F acts About Menopausal

Menopausal once seemed the answer for many of the conditions women face as they age. It was thought that hormone therapy could ward off disease, , and , while improving women’s quality of life.

But beginning in July 2002, findings emerged from clinical trials that showed this was not so. In fact, long-term use of hormone therapy poses serious risks and may increase the risk of heart attack and .This fact sheet discusses those findings and gives an overview of such topics as , hormone therapy, and alternative treatments for the symptoms of menopause and the various health risks that come in its wake. It also provides a list of sources you can contact for more information.

U.S. DEPARTMENT OF HEALTH AND SERVICES National Institutes of Health National Heart, , and Institute Menopause and Hormone Eventually, your periods stop. You also can undergo menopause Therapy Menopause marks the time as the result of surgery.A surgical of your last menstrual period. procedure, called a , As you age, significant internal It is not considered the last until removes the .This surgery changes take place that affect your you have been period-free for puts an end to your menstrual production of the two 1 year without being ill, pregnant, cycle but does not affect , and proges- -feeding, or using certain menopause, which still occurs terone.The hormones, which are , all of which also can naturally. important in regulating the men- cause menstrual cycles to cease. strual cycle and having a successful There should be no , You go through menopause , are produced by the even spotting, during that year. immediately if both of your , two small oval-shaped Natural menopause usually hap- ovaries are also removed organs found on either side of pens sometime between the ages at surgery.Whether you go the uterus. of 45 and 54. through menopause naturally

During the years just before menopause, known as peri- menopause, your ovaries begin to shrink. Levels of estrogen and fluctuate as your ovaries try to keep up hormone production.You can have irregular menstrual cycles, along with unpredictable episodes of heavy bleeding during a period. Perimenopause usually lasts several years.

Box 1 Examples of Oral Estrogen and Estrogen/Progestin Products Estrogen pills: Progestin pills: Estrogen-plus-progestin pills: Brand Generic Brand Generic Brand Generic

Premarin conjugated equine Cycrin Premphase conjugated equine acetate estrogens and Cenestin synthethic conjugated Provera medroxyprogesterone medroxyprogesterone estrogens acetate acetate Estratab Aygestin norethindrone acetate Prempro conjugated equine Menest esterified estrogens Norlutate norethindrone acetate estrogens and Ortho-Est ( Prometrium progesterone USP medroxyprogesterone ) (in peanut ) acetate Ogen estropipate (piperazine Femhrt and ) norethindrone acetate Estrace micronized 17-beta- Activella 17-beta- and estradiol norethindrone acetate Estinyl ethinyl estradiol Ortho-Prefest 17-beta-estradiol and

2 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

Box 2 Box 3 Examples of , Creams, Patches, and Other Hormone Therapy Hormone Products Schedules Estrogen products: Cyclic or sequential Type Brand Generic ■ Estrogen every day

Vaginal Estrace micronized 17-beta-estradiol ■ Progesterone or progestin added Ortho dienestrol for 10–14 days out of every Ogen estropipate (piperazine estrone sulfate) 4 weeks Premarin conjugated equine estrogens Vaginal Vagifem estradiol hemihydrate Continuous-combined Estring micronized 17-beta-estradiol ■ Estrogen and progestin daily Femring without a break Patch Alora micronized 17-beta-estradiol Climara micronized 17-beta-estradiol Esclim micronized 17-beta-estradiol to . If you haven’t Estraderm micronized 17-beta-estradiol Vivelle micronized 17-beta-estradiol had a hysterectomy,you’ll receive Vivelle-Dot micronized 17-beta-estradiol estrogen plus progesterone or Skin Estrogel estradiol gel a progestin; if you have had a Skin Cream Estrasorb estradiol topical hysterectomy,you’ll receive only estrogen. Hormones may be taken Progestin products: daily (continuous use) or on only certain days of the month (cyclic Vaginal Gel Crinone progesterone use). (See Box 3.) IUD Mirena

Estrogen plus progestin products: They also can be taken in several ways, including orally, through Skin Patch Combipatch 17-beta-estradiol and norethindrone a patch on the skin, as a cream acetate or gel, or with an IUD (intrauter- Ortho-Prefest 17-beta-estradiol and norgestimate ine device) or vaginal ring (See Box 2.). How the therapy is taken can depend on its purpose. For or surgically, symptoms can result called .) But the drop instance, a ring as your body adjusts to the drop in estrogen also can contribute to or cream can ease vaginal dryness, in estrogen levels.These symptoms changes in the vaginal and urinary urinary leakage, or vaginal or uri- vary greatly—one may tracts, which can cause painful nary , but does not go through menopause with few intercourse and urinary infections. relieve hot flashes. symptoms, while another has difficulty. Symptoms may last for To r elieve the symptoms of Hormone therapy may cause side several months or years, or persist. menopause, doctors may prescribe effects, such as bleeding, , hormone therapy.This can involve breast tenderness or enlargement, The most common symptoms are the use of either estrogen alone , mood changes, and hot flashes or flushes, night sweats, or with another hormone called . Further, side effects vary and disturbances. (A progesterone, or progestin in its by how the hormone is taken. For is a feeling of heat in your face synthetic form (See Box 1.). The instance, a patch may cause irrita- and over the surface of your body, two hormones normally help to tion at the site where it’s applied. which may cause the skin to regulate a woman’s . appear flushed or red as blood Progestin is added to estrogen to There also are nonhormonal vessels expand. It can be followed prevent the overgrowth (or hyper- approaches to easing the symp- by sweating and shivering. Hot plasia) of cells in the lining of the toms of menopause. Box 4 offers flashes that occur during sleep are uterus. This overgrowth can lead a list of some of these alternatives.

