Symptom experience after discontinuing use of estrogen plus progestin

Judith K. Ockene, David H. Barad, Barbara B. Cochrane, Joseph C. Larson, Margery Gass, Sylvia Wassertheil-Smoller, Jo Ann E. Manson, Vanessa M. Barnabei, Dorothy S. Lane, Robert G. Brzyski, Milagros C. Rosal, Judy Wylie-Rosett, Jennifer Hays

Research output: Contribution to journalArticle

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Abstract

Context: Little is known about women's experiences after stopping menopausal hormone therapy. Objective: To describe women's symptoms and management strategies after stopping the intervention in a large estrogen plus progestin trial. Design, Setting, and Participants: Cross-sectional survey of 8405 women (89.9%; N = 9351) at 40 clinical centers who were still taking study pills (conjugated equine estrogens plus medroxyprogesterone [CEE + MPA] or placebo) when the estrogen plus progestin intervention (Women's Health Initiative) was stopped. Surveys were mailed 8 to 12 months after the stop date. Logistic regression was used to model vasomotor symptoms and pain or stiffness symptoms as functions of former treatment and baseline symptoms, adjusted for appropriate covariates. Main Outcome Measures: Symptoms (vasomotor or pain and stiffness) and management strategies. Results: Respondents' mean (SD) age at trial stop date was 69.1 (6.7) years. They averaged 5.7 years of taking study pills. Moderate or severe vasomotor symptoms after discontinuing study pill use were reported by 21.2% of former CEE + MPA and 4.8% of placebo group respondents overall and by 55.5% and 21.3%, respectively, with these symptoms at baseline (randomization). Compared with respondents in the former placebo group, moderate or severe vasomotor symptoms (adjusted odds ratio [AOR] 5.82; 95% confidence interval [CI], 4.92-6.89) and pain or stiffness symptoms (AOR, 2.16; 95% CI, 1.95-2.40) were more likely in respondents in the former CEE + MPA group. Both vasomotor symptoms (AOR, 5.36; 95% CI, 4.51-6.38) and pain or stiffness symptoms (AOR, 3.21; 95% CI, 2.90-3.56) also were more likely in women with these symptoms at baseline. Women reported a wide range of strategies to manage symptoms. Conclusions: More than half of the women with vasomotor symptoms at randomization to active CEE + MPA also reported these symptoms after discontinuing use of the study pills. However, these participants did not include women who were unwilling to be randomized or who had stopped taking the study pills earlier. These findings should be considered when advising women to treat menopausal symptoms with hormone therapy for as short duration as possible. Investigation of alternative strategies to manage menopausal symptoms is warranted.

Original languageEnglish
Pages (from-to)183-193
Number of pages11
JournalJournal of the American Medical Association
Volume294
Issue number2
DOIs
StatePublished - 13 Jul 2005

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Progestins
Estrogens
Odds Ratio
Confidence Intervals
Placebos
Random Allocation
Pain
Medroxyprogesterone
Hormones
Conjugated (USP) Estrogens
Women's Health
Pain Management
Therapeutics
Cross-Sectional Studies
Logistic Models
Outcome Assessment (Health Care)
Surveys and Questionnaires

