FEMALE HORMONE REPLACEMENT

FDA Article on Menopause and HRT
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healther skin with HRT
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FDA Article on Menopause and HRT
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alcohol and higher estradiol and testosterone levels in postmenopausal women

A less technical article which in general confirms the conclusions of Hormone Replacement Therapy ReviewWomen. 

The two significant differences.  One is the reference to the loss of libido which is both observed and known.  The second is its suggestively favorable (rather than definitively) about soy protein.  This I am skeptical about for two reasons:  one is that without exception naturalistic products have at best been marginally effective--though a number of them have been purified, concentrated and/or modified to yielded important drugs.  The second cause is that even minor modifications of a substance naturally used in the body will in almost all cases diminish significantly certain of its desired effects.  Soy protein is quite different than estrogen and thus very probably will have much less of the desirable qualities of estrogen.  Thus without examing the body of research on soy protein, I have good reason to be skeptical of its touted benefits. 

Taking Charge of Menopause

by Lynne L. Hall

"I was 40 when I first started having night sweats," says Patti Shields, 42, of Birmingham, Ala. "I'd wake up in the middle of the night, and even though the air conditioner was running full blast, I'd be covered in sweat."

Shields is talking about menopause, the rite of passage that signals the end of a woman's reproductive years. "Those night sweats--and the other symptoms I began to notice--suddenly made me feel old. One day I'm a young woman in her prime, and the next day I'm worrying about whether or not I'm prepared for retirement and thinking about 'getting my affairs in order.' It was a classic overreaction," she says, laughing.

Medical scholars dispassionately define menopause as "the cessation of menstruation." For women, it is much more than that. Because menopause marks the end of fertility, many women see it as a time of freedom from menstrual periods and pregnancy.

"Women shouldn't think of menopause as a death sentence," says Holly Richter, M.D., assistant professor of medical/surgical gynecology at the University of Alabama at Birmingham. "It is a transition from a healthy reproductive life to a healthy nonreproductive life. If women see themselves not just as a uterus, but instead look at themselves as a whole person, this nonreproductive life can be as fulfilling as their reproductive years."

Menopause is the result of ovarian failure, which sounds ominous, but is actually a normal part of aging. Over time, the ovaries gradually lose the ability to produce estrogen and progesterone, the hormones that govern the menstrual cycle. Estrogen can also protect against several health threats, most notably heart disease and osteoporosis. Loss of these hormones, especially estrogen, causes hot flashes and other symptoms associated with menopause.

In the United States, the average age of natural menopause--defined as one year without a menstrual period--is 51, but some women reach menopause in their 40s, and a few in their 60s.

Menopause before age 40 is considered premature menopause. There can be several causes, including genetics or autoimmune disorders, and a medical evaluation is needed.

Induced menopause can occur at any age due to surgical removal of the ovaries or damage to ovaries from treatments such as chemotherapy or radiation.

The Journey Begins

Menopause is a gradual process, says Richter, a journey that takes years to navigate. Most women notice their bodies are changing by their mid-30s. Hormone fluctuations cause disruptions in the menstrual cycle, such as lighter or heavier bleeding, and longer, shorter or skipped periods.

As ovarian function decreases, hormone production becomes erratic and diminishes, causing the onset of menopausal symptoms. Most women begin experiencing these symptoms two to 10 years before menstrual periods end. These years mark the "perimenopause."

As estrogen levels wane, many woman experience only a few changes, while others find themselves plagued by the full array, which include:

  • Hot flashes--This is the hallmark symptom of menopause, and experts say 85 percent of women will experience these personal heat waves. Starting in the center of the body, a flash of heat spreads like a wall of flame to the top of the head, flushing the face, neck and arms a fiery red, and making skin warm to the touch. The flash can last from seconds to 30 minutes and is accompanied by increased heart rate, shallow breathing, and sweating. A chill and exhaustion usually follow. Hot flashes can occur as many as 50 times a day.
  • Night sweats--These hot flashes that occur during sleep cause a woman to wake drenched in sweat, sometimes several times a night. Because of these sleep disturbances, daytime fatigue can become a problem.
  • Vaginal atrophy--The loss of estrogen causes the tissues of the vagina and vulva to become thin and dry. Sex often becomes painful. Additionally, the vagina can become inflamed and irritated from a high alkaline content, a condition called "atrophic vaginitis."
  • Urinary tract changes--Thinning of the lining of the urethra and weakening of surrounding pelvic muscles may lead to more frequent urination, frequent bladder infections, painful urination, sudden urinary urgency, and frequent urination during the night. Urinary incontinence may also become a problem.
  • Loss of libido--In addition to losing their ability to secrete estrogen, the ovaries no longer produce testosterone--the hormone responsible for sex drive in both men and women. Some women's bodies may produce the tiny amount needed through the adrenal glands. Many women, however, lose all testosterone, and with it their sex drive.
  • Emotional changes--Irritability, mood swings, anxiety, and depression are frequently the result of fluctuating hormones.
  • Formication--This bizarre symptom, the feeling that ants are crawling over the skin, occurs in about 20 percent of women, according to Lois Jovanovic, M.D., in her book A Woman Doctor's Guide to Menopause.