3 Box 4 Alternatives to Hormone Therapy To Help Prevent Postmenopausal Conditions and Relieve Menopausal Symptoms You may want to consider alternatives to hormone therapy For Menopausal Symptoms: to ease menopausal symptoms. The list below includes Hot flashes some locally applied hormone products, which might ■ Lifestyle changes. These include dressing and eating not carry the same risks as those that deliver to avoid being too warm, sleeping in a cool room, and throughout the body. reducing . Avoid spicy and . Try deep breathing and stress reduction techniques, including medi- Be aware that some of these remedies are regulated by the tation and other relaxation methods. Federal Government as dietary supplements, and as such do ■ . and some soy-based not undergo premarket approval and may not have data show- ing them to be safe and effective (See Box 5.). Talk with your foods contain phytoestrogens, which are estrogen-like doctor or other health care provider about the best treatment compounds. Soy phytoestrogens can be consumed for you for each symptom. through foods or supplements. Soy products include tofu, tempeh, soy milk, and soy nuts. Other sources Positive moves you can make to feel better are related to of phytoestrogens include such botanicals such as black adopting a healthy lifestyle—don’t smoke, eat a variety of cohosh, wild , dong quai, red clover, and . foods low in saturated , trans fat, and and mod- However, there is no solid evidence that the phytoestrogens erate in total fat. Include grains, especially whole grains and a in soybeans, soy-based foods, other plant sources, or variety of dark green leafy vegetables, deeply colored fruit, and dietary supplements really do relieve hot flashes. Further, dry beans and peas in your eating plan. Also, maintain a the risks of taking the more concentrated forms of soy healthy weight, and be physically active for at least 30 minutes phytoestrogens, such as pills and , are not known. most days of the week, preferably daily. Alternatives include: Dietary supplements with phytoestrogens do not have For Postmenopausal Conditions: to meet the same quality standards as do . Little is Osteoporosis known about the safety or of these products. ■ See Box 13 for lifestyle behaviors to protect density. ■ , such as Effexor, Paxil, and Prozac. ■ Designer estrogen (Evista), which preserves bone These have been proved moderately effective density and prevents fractures (although not fractures). in clinical trials. ■ Actonel or Fosamax, which preserve Vaginal dryness , prevent fractures, and can reverse bone loss ■ Vaginal lubricants and moisturizers (available over the ■ Teraparatide (), which may reverse counter). bone loss ■ Products that release estrogen locally (such as vaginal ■ (a or injectable), used to treat women creams, a vaginal , called Vagifem, and a who have osteoporosis, which may prevent some fractures ring, called an Estring)—these are used for more severe (This is not approved for preventing osteoporosis.). dryness. The ring, which must be changed every 3 months, ■ Note: Phytoestrogens (see hot flashes) have not been shown contains a low dose of estrogen and may not protect to prevent osteoporosis or reduce the risk of fractures. against osteoporosis. Heart disease Mood swings ■ Lifestyle behaviors, including: ■ Lifestyle behaviors, including getting enough sleep and ■ Following a healthy eating plan that includes a variety of being physically active foods low in saturated fat, trans fat, cholesterol and ■ Relaxation exercises moderate in total fat, and rich in fruits and vegetables ■ or anti- drugs ■ Choosing and preparing foods with less salt ■ Not ■ Maintaining a healthy weight ■ Over-the-counter sleep aids ■ Being physically active ■ Milk products, such as a glass of milk or cup of yogurt— ■ Preventing and controlling high choose low-fat or fat-free varieties—consumed at bedtime ■ Preventing and controlling high blood cholesterol ■ Do physical activity in the morning or early afternoon— ■ Managing exercising later in the day may increase wakefulness ■ Taking prescribed medication to control heart disease ■ Hot shower or bath immediately before going to bed problems ■ Mental exercises ■ Lifestyle behaviors, especially getting enough sleep and being physically active

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Postmenopausal Use Box 5 About Dietary Supplements Menopause may cause other changes that produce no symp- If you use dietary supplements to try to ease hot flashes and other menopausal toms yet affect your health. For symptoms, be aware that these products instance, after menopause, women’s do not require U.S. Food and Drug rate of bone loss increases.The Administration (FDA) review or approval increased rate can lead to osteo- prior to their marketing. Because they are porosis, which may in turn increase considered “dietary supplements,” they the risk of bone fractures.The risk are covered by less stringent regulations of heart disease increases with age, than those involving prescription drugs. but is not clearly tied to the Manufacturers are responsible for estab- lishing that they are safe and efficacious. menopause. They can be sold without the review or approval of the FDA. Thus, the quality of Through the years, studies were these products is not often known. It is finding evidence that estrogen important to tell your health care provider might help with some of these that you are taking such remedies. postmenopausal health risks— especially heart disease and The products sold over the counter as dietary supplements may be in pill or osteoporosis.With more than form or as fortified items, such as candy bars. The possible effects of the products are not known. Some of the substances they contain are being 40 million American women over studied. For example, soy contains phytoestrogens, which are being studied age 50, the promise seemed great. to see if they have the same risks and benefits as estrogen. Although many women think it is a “’s disease,” heart disease Some of this research is being supported by the Office of Dietary Supplements, is the leading killer of American the National Center for Complementary and Alternative , the National women.Women typically develop Institute on Aging, and other units of the NIH. it about 10 years later than men. Until more is known about these substances, you should use them with caution. Also, as noted, tell your health care provider if you take a dietary Furthermore, women are more supplement or if you increase your intake of dietary phytoestrogens. There prone to osteoporosis than men. may be dangerous side effects. An increase in the level of estrogens in your Menopause is a time of increased body could interfere with other prescription medications you are taking or even bone loss. Bone is living . cause an overdose. Old bone is continuously being broken down and new bone formed in its place.With menopause, bone loss is greater and, if not enough new bone is made, the result can be weakened and osteoporosis, which increases the risk of breaks. One of every two women over age 50 will have an osteoporosis-related fracture during her life.

Many scientists believed these increased health risks were linked to the postmenopausal drop in estrogen produced by the ovaries and that replacing estrogen would help protect against the diseases.

5 Box 6 What We Learn From Different Types of Studies Medical researchers conduct many types of studies. The reason is that the studies yield different kinds of information. Together, the studies help scien- tists understand health and disease, and how to educate people so they can lead healthier lives.

Three main types are: observational studies, clinical trials, and community prevention studies. Each type is discussed briefly below:

■ Observational studies follow women’s medical and lifestyle practices but do not intervene. Such studies can turn up possible relationships between various factors and health or illness. Those factors include population traits, ethnicity, genetic attributes, and behaviors. For Early Findings instance, researchers can track women who do and do not take menopausal hormone therapy. The results may show that the hormone Early studies seemed to support users have fewer heart attacks. But the results cannot conclude that hormone therapy’s ability to hormone therapy reduces heart disease risk. Other factors may have protect women against the played a part. For instance, compared with women who do not use hor- diseases that tend to occur after mone therapy, those who do are often healthier, have a higher education menopause. For instance, research level, better access to medical care, and are more willing to follow a pre- showed that the treatment does scribed therapy. prevent osteoporosis. However, other findings lacked evidence ■ Clinical trials control and compare specific medical interventions, such or were unclear. No large clinical as the use of menopausal hormone therapy. Women on an intervention trials had proved that hormone are compared with those who do not receive the treatment. Researchers therapy prevents heart disease try to control all of the experimental conditions so that any difference or fractures. Answers also were between the two groups can be tied to the intervention. needed about other possible effects of long-term use of hormones, The most rigorous of these investigations is the randomized, controlled, double-blinded . Women are randomly assigned to the study especially on such conditions as groups and, in a drug trial for instance, neither the women nor the breast and colorectal . researchers typically know who is receiving an active drug or a . Further, on average women in the two groups are similar in age, educa- Further, prior research on tion, health, and other factors that may affect the results upon entering menopausal hormone therapy’s the trial. These trials are consid- effect on heart disease had ered to be the “gold standard” involved mainly observational studies because they yield the studies, which can indicate possible most reliable information. relationships between behaviors or treatments and disease, but cannot Clinical trials are often done to test establish a cause-and-effect tie. a possible relationship uncovered (See Box 6 for more about types in an observational study. The tri- of studies.) als help establish a causal link between a treatment and a specific There were some clinical trials, medical outcome, such as fewer considered the “gold standard” heart attacks. in establishing a cause-and-effect connection between a behavior ■ Community prevention studies or treatment and a disease, but explore ways to encourage people most looked at the therapy’s effects to adopt healthier behaviors. on the risk factors or predictors of various diseases. 6 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