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Ockene, J. K., Barad, D. H., Cochrane, B. B., Larson, J. C., Gass, M., Wassertheil-Smoller, S., ... Hays, J. (2005). Symptom experience after discontinuing use of estrogen plus progestin. Journal of the American Medical Association, 294(2), 183-193. https://doi.org/10.1001/jama.294.2.183
Ockene, Judith K. ; Barad, David H. ; Cochrane, Barbara B. ; Larson, Joseph C. ; Gass, Margery ; Wassertheil-Smoller, Sylvia ; Manson, Jo Ann E. ; Barnabei, Vanessa M. ; Lane, Dorothy S. ; Brzyski, Robert G. ; Rosal, Milagros C. ; Wylie-Rosett, Judy ; Hays, Jennifer. / Symptom experience after discontinuing use of estrogen plus progestin. In: Journal of the American Medical Association. 2005 ; Vol. 294, No. 2. pp. 183-193.
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abstract = "Context: Little is known about women's experiences after stopping menopausal hormone therapy. Objective: To describe women's symptoms and management strategies after stopping the intervention in a large estrogen plus progestin trial. Design, Setting, and Participants: Cross-sectional survey of 8405 women (89.9{\%}; N = 9351) at 40 clinical centers who were still taking study pills (conjugated equine estrogens plus medroxyprogesterone [CEE + MPA] or placebo) when the estrogen plus progestin intervention (Women's Health Initiative) was stopped. Surveys were mailed 8 to 12 months after the stop date. Logistic regression was used to model vasomotor symptoms and pain or stiffness symptoms as functions of former treatment and baseline symptoms, adjusted for appropriate covariates. Main Outcome Measures: Symptoms (vasomotor or pain and stiffness) and management strategies. Results: Respondents' mean (SD) age at trial stop date was 69.1 (6.7) years. They averaged 5.7 years of taking study pills. Moderate or severe vasomotor symptoms after discontinuing study pill use were reported by 21.2{\%} of former CEE + MPA and 4.8{\%} of placebo group respondents overall and by 55.5{\%} and 21.3{\%}, respectively, with these symptoms at baseline (randomization). Compared with respondents in the former placebo group, moderate or severe vasomotor symptoms (adjusted odds ratio [AOR] 5.82; 95{\%} confidence interval [CI], 4.92-6.89) and pain or stiffness symptoms (AOR, 2.16; 95{\%} CI, 1.95-2.40) were more likely in respondents in the former CEE + MPA group. Both vasomotor symptoms (AOR, 5.36; 95{\%} CI, 4.51-6.38) and pain or stiffness symptoms (AOR, 3.21; 95{\%} CI, 2.90-3.56) also were more likely in women with these symptoms at baseline. Women reported a wide range of strategies to manage symptoms. Conclusions: More than half of the women with vasomotor symptoms at randomization to active CEE + MPA also reported these symptoms after discontinuing use of the study pills. However, these participants did not include women who were unwilling to be randomized or who had stopped taking the study pills earlier. These findings should be considered when advising women to treat menopausal symptoms with hormone therapy for as short duration as possible. Investigation of alternative strategies to manage menopausal symptoms is warranted.",
author = "Ockene, {Judith K.} and Barad, {David H.} and Cochrane, {Barbara B.} and Larson, {Joseph C.} and Margery Gass and Sylvia Wassertheil-Smoller and Manson, {Jo Ann E.} and Barnabei, {Vanessa M.} and Lane, {Dorothy S.} and Brzyski, {Robert G.} and Rosal, {Milagros C.} and Judy Wylie-Rosett and Jennifer Hays",
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Ockene, JK, Barad, DH, Cochrane, BB, Larson, JC, Gass, M, Wassertheil-Smoller, S, Manson, JAE, Barnabei, VM, Lane, DS, Brzyski, RG, Rosal, MC, Wylie-Rosett, J & Hays, J 2005, 'Symptom experience after discontinuing use of estrogen plus progestin', Journal of the American Medical Association, vol. 294, no. 2, pp. 183-193. https://doi.org/10.1001/jama.294.2.183

Symptom experience after discontinuing use of estrogen plus progestin. / Ockene, Judith K.; Barad, David H.; Cochrane, Barbara B.; Larson, Joseph C.; Gass, Margery; Wassertheil-Smoller, Sylvia; Manson, Jo Ann E.; Barnabei, Vanessa M.; Lane, Dorothy S.; Brzyski, Robert G.; Rosal, Milagros C.; Wylie-Rosett, Judy; Hays, Jennifer.

In: Journal of the American Medical Association, Vol. 294, No. 2, 13.07.2005, p. 183-193.

Research output: Contribution to journalArticle

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T1 - Symptom experience after discontinuing use of estrogen plus progestin

AU - Ockene, Judith K.

AU - Barad, David H.

AU - Cochrane, Barbara B.

AU - Larson, Joseph C.

AU - Gass, Margery

AU - Wassertheil-Smoller, Sylvia

AU - Manson, Jo Ann E.

AU - Barnabei, Vanessa M.

AU - Lane, Dorothy S.

AU - Brzyski, Robert G.

AU - Rosal, Milagros C.

AU - Wylie-Rosett, Judy

AU - Hays, Jennifer

PY - 2005/7/13

Y1 - 2005/7/13

N2 - Context: Little is known about women's experiences after stopping menopausal hormone therapy. Objective: To describe women's symptoms and management strategies after stopping the intervention in a large estrogen plus progestin trial. Design, Setting, and Participants: Cross-sectional survey of 8405 women