Cited by 686Menopause: Health Impacts and TreatmentsEstrogen and related hormone effectsSexual function and dysfunction studies

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Effects of Estrogen plus Progestin on Health-Related Quality of Life

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Hays, Jennifer, Ockene, Judith K., Brunner, Robert L., Kotchen, Jane M., Manson, JoAnn E., Patterson, Ruth E., Aragaki, Aaron K., Shumaker, Sally A., Brzyski, Robert G., LaCroix, Andrea Z., Granek, Iris A., Valanis, Barbara G.·2003·New England Journal of Medicine

DOI 10.1056/nejmoa030311

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Abstract

BACKGROUND: The Women's Health Initiative (WHI) and other clinical trials indicate that significant health risks are associated with combination hormone use. Less is known about the effect of hormone therapy on health-related quality of life. METHODS: The WHI randomly assigned 16,608 postmenopausal women 50 to 79 years of age (mean, 63) with an intact uterus at base line to estrogen plus progestin (0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate, in 8506 women) or placebo (in 8102 women). Quality-of-life measures were collected at base line and at one year in all women and at three years in a subgroup of 1511 women. RESULTS: Randomization to estrogen plus progestin resulted in no significant effects on general health, vitality, mental health, depressive symptoms, or sexual satisfaction. The use of estrogen plus progestin was associated with a statistically significant but small and not clinically meaningful benefit in terms of sleep disturbance, physical functioning, and bodily pain after one year (the mean benefit in terms of sleep disturbance was 0.4 point on a 20-point scale, in terms of physical functioning 0.8 point on a 100-point scale, and in terms of pain 1.9 points on a 100-point scale). At three years, there were no significant benefits in terms of any quality-of-life outcomes. Among women 50 to 54 years of age with moderate-to-severe vasomotor symptoms at base line, estrogen and progestin improved vasomotor symptoms and resulted in a small benefit in terms of sleep disturbance but no benefit in terms of the other quality-of-life outcomes. CONCLUSIONS: In this trial in postmenopausal women, estrogen plus progestin did not have a clinically meaningful effect on health-related quality of life.

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Authors: Hays, J., Ockene, J. K., Brunner, R. L., Kotchen, J. M., Manson, J. E., Patterson, R. E., Aragaki, A. K., Shumaker, S. A., Brzyski, R. G., LaCroix, A. Z., Granek, I. A., & Valanis, B. G.
Affiliations: University of Massachusetts Chan Medical School (US)
University of Nevada, Reno (US)
Medical College of Wisconsin (US)
Brigham and Women's Hospital (US)
Fred Hutch Cancer Center (US)
Wake Forest University Health Sciences (US)
The University of Texas at San Antonio Health Science Center (US)
State University of New York (US)
Kaiser Permanente Center for Health Research (US)
ORCID: Ockene, Judith K.
Brunner, Robert L.
Manson, JoAnn E.
Patterson, Ruth E.
Aragaki, Aaron K.
LaCroix, Andrea Z.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2003-05-08
Volume: 348
Issue: 19
Pages: 1839-1854
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa030311
OpenAlex: W2110502449
Cited by: 686
References: 36
Citations by year: 2026: 6 · 2025: 14 · 2024: 2 · 2023: 4 · 2022: 7 · 2021: 9 · 2020: 6 · 2019: 11 · 2018: 12 · 2017: 9 · 2016: 17 · 2015: 15 · 2014: 18 · 2013: 23 · 2012: 25
FWCI: 66.22
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
eScholarship@UMassChan (submittedVersion)
eScholarship (California Digital Library) (submittedVersion)
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 › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Keywords: estrogen plus progestin, hormone therapy, health-related quality of life, postmenopausal women, conjugated equine estrogens, medroxyprogesterone acetate, vasomotor symptoms, sleep disorders, physical function, bodily pain, depressive symptoms, sexual satisfaction, Women's Health Initiative
MeSH terms: Aged, Cognition, Depression, Estrogens, Female, Health Status, Humans, Mental Health, Middle Aged, Progestins, Quality of Life, Sexual Behavior, Sleep Wake Disorders, Estrogen Replacement Therapy, Linear Models, Hot Flashes

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