Two important clinical trials Box 7 were the “Postmenopausal WHI In Profile* Estrogen/Progestin Interventions Altogether, the WHI involved about 161,000 healthy postmenopausal women. Tr ial” (PEPI) and the “Heart and Here’s the breakdown of participants in each study: Estrogen-Progestin Replacement

Study” (HERS). Estrogen Alone Estrogen Plus Progestin

PEPI looked at the effect of Participants 10,739 16,608 estrogen-alone and combination Race on key heart disease risk White 75% 84% factors and bone mass. It found Black 15% 7% generally positive results, including Hispanic 6% 5% a reduction by both types of ther- apy of “bad” LDL cholesterol and Average age 64 63 an increase of “good” HDL 50–59 31% 33% cholesterol. (LDL, or low density 60–69 45% 45% , carries cholesterol to 70–79 24% 23% tissues, while HDL, or high density Hormone use lipoprotein, carries it away, aiding Ever 35% 20% in its removal from the body.) At enrollment 13% 6%

HERS tested whether estrogen BMI plus progestin would prevent Normal 21% 31% a second heart attack or other 35% 35% coronary event. It found no Obese 45% 34% reduction in risk from such Smoking hormone therapy over 4 years. Ever 38% 40% In fact, the therapy increased At enrollment 10% 11% women’s risk for a heart attack during the first year of hormone Treated for high blood pressure use.The risk declined thereafter. 48% 36% HERS also found that the therapy caused an increase in blood clots *Percentages are rounded in the legs and .The “HERS Follow-Up Study,” which tracked the participants for about 3 more years, found no lasting decrease in heart disease from estrogen-plus- progestin therapy.

The Women’s Health Initiative

In 1991, the National Heart, Lung, and Blood Institute (NHLBI) and other units of the National Institutes of Health (NIH) launched the Women’s Health Initiative (WHI), one of the largest studies of its kind ever undertaken in the .

7 Box 8 WHI Hormone Therapy Findings The two WHI studies’ findings should not be compared directly. Women in the estrogen-alone study began the trial with a higher risk for than those in the estrogen-plus-progestin study. They were more likely to have such heart disease risk factors as high blood pressure, high blood cholesterol, diabetes, and .

Also, as you read the percentages below, bear in mind that the WHI involved healthy women, and only a small number of them had either a negative or positive effect from either hormone therapy. The percentages given below describe what would happen to a whole population—not to an individual woman. For example, risk for the women in the WHI study taking estrogen plus progestin increased less than a tenth of 1 percent each year. But if you apply that increased risk to a large group of women over several years, the number of women affected becomes an important public health concern. About 6 million American women take estrogen-plus-progestin therapy. That would translate into nearly 6,000 more breast cancer cases every year, and, if all of the women who took the therapy for 5 years, that could result in 30,000 more breast cancer cases.

Further, know that percentages aren’t fate. Whether expressing risks or benefits, they do not mean you will develop a disease. Many factors affect that likelihood, including your lifestyle and other environmental factors, heredity, and your personal medical history.

Estrogen Plus Progestin Increased risk for With 5.2 years of followup. For every 10,000 women each year, Stroke estrogen plus progestin (combination therapy) use compared ■ 39 percent increase in —12 more strokes (44 cases with a placebo on average resulted in: in those on estrogen alone and 32 in those on placebo) Venous (blood clot, usually in a deep vein of legs) Increased risk for ■ About a 47 percent higher risk—6 more cases (21 cases in Breast cancer those on estrogen alone and 15 in those on placebo.) An ■ 26 percent increased risk—8 more cases (38 cases on increased risk of pulmonary (blood clots in the combination therapy and 30 on placebo) lungs) was not statistically significant. There were 13 cases Stroke in those on estrogen alone and 10 in those on placebo. ■ 41 percent increased risk—8 more cases (29 cases on combination therapy and 21 on placebo) No difference in risk (neither increased nor decreased) Heart attack or of uncertain effect ■ 29 percent increased risk—7 more cases (37 cases on Coronary heart disease combination therapy and 30 on placebo) ■ No significant difference—5 fewer cases (49 cases in those Blood clots (legs, lungs) on estrogen alone and 54 in those on placebo). During the ■ Doubled rates—18 more cases (34 cases on combination first 2 years of use, the risk was slightly increased for estro- therapy and 16 on placebo) gen alone, but it appeared to diminish over time. Colorectal/total cancer Increased benefits ■ No significant difference—1 more case for Colorectal Cancer and 7 fewer cases for total cancer (for colorectal cancer, 17 ■ 37 percent less risk—6 fewer cases (10 cases on combina- cases with estrogen alone and 16 with placebo; for total tion therapy and 16 on placebo) cancer, 103 cases in those on estrogen alone and 110 in Fractures those on placebo.) ■ 37 percent fewer hip fractures—5 fewer cases (10 on com- (all or specific cause) bination therapy and 15 on placebo ■ No significant difference—3 more deaths (for all deaths, 81 in those on estrogen alone and 78 in those on placebo) No difference Breast cancer Deaths ■ Uncertain effect—7 fewer cases (26 cases in those on Total cancer cases estrogen alone and 33 in those on placebo). This finding was not statistically significant. Estrogen Alone With 6.8 years of followup. For every 10,000 women each year, Increased benefit estrogen-alone use compared with a placebo on average Bone fractures resulted in: ■ 39 percent fewer hip fractures—6 fewer cases (11 cases in those on estrogen alone and 17 cases in those on placebo)

8 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

equine estrogens taken daily plus 2.5 milligrams of medroxyproges- terone acetate (PremproTM) taken daily.The estrogen-alone trial used 0.625 milligrams of conjugated equine estrogens (PremarinTM) taken daily.

Prempro and Premarin were chosen for two key reasons: They contain the most commonly pre- scribed forms of estrogen-alone and combined therapies in the United States, and, in several observational studies, these drugs appeared to It consists of a set of clinical trials, The menopausal hormone benefit women’s health. an observational study, and a therapy clinical trial had two community prevention study, parts.The first involved 16,608 Women in the trials were aged which altogether involve postmenopausal women with 50 to 79—their average age at more than 161,000 healthy a uterus who took either estrogen- enrollment was about 64 for both postmenopausal women. plus-progestin therapy or a placebo. trials (See Box 7 for a profile of (The added progestin protects the participants.). They enrolled The observational study is looking women against uterine cancer.) in the studies between 1993 and for predictors and biological The second involved 10,739 1998.Their health was carefully markers for disease and is being women who had had a hysterec- monitored by an independent conducted at more than 40 centers tomy and took estrogen alone or a panel, called the Data and Safety across the United States.The com- placebo. (A placebo is a substance Monitoring Board (DSMB). munity prevention study, which that looks like the real drug but has ended, sought to find ways to has no biologic effect.) Both hormone studies were to get women to adopt healthful have continued until 2005, but behaviors and was done with the The estrogen-plus-progestin trial were stopped early. The estrogen- Federal Government’s Centers for used 0.625 milligrams of conjugated plus-protestin study was halted in Disease Control and Prevention.

