MEDICATIONS: HORMONE THERAPY

What Is Hormone Therapy?

Hormone therapy (HT) is a means of replacing the sex hormones estrogen and often progesterone that a woman's body stops making in sufficient quantities when she reaches natural menopause (or after surgical removal of the ovaries). HT is usually begun at menopause to relieve menopausal symptoms such as hot flashes and night sweats.

Doctors used to recommend that women take HT for the rest of their lives to achieve long-term health benefits such as a reduced risk of osteoporosis, bone fractures, colon cancer, and possibly heart disease and Alzheimer's disease. But in 2002, a large study called the Women's Health Initiative, sponsored by the National Institutes of Health, was stopped early because of evidence of an increased risk of heart disease, stroke and breast cancer in women taking a specific estrogen-progestin combination drug regimen.

HT is available by prescription in pills, patches and creams. A woman and her doctor choose the appropriate delivery method based on the woman's health risks, her preferences, and the risks and benefits to her personally.

Weighing the Risks and Benefits of HT

In making the decision to take HT, each woman needs to discuss the risks and benefits with her doctor in the context of her health history and health risks. Women who should not take estrogen are those who have breast cancer or a history of breast cancer, abnormal vaginal bleeding, very high triglyceride (a potentially harmful type of fat in the blood) levels, a history of blood-clotting disorders, active liver disease, or gallstones or gallbladder disease. If you have or had any of these conditions, talk to your doctor. You may be able to use estrogen patches rather than pills.

Benefits

For women who experience debilitating short-term symptoms of menopause that interfere with their quality of life — such as hot flashes, night sweats, sleep disturbances, mood swings, and vaginal dryness, itching and burning — HT is the most effective treatment. Estrogen also reduces thinning of the vaginal walls and pain with intercourse and, in many cases, improves mood, sleep and short-term memory. Low doses of HT can relieve these symptoms. Many newer lower-dose estrogen products are available.

HT protects against osteoporosis by slowing the rate of bone loss and improving bone density throughout the body, including in the hips and spine. Postmenopausal women who take HT have a decreased risk of fractures. However, because of the potential slightly increased risk of heart disease, stroke and breast cancer from HT, unless a woman also has severe menopausal symptoms such as hot flashes, doctors no longer recommend HT solely for preventing or treating osteoporosis. If you have osteoporosis or its precursor condition osteopenia, your doctor can recommend another bone-building medication (see below).

Disadvantages and Health Risks

Taking estrogen alone, the former HT regimen sometimes called estrogen replacement therapy (or ERT), was found to increase the risk of uterine cancer (in women who had not had a hysterectomy). For this reason, progestin (a synthetic form of the female hormone progesterone, which counterbalances estrogen in the body) is now combined with estrogen in HT for women who have a uterus. Women who have had a hysterectomy (and therefore no longer have a uterus) are not at risk for uterine cancer and can take estrogen alone.

Side effects of HT can include vaginal bleeding, breast tenderness, nausea and bloating. In some cases, these side effects can be eliminated by reducing the dose or trying a different drug combination. Various formulas are available that provide different types of estrogens and progestins or a different estrogen-progestin ratio.

The Women's Health Initiative found a link between taking HT longer than five years and a slightly increased risk of breast cancer. For this reason, most doctors recommend that women who have had breast cancer should not take estrogen. Women who have a family history or other risk factors for breast cancer should talk to their doctor if they are considering taking HT. Whether or not you are taking HT, you need to continue doing month breast self-examinations and, after age 40, have regular mammograms as often as your doctor recommends.

The 2002 Women's Health Initiative study found that HT slightly increased some women's risk of heart disease. The precise effect that estrogen has on cholesterol levels and heart disease risk is not clear, but normal levels of estrogen in the body before menopause seem to protect women from heart disease; before menopause, women are much less likely than men to die of heart disease. After menopause, by age 65, women's death rates from heart disease equal those of men. Doctors no longer recommend that women take HT solely to reduce their risk of heart disease.

Choosing the Right Method for You

If you and your doctor determine that HT might be beneficial for you, the next step is to choose the delivery method. You can choose from different pill combinations and doses, patches, and creams.

Estrogen Pills
Estrogen-only pills are usually taken every day. Estrogen-only pills are prescribed only for women who have had a hysterectomy. Women who have not had a hysterectomy should take a combination of an estrogen and a progestin (either in separate pills or in one tablet) to avoid the increased risk of uterine cancer from taking estrogen alone.

Estrogen/Progestin Pill Regimens
There are two methods for taking estrogen and progestin: the continuous method and the cyclic method.

