ou may want to consider alternatives to hormone therapy to ease menopa - PDF document

1 4 Box 4 ou may want to consider alternat
4 Box 4 ou may want to consider alternatives to hormone therapy to ease menopausal symptoms. The list below includes some locally applied hormone products, which might throughout the body.Be aware that some of these remedies are regulated by theFederal Government as dietary supplements, and as such donot undergo premarket approval and may not have data show-ing them to be safe and effective (See Box 5.). Talk with yourdoctor or other health care provider about the best treatmentPositive moves you can make to feel better are related toadopting a healthy lifestyleÑdonÕt smoke, eat a variety offat, and cholesterol and mod-erate in total fat. Include grains, especially whole grains and avariety of dark green leafy vegetables, deeply colored fruit, anddry beans and peas in your eating plan. Also, maintain amost days of the week, preferably daily. Alternatives include:OsteoporosisSee Box 13 for lifestyle behaviors to protect bone density.Designer estrogen raloxifene (Evista), which preserves bonedensity and prevents fractures (although not hip

2 fractures).Bisphosphonates Actonel or F
fractures).Bisphosphonates Actonel or Fosamax, which preservebone density, prevent fractures, and can reverse bone losseraparatide (parathyroid hormone), which may reverseCalcitonin (a nasal spray or injectable), used to treat womenwho have osteoporosis, which may prevent some fractures(This drug is not approved for preventing osteoporosis.).Note: Phytoestrogens (see hot flashes) have not been shownto prevent osteoporosis or reduce the risk of fractures.fat, cholesterol andChoosing and preparing foods with less saltPreventing and controlling high blood pressurePreventing and controlling high blood cholesterolaking prescribed medication to control heart diseaseLifestyle changes. These include dressing and eating to avoid being too warm, sleeping in a cool room, andeducing stress. Avoid spicy foods and caffeine. Try deepbreathing and stress reduction techniques, including medi-tation and other relaxation methods.Phytoestrogens. Soybeans and some soy-based foods contain phytoestrogens, which are estrogen-likecompounds. Soy phytoestrogens

3 can be consumedthrough foods or supplem
can be consumedthrough foods or supplements. Soy food products includetofu, tempeh, soy milk, and soy nuts. Other plant sources of phytoestrogens include such botanicals such as blackcohosh, wild yam, dong quai, red clover, and valerian root.However, there is no solid evidence that the phytoestrogensin soybeans, soy-based foods, other plant sources, ordietary supplements really do relieve hot flashes. Further,the risks of taking the more concentrated forms of soy phytoestrogens, such as pills and powders, are not known.Dietary supplements with phytoestrogens do not have to meet the same quality standards as do drugs. Little isknown about the safety or efficacy of these products. Antidepressants, such as Effexor, Paxil, and Prozac. These medications have been proved moderately effectiveProducts that release estrogen locally (such as vaginalcreams, a vaginal suppository, called Vagifem, and a plasticring, called an Estring)Ñthese are used for more severedryness. The ring, which must be changed every 3 months,contains a low dose of estrog

4 en and may not protectagainst osteoporos
en and may not protectagainst osteoporosis. Relaxation exercisesAntidepressant or anti-anxiety drugsOver-the-counter sleep aidsMilk products, such as a glass of milk or cup of yogurtÑchoose low-fat or fat-free varietiesÑconsumed at bedtimeDo physical activity in the morning or early afternoonÑexercising later in the day may increase wakefulnessHot shower or bath immediately before going to bedMemory problemsMental exercises Alternatives to Hormone Therapy To Help Preventostmenopausal Conditions and Relieve Menopausal Symptoms Menopause may cause otherchanges that produce no symp-toms yet affect your health.Forinstance,after menopause,womenÕsrate of bone loss increases.Theincreased rate can lead to osteo-porosis,which may in turn increasethe risk of bone fractures.The riskof heart disease increases with age,menopause.Through the years,studies werefinding evidence that estrogenpostmenopausal health risksÑespecially heart disease and osteoporosis.With more than 40 million American women overage 50,the promise seemed great.Although many women th

