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When the same women in NSABP were rerandomized to receive either placebo or more prolonged tamoxifen treatment, no additional advantage was obtained through 7 years of followup after rerandomization from tamoxifen administered beyond 5 years. 152 Two other clinical trials of tamoxifen in breast cancer prevention have presented interim results. In a British trial, 2,494 women aged 30 to 70 years with a family history of breast cancer were randomly assigned to tamoxifen or placebo and followed for up to 8 years. 153 The risk of invasive or in situ breast cancer was 1.06 in the group given tamoxifen compared to the group given placebo. One difference between this and the U.S. trial study was that the British women were allowed to use HRT during the trial (about one-third of study participants were users). In a trial conducted in Italy, 5,408 women who had a hysterectomy were randomized to 5 years of tamoxifen or placebo. 154 The study was stopped prematurely because of patient drop-out. After a median of 46 months of followup, there was no difference in breast cancer incidence by treatment arm. Despite the inconsistent trial results, the U.S. F.D.A. has approved the use of tamoxifen for breast cancer risk reduction in high-risk women. 155 Less information is available for other SERMs. In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial of 7,705 postmenopausal osteoporotic women under age 81, 60 or 120 mg of raloxifene daily decreased breast cancer risk by 76 percent (RR = 0.24, 95 percent CI, 0.1–0.4) as compared to nonusers. 156 In most studies, HRT has been related to increased ovarian and decreased colorectal cancer risk, but these issues await further investigation. Risk for thromboembolic disease was increased threefold, but there was no increased risk for endometrial cancer in raloxifenetreated compared with placebo-treated women. The 242 U.S. <strong>National</strong> Cancer Institute and the NSABP are now conducting a large, multicenter study to test tamoxifen versus raloxifene to determine whether raloxifene shows the same risk reduction as tamoxifen and to determine whether the risk for adverse events differs. In a 5-year osteoporosis prevention trial, mammographic density decreased significantly in women receiving raloxifene and placebo and showed a nonsignificant increase in women receiving ERT. 157 Consequently, raloxifene should not interfere with mammographic detection of breast cancer. Risk for invasive breast cancer is also being evaluated in 10,101 postmenopausal women with CHD or at high risk for its occurrence randomized to raloxifene or placebo in the RUTH trial. Research is also beginning to focus on whether more natural approaches to treating the menopause should be recommended. Although there is a growing enthusiasm for use of phytoestrogens, termed by some as natural SERMs, 158 their effects on cancer risk remain unresolved. 8. CONCLUSIONS Most potential favorable and adverse effects on cancer risk of HRT are restricted to current users. On the basis of observational epidemiologic data, the RR of breast cancer is moderately elevated in current and recent HRT users, and increases by approximately 2.3 percent per year with longer duration of use, but the effect decreases after cessation and largely, if not totally, disappears after about 5 years. Unopposed estrogen use is strongly related to endometrial cancer risk, but cyclic combined estrogen-progestin treatment appears to largely or totally reduce this side effect if progestin is used for more than 10 days per cycle. However, combined HRT may be related to higher risk of breast cancer as compared to unopposed estrogen.