These changes may continue up to three years following a woman's last menstrual period, a time known as the "climacteric."

Long-Term Health Risks

Since women today live an average of 35 years longer than they did 150 years ago, scientists have only recently come to understand the long-term outcomes of living without the protective effects of estrogen. Ongoing studies have confirmed these effects, and women should be aware of them in order to avoid serious health risks.

Cardiovascular disease is the leading killer of American women. Before menopause, estrogen appears to help women maintain a healthy balance between LDL (bad) and HDL (good) cholesterol, making them six times less likely to experience a heart attack than men age 50 and younger, according to Jovanovic. Once estrogen is no longer present, LDL levels rise, and atherosclerosis (narrowing of the arteries) occurs. After menopause, a woman's risk for heart disease is about the same as a man's.

Estrogen also protects a woman against osteoporosis, the bone disease that affects 50 percent of American women over 60. In osteoporosis, bones become brittle and are easily fractured. It is the cause of the distinctive hump noticed in some elderly women and of dangerous hip fractures-the twelfth leading cause of death in the United States.

A 1996 study, reported in the medical journal The Lancet suggests estrogen protects against Alzheimer's disease, as well. The study showed that patients with Alzheimer's were significantly less likely to have taken estrogen following menopause (7 percent versus 18 percent). Additionally, the study found that four of seven Alzheimer's patients taking daily estrogen improved on mental test scores.

"It's predicted that the number of Americans with Alzheimer's will double in the next 30 years--affecting up to 14 million people. It's a major health issue for women, and the fact that estrogen may help prevent the disease is an important finding," says Richter.

Other health risks associated with the loss of estrogen include increased risk for ovarian and colon cancer, periodontal (gum) disease and tooth loss, and cataract formation.

When menopause symptoms begin, a woman should see her doctor to rule out pregnancy or serious health problems such as uterine cancer. A blood test to assess estrogen status also should be performed.

The most reliable test measures the level of follicle stimulating hormone (FSH), a hormone that is secreted by the pituitary gland to stimulate estrogen production. Levels of 30 to 40 milli International Units per milliliter (MIU/mL) or above means a woman has reached menopause. A level in the teens or 20s means there is still partial ovarian function.

If the ovaries are still functioning, many physicians prescribe low-dose contraceptive pills, which regulate periods and alleviate other symptoms. Because contraceptives can mask menopausal changes, a yearly FSH test should be performed beginning at age 50 to assess ovary status.

"Once a woman reaches menopause [and ovaries no longer function], we discontinue the contraceptives and consider other options," Richter says.

Replacing Estrogen

Estrogen replacement therapy (ERT) is an effective treatment for menopausal symptoms and has been approved for this use since the 1940s. During the 1980s, ERT also received approval by the Food and Drug Administration for preventing osteoporosis. When taken for many years, ERT reduces the risk of wrist, hip and spine fractures by 50 to 75 percent.

Its health benefits don't stop there. Numerous studies suggest possible effectiveness in prevention of heart disease, Alzheimer's, and other menopause-related conditions. In fact, a study published in the Feb. 1999, issue of The Lancet cited research revealing that postmenopausal women who use ERT have a 30 to 50 percent lower death rate than those who do not.

Currently ERT is available in pill and transdermal (skin) patch form. Different regimens and dosages are available. Health status and personal choice determine which is best. Because estrogen causes the buildup of endometrial tissue, and may increase the risk of cancer, a woman who still has her uterus must also take a progestin, which causes the excess tissue to shed.

Progestins can be taken either cyclically or continuously. In the cyclical regimen, estrogen is taken daily and progesterone is added for 12 to 14 days of each month. Several days after progesterone is stopped, a woman will usually experience a short period. Monthly bleeding can be lessened by taking a low dose of progestin with estrogen every day.

ERT may increase the risk for uterine cancer, blood clots, or gallbladder disease. Many studies have evaluated the possibility of increased breast cancer risk, but results are conflicting. Women taking ERT should perform monthly breast self-exams, says Richter, and have yearly mammograms after age 50.

Side effects associated with ERT include weight gain, bloating, breast tenderness, and nausea.

The hormones available for ERT are derived from two sources. Premarin (conjugated estrogens), the oldest and still the most widely prescribed estrogen, is derived from pregnant horse urine. It is approved for both symptom relief and prevention of osteoporosis.