5 ink it is a ÒmanÕs disease,Óheart diseas
ink it is a ÒmanÕs disease,Óheart diseaseis the leading killer of Americanomen.Women typically developit about 10 years later than men.Furthermore,women are moreprone to osteoporosis than men.Menopause is a time of increasedbone loss.Bone is living tissue.Old bone is continuously beingbroken down and new boneformed in its place.Withmenopause,bone loss is greaterand,if not enough new bone ismade,the result can be weakenedbones and osteoporosis,whichincreases the risk of breaks.One of every two women over age 50will have an osteoporosis-relatedfracture during her life.Many scientists believed theseincreased health risks were linkedto the postmenopausal drop inestrogen produced by the ovariesand that replacing estrogen wouldhelp protect against the diseases. acts About Menopausal Hormone Therapy Box 5 symptoms, be aware that these productsdo not require U.S. Food and DrugAdministration (FDA) review or approvalprior to their marketing. Because they areconsidered Òdietary supplements,Ó theyare covered by less stringent regulationsthan those invol

6 ving prescription drugs.Manufacturers ar
ving prescription drugs.Manufacturers are responsible for estab-lishing that they are safe and efficacious.They can be sold without the review orapproval of the FDA. Thus, the quality ofthese products is not often known. It isimportant to tell your health care providerthat you are taking such remedies.The products sold over the counter as dietary supplements may be in pill orcapsule 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 beingstudied. For example, soy contains phytoestrogens, which are being studied to see if they have the same risks and benefits as estrogen.Some of this research is being supported by the Office of Dietary Supplements,the National Center for Complementary and Alternative Medicine, the NationalUntil 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 supplement or if you increase your intake of dietary phytoestrogens. Theremay be dan

7 gerous side effects. An increase in the
gerous side effects. An increase in the level of estrogens in yourbody could interfere with other prescription medications you are taking or evencause an overdose. About Dietary Supplements o important clinical trials the ÒPostmenopausalEstrogen/Progestin InterventionsialÓ(PEPI) and the ÒHeart andEstrogen-Progestin ReplacementStudyÓ(HERS).PEPI looked at the effect of estrogen-alone and combinationtherapies on key heart disease riskactors and bone mass.It foundgenerally positive results,includinga reduction by both types of ther-apy of ÒbadÓLDL cholesterol andan increase of ÒgoodÓHDL cholesterol.(LDL,or low densitylipoprotein,carries cholesterol totissues,while HDL,or high densitylipoprotein,carries it away,in its removal from the body.) HERS tested whether estrogenplus progestin would prevent a second heart attack or othercoronary event.It found noeduction in risk from such hormone therapy over 4 years.In fact,the therapy increasedmenÕs risk for a heart attackduring the first year of hormoneuse.The risk declined thereafter.HERS also found t

8 hat the therapycaused an increase in blo
hat the therapycaused an increase in blood clotsin the legs and lungs.The ÒHERSollow-Up Study,Ówhich trackedthe participants for about 3 moreears,found no lasting decrease inheart disease from estrogen-plus-progestin therapy.The WomenÕs HealthInitiativeIn 1991,the National Heart,Lung,and Blood Institute(NIH) launched the WomenÕsHealth Initiative (WHI),one ofthe largest studies of its kind everundertaken in the United States. acts About Menopausal Hormone Therapy Box 7 Estrogen AloneEstrogen Plus Progestin10,73916,608White75%84%Black15%7%Hispanic6%5%646350Ð5931%33%60Ð6945%45%70Ð7924%23%Ever35%20%At enrollment13%6%Normal21%31%Overweight35%35%Obese45%34%Ever38%40%At enrollment10%11%eated for high blood pressure48%36%*Percentages are rounded Altogether, the WHI involved about 161,000 healthy postmenopausal women.HereÕs the breakdown of participants in each study:WHIIn Profile* 8 Box 8 The two WHI studiesÕ findings should not be compared directly. Women in the estrogen-alone study began the trial with a higherrisk for cardiovascular disease than