In most studies, HRT has been related to increased ovarian and decreased colorectal cancer risk, but these issues await further investigation. Based on the available evidence, no strong or consistent relationship is present between HRT and liver or other gastrointestinal neoplasms, or melanoma. 9. FUTURE NEEDS • The breast cancer risk of the combination of estrogen and progestin should be further quantified: there are biological reasons to suspect an unfavorable effect of added progestin on breast carcinogenesis, and some epidemiological studies have suggested an excess risk. • Research is needed to determine whether the relation between HRT and breast cancer risk differs at various ages. Any risk-benefit ratio is particularly critical and must be carefully and individually assessed for elderly women using HRT after menopause in terms of relative and absolute risk. • In consideration of the better prognosis of breast cancer in HRT users, future research should further investigate a potentially favorable effect of hormone use on the biologic characteristics of breast tumors. • Additional studies are needed on HRT use in women with a diagnosis of breast cancer. • Although use of estrogen alone increases endometrial cancer risk, several studies indicate that combined HRT is not related to a major excess of endometrial cancer if progestin is given more than 10 or 14 days in each cycle. This should be better quantified to provide information for prescription. • The evidence on HRT and epithelial ovarian cancer risk is less consistent than that for endometrial and breast cancer, though available data suggest a positive relationship. • Additional research is needed to confirm a potentially favorable effect of HRT on colorectal cancer. In western countries, the number of deaths from colorectal cancers in women aged 55 or older are similar. Thus, a decrease in incidence or mortality from colorectal cancer could greatly affect the balance of risks and benefits associated with the use of HRT. • Further data on lung and liver cancer would also be useful. • Research is required on the use of tamoxifen and other SERMs and perhaps more natural approaches to treating the menopause. Although there is growing enthusiasm for use of phytoestrogens, termed by some as “natural” SERMs, their effects on cancer risk, if any, should be better understood. 243
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National Heart, Lung, and Blood Ins
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CHAIRS AND EDITORS Chair and Editor
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Anne McTiernan, M.D., Ph.D. Associa
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Lenore Manderson, Ph.D. Director an
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Michael Mendelsohn, M.D. Director,
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TABLE OF CONTENTS Preface XIII 1 Ex
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PREFACE Women’s health and menopa
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CHAPTER 1: EXECUTIVE SUMMARY Nanett
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TABLE 1-1 Evidence Categories Evide
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TABLE 1-2 (continued) Possible Bene
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symptom measures, cultural factors,
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5. PHYSIOLOGICAL ROLE OF ESTROGEN A
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The atherogenic risk profile of old
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• Hormone replacement therapy: Fi
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tion of the remaining ridge in area
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9.3.1 Interventions • In many cas
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Parkinson’s disease, no overall p
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TABLE 1-3 (continued) Sexuality •
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CHAPTER 2: THE MENOPAUSE AND AGING
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oped and are less prepared to addre
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FIGURE 2-4 Diabetes Mellitus. Estim
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Sarcopenia, defined as reduced musc
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Perimenopause WHO The term “perim
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decrease about 2 years before the F
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4.3 Menstrually Defined Menopausal
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to be under stress and to hold part
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21 Brincat MP. Hormone replacement
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62 Orentreich N, Brind JL, Rizer RL
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CHAPTER 3: SYMPTOMS AND THE MENOPAU
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women who may have reached natural
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numb-tingling feelings, headaches,
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(47 percent), problems sleeping (39
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FIGURE 3-2 Proportion of Women Both
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tomized hypogonadotropic women expe
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5.1 Exercise It has been suggested
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to consume 20-150 mg/day of isoflav
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REFERENCES 1 Stewart AL, Hays RD, W
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48 Avis NE, Crawford SL, McKinlay S
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92 Albertazzi P, Pansini F, Bonacco
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Hällström wrote that the psycholo
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countries. Perhaps, as the authors
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Beyene used a systematic ethnograph
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ange of variables, such as genetic
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REFERENCES 1 Gannon L, Ekstrom B. A
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47 George T. Women in a south India
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9. Estrogen and inhibins produced b
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HRT) display tissue-selective estro
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a partial agonist. In contrast, wit
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3. UROGENITAL TRACT ERα and ERβ a
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4. BONE: DEVELOPMENT AND HOMEOSTASI
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in response to estrogen. 106,105 In
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lation of sleep, motor behavior, an
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7. HORMONE REPLACEMENT THERAPY: TRA
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REFERENCES 1 Jensen EV, Jacobsen HI
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40 Power RF, Mani SK, Codina J, Con
