Condition: The medical definition of menopause is that portion of life which occurs after the women has had no menses for one year. Born with a set number of eggs in her ovaries, monthly ovulation begins to dwindle around the age of 32. By the 40's, most women will experience anovulatory or "skipped" menstrual cycles. This results in hormonal fluctuations leading to "perimenopausal" and menopausal symptoms: hot flashes/flushes, changes in sleeping patterns, mood swings, changes in hair patterns, irregular bleeding, etc. Other terms for this event are climateric and change of life. Complaints often bring the women into the healthcare system because they are so disruptive to her lifestyle. There are an ever-increasing array of choices to be made by the women with regard to symptoms and health.

Prevalence: With the increasing longevity of each subsequent generation and the population burst affectionately known as the "baby-boomers", an estimated 63 million women in the U.S. will be either menopausal or postmenopausal by the year 2005.¹ In addition to the numbers issue is the fact that "menopause" is a relatively new health care concern given that, until the 1900's, women did not live long enough past their egg-producing/child-bearing years to experience menopause. The current life expectancy for U.S. women is 79 years. The average age of menopause is 51. With the onset of perimenopausal symptoms and increased awareness thru discomfort that is often difficult to ignore, women can anticipate a third of their life-span spent dealing with hormone deficiency health-related decisions.

Many of the social, psychological and cultural issues surrounding hormone or "medical" management of menopause arise from myths and lack of knowledge. Ironically, much of the knowledge lag is a direct result of the strides made in health care of the aging. We now have a population of women reaching their 50's who are experienced users of hormones having been the generation exposed to birth control pills. Their comfort level contrasts with that of their mother's whose knowledge base grew out of the earlier hormone trials and tribulations which yielded strokes, pulmonary emboli, and breast cancer. Traditionally, the woman turns to her family and friends for health information. This information this source provides the women can be in direct conflict with solutions discussed by her clinician.

A new social trend is that of "herbal" or "natural" supplements. While scientific and cultural studies are yielding information showing promise in yams and soy protein, your patient will come to you with Internet, tabloid, talk show or book based "factoids" that overreach published results of these studies.² Clinicians dealing with this population must keep up to maintain credibility. Most individuals resist taking medication on several levels: it implies illness versus a normal process, it requires remembering/scheduling dosing, and it is a financial burden of some degree. With hormone replacement therapy (HRT), the woman may not see or feel any changes and therefore not be as aware of the need to continue dosing. Additionally, women on hormones face the fact that they are aging; hormone therapy cannot be rationalized as useful for any other reason.

Physiologic Changes of Menopause: Most of our knowledge of menopause accepts it as an estrogen deficiency state related to the decline in ovarian function. Estrogen receptor sites occur in the endothelium, on osteoblasts and growth factors, and in tissue throughout the central nervous system. Target tissue includes: brain, eyes, teeth, vasomotor, heart, breast, colon, urogenital tract, bone. This hypoestrogenic state leads to increased risk for: Altzheimers and decreased cognitive function, age-related macular degeneration, cardiovascular disease, colon cancer, vaginal atrophy, decreased libido, incontinence, and osteoporosis.

At the heart of management decision making are several issues, which will determine the clinician's role in assisting the menopausal woman.

• Is menopause a natural phenomenon - keeping in mind that menopause did not emerge as a physical, societal or medical concern until the 1900's? Does the woman want to do anything outside of her normal health regimen.
• Does the woman consider menopause as an inter-related constellation of changes or does she have specific concerns? For example, she may be concerned about osteoporosis but not about heart disease because her family history is positive for the one event but negative for the other.
• Are menopause related changes an inevitable aspect of aging or an opportunity for disease prevention? Does the woman see menopause care as symptom management or prevention of long-term consequences of estrogen deficiency?
• What is her tolerance for vaginal bleeding? This will affect decisions regarding hormone regimens.
• Does she have any preference for synthetic, natural, or herbal management?