WHI’s three clinical trials, con- ducted at the same U.S. centers, are designed to test the effects of menopausal hormone therapy, diet modification, and and supplements on heart disease, osteoporotic frac- tures, and breast and colorectal cancer risk.

The hormone trials also were checking whether the therapies’ possible benefits outweighed possible risks from breast cancer, endometrial (or uterine) cancer, and blood clots.The hormone therapy trials have ended.

9 Box 9 What Do the Data Really Mean? The data sound scary—and confusing. Estrogen plus progestin cancer, heart attacks, strokes, and blood clots in the lungs and increases stroke risk by 41 percent—and decreases the risk for subtract the fewer cases of colorectal cancer and hip fractures, hip fractures by 34 percent? Which is more important? you’d still get about 100 extra harmful events among the The bad news, or the good? 10,000 hormone users after 5.2 years—the period the study ran. Multiply that by 10 years and millions of women taking Either way, the percentages sound big. So it’s good to take hormones and the number of cases of adverse effects grows. a moment and check out what they’re really saying. Remember too that reports of There are two main ways to express risk—“” and increased risks do not “absolute risk.” Relative risk estimates percent increase or mean you will develop decrease in a health event occurring in one group compared breast cancer or to another group. Absolute risk estimates the number of health another condition events among individuals in a group, and gives a better if you have been of personal or individual risk. using the hormone therapy. Your per- The risk to an individual can be low, but in a large population sonal and family the number of health events can be great. medical history, along with your For example, the WHI study found that, among 10,000 women lifestyle and other taking estrogen plus progestin for one year, there will be 8 more influences, play a big cases of breast cancer among the hormone users than if they role in your chance had not taken the therapy. So, the absolute risk to the individ- of developing ual is relatively low. a disease.

But, the risk of taking hormones to the overall population was substantial. If you count up all the added cases of breast

July 2002, and the estrogen-alone plus progestin before entering the greater—or 18 more women with study at the end of February 2004. study, indicating that the therapy blood clots each year for every Women in both trials are now in may have a cumulative effect. 10,000 women. a followup phase, due to last until The combination therapy also 2007. During the followup, their increased the risk for heart attack, Estrogen plus progestin also health will be closely monitored. stroke, and blood clots. For heart reduced the risk for hip and other See Boxes 8 and 9. attack, the risk was particularly fractures, and colorectal cancer. high in the first year of hormone The reduction in colorectal cancer Effects on Disease and use and continued for several years risk appeared after 3 years of Briefly, the combination therapy thereafter. Unlike HERS, which hormone use and became more study was stopped because of an involved women with heart marked thereafter. However, increased risk of breast cancer and disease, there was an overall the number of cases of colorectal because, overall, risks from use of increased risk from the hormone cancer was relatively small, the hormones outnumbered the therapy over the 5.6 years of the and more research is needed benefits. “Outnumbered” means trial.The risk for blood clots was to confirm the finding. that more women had adverse greatest during the first 2 years of effects from the therapy than hormone use—four times higher The estrogen-alone study was benefited from it. For breast than that of placebo users. By the stopped after almost 7 years cancer, the risk was greatest among end of the study,the risk for blood because the hormone therapy women who had used estrogen clots had decreased to two times increased the risk of stroke and 10 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

Box 10 did not reduce the risk of coro- nary heart disease. It also increased Significant Statistics the risk for Sometimes, studies report results that are not “statistically significant.” For (blood clots deep in a vein, usually instance, in the WHI, estrogen alone caused fewer cases of breast cancer, but in the leg).There also was a the finding was not statistically significant. How can that be? trend towards increased risk for (blood clots Significance with statistics refers in the lungs), but it was not statis- to the likelihood that a finding is tically significant (See Box 10 probably true—and probably not for explanation of statistical signifi- due to chance. With breast cancer, cance.).The therapy had no the result could be due to factors significant effect on the risk of other than hormone therapy, such heart disease or colorectal cancer. as or environmental Its effect on breast cancer was exposures. The difference in breast uncertain. Although the risk for cancer cases between the estrogen- breast cancer for those on estrogen alone and placebo groups was alone appeared to be lower, this not large enough to rule out finding was not statistically signifi- other factors. cant (see Box 10). Estrogen alone reduced the risk for hip and other Some of the WHI findings are of fractures.The reduction began uncertain effect or not statistically early in the study and persisted significant. They are intriguing throughout the followup period. findings that need more research.

Neither estrogen plus progestin nor estrogen alone affected the risk of death.

Effects On Mental Functions An ancillary study of the hormone trials, the WHI Memory Study (WHIMS), included women age 65 and older. It found that women taking estrogen plus progestin had twice the rate of , includ- ing Alzheimer’s disease, as those on the placebo. The combination therapy also did not protect women against mild cognitive impairment, which is a less severe loss of mental abilities such as having trouble paying attention and remembering.

Estrogen alone also increased the risk of mild cognitive impairment plus dementia, though the number of cases of dementia alone was too small to be statistically significant.

11 Box 11 Effects On Results for the estrogen-alone Risk Factors for Stroke The WHI has shown that estrogen therapy are not yet available. and estrogen combined with Main risk factors are: ■ High blood pressure progestin increase the risk of Putting It All Together developing urinary incontinence ■ smoking and worsen the symptoms of The WHI findings finally offer incontinent women. women guidance about the use ■ Heart disease of menopausal hormone therapy. Effects On Quality Of Life They establish a causal link ■ Diabetes WHI also studied the effects between use of the therapies of menopausal hormone therapy tested and their effects on diseases. ■ Transient ischemic attacks (small strokes lasting for only a few on women’s quality of life, which Further, the results apply broadly— minutes or hours) includes of general the studies found no important health, energy, social functioning, differences in risk by prior health ■ Age , , and status, age, or ethnicity. sexual satisfaction.There was no Other risk factors include: improvement with estrogen plus As you read the information given ■ Family history—stroke appears progestin. Slight improvements below, realize that most treatments to run in some families, whether in women’s physical functioning, carry risks and benefits.Talk with due to genetics and/or shared lifestyle body , and sleep disturbances your doctor or other health care did occur after 1 year of hormone provider and decide what’s best ■ Heavy consumption of alcoholic use, but those effects were very for your health and quality of life. beverages small. Among younger WHI Begin by finding out your personal participants (ages 50–54), there risk profile for heart disease, stroke, ■ High blood cholesterol was a slight improvement in sleep. breast cancer, osteoporosis, colorec- Relief of hot flashes and night tal cancer, and other conditions sweats occurred in the majority (See Boxes 11, 12, 13, 15, 16, 17, of women who had these 18, and 19.). Discuss quality of symptoms when they life issues and alternatives to started the study. menopausal hormone therapy. Box 20 will help you talk with your health care provider.