9 those in the estrogen-plus-progestin stu
those in the estrogen-plus-progestin study. They were more likely to have such heart diserisk factors as high blood pressure, high blood cholesterol, diabetes, and obesity.Also, as you read the percentages below, bear in mind that the WHI involved healthy women, and only a small number of themhad either a negative or positive effect from either hormone therapy. The percentages given below describe what would happen ta whole populationÑnot to an individual woman. For example, breast cancer risk for the women in the WHI study taking estrogenplus progestin increased less than a tenth of 1 percent each year. But if you apply that increased risk to a large group of woover several years, the number of women affected becomes an important public health concern. About 6 million American womentake 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 a

10 renÕt fate. Whether expressing risks or
renÕt 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. WHIHormone Therapy FindingsEstrogen Plus ProgestinWith 5.2 years of followup. For every 10,000 women each year,estrogen plus progestin (combination therapy) use comparedwith a placebo on average resulted in:Increased risk forBreast cancer26 percent increased riskÑ8 more cases (38 cases onStroke41 percent increased riskÑ8 more cases (29 cases on29 percent increased riskÑ7 more cases (37 cases onDoubled ratesÑ18 more cases (34 cases on combinationIncreased benefitsColorectal Cancer37 percent less riskÑ6Fractures37 percent fewer hip fracturesÑ5 fewer cases (10 on com-No differenceEstrogen AloneWith 6.8 years of followup. For every 10,000 women each year,estrogen-alone use compared with a placebo on averageIncreased risk forStroke39 percent increase in strokesÑ12 more strokes (44 casesin those on estrogen alone an

11 d 32 in those on placebo)enous thrombosi
d 32 in those on placebo)enous thrombosis (blood clot, usually in a deep vein of legs)About a 47 percent higher riskÑ6 more cases (21 cases inthose on estrogen alone and 15 in those on placebo.) Anincreased risk of pulmonary embolism (blood clots in thelungs) was not statistically significant. There were 13 casesin those on estrogen alone and 10 in those on placebo.No difference in risk (neither increased nor decreased) or of uncertain effectCoronary heart diseaseNo significant differenceÑ5 fewer cases (49 cases in thoseon estrogen alone and 54 in those on placebo). During thefirst 2 years of use, the risk was slightly increased for estro-gen alone, but it appeared to diminish over time.Colorectal/total cancerNo significant differenceÑ1 more case for colorectal cancerand 7 fewer cases for total cancer (for colorectal cancer, 17cases with estrogen alone and 16 with placebo; for totalcancer, 103 cases in those on estrogen alone and 110 inNo significant differenceÑ3 more deaths (for all deaths, 81in those on estrogen alone and 78 in those on pl

12 acebo)Breast cancerUncertain effectÑ7 fe
acebo)Breast cancerUncertain effectÑ7 fewer cases (26 cases in those onestrogen alone and 33 in those on placebo). This findingIncreased benefitBone fractures39 percent fewer hip fracturesÑ6 fewer cases (11 cases inthose on estrogen alone and 17 cases in those on placebo) ly 2002,and the estrogen-alonestudy at the end of February 2004.men in both trials are now in a followup phase,due to last until2007.During the followup,theirhealth will be closely monitored.See Boxes 8 and 9.Effects on Disease and DeathBriefly,the combination therapystudy was stopped because of anincreased risk of breast cancer andbecause,overall,risks from use ofthe hormones outnumbered thebenefits.ÒOutnumberedÓmeansthat more women had adverseeffects from the therapy than benefited from it.For breast cancer,the risk was greatest amongmen who had used estrogenplus progestin before entering thestudy,indicating that the therapymay have a cumulative effect.The combination therapy alsoincreased the risk for heart attack,stroke,and blood clots.For heartattack,the risk was parti

