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dc.contributor.authorHays, Jennifer
dc.contributor.authorOckene, Judith K.
dc.contributor.authorBrunner, Robert L.
dc.contributor.authorKotchen, Jane Morley
dc.contributor.authorManson, JoAnn E.
dc.contributor.authorPatterson, Ruth E.
dc.contributor.authorAragaki, Aaron K.
dc.contributor.authorShumaker, Sally A.
dc.contributor.authorBrzyski, Robert G.
dc.contributor.authorLaCroix, Andrea Z.
dc.contributor.authorGranek, Iris A.
dc.contributor.authorValanis, Barbara G.
dc.date2022-08-11T08:11:04.000
dc.date.accessioned2022-08-23T17:32:04Z
dc.date.available2022-08-23T17:32:04Z
dc.date.issued2003-05-08
dc.date.submitted2008-02-26
dc.identifier.citationN Engl J Med. 2003 May 8;348(19):1839-54. Epub 2003 Mar 17. <a href="http://dx.doi.org/10.1056/NEJMoa030311">Link to article on publisher's site</a>
dc.identifier.issn1533-4406 (Electronic)
dc.identifier.doi10.1056/NEJMoa030311
dc.identifier.pmid12642637
dc.identifier.urihttp://hdl.handle.net/20.500.14038/50876
dc.description.abstractBACKGROUND: 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.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12642637&dopt=Abstract ">Link to article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1056/NEJMoa030311
dc.subjectAged
dc.subjectCognition
dc.subjectDepression
dc.subject*Estrogen Replacement Therapy
dc.subjectEstrogens
dc.subjectFemale
dc.subjectHealth Status
dc.subjectHot Flashes
dc.subjectHumans
dc.subjectLinear Models
dc.subjectMental Health
dc.subjectMiddle Aged
dc.subjectProgestins
dc.subject*Quality of Life
dc.subjectSexual Behavior
dc.subjectSleep Disorders
dc.subjectLife Sciences
dc.subjectMedicine and Health Sciences
dc.subjectWomen's Studies
dc.titleEffects of estrogen plus progestin on health-related quality of life
dc.typeJournal Article
dc.source.journaltitleThe New England journal of medicine
dc.source.volume348
dc.source.issue19
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/wfc_pp/405
dc.identifier.contextkey437161
html.description.abstract<p>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.</p> <p>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.</p> <p>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.</p> <p>CONCLUSIONS: In this trial in postmenopausal women, estrogen plus progestin did not have a clinically meaningful effect on health-related quality of life.</p>
dc.identifier.submissionpathwfc_pp/405
dc.contributor.departmentDepartment of Medicine, Division of Preventive and Behavioral Medicine
dc.source.pages1839-54


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