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83 Oursler MJ, Pederson L, Fitzpatr
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125 Gabrielsson BG, Carmignac DF, F
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169 Renier MA, Vereecken A, Buytaer
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FIGURE 6-1 Structural features of E
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ound, the conformation of the recep
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with extremely potent estrogenic ac
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Its potency as an antiestrogen was
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The observation that the degree of
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findings were remarkable because a
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Recently, the use of phage display
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20 Crawley G. Non steroidal estroge
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65 Qu Q, Zheng H, Dahllund J, et al
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in their survey of postmenopausal w
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where over half the world’s popul
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The Danish study of Koster and Gard
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Many studies of sexual interest in
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7. ASSESSING SEXUAL ACTIVITY Clinic
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None of these studies evaluated the
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estrogen-androgen group during the
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REFERENCES 1 Sarrel PM, Whitehead M
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52 Utian WH. The true clinical feat
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140
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outes of administration and differe
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FIGURE 8-2 Change in Age-Adjusted D
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fied as overweight or obese. 32 The
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TABLE 8-1 148 Guide to Risk Reducti
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TABLE 8-1 (continued) 150 Recommend
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TABLE 8-1 (continued) 152 Recommend
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Interesting differences in atherosc
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similar effects in both patients wi
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a lowering of triglycerides, 140 an
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may account for a substantial propo
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associated with an independent prot
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eases preoperatively. Quality of li
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excess risk of 6-18 per 10,000 per
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REFERENCES 1 NHLBI Morbidity and Mo
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36 Samaras K, Hayward CS, Sullivan
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79 Collins P, Rosano GM, Jiang C, L
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121 Mäkelä S, Savolainen H, Aavik
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162 Clarke S, Kelleher H, Lloyd-Jon
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201 Rahimtoola SH, Bennett AJ, Grun
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243 Varas-Lorenzo C, Garcia-Rodriqu
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7. A connection between menopausal
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3. PATHOGENESIS OF FRACTURE Fractur
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Diagnosis of osteoporosis according
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density and has a favorable effect
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How should this information be inco
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Page 210 and 211: Data on the relation between skelet
Page 212 and 213: REFERENCES 1 Osteoporosis Preventio
Page 214 and 215: 42 Gluer CC. Quantitative ultrasoun
Page 216 and 217: 85 Ettinger B, Pressman A, Silver P
Page 218 and 219: 130 Jeffcoat MK, Lewis CE, Reddy M,
Page 220 and 221: 1. INTRODUCTION Perimenopausal wome
Page 222 and 223: for breast cancer are at increased
Page 224 and 225: findings on biopsy in women with an
Page 226 and 227: thra. Patients typically describe l
Page 228 and 229: Biofeedback: Used in conjunction wi
Page 230 and 231: There has been one systematic revie
Page 232 and 233: ence in pelvic organ prolapse. The
Page 234 and 235: 21 Ferenczy A. Endometrial carcinom
Page 236 and 237: 65 Wyman JF, Fantl JA, McClish DK,
Page 238 and 239: 222
Page 240 and 241: 1. INTRODUCTION Worldwide, breast c
Page 242 and 243: difficult to compare because of com
Page 244 and 245: Although HRT has been related to an
Page 246 and 247: cyclic use and 2.9 (95 percent CI 2
Page 248 and 249: TABLE 11-3 Selected Studies on Horm
Page 250 and 251: TABLE 11-3 (continued) Thus, a stro
Page 252 and 253: TABLE 11-4 236 Cohort Studies on Ho
Page 254 and 255: TABLE 11-5 238 Case-Control Studies
Page 256 and 257: TABLE 11-5 (continued) 240 Adjustme
Page 260 and 261: REFERENCES 1 Pisani P, Parkin DM, B
Page 262 and 263: 47 Day NE. Epidemiology: the role o
Page 264 and 265: 93 Rodriguez C, Patel AV, Calle EE,
Page 266 and 267: 139 Parazzini F, La Vecchia C, Negr
Page 268 and 269: 1. INTRODUCTION Menopause is associ
Page 270 and 271: inverse relation with nonverbal mem
Page 272 and 273: ease decreased significantly with i
Page 274 and 275: of households selected to be repres
Page 276 and 277: standard antipsychotic drugs increa
Page 278 and 279: 5. FUTURE NEEDS • Explore the pos
Page 280 and 281: 19 Berman KF, Schmidt PJ, Rubinow D
Page 282 and 283: 64 Lerner A, Koss E, Debanne S, Row
Page 284 and 285: 114 Smith R, Studd JW. A pilot stud
Page 286 and 287: 162 Klein BE. Lens opacities in wom
Page 288 and 289: patients with strong personal convi
Page 290 and 291: Therefore, convincing evidence of t
Page 292 and 293: 3.1.1 Risk Factors Many factors are
Page 294 and 295: 278 lower dosages of estrogen will
Page 296 and 297: • Diabetes: Women with diabetes b
Page 298 and 299: Lipids and lipoproteins • LDL cho
Page 300 and 301: 284 persists but is less steep in w
Page 302 and 303: 5.2.3 Pharmacotherapy Breast Cancer
Page 304 and 305: • There is no clinical trial evid
Page 306 and 307: Sirtori CR, Pazzucconi F, Colombo L
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Hansson L, Zanchetti A, Carruthers
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Dementia and Mental Health Forette
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CRP C-reactive protein CT computed
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PTCA percutaneous transluminal coro
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U.S. DEPARTMENT OF HEALTH AND HUMAN
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