Herbal Therapies for Perimenopausal and Menopausal complaints

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 medicine^3,4. 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.

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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.

Conclusions

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.

REFERENCES

1. Garner C.H. The climateric, menopause and the process of aging. In: Youngkin EQ, Davis MS, eds. Women's health: a primary clinical 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 as use skyrockets. Pharm Pract News 1995; May:24-25.