13 cularlyhigh in the first year of hormone
cularlyhigh in the first year of hormoneuse and continued for several yearsthereafter.Unlike HERS,whichinvolved women with heart disease,there was an overallincreased risk from the hormonetherapy over the 5.6 years of theisk for blood clots waseatest during the first 2 years ofhormone useÑfour times higherthan that of placebo users.By theend of the study,the risk for bloodclots had decreased to two timeseaterÑor 18 more women withlood clots each year for every10,000 women.Estrogen plus progestin alsoeduced the risk for hip and otherfractures,and colorectal cancer.The reduction in colorectal cancerisk appeared after 3 years of hormone use and became moremarked thereafter.However,the number of cases of colorectalcancer was relatively small,and more research is needed to confirm the finding.study wasstopped after almost 7 yearsbecause the hormone therapyincreased the risk of stroke and 10 Box 9 The data sound scaryÑand confusing. Estrogen plus progestinincreases stroke risk by 41 percentÑand decreases the risk forhip fractures by 34 percent?

14 Which is more important? Either way, th
Which is more important? Either way, the percentages sound big. So itÕs good to take a moment and check out what theyÕre really saying.There are two main ways to express riskÑÒrelative riskÓ andÒabsolute risk.Ó Relative risk estimates percent increase ordecrease in a health event occurring in one group compared to another group. Absolute risk estimates the number of healthevents among individuals in a group, and gives a better senseThe risk to an individual can be low, but in a large populationthe number of health events can be great. taking estrogen plus progestin for one year, there will be 8 morecases of breast cancer among the hormone users than if theyhad not taken the therapy. So, the absolute risk to the individ-ual is relatively low. substantial. If you count up all the added cases of breast cancer, heart attacks, strokes, and blood clots in the lungs andsubtract the fewer cases of colorectal cancer and hip fractures,ran. Multiply that by 10 years and millions of women takinghormones and the number of cases of adverse effects g

15 rows.Remember too that reports ofincreas
rows.Remember too that reports ofincreased risks do notbreast cancer ortherapy. Your per-medical history, What Do the Data Really Mean? did not reduce the risk of coro-nary heart disease.It also increasedthe risk for venous thrombosis(blood clots deep in a vein,usuallyin the leg).There also was a trend towards increased risk forpulmonary embolism (blood clotsin the lungs),but it was not statis-tically significant (See Box 10 cance.).The therapy had no significant effect on the risk ofheart disease or colorectal cancer.Its effect on breast cancer wasuncertain.Although the risk forbreast cancer for those on estrogenalone appeared to be lower,thisfinding was not statistically signifi-cant (see Box 10).Estrogen aloneeduced the risk for hip and otherfractures.The reduction beganearly in the study and persistedthroughout the followup period.Neither estrogen plus progestinnor estrogen alone affected theEffects On Mental Functions An ancillary study of the hormonetrials,the WHI Memory Study(WHIMS),included women age65 and older.It found that woment

16 aking estrogen plus progestin hadtwice t
aking estrogen plus progestin hadtwice the rate of dementia,includ-ing AlzheimerÕs disease,as those onthe placebo.The combinationtherapy also did not protectomen against mild cognitiveimpairment,which is a less severehaving trouble paying attentionand remembering.Estrogen alone also increased theisk of mild cognitive impairmentplus dementia,though the numberof cases of dementia alone was too acts About Menopausal Hormone Therapy Box 10 Sometimes, studies report results that are not Òstatistically significant.Ó Forinstance, in the WHI, estrogen alone caused fewer cases of breast cancer, butthe finding was not statistically significant. How can that be?Significance with statistics refers probably trueÑand probably notdue to chance. With breast cancer,the result could be due to factorsother than hormone therapy, suchas genetics or environmental exposures. The difference in breast cancer cases between the estrogen-alone and placebo groups was not large enough to rule outSome of the WHI findings are ofuncertain effect or not statisticallysigni

