Other than the fact that breast cancer is the number two cancer killer of women and prostate cancer the number two cancer killer of men, the two diseases would appear to have little in common. But both strike in response to the workings of sex hormones. Moreover, some scientists now suspect that women and men can take exactly the same step to reduce the risk of succumbing to these diseases. The answer, they believe, is in the diet.

As it turns out, plant foods, like humans, have hormones. These plant hormones, called phytoestrogens, are weaker versions of human estrogen. And research suggests that if they are consumed in large enough amounts, they may have profound effects not only on the incidence of breast and prostate cancer but also on menopausal symptoms such as hot flashes and mood swings.

It may even be that phytoestrogens will prove an alternative to estrogen replacement therapy, a treatment regimen now used by more than 10 million American women but which has the downside of potentially raising the risk for breast cancer as well as cancer of the uterus.

Animal nutritionists have known for decades that the hormonal balances of mammals could be affected by plant foods. Sheep, for example, can become infertile or lambs go into heat by grazing on red clover sprouts. But the array of plant foods involved and the extent to which the animal findings apply to humans has only recently come under scientific scrutiny.

The "phyto" in phytoestrogens is from the Greek for plant, an apt prefix since phytoestrogens are found in all manner of plant foods. There are several classes of phytoestrogen compounds:

• Coumestans are contained in bean sprouts, red clover, and sunflower seeds.

• Lignans are formed when bacteria in the human gut "nibble on" compounds found in such grains as rye and wheat and in seeds like sesame and linseed.

• Isoflavones exist in many different types of plants, including "everyday" fruits and vegetables, but they are especially prominent in soy--apparently the most potent food in terms of its estrogen-like effects on the body.

So far, some 300 plants with estrogen-like activity have been identified, including common foods such as carrots, corn, apples, barley, and oats. Yet products made from soybeans--tofu, for instance--have received the lion's share of attention because they appear to pack a much more potent estrogenic punch. Indeed, researchers have observed that in countries where people eat diets high in soy foods, such as Japan, China, and Korea, breast cancer rates are much lower than in the West, death from prostate cancer is minimal, and the unpleasant symptoms of menopause appear scant.

Understanding the hypothesis behind the protective effects of the phytoestrogens in soy and other foods can be a bit tricky, especially when it comes to women, because it relies on seemingly contradictory concepts that have to do with whether a woman is pre- or post-menopausal. Namely, scientists speculate that during childbearing years, prior to menopause, phytoestrogens stave off breast cancer by blocking the action of some of the body's naturally occurring estrogen and thereby acting as antiestrogens. Consider that in females, estrogen is necessary for reproduction as well as for the development of the breasts and other secondary sex characteristics. But it can also cause a problem, because inside breast tissue it can encourage cancerous tumors to develop.

After menopause, however, when a woman's natural estrogen declines by 70 percent, phytoestrogens provide an estrogen "lift" to make up for the "lack" of the hormone--without raising cancer risk. In men, phytoestrogens appear to act as a blocker of testosterone--the male hormone that, while necessary for a man's maleness, can spur the growth of prostate tumors. And they accomplish the task without making men "feminine."

Q. What is the incidence of depression among women at the onset of menopause? For how long are antidepressants usually prescribed for menopausal depression?

A. "There is a mental health side to menopause that is as much a part of the physical process as our minds are part of our bodies," says Rosemary Tofalo Bowes, Ph.D., a Washington D.C.-based psychologist. "Yet, just as menopause is a natural passage, not itself a physical illness, the mental side of this passage should not be confused with mental illness."

Menopause, the cessation of menstrual periods, occurs on average at age 51.There is NO evidence to suggest that women are more susceptible to clinical depression after menopause. Because of declining estrogen levels after menopause, many women experience short-term physical symptoms such as hot flashes, irregular uterine bleeding and vaginal dryness. Irritability, depression (feeling "depressed" as opposed to a clinical diagnosis) and mood swings are the most common emotional symptoms. They are not believed to be the result of declining estrogen levels, but rather the result of the physical symptoms of menopause. For example, when hot flashes occur at night (night sweats), the quality and quantity of sleep can be significantly affected, leaving one more susceptible to mood swings. Women who develop constructive responses to menopause tend to live healthier and more balanced lives.