Then weigh every factor carefully and choose the best option for your health and quality of life. And keep the dialogue going— your health status can change and so can your choice.

U.S. Food and Drug Administration (FDA) Approved Use of Menopausal Hormone Therapy ■ Menopausal hormone therapy products are effective for treating moderate-to-severe hot flashes and night sweats, moderate-to-severe vaginal dryness, and prevention of osteoporosis associated 12 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

Box 12 with menopause, but carry Breast Cancer Risk Factors serious risks.Therefore, post- menopausal women who use or One of every eight American women will develop breast cancer in her lifetime. are considering using estrogen The risk increases with age—and is greatest after age 60. Some factors increase the risk for breast cancer. However, most women who develop breast or estrogen with progestin treat- cancer do not have any risk factors. ments should discuss with their health care providers whether Key factors that increase the risk of developing breast cancer are: the benefits outweigh the risks. ■ Personal history—if you’ve had it once, you’re more likely to develop breast cancer again. ■ If these products are prescribed solely for vaginal symptoms, ■ Family history—if your , sister, or daughter had breast cancer, health care providers are advised especially at an early age, you’re more likely to develop it. to consider the use of topical vaginal products (gel or cream ■ Other breast changes (not including ordinary “lumpiness”)—such as atypical applied locally). (an irregular pattern of growth).

■ ■ Genetic alterations—mutated forms of BRCA1 and BRCA2 , If menopausal hormone therapy which are believed to be responsible for about half the cases of is used for osteoporosis, the risks inherited breast cancer. for osteoporosis must outweigh the risk of estrogen or estrogen Other factors also may increase the risk of developing breast cancer. with progestin. Health care These include: providers are encouraged ■ Race—white women are more likely to develop it than African American to consider other treatments or Asian women. before providing menopausal hormone therapy for ■ Estrogen exposure—risk is somewhat increased for those who osteoporosis. began early (before age 12), had menopause late (after age 55), never had children, never breastfed, or took hormone ■ Menopausal hormone therapy therapy for long periods. has never been approved for

■ Late childbearing—having a first after age 30. the prevention of cognitive disorders such as Alzheimer’s ■ —if given to the chest more than 10 years ago, especially disease or memory loss. in women younger than age 30. In fact, the WHI found that women treated with ■ Breast density— with a high proportion of lobular and ductal tissue, menopausal hormone therapy which is dense and prone to breast cancer. have a greater risk of develop- ing dementia. ■ Obesity after menopause—the body makes some of its estrogen in fatty tissue and being obese means a woman has abnormally high body fat; ■ Menopausal hormone therapy gaining weight after menopause increases the risk. should be used at the lowest doses for the shortest duration ■ Physical inactivity—women who are physically inactive throughout life have an increased risk, possibly because physical activity helps prevent obesity. to reach treatment goals, although it is not known at ■ Alcoholic beverage consumption. what doses there may be less risk of serious side effects.

13 Box 13 Boning Up On Osteoporosis More than eight million American women have osteoporosis— as supplements but check with your health care provider first. and millions more have such low bone density that they’re Too much of either can cause problems. Recommended daily likely to develop it. intakes of calcium and vitamin D are given in Box 14. Good food sources of calcium include canned with bones (such Osteoporosis can happen at any age, but the risk increases as as salmon and sardines), broccoli, dark green leafy vegetables, you get older. The first noticeable sign of osteoporosis is often (such as kale, turnip greens, and collards), dairy foods such as losing height or breaking a bone easily. Other signs can be nonfat or low-fat milk, calcium-fortified orange juice, soy-based changes in spine shape, prolonged severe pain in the middle beverages with added calcium, and cereal with added calcium. of the back, and tooth loss. Vitamin D is made by the body—being in the sun 20 minutes a day helps most women make enough. But it’s also found Risk factors for osteoporosis include: in foods such as fatty fish (sardines, mackerel, and salmon), ■ Age—risk increases as you grow older. and cereal and milk fortified with Vitamin D. Thirty minutes of weight-bearing exercises such as walking, jogging, stair ■ Being female—Women have less bone tissue than do men climbing, weight training, tennis, and dancing, done three and tend to experience a rapid loss of bone in the first few to four times a week can help prevent osteoporosis. years after menopause. It’s also important not to smoke and to limit ■ Body size—small, thin-boned women are at greatest risk. how many alcoholic beverages you drink. Too much (for women, more than ■ Ethnicity—White and Asian women are at highest risk. one a day) can put you at risk for developing osteoporosis. Smoking ■ Having with a history of osteoporosis as well as increases bone loss by decreasing estrogen fractures in adulthood can place someone at increased risk production. for osteoporosis. Osteoporosis is treated by stopping bone ■ Sex hormones—abnormal absence of menstrual periods loss with lifestyle changes and medication. () or menopause. Hormone therapy has been used to prevent and treat osteoporosis. But other drugs ■ Anorexia. are available:

■ Lifetime diet low in calcium and vitamin D. ■ Raloxifene is a selective estrogen modulator (SERM), which preserves bone density and prevents ■ Certain medications, such as (prescribed fractures (although not hip fractures). Possible side effects for various diseases, including arthritis, asthma, and ) include hot flashes and blood clots. and some . ■ Alendronate (brand name Fosamax) and risedronate (brand ■ Physical inactivity or extended bed rest. name Actonel) are bisphosphonates, drugs that slow the breakdown of bone, prevent fractures, and may increase ■ Cigarette smoking. reverse bone loss. Side effects may include nausea, heart- burn, and pain in the . ■ Excessive use of alcoholic beverages. ■ Calcitonin is a naturally occurring nonsex hormone that If you think you’re at risk for osteoporosis or if you’re increases bone mass in the spine, and it may prevent some menopausal or postmenopausal, you may want to ask your fractures. It is used to treat women who have osteoporosis doctor or other health care provider about having a DXA-scan and who are at least 5 years beyond menopause. The drug (dual-energy x-ray absorptiometry). It measures spine, hip, is taken by or nasal spray. The injection may cause or total body density, or how solid bones are. an allergic reaction and has some unpleasant side effects, The results can show the presence and severity of osteoporosis, including of the face and hands, urinating often, or if you’re at risk of developing it or having fractures. nausea, and skin rash. The nasal spray may cause a runny nose. You can prevent osteoporosis. The key steps are to follow an eating plan rich in calcium and vitamin D, and be sure to get ■ Teriparatid (parathyroid hormone), which may reverse regular weight-bearing exercise. Although food sources are usu- bone loss. ally better absorbed, calcium and vitamin D intake can be taken