Other ERTs are plant-derived, and several are available in both pill and patch form. One of the newest to receive FDA approval is Cenestin (synthetic conjugated estrogens, A), which is synthesized from soy and yam extracts. "Cenestin is approved for the relief of vasomotor symptoms such as hot flashes," says Lisa Rarick, M.D., director of FDA's division of reproductive and urologic drug products. "There have been no trials on osteoporosis prevention yet."

Other plant-derived estrogens approved for menopausal symptoms include Alora (estradiol), Climara (estradiol), FemPatch (17-beta-estradiol), Menest (esterified estrogens), Ortho-est (estropipate), Vivelle (estradiol), and Ogen (estropipate). Estrace (estradiol), Estraderm (estradiol), and Estratab (esterified estrogens) are plant-based estrogens approved for both menopausal symptoms and osteoporosis prevention. Estrogen/progesterone combinations also are available in either patch or pill form.

Relief from vaginal atrophy can be attained with a variety of FDA-approved vaginal creams containing estrogen, such as Estrace (estradiol), Ortho Dienestrol (dienestrol), Premarin (conjugated estrogens), and Ogen (estropipate). Estring (17-beta-estradiol), a vaginal ring, also is available. The ring is inserted into the upper vagina, where it provides a consistent low dose of estrogen for three months. Since only a small amount of the hormones provided by the ring and creams is absorbed into the system, they are not believed to increase the risk for endometrial or breast cancer. Estradiol rings do not alleviate symptoms such as hot flashes, and are not believed to provide protection against menopause-related diseases such as osteoporosis and heart disease.

Estrogen Alternatives

In 1997, FDA approved Evista (raloxifene), a drug that mimics estrogen's protective effects on the bones and heart. Clinical studies show that this drug, one of a new class called selective estrogen receptor modulators (SERMs), increases bone density and reduces levels of LDL, or "bad" cholesterol. But it does not cause the endometrial buildup or breast changes that may increase cancer risk. It does carry the risk of blood clots and is not effective for menopausal symptoms such as hot flashes. More studies are in progress to determine the long-term effects and efficacy of Evista and other SERMs.

Miacalcin (calcitonin) and Fosamax (alendronate) are two drugs FDA has approved for treating osteoporosis. Miacalcin is effective in women who are not candidates for HRT and who are at least five years postmenopausal and are suffering from osteoporosis. Available as a nasal spray, it has been found to increase bone density.

Fosamax reduces the activity of the cells that cause bone loss and thereby increases the amount of bone present. Both drugs can cause side effects, making a consultation with a physician essential.

Some women may prefer to "let nature take its course" and choose not to take prescription hormones. Others turn to alternative remedies touted to relieve menopausal symptoms and protect against related diseases.

One type of foods being extensively researched are "phytoestrogens." These are natural compounds similar in chemical structure to estrogen that may produce estrogen-like effects in menopausal women.

Of these compounds, the isoflavones found in soy protein seem to be the most promising. Studies being conducted at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., show the phytoestrogens in soy protein to be just as effective as Premarin in monkeys at limiting the formation of atherosclerosis, a major cause of heart disease. Additionally, women who added 20 grams of soy protein to their diets reported less intense menopausal symptoms, such as hot flashes and night sweats.

"We believe soy may offer many of the benefits of estrogen replacement therapy without the risks," says study leader Greg Burke, M.D.

The benefits of soy protein first drew interest when studies showed that in Asian countries, where diets are high in soy, both the incidence of breast cancer and the heart disease mortality rate are four times lower than in the United States. In addition, Asian women report fewer hot flashes and night sweats during menopause. These women get about 30 to 50 milligrams of isoflavones daily, the levels found in half a cup of soy milk or tofu or a quarter cup of roasted soy nuts.

In 1998, FDA proposed allowing health claims about the role soy protein may play in reducing the risk of heart disease on the labels of foods containing soy protein. Studies show that 25 grams of soy protein per day may lower blood cholesterol levels.

Be Prepared

Making some lifestyle changes can help women increase longevity and avoid the health risks associated with menopause. The American Heart Association recommends limiting total fat intake to no more than 30 percent of calories, cholesterol to no more than 300 milligrams daily, and salt to no more than 3,000 milligrams daily. The association also recommends eating lean meats, low-fat dairy products, and at least five servings of fruits and vegetables daily. (See "Eating for a Healthy Heart" on FDA's Easy Reader Website at www.fda.gov/opacom/lowlit/englow.html.)

In addition to a heart-healthy diet, exercise that includes cardiovascular and weight-bearing workouts is good for the heart and bones. The action of muscle on bone helps to increase bone density, so exercises such as weight training, running, walking, or jogging are important. Check with a doctor before beginning an exercise program.

"Preparing for the change of life is essential, since women are living one third or more of their lives in menopause," says Richter. "Together with their physicians they can minimize the associated health risks and help sustain a good quality of life throughout their nonreproductive years."

Lynne L. Hall is a writer based in Birmingham, Ala.

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