17 ficant. They are intriguing findings th
ficant. They are intriguing findings that need more research. Significant Statistics 14 Box 13 More than eight million American women have osteoporosisÑand millions more have such low bone density that theyÕre Osteoporosis can happen at any age, but the risk increases asyou get older. The first noticeable sign of osteoporosis is oftenlosing height or breaking a bone easily. Other signs can bechanges in spine shape, prolonged severe pain in the middle Risk factors for osteoporosis include:AgeÑrisk increases as you grow older.Being femaleÑWomen have less bone tissue than do menBody sizeÑsmall, thin-boned women are at greatest risk.EthnicityÑWhite and Asian women are at highest risk.Having parents with a history of osteoporosis as well asfractures in adulthood can place someone at increased riskfor osteoporosis.Anorexia.Certain medications, such as glucocorticoids (prescribedPhysical inactivity or extended bed rest.Cigarette smoking.If you think youÕre at risk for osteoporosis or if youÕremenopausal or postmenopausal, you may want to ask your

18 doctor or other health care provider abo
doctor or other health care provider about having a DXA-scan(dual-energy x-ray absorptiometry).It measures spine, hip, or total body bone mineral density, or how solid bones are. The results can show the presence and severity of osteoporosis,or if youÕre at risk of developing it or having fractures.ou can prevent osteoporosis. The key steps are to follow aneating plan rich in calcium and vitamin D, and be sure to getegular weight-bearing exercise. Although food sources are usu-as supplements but check with your health care provider first.oo much of either can cause problems. Recommended dailyintakes of calcium and vitamin D are given in Box 14. Goodfood sources of calcium include canned fish with bones (suchas salmon and sardines), broccoli, dark green leafy vegetables,(such as kale, turnip greens, and collards), dairy foods such asnonfat or low-fat milk, calcium-fortified orange juice, soy-basedbeverages with added calcium, and cereal with added calcium.itamin D is made by the bodyÑbeing in the sun 20 minutes a day helps most women make

19 enough. But itÕs also found in foods s
enough. But itÕs also found in foods such as fatty fish (sardines, mackerel, and salmon), and cereal and milk fortified with Vitamin D. Thirty minutes of weight-bearing exercises such as walking, jogging, stairclimbing, weight training, tennis, and dancing, done three to four times a week can help prevent osteoporosis.ItÕs also important not to smoke and to limitoo much alcohol (for women, more thanfor developing osteoporosis. Smokingincreases bone loss by decreasing estrogenproduction.Osteoporosis is treated by stopping boneHormone therapy has been used to preventand treat osteoporosis. But other drugs are available:Raloxifene is a selective estrogen receptor modulator(SERM), which preserves bone density and prevents fractures (although not hip fractures). Possible side effectsAlendronate (brand name Fosamax) and risedronate (brandname Actonel) are bisphosphonates, drugs that slow thebreakdown of bone, prevent fractures, and may increaseeverse bone loss. Side effects may include nausea, heart-burn, and pain in the stomach.increases bo

20 ne mass in the spine, and it may prevent
ne mass in the spine, and it may prevent somefractures. It is used to treat women who have osteoporosisand who are at least 5 years beyond menopause. The drugis taken by injection or nasal spray. The injection may causean allergic reaction and has some unpleasant side effects,nausea, and skin rash. The nasal spray may cause a eriparatid (parathyroid hormone), which may reverse Boning Up On Osteoporosis acts About Menopausal Hormone Therapy Box 14 AgeVitamin DCalcium19Ð50200 IU*1,000 mg** 51Ð70400 IU*1,200 mg**70+600 IU*1,200 mg**Note: International Units * not to exceed 2,000 IU Recommended Daily Intakes of Calcium and Vitamin D Box 15 About 30,000 women a year die of colorectal cancerÑit is the third-leading cause of cancer deaths for women after lung and breast cancers.Factors that increase the risk of colorectal cancer include:AgeÑrisk increases after age 50.Body Mass Index of 25 or greater (overweight and obesity).PolypsÑthese are benign growths on the inner wall of the colon and rectum.cancer of the ovary, uterus, or breast; alsohav

