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Longitudinal changes in menopausal symptoms comparing women randomized to low-dose oral conjugated estrogens or transdermal estradiol plus micronized progesterone versus placebo: the Kronos Early Estrogen Prevention Study
- Source :
- Menopause (New York, N.Y.), vol 24, iss 3, Santoro, N; Allshouse, A; Neal-Perry, G; Pal, L; Lobo, RA; Naftolin, F; et al.(2016). Longitudinal changes in menopausal symptoms comparing women randomized to low-dose oral conjugated estrogens or transdermal estradiol plus micronized progesterone versus placebo: The kronos early estrogen prevention study. Menopause, 24(3), 238-246. doi: 10.1097/GME.0000000000000756. UCLA: Retrieved from: http://www.escholarship.org/uc/item/63d0d2d8
- Publication Year :
- 2017
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2017.
-
Abstract
- Copyright © 2016 The North American Menopause Society. Objective: The objective of the present study was to compare the efficacy of two forms of menopausal hormone therapy in alleviating vasomotor symptoms, insomnia, and irritability in early postmenopausal women during 4 years. Methods: A total of 727 women, aged 42 to 58, within 3 years of their final menstrual period, were randomized to receive oral conjugated estrogens (o-CEE) 0.45 mg (n = 230) or transdermal estradiol (t-E2) 50 μg (n = 225; both with micronized progesterone 200 mg for 12 d each mo), or placebos (PBOs; n= 275). Menopausal symptoms were recorded at screening and at 6, 12, 24, 36, and 48 months postrandomization. Differences in proportions of women with symptoms at baseline and at each follow-up time point were compared by treatment arm using exact x2tests in an intent-to-treat analysis. Differences in treatment effect by race/ethnicity and body mass index were tested using generalized linear mixed effects modeling. Results: Moderate to severe hot flashes (from 44% at baseline to 28.3% for PBO, 7.4% for t-E2, and 4.2% for o-CEE) and night sweats (from 35% at baseline to 19% for PBO, 5.3% for t-E2, and 4.7% for o-CEE) were reduced significantly by 6 months in women randomized to either active hormone compared with PBO (P < 0.001 for both symptoms), with no significant differences between the active treatment arms. Insomnia and irritability decreased from baseline to 6 months postrandomization in all groups. There was an intermittent reduction in insomnia in both active treatment arms versus PBO, with o-CEE being more effective than PBO at 36 and 48 months (P =0.002 and 0.05) and t-E2being more effective than PBO at 48 months (P = 0.004). Neither hormone treatment significantly affected irritability compared with PBO. Symptom relief for active treatment versus PBO was not significantly modified by body mass index or race/ethnicity. Conclusions: Recently postmenopausal women had similar and substantial reductions in hot flashes and night sweats with lower-than-conventional doses of oral or transdermal estrogen. These reductions were sustained during 4 years. Insomnia was intermittently reduced compared with PBO for both hormone regimens.
- Subjects :
- Aging
Conjugated
medicine.medical_treatment
Administration, Oral
Physiology
Medical and Health Sciences
Conjugated (USP)
law.invention
0302 clinical medicine
Night sweats
Randomized controlled trial
law
Sleep Initiation and Maintenance Disorders
Medicine
Longitudinal Studies
030212 general & internal medicine
Progesterone
Hot flashes
Transdermal
Estrogens, Conjugated (USP)
030219 obstetrics & reproductive medicine
Estradiol
Vasomotor
Estrogen Replacement Therapy
Obstetrics and Gynecology
Middle Aged
Irritable Mood
Vasomotor System
Postmenopause
Menopause
Treatment Outcome
6.1 Pharmaceuticals
Combination
Administration
Drug Therapy, Combination
Female
medicine.symptom
Oral
Adult
medicine.medical_specialty
Insomnia
Hormone Replacement Therapy
medicine.drug_class
Clinical Trials and Supportive Activities
Administration, Cutaneous
Placebo
Irritability
Article
03 medical and health sciences
Drug Therapy
Clinical Research
Humans
Obstetrics & Reproductive Medicine
Hormone therapy
Gynecology
business.industry
Contraception/Reproduction
Prevention
Evaluation of treatments and therapeutic interventions
Estrogens
medicine.disease
Estrogen
Cutaneous
Autonomic Nervous System Diseases
Hot Flashes
Progestins
business
Subjects
Details
- ISSN :
- 15300374 and 10723714
- Volume :
- 24
- Database :
- OpenAIRE
- Journal :
- Menopause
- Accession number :
- edsair.doi.dedup.....f7aff3bcf04a24c320c383545009273a