These answers will help the clinician select options to explore with the woman. Various figures show the dropout rate for hormone replacement therapy to be approximately 20% to 50% in the first nine months with one third of patients never filling their prescriptions. A 1995 study showed hormone replacement therapy use to be: higher among those who had hysterectomies (58.7% versus 19.6%); lower in the Northeast; higher in the south and west; less common among women who had not graduated from college; less likely among diabetic women; least likely among ages 70 to 74. Concerns re: aging and appearance was strongly associated with hormone replacement therapy use.⁵

Clinical Presentation:

Subjective: Most women seek health care because of nuisance changes which they cannot manage themselves. Hot flashes or more commonly the sensation of heat with or without sweating, insomnia, irritability, irregular bleeding, fatigue, and vaginal dryness are the most common complaints.

When performing a risk assessment, the clinician should keep in mind the lifetime picture of estrogen deficiency. Clinical risk factors include predisposition to osteoporosis, cardiac disease, endometrial and breast cancers.

The history should include:

Age: the average age is 51 with a consideration in your clinical decision making to the fact that younger women have more years to weather the damage caused by the hypoestrogenic state on target tissue. Smokers will experience menopause an average of 2 years earlier than non-smokers.

Past Medical History:

Hormone replacement therapy is absolutely contraindicated:

• Known or suspected pregnancy
• Known or suspected cancer of the breast
• Undiagnosed genital bleeding
• Active thrombophlebitis or thromboembolic disorder; thrombophlebitis or thromboembolism associated with prior hormone use
• Active liver disease

No contraindication to hormone replacement therapy use:

• Hypertension
• Diabetes mellitus
• Cervical or ovarian cancer

History of venous thromboembolism: (VTE) (current use of hormones is associated with the risk of VTE: 20 per 100,000 cases in users versus approximately 6 per 100,000 in nonusers however, after the first year, incidence is comparable). ³

History of abnormal vaginal bleeding: (hormone replacement therapy may mask the development of endometrial cancer a sign of which is abnormal vaginal bleeding. Any abnormal vaginal bleeding should be evaluated with an endometrial biopsy (endometrial biopsy) or a transvaginal ultrasound measurement of the endometrial stripe with evaluation of endometrial contour and treated accordingly prior to initiating extraneous estrogen. Where the endometrial stripe is greater than 4mm, an endometrial biopsy is recommended.)

History of breast cancer: (The American College of Obstetricians and Gynecologists holds that studies have failed to consistently or conclusively demonstrate a detrimental impact of hormone replacement therapy on the incidence of breast cancer. Counseling may include the fact that estrogen does not appear to cause breast cancer but it may increase the growth of any cancer cells that are currently present and that studies show that estrogen users who develop breast cancer, develop types that are treatable.)

Surgical history of hysterectomy with or without oophorectomy: (Progesterone plays a role in preventing endometrial hyperplasia in those patients with a uterus and has no current role in patients without a uterus. Women under the age of 51 whose surgery includes oophorectomy will experience surgical menopause and should be counseled as such.)

Elevated triglycerides: (Women with triglyceride levels 300 mg/dL or higher risk more severe hypertriglyceridemia and sequelae such as acute pancreatitis. Patch forms of estrogen bypass liver metabolism and minimize this risk.)

Family history: women are at increased risk for several conditions if there is also a family history: osteoporosis, Altzheimers, breast cancer, colon cancer, or cardiovascular disease.

Menses pattern: patterns/schedules change during perimenopause to the point where the clinician might consider "change" to be normal. When the woman reports "irregular" periods, get a description. Abnormal is an interval less than 15 days or longer than 3 months; bleeding in between menses, or menses lasting longer than 7 days.

If she is skipping periods intermittently but otherwise having normal cycles: this signifies continued ovarian/hypothalamic function whereby her own hormone influence comes into play in deciding external replacement. If choosing hormone replacement therapy, introduce estrogen first (see management below). If she continues to have a period, she has enough progesterone production to prevent hyperplasia.

If she has skipped more than three consecutive menses: after determining she is not pregnant, administer a progesterone challenge (ex, Provera 10 mg twice daily for 5 days and expect a withdrawal bleed within a week of completion of the progesterone) or order a Follicular Stimulating Hormone level (FSH). If she has a withdrawal bleed or the FSH is low, she is not menopausal. Treat based on symptoms and fertility status (ie, low dose estrogen or low dose birth control pills (BCPs). Counsel all perimenopausal women to keep a menstrual diary and follow-up if she has any irregular bleeding.

If she has any intramenstrual spotting or bleeding, an endometrial biopsy is indicated in this age group to evaluate the cause.

