Menopausal symptom experience before and after stopping estrogen therapy in the Women's Health Initiative randomized, placebo-controlled trial

Robert L. Brunner, Aaron Aragaki, Vanessa Barnabei, Barbara B. Cochrane, Margery Gass, Susan Hendrix, Dorothy Lane, Judith Ockene, Nancy F. Woods, Shagufta Yasmeen, Marcia Stefanick

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

Objective: The aim of this study was to assess vasomotor and other menopausal symptoms before starting estrogens or placebo, 1 year later, again at trial closure, and after stopping estrogens or placebo. The role of baseline symptoms and age was examined, as was the frequency and determinants of hormone use and symptom management strategies after discontinuing conjugated equine estrogens (CEE) or placebo. Methods: Intent-to-treat analyses of 10,739 postmenopausal women before and 1 year after randomization to CEE or placebo at 40 clinical centers and a cohort analysis of participants (n = 3,496) who continued taking assigned study pills up to trial closure and completed symptom surveys shortly before (mean, 7.4 ± 1.1 y from baseline) and after (mean, 306 ± 55 d after trial closure) stopping pills were performed. Generalized linear regression modeled vasomotor symptoms, vaginal dryness, breast tenderness, pain/stiffness, and mood swings as a function of treatment assignment and baseline symptoms, before and after stopping study pills. Results: Approximately one third of participants reported at least one moderate to severe symptom at baseline. Fewer symptoms were reported with increasing age, except joint pain/stiffness, which was similar among age groups. At 1 year, hot flashes, night sweats, and vaginal dryness were reduced by CEE, whereas breast tenderness was increased. Breast tenderness was also significantly higher in the CEE group at trial closure. After stopping, vasomotor symptoms were reported by significantly more women who had reported symptoms at baseline, compared with those who had not, and by significantly more participants assigned to CEE (9.8%) versus placebo (3.2%); however, among women with no moderate or severe symptoms at baseline, more than five times as many reported hot flashes after stopping CEE (7.2%) versus placebo (1.5%). Conclusions: CEE significantly reduced vasomotor symptoms and vaginal dryness in women with baseline symptoms but increased breast tenderness. The likelihood of experiencing symptoms was significantly higher after stopping CEE than placebo regardless of baseline symptom status. These potential effects should be considered before initiating CEE to relieve menopausal symptoms.

Original languageEnglish (US)
Pages (from-to)946-954
Number of pages9
JournalMenopause
Volume17
Issue number5
DOIs
StatePublished - Sep 2010

Fingerprint

Conjugated (USP) Estrogens
Women's Health
Estrogens
Randomized Controlled Trials
Placebos
Hot Flashes
Breast
Therapeutics
Mastodynia
Sweat
Arthralgia
Random Allocation
Linear Models
Cohort Studies
Age Groups
Hormones

Keywords

  • Estrogen therapy
  • Postmenopause
  • Randomized trial
  • Symptoms

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Menopausal symptom experience before and after stopping estrogen therapy in the Women's Health Initiative randomized, placebo-controlled trial. / Brunner, Robert L.; Aragaki, Aaron; Barnabei, Vanessa; Cochrane, Barbara B.; Gass, Margery; Hendrix, Susan; Lane, Dorothy; Ockene, Judith; Woods, Nancy F.; Yasmeen, Shagufta; Stefanick, Marcia.

In: Menopause, Vol. 17, No. 5, 09.2010, p. 946-954.

Research output: Contribution to journalArticle

Brunner, RL, Aragaki, A, Barnabei, V, Cochrane, BB, Gass, M, Hendrix, S, Lane, D, Ockene, J, Woods, NF, Yasmeen, S & Stefanick, M 2010, 'Menopausal symptom experience before and after stopping estrogen therapy in the Women's Health Initiative randomized, placebo-controlled trial', Menopause, vol. 17, no. 5, pp. 946-954. https://doi.org/10.1097/gme.0b013e3181d76953
Brunner, Robert L. ; Aragaki, Aaron ; Barnabei, Vanessa ; Cochrane, Barbara B. ; Gass, Margery ; Hendrix, Susan ; Lane, Dorothy ; Ockene, Judith ; Woods, Nancy F. ; Yasmeen, Shagufta ; Stefanick, Marcia. / Menopausal symptom experience before and after stopping estrogen therapy in the Women's Health Initiative randomized, placebo-controlled trial. In: Menopause. 2010 ; Vol. 17, No. 5. pp. 946-954.
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AU - Gass, Margery

AU - Hendrix, Susan

AU - Lane, Dorothy

AU - Ockene, Judith

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N2 - Objective: The aim of this study was to assess vasomotor and other menopausal symptoms before starting estrogens or placebo, 1 year later, again at trial closure, and after stopping estrogens or placebo. The role of baseline symptoms and age was examined, as was the frequency and determinants of hormone use and symptom management strategies after discontinuing conjugated equine estrogens (CEE) or placebo. Methods: Intent-to-treat analyses of 10,739 postmenopausal women before and 1 year after randomization to CEE or placebo at 40 clinical centers and a cohort analysis of participants (n = 3,496) who continued taking assigned study pills up to trial closure and completed symptom surveys shortly before (mean, 7.4 ± 1.1 y from baseline) and after (mean, 306 ± 55 d after trial closure) stopping pills were performed. Generalized linear regression modeled vasomotor symptoms, vaginal dryness, breast tenderness, pain/stiffness, and mood swings as a function of treatment assignment and baseline symptoms, before and after stopping study pills. Results: Approximately one third of participants reported at least one moderate to severe symptom at baseline. Fewer symptoms were reported with increasing age, except joint pain/stiffness, which was similar among age groups. At 1 year, hot flashes, night sweats, and vaginal dryness were reduced by CEE, whereas breast tenderness was increased. Breast tenderness was also significantly higher in the CEE group at trial closure. After stopping, vasomotor symptoms were reported by significantly more women who had reported symptoms at baseline, compared with those who had not, and by significantly more participants assigned to CEE (9.8%) versus placebo (3.2%); however, among women with no moderate or severe symptoms at baseline, more than five times as many reported hot flashes after stopping CEE (7.2%) versus placebo (1.5%). Conclusions: CEE significantly reduced vasomotor symptoms and vaginal dryness in women with baseline symptoms but increased breast tenderness. The likelihood of experiencing symptoms was significantly higher after stopping CEE than placebo regardless of baseline symptom status. These potential effects should be considered before initiating CEE to relieve menopausal symptoms.

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