Dr. Bowes offers the following tips:

DON'T:

• smoke or abuse alcohol
• try to be too thin or allow yourself to be too heavy
• drink caffeine or soft drinks, except in moderation
• fret or focus on negative thoughts
• close down and think you are alone

DO:

• exercise and stretch
• use relaxation techniques, especially deep breathing
• watch your diet, and be wary of fats and cholesterol
• think positive thoughts
• try to be flexible
• try to laugh as often as possible
• see your friends

Drinking Raises Estrogen Levels In Women Taking HRT
By Damaris Christensen
December 3, 1996

For postmenopausal women who take estrogen replacement therapy, drinking the equivalent of one to two glasses of wine can lead to a threefold increase in the levels of estrogen circulating in their blood, according to a new study. "If alcohol alters the intended biological effects of estrogen replacement therapy, it could weigh negatively when assessing the risks against the benefits of hormone replacement," said researcher Dr. Elizabeth S. Ginsburg, of the division of obstetrics and gynecology at Brigham and Women's Hospital in Boston.

For example, increased blood levels of estrogen may heighten a woman's risk of breast cancer, Ginsburg speculated. Previous studies have linked estrogen replacement therapy with the development of breast cancer, she noted. But this link is highly controversial, pointed out Trudy L. Bush, a professor of epidemiology and preventive medicine at the University of Maryland School of Medicine in Baltimore. "I don't see any clinical implications from this study," she said, adding that the observed rise in estrogen levels may have no effect. "In premenopausal women, estrogen levels may vary more than threefold over the course of a month."

An estimated 25 percent of U.S. women over age 50 take estrogen replacement therapy to combat the symptoms of menopause, prevent bone loss and stave off heart disease. Ginsburg's team looked at the effects of drinking alcohol in 24 postmenopausal women, 12 of whom used estrogen replacement.

In the study, published Wednesday in the Journal of the American Medical Association, the women were admitted into a hospital in the afternoon and fed specified meals and snacks. The following morning, each woman was given either an alcoholic drink or a non-alcoholic drink. Her blood was sampled every 10 minutes for six hours.

Each woman remained in the hospital and the next morning was given either an alcoholic or non-alcoholic drink _ whichever she had not received the day before. Again, her blood was tested every 10 minutes for six hours.

Estrogen levels of the women on estrogen replacement began to rise within 10 minutes of taking a drink of alcohol, but not after the nonalcoholic drink, the researchers found. As a woman's blood-alcohol levels rose, so did her blood-estrogen levels; as alcohol levels dropped, so did estrogen levels. The estrogen levels remained elevated for up to five hours, the team reported.

Women who were not using estrogen replacement did not show any significant changes in their blood-estrogen levels, which were much lower to start with, the study showed. "It's a very interesting study," said Dr. William C. Andrews, a professor of obstetrics and gynecology at Eastern Virginia Medical School in Norfolk, Va.

"But it's too early to say whether this has any implications for a woman who may have one or two drinks once in a while. I don't think that, at this point, this should affect a woman's choice to use estrogen replacement therapy," he said. The study did not replicate "real life," Ginsburg noted, since each of the women ate a controlled diet, drank a specified amount of alcohol and was carefully monitored.

More research is needed to look at whether these high estrogen levels occur in a less controlled setting, and if they might raise a woman's chance of developing breast cancer, Ginsburg added.

© Medical Tribune News Service

Heavy bleeding, while usually not medically serious, can cause major disruption in a woman's life. It can cause embarrassment and result in a decrease in exercise and other beneficial activities. If severe enough, it can also result in anemia.

