|
by
Debra Israel, Pharma.D. and Ellis Wuinn Youngkin, Ph.D., R.N.C.
Consumer
use of alternative medicines in the United States is growing
rapidly. Included in this phenomenon are herbal therapies
instead of or as adjuncts with traditional medicine for perimenopausal
and menopausal complaints. Of significant concern is the safety
of these herbs. Since many women are using herbal therapies,
clinicians must be knowledgeable about their use, quality,
and safety. There are currently no government standards on
the quality of herbal products in the United States and some
products are either unsafe or little is known scientifically
about them. Selected herbal therapies touted in the lay press
for common perimenopausal complaint are examined with advice
on their use and safety based on scientific sources. (Pharmacotherapy
1997; 17(5): 970-984)
Outline
General
Concepts Related on Herbal Therapies Safety Concerns
Common
Complaints and Selected Herbal Therapies
Hot
Flushes, Flashes and Sweats
Menstrual
Irregularities
Dyspareunia
and Vaginal and Urinary Complaints
Insomnia,
Mood Alterations and Memory and Concentration Difficulties
Decreased
or Increased Libido
Review
of Herbal Therapies
Conclusions
Significant
numbers of women approaching or in menopause have complaints
serious enough to warrant seeking medical attention. The most
common are menstrual irregularities; hot flashes, flushes
and sweats; atrophic vaginitis and urethritis; stress incontinence;
mood alterations including irritability, depression and anxiety;
sleep disorders; concentration and memory changes; and diminished
libido.1,2 The current trend is to treat is to
treat climacteric women with some form of hormone replacement
therapy (HRT), but many women prefer not to or cannot take
HRT2. Instead some may take herbs to alleviate
symptoms and others may use herbs together with prescribed
agents.
Commonly
women seeking these remedies are under the misconceptions
that herbal remedies are "natural" and not medicinal and therefore
safe. With the burgeoning number of herbal products available
to the consumer and the conflicting data regarding their efficacy,
making appropriate choices among them can be bewildering.
General
Concepts Related to Herbal Therapies
Entire
books are available that provide some real and some misleading
concepts for herbal management of various complaints. Two,
for instance, give the impression that all the remedies are
natural and outside the realm of traditional medicine3,4.
Many of the suggested therapies are, in fact, lifestyle changes,
vitamins, diet changes and other remedies that do not require
a prescription. However, many are herbs that are known to
have medicinal effects and as such must be considered drugs,
albeit not prescription or over the counter (OTC) ones indicating
Food and Drug Administration (FDA) approval.
Several
issues are of extreme importance for the provider in managing
women with menopausal or other complaints. First and foremost,
providers must always understand that herbs are drugs. In
the evolution of traditional medicine, the first agents, used
by healers were herbs. Over the millennia, some of these evolved
to products that ware prepared and sold by strict standards
as prescription or OTC compounds. Second, consumers often
believe that herbs are not medicines and are safe, especially
since they are sold in places such as health food stores and
grocery stores. Thus purchasers may conclude that if the herbs
were not safe, they would not be available, and this is not
always the case.
Third,
herbs that are sold today make no (claims) of preventing or
treating disease, otherwise they could not be sold as food
products. Fourth, consumers are going to use herbs regardless
of safety issues if the believe they have certain medicinal
effects. Finally herbs cannot be ignored as important sources
of therapy; to do so would be to ignore "about 25 percent
of our current materia medica that is derived from such sources."
5
The
various definitions of herbs gives rise to related problems.
Horticulturalists see them as "non-woody seed-producing plants."
Chefs see them as enhancing foods' flavors and aromas. However,
medicine defines them as crude drugs of vegetable origin utilized
for the treatment of disease states, often of a chronic nature,
or to attain or maintain a condition of improved health."
5 This includes tinctures, extracts, and similar preparations
that, as such, are called phytomedicinals (plant medicines).
The
amount of drug in herbal preparations varies widely from product
to product. In addition, other compounds may increase, decrease,
or other components may increase, decrease, or change the
effects of an herb. The quality of herbs varies since there
are no standards; the plants may be gathered or purveyed by
people with no knowledge of these variations, which are often
subtle but have an impact on effect. Finally, consumers should
be aware of the possibility of products having been adulterated
or containing substitutes or other ingredients. One study
analyzed 54 ginseng products and concluded that 60% of them
were without worth.5 In addition, poisonings have
been caused by adulterants or by substitutes; for example,
phenylbutasone, (termcinolone, desamethasone, prednisolone,
indomethacin, and acetaminophen.6 Users have suffered
serious adverse effects from these ingredients.
With
the passage of the Keafuver-Harris Amendments in 1962, all
marketed drugs were investigated, including herbs, the panels
evaluated them concentrated only on active ingredients. Herbal
preparations were then promoted by manufacturers as food products
and could only be sold if the lables did not make statements
about preventing or treating a disease. Many drugs containing
herbs were judged unsafe or ineffective, or lacking evidence
for evaluation. Some herbs were no longer marketed, but most
companies merely removed the information claiming their effects
from the labels. The FDA does keep a list of herbs that are
generally recognized as safe (GRAS) but this is based primarily
on a food use.
According
to Varro E. Tyler, professor of pharmacognosy at Purdue University,
what is needed is a "rational use of phytomedicinals."
5 Such a system would provide effective indications
for use on the label as well as standards for purity and quality
in preparation. Tyler believes that access to safe and effective
herbs would help with the increasing cost associated with
traditional drug therapy.
Some
progress has been made. In 1984 Canada banned more than 50
herbs as unsafe, and required warning labels as harmful in
pregnancy in 5 others8 In 1978 Germany established
Commission E to review the safety and use of over 1500 herbal
drugs. From this panel's study of clinical trials have come
about 300 monographs that are reported to be the most accurate
summaries available on the safety and efficacy of herbs and
phytomedicinals.9 Approval by Commission E, however
does not mean the herb is approved for use in the United States.