In the continuous method, you take a pill that contains both estrogen and progestin or separate estrogen and progestin pills every day. Like other HT regimens, the continuous method can cause irregular bleeding (especially during the first three months), but the bleeding usually stops after a few months.

In the cyclic method, you take estrogen and progestin in separate pills, as prescribed, or a combination formula that packages the proper dose in a pill-pack. You take estrogen either every day or for 25 days of the month and progestin for 10 to 14 days each month. The cyclic method can cause monthly bleeding that can last up to a year or longer.

Hormone Patches
To use the estrogen patch or the estrogen-progestin patch, a woman applies the patch to the skin of her abdomen or buttock for three and a half or seven days, and then applies a new one. A patch is worn every day and can be left on all the time, including while bathing and swimming. The hormones are delivered through the skin into the bloodstream. Progestin can be taken in pill form with the estrogen patch. Both patches may cause monthly bleeding. Estrogen patches relieve menopausal symptoms and protect against bone loss

Estrogen Cream
Estrogen cream is inserted into the vagina or around the vulva to ease vaginal dryness and urinary problems. Women who are not bothered by hot flashes may choose this method to decrease vaginal or urinary symptoms such as painful intercourse or urinary frequency. However, if a woman still has a uterus and she uses the vaginal cream more often than once a month, she needs to take progestin for at least 10 days every other month to counteract the increased risk of uterine cancer from the estrogen. Talk to your doctor about whether you need to take progestin while you are using the vaginal estrogen cream.

Raloxifene
Raloxifene is an estrogen-like drug that is part of a class of drugs called selective estrogen receptor modulators (SERMs). Raloxifene can be prescribed to prevent or treat osteoporosis. The drug does not seem to increase the risk of uterine cancer as estrogen does, and it may actually protect against some invasive forms of breast cancer. Raloxifene does not cause monthly bleeding, but it also does not relieve hot flashes or other menopausal symptoms.

HT can usually be customized to provide maximum benefits with minimum side effects. If you have irregular bleeding or other side effects while taking HT, talk with your doctor about switching regimens or lowering the dose. Such adjustments can often decrease or eliminate the symptoms. Women who start HT usually have a three-month checkup, followed by six-month or annual checkups that include pelvic and breast examinations. These checkups may also include blood tests to measure cholesterol levels, especially if you have risk factors for heart disease. In addition, remember that after menopause you should have a mammogram every year.

Questions to Ask Your Doctor

Your doctor is familiar with your health history and can help you make decisions about HT. Here are some questions you might want to ask your doctor:

· If I decide to take HT, when should I begin?

· Which form of HT is most appropriate for me?

· What side effects are possible from the form of HT I'm taking?

· What tests or procedures might I have during my regular checkups?

· How long should I wait for any side effects to stop before considering a change in dosage or regimen?

· For how long should I take HT?

Hormone Replacement Therapy: Risks vs. Benefits

Like all medications, hormone replacement (HT) can have side effects. The hormone estrogen in HT can cause nausea, bloating, breast tenderness or headaches. Progestin, the other hormone used in HT, tends to cause more side effects than estrogen including water retention, bloating, irritability, mood swings and anxiety. The higher the progestin dose, the greater the chance of side effects.

Although the side effects of HT vary from woman to woman, the side effects described below are the most common.

· Withdrawal Bleeding. If progestin is taken cyclically for 10 to 14 days every month, bleeding resembling a light menstrual period can occur at the end of each progestin cycle. This so-called withdrawal bleeding is the most frequent reason women give for stopping HT. Irregular bleeding also causes some women to worry that they may have cancer. Different regimens, such as continuous combined therapy in which you take both progestin and estrogen continuously, are available that eliminate or reduce withdrawal bleeding.

· PMS-like Symptoms. Some possible PMS-like side effects of HT include depression, irritability, bloating and breast tenderness, most of which are caused by the progestin. But estrogen can also cause fluid retention and bloating, and swollen, sore breasts. You may be able to find relief from these symptoms by trying a lower dosage or different form or regimen of HT. Ask your doctor about decreasing your progestin dosage to the minimum required to get the benefits you seek.

· Skin Irritation. Transdermal skin patches can sometimes cause itching and temporary redness on the skin under the patch. Vaginal creams can cause allergic skin reactions in some women, and some hormones can cause acne-like skin problems. If skin irritation is a problem, talk to your doctor about reducing the hormone dosage or trying another method. Skin irritation is usually temporary and can often be avoided by placing the estrogen only on clean, dry skin and not in an area where lotion or other skin products have already been applied.

· Headaches. Estrogen may trigger migraines in women who have a history of migraines related to their menstrual cycle. For these women, doctors often recommend taking estrogen and progestin continuously.

Risks of Hormone Therapy

Women who have some health conditions are not good candidates for HT and must use other treatments for relief of menopausal symptoms. Many women choose not to use HT because they are worried about the risk of breast cancer or heart disease. Any woman who is considering HT should talk to her doctor, who can help her evaluate her health risk profile and make an informed decision about HT.

Hormone Therapy and Uterine Cancer
Many women stopped using estrogen in the late 1970s because it was found to increase the risk of endometrial cancer (cancer of the lining of the uterus). Since then, progestin (a synthetic form of the female hormone progesterone, which counterbalances the effects of estrogen on the lining of the uterus) has been combined with estrogen in HT. In fact, the risk of endometrial cancer is lower for women taking combined estrogen-progestin therapy than for women who are not taking HT. However, taking estrogen with adequate progestin does not totally eliminate the risk of endometrial cancer, so monitoring is still important. Always tell your doctor about any unexpected vaginal bleeding, no matter how light.

Obesity (defined as having a BMI over 30 or being 20 percent or more over your ideal weight) can also raise a woman's risk of endometrial cancer because being overweight increases the amount of natural estrogen formed in the body's fat cells. If you are obese and are taking HT, your doctor will emphasize the importance of taking progestin along with estrogen as prescribed.

Hormone Therapy and Breast Cancer
Breast cancer is the second leading cancer killer among women, after lung cancer. The issue of HT and breast cancer is somewhat confusing because of conflicting study results. However, the Women's Health Initiative, a major study funded by the National Institutes of Health, in 2002 was stopped early because it found that taking HT in a specific estrogen-progestin combination pill for more than 10 years slightly raised the risk of breast cancer. Studies are still under way to understand the precise relationship between HT and breast cancer.

Because the risk of breast cancer seems to go up slightly with long-term use of HT, doctors now prescribe it in low doses primarily to treat menopausal symptoms over the short term. Even if you have a family history of breast cancer, you can take estrogen as long as you have normal mammograms. Your doctor can help you evaluate your health history and health risks in helping you make a decision about HT. Regardless of whether you are taking hormone therapy, you should continue to do monthly breast self-examinations and, after age 40, have regular mammograms as often as your doctor recommends.

Hormone Therapy and Blood Clots
In the past, early high-dose oral contraceptives increased the risk of blood clots in some women, especially those over age 35 who smoked cigarettes. High doses of estrogen seem to increase clotting factors in the blood. The higher the dose of estrogen, the higher the risk of clotting.

The doses of estrogen used in postmenopausal HT are significantly lower than those used in birth-control pills. For this reason, if you do not currently have a blood clot or inflammation in the deep veins in the legs, you may be able to use HT after menopause if you have severe menopausal symptoms. However, your doctor is likely to recommend alternative treatments for your symptoms.

Hormone Therapy and Uterine Fibroids
Uterine fibroids are benign overgrowths of the smooth muscle of the wall of the uterus. In some women during pregnancy, the increased levels of circulating estrogen produced by the body stimulate the fibroids to grow. In most women, fibroids shrink after menopause because of decreased estrogen levels, and they rarely cause any more problems. The prescribed doses of HT are so low that they seldom affect fibroids. For most women with fibroids who take HT at or after menopause, fibroids continue to shrink.

Testosterone's Risks
Some doctors prescribe testosterone along with estrogen-progestin therapy for postmenopausal women who are experiencing a decrease in sexual desire, or libido. Testosterone seems to improve sexual desire in some women.

Possible side effects from testosterone include acne, facial hair growth, weight gain or oily skin. These side effects are quickly reversed when testosterone is reduced or stopped.

Benefits of Hormone Therapy

Although HT is no longer prescribed for most women, as it used to be, some women can benefit from it. HT remains the most effective treatment for hot flashes and other symptoms of menopause and for the bone-thinning disorder osteoporosis. For women who have life-disrupting menopausal symptoms and osteoporosis and no known risk factors for breast cancer or heart disease, HT is especially beneficial.

Relief of Menopausal Symptoms
Short-term HRT can reduce or eliminate many of the uncomfortable, unpleasant symptoms of menopause such as the following.

Hot flashes: Estrogen is the most effective form of therapy for hot flashes and other symptoms of menopause. To treat hot flashes, your goal should be to find the lowest dose possible to reduce their occurrence. Work with your doctor to find the most effective dosage for you. Your doctor will probably start with the average therapeutic dose and adjust it down or up, depending on your hot flashes and any side effects. Keeping a diary of your hot flashes is a good way to monitor the effectiveness of the treatment.

One or two weeks after starting HT, you will find that your hot flashes begin to subside significantly. If you stop taking estrogen, however, your hot flashes will probably return. For hot flashes that occur during perimenopause (the years leading up to menopause), many doctors recommend that women hold off on HT and consider using a low-dose birth-control pill instead, as long as they do not smoke cigarettes. The estrogen and progestin in oral contraceptives can help relieve hot flashes, regulate the menstrual cycle, and control the irregular bleeding that can occur during perimenopause. The estrogen in the low-dose pill is actually a higher dose than that commonly used for HT after menopause.

If you decide to use oral contraceptives, your regular menstrual cycles will continue, even when you reach menopause. You are advised against taking low-dose oral contraceptives if you smoke or have a history of breast cancer or blood clots. When used to relieve perimenopausal symptoms, oral contraceptives have the added benefit of providing contraception, which can be of particular benefit to sexually active women with a history of irregular menstrual cycles.

Vaginal symptoms: Before menopause, one of the actions of estrogen is to keep the vaginal lining thick, elastic, and well-lubricated. When estrogen levels drop, the vaginal lining becomes thinner, drier, and less elastic. The vagina is then more likely to become sore or irritated. HT can relieve these symptoms.

If your only symptom is vaginal dryness, you may want to try vaginal estrogen therapy in a cream. Estrogen creams treat the vagina directly and therefore tend to be more effective than estrogen pills or patches. But even with the cream, you may find that it takes a few weeks to have an effect. If you have osteoporosis, you should know that the estrogen in the vaginal cream is not absorbed in amounts sufficient to help prevent or treat osteoporosis. However, you need to take progestin in pills along with the estrogen cream to lower your risk of endometrial cancer, unless you only use the cream sporadically (less than once a month).

An estrogen-releasing ring similar to the contraceptive vaginal ring is also available. The vaginal ring is placed inside the vagina, where it slowly releases minute amounts of estrogen that restore the vaginal lining and its ability to lubricate itself. The ring must be replaced every three months and you have to take a progestin pill for at least 10 to 14 days every few months while you are using the ring.

A low-dose estradiol (a form of estrogen) vaginal tablet is the only form of vaginal estrogen therapy that can be taken without progestin because the estrogen stays mainly in the vagina and is not absorbed into the bloodstream.

Emotional symptoms: While menopause itself does not cause emotional problems, its symptoms may. Hot flashes, night sweats, decreased libido and other symptoms can all affect a woman's emotional well-being. These symptoms, which can cause loss of sleep, can sometimes lead to fatigue, nervousness and irritability. By treating severe menopausal symptoms, HT can help restore a women's sense of well-being. However, doctors do not recommend HT solely for treating emotional or psychological problems such as depression that are not related to menopause or that go beyond the normal sadness that accompanies major life events.

Preventing and Treating Osteoporosis
Research has shown that HT can stop the bone loss associated with menopause and may help rebuild some of the bone lost, reducing a woman's risk of fractures (especially in the hip), even when treatment is begun well after menopause. The best HT-related protection against osteoporosis, however, occurs when therapy is begun within three years of menopause and is continued for 10 years or more. Estrogen must be taken over a long term to realize its full effects on the bones. The hormone's therapeutic effects wear off soon after therapy is discontinued. In fact, when estrogen is stopped, bone density will begin to decrease again.

However, in order to maximize the ability of any treatment to significantly stimulate bone growth, doctors recommend that all women-including those who are on HT-maintain healthy bones by eating a nutritious, calcium-rich diet; exercising regularly, especially weight-bearing exercise such as walking and lifting weights; not smoking; and drinking only in moderation (no more than one drink a day). Avoid situations in which you might fall and fracture a bone (for example, wearing high heels).

All women should take in 1,200 milligrams of calcium each day before menopause and 1,500 milligrams after menopause, unless they are on HT (and then 1,200 milligrams a day are sufficient). If you don't get enough calcium from your diet, such as from low-fat dairy products and green leafy vegetables, take calcium supplements every day to reach the 1,200- to 1,500-milligram requirement to keep your bones strong.

Preventing Colon Cancer
Colon cancer is the second most common cancer in women, after breast cancer. Studies have shown a significant decrease in colon cancer and deaths related to colon cancer among women using HT. However, because of the increased risk of heart disease, stroke and breast cancer from HT, doctors do not recommend that women take HT solely to reduce their risk of colon cancer.

Regular exercise and eating a high-fiber diet, rich in whole grains, vegetables, and fruits and low in saturated fats (such as from full-fat dairy products, red meat and poultry skin) can also help prevent colon cancer. Calcium, vitamin D and folic acid may also be helpful.

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