Dysfunctional Uterine Bleeding (DUB) refers to excessive bleeding that is not related to fibroids, polyps, endometriosis, adenomyosis, pregnancy, cancer or other identifiable causes. It is usually related to hormone imbalance or changes and is more likely to occur during perimenopause when women often do not ovulate regularly. About half of the cases are women between 40 and 50 and 20% are adolescents. Some of the common imbalances are excessive estrogen, lack of progesterone or an imbalance of these hormones.

Hypothalamic dysfunction, pituitary or adrenal hyperplasia (which is usually associated with excessive hair growth or other signs of virilization) or thyroid problems can also cause heavy bleeding. Drugs such as steroids and psychopharmacologic agents can inhibit ovulatory function and result in bleeding problems. But because bleeding can be an indication of cancer, fibroids, endometriosis, polyps or pregnancy, it is important to have it evaluated by your health care provider. An abnormality of the arteries supplying the uterus can also cause bleeding, but this is rare.

Dr. Winifred Cutler has found that for some women, excessive bleeding may be a consequence of having intercourse during menses. Obesity, polycystic ovary syndrome, stress, crash diets, and excessive exercise can all disrupt ovarian function. Those on hormone replacement therapy may experience bleeding problems but it is rarely a cause of heavy bleeding.

DIAGNOSIS

The most important step is to determine what is causing the bleeding. Dilatation and Curettage (D&C) involves scraping the interior of the uterus and may still be used for diagnosis,. However, a procedure which reduces the risk of uterine puncture and is less expensive, is aspiration curettage which removes a thin layer of the endometrium with suction.

While an endometrial biopsy (a sample of the uterine lining is taken to determine if suspicious cells are present) has been standard procedure to check for precancerous conditions, the use of ultrasound which shows the thickness of the uterine lining is becoming more common. Studies reported in both the American Journal of Obstetrics and Gynecology and the Journal of Reproductive Medicine found that ultrasound was an effective screening tool for the presence of uterine abnormalities. It identifies those who need further diagnostic evaluation such as a biopsy if the test is abnormal or inconclusive. This procedure allows a view of the whole uterus. A biopsy may not be representative of the condition of the entire endometrium.

If abnormalities are found further procedures such as Magnetic Resonance Imaging (MRI) which uses a magnet to create images of live tissue, Computerized Axial Tomography (CT or CAT) which takes X-ray pictures of slices of a region, and hysteroscopy which allows the physician to look at the inner walls of the uterus and cervix may be used.

TREATMENTS

One of the key questions in dealing with DUB is recognizing whether you are dealing with life-threatening bleeding (causing severe anemia, or caused by cancer) or lifestyle-threatening bleeding which is the most common cause of hysterectomies in this country. (See issue 3.3 on hysterectomy.) While heavy bleeding can be very disruptive to your daily activities, the safest approach is appropriate diagnosis and therapy beginning with the least invasive procedures.

While DUB is the reason given for 20% of hysterectomies in this country, there are less drastic measures available that may solve the problem. Nonsteroidal anti-inflammatory drugs such as Advil may work for some women. These are to be started one week before menses and continued through the flow.

For perimenopausal women, oral contraceptives may be effective. Cyclic progesterone treatment or hormone replacement therapy are additional options. For more severe cases Danazol or injections of Depo-Provera or Depo-Lupron may be used. (D&C) may stop the bleeding, but it may return and is seldom used. Endometrial ablation (burning away or vaporizing the uterine lining) with laser or electrocautery is also often an effective alternative to hysterectomy.

A report this year in the New England Journal of Medicine reported that after five years 79% to 87% of women were happy with this surgery and it controlled bleeding in at least 85% of the women. During five years of follow up, only 9% underwent hysterectomy and 10% had another ablation. One possible down side to this treatment is future endometrial cancers may be harder to diagnose due to scar tissue in the uterus.