In 1994 the Dietary and Supplement Health and Education Act
was passed. It states that herbs can be labeled with information
on effects on the body's structure and function, but must
state that the FDA has not reviewed them and they are not
intended for use as drugs.10 However, until some
agreement among the FDA, manufacturers and pharmacology experts
is reached on interpretation of data, safety and efficacy
issues will remain.
Safety
Concerns
Issues
of safety are of paramount importance to the consumer and
the provider. Some of these are dosage, source and quality
of purity.
Since
adulteration or substitution may occur, the dosage may vary
considerably from dose to dose. For example, the longer teas
are steeped, the stronger the dose. Thus teas thought safe
by the consumer because it is a food, must be considered a
drug. One laypress story of a woman who used two tea bags
of a dieter's tea and died from cardiac arrest signifies the
importance of such warnings.11 Another woman drank
up to 10 cups of comfrey tea for stomach pains and later developed
liver disease. 8
Many
consumers grow their own herbs or use imported ones. There
is no way of knowing exact amounts or quality of components.
Environment, climate and conditions in which the herb is grown
can cause many differences in the product, and different parts
of the plant can have different effects. Thus dangers have
increased, decreased, or aberrant effects exist if consumers
do know what they are using. One woman thought she was drinking
eucalyptus tea because she had picked the leaves, but in fact
she drank a poisonous tea from oleander leaves.
Imported
products may contain substances that in this country are regulated
as prescribed drugs, such as digitalis. Those at particular
risk, such as the elderly, may be in special danger from such
products, which may interact with traditional drugs they are
taking.9
Thus,
health care providers have an obligation to elicit as exact
information as possible about herbal products patients are
using, the amount per dose, and amounts consumed daily, to
offer the best advise for safety. Table 1 provide details
on different types of herbal preparations.
Table
1 Herbal Prescriptions
Preparation Description
Bulk
Herbs Raw dried material found in jars or bins;
used in teas, tinctures, powdered
for capsules, tablets
Oil External
use only, some are fatal if ingested, used
in aromatherapy
Tablets,
capsules Stored and transported easily; popular
in the country
Teas Hot
water extracts, 3 types
Beverages,
teas--steeped 1-2 minutes
Infusions
- steeped 10-20 minutes
Decoctions
- plant material simmered in boiling
water 10-20 minutes
Tinctures Alcohol
extracts; highly concentrated; come in small
bottles with eyedropper caps, few drops usually
used.
++++++++++
Common
Complaints and Selected Herbal Therapies
Hot
Flushes, Flashes and Sweats
Approximately
75-85% of perimenopausal and menopausal women complain of
hot flashes, flushes and sweats, and about 33% seek medical
attention. 1,12,13 Sudden feelings of heat (flashes)
occur, with flushing from the waist moving up to the chest,
neck, and face, accompanied by perspiration. These can last
seconds or up to 20 minutes and may occur infrequently or
as often as 15 times a day. Some women awaken suddenly, drenched
in perspiration, and suffer from insomnia. On the average,
hot flash attacks last about 2-3 years; some last up to 5
years without HRT.13 Triggers include warm environment,
alcohol, certain food, such as spicy foods, caffeine, hot
drinks, stress, embarrassment, and exercise immediately before
bedtime.1 One causal theory is that central temperature-regulating
control is lost secondary to decreases in estrogen, with subsequent
loss of autonomic control of the peripheral vasculature.
13 The flush is not a release of the heat that has accumulated,
but an inappropriate, sudden excitement of the mechanisms
that control heat release.12
The
usual medical therapy for hot flashes is estrogen with or
without progestin (HRT) or vasodilator therapy. Herbs recommended
by the laypress include black cohosh, dong quai, ginseng,
gotu kola, licorice root, sage, and sarsaparilla. The lay
press claims and the scientific evidence bearing on these
claims of selected agents are discussed below.
Menstrual
Irregularities
Follicular
decline in the perimenopausal period is accompanied by decreasing
estrogen levels that can lead to annovulation and menstrual
irregularities.1 Ideally, bleeding episodes become
scantier and farther apart until menses stop altogether. For
many women, however, the episodes wax and wane with fluctuating
estrogen levels, becoming heavier then lighter, and closer
together then farther apart, in an irregular pattern. Period
may be excessively heavy lasting 10-12 days or more.
With
anovulation, no progesterone is produced to convert the endometrium
from a proliferative to a secretory state. Irregular abnormal
bleeding results, and the constant influence of estrogen may
lead to hyperplasia and even carcinoma.12 It is
mandatory to make a proper diagnosis of any irregular, heavy
and frequent bleeding. Pregnancy must be ruled out, as well
as hyperplasia, carcinoma, fibroid tumors, and polyps. The
traditional treatment, once pathology and pregnancy are excluded
is periodic medroxyprogesterone or another progestin, low-dose
combined oral contraceptives (unless contraindicated) or HRT.
2, 12 Nonsteroidal antiinflamatory drugs, androgen
compounds and endometrial ablation are other measures to decrease
the amount of bleeding.2 Anemia must always be
considered when blood loss is heavy.
One
significant concern is that some herbal therapies may have
estrogenic properties that could stimulate the endometrium.
Thus the dangers must always be considered with these as estrogen
therapies. For additional details on herbs recommended by
the laypress for menstrual irregularities, see angelica, chaste
tree, dandelion, fenugreek and life root.
Dyspareunia
and Vaginal Urinary Complaints
With
declining estrogen levels, atrophy of the vagina, urethra,
bladder, and vulva becomes a significant problem for many
women. 1,12,14 The mucosa becomes pale, thin, dry,
and inelastic; friability increases, as does the risk of infection
leading to erythema, discharge and bleeding. Dyspareunia is
a frequent complaint, and its impact on sexual functioning
may cause psychologic distress. Other symptoms are pain, itching,
urinary discomfort, frequency, urgency, and stress incontinence.