14 Facts About Menopausal Hormone Therapy 15 amoxifen—taken to prevent amoxifen—taken to prevent Obesity and related conditions. Obesity and related T cancer. breast or treat Race—White women are likely than African more American women to develop uterine cancer. cancer—those who Colorectal at have an inherited form are a higher risk of developing uterine cancer. exposure Factors that increased menstrua- to estrogen—starting tion at an early age, not having never , children, or entering menopause late. Age—usually occurs after age Age—usually occurs after 50. — in cells in the lining an increase of the uterus. Hormone therapy—using estro- gen without progesterone. Risk Factors for Risk Factors Uterine Cancer ■ ■ ■ ■ ■ There are various types of uterine various types of are There The most common is cancer. which begins in , It is the uterine lining (). to as uterine cancer. often referred Key risk factors for uterine cancer are: ■ ■ ■ Box 16 Box (IU) Ulcerative colitis— a condition in which the lining of the colon becomes inflamed. Family medical history—having (parents, relatives first-degree with colorectal siblings, or children) especially at a young age; risk cancer, if many family even more increases members have had cancer. colorectal Personal medical history—having had also uterus, or breast; cancer of the , cancer once having had colorectal the chance of developing increases it again. Age—risk increases after age 50. after age Age—risk increases (overweight and obesity). of 25 or greater on the inner benign growths Polyps—these are wall of the colon and rectum. ■ ■ ■ ■ ■ Factors that increase the risk of colorectal cancer include: of colorectal the risk Factors that increase ■ About 30,000 women a year die of colorectal cancer—it is the third-leading cancer—it is the third-leading About 30,000 women a year die of colorectal cancers. and breast cause of cancer deaths for women after lung Risk Factors for Colorectal Cancer Colorectal for Risk Factors Note: International Units Note: International Units 70+ 600 IU* 1,200 mg** 51–70IU * not to exceed 2,000 400 IU*mg **not to exceed 2,500 1,200 mg** Age19–50 D Vitamin 200 IU* Calcium 1,000 mg** Recommended Daily Intakes of Calcium Intakes of Calcium Daily Recommended and Vitamin D Box 15 Box Box 14 Box When Menopausal Hormone terol, and moderate in total fat. Therapy Should Not Be Used In addition, limiting how much Findings from the WHI and salt and other forms of sodium HERS have led to conclusions you eat will help keep your blood about when menopausal hormone pressure at a healthy level. therapy should not be used: Take action to prevent osteoporosis ■ Menopausal hormone therapy and bone loss, including consum- should not be used to prevent ing enough calcium and vitamin heart disease. In fact, estrogen D (See Box 14.), being physically plus progestin actually increases active, especially with weight- the chance of a first heart bearing exercises (such as walking, attack, as well as breast cancer. jogging, playing tennis, and danc- Both forms of hormone therapy ing), not smoking, and limiting increase the risk for blood clots. how many alcoholic beverages you drink. Smoking and drinking ■ Women with heart disease excessive amounts of alcohol effective in preventing osteoporosis should not use menopausal increase your risk of osteoporosis. and fractures.These include hormone therapy to prevent oral biphosphonates, such as the risk of further heart disease. Talk with your health care alendronate (or Fosamax) and Such use increases the risk of provider about what your personal risedronate (or Actonel), and blood clots. It also increases the risks and benefits would be from selective risk of heart attack in the first either estrogen-alone or estrogen- modulators (SERMs), such as year of therapy. plus-progestin therapy to prevent raloxifene (or Evista). SERMs osteoporosis. Consider whether are also known as designer What Can You Do Instead? the risks of osteoporosis outweigh estrogens.They are substances Talk to your health care provider the risks of hormone therapy. that have estrogen-like effects about lifestyle changes and other on some tissues and anti-estrogen action steps that have proven to Ask about alternate medications effects on others. For more on be safe and effective in helping that are considered safe and osteoporosis, see Box 13. to prevent heart disease and osteoporosis.Ways to prevent heart disease and stroke include lifestyle changes and such drugs as cholesterol-lowering and blood pressure medications. Lifestyle changes include: not smoking, maintaining a healthy weight, being physically active, and managing diabetes. (See Box 21 to learn more about heart dis- ease risk factors.)

Another key lifestyle change is to follow a healthy eating plan that has a variety of foods, including grains, especially whole grains, and dark green leafy vegetables, deeply colored fruits, and dry beans and peas. It should also be low in saturated fat, trans fat, and choles- 16 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

Box 17 Risk Factors for About 1 in 57 American women will develop ovarian cancer. Most will be over age 50, but younger women also can develop the disease.

Here are some factors that increase or decrease the risk of ovarian cancer:

Increases risk Decreases risk ■ Age—risk increases as a woman ages. ■ Oral contraceptives—the longer the use, the lower the risk may be, and the decrease may last after use has ended. ■ Family history of ovarian cancer—higher risk if mother or sister has had ovarian cancer; somewhat higher risk if other ■ Childbearing and breast-feeding. relatives, such as grandmother, aunt, or cousin, have devel- oped ovarian cancer. ■ () or hysterectomy.

■ Menopausal hormone therapy—may increase risk. ■ Surgery to remove one or ovaries to help prevent ■ drugs. ovarian cancer, which is called a prophylactic ■ Personal history of breast and/or colon cancer. .

General Advice for the Postmenopausal Years The postmenopausal years are a time when the risk for various conditions rises. Be sure to protect your health by having certain tests (See Box 22 for details.):

■ Keep a regular schedule of mammograms, and breast and clinical exams.

■ Check your blood pressure at least every 2 years (more frequently if it is elevated). every 3 years, beginning at age or if you’re at risk for develop- ■ Know your cholesterol 45. If you have risk factors ing it or having fractures. levels—they should be tested for diabetes, start the test at least once every 5 years at a younger age and take ■ Learn your body mass index (more frequently if levels it more often. (BMI) and waist circumfer- are elevated). ence—this will tell if you need ■ Find out your bone mineral to lose weight. Check these ■ Test your fasting blood density with a DXA-scan (dual- every 2 years or more often (sugar) level—this is a test to see energy x-ray absorptiometry)— if your doctor recommends. if you have diabetes or are likely results can show the presence (See Box 23.) to develop it.Take it at least and severity of osteoporosis,

17 Box 18 Menopausal Hormone Therapy and Ovarian Cancer Risk Early menopausal hormone therapy studies found inconsistent results about its effect on the risk of ovarian cancer: some reported increased risk with estrogen use, while others reported no effect or even a protective one. Most of those studies were relatively small and did not take into account the key ovarian cancer risk factors.

However, two large observational studies have indicated that long-term estrogen use may increase the risk of ovarian cancer. It’s important to keep in mind that observational studies do not prove that a treatment causes a disease (See Box 6.). The evi- dence from these studies is cautionary, not definitive.