A new procedure which uses a catheter with a balloon attached is being studied. The catheter is inserted into the uterus. The balloon is inflated with sterile solution so it fills the uterus and takes its shape. Then a heating element raises the temperature to 189 degrees. This destroys the endometrial lining. This is still an experimental procedure but new techniques will be evolving.

SELF-HELP

If you have consulted with your health care provider, you are dealing with heavy bleeding and no cause has been identified, here are some things you can do for yourself.

• Diet: If you are losing a lot of blood, you want to protect yourself from anemia by getting extra iron. Liver is a good animal source. A non-animal source is legumes, but you should take vitamin C (75mg.) with it because it aids absorption. Seeds, nuts, blackstrap molasses, some fruits such as raisins, dates, and prunes and some vegetables such as beets, corn, spinach, sweet potato, and dandelion greens, are also good. Fresh, dark green, leafy vegetables are a good source of Vitamins K and C and iron. Deficiencies in these may contribute to heavy bleeding.
• Herbs: Lady's mantel, vitex, wild yam root, uva ursi, raspberry leaves, garden sage, black haw bark, golden seal, yellow dock, turmeric, silymarin and pau d'arco.
• Bioflavonoids: Citrus fruit inner peel, buckwheat, elder, hawthorn, horsetail, shepherd's purse.
• Essential Fatty Acids: Oils -- flax seed, borage seed, black currant, and evening primrose.
• Homeopathy: Lachesis, sepia, belladonna, ipecacuanha, secale, sabina, china, crocus sativa, natrum mur, sulfur.
• Supplements: Zinc, Copper, Iodine, Vitamin B6 Warning: Large doses of vitamin C may thin the blood and increase bleeding.
• Acupressure, yoga: Some women find specific yoga positions or acupressure points helpful.

The belief is that these approaches balance the body and stabilize energy flow, allowing the body to heal. See Heavy Menstrual Flow & Anemia by Dr. Susan Lark for further information.

For some women hysterectomy is the only solution. However, this surgery is too often used for problems that are not life-threatening. Because it is so common, we may not recognize its seriousness and too many women are not told of the possible side effects such as reduced sex drive, urinary problems, constipation, or back pain. If you consider surgery, be sure you are fully informed.

Excellent article prepared by Power Surge's herbal consultant, Kathy Shull Abascal. Contained herein is information about various herbs which have been found to be helpful in combatting menopausal symptoms, without resorting to synthetic prescription drugs or hormones, for those who choose the more natural path.

HERBS AND MENOPAUSE

Herbal formulations cannot take the place of medical care by a doctor or medications prescribed by a doctor. Herbalists have traditionally recommended the herbs discussed in this article for peri-menopause and menopause. They are a safe adjunct to medical care but are NOT a substitute for medical treatment and have not been shown to treat or cure any disease condition. Herbs marked with an asterix (*) hold some degree of risk in pregnancy, real or potential. The common names of the herbs are in bold, their latin name follows in parenthesis.

Long ago, wise women began collecting herbs to maintain the health of their people. Herbalism grows out of women's knowledge and ways. As you might expect, there are herbal remedies for a wide variety of women's needs: Herbs can balance menstrual cycles, increase fertility, help maintain pregnancy and ease birthing. Herbs can also help women through the transition into menopause. This article will touch on a few herbs than can be of great help in peri-menopause and menopause.

HERBS FOR PERI-MENOPAUSE

As we approach menopause, our menstrual cycles shift. In some women they get longer, in others they get shorter. Cycles double up, overlap, and become more irregular. We may begin to experience migraines, bloating, breast tenderness, hot flashes and moodiness as our hormones change. Herbs can be used to restore balance to our menstrual cycles in menopause. A cyclic herbal elixir chosen for the individual woman will provide the most relief. Nonetheless, even single herbs may provide substantial relief -- provided our cyclical nature is respected.

Our menstrual cycles can be divided into two phases. Phase One begins on the first day of menses and ends at ovulation, fourteen days before the next menses. Phase Two begins at ovulation and runs to the first day of menses. Different herbs are needed in the two phases.