Inflammation and infection are common.
Traditional
management is HRT. It takes about 1 month for significant
response and up to 1 year for full recovery.12
Lubricants are frequently advised, such as commercial water-soluble
lubricants, vegetable oils, and unscented oils such as mineral
oil. Some authors suggest a combination of herbs for these
conditions as a tea, douche, or ointment.15-17
Herbs recommended for various vaginal complaints by the laypress
include agrimony, chaste tree, dong quai, and witch hazel.
Cultural
factors can influence the use of herbs. Two studies evaluated
the use of herbs to enhance sexual experience in Zimbabwean
women.18, 19 Most women interviewed in both studies
stated they routinely inserted herbal agents into the vagina
to achieve satisfactory sexual experience. The goal was to
facilitate "dry sex," which is regarded as a necessary part
of successful marital relations. Although many of the women
were aware of a possible increased risk of cervical cancer
with the practice, most were not aware of contracting human
immunodificiency virus (HIV) or other sexually transmitted
diseases.
Insomnia,
Mood Alterations, and Memory and
Concentration Difficulties
Many
women complain of mood changes during the years from age 40
to 60. 1, 20 The causes of these and similar symptoms
are numerous and little understood.13 The changes
are often associated with the many life changes that occur
during these years. Sleep disorders may be due to hot flashes
and night sweats, decreases in REM sleep, age and many other
factors, such as anxiety, stress, lack of exercise, and some
drugs.1 Many women say they become forgetful in
the climacteric years.1,20 This may be due to aging
and increased neuron loss, or to lack of sleep or decreasing
stimulation.
Some
herbs are touted as helpful are touted as helpful for these
problems. However, any therapy should be tried after or coupled
with healthy lifestyle habits, such as stopping smoking, minimum
alcohol consumption, sufficient exercise, proper diet, and
reduced stress. Herbs recommended for these problems include
balm, chamomile, damiana, ginkgo biloba, gotu kola, hops,
passion flower, scullcap and valerian.
Clinicians
must rule out serious depression and major emotional and physical
illnesses, such as thyroid disease, in determining a plan
of care. A word of caution is in order if the woman is receiving
traditional therapy for any disorder such as depression. Herbal
substances may cause serious illness when ingested with some
drugs. For instance, St. John' wort, an herb that may have
antidepressant properties, also contains a compound that inhibits
monoamine oxidase (MAO) and can be dangerous if taken with
a drug such as fluoxetine.21 Women must be warned
to check with health care providers before taking any herbal
or natural substance.
Decreased
or Increased Libido
Changes
in libido during or around menopause may or may not be associated
with changes with hormones.1 Many other factors
may affect sexual desire, such as aging, body image, and drugs
taken for chronic illnesses. However, sexuality and desire
normally continue throughout life. Thus decreased or increased
libido may be of concern. Hormone replacement therapy and
vaginal lubricants may improve decreased libido if it is due
to declining hormone levels and associated discomforts such
as atrophy and hot flashes. Taking methylestestosterone daily
may be helpful in increasing libido.12 Herbal therapies
recommended by lay press sources include chaste tree, damiana,
ginseng, gotu kola and sarsapirilla.
Review
of Herbal Therapies
Agrimony
(Agrimonia eupatoria)
Laypress
Claims: This herb's properties of astringency and bitter tonic
make it useful for incontinence and cystitis.16
Scientific
Evidence: Agrimony lowers basal plasma glucose in diabetic
mice22, whether this effect occurs in humans is
not known. This herb was approved by Commission E for use
internally in mild acute diarrhea and for inflammations of
the mouth and throat, but it has no known activity in incontinence
and cystitis.23
Adverse
Effects: Photdermatitis has been reported in humans.24
Angelica
(Angelica archangelica)
Laypress
claims: This herb has been used widely and for hundreds of
years in Europe for women's disorders, including menstrual
irregularities and discomfort.15,16,25 Care in
harvesting angelica is urged, as it looks similar to the deadly
poison hemlock. Laypress information also states that angelica
is considered safe and nontoxic.15
Scientific
Evidence: Angelica seeds and roots are used as flavoring in
several alcoholic beverages including gin. No scientific evidence
supports its efficacy in menstrual irregularities.5,26
Angelica root causes contraction of rabbit uterine tissue,
possibly through cholinergic action. 27 It also
has effects on [ileal ande] tracheal tissues in the guinea
pig.28 Commission E approved angelica for use in
anorexia and some dyspeptic complaints.23
Adverse
Effects: The stems of the angelica plant contain psorales,
which may induce photosensitivity and dermatitis. These psoralens
are photocarcinogenic in laboratory animals, and exposure
to them should be avoided. Collectors should be sure not to
confuse angelica with a highly poisonous plant, water hemlock.
5,26
Recommendations:
Angelica is not recommended for perimenopausal or menopausal
complaints.
Balm
(Melissa officinalis)
Laypress
Claims: Said to have a vasodilatation effect on the circulatory
system, balm is suggested for relief of tension, anxiety,
stress reactions, and depression.12 In addition,
it is said to be effective in menopause for "increased tensions."2
Scientific
Evidence: Balm has sedative, antispasmodic, antihormonal,
and antiviral actions in various animal models.29
These actions are thought to be due4 to the presence
of volatile oils. Commission E approved balm for treatment
of nervous disturbances.23 Current studies are
evaluating balm's use in ointment preparations as a bacterial
and viral inhibitor.9
Adverse
Effects: No information is available but balm should be used
with caution.
Recommendations:
Balm is recommended to be used with caution. A tincture of
2-6 ml 3 times/day is suggested, or 2-3 teaspoons of dried
herb steeped in 1 cup of boiling water twice/day.
Black
Cohosh (cimicifuga racemosa)
Black
cohosh is said to have an estrogen-like action and be a progesterone
precurser.3,4,15 Its antispasmodic and pain relief
effects make it commonly used for menstrual complaints.17
"These natural sources of both estrogen and progesterone can
be incorporated into your regimen for building bone. Plant
phytoesterols are safer than synthetic hormones. They encourage
your own body to produce small amounts of hormones--but no
more than you need. Unlike estrogen replacement therapy...excess
dosages are not a worry."3
Scientific
Evidence: This herb is long reputed as a remedy for women's
disorders and continues to be used in Europe for symptoms
associated with premenstrual syndrome (PMS), dysmenorrhea,
and menopause.5,9,23,26 One study evaluating the
scientific evidence of estrogenic-like activity after hysterectomy
found no significant differences in groups receiving various
estrogen products to those given black cohosh extracts. An
alcoholic extract of black cohosh reduced secretion of luteinizing
hormone (LH) but not follicle-stimulating hormone (FSH) in
menopausal women, and reduced hot flashes.30 Commission
E approved the product for the treatment of PMS, dysmenorrhea,
and nervous conditions associated with menopause.5,23,26
Adverse
Effects: Data on toxicity are limited. Ingestion of the leaves
and roots may cause nausea and vomiting. Additive hypotensive
effects may occur in patients taking both black cohosh and
antihypertensive agents.24
Recommendations
and Dosing: Commission E recommends daily doses of 40-200
mg. of black cohosh, with use not to exceed 6 months.9
The herb is usually taken as a decoction or ethanol tincture
in amounts corresponding to the stated dosage.
Catnip
(Nepeta cataria)
Laypress
Claims: Touted with powers to drive cats into a frenzy, catnip
has the effect of sedation and relaxation on humans. It is
best taken as a tea, or combined with other herbs, such as
chamomile and lemon balm.16,25
Scientific
Evidence: Catnip contains a volatile oil that causes characteristic
stimulatory responses in cats when the oil is smelled, but
not taken orally. Hot catnip teas at bedtime has been promoted
as a sleep aid, although no studies have confirmed the effects
as a sedative.5,24,26
Adverse
Effects: Large amounts of catnip tea may cause emesis, but
no adverse effects have been reported from drinking smaller
quantities.5,24,26
Recommendations:
Although the teas cannot be recommended as a sleep aid, it
is inexpensive and many people like the taste.5,26
Chamomiles
(Matricaria recutia, Chamaemelum mobile)
Laypress
Claims: This family of herbs is said to have relaxant and
antianxiety properties.3,16,17,25
Scientific
Evidence: Chamomile is widely used in Europe for a variety
of medical conditions.23,26 Many of its properties
are due to the presence of essential oils, which have antiinflmaatory,
antipyrectic, antiulcer, and antispasmodic effects in animal
model.24 Chamomile was approved by Commission E
for gastrointestinal complaints and mouth and throat inflammation,23
but no evidence supports its role as an antianxiety agent.
Adverse
Effects: Chamomile tea may cause dermatitis,24
conjunctivitis,31 and anaphylactic reactions.32
Cross-sensitivity with chamomile may occur in persons allergic
to ragweed pollens, but this relationship is not well established.24
Recommendations:
Many people enjoy the flavor of chamomile as a tea or infusion,
but there is not evidence to support its action as an antianxiety
agent.
Chaste
Tree, Chasteberry (Vitex agnus-castus)
This
herb is widely suggested for menopause symptoms, including
hot flashes, is said to stimulate pituitary function, alter
LH and FSH secretions, and increase natural levels of progesterone.
It is considered the best herb to maintain emotional balance
before and during menses or menopause, and is very popular
in Europe in treating PMS and menopause.3,15-17,25
Chasteberry also is said to decrease excessive bleeding3
because of its properties as a progesterone precursor.3,15-17
Some consider it a "natural replacement alternative for estrogen
replacement therapy."25 It is reputed to have both
aphrodisiac and anaphordisiac properties.16 It
was used in ancient times to decrease libido in temple priestesses,17
and is still taken in Europe to treat "excessive sexual desire."25
Scientific
Evidence: The German Commission E recommends chasteberry for
a number of disorders including PMS, mastalgia, menopausal
symptoms, and poor lactation.9 Evidence exists
that the herb inhibits the secretion of prolactin by the pitutiary
gland. Thus, it may have a role in correcting some types if
anerbirrhea and menopause are not established. In one clinical
survey, over 1,000 women diagnosed with PMS were given 40
drops of chastetree berry preparation/day for an average of
166 days.9 Ninety percent reported complete symptoms
relief in an average of 253 days.
Adverse
Effects: The drug may cause an itchy rash and gastrointestional
discomfort, but other adverse effects are not known.5,9,24
Chaste tree preparations may interact with dopamine-receptor
antagonists, but this interaction is not well described.9
Recommendations:
Prepared as a tincture, chasetree berry extract provides an
average daily dose equal to 20 mg. of the crude fruit or 3040
mg. of the fruit in a decoction.9
Damiana
(Turnera aprhodisiaca)
Laypress
Claims
This
herb's primary reputation is as an aphrodisiac.16,17,25
with the effect reportedly due to testosterone-like properties
from alkaloids in the plant. It is reported to be useful as
a sexual stimulant for both men and women. 17
Scientific
Evidence
Damiana
is promoted as a powerful aphrodisiac and to have a specific
effect on all organs in the pelvis. It contains between 0.2%
and 0.9% of a complex volatile liquid, but no evidence supports
its consumption by humans.24,26 It falls into the
category of herbal hoax.
Adverse
Effects
Toxicity
with damiana is not known, although some users claim a hallucinogenic
effect.24
Recommendations
Daminana
is not recommended for any condition.