21 ing had colorectal cancer onceincreases
ing had colorectal cancer onceincreases the chance of developing first-degree relatives (parents, siblings, or children) with colorectal cancer, especially at a young age; riskincreases even more if many familycolorectal cancer. Risk Factors for Colorectal Cancer Box 16 There are various types of uterinecancer. The most common isendometrial cancer, which begins inthe uterine lining (endometrium). It isoften referred to as uterine cancer.cancer are:an increase in cells in the liningHormone therapyÑusing estro-gen without progesterone.Obesity and related conditions.amoxifenÑtaken to prevent or treat breast cancer.RaceÑWhite women are more likely than Africanuterine cancer.Colorectal cancerÑthose whohave an inherited form are at uterine cancer.Factors that increased exposureto estrogenÑstarting menstrua-children, never breastfeeding, Risk Factors forUterine Cancer General Advice for theostmenopausal YearsThe postmenopausal years are a time when the risk for variousconditions rises.Be sure to protectour health by having certain tests(See Box 2

22 2 for details.):eep a regular schedule o
2 for details.):eep a regular schedule ofmammograms,and breast andCheck your blood pressure at least every 2 years (more frequently if it is elevated).Know your cholesterol levelsÑthey should be tested at least once every 5 years(more frequently if levels are elevated).est your fasting blood glucose(sugar) levelÑthis is a test to seeif you have diabetes or are likelyto develop it.Take it at leastery 3 years,beginning at age45.If you have risk factors for diabetes,start the test at a younger age and take it more often.Find out your bone mineralenergy x-ray absorptiometry)Ñesults can show the presenceand severity of osteoporosis,or if youÕre at risk for develop-ing it or having fractures.Learn your body mass index(BMI) and waist circumfer-enceÑthis will tell if you needto lose weight.Check theseevery 2 years or more often if your doctor recommends.(See Box 23.) acts About Menopausal Hormone Therapy Box 17 About 1 in 57 American women will develop ovarian cancer. Most will be over age 50, but younger women Here are some factors that increase or

23 decrease the risk of ovarian cancer: Ri
decrease the risk of ovarian cancer: Risk Factors for Ovarian CancerIncreases riskAgeÑrisk increases as a woman ages.elatives, such as grandmother, aunt, or cousin, have devel-oped ovarian cancer.Menopausal hormone therapyÑmay increase risk.Personal history of breast and/or colon cancer.Decreases riskmay be, and the decrease may last after use has ended.Childbearing and breast-feeding.ubal ligation (sterilization) or hysterectomy.Surgery to remove one or ovaries to help prevent ovarian cancer, which is called a prophylactic oophorectomy. As noted,the WHI will continue to follow women in the menopausal hormone therapy trials until 2010.Amongthe questions yet to be answeredare if and when increased risks of the therapy ends.The WHI observational study isalso examining other forms ofhormone therapy,including otherestrogens,progestins,and SERMs.Additionally,scientists funded bythe NHLBI,the National CancerInstitute,the National Institute on Aging,the National Institute of Arthritis and Musculoskeletaland Skin Diseases,the NationalCenter for Comp

24 lementary andAlternative Medicine,the Na
lementary andAlternative Medicine,the NationalInstitute of Mental Health,andother units of the NIH are supporting research on the effectsof menopausal hormones andalternative therapies on menopausesymptoms and postmenopauseconditions.The research includes studies of:The effects of soy phytoestrogens on cardiovasculardisease and osteoporosis,post-menopausal use of phytoestrogenson cardiovascular risk and health,lack cohosh and antidepressantson hot flashes,botanical dietary supplements on womenÕs health,plant estrogens on breast cancer,and estrogen on cognition. acts About Menopausal Hormone Therapy or More InformationThe following resources can help you learn more about hormone therapy-related topics:National Heart,Lung,NHLBI Health Information CenterBox 30105Bethesda,MD 20824-30105Phone:(301) 592-8573TTY:(240) 629-3255Fax:(301) 592-8563eb site:www.nhlbi.nih.govWHI Web site:www.whi.orgPhone:(800) 4-CANCEReb site:www.nci.nih.govNational Center for Alternative and Complementary MedicineNCCAM ClearinghouseBox 7923Gaithersburg,MD 20898-7923Phone: