Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials
Open accessAbstract
IMPORTANCE: Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention. OBJECTIVE: To report a comprehensive, integrated overview of findings from the 2 Women's Health Initiative (WHI) hormone therapy trials with extended postintervention follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 27,347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers. INTERVENTIONS: Women with an intact uterus received conjugated equine estrogens (CEE; 0.625 mg/d) plus medroxyprogesterone acetate (MPA; 2.5 mg/d) (n = 8506) or placebo (n = 8102). Women with prior hysterectomy received CEE alone (0.625 mg/d) (n = 5310) or placebo (n = 5429). The intervention lasted a median of 5.6 years in CEE plus MPA trial and 7.2 years in CEE alone trial with 13 years of cumulative follow-up until September 30, 2010. MAIN OUTCOMES AND MEASURES: Primary efficacy and safety outcomes were coronary heart disease (CHD) and invasive breast cancer, respectively. A global index also included stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and death. RESULTS: During the CEE plus MPA intervention phase, the numbers of CHD cases were 196 for CEE plus MPA vs 159 for placebo (hazard ratio [HR], 1.18; 95% CI, 0.95-1.45) and 206 vs 155, respectively, for invasive breast cancer (HR, 1.24; 95% CI, 1.01-1.53). Other risks included increased stroke, pulmonary embolism, dementia (in women aged ≥65 years), gallbladder disease, and urinary incontinence; benefits included decreased hip fractures, diabetes, and vasomotor symptoms. Most risks and benefits dissipated postintervention, although some elevation in breast cancer risk persisted during cumulative follow-up (434 cases for CEE plus MPA vs 323 for placebo; HR, 1.28 [95% CI, 1.11-1.48]). The risks and benefits were more balanced during the CEE alone intervention with 204 CHD cases for CEE alone vs 222 cases for placebo (HR, 0.94; 95% CI, 0.78-1.14) and 104 vs 135, respectively, for invasive breast cancer (HR, 0.79; 95% CI, 0.61-1.02); cumulatively, there were 168 vs 216, respectively, cases of breast cancer diagnosed (HR, 0.79; 95% CI, 0.65-0.97). Results for other outcomes were similar to CEE plus MPA. Neither regimen affected all-cause mortality. For CEE alone, younger women (aged 50-59 years) had more favorable results for all-cause mortality, myocardial infarction, and the global index (nominal P < .05 for trend by age). Absolute risks of adverse events (measured by the global index) per 10,000 women annually taking CEE plus MPA ranged from 12 excess cases for ages of 50-59 years to 38 for ages of 70-79 years; for women taking CEE alone, from 19 fewer cases for ages of 50-59 years to 51 excess cases for ages of 70-79 years. Quality-of-life outcomes had mixed results in both trials. CONCLUSIONS AND RELEVANCE: Menopausal hormone therapy has a complex pattern of risks and benefits. Findings from the intervention and extended postintervention follow-up of the 2 WHI hormone therapy trials do not support use of this therapy for chronic disease prevention, although it is appropriate for symptom management in some women. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000611.
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Subsequent re-analyses of the Women's Health Initiative data revealed cardiometabolic benefits of MHT in women aged 50-59.
“subsequent re-analyses of the WHI data revealed cardiometabolic benefits of MHT in women aged 50-59 (216–218).”
From Metabolic impact of endogenously produced estrogens by adipose tissue in females and males across the lifespan (2025) · cites this paper as [216]
The Abstract reports more favorable myocardial-infarction results for women aged 50–59 receiving estrogen alone, and the Discussion reports reduced diabetes risk during intervention with both regimens. But the paper does not establish broad cardiometabolic benefits of MHT in that age group: it reports increased stroke and venous-thrombosis risks with both regimens, and says the risks of estrogen plus progestin outweighed its benefits across age groups. Page numbers were not available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredHormone therapy is effective in treating hot flashes, but its use is contraindicated for individuals initiating hormone therapy more than 10 years from menopause onset or older than 60 years, and with a history of breast cancer, uterine cancer, thromboembolic, or cardiovascular diseases.
“Although hormone therapy is effective in treating hot flashes, its use is contraindicated for individuals initiating hormone therapy more than 10 years from menopause onset or older than 60 years, and with a history of breast cancer, uterine cancer, thromboembolic, or cardiovascular diseases.10,11,12”
From Self-Administered Hypnosis vs Sham Hypnosis for Hot Flashes (2025) · cites this paper as [11]
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Lovre, D., Lindsey, S. H., & Mauvais-Jarvis, F. (2017) · Therapeutic Advances in Cardiovascular Disease · doi:10.1177/1753944716649358 · Cited by 44 · see citing works
Appleton, S., Gill, T., Taylor, A., McEvoy, D., Shi, Z., Hill, C., Reynolds, A., & Adams, R. (2018) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph15050930 · Cited by 42 · see citing works
Transgender patients and the role of the coagulation clinician
Connors, J. M., & Middeldorp, S. (2019) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.14626 · Cited by 42 · see citing works
Park, J. Y., & Kim, K. H. (2016) · Climacteric · doi:10.1080/13697137.2016.1238453 · Cited by 32 · see citing works
Iñigo, M. R., Amorese, A. J., Tarpey, M. D., Balestrieri, N. P., Jones, K. G., Patteson, D. J., Jackson, K. C., Torres, M. J., Lin, C.-T., Smith, C. D., et al. (2020) · Molecular Metabolism · doi:10.1016/j.molmet.2019.12.010 · Cited by 29 · see citing works
Taking action to advance the study of race and ethnicity: the Women’s Health Initiative (WHI).
Garcia, L., Follis, S., Thomson, C. A., Breathett, K., Cené, C. W., Jimenez, M., Kooperberg, C., Masaki, K., Paskett, E. D., Pettinger, M., et al. (2022) · Women's Midlife Health · doi:10.1186/s40695-021-00071-6 · Cited by 29 · see citing works
Self-citationA review of mathematical modeling of bone remodeling from a systems biology perspective
Cook, C. V., Lighty, A. M., Smith, B. J., & Ford Versypt, A. N. (2024) · Frontiers in Systems Biology · doi:10.3389/fsysb.2024.1368555 · Cited by 25 · see citing works
Lee, A. A., & Den Hartigh, L. J. (2025) · Frontiers in Endocrinology · doi:10.3389/fendo.2025.1682231 · Cited by 32 · see citing works
Increased detection of co-morbidities with evaluation at a dedicated adult Turner syndrome clinic
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Anabolic Activity of a Soy Extract and Three Major Isoflavones in C2C12 Myotubes
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- Authors
- Manson, J. E., Chlebowski, R. T., Stefanick, M. L., Aragaki, A. K., Rossouw, J. E., Prentice, R. L., Anderson, G., Howard, B. V., Thomson, C. A., LaCroix, A. Z., Wactawski-Wende, J., Jackson, R. D., Limacher, M., Margolis, K. L., Wassertheil-Smoller, S., Beresford, S. A., Cauley, J. A., Eaton, C. B., Gass, M., Hsia, J., Johnson, K. C., Kooperberg, C., Kuller, L. H., Lewis, C. E., Liu, S., Martin, L. W., Ockene, J. K., O’Sullivan, M. J., Powell, L. H., Simon, M. S., Van Horn, L., Vitolins, M. Z., & Wallace, R. B.
- Affiliations
- Brigham and Women's Hospital (US)
- Regions Hospital (US)
- AstraZeneca (United Kingdom) (GB)
- University of Iowa (US)
- ORCID
- Manson, JoAnn E.
- Chlebowski, Rowan T.
- Stefanick, Marcia L.
- Aragaki, Aaron K.
- Rossouw, Jacques E.
- Prentice, Ross L.
- Anderson, Garnet
- Howard, Barbara V.
- Thomson, Cynthia A.
- LaCroix, Andrea Z.
- Limacher, Marian
- Margolis, Karen L.
- Wassertheil-Smoller, Sylvia
- Beresford, Shirley A.
- Cauley, Jane A.
- Eaton, Charles B.
- Hsia, Judith
- Johnson, Karen C.
- Kooperberg, Charles
- Kuller, Lewis H.
- Lewis, Cora E.
- Liu, Simin
- Martin, Lisa W.
- Ockene, Judith K.
- Powell, Lynda H.
- Simon, Michael S.
- Vitolins, Mara Z.
- Wallace, Robert B.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2013-10-02
- Volume
- 310
- Issue
- 13
- Pages
- 1353
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC3963523
- OpenAlex
- W2096913799
- Cited by
- 1,650
- References
- 50
- Citations by year
- 2026: 130 · 2025: 146 · 2024: 119 · 2023: 128 · 2022: 150 · 2021: 142 · 2020: 118 · 2019: 117 · 2018: 116 · 2017: 124 · 2016: 117 · 2015: 121 · 2014: 106 · 2013: 10 · 2012: 2
- FWCI
- 92.82
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- D-Scholarship@Pitt (University of Pittsburgh) (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- U.S. Department of Health and Human Services (42129‐32, 42107-26, 32108‐9, 32118-32119, 32111‐13, 32100‐2, 44221, 32105‐6, 32122, 24152, N01-WH-2-2110)
- Amgen
- Pfizer
- National Institutes of Health (n01wh42124-20-0-0, n01wh32105-27-0-1, n01wh42120-22-0-1, n01wh32106-28-0-1, N01-WH-4-2107, n01wh42125-19-0-1, n01wh32108-30-0-1, n01wh042116-008, n01wh32112-26-0-1, N01-WH-4-2122, n01wh32100-28-0-1, N01-WH-3-2109, n01wh42130-23-0-1, n01wh42123-22-0-1, N01-WH-3-2106, n01wh42108-21-0-1, N01-WH-3-2111, n01wh042114-008, n01wh32118-27-0-1, N01-WH-3-2119, 32122, n01wh42110-25-0-0, 32111‐13, n01wh42122-22-0-1, N01-WH-4-2126, 32108‐9, N01-WH-4-2111, N01-WH-3-2105, N01-WH-3-2100, N01-WH-4-2129, n01wh42131-22-0-1, N01-WH-4-2130, n01wh44221-7-0-1, N01-WH-3-2118, 42107–26, n01wh42129-23-0-1, N01-WH-4-2116, N01-WH-3-2108, N01-WH-4-2110, n01wh42115-19-0-1, N01-WH-3-2101, n01wh32111-28-0-1, N01 WH 44221, n01wh22110-38-0-0, N01-WH-4-2117, N01WH24152, 32118-32119, n01wh42132-22-0-1, 44221, n01wh42121-21-0-1, n01wh32101-25-0-1, n01wh42111-19-0-1, 32100‐2, N01-WH-4-2124, n01wh24152-12-0-0, n01wh42113-23-0-1, N01WH321115, N01-WH-4-2131, n01wh32113-30-0-1, N01-WH-4-2113, n01wh42119-25-0-1, N01-WH-4-2109, N01-WH-4-2115, N01-WH-4-2132, N01-WH-3-2112, N01-WH-4-2121, n01wh42126-26-0-1, n01wh32122-31-0-1, n01wh42118-20-0-1, N01-WH-4-2119, n01wh32119-24-0-1, N01-WH-3-2122, n01wh42107-22-0-1, N01-WH-4-2125, n01wh42109-28-0-1, n01wh042112-013, N01-WH-4-2120, N01-WH-2-2110, N01-WH-4-2114, n01wh42117-21-0-1, n01wh32102-33-0-0, N01-WH-4-2123, N01-WH-4-2118, N01-WH-3-2102, 24152, N01-WH-4-2112, N01-WH-4-2108, N01 WH022110, N01 WH032109, n01wh32109-27-0-1, N01-WH-3-2113, 32105-6)
- National Heart, Lung, and Blood Institute (32100‐2, 32118‐32119, N01‐WH‐22110, 32118, 42107‐26, 32119, 24152, 32105–6, 32108‐9, 32111–13, 42129‐32, 32122, 44221)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
- Health Sciences › Medicine › Pathology and Forensic Medicine › Phytoestrogen effects and research
- Keywords
- hormone replacement therapy, Women's Health Initiative, conjugated equine estrogens, medroxyprogesterone acetate, coronary artery disease, invasive breast cancer, stroke, pulmonary embolism, dementia, hip fracture, endometrial cancer, colorectal cancer, vasomotor symptoms, postmenopausal women, hysterectomy, long-term follow-up, benefits and risks
- MeSH terms
- Aged, Breast Neoplasms, Coronary Disease, Drug Therapy, Combination, Estrogens, Conjugated (USP), Estrogens, Female, Follow-Up Studies, Hip Fractures, Humans, Middle Aged, Pulmonary Embolism, Quality of Life, Risk, United States, Colorectal Neoplasms, Endometrial Neoplasms, Treatment Outcome, Medroxyprogesterone Acetate, Postmenopause, Hormone Replacement Therapy, Stroke
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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