Dandalion
(Taraxacum officiale)
Laypress
Claims
Used
to prevent or treat iron-deficiency anemia (the root), dandelion
also is said to be a good herb (the leaf) for women's problems,
including menstrual bloating, PMS, fluid retention, and breast
tenderness.3,15-17,25
Scientific
Evidence
The
only known beneficial effects of dandelion are as a mild laxative
and a diuretic.5,26 Dandelion was approved by Commission
E for use in biliary disorders and gastrointestinal complaints,
but it has no indications in the treatment of menopausal complaints.23,24
Recommendations
Dandelion
is not recommended for perimenopausal or menopausal complaints.
Dong
Quai (Angelica sinensis)
Laypress
Claims
Often
given to treat hot flashes and called women's ginseng, dong
quai is touted as effective for menopausal complaints.15
Dong Quai is a type of angelica, and some authors suggest
using the two interchangeably, but angelica is harsher and
more of a stimulus.15,17 The herb is reputed to
regulate hormonal balance, and some call it an estrogen precursor.30
It is said to contain vitamins A, B12 and E 25,
and is used for "almost every female gynecologic complaint"
as well as for insomnia.17
Scientific
Evidence
Dong
quai contains several coumarin derivatives and an essential
oil, which may explain some of its purported properties, but
these components may also be the cause of adverse effects
associated with it. Photosensitization leading to dermatitis
may occur due to the presence of psoralens. The essential
oil contains a carcinogenic substance.24,26
Adverse
Effects
See
above.
Recommendations
The
psoralens and essential oil pose sufficient risk to humans
such that all unnecessary exposure to dong quai should be
avoided.24,26
Fenugreek
(Trigonella foenum-graecum)
Laypress
Claims
This
herb is claimed to be a natural source of estrogenic substance
that acts on the pituitary and adrenal glands to stabilize
menstrual cycle.3
Scientific
Evidence
Fenugreek
is used as a cooking spice and to flavor maple sugar substitutes.24
Studies in animals evaluated its use in the treatment
of cancer, hypercholosterolemia, diabetes, and infections.
In dogs and humans, fenugreek had a hypoglycemic effect.24,35
No data support its use for menopausal complaints. Commission
E approved fenugreek internally for the treatment of anorexia
and externally as a poultice for local inflammation.
Adverse
Effects
No
adverse effects of this herb have been reported when used
as a spice or flavoring agent. Large doses may cause hypoglycemia.
Ingestion of fenugreek caused severe myopathy in cattle, sheep,
and chickens.24,36
Recommendations
Ingestion
of this herb as other than as a spice is not recommended.
Ginko
(Ginko biloba)
Laypress
Claims
The
ginko tree dates back millions of years and research shows
that the herb improves memory and relieves senility.25
Hundreds of studies substantiated the ability of ginko biloba
extract (GBE) to improve mental health.20 It is
suggested that it may slow the aging process. "Just about
any condition that can benefit from increased blood flow is
an indication for this herb.17
Scientific
Evidence
The
fruits and seeds of the ginko tree have been widely used in
China since 2,800 B.C. Today GBE is extremely popular in Europe
for use as an antiasthmatic and to increase vasodilation and
peripheral blood flow. Of interest, in 1988 GBE was the drug
most widely prescribed by German physicians, with 5.4 million
prescriptions written. It is also available over the counter
in Europe. Based on numerous studies, German health officials
concluded that GBE is effective in the treatment of circulatory
disturbances and can be given to treat resulting symptoms,
such as varicose problems, postrhombtoic syndrome, and chronic
cerebovascular insufficiency9, as well as vertigo,
tinntus, weakened memory, dementia, and mood swings.37-41
In addition, GBE may be useful for peripheral vascular disease
and intermittent claudication. One study concluded that it
improves transmission of nerve signals and is capable of relieving
symptoms such as depressive moods, anxiety, tiredness, confusion,
poor memory, and absent-mindedness.37 It is postulated
that GBE may act as a free radical scavenger.
Adverse
Effects
Side
effects include gastrointestinal disturbances, headache, and
allergic skin reactions; larger doses may also produce restlessness.
Caution should be taken in patients taking anticoagulants,
since GBE may reduce clotting time of blood.5,24,26
A severe poison ivy-like dermatitis may occur after contact
with the fruit pulp.24
Dosage
The
daily dose is 120-160 mg of standardized ginko leaf extract.9
Ginseng
(Panax ginseng [Oriental]; Panax quinquefolis [America])
Laypress
Claims
Panas
(from panacea) ginseng is considered a wonder herb by the
Chinese who have used it for over 5000 years.25
"Millions of people the world over praise its stimulating
qualities...Ginseng is also believed to increase estrogen
levels and is recommended for women at menopause. None of
the tests to which modern scientists have subjected this ancient
herb have shown it to have a single deleterious side effect."3
American ginseng is said to provide more cooling properties
than Oriental ginseng and to be a better temperature regulator.