• Herbs For Phase One

  In Phase One of the menstrual cycle, estrogen dominates. The estrogen causes uterine and breast tissue to proliferate. It also helps mature an egg. In Phase One, less than perfect menstrual cycles can be balanced by herbs that help the body cycle up estrogen. Both cycles that are too long and cycles that are too short are helped by the same herbs. In a long cycle, herbs increase the effect of circulating estrogen, allowing an earlier ovulation. In a short cycle, herbs increase the ability of estrogen to form adequate progesterone binding sites, which will stabalize the cycle. In both cases, the herbs should be taken only during Phase One of the cycle --Day one to Day fourteen.

• Dong Quai (Angelica sinensis) helps promote the body's use of, and response to, available estrogen. Dong Quai is available as a tincture that can be added to a little warm or cold water. Most of us need about 30 drops of tincture three times a day. Dong Quai is also available as thin slices of cured root. One/16th of a slice of root once a day is about right for most women. The root can be chewed or brewed into tea. (Dong Quai is also available in powder form. The quality and potency of the powder varies greatly, and may not be adequate.)

• Gotu Kola (Centella) helps the body utilize circulating thyroid hormones. Thyroid is important to ovulation. Gotu Kola is particularly helpful in women with long cycles because they may be having trouble maturing an egg. Thyroid levels increase at night, so Gotu Kola will be most effective if taken midday, at dinner, and right before bed in Phase One.

• Herbs for Phase Two

  In Phase Two (from ovulation to menses) progesterone is the dominant hormone. Progesterone is secreted by corpus luteum that is formed when the egg matures. This hormone organizes the tissue in our breasts and uterus for pregnancy. As we approach menopause, many of our eggs fail to secrete enough progesterone. We always have some estrogen circulating in the background. When progesterone dies back, estrogen takes over. Estrogen dominance in Phase Two will make the lining of the uterus thicker and our breast tissue "disorganized." This causes water retention, breast tenderness, and longer menses. Herbs that help maintain our progesterone phase are most helpful when taken from ovulation to menses.

• Chasteberry (Vitex agnus) probably stimulates the hypothalamus to increase Luteinizing Hormone which matures the egg and the corpus luteum. Chasteberry is a basic herb for women with longer menstrual cycles.

• Yellow Pond Lily (Nufar ) can help restore balance to the overly short menstrual cycle. It is a tonic sedative to "heat" in the ovaries.

• Herbal Teas that provide minerals in dissolved form can be a tremendous aid in Phase Two. During this phase, tissue is manufactured and broken down at a rapid pace. These activities generate a lot of waste that the liver must process. Providing an abundance of bioavailable minerals will help your body handle the increased waste load without stress. Mineral rich herbal teas also provide a good source of calcium which becomes increasingly important as you approach menopause. Good mineral rich tea can be brewed from any combination of: Lemon Balm, Raspberry, Green Oat Straw, Nettles, Dandelion, and Mormon Tea. A strong cup of tea once a day in Phase Two will minimize bloating, breast tenderness, and headaches.

• Garlic as food, in capsule or in tincture can be very helpful in the PMS period -- especially if the blood pressure rises premenstrually -- which happens frequently to women in their 30s and 40s. This blood pressure rise is often accompanied by an increase in blood fats. Fat filled blood does not move well through our capillaries and often causes premenstrual headaches, acne, and hemorrhoid flare-ups. Garlic "thins" the blood by increasing its electrical charge, allowing it to flow better.

• HERBS FOR MENOPAUSE

  As we move into menopause, our cycles will become increasingly unpredictable. Cyclical heral elixirs do not fit any longer because the phases blur together. Eventually, our menstrual cycles stop. As our estrogen levels drop, our hypothalamus will begin secreting large amounts of Follicular Stimulating Hormone (FSH) in a vain attempt to make our ovaries secrete estrogen. High levels of FSH often change the levels of thyroid in our bodies. These hormonal changes account for many of the metabolic shifts we experience in menopause: Hot flashes, night sweats, headaches, bloating, mood changes, etc. Herbs can be wonderful allies in this change.