Here’s more on the studies:

■ One study followed 211,581 postmenopausal women More research is needed to see if estrogen plus progestin from 1982–1996. Of those, 44,260 had used estrogen- affects ovarian cancer risk—and on other aspects of only hormone therapy; the rest did not use hormone ther- menopausal hormone use. For instance, another recent apy. None of the women had had a hysterectomy, ovari- study found that estrogen alone or estrogen plus progestin an surgery, or cancer. Those with 10 or more years of used on a sequential basis increased the risk of ovarian can- estrogen use had an increased risk of dying from ovarian cer, while estrogen plus progestin used continuously did not cancer—and, while the risk decreased somewhat long increase ovarian cancer risk. The WHI trial of estrogen plus after use was stopped, it was still higher than that of progestin found a small increase in ovarian cancer, which is women who had never used estrogen-only therapy. not statistically significant.

■ Another study followed 44,241 women from 1979–1998. It found that estrogen-only therapy increased the risk of ovarian cancer. Women who used estrogen-only for 10 or more years had an 80 percent higher risk of ovarian cancer than women who had never used the hormone therapy; women who used estrogen-alone for 20 or more years had a 220 percent higher risk than women who had never used hormone therapy.

The study found no increased risk of ovarian cancer for users of estrogen plus progestin. However, few women in the study had used the combination therapy for more than 4 years.

18 Facts About Menopausal Hormone Therapy 19 care provider can speak with provider care What alternatives osteoporosis? can help me prevent returning? from What can I do to keep menopausal symptoms also important to bear in mind that your doctor or other s our risk for heart disease, osteoporosis, breast cancer, cancer, breast our risk for heart disease, osteoporosis, Oral contraceptives do pose risks, however: combination oral however: combination do pose risks, Oral contraceptives Oral contracep- clots. the risk of blood increase contraceptives for blood at an elevated risk if you are tives should not be used or another condition, or if you clots because of diabetes your and smoking increases oral contraceptives Taking smoke. stroke. risk for heart attack and the risk of has benefits too: it can reduce Oral contraceptive use pelvic and cancer, colorectal endometrial cancer, ovarian cancer, that can lead to ). inflammatory disease (an ■ ■ health care provider may not be able to answer all of your ques- may not be able provider health care tions—many questions about menopausal hormone use remain not yet known if disease risk For instance, it’s unanswered. drop when long-term use of estrogen-plus-progestin increases weigh you need to carefully As with any treatment, use stops. your personal risks against the possible benefits and make the best choice possible for your health and lifestyle needs. your doctor or other health Finally, of For a list a WHI principal investigator about the study results. site or the principal investigators, check the NHLBI WHI Web contact the NHLBI Health Information Center (See page 24.). Y So remember cancer may change over time. and colorectal your health status with your doctor or other review to regularly provider. health care It’ Is there an alternativeIs there therapy that I can use long term? What alternatives heart disease? can help me prevent Should I stop taking the hormone therapy? will the best way for me to stop? What side effects What’s I have? Why am I taking hormone therapy? or Why should I take hormone therapy? Which hormone therapy am I on? cancer, my risks for heart disease, breast What are or osteoporosis? cancer, colorectal alking With Your Your alking With Doctor What About Pills? Control What In June 2002, findings of the Women’s Contraceptive and In June 2002, findings of the Women’s (also called the Women’s Experiences Study Reproductive risk of and showed no increased released CARE Study) were of length of oral contraceptive use, regardless cancer, breast factors for develop- timing of use, age at use, or the users’ risk National supported by the NIH’s The study, cancer. ing breast involved Institute of Child Health and Human Development, the ages of 35 and 64. than 9,257 women between more about their contraceptive use. interviewed The women were There had been concern about pills’ effect on the had been concern pills’ effect There birth control about studies had found cancer because, until recently, risk of breast a 1996 analysis of 54 small For example, conflicting results. cancer rates among in breast increase studies found a slight But oral contraceptives. used or had recently women who were included oral con- in quality and some the 54 studies differed Other studies, such as no longer in use. traceptive preparations found no Hormone (CASH) study, the 1986 Cancer and cancer risk. breast increased Recent findings about risks of long-term menopausal hormone about risks of long-term Recent findings pills, which have control not apply to use of birth therapy do risk. cancer breast not been found to increase ■ ■ ■ ■ ■ ■ ■ It’s important to be involved in your health care. Ask questions important to be involved in your health care. It’s some questions that are Here your concerns. and express about provider may help you talk with your health care hormone therapy: T Box 19 Box Box 20 Box Box 21 Your Heart Disease Risk Profile One in three American women dies of heart disease. Risk factors beyond your control: Heart disease kills more American women than any other ■ Being age 55 or older cause. It also can lead to disability and decrease one’s quality of life. Yet, many women don’t take the threat of ■ Having a family history of early heart disease—this heart disease seriously. means having a mother or sister who has been diagnosed with heart disease before age 65, or a But menopause is a time when you need to get very father or brother diagnosed before age 55 serious about heart disease because that’s when your risk starts to rise. Risk factors are behaviors or habits Risk factors you can control: that make a person more likely to develop a disease. ■ Cigarette smoking They can also increase your chances that an existing disease will get worse. Having more than one risk factor ■ High blood cholesterol for heart disease is especially serious, because risk factors tend to “gang up” and worsen each other’s effects. ■ High blood pressure So it’s vital to prevent the development of risk factor, if you already have any, keep them under control. ■ Diabetes (high blood sugar)

So, it’s more important than ever to talk with your health ■ Overweight/obesity care provider about how to lower your risk of heart disease— or, if you already have it, to keep it under control. Ask ■ Physical inactivity about your “heart disease profile,” a check for heart disease risk factors you already have, or are at an For more on how to start reducing your heart disease increased risk of developing. risk, see the resources list on page 24.

Fortunately, most heart disease risk factors can be prevented or controlled. Here’s a breakdown of both types:

20 Facts About Menopausal Hormone Therapy 21 ectum using a thin, lighted tube called a colonoscope; a thin, lighted tube called ectum using Colonoscopy—examines the inside of the colon and the inside Colonoscopy—examines r have it once every 10 years healthy women should starting at age 50. and bone thickness measures Bone density—this x ray (See Box 13.); postmenopausal women with strength (besides risk factors for osteoporosis one or more women age and fractures, menopause) or who suffer factors should of added risk 65 and older regardless have this test. (EKG or ECG)—this tests the heart’s Electrocardiogram 40 electrical activity as it beats; women over age should have a baseline EKG. ■ ■ ■ elative to your height, while waist circumference meas- elative to your height, while waist circumference —this test checks a sample of cervical cells for changes that may lead to cancer; begin by having it as part of an annual gynecological exam and if normal 3 talk with your doctor about how often to years in a row, have it after that. Mammogram—a special x ray of the breast; healthy Mammogram—a special x ray of the breast; for women age 40 and older should be screened cancer with mammography once every 1 to 2 breast is especially important years; studies show screening for those aged 50–69; women also should do breast self-exams and have their doctor or health care exam during routine do a clinical breast provider physical exams. ures abdominal fat. Box 23 tells you how to calculate abdominal fat. ures A BMI of 25 or higher is overweight or your BMI. than of more For women, a waist circumference obese. risk for heart disease 35 inches indicates an increased also will provider health care Your and other conditions. associ- check you for other risk factors and conditions ated with obesity to determine the best treatment. Overweight and obesity check—this is done by calcu- Overweight and obesity check—this is done your lating your BMI (body mass index) and measuring of your weight BMI is a measure waist circumference. r Blood glucose—tests blood levels of glucose (a sugar) Blood glucose—tests healthy women age 45 and indicates risk for diabetes; especially and older should have blood glucose tested, normal and women are overweight; if it’s if they are again in healthy and not overweight, it should be taken often. 3 years, while others will need it more Lipoprotein profile—checks blood levels of LDL, HDL, blood levels profile—checks Lipoprotein and ; healthy women and total cholesterol 5 years. should have it once every Blood pressure—healthy women should have it women Blood pressure—healthy others may need it checked checked every 2 years; often. more ■ ■ ■ ■ ■ ■ Here’s a prescription for better health: a prescription Here’s CheckOut It Box 22 Box Box 23 How Do I Stop Therapy? Check Your BMI Body mass index—or BMI—relates weight to height and is used as an indicator If you are on menopausal hormone of total body fat. It is used with waist circumference to see if you’re overweight therapy,talk with your health care or obese. provider about whether or not to stop it. Also ask about the best way To find your BMI, use the method below or go to the Aim For A Healthy Weight to discontinue the treatment.You Web page at www.nhlbi.nih.gov/health/public/heart/obesity/lose_wt/index.htm, can stop abruptly or by gradually which offers tables and an automatic calculator. reducing the dose over several months.With either method of Here are three steps to find your BMI: stopping the medication, you may have menopause-like symptoms. Step 1: Multiply your weight* in pounds by 703. Bone loss will likely resume after Step 2: Divide the answer by your height in inches. discontinuing hormone therapy. So if you have been taking hor- Step 3: Divide the answer again by mones to prevent osteoporosis, your height in inches. be sure to talk to your health care provider about other FDA- The BMI score means: approved medications and lifestyle actions that can help to minimize 18.5–24.9 Normal further bone loss. (See Box 13.) 25.0–29.9 Overweight If you stop treatment and 30.0 and above Obese menopausal symptoms occur, talk with your health care provider about alternative treatments (See Box 4.). But be aware that

*Weight wearing underwear but no shoes some of these remedies have not been proven effective or safe.

22 F acts About Menopausal Hormone Hormone Therapy Menopausal acts About

Questions Remain Additionally, scientists funded by studies of: The effects of soy the NHLBI, the National Cancer phytoestrogens on cardiovascular As noted, the WHI will Institute, the National Institute disease and osteoporosis, post- continue to follow women on Aging, the National Institute menopausal use of phytoestrogens in the menopausal hormone of Arthritis and Musculoskeletal on cardiovascular risk and health, therapy trials until 2010. Among and Skin Diseases, the National black cohosh and antidepressants the questions yet to be answered Center for Complementary and on hot flashes, botanical dietary are if and when increased risks , the National supplements on women’s health, and benefits decline after use Institute of Mental Health, and plant estrogens on breast cancer, of the therapy ends. other units of the NIH are and estrogen on . supporting research on the effects The WHI observational study is of menopausal hormones and also examining other forms of alternative therapies on menopause hormone therapy, including other symptoms and postmenopause estrogens, progestins, and SERMs. conditions.The research includes

23 For More Information The following resources can help you learn more about hormone therapy-related topics:

National Heart, Lung, NIH Osteoporosis and Related Bone North American Menopause Society and Blood Institute Diseases—National Resource Center Post Office Box 94527 National Institutes of Health 1232 22nd Street, NW Cleveland, OH 44101 NHLBI Health Information Center Washington, DC 20037-1292 Phone: (440) 442-7550 P. O. Box 30105 Phone: (202) 223-0344 Automated Consumer Request Line: Bethesda, MD 20824-30105 or toll-free (800) 624-BONE (800) 774-5342 Phone: (301) 592-8573 Fax: (202) 293-2356 Fax: (440) 442-2660 TTY: (240) 629-3255 TTY: (202) 466-4315 E-Mail: [email protected] Fax: (301) 592-8563 Web site: www.osteo.org Web site: www.menopause.org Web site: www.nhlbi.nih.gov WHI Web site: www.whi.org National Institute of Child Health Alliance for Aging Research and Human Development 2021 K Street, NW,Suite 305 National Cancer Institute National Institutes of Health Washington, DC 20006 National Institutes of Health NICHD Clearinghouse Phone: (202) 293-2856 Phone: (800) 4-CANCER P. O. Box 3006 Fax: (202) 785-8574 (800-422-6237) Rockville, MD 20847 Web site: www.nci.nih.gov Phone: (800) 370-2943 American Heart Association Fax: (301) 984-1473 National Center National Center for Alternative Email: 7272 Greenville Avenue and Complementary Medicine [email protected] Dallas,TX 75231 National Institutes of Health Web site: www.nichd.nih.gov Phone: (800) AHA-USA-1 NCCAM Clearinghouse (800-242-8721) P. O. Box 7923 Food and Drug Administration Web site: www.americanheart.org Gaithersburg, MD 20898-7923 U.S. Department of Health and Phone: (888) 644-6226 Human Services American Stroke Association TTY: (866) 464-3615 5600 Fishers Lane National Center International Phone: (301) 519-3153 Rockville, MD 20857 7272 Greenville Avenue Fax: (866) 464-3616 Phone: (888) INFO-FDA Dallas TX 75231 Web site: www.nccam.nih.gov (888-463-6332) Phone: (888) 4-STROKE Web site: www.fda.gov (888) 478-7653 National Institute on Aging Web site: www.strokeassociation.org National Institutes of Health Office on Women’s Health P. O. Box 8057 U.S. Department of Health National Osteoporosis Foundation Gaithersburg, MD 20898-8057 and Human Services 1232 22nd Street, NW Phone: (800) 222-2225 200 Independence Avenue, SW Washington, DC 20037-1292 TTY: (800) 222-4225 Room 730B Phone: (202) 223-2226 Web site: www.nia.nih.gov Washington, DC 20201 Web site: www.nof.org Publications Web site: Phone: (202) 690-7650 www.niapublications.org Fax: (202) 205-2631 Alzheimer’s Disease Web site: Web site: www.4women.gov/owh www.alzheimers.org National Women’s Health National Institute of Arthritis and Information Center Musculoskeletal and Skin Diseases Department of Health Information Clearinghouse and Human Services National Institutes of Health 8550 Arlington Blvd 1 AMS Circle Suite 300 Bethesda, MD 20892-3675 Fairfax,VA 22031 Phone: (301) 495-4484 Phone: (800) 994-WOMAN or (toll free) (877) 22-NIAMS (800-994-9662) TTY: (301) 565-2966 or (888) 220-5446 Fax: (301) 718-6366 Web site: www.4women.gov Web site: www.niams.nih.gov

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute

NIH Publication No. 05-5200 Originally Printed October 2002 Revised June 2005

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