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Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial
Open accessAbstract
CONTEXT: Despite decades of accumulated observational evidence, the balance of risks and benefits for hormone use in healthy postmenopausal women remains uncertain. OBJECTIVE: To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. DESIGN: Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. INTERVENTIONS: Participants received conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102). MAIN OUTCOMES MEASURES: The primary outcome was coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome. A global index summarizing the balance of risks and benefits included the 2 primary outcomes plus stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years. CONCLUSIONS: Overall health risks exceeded benefits from use of combined estrogen plus progestin for an average 5.2-year follow-up among healthy postmenopausal US women. All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD.
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In the citing paper
“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 [10]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“The WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis during 5 years of treatment with conjugated equine estrogen and medroxyprogesterone acetate (Prempro®) [69].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [69]
The cited source says what the claim attributes to it.
In the citing paper
“The Woman’s Health Initiative (WHI) found that 5 years of HT (Prempro®) reduced the risk of clinical vertebral fractures and hip fractures by 34 % and other osteoporotic fractures by 23 % [69].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [69]
The cited source says what the claim attributes to it.
In the citing paper
“The Woman’s Health Initiative (WHI) found that 5 years of HT (Prempro®) reduced the risk of clinical vertebral fractures and hip fractures by 34 % and other osteoporotic fractures by 23 % [69].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [69]
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In the citing paper
“Yet all of about 90 HIV vaccines that succeeded in animals failed in humans.55”
From The Flaws and Human Harms of Animal Experimentation (2015) · cites this paper as [55]
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In the citing paper
“The increases were followed by equally pointed reductions within a few years, likely reflecting a depletion of prevalent cancers”
From Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. (2024) · cites this paper as [89]
Experimental — accuracy not yet measuredIn the citing paper
“Data from the Women’s Health Initiative (WHI) shows several risks of menopausal hormone therapy among healthy postmenopausal women, including an excess risk of coronary heart disease, stroke, and breast cancer (151).”
From From mitochondria to sarcopenia: role of 17β-estradiol and testosterone (2023) · cites this paper as [151]
In the citing paper
“The recent data of the Women's Health Initiative Study show that the combination of Premarin and Provera (Prempro) causes a 26% increase in the risk of breast cancer at 5.2 yr of follow-up”
In the citing paper
“the recent results of the Women's Health Initiative Study (8) clearly indicate that this compound is not recommended for longterm use in normal women where the stimulatory progestational component could well be predominant.”
In the citing paper
“The most effective treatment of hot flushes is estrogen replacement therapy, but the Women’s Health Initiative Study raised questions about the long-term safety of this treatment (Rossouw et al., 2002).”
From Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: A novel hypothesis on the mechanism of hot flushes (2013) · cites this paper as Rossouw et al., 2002
In the citing paper
“Estrogen replacement therapy and hormone replacement therapy appear to have a neutral effect on BP, as illustrated by the following observations from 2 large randomized trials.”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [212]
In the citing paper
“The Women’s Health Initiative, a randomized placebo-controlled trial, assessed the effect of estrogen-progestin replacement on outcomes in postmenopausal women211 and found that at 5.2 years hormone replacement therapy produced only a small increase (1.5 mm Hg) in SBP compared with placebo.212”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [212]
In the citing paper
“Estrogen has also been associated with increased risk of “unusual site” thromboses, as well as arterial thrombosis.”
From Estrogen and thrombosis: a bench to bedside review (2020) · cites this paper as [97]
In the citing paper
“That same year, data from the Women’s Health Initiative randomized clinical trial showed an increased risk of MI and cardiovascular death in women on MHT (HR 1.29, 95% CI, 1.02–1.63) [97].”
From Estrogen and thrombosis: a bench to bedside review (2020) · cites this paper as [97]
In the citing paper
“For example, the hypothesis that the effect of hormone replacement therapy (HRT) on coronary heart disease (CHD) might differ depending on the timing of its use (in relation to menopausal status) was not raised until after results from RCTs were published.47,48”
From Triangulation in aetiological epidemiology (2017) · cites this paper as [48]
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Metadata
- Authors
- Writing Group for the Women's Health Initiative Investigators
- Affiliations
- National Heart, Lung, and Blood Institute (US)
- Corresponding author
- Writing Group for the Women's Health Initiative Investigators
- Venue
- JAMA: The Journal of the American Medical Association
- Publisher
- American Medical Association (AMA)
- Published
- 2002-07-17
- Volume
- 288
- Issue
- 3
- Pages
- 321-333
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- 1538-3598
- OpenAlex
- W1593442063
- Cited by
- 15,889
- References
- 54
- Citations by year
- 2026: 283 · 2025: 348 · 2024: 342 · 2023: 365 · 2022: 459 · 2021: 465 · 2020: 452 · 2019: 453 · 2018: 455 · 2017: 452 · 2016: 486 · 2015: 572 · 2014: 546 · 2013: 688 · 2012: 713
- FWCI
- 647.30
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship@UMassChan (submittedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › Estrogen and related hormone effects
- Health Sciences › Nursing › Nutrition and Dietetics › Phytoestrogen effects and research
- Keywords
- estrogen plus progestin, conjugated equine estrogens, medroxyprogesterone acetate, postmenopausal women, hormone replacement therapy, coronary artery disease, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, mortality, benefits and risks, Women's Health Initiative, early trial termination, primary prevention
- MeSH terms
- Aged, Breast Neoplasms, Coronary Disease, Estrogens, Conjugated (USP), Female, Humans, Middle Aged, Myocardial Infarction, Pulmonary Embolism, Risk, Thrombosis, Colorectal Neoplasms, Estrogen Replacement Therapy, Proportional Hazards Models, Survival Analysis, Endometrial Neoplasms, Treatment Outcome, Medroxyprogesterone Acetate, Postmenopause, Stroke, Clinical Trials Data Monitoring Committees, Progesterone Congeners, Fractures, Bone
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