• Dong Quai (Angelica sinensis) can be taken on a daily basis in menopause. It increases the effectiveness of the estrogen that now is eleased primarily from our fat tissue (rather than from our ovaries). Dong Quai can substantially soothe menopausal discomfort.

• Black Cohosh (Cimecifuga) or *Baneberry (Actea) are often helpful in menopause. (These two herbs work identically, so either one can be used. I prefer Baneberry because it is usually harvested more environmentally.) These herbs quiet the hypothalamic screams for estrogen. The hypothalamus perceives them as estrogen breakdown products. Estrogen breakdown products signal the hypothalamus that there is enough estrogen in the system, and less FSH is manufactured. Five to ten drops of either herb, taken as needed, can quiet a hot flash or ease other menopausal discomfort as the body adapts to menopause. More is not better though. Taking more than 15 drops at one time can increase the discomfort.

• Chasteberry (Vitex agnus) can also be taken on a daily basis in menopause, and it works wonderfully for many women, again by soothing the hypothalamus. Chasteberry is more individual though, and can cause discomfort in some women.

  As our estrogen levels decline, other hormones that were always in the background (like small amounts of testosterone) play a greater role in our metabolism. This can make our kidneys retain more sodium and water which raises our blood and cerebrospinal fluid pressure. We may experience bad headaches when the pressure rises.

• Pulsatilla (Anemone) can be wonderful here. Five drops of Pulsatilla when we feel a tightness over the eyes can turn an impending migraine around. It is also good for emotional surges that are hard to deal with. Pulsatilla is a "low dose" herb, however. Do not take more than 10 drops at a time.

  There are many other herbs that will help us through the emotional changes that often come with menopause. *Blue Vervain (Verbena) can be used as a tonic in a menopausal woman who experiences sudden angry outbursts. It relaxes the arteries, and creates a sense of relief and well being. Oat tincture (Avena) can help cycle up endorphins and help us relax at night (which can decrease those night sweats). It is a great soother when life gets a little exhausting. Kava Kava (Piper methysticum) can prevent headaches caused by tight muscles in the neck and shoulders, and can keep the mind feeling light.

  Finally, as our estrogen levels decrease, we have to pay greater attention to our calcium metabolism if we are going to keep our bones strong. A daily cup of calcium rich herbal tea becomes important. The calcium in herbal tea is absorbed directly into our blood from the stomach. It is more bioavailable than other sources of calcium that are absorbed through our intestine. A cup of Oat Straw, Nettle, Dandelion Leaf, and Mormon Tea with Raspberry Leaf and Peppermint for flavor will boost our calcium levels. Dandelion Root vinegar is easy to make, and a tablespoon of that vinegar in a salad dressing will provide a significant amount of easily absorbed calcium.

  CONCLUSION

  Ultimately, herbs do not work the way prescription drugs do. Usually herbs do not suppress symptoms. Instead, selected for a particular individual, herbs will change blood and hormone flow so that the body achieves a balance. A good balance cures the symptoms. A woman experiencing an unpleasant transition to menopause can benefit greatly from an individual herbal consultation. (Herbal consultations are available by mail as well as by personal visit.) The herbalist can select a combination of herbs that will support the liver, the kidneys, and the entire body as the woman goes through the metabolic change of menopause. The herbalist will also know of herbs that can ease other problems like flooding, fibroids, and vaginal dryness. A good herbalist will also recommend appropriate dietary and life style changes that will support a healthful balance in the individual woman. Exploring herbal alternatives before starting on hormone replacement therapy will also ensure that the woman knows that she has considered all of the choices and has chosen a path through menopause that really is best for her and her body.

  Kathy Shull Abascal, C.H., J.D., P.D.T.
  Power Surge Herbal Consultant
  Write to Kathy With Your Herbal Questions
  

MORRIS PLAINS, N.J., Dec. 5, 1996 -- FemPatch(TM), an innovative, low-dose transdermal estrogen replacement system for the treatment of menopausal symptoms, was cleared for marketing by the U.S. Food and Drug Administration, Warner-Lambert Company (NYSE: WLA) announced today. FemPatch was co-developed by Parke-Davis, a division of Warner-Lambert, and Cygnus, Inc., who will manufacture the product.

Using a low, 0.025 mg dose of 17 beta-estradiol (a natural form of estrogen) in a thin, flexible once-weekly patch, FemPatch provides highly effective relief of vasomotor symptoms such as hot flashes and night sweats. In clinical trials, the vasomotor symptom relief of FemPatch was comparable to that achieved with a 0.05 mg transdermal dose of 17 beta-estradiol.

FemPatch treats moderate to severe vasomotor menopausal symptoms using a patented matrix system that delivers estradiol through the skin in a consistent, low dose, reaching maximum blood levels within 24 hours and then maintaining constant blood levels for seven days. Clinical studies with FemPatch showed a low incidence of discontinuation due to skin effects (3%) or adhesion failure (less than 2%). Overall, discontinuation due to adverse events for FemPatch (2.8%) was comparable to placebo (2.8%).

Transdermal estrogen replacement systems currently on the market all contain the active ingredient 17 beta-estradiol in doses ranging from 0.0375 mg to 0.1 mg.

"FemPatch delivers a 0.025 mg daily dose of estradiol, giving women and their health care providers a new low-dose option for the treatment of moderate to severe vasomotor menopausal symptoms," said Jean Rowan, M.B. Ch.B., senior director, Clinical Research Department, Parke-Davis Pharmaceutical Research Division. "Physicians who have menopausal patients requiring low-dose estrogen will find FemPatch to be a desirable choice." There are approximately 15 million women in the U.S. between the ages of 45 and 55; the typical age range for menopause. Menopause, characterized by the cessation of menstruation, can result in vasomotor symptoms ranging from multiple hot flashes during the day to numerous nighttime flashes, or "night sweats." In clinical trials, FemPatch was shown to effectively reduce vasomotor symptoms by consistently delivering a nominal 0.025 mg dose of estradiol. Two independent, 12-week, double-blind, placebo-controlled studies conducted with 324 surgically or naturally menopausal women, with moderate to severe vasomotor symptoms (a mean of 80 hot flashes per week and a range of 56-140 hot flashes per week), showed that FemPatch significantly reduced the number of hot flashes. By week 12, hot flash frequency decreased from 80 hot flashes to 13 per week -- a reduction of 84%. Reduction of hot flashes was significant as early as week two in some treatment groups, and by week three in all treatment groups.

FemPatch is a translucent, skin-like, rectangular-shaped laminated matrix system composed of three distinct layers. The recommended starting dose of FemPatch, when initiating estrogen replacement therapy in the management of vasomotor symptoms of menopause, is one patch every seven days. The buttocks is the preferred site of FemPatch application.

As with other estrogen replacement therapies, FemPatch may not be suitable for all patients and should not be used by women with any known or suspected pregnancy, breast cancer or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active thrombophlebitis; or thromboembolic disorders.

Side effects with FemPatch are similar to those seen with other estrogen replacement therapies. As with all estrogen products, there are possible common side effects such as: headache, nausea, abdominal cramps, fluid retention, irregular bleeding, breast tenderness or increase or decrease in weight. Estrogens also have been reported to increase the risk of endometrial carcinoma in postmenopausal women.

Parke-Davis, a division of Warner-Lambert Company, is devoted to discovering, developing, manufacturing and marketing quality pharmaceutical products. Its central research focus is on heart disease, diabetes, stroke, anti-infectives, central nervous system, cancer and women's healthcare. Warner-Lambert is a worldwide company employing approximately 37,000 people, and along with Parke-Davis is headquartered in Morris Plains, N.J.