudoephedrine,
norephedrine and several other central nervous system stimulants.
These alkaloids stimulate receptors and
cause the release of epinephrine. In the past, ephedrine
was used in conventional Western medicine for the treatment of
asthma and as a topical nasal decongestant, but has generally been
replaced by safer drugs.
Quality & Labeling
There is marked variability between labeled ephedra alkaloid/ephedrine content
and actual content, and is one of the many concerns with the use of this
herb. A study of twenty products found discrepancies between labeled and
actual content for 10 products and significant lot to lot variations for
four of the products.
Adverse Effects
The adverse effects of Ma huang include anxiety, insomnia,
headache, increased heart rate, increased blood pressure, urinary
retention, increased blood glucose and a "flushing" sensation.
The FDA has received hundreds of adverse effect reports, including
deaths in previously healthy, young adults taking the manufacturer's
recommended dose of ma huang supplements. Acute hepatitis, kidney
stones, myocarditis, stroke and psychosis have been reported. Excessive
doses have resulted in heart failure, hypertensive crisis, and
death. The FDA recently withdrew recommendations for a daily intake
of no more than 24 mg ephedrine, used for no more than seven consecutive
days. More information on the FDA and Ma huang/ephedrine is available
on the FDA website.
As might be expected, other CNS stimulants such as decongestants
and caffeine should be avoided or used with caution by individuals
taking Ma huang. Alarmingly, supplements often contain MH in combination
with other stimulants, including botanical sources of caffeine
such as guarana and kola nut. Ma huang has the potential to interact
with a plethora of conventional drugs, including theophylline,
MAO inhibitors, hypoglycemic drugs, antihypertensives and digoxin.
Patients should be counseled to avoid products that contain Ma
huang. Individuals with hypertension, angina, heart failure, diabetes,
a psychiatric condition, or a previous heart attack or stroke should
be especially advised to avoid this herb.
Harmful Substances in Herbal Products
Heavy Metals
Excessive amounts of arsenic, lead and mercury have been found in some herbal products. Among
251 Asian medicines collected from herbal stores in California,
24 contained lead, 36 contained arsenic and 35 contained mercury.
Da Huo Lo Dan (Herbal Pill), a commercial product containing 17 herbs, was found
to contain excessive amounts of heavy metals. Some, but not all,
herbal product manufacturers have their raw herbs assayed for heavy
metal content.
Prescription Drugs
Prescription drugs such as phenobarbital,
ephedrine, chlorpheniramine, NSAIDs, benzodiazepines, corticosteroids
and methyltestosterone have been found in some herbal products,
most often those containing multiple herbs that were manufactured
overseas. Among 243 Asian medicines collected in California herbal
stores, 17 contained undeclared pharmaceuticals. Five Chinese herbal
products for control of blood sugar sold by two California companies
were removed from the market in the U.S. after they were found
to contain glyburide and phenformin. Cases of liver damage
associated with the use of jin bu h uan (also known as jin bu huan
anodyne), may have been due to adulteration with a Chinese pharmaceutical
not listed on the label.
Misidentification of Herbs
The fact that some herbs can cause serious toxicity is well documented.
The identification of raw herbs is traditionally made on the basis
of appearance, taste, smell and feel. This may not be sufficient
when the desired herb closely resembles a toxic botanical. In these
instances, chemical analysis is required.
In some cases, misidentified herbs have caused serious adverse
effects. The addition of a misidentified, toxic herb to a
herbal product for weight loss marketed in Belgium resulted in
severe kidney damage in about 100 women. Another herbal
product containing the same toxic herb species, Aristochlia,
caused kidney failure in two English women.
Summary
Herbal medicines can be manufactured
and marketed without strict quality control or standardization,
and consumers should consider the risks before using any herbal
product.
The information in this web page
is from the Rx Consultant newsletter and is included here, by
permission, from the original article:
Rx Consultant
Traditional Chinese Medicine
The Western Use of Chinese Herbs
Paul C. Wong, PharmD, CGP and Ron Finley, RPh
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