Grown in Wisconsin, Asian countries value it highly.25
It is milder and less stimulating than Panax ginseng but similar
in properties. "Women also take it for everything from normalizing
menstruation to easing childbirth...it is said to promote
both mental and physical vigor; and considering the population
of China, who can quarrel with its reputation as an aphrodisiac?"42
Scientific
Evidence
The
use of ginseng is surrounded by controversy and confusion.5,26
Consumers can find packages labeled Oriental ginseng, wild
red American ginseng, Korean ginseng, Tienchi-ginseng, Chinese
ginseng, and many others. The herb is so popular that its
collection and sale in the United States are under strict
regulation, requiring permits, registration, and an official
growing season.5,26 A large number of in vitro
and animal studies have been performed on ginseng, as well
as some poorly designed human studies.24,43 Some
of the effects on animals are prolonged swimming times, prevention
of stress-induced ulcers, stimulation of hepatic ribosome
proliferation, increased killer cell activity with possible
enhanced production of interferon,24 and alteration
of body fuel homeostasis during prolonged exercise.44
Several studies found altered hormonal activity.45,46
Others found central nervous system depression or stimulation,
blood pressure changes, smooth muscle effects, and analgesic
and antiinflammatory activity.47 Findings in human
trials include decreased high-density lipoprotein levels24;
no significant changes in serum cholesterol, high-density
lipoprotein, or triglyceride levels in postmenopausal women48;
and increased work capacity by improving oxygen use.43
Overall,
some evidence exists that ginseng may improve the effects
of stress on diet and exercise. Beneficial effects were documented
in conditions such as depression, diabetes, atherosclerosis
and hyptertension; no scientific evidence supports it as an
aphrodisiac or as having estrogenic properties. The root contains
triterpenoid saponin glycosides, which are believed to contribute
to some of these actions, although differences in composition
exist between American and Oriental plants. As mentioned,
obtaining authentic ginseng is a problem. High-quality ginseng
root may retail at more than $20 an ounce.
Controversy
in the scientific literature exists concerning the merits
of ginseng ingestion. Evidence of its efficacy in humans is
lacking, and the herb cannot be recommended until proper clinical
trials are conducted.5,26 A number of other studies
were inconclusive as to the herb's effects.43 Commission
E approved ginseng to treat fatigue, diminished work capacity
and loss of concentration, but recommended its use for only
up to 3 months.23,24
Adverse
Effects
Although
generally thought to be safe,9,24,43 there are
some reports of adverse. Cerebral arteritis was reported in
a 28-year old woman who ingested a large amount of ethanol-extracted
ginseng.49 Sleeplessness, nervousness, dizziness,
inability to concentrate, hyptertension, and euphoria also
were reported.43,50 Central nervous system excitation
and arousal resulting in ginseng abuse syndrome have been
described.51 Estrogen-like effects on the uterus,
vagina and breasts (mastalgia) occurred in postmenopausal
women.43,52-56 Women should be cautioned particularly
not to take ginseng with hormone therapy in light of case
reports of uterine bleeding after use. Insomnia, diarrhea,
and skin eruptions are rare. Possible ginseng-associated Stevens-Johnson
syndrome was described,57 although this may be
due to impurities in the product.58 The frequency
of these effects is difficult to establish since many reports
did not document dose or species of ginseng.
Recommendations
Despite
positive finding from animal studies and volumes of anecdotal
support over the years, no well-designed studies of ginseng's
efficacy in humans have been performed. Until clinical trials
are conducted to establish proper use, dosing, and duration
of use, the ingestion of ginseng for perimenopausal and menopausal
complaints cannot be supported.5,24,26,43
Gotu
Kola (Centalla asiatica)
Laypress
Claims
First
used in India, this herb is promoted as a relaxant and to
improve memory. In the Orient, it is used to treat depression
and other emotional problems, and as an aphrodisiac.24
Scientific
Evidence
This
herb should not be confused with kola (or cola) nuts, which
contain caffeine; gota kola does not. Studies of large doses
of gotu kola given to small animals showed a sedative effect
due to the presence of two saponin glycosides. Additional
animal studies reported antifertility effects in Swiss albino
mice. Limited studies in humans reveal gotu kola may have
some antiinflamatory activity, wound-healing properties, and
antihypertensive effects. None of the laypress claims listed
has been substantiated.24,26
Adverse
Effects
Limited
data exist on possible toxicity, although dermatitis has been
reported.24
Recommendations
Due
to limited data in humans, gotu kola cannot be recommended
to manage perimeno-pausal or menopausal complaints.
Hops
(humulus lupulus)
Laypress
Claims
Hops
are said to have significant effects on the central nervous
system, and can be used for relaxation and sedation, and as
a hypnotic.16 It is especially effective for insomnia
and its calming effect.16,25
Scientific
Evidence
This
herb is a well-known preservative in brewing beer.23,26
Several compounds have been identified in hops, including
a volatile oils and a volatile alcohol. Any sedative or hypnotic
properties may be due to the volatile alcohol, although no
clinical studies support this action.24 A scientific
paper in 1960 suggested hops had estrogenic activity, but
subsequent studies in animals failed to find this or other
hormonal activity.24,59
Adverse
Effects
Contact
dermatitis has been reported.
Recommendations
The
use of hops is not recommended for perimenopausal or menopausal
complaints.
Licorice
Root (Glycrrhiza glabra)
Laypress
Claims
This
herb is listed among "natural sources of estrogenic substances
which act on the pituitary and adrenal gland to stabilize
the menstrual cycle."3 It is said to have a structure
similar to that of natural steroids, including estrogen,15-17
and the primary ingredient, glycyrrhizin, a saponin, is considered
to have antiinflamatory effects.
Scientific
Evidence
No
information supports the estrogenic properties of licorice.
The herb is useful in the treatment of peptic ulcers and as
a cough suppressant and expectorant, but may produce serious
side effects especially in high doses.9 Side effects
such as headache, lethargy, sodium and water retention, high
blood pressure, and hypokalemia due to licorice causing an
excessive secretion of adosterone are well described in the
literature.5,26,60-64 These mineralocorticoid effects
may eventually result in heart failure and cardiac arrest.
Elderly patients and those with a history of cardiovascular
disease and liver or kidney problems should consume the herb
with caution.5,26 Commission E approved licorice
for use in catarrh in upper respiratory tract conditions in
addition to the treatment of stomach and duodenal ulcers,
with use limited to 4-6 weeks.9,23
Adverse
Effects
Use
is contraindicated in pregnancy.
Recommendations
Licorice
is not recommended for perimenopausal or menopausal complaints.
