If you're a woman navigating the transition through menopause, it may seem as though these are the best of times and the worst of times. On the bright side, solid research is finally providing long-awaited answers to crucial women's health questions that researchers and women have been asking for years. Some of that research has led to a broader range of treatment options for the management of menopausal symptoms and some of the long-term health risks associated with menopause, such as osteoporosis.

On the down side, sometimes the long-awaited answers aren't what anyone expected, as was the case with the Women's Health Initiative (WHI), which made headlines in 2002 and again in 2004 when two arms of the federally funded study were halted prematurely after finding that hormone therapy (estrogen and progestin, or HT) and estrogen alone (ET) did not protect against heart disease, as was once believed.

Even before the WHI study results were announced, The American College of Obstetricians and Gynecologists (ACOG) in early 2002 had created a task force of 21 national experts to look at questions surrounding the use of HT and ET. The Task Force met over the next two years to evaluate all of the studies to date, including new research published since the WHI results were released, and to develop guidelines for the appropriate use of hormone therapies based on the most current research.

One of the most significant achievements of the Task Force was to put into perspective - for both doctors and patients - the results of the WHI and their relevance to the way hormones are prescribed in the management of menopause. Indeed, as important as the WHI was in advancing our knowledge about the use of hormones for the prevention of chronic illness and in clarifying some of the risks of hormones, it's important to keep in mind that the WHI was designed to investigate whether or not HT or ET could prevent disease - not whether they relieve menopausal symptoms. In fact, most of the women in the WHI were 10 years older than women who use hormones to relieve menopausal symptoms, and most of the WHI study participants had no menopausal symptoms while they were enrolled in the study. So although the WHI clearly showed that hormones should not be used for disease prevention, they are still appropriate as a treatment for the relief of menopausal symptoms. As with all medications, the decision to use HT or ET is a personal one based on a review of the individual woman's health needs.

What does this mean for you? Essentially, HT and ET can still play a role in the treatment of menopause, provided you use the medications for appropriate reasons and after weighing the benefits and risks.

To help you evaluate the benefits and risks, here are answers to some of the most frequently asked questions about HT and ET, based on ACOG's new Hormone Therapy report.

Background: Hormone Therapy Then and Now

If you're not already familiar with ET, it is a form of drug therapy in which you're given estrogen to supplement the estrogen your body makes much less of after menopause. If you haven't had a hysterectomy and therefore still have your uterus, you should also be given a progesterone-like agent (synthetic forms are called progestins) to help reduce the risk of uterine cancer, which is referred to as hormone therapy, or HT. Sometimes, androgens (male reproductive hormones) may be prescribed, either alone or in combination with estrogen (and progestin, if needed) for certain women who are having problems with sexual desire -- although studies are still ongoing as to whether androgens are effective for treating women's sexual libido.

Estrogen comes in the form of pills, patches, gels, and emulsions, and, for women who have vaginal dryness, vaginal creams, tablets, and a flexible vaginal ring. For women with a uterus who also need progestin, there are progestin-only and combination (estrogen-progestin) pills and patches, as well as a vaginal progesterone gel. Most formulations of estrogen also come in varying strengths, or dosages.

For more than 60 years, hormone therapy (HT) has been a mainstay in the treatment of menopausal symptoms, such as hot flashes and vaginal dryness. When, in the mid-1980s, estrogen was found to retard (or slow) bone loss in postmenopausal women, the FDA approved it for the treatment of osteoporosis.

At the same time, other observational studies suggested that HT might prevent heart disease - the groups of women in these studies who used estrogen had about half the number of heart attacks as those who didn't use estrogen. This research was buoyed by evidence that estrogen lowered levels of the 'bad' LDL cholesterol and raised levels of the 'good' HDL cholesterol in postmenopausal women. Lower cholesterol levels are associated with a reduced risk of heart disease. Other research had suggested that HT might help prevent the onset of Alzheimer's disease.

Even so, questions remained about HT, in spite of the fact that it is one of the most thoroughly studied drugs on the market today. Was the heart protection found among estrogen users due to the estrogen, or did those women simply take better care of their health than other women enrolled in those studies? Would adding progestin to estrogen, necessary for reducing the known risk of uterine cancer, cancel out estrogen's heart protection? What about an increased risk of breast cancer?

Because so many questions about HT and ET remained unanswered, in 1993 the National Institutes of Health decided to look for definitive answers. The result was a randomized controlled study involving a total of 161,809 women nationwide known as the Women's Health Initiative. The main thrust of the WHI was to determine the exact degree to which hormone therapies presumably protected the heart, and to investigate the degree to which some of the known and potential risks of hormone therapies, such as breast cancer and blood clots, cancelled out any benefits. The WHI also explored whether hormone therapies prevented fractures, colon cancer and dementia, including Alzheimer's disease. Still other parts of the study looked at the effects of HT and ET on quality of life and cognitive function, energy levels, sleep and sex.

The main reason the study results carried so much weight had to do with the way the study was designed and carried out. First, the sheer number of study participants was huge. Many of the earlier studies on HT and ET involved small groups of women. Having large numbers of women participating in the study increases the accuracy of the statistics on which the researchers base their conclusions.

Second, the study was designed to take place over a number of years. Many of the questions researchers had about HT and ET - particularly their role in the prevention of heart disease and osteoporosis - involved the use of hormones over many years' time.

Finally, the study was designed to compare women using HT with those taking a placebo, or inactive tablet. Neither the researchers nor the study participants knew for sure until after the study was over which women were taking HT and which were taking a placebo. This type of study design gives the most definitive and objective results - in essence, by comparing apples to apples. In effect, one of the things the WHI did best was to clarify some of the risks involved with the use of hormone therapy.

What the WHI Found

One part of the WHI, an 8-year trial involving some 16,608 healthy women with a uterus, was designed to explore whether hormone therapy (estrogen and progestin) protected against heart disease and osteoporosis. But when researchers analyzed the data they had collected after only 5.2 years, they concluded that the risks for the study group on combined HT outweighed the benefits. Moreover, the risks, although small, were outside of the safety standards set for the study, which led to early termination of the study. Risks included a small but significant increased risk of breast cancer (38 women out of 10,000 women per year compared to 30 women taking placebo), heart attacks (37 women out of 10,000 women per year compared to 30 women taking placebo), strokes (29 women out of 10,000 women per year compared to 21 women taking placebo) and blood clots (34 women out of 10,000 women per year compared to 16 women taking placebo) for the group of women on HT.

To be sure, HT offered health benefits as well. HT users had a lower risk of spine and hip fractures. In the HT group, there was a 24 percent reduction in total fractures, and a 34 percent reduction in hip fractures. On average, per year, there were 10 cases of hip fracture per 10,000 women on HT compared to 15 per 10,000 women on placebo.

The WHI also reported a reduced risk of colon cancer among HT users, which was down by 37 percent (or 10 cases of colorectal cancer per 10,000 women per year on HT compared to 16 cases per 10,000 women per year on placebo). But given the risks for breast cancer and cardiovascular problems shown in the study, the risks of using HT for prevention of heart disease outweighed these benefits for most women.

Another part of the WHI, involving 11,000 healthy postmenopausal women who were using estrogen alone, continued for two more years after the estrogen-progestin part of the study was halted. But early in 2004, that arm of the study was halted as well. Researchers discovered that ET did not prevent cardiovascular disease and appeared to increase the risk of stroke at about the same rate as HT did. That is, women using ET had about 12 more strokes per year for every 10,000 women than did those who took a placebo (44 on ET vs. 32 on placebo). ET also increased the risk of blood clots (21 on ET vs. 15 on placebo).

The good news: ET did not appear to increase or decrease a woman's risk of breast cancer during the seven years the women took it. And the women on ET had a lower risk of hip fractures.

Although ET appears to pose fewer risks to women than HT, the researchers decided to halt the study a year early because after seven years of follow up, the results were unlikely to change in the one year remaining in the ET study to answer the primary question: is ET effective in reducing heart disease in women? There was also concern that the increased risk of stroke was no longer acceptable in healthy women participating in a research study on a drug that's supposed to prevent disease.

YOUR QUESTIONS

I'm confused. Do the findings of the WHI mean that menopausal women should never take hormones because the drugs are too dangerous?

No. Remember: The WHI was designed to determine whether HT and ET were effective in preventing illnesses such as cardiovascular disease and osteoporosis, and not their usefulness in the treatment of menopausal symptoms. What's more, all medications have side effects, and the WHI helped to clarify and quantify what some of those side effects were for hormone therapy.

In fact, for as much good information as the WHI provided about HT and ET, many physicians and researchers believe many more questions about hormone therapy have yet to be answered. For instance, do the results of the WHI study, which involved the use of a certain formulation of estrogen and progestin taken together daily, apply to the numerous other brands of estrogen and progestin on the market? What about lower doses of estrogen and progestin? Do estrogen-containing skin patches, vaginal creams and the new vaginal ring carry the same risks? Equally important are questions about the safety and effectiveness of over-the-counter products, which are not stringently regulated by the U.S. Food and Drug Administration (FDA) and, more often than not, have not been as rigorously tested for safety and effectiveness as prescription medications.

It does mean, however, that when considering hormones for relief of menopausal symptoms, you and your physician must carefully evaluate the benefits and risks of HT or ET as they apply to you as an individual.

So how do I weigh the risks?

First, it's important to distinguish between individual risk and public health risk. In the WHI trial, the size of the health risks for each individual woman was actually quite small. For instance, a woman's risk of developing breast cancer while using combination HT was 8 per 10,000 women taking HT per year - in other words, less than one tenth of one percent a year, according to the study authors. (There's a caveat, however: Although the increase was small, it was cumulative over time. In other words, the longer a woman stayed on HT, the more her risk for breast cancer increased, at a higher rate than would normally occur with advancing age.)

The National Institutes of Health stopped the study both in fairness to the group of women on HT and because the researchers were looking at the increased risks for an entire population of women over time. While the rate of increased breast cancer risk may not sound huge - only 8 additional cases of breast cancer diagnosed per 10,000 women per year in the HT group - the numbers become unacceptably large when you factor in the millions of women who take the drug over many years' time.

You may decide that the relief you get from your symptoms with HT may be well worth the slight individual risks. The decision is yours to make, as long as you have discussed the risks and benefits with your doctor.

Do the risks apply to other forms of hormone therapy, such as the skin patch?

