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Menopausal Estrogen-Alone Therapy and Health Outcomes in Women With and Without Bilateral Oophorectomy: A Randomized Trial.

Published on Sep 17, 2019in Annals of Internal Medicine19.315
· DOI :10.7326/M19-0274
JoAnn E. Manson235
Estimated H-index: 235
(Brigham and Women's Hospital),
Aaron K. Aragaki40
Estimated H-index: 40
(Fred Hutchinson Cancer Research Center)
+ 17 AuthorsRoss L. Prentice90
Estimated H-index: 90
(Fred Hutchinson Cancer Research Center)
Abstract
Background: Whether health outcomes of menopausal estrogen therapy differ between women with and without bilateral salpingo-oophorectomy (BSO) is unknown. Objective: To examine estrogen therapy outcomes by BSO status, with additional stratification by 10-year age groups. Design: Subgroup analyses of the randomized Women's Health Initiative Estrogen-Alone Trial. (ClinicalTrials.gov: NCT00000611). Setting: 40 U.S. clinical centers. Participants: 9939 women aged 50 to 79 years with prior hysterectomy and known oophorectomy status. Intervention: Conjugated equine estrogens (CEE) (0.625 mg/d) or placebo for a median of 7.2 years. Measurements: Incidence of coronary heart disease and invasive breast cancer (the trial's 2 primary end points), all-cause mortality, and a "global index" (these end points plus stroke, pulmonary embolism, colorectal cancer, and hip fracture) during the intervention phase and 18-year cumulative follow-up. Results: The effects of CEE alone did not differ significantly according to BSO status. However, age modified the effect of CEE in women with prior BSO. During the intervention phase, CEE was significantly associated with a net adverse effect (hazard ratio for global index, 1.42 [95% CI, 1.09 to 1.86]) in older women (aged ≥70 years), but the global index was not elevated in younger women (P trend by age = 0.016). During cumulative follow-up, women aged 50 to 59 years with BSO had a treatment-associated reduction in all-cause mortality (hazard ratio, 0.68 [CI, 0.48 to 0.96]), whereas older women with BSO had no reduction (P trend by age = 0.034). There was no significant association between CEE and outcomes among women with conserved ovaries, regardless of age. Limitations: The timing of CEE in relation to BSO varied; several comparisons were made without adjustment for multiple testing. Conclusion: The effects of CEE did not differ by BSO status in the overall cohort, but some findings varied by age. Among women with prior BSO, in those aged 70 years or older, CEE led to adverse effects during the treatment period, whereas women randomly assigned to CEE before age 60 seemed to derive mortality benefit over the long term. Primary Funding Source: The WHI program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and U.S. Department of Health and Human Services. Wyeth Ayerst donated the study drugs.
  • References (32)
  • Citations (2)
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References32
Newest
#1JoAnn E. Manson (Brigham and Women's Hospital)H-Index: 235
#2Aaron K. Aragaki (Fred Hutchinson Cancer Research Center)H-Index: 40
Last. Jean Wactawski-Wende (UB: University at Buffalo)H-Index: 18
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© 2017 American Medical Association. All rights reserved. IMPORTANCE: Health outcomes from the Women’s Health Initiative Estrogen Plus Progestin and Estrogen-Alone Trials have been reported, but previous publications have generally not focused on all-cause and cause-specific mortality. OBJECTIVE: To examine total and cause-specific cumulative mortality, including during the intervention and extended postintervention follow-up, of the 2 Women’s Health Initiative hormone therapy trials. DESIGN, SE...
108 CitationsSource
#1Marisa R. Adelman (UofU: University of Utah)H-Index: 5
#2Howard T. Sharp (UofU: University of Utah)H-Index: 19
Over the last 2 decades, the rate of oophorectomy at the time of hysterectomy in the United States has consistently been between 40-50%. A decline in hormone use has been observed since the release of the principal results of the Women’s Health Initiative. Oophorectomy appears to be associated with an increased risk of coronary heart disease, as well as deleterious effects on overall mortality, cognitive functioning, and sexual functioning. Estrogen deficiency from surgical menopause is associat...
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#1Jemma Mytton (University Hospitals Birmingham NHS Foundation Trust)H-Index: 3
#2Felicity Evison (University Hospitals Birmingham NHS Foundation Trust)H-Index: 8
Last. Richard J. Lilford (Warw.: University of Warwick)H-Index: 70
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Objective To conduct a nationwide study of associations between removal of all ovarian tissue versus conservation of at least one ovary at the time of hysterectomy and important health outcomes (ischaemic heart disease, cancer, and all cause mortality). Study design and setting Retrospective analysis of the English Hospital Episode Statistics database linked to national registers of deprivation indices and of deaths. Participants 113 679 patients aged 35-45 who had had a hysterectomy for benign ...
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#1Kemi M. Doll (UNC: University of North Carolina at Chapel Hill)H-Index: 11
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: Black women experience higher rates of hysterectomy than other women in the United States. Although research indicates that premenopausal hysterectomy with bilateral oophorectomy decreases the risk of breast cancer in black women, it remains unclear how hysterectomy without ovary removal affects risk, whether menopausal hormone therapy use attenuates inverse associations, and whether associations vary by cancer subtype. In the population-based, case-control Carolina Breast Cancer Study of inva...
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Population-level cancer incidence rates are one measure to estimate the cancer burden. The goal is to provide information on trends to measure progress against cancer at the population level and identify emerging patterns signifying increased risk for additional research and intervention. Endometrial cancer is the most common of the gynecologic malignancies but capturing the incidence of disease among women at risk (i.e. women with a uterus) is challenging and not routinely published. Decreasing...
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#1Gretchen L. Gierach (NIH: National Institutes of Health)H-Index: 21
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Objective As bilateral salpingo-oophorectomy is frequently performed with hysterectomy for nonmalignant conditions, defining health outcomes associated with benign bilateral salpingo-oophorectomy performed at different ages is critical.
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#1John K. Chan (UCSF: University of California, San Francisco)H-Index: 31
#2Renata R. Urban (Stanford University)H-Index: 10
Last. Laurel A. Habel (Stanford University)H-Index: 40
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Objective To estimate ovarian and peritoneal cancer rates after hysterectomy with and without salpingo-oophorectomy for benign conditions.
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BACKGROUND: Approximately 80% of breast cancers amongst premenopausal women are hormone receptor-positive. Adjuvant endocrine therapy is an integral component of care for hormone receptor-positive breast cancer and in premenopausal women includes oestrogen receptor blockade with tamoxifen, temporary suppression of ovarian oestrogen synthesis by luteinising hormone releasing hormone (LHRH) agonists, and permanent interruption of ovarian oestrogen synthesis with oophorectomy or radiotherapy. Recen...
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