Symptom profile: when does it occur, both on a daily basis and in relation to her menses (if she has one), what brings it on or relieves it, how long does it last.

Prior use of hormones: which hormones, why and what was her experience with them.

Objective:

Minimally, an exam should include the breasts and pelvic organs and a measured height (useful in the crude monitoring of bone loss). Noted changes associated with menopause: fatty replacement of breast tissue leading to cystic findings on exam; flattening of the normal labial landmarks with paleness on inspection; decreased vaginal rugae with dry, pale vaginal walls and cervix; pelvic relaxation noted by any degree of prolapse of bladder, uterus, and/or rectal wall as well as decreased in vaginal tone evaluated by asking the patient to perform a Valsalva or Kegal.

Optimally, the exam should include all those elements included in a routine or full physical exam keeping in mind that estrogen has multiple receptor sites.

Diagnostic Studies: In addition to routine health screening for the age group.

Mammogram: with the potential affect of increasing tumor growth in any currently present mass and the general lay perception that hormones cause breast cancer, a recent mammogram is accepted practice prior to initiating external estrogen.

Lipid Profile: Estrogen has been shown to decrease LDL cholesterol and increase HDL cholesterol. Other actions include prevention of plaque formation, antioxidant activity and vasodilation.⁴

With a triglyceride level greater than 300, consideration should be made to using a patch rather than an oral form of estrogen to bypass liver metabolism.

Hormone Levels: Women may request hormone levels believing they are needed to diagnose and treat menopause or perimenopause. Follicular Stimulating Hormone (FSH), Lutinizing Hormone (LH) and Estradiol levels are not generally useful in management. They can show menopause or no menopause with regard to the need for contraception (for example in the patient who is on oral contraceptives and wants to know if it is safe to discontinue them: both FSH and LH levels should show an increase) but yields minimal information for hormone replacement therapy management. Estadiol levels have been used to assess the adequacy of estrogen replacement with regard to bone replacement (levels between 40 and 150). When the clinical picture does not support the diagnosis of estrogen deficiency as the cause of hot flushes, FSH levels should be obtained.

Bone Density Evaluation: Estrogen has a proven role in osteoporosis prevention and management. Bone synthesis begins its decline at age 36. The correlation between bone loss and fracture risk has not been established but we know that the incidence of fractures increases at age 60. A baseline bone density evaluation seems prudent at perimenopause even though few insurers provide coverage. Three groups deserve this evaluation:

• Where there is a family history of osteoporosis
• Early menopause (ie, prior to the average age of 51)
• Women 10 or more years postmenopausal (Optimal bone protection occurs if hormone replacement therapy occurs within the first 10 years).

Therapeutic Management

Herbal medicine, homeopathy, accupressure, dietary adjustments, exercise, stress-reduction and others are common non-hormone replacement therapy treatment options. Scientific support of many of these options is scant to non-existent.

Hormone replacement therapy and Non-hormone replacement therapy comfort measures can be suggested based on the presenting complaints which most commonly include:

Vasomotor: Hot Flashes (a rise in skin temperature or a sensation of heat) and Hot Flushes (flushed, red chest up through the scalp) are often reported by the woman when they reach the point of interfering with her sleep. Disruption in sleep is felt to lead to irritability and moodiness, another common menopausal complaint. Self-analysis of precipitating factors will help the patient regain some control. Common factors to acknowledge and/or avoid are alcohol, caffeine, hot and/or spicy foods, large meals, stress, increased temperatures, and exercise. Formalize this process by advising the woman to keep a diary. Don't ignore the obvious when advising the menopausal woman: layered clothing, loose fitting and absorbent materials, using a fan, adjusting environment temperatures, deep breathing are all suggestions that will lead to increased comfort.

Other Treatment measures:

1. Hormone replacement therapy addressed below.
2. Progestin alone (Medroxyprogesterone acetate 10 to 20 mg po daily, Prometrium 100 mg hs daily, depo progesterone (DMPA) 150 mg IM every 12 weeks)
3. Clonidine 0.05 - 0.2 mg daily or 100 u transdermal weekly and monitor BP in non-hypertensive women.
4. Methyldopa 250 - 500 mg daily although there are no controlled studies in comparison to placebo.
5. Megestrol acetate 20 mg twice daily
6. Androgens (testosterone 200 mg in oil IM monthly)
7. Bellergal, an ergot alkaloid, hs
8. Herbs can be taken as a tea or a tincture and may take six to eight weeks before relief is felt. Caution the woman to shop her herbs where she can be confident of the authenticity, quality control, freshness and to read/follow labels for storage and preparation. She should inform her clinician of herb usage just as she would of medication use.
   • Dong Quai (Angelica sinensis, a Chinese herb), as an estrogen precursor, has been used to treat hot flashes.
   • Black cohash is a progesterone precursor used for dysmenorrhea or menopausal cognitive and vasomotor complaints.
   • Lady's slipper for anxiety/insomnia relief.
   • False Unicorn or Saint John's Wort are used for depression treatment.
   • Valerian (0.8% valeric acid or 1.0 - 1.5% valtrate), Passion Flower, Kava kava and Lemon Balm are used for restlessness and difficulty sleeping.
   • Ginkgo has been used for memory deficits, decreased concentration, depression, dizziness, tinnitus, and headaches.
   • Ginseng can relieve fatigue, debility and improve concentration.
9. Homeopathic treatments are based on the the principle that the mind and the body are inseparable. Homeopathic remedies are highly specific to the complaint.
   • Ignatia (hot flushes)
   • Lachesis (anxiety)
   • Pulsatilla (insomnia)
   • Nux vomica (insomnia)
   • Natrum muriaticum (emotional sensitivity)
   • Lycopodium (poor memory).
10. Aromatherapy, or the use of fragrance to heal, involves the use of oils applied directly to the skin or inhaled.
    • Rosemary and Chamomile (hot flashes and CNS problems)
    • Lavender (stress)
    • Jasmine (depression).
11. Vitamin E, up to 1,000 units/day, or increasing foods rich in E such as soybean products, spinach, and wheat germ. Vitamin E is fat soluble and can accumulate in tissue therefore caution the woman about side effects such as nausea or blurred vision.
12. Therapeutic Touch⁶
13. Accupressure

Other CNS symptoms such as insomnia, irritability, headache, anxiety, worry, memory loss, inability to concentrate improve more with estrogen.

Urogenital: Without estrogen, the vaginal tissue becomes dry, thinned out and looses its suppleness. Symptomatically, the woman may notice vaginal dryness (atrophy), frequent UTIs and/or incontinence.

1. Hormone replacement therapy addressed below.
2. Evaluate and treat UTI.
3. Evaluate and treat incontinence.
4. Aromatherapy lists Fennel for cystitis.
5. Eliminate, where possible, products that promote vaginal dryness such as antihistamines and decongestants, feminine hygiene products, douches and deodorant soaps.
6. Many over the counter products are available for symptomatic relief of vaginal dryness. These include moisturizers and lubricants. In general, lubricants provide episodic relief when used as the symptom occurs whereas moisturizers should be used on a regular basis to prevent symptom occurrence. Vaginal dryness with coitus can be managed with a water-soluble lubricant such as Astroglide. Advise the woman to avoid petroleum-based products which will further dry the vaginal tissue even as they provide immediate lubrication. Lubrication may decrease even more in the woman who is not sexually active.
7. Herbal therapy such as Chasteberry (revitalizes tissue) and Dong quai, as an estrogen precursor, may provide lubrication if used over several months.
8. Homeopathic treatments includes Sepia for dry vaginal tissue.

Decreased Sex Drive: Androgen production decreases with the decline in ovarian function, which may lead to a decline in libido. The clinician should explore other possible factors with the woman such as vaginal dryness, depression, fatigue and lack of romance (i.e., does the couple continue to participate in the rituals that lead to intercourse). Does she achieve orgasm? If so, review those episodes with her to problem solve this issue.

1. Vaginal or water soluble lubricants.
2. Other forms of sexual behavior or changing coital position to allow the woman to control the degree of penetration.
3. Testosterone, either IM, po or cream applied to the clitoris daily, with a consideration to possible viralizing and lipoprotein affects. Available are: testosterone cypionate (Depo-Testosterone) or testosterone enanthate (Delatestryl Injection) 200 mg IM the affects of which may last 4 weeks or longer as well as esterified estrogen with methyltestosterone (Estratest tablets) discussed in hormone replacement therapy below.

Osteoporosis: Pain, loss of height, uneven hem-lines, kyphosis, spinal deformity, decreased mobility, loss of independence and self esteem are all presenting complaints for osteoporosis.

1. Hormone replacement therapy addressed below.
2. Progesterone alone: some early studies are showing progesterone has a role in the prevention of bone loss as well as in increasing density and strength.
3. Bisphosphonates such as Alendronate (Fosamax) 5 mg daily for prophylaxis; 10 mg daily for treatment. Alendronate should be taken with 6 to 8 ounces of water to reduce esophageal irritation. It is recommended the woman drink her 6 to 8 ounces of water on arising, after an overnight fast, complete her morning dressing routine, take her Alendronate, and continue her day to reduce GI symptoms.
4. Raloxifene (Evista) 60 mg daily for osteoporosis prophylaxis. Raloxifene is one of an emerging group of drugs known as SERMs (Selective Estrogen Receptor Modulator). With the identification in 1996 of specific estrogen receptors comes scientific evidence that not all estrogens are the same hence, there is no generic estrogen. SERMs bind to specific estrogen receptors and produce estrogen-like effects.
   Raloxifene:
   • Decreases bone resorption
   • Lowers total and LDL cholesterol without affecting triglycerides
   • Increases risk of VTE
   • No effect on endometrium
   • No breast tenderness
   • No affect or may increase hot flashes
   • Some data to suggest reduction in the development of breast cancer
5. Calcitonin (Miacalcin) is used in the treatment of osteoporsis (injections IM or SC of 50 units 3 times/week, 100 units daily, or 200 units spray daily, alternating nostrils). Rhinnitis is a common side effect.
6. Calcium alone retards but does not prevent osteoporosis. The recommended daily allowance for menopausal women is 1200 to 1500 mg daily. When combined with weight bearing exercises, there is demonstrable prevention of osteoporosis. Vitamin D, 400 IU to 800 IU, and/or sunlight enhance the absorption of calcium. Clinicians should encourage all postmenopausal women to maintain a diet adequate in calcium and vitamin D and perform weight-bearing exercises for 20 minutes daily.
7. Horsetail and Oatstraw are herbs which are high in silicin and calcium therefore suggesting a role in protection against bone loss.
8. Avoid caffeine, smoking and alcohol, all of which inhibit the absorption of calcium. Fall-proof households, with attention to any medications that predispose to loss of balance.

Hormone Replacement Therapy

Benefits associated with hormone replacement therapy users:

Cardiovascular Disease Prevention: cardiovascular disease is the leading cause of death in women. Many studies are looking at the influence of hormone replacement therapy on cardiovascular disease and mortality. Most yield data to show the risk of death from cardiovascular disease to be 49% to 54% whereas the risk of death from breast cancer is 4%.⁷ Issues to be addressed with the perimenopausal woman include: smoking, physical inactivity and obesity. Obviously, measures should be taken to treat hypertension, dyslipidemia, and diabetes. Information from the Heart and Estrogen/progestin Replacement Study suggests that hormone replacement therapy not be used for the secondary prevention of cardiovascular disease in women with established heart disease. Data does suggest a role in the primary prevention of cardiovascular disease.⁸

Hormone replacement therapy mechanisms of action:

• Decreased plaque formation
• Increased HDL; decreased total cholesterol
• Possible estrogen receptors on myocardium and aorta
• Decreased plasma homocysteine levels
• Peripheral vasodilitation
• Lower incidence of coronary calcification
• Antioxidant activity

Altzheimer's Disease: various studies are now yielding data with regard to improved cognitive scores for hormone replacement therapy versus non-hormone replacement therapy users.⁹

Hormone replacement therapy Regimens: Oral estrogen at 0.3 mg has been shown to provide bone protection when combined with 1500 mg of calcium.10 The accepted average or starting dose for estrogen is 0.625 mg. Adjustments in estrogen dose can be made to control symptoms and hormone replacement therapy related complaints. The most common adjustment is based on the woman's continued vasomotor symptoms. Younger woman may require 2.5 mg or more estrogen a day to control hot flashes.

Vaginal bleeding is the most common side effect.

Estrogen related side effects include:

• Risk of endometrial cancer. An endometrial biopsy is indicated for any abnormal bleeding not related to incorrect dosing
• Nausea/vomiting, bloating, cramps
• Breast tenderness, enlargement or nipple secretion
• Cystitis-like syndrome
• Fibroid enlargement
• Intolerance to contact lenses
• Fluid retention
• Change in skin pigmentation

Progestin related side effects include:

• Changes in libido
• Increased total cholesterol
• Fluid retention
• Allergic reactions
• Rash, with or without pruritus
• Depression
• Pyrexia
• Insomnia

Many of these will clear with time (as with birth control pills, urge the woman to give hormone replacement therapy a trial period of 3 months). A mild diuretic helps alleviate most symptoms. Changing the hormone replacement therapy product can also help symptom relief.

Estrogen alone: can be used if there is no uterus (i.e., no risk of endometrial hyperplasia). It is also used when there is an intolerance of progestin. If the uterus is present it must be combined with periodic (generally yearly) monitoring of the endometrium with an endometrial biopsy.

Combination progestin and estrogen: is recommended for women with an intact uterus:

• Cyclic or sequential therapy will cause a withdrawal bleed ("period") in most women. This will decrease with time and is seen most often in the early menopausal woman. Cyclic therapy requires the woman to remember a change in dosing and can be cumbersome for that reason. Woman taking an estrogen "holiday" may experience vasomotor symptoms on these days. You may find woman in your practice who take estrogen every other day or Monday thru Friday rather than day 1 thru 25. This dosing method evolved in an effort to minimize the estrogen withdrawal symptoms. An endometrial biopsy is indicated if there is heavier than normal withdrawal bleeding, a change in the bleeding pattern, or bleeding while on progesterone.
  • Estrogen taken on calendar days 1 through 25 with progesterone 10 mg on days 14 through 25, or
  • Estrogen taken daily with progesterone 10 mg taken on calendar days 1 through 10
• If the woman experiences progesterone related side effects, try reducing the dose to 5 mg and monitor for irregular bleeding.

Continuous therapy will cause spotting for approximately 6 to 9 months until the endometrium thins. The daily addition of progestin prevents endometrial stimulation. The early menopausal woman is more prone to spotting to the point of bleeding than the woman who has been menopausal for several years. The clinician should be sure the woman understands this at the onset of therapy as unacceptable bleeding may cause her to discontinue therapy and become disenfranchised with future consideration of hormone replacement therapy. An endometrial biopsy is indicated for heavier than normal bleeding, bleeding longer than 5 consecutive days, and bleeding 12 months after the initiation of hormone replacement therapy.

• Estrogen and progestin 2.5 mg daily

If the woman experiences breakthrough bleeding, try increasing the progesterone to 5 mg daily. Monitor for progestin related side-effects.

Intermittent progesterone therapy is a regimen being used by some providers for those patients who have a low tolerance for progesterone. Progesterone 10 mg daily for 10 days is used every third month to reduce the risk of hyperplasia. This is preferable to unopposed estrogen but requires a compliant patient. As usual, any abnormal bleeding should be evaluated with an endometrial biopsy.

Topical estrogen is used to treat urogenital atrophy with its associated complaints. Systemic absorption is minimal lessening the concern with endometrial stimulation. Likewise, there is no associated hormone replacement therapy protection for vasomotor symptoms, osteoporosis, cardiovascular disease and so on.

• Estrogen cream (ie, Premarin, Estrace) 0.5 gm to 1 gm vaginally with fingertip application to the labia and urethral meatus at bed time for 2 to 4 weeks then biweekly to weekly as needed. More cream can be used but is not necessary and tends to be messy for the woman.
• Estrogen ring (Estring) can be inserted by the woman and provides estrogen release for 90 days. It can be replaced at that time if needed. The package insert provides instructions for the woman. Estring claims to provide relief of vasomotor complaints.

Local estrogen preparations can be used in combination with oral hormone replacement therapy to control symptoms.

Natural versus Synthetic Hormones

Many products claim to be natural because they are derived from soybeans or yams. While these products (ie, Cenestin, Estratab and others) start with a plant or phytoestrogen, there are chemical or man-made modifications which yield the final estrogen. Premarin, conjugated equine estrogen, may be the most "natural" estrogen product available in that it is an extraction from the urine of pregnant mares.

Osaderm is a cream containing both plant-derived estrogens and progesterones. It is applied to the stomach, one-quarter teaspoon daily, until menopausal symptoms clear then daily calendar day 1 through 26 with the remainder of the month cream-free. The usual precautions apply to vaginal bleeding (ie, an endometrial biopsy should be done if spotting/bleeding occurs on those days the cream is in use).¹¹

Progest is a yam preparation used for PMS and perimenopausal symptoms. It is applied to the thigh. Used with estrogen, it claims to prevent hyperplasia. The clinician should consider periodic endometrial biopsy to monitor the endometrium. Again, an endometrial biopsy should be performed for any abnormal bleeding.¹¹

Soybeans, 60 to 140 mg daily may decrease hot flashes and provide estrogen related benefits.¹²

The clinician should consider the PDR for Herbal Medicines. First Edition. Montvale, NJ: Medical Economics, 1998.

Potency

Women may be concerned about the amount of hormone they take comparing the dose to that in birth control pills. Hormone replacement therapy is pharmacologically different for birth control pills in that the estrogen is approximately one-fifth as strong as that of the ethinyl estradiol used in contraception. The progesterones used in hormone replacement therapy are less androgenic that those used in birth control pills.

Compliance Issues

It's important for the clinician to discuss hormone replacement therapy. Never assume a menopausal woman has been offered hormone replacement therapy as a health care option! Variously, studies have shown that up to 65% of women have never discussed menopause or hormone replacement therapy with a clinician. Include risks as well as benefits in your discussion. Address breast cancer and bleeding concerns, as they are the primary reasons a woman will decline hormone replacement therapy. Urge her to follow-up with you should she have any side effects or second thoughts/questions so these can be addressed. The woman should know she can start hormone replacement therapy at any time and will get hormone replacement therapy benefits while she takes hormone replacement therapy; conversely, she will not realize any ongoing benefits once she stops hormone replacement therapy.

It's helpful to emphasize that there are many hormone replacement therapy products and regimens available. It may be a process of fine-tuning her regimen.

Consider the Whole Picture

The woman is more than her vagina. Look at the whole picture.

1. U.S. Bureau of the Census. Statistical Abstract of the United States: 1997. 117th ed. Washington, DC. 1997:17, 117.
2. Lee, John R. MD. What Your Doctor may not tell you about Menopause. Warner Books, 1996.
3. Sheehy, Gail. The Silent Passage: menopause. Random House, 1991.
4. 3. Daly E, Vessey MP, Hawkins MM, Carson JL, Gough P, Marsh S. Risk of venous thromboembolism in users of hormone replacement therapy. Lancet. 1996; 348: 977-980.
5. Gutthann SP, Rodriques LAG, Castellsague J, Oliart AD. Hormone replacement therapy and risk of venous thromboembolism: population based case-control study. BMJ. 1997; 314: 796-800.
6. 4. Stampfer MJ, Colditz GA, Willett WC, et al. Postmenopausal estrogen therapy and cardiovascular disease: ten-year follow-up from the Nurses' Health Study. New England Journ. of Med. 1991; 325(11): 756-762.
7. Pickar JH, Thorneycroft I. Whitehead M. Effects of hormone replacement therapy on the endometrium and lipid parameters: a review of randomized clinical trials, 1985 to 1995. American Journal ObGyn. 1998; 178: 1087-1099.
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9. 6. Macrae J: Therapeutic Touch – A Practical Guide. New York, Knopf, 1988. Wytias CA: Therapeutic touch in primary care. Nurse Practitioner Forum 1994; 5(2): 91.
10. 7. The Contraception Report. Baylor College of Medicine. 9/92: vol. III, no. 4.
11. 8. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280: 605-613.
12. 9. Paganini-Hill A, Henderson VW. Estrogen replacement therapy and risk of Alzheimer's disease. Arch Intern Med. 1996; 156: 2213 -2217.
13. 10. Ettinger B, Genant HK, Cann CE. Postmenopausal bone loss is prevented by treatment with low-dosage estrogen with calcium. Ann Interna Med 1987;106: 40 -45.
14. 11. Women's International Pharmacy in Madison, Wisconsin. 800.279.5708.
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