The women in the hormone therapy arm of the WHI study used a combination form of HT containing .625 milligrams of conjugated equine estrogens and 2.5 milligrams of medroxyprogesterone acetate (brand name Prempro®) in the form of a daily pill. For now, experts advise doctors and patients to assume that all formulations carry the same risks as those reported in the WHI. But in fact, until more research is conducted, it's impossible to say whether other formulations or types of hormones will carry the same risks.

Some of that research is already under way. In August 2003, for instance, the Million Women Study, a large observational survey investigating the link between hormone use and breast cancer, confirmed the results of the WHI but also looked at which kinds of HT are associated with the greatest risk. In that study, women taking combinations of estrogen and progestin had four times as many breast cancers as those using estrogen alone. The study found that for every 10,000 women taking estrogen for 10 years, there would be five extra breast cancers; for those using combined HT, there would be 19. The results were similar for estrogen and progestin combinations in pills and patches, when taken daily or in cycles, and at higher and lower doses. The researchers also found that the increased risk falls to that of nonusers five years after HT is stopped.

In another small study, French researchers found that women who took estrogen pills were more likely to develop blood clots in the legs than those who used an estrogen patch. One reason may be that pills are broken down in the liver, where proteins involved in the formation of blood clots are activated. The estrogen in skin patches is released directly into the bloodstream, bypassing the liver completely.

Your best bet, regardless of the type or dosage of HT you use, is simply to be aware of the increased risks found in the WHI trial and, until we know more about your particular regimen, to factor those risks into your decision.

Is it safe to take hormones for the treatment of hot flashes and night sweats?

If you have hot flashes, night sweats, sleep disruptions or other symptoms, the Task Force found that HT and ET still are the most effective therapies, reducing hot flashes by up to 90 percent. In fact, for severe hot flashes, nothing works better. Numerous studies have shown that, in addition to oral estrogens, transdermal estrogen patches effectively alleviate hot flashes.

For the majority of women, hot flashes dissipate on their own within an average of four years. If you have mild to moderate hot flashes, a number of lifestyle changes can help you cope, such as wearing layers of light clothing, setting the thermostat to a lower temperature and avoiding spicy foods and caffeinated beverages and alcohol, which may help reduce the severity of hot flashes. Relaxation exercises or biofeedback may also help control temperature fluctuations.

If those or other measures don't work or if symptoms are severe and you have no family or personal history of blood clots, premature cardiovascular disease, or breast cancer, talk to your doctor about using hormones. If you do use estrogen alone or with progestin for relief of hot flashes, the Task Force recommends that you use the lowest effective dose for the shortest possible time. Be sure to reassess your need for hormones with your doctor at least on an annual basis.

Can hormone therapy improve my sex life?

It depends. If the chief complaint is painful intercourse as a result of vaginal dryness, then the answer may be yes. When estrogen levels fall after menopause, vaginal lubrication is diminished and vaginal tissues may become dry and irritated, especially during and right after intercourse. Vaginal estrogen creams, the vaginal estrogen ring, and even low doses of estrogen in the form of pills or patches can help relieve vaginal dryness and improve lubrication. It doesn't take much estrogen to do this, either, so the risks associated with the use of hormone therapy can be minimized. Still, many women find that over-the-counter vaginal lubricants and moisturizers work just as well.

Although vaginal dryness is one of the most common contributors to a decline in sexual activity after menopause, it is by no means the only one. In fact, sexual problems are complex issues that may stem from any number of physical, emotional and social factors. In a woman, physical changes, including a decline in estrogen and testosterone (yes, even women produce small amounts of this 'male' hormone) can contribute to the problem, as can emotional conflict, certain drugs, and depression.

Sometimes, the discomforts of menopause, such as hot flashes, night sweats, sleep problems, and irritability, can contribute to sexual problems. But so far, there's little evidence to support the use of systemic hormone therapy (pills, patches) to improve sexual libido.

Some research has suggested that women who have had their ovaries surgically removed may benefit from high dose transdermal androgen in addition to estrogen. But androgen can raise harmful blood lipids, which may increase a woman's risk of heart disease.

The Task Force concluded that, at this time, there are too few studies in the scientific literature to say that the use of estrogen or androgen improves sex drive in postmenopausal women.

What about urinary incontinence?

There's no evidence to support treating urinary incontinence with estrogen. In fact, some studies suggest that hormone therapy may actually contribute to a worsening of symptoms in some women.

Can hormone therapy lift depression?

The majority of women do not develop depression during menopause, although some studies do suggest that perimenopausal women may be somewhat more susceptible to depressive symptoms during this biologically tumultuous time.

Before beginning any medication for depression, you should undergo a thorough physical evaluation, including a check for thyroid problems, which can often mimic depressive symptoms. Although a couple of small studies have found estrogen to have antidepressive effects in perimenopausal women, the Task Force recommends trying antidepressant medications first. Selective serotonin re-uptake inhibitors (SSRIs), such as Prozac®, Paxil® and Effexor®, have the added benefit of helping to relieve hot flashes. If you don't want to or can't take antidepressants, talk with your doctor about trying estrogen for mild to moderate depression, particularly if you also suffer from hot flashes or other symptoms of menopause. Short-term use of HT or ET may facilitate the action of antidepressants in some women.

I'm at high risk for osteoporosis. Can I continue on HT?

If you are also taking HT for treatment of menopausal symptoms, it may be appropriate. If you are taking HT solely for the prevention of osteoporosis, consider stopping it, because there are other medications that can help prevent osteoporosis and fractures that appear to carry lower risks for conditions such as breast cancer.

Other preventive drug therapies include the family of drugs known as bisphosphonates, which can reduce the breakdown of bone. Still other options are the selective estrogen receptor modulators, or SERMs, which are a new class of synthetic estrogens that act like estrogen in certain parts of the body (such as the bone) while leaving other body tissues unaffected. Studies have shown that some SERMs may actually protect against breast cancer.

Some women with heartburn or ulcer problems may be unable to take bisphosphonates, and each of the medications discussed here has its own side effects. Although these medications appear to have a different ratio of benefits to risks compared to HT, it's not clear yet whether they're better. Studies are continuing to investigate the effects of these drugs.

To protect their bones, all peri- and postmenopausal women should be sure to consume 1,200 to 1,500 milligrams of calcium per day, a multi-vitamin containing vitamin D, and engage in regular weight-bearing exercise such as walking.

So, if I'm taking HT just to protect against heart disease, should I stop?

Yes. The WHI did not show any benefit to the heart. Lifestyle changes can help prevent heart disease - particularly regular exercise, smoking cessation and weight control. And, for certain women at high risk for heart disease, other medications have been shown to be effective. Medications such as statins can help reduce high cholesterol levels, and hypertension medications can help reduce high blood pressure. You'll want to discuss with your doctor the specific type of medication that may be right for you, along with any risks and side effects associated with those drugs.

Does hormone therapy prevent Alzheimer's disease and other types of dementia?

The ACOG Task Force on Hormone Therapy found no evidence that hormone therapy prevents cognitive decline in older women. Nor does it appear to improve cognition in women who already have Alzheimer's disease or other forms of dementia. However, more research needs to be conducted to determine whether the age at which a woman begins taking hormones has any bearing on the issue.

Is it true that women who take hormones gain weight?

No. The Task Force found no evidence that using hormones leads to weight gain. The cause is more likely to be associated with your diet and activity level than with hormone therapy.

The weight gain that occurs during this time in a woman's life appears to be related to aging, not menopause or HT. In one three-year study involving 485 women ranging in age from 42 to 50, researchers found the women gained an average of about 5 pounds. This weight gain occurred even among women who did not experience menopause during the study period.

As you grow older, your body's metabolism (the rate at which you burn calories) declines. When combined with a lower activity level, the result is added pounds. What's more, when you gain weight in the middle and later years, it's more likely to accumulate around your abdomen, rather than the hips and thighs. Abdominal weight is associated with a greater risk of heart disease, high blood pressure and diabetes.

The good news is that you can help stave off so-called middle-aged spread with a sensible low-fat diet and plenty of physical activity (a minimum of 30 minutes of activity, such as brisk walking, on most days of the week).

I have Type 2 diabetes. Will hormone therapy interfere with my ability to control my blood sugar?

No. According to the Task Force, long-term control of blood sugar in women with Type 2 diabetes doesn't appear to be adversely affected by hormone therapy. In fact, women who use HT have been found to have a lower risk of Type 2 diabetes than women who don't take hormones.

If you have diabetes and choose to use hormone therapy to relieve hot flashes and other symptoms, you need to be aware of the slightly increased risk of heart disease and stroke associated with its use, since you already face an elevated risk of cardiovascular disease by virtue of having diabetes.

Does hormone therapy increase the risk of developing ovarian cancer?

The Task Force concluded that hormone therapy doesn't appear to increase the risk of developing ovarian cancer. Although a few observational studies suggest the risk may be increased after 10 years of use, other studies found no such association.

Since the WHI found that hormone therapy reduces the risk of colon cancer, should I take hormones to prevent colon cancer?

No. Although a number of studies have associated hormone therapy use with a decreased risk of colon cancer, the Task Force does not recommend its use to prevent colon cancer.

How does my family health history factor into my decision?

Since many chronic conditions, such as heart disease and certain cancers, appear to have hereditary links, it's crucial that you and your doctor factor any potential hereditary health problems into your decision to use hormones. If you have a family or personal history of heart disease, stroke, blood clots, or breast cancer, you'll need to carefully consider those risk factors when making a decision to use HT. If, on the other hand, you have a family history of osteoporosis or colon cancer along with severe menopausal symptoms, HT or ET may provide added protection while you use it for short-term relief of your symptoms. But hormones should not be taken just for these benefits.

Is a woman ever too young or too old to use hormones?

Unfortunately, there are no good studies to answer this question definitively. If you're perimenopausal (you're still menstruating) and are experiencing mood swings, insomnia, and even hot flashes, you may find temporary relief with low-dose oral contraceptives or a low-dose estrogen patch, as long as you don't smoke. Risks appear to be relatively low, possibly because your body is still producing its own estrogen and progestin. (Cigarette smoking greatly increases the cardiovascular risks among cigarette smokers who are over 35 and who use birth control pills or hormone therapy.)

After menopause (when you haven't had a period for at least 12 months), ET or HT can help extinguish hot flashes and relieve vaginal dryness. In fact, estrogen is the single most effective treatment for hot flashes. It's not understood why some women have mild menopausal symptoms for only a short time, while others have severe symptoms for years at a time. If you're in the latter group, just remember that your natural risks for conditions such as breast cancer and heart disease rise as you age. You'll want to keep that in mind as you assess the benefits and risks of HT for an older woman.

If you're past menopause and are no longer having hot flashes or other symptoms of menopause, the WHI clearly shows that there really aren't many good reasons to continue taking hormones. But there appear to be several convincing reasons (slightly increased risks of heart disease, stroke, blood clots and breast cancer) to stop.

If ET is safer than HT, why can't all women just use estrogen alone?

If you have a uterus, the added progestin protects against an increased risk of endometrial cancer that occurs when taking estrogen alone.

It's also not clear that progestin is the sole factor that affected breast cancer risk among the women in the WHI who took HT instead of ET. Women who used estrogen alone had had a hysterectomy. They also were more likely to have high blood pressure and be overweight than the women who took HT. Any one of those differences might also have affected the study outcome.

What other risks and side effects are associated with hormone therapy?

About 10 percent of all women who take HT experience breast tenderness, fluid retention and pelvic cramping. Those who take progestin along with estrogen occasionally may have periodic bleeding similar to menstruation.

Some women who are prone to migraine headaches find they develop more headaches when using hormones, but others have fewer headaches when taking hormones.

Another long-term complication is a slightly increased risk of gallbladder problems. If you experience any problems, talk to your ob/gyn. Often, the form of HT or the dosage of your medication can be changed to alleviate any side effects.

What else is available for relief from hot flashes if I can't or don't want to take hormones?

Other medications that have been found to help relieve hot flashes are a class of antidepressant medications known as selective-serotonin re-uptake inhibitors, or SSRIs (Prozacâ, Paxilâ, Effexorâ).

What about alternative therapies, such as black cohosh or phytoestrogens?

The Task Force found that few nutritional supplements have been rigorously studied and tested for safety and effectiveness. Ongoing research should help shed some light on the subject, but the results from these studies are still a number of years away. Here's a roundup of some of the more common over-the-counter remedies that are frequently recommended for the treatment of menopause, and what researchers now know about them.

Soy Foods, Beverages and Supplements. Soybeans are made up of two primary components, soy protein and isoflavones, plant chemicals that have estrogen-like properties. The isoflavones genistein and diadzein in soy are thought to be responsible for relieving menopause symptoms, such as hot flashes. But the effectiveness of soy foods and supplements on hot flashes and other menopause symptoms isn't clear. In one or two studies, soy protein supplements were found to reduce the incidence of hot flashes by up to 45 percent. Other reports, however, have found that soy was no more effective than a placebo.

Soy protein in foods does lower blood cholesterol levels and, theoretically, may reduce the risk of heart disease. However, some research suggests that when isoflavones are removed from soy protein and ingested alone, as they are in soy supplements, they may not be effective for reducing cholesterol. Ongoing research should help shed some light on the subject.

Soy's effect on bone loss is unclear, too. Women who take soy protein supplements while they are experiencing menopause and still having menstrual periods on their own appear to lose bone mass while taking soy supplements. But there may be a role for soy products in preventing further bone loss after menopause. Current studies are not entirely consistent. For this reason, soy is not recommended to help prevent bone loss.

As for safety, more research is needed before scientists know for sure whether the plant estrogens in soy are safer than prescription estrogens. But one recent study suggested that the use of soy supplements for up to five years may possibly increase a woman's risk of endometrial cancer, just as estrogen does in women with a uterus who don't also take progestin. In a 2004 randomized, placebo-controlled study involving 376 postmenopausal women, those who took soy phytoestrogen for up to five years had an increased rate of endometrial hyperplasia - an overgrowth of cells in the uterine lining.

Black Cohosh. This plant, also known as snakeroot, "squaw" root and bugbane, has been used for centuries in the treatment of women's reproductive disorders, although no one knows exactly how - or even if - it works. For the past 40 years, black cohosh has been prescribed in Germany where it is regulated and used by women for hot flashes, depression, and sleep disturbances common during perimenopause.

Because no large, controlled studies of black cohosh have yet been conducted, no recommended doses have been established, nor have specific claims been allowed regarding the herb's effectiveness. Black cohosh does not appear to have any effect on bone density or cardiovascular health. Some researchers recommend that you limit its use to six months.

Topical Progesterone, Testosterone and other 'Natural' Hormones. These topical creams are sold in health food stores and via the Internet as an alternative to synthetic forms of progesterone (progestins) and testosterone (also known as androgen), amid claims that these products can build bone, increase sexual desire, prevent endometrial and breast cancer, and substitute for hormone therapy.

At this point, no formal studies have been conducted to determine the safety and/or effectiveness of these products. Many so-called 'natural' progesterone creams do not contain substances that the human body can use as progesterone. These products are often derived from wild yam extracts and contain a substance, diosgenin, that only plants can metabolize into active progesterone. Other such products contain these plant extracts plus chemically synthesized progesterone, which is added to the plant extract in the cream. It is not always possible for a woman to tell exactly how much progesterone is available to her body by using these creams. And there's no evidence to date that progesterone creams can prevent the over-stimulation of the uterine lining by estrogen or reduce the risk of endometrial cancer. There's even less information about the safety and effectiveness of testosterone creams, which have been studied only in men.

The bottom line: The Task Force's review of studies to date has found no evidence that treatment with alternative therapies, such as wild yam extract, black cohosh, or dietary phytoestrogen supplements derived from red clover extracts has any significant effect on hot flashes.

If you decide to use alternative therapies, be sure to tell your physician. Some treatments have the potential to cause drug interactions with other medications you are using. Your doctor may recommend that you be monitored more closely for safety's sake while using alternative or complementary therapies. Remember, too, that dietary supplements, including herbal products, are not as strictly regulated by the federal government as are prescription and over-the-counter drugs. As a result, potency may vary from product to product, or even from batch to batch of the same product. Bear in mind that just because alternative therapies are referred to as 'natural' remedies doesn't mean they're without risks or side effects. For this reason, you should take the same care when using alternative supplements or products as you would when using any over-the-counter or prescription medication. Be sure to inform your physician that you are using these therapies, as well as any prescription medications, during medical visits.

I've been taking hormones to treat hot flashes for the past two years. How long is "too long?"

Again, there are no good studies to tell us precisely what constitutes safe short-term use. In the past, hormone therapy of five years or less was believed to be associated with little or no risk. However, the WHI study found an increase in the incidence of blood clots and stroke during the first year of use, and a rise in the diagnosis of breast cancer after 4 years, suggesting that even the first four years of use may not be risk-free. The estrogen-only arm did not show an increased risk for breast cancer after nearly seven years, but did find similar small increases in blood clots and stroke after just one or two years' use.

Keep in mind that the risks are low. If you don't already have a hereditary risk of blood clots, strokes, heart disease or breast cancer, you and your doctor may decide that the slightly elevated risks associated with the use of hormone therapy are perfectly acceptable to you when you factor in the relief you get from hot flashes. Again, you'll also want to reassess on an annual basis whether you still need relief for hot flashes.

What do I do when I'm ready to stop taking hormones?

So far, there aren't many good studies to guide you. You and your physician will have to discuss whether it's better for you to go "cold turkey" and simply stop taking hormones one day, or whether you might benefit from a more gradual approach.

Not all women can comfortably quit using hormone therapy. Some women experience heavy vaginal bleeding for several days after they stop taking hormones. Hot flashes and other menopausal symptoms may return, too, especially if you stop abruptly. A recent survey of patients from the Northern California Kaiser Permanente group suggests that one in four women who stopped using hormone therapy following the publication of the WHI results have re-initiated therapy because of persistent bothersome symptoms.

If you experience any of these problems, talk with your doctor about how you might taper off the dosage over time.

If I stop taking hormone therapy, will the elevated risks associated with its use go down?

There's no evidence to suggest that the slightly increased risks associated with using hormones - blood clots, strokes, heart attacks and breast cancer - remain elevated after you stop taking hormones. In fact, observational studies suggest that these risks do decline after you stop taking hormones. WHI researchers are monitoring their study participants to answer this question definitively.

Making a Decision

Only you, working together with your physician, can decide whether the benefits of using HT for relief of menopause symptoms are worth the small risks that have been identified. Start with a thorough medical evaluation to assess your current health status. You'll also want to learn as much as you can about the options available to you. This way, the choices you make will be informed ones, tailored to your individual needs.

If you do choose HT, the Task Force recommends that you use the smallest effective dose for the shortest time you can, and that you see your doctor at least once a year to discuss whether you are ready to stop, and what new information may be available that might influence your decision to stop or continue using hormones. Of course, you'll want to continue to get regular breast cancer screenings, including annual physician breast exams and periodic mammograms (which ACOG recommends every one to two years during your forties, and annually thereafter).

As with most issues concerning your health, the decision to use hormones is a very personal one that rests with you. Just make sure it's a well-informed one with which you feel comfortable.

An Important Note: Research Continues, Recommendations May Change

ACOG's statements here are for general information purposes and should not be construed as medical advice. Before making a decision about HT, consult with your physician for individualized advice that takes into account your personal needs and your medical and family history.

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Washington, DC -- The American College of Obstetricians and Gynecologists (ACOG) today announced the most comprehensive, evidence-based clinical recommendations to date on hormone therapy (HT). ACOG's Hormone Therapy report, written by a task force of 21 national experts, "is an exhaustive, one-stop guide for doctors and their menopausal patients reviewing the risks, benefits, and continuing questions about hormone therapy," says ACOG President Vivian M. Dickerson, MD.

In addition to reaffirming most of the recommendations it issued after the landmark 2002 Women's Health Initiative study -- e.g., that combined HT (estrogen plus progestin) is effective treatment for menopausal symptoms but should not be taken to prevent certain diseases -- ACOG tempers some of its earlier advice regarding the length of time and reasons women might take hormone therapy. ACOG's encyclopedic report also "catalogues what medical science knows so far about the effect of reproductive hormones on everything from sex life to mental health, cancer to weight gain," adds Isaac Schiff, MD, chair of the ACOG Task Force on Hormone Therapy.

Among the findings released today in a special supplement to the October issue of ACOG's Obstetrics & Gynecology journal:

• Jury Still Out on Sex Drive - There have been too few studies to prove that taking estrogen or the male hormone testosterone -- either orally or topically -- can improve a woman's sexual libido (sex drive). However, there is ample evidence that estrogen given topically or orally can improve the quality of a woman's sex life, by relieving vaginal dryness and related symptoms that make sexual intercourse uncomfortable for many menopausal women.
• SSRIs Relieve Hot Flashes; Herbal Remedies Do Not - The category of anti-depressants known as selective serotonin reuptake inhibitors (SSRIs) can be effective alternatives to HT for the relief of menopausal vasomotor symptoms like hot flashes. As for herbal remedies, the Task Force concludes: "Treatment with wild yam extract, black cohosh, or dietary phytoestrogen supplements derived from the isoflavone red clover has no significant effects on vasomotor symptoms."
• Estrogen May have Anti-Depressive Effects - Estrogen appears to have mood- elevating effects in some perimenopausal women, who may be more vulnerable to depression than pre- or post-menopausal women. Due to its risks, estrogen should not be a first-choice treatment for depression, but it may be appropriate therapy under certain circumstances.

Beyond the WHI

ACOG experts say the report puts the 2002 Women's Health Initiative (WHI) study in the context of the wide range of research studies that came before and after it. "The WHI was a huge milestone in our understanding of the risks and benefits of hormone therapy," says Dr. Dickerson. "Though significant, it's only an early step in the continuing quest to understand how women's hormones affect their health."

Over two years ago, WHI study authors announced not only that the risks of combined HT outweighed its benefits when used to prevent certain diseases, but that it could actually increase the risk of certain conditions it was previously believed to prevent, such as a heart attack. Dr. Schiff believes that ACOG's Task Force, which was created prior to the 2002 WHI announcement by past ACOG president Charles B. Hammond, MD, has had the benefit of reviewing multiple studies over several years and can now look at the big picture.

"When the WHI came out, the pendulum of popular opinion on hormones swung wildly, from a mistaken belief that estrogen was the panacea for a variety of ills, to the frightened belief that it was now anathema even for conditions like hot flashes," says Dr. Schiff.

"Approximately 65% of women on HT stopped therapy after the WHI," notes Dr. Schiff. "Two years later, reports suggest that about 1 in 4 women who stopped HT went back on it because it still offers the best relief for menopausal symptoms. So we're moving back to an appropriate balance -- accepting that HT has risks, but recognizing that it can be appropriate for conditions like hot flashes so long as women are informed about the risks and weigh their decision with their doctor."

Adds Deborah M. Smith, MD, an advisor to ACOG's Managing Menopause consumer magazine, "From the WHI we also learned more about what we don't know. For example, the average age of women in the WHI study was 63. ACOG would like to see more research that answers key questions. Are the effects of hormones different for the more typical menopausal patient at the average age of 51, or for younger women who have undergone surgical or premature menopause? Are hormones more dangerous or beneficial at one time of life than another and, if so, why?"

ACOG's Hormone Therapy report includes 15 chapters examining available studies on hormone therapy and its relation to over 20 health conditions. These include sexual dysfunction, depression, cognition and dementia, coronary heart disease, breast and gynecologic cancers, osteoporosis, weight and insulin resistance, skin, stroke, gall bladder conditions, and genitourinary tract changes. The following are some report highlights:

Use of HT: Some Confirming, Some Loosening of Post-WHI Recommendations

In Hormone Therapy, ACOG reaffirms many of its earlier recommendations issued in the months immediately following the 2002 WHI announcement on combined HT, and the 2004 WHI announcement on estrogen-alone (ET) therapy. This includes advice that:

• Combined hormone therapy should not be used for prevention of diseases such as cardiovascular disease, due to the small but significant increased risk of conditions such as breast cancer, heart attack, stroke, and blood clots;
• Estrogen-alone therapy, used for women who have had a hysterectomy, should also not be used for prevention of diseases, due to increased risks of blood clots and stroke. Although ET carries fewer risks than combined HT, women with a uterus should not use estrogen alone due to their increased risk of uterine cancer;
• Hormone therapies are appropriate for the relief of vasomotor symptoms, so long as a woman has weighed the risks and benefits with her doctor; and
• Women on combined HT or ET should take the smallest effective dose for the shortest possible time and annually review the decision to take hormones.

The Task Force also softens some recommendations on the duration and need for hormone treatment, noting that although women should use HT for the shortest possible time, about 10% of menopausal women will continue to have vasomotor symptoms beyond the average four years it takes such symptoms to resolve. "It is inappropriate to withhold HT from persistently symptomatic women who prefer to continue HT or who do not derive relief from currently available alternatives," concludes the report.

"The report also says it is appropriate to treat women who feel better on hormone therapy or who feel it improves sexuality," says Dr. Schiff.

Although the report notes that hormone therapies should not be used solely for disease prevention, there are instances where disease prevention is appropriate as a secondary benefit for women who are already taking hormones for vasomotor symptoms. This includes its use to prevent osteoporosis, or to treat depression under certain limited circumstances for women with mild to moderate depression.

Alternatives to HT: What Does and Doesn't Work

Other Medications

The report affirms that to date estrogen is the most effective treatment for symptoms like hot flashes or night sweats, and that nasal sprays or transdermal (patch) hormone treatments provide comparable results to hormones taken orally. The report also catalogues the range and quality of research studies on alternative treatments for women who cannot or do not wish to take hormones.

"So far, research that includes randomized, double-blind studies shows that SSRI anti-depressants appear to be effective in reducing or relieving hot flashes," notes Dr. Schiff. "This is probably not surprising, given that certain types of serotonin receptors in the brain are believed to play a role in causing hot flashes."

Another agent that showed relief in a small, randomized, double-blind, placebo-controlled trial is an anticonvulsant medication known as gabapentin. "The reasons why it improves hot flashes are not yet understood," he adds.

Herbal Alternatives

"There has been a lack of published reports on most alternative medicine treatments," says Dr. Schiff. "The few studies done so far show disappointing results about the effectiveness of botanical treatments."

Studies on wild yam showed little difference in results between this method and placebo, and there was a high withdrawal rate of study participants due to unrelieved symptoms.

Soy contains isoflavones, one of the types of plant-based estrogens or phytoestrogens. The report notes, "A few very limited studies have suggested that soy helps with vasomotor symptoms in the short-term (less than 2 years), while other studies show little difference between soy beverages or extracts and placebo."

A study of two dietary phytoestrogen supplements derived from red clover showed no clinical effects on hot flashes or other symptoms.

Although black cohosh is a botanical treatment widely used in Europe for menopausal symptoms, "its benefits have been evaluated primarily in small short-term studies using since-invalidated measures," notes Dr. Schiff. The few randomized, controlled trials on black cohosh showed no significant reduction in hot flashes.

The report also cautions that since soy and dietary isoflavones appear to affect estrogen receptors, they may not be safe for women with estrogen-dependent cancers such as breast cancer.

Sexual Function: Too Few Studies on Female Sexual Libido, but Several Options for Relieving Vaginal Discomfort

"After years of publicity about Viagra and other products to improve male sexual performance, we still know pitifully little about what hormones or other products might enhance female sexual functioning," notes Dr. Dickerson.

Sexual response and function in women are complex, adds Dr. Dickerson, and include biologic, physiologic, and social factors. A National Health and Social Life Survey of 1,749 women ages 18-59 years found that 43% of respondents reported sexual dysfunction.

Sexual Libido

"Despite some claims about the benefits of certain hormone creams for sexual libido, it's still too early to know whether reproductive hormones like testosterone or estrogen, applied either topically or orally, can improve women's sex drive," says Dr. Dickerson. "There just haven't been enough studies on these or other therapies," she notes.

The report observes that the use of oral estrogen to improve sexual desire is supported by only one short-term, randomized, placebo-controlled trial. The same is true for the use of testosterone added to estrogen therapy. The most noteworthy improvements to sexual function were seen in studies involving women who have had an oophorectomy (ovary removal, or surgical menopause). These women are much more likely than women who have had a hysterectomy to report adverse changes in their libido and orgasmic response. Significant improvements in sexual desire were seen in these women when transdermal testosterone was added to ET, but only at high doses (300 micrograms).

"It's still premature to say what does or doesn't work in improving women's sexual libido, but researchers are learning more all the time," says Dr. Dickerson. Just this month, for example, the US Food and Drug Administration granted priority review to an investigational female testosterone patch for the treatment of low sexual desire in women who have undergone oophorectomy.

Relief of Vaginal Pain

"What we do know," adds Dr. Dickerson, "is that there are ample studies showing that even very low doses of estrogen can relieve vaginal dryness, which has been associated not only with painful intercourse, but with a decrease in sexual desire. The good news," she says, "is that there are several methods for relieving vaginal dryness with estrogen, including pills, vaginal creams or rings."

Heart Health and Weight: Lifestyle and Other Factors, Not Estrogen, Make the Difference

"One of the most notable results of the WHI was its confirmation that higher-evidence studies give us more reliable results," says Dr. Smith. "Nowhere was that more apparent than in our understanding of estrogen and heart disease."

The WHI was the largest randomized, double-blind, placebo-controlled study on hormone therapy to date, meaning that neither the health providers nor the patients in the study knew whether the patients were taking hormones or placebo. Prior to that study, smaller observational studies suggested that HT protected against heart disease by elevating the levels of so-called good cholesterol (HDL) and reducing so-called bad cholesterol (LDL) that can be a factor in heart disease.

"Now we know that at least two things were going on," says Dr. Smith. "First, there was probably 'user bias' in those earlier studies, meaning that the women on HT were already healthier than the women not taking hormones. Second, medical experts may have overestimated the effect of cholesterol in heart health, and been unaware of other factors in heart disease that we still don't understand."

"Where does that leave us today?" questions Dr. Smith. "Since the average age of WHI participants was 63, ACOG believes that more research is needed to determine whether hormones taken in perimenopause or early in menopause have a different effect on heart health. But very importantly, we know that lifestyle factors -- such as eating a healthy diet, not smoking, and getting plenty of exercise -- are the biggest contributors to heart disease prevention."

"Finally," notes Dr. Smith, "the Task Force reminds us that it's not hormone therapy, but the normal process of aging that accounts for the average weight gain of women during middle age." She points to what the report calls the "single biggest modifier for weight gain: physical activity."

"No matter how many studies are conducted about weight, we can't avoid the inevitable," concludes Dr. Smith. "If we want to lose, we've got to move."

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Editor's Note: ACOG's Hormone Therapy report is published as a special supplement to the October issue of Obstetrics & Gynecology. As of Friday, October 1, 2004, consumers can be referred to www.acog.org for a detailed update, entitled "Frequently Asked Questions About Hormone Therapy."