Life
Root (Seneico aureus)
Laypress
Claims
Life
root is a "uterine tonic" and is recommended for menopausal
problems.16
Scientific
Evidence
This
herb was popularized with the name "female regulator" since
it was promoted for the treatment of various uterine diseases.
It is not safe due to the presence of detectable quantities
of senecionine. This alkaloid is a known hepatotoxin, inducing
chronic liver disease in rats with only a few doses. It is
postulated that this type of alkaloid may be involved in the
development of human liver disease, including Budd-Chiari
syndrome, hepatic veno-occlusive disease, and possibly primary
liver cancer.5,26,65,66
Adverse
Effects,
See
above
Recommendations
Ingestion
of this plant cannot be recommended for nay purpose.5,24,26
Passion
Flower (Passiflora incarnata)
Laypress
Claims
The
passion flower is another of nature's "safe, natural tranquilizers."15
It is said to relieve anxiety, insomnia, restlessness, muscle
tension, and headaches due to nervous tension. It is the herb
of choice for temporary insomnia as it induces sleep without
a hangover effect.3,16,25 A person should not drive
or operate machinery after taking this herb.3
Scientific
Evidence
The
FDA does not recognize this herb to be safe or effective due
to the lack of supporting scientific evidence. Passion flower
continues to be found in some sedative-hypnotic mixtures marketed
in Europe, where German authorities approved its use for "nervous
unrest" conditions.
Adverse
Effects
Currently
little information is available on side effects and contraindications.5,23,26
There is one report of an older man developing an erythematous
rash, blister, and purpura over his chest after taking a preparation
that included passion flower.9
Recommendations
The
use of this herb for menopausal complaints is not recommended.
Sage
(Salvia officinalis)
Laypress
Claims
Sage
is said relieve hot flashes15 and to decrease excessive
perspiration.17,25 It is called a yang grounding
herb according to Chinese philosophy, which means that acute
diseases with "hot or excess" symptoms require a cool yin
herb for grounding.17 Sage is promoted by herbalists
for over 60 ailments, including control of night sweats as
an anhidrotic, and relief of mouth inflammation as a liquid
preparation.
Scientific
Evidence
Dried
and fresh sage leaves are used in cooking. Sage contains a
volatile oil and tannin which make it useful for treating
mouth and throat irritations. Evidence supporting other claims
is unclear, as information is conflicting. Commission E states
it is effective when applied topically for inflammations of
the mouth and throat, and allows its use internally for digestive
complaints.5,24,26
Adverse
Effects
Long-term
use of low dosages of sage and short-term use of larger doses
have been associated with adverse mental and physical effects,
together with convulsions and loss of consciousness.5,24,26
Recommendations
Sage
is sage when used in small quantities in cooking, but it cannot
be recommended for perimenopausal or menopausal complaints
since there are no data support its efficacy.
Sarsaparilla
(Smilax sp)
Laypress
Claims
This
herb is considered a "natural source of estrogenic substance
which acts on the pituitary and adrenal gland to stabilize
menstrual cycle."3
Scientific
Evidence
Claims
that sarsaparilla contains estrogenic substances are not substantiated
by studies. Known effects of this herb include a diuretic
action, together with some expectorant and laxative properties.26
The herb's only legitimate use is as a flavoring agent
in soft drinks, such as root beer.5,26
Adverse
Effects
No
information is available on toxicity.
Recommendations
No
data support the use of sarsaparilla for perimenopausal or
menopausal complaints.
Scullcap
and Skullcap (Scutellaria lateriflora)
Laypress
Claims
Said
to be a sedative, antispasmodic, and nervine, skullcap is
suggested for PMS, depression, and states of exhaustion, especially
when taken with valerian.16 It has been known for
centuries for its calming effect on the body.3
Skullcap is also claimed to relieve menstrual cramps and muscle
pain secondary to stress due to its purported antispasmodic
action.17
Scientific
Evidence
That
"a nearly worthless and essentially inactive plant...could
be recommended for nervous system conditions...says much for
the gullibility of human beings."26 Scullcap was
initially introduced to treat cases of hydrophobia and was
promoted as a tranquilizer, an antispasmodic, and for problems
of "female weakness." In vitro studies evaluating teas made
from scullcap showed some evidence for antibacterial and antifungal
activity.24 In addition, preliminary data in animals
suggest it may help improve tolerability of some chemotherapeutic
agents. There is no evidence that it has any properties that
make it effective for menopausal complaints. Ingestion of
scullcap should be avoided.26
Adverse
Effects
High
doses of this herb reportedly cause giddiness, stupor, confusion,
and other symptoms suggestive of epilepsy.24 Hepatotoxicity
occurred in four women who were taking scullcap for relief
of stress.67
Recommendations
The
use of scullcap for perimenopausal or menopausal complaints
is not recommended.
St.
John's Wort (Hypericum perforatum)
Laypress
Claims
Said
to spring from John the Baptist's blood, this herb is touted
to be a mild tranquilizer, a treatment for depression, anxiety,
and insomnia.25 In addition, it is said to be a
muscle relaxer and useful for menstrual cramps, to promote
wound healing, and to help fight viral infections. In research
at New York University and the Weizman Institute of Science
in Israel, the active ingredients in St. John's wort inhibited
retrovirus in animals. Tests of synthetic hypericin were to
be performed. The herb is used as a pain reliever for neuralgia,
sciatica, and rheumatic pain.16
Scientific
Evidence
This
herb should be classified as an antidepressant based on four
published clinical trials since 1987.9 In a placebo-controlled,
double blind study of 105 subjects diagnosed with depression
or depressive moods, St. Johns wort significantly relieved
depression compared with placebo.68 One active
ingredient believed to relieve depression is hypericin, a
naphthodianthrone pigment,9 although the xanthone
and flavonoid fractions of the plant have MAO-inhibiting qualities.5
Adverse
Effects
Hypericin
causes photodermatitis in animals.5,9 Although
no human cases have been reported except with the synthetic
hypericin, it is advisable to stay out of the sun if taking
this herb. Commission E did not believe that concern about
toxicity of the preparation is warranted,5 however,
others advised short-term use only under medical supervision.25
Until additional information is available, patients should
be aware of possible food and drug interaction warnings similar
to traditional MAO inhibitors.
Recommendations
The
usual dosage is 2-4 g of hypericin in capsule form 1-2 times/day.
The equivalent may be steeped in 1 cup of boiling water for
10 minutes to gain a similar amount. The antidepressant effect
is said to be greatest when the herb is consumed for 4-6 weeks.5
Valerian
Laypress
Claims
Valerian
is "recognized worldwide for its relaxing effect..."3
It is said to decrease insomnia, improve the quality of sleep,
be useful for stress, and be safe and nonaddictive.3,15
Called the valium of the nineteenth century," it is often
given to treat anxiety.25 Its effects are increased
with alcohol. It is one of the "most useful relaxing nervines"
available,25 and is thought to decrease depression
and melancholia. Annually the French buy about 50 tons of
this herb for it sedative properties.24
Scientific
Evidence
Valerian
has been used for over 1000 years as a tranquilizer and sedative.
It may be the most effective of the various herbs promoted
as a sleep aids. Commission E approved it as a sedative and
sleep-inducing preparation to mediate states of excitation
and difficulty in falling asleep due to nervousness."9
Evidence from numerous animal and human studies points to
the valepotriates as one of the primary active ingredients
for sedation,24 but the action is most likely due
to a combination of ingredients and their additive effects.24
Studies in humans supported a tranquilizing, sedative and
hypnotic effect,69-72 and an effect that increases
slow-wave sleep and decreases stage 1 sleep in poor sleepers.
It is likened to the effects of a short-acting benzodiazepine.24
One study found valerian to more a mood elevator than sedative.73
Adverse
Effects
Positive
and negative data exists about this herb. It is generally
thought to be safe and have low toxicity,9,24 but
some adverse effects have been reported. It was linked to
four cases of severe liver damage.67 An attempted
suicide victim had ataxia, hypothermia, significant muscle
relaxation, fatigue, abdominal cramping, mydriasis, and tremor
due to valerian, but these effects were somewhat confounded
due to prior marijuana use.74 Headaches, excitability,
uneasiness, and cardiac changes were reported in clinical
trials.24 Not all the active ingredients have been
identified, and thus controlled clinical trials are necessary
to determine a dose-response relationship.9
Witch
Hazel (Hamamelis virginiana)
Laypress
Claims
This
herb is used for a variety of women's disorders including
menorrhagia, vaginal discharge, and loss of uterine tone.
A douche is suggested for vaginal discharge. Witch hazel is
said to be analgesic, astringent, hemostatic, and antiinflammatory.16,17,25
Scientific
Evidence
Witch
hazel is approved by the FDA as an astringent. It contains
8-10% tannin as the principal active ingredient which likely
gives it astringent property.5,9,23,26 Commission
E approved it for the treatment of local, mild skin inflammation,
hemorrhoids and varicose veins. There is no evidence to support
additional claims.23
Adverse
Effects
None
are notes.
Recommendations
Witch
hazel may be applied topically; no data support its use as
a vaginal douche.
Of
the 24 herbs discussed, only witch hazel is FDA approved.
None is currently approved for perimenopausal or menopausal
complaints. Eight herbs were considered by Commission E to
be effective for one or more perimenopausal or menopausal
complaints--balm, black cohosh, chasteberry, ginko, ginseng,
passion flower, St. John's wort, and valerian. Once again,
approval by the commission does not mean these herbs are approved
for use in the United States. Many herbs have unfounded claims
for success, whereas others, such as angelica, dong quai,
liferoot, and skullcap, may be dangerous. Thus it behooves
the clinician to be cautious in supporting use of such substances
for relief of common complaints.
Herbal
therapies are growing in popularity. Recognizing that women
are using them to self-manage complaints of the perimenopausal
and menopause is an important first step accurate information
on the therapies. However with no government standards on
quality, it is difficult to judge their safety and effectiveness
in offering women advice. If a woman is intent on using herbal
preparations, she should be urged to use ones that have well-recognized
labels and consistent dosages. As with any drug therapy, she
should have appropriate follow-up and be monitored for therapeutic
efficacy and possible toxicity, including adverse effects
and drug interactions.
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C.H. The climateric, menopause and the process of aging. In:
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guide. Norwalk, CT: Appleton & Lange, 1994:309-44.
2. Bachman
G. Nonhormonal alternatives for the management of early menopause
in younger women with breast cancer. J Natl Cancer Inst Monogr
1994;16:61-67.
3. Ojeda
L Menopause without medicine, 3rd ed. Alameda CA: Hunter House
1995.
4. Stein
D. The natural remedy book for women. Freedom, CA: Crossing
Press, 1992.
5. Tyler
VE. Herbs of choice: the therapeutic use of phytomedicinals.
New York: Pharmaceutical Products Press, 1994.
6. Cetaarukm
EW, Aaron CK. Hazards of nonprescription medications. Emerg
Med Clin North Am 1994;12:483-510.
7. Capobianco
DJ, Brazis PW. Fox TP. Proximal muscle weakness induced by
herbs [letter]. N Eng J Med 1993;329(19):1430
8. Snyder
S. Herbal teas and toxicity. Rockville, MD: U.S. Government,
Printing Office, DHHS publication no. 92-1185, 1991.
9. Tyler
VE, Foster S. Herbs and phytomedicinal products. In Handbook
of nonprescription drugs. Washington, D.C: American Pharmaceutical
Association, 1996.
10. Hurley,
D. Pharmacists need to increase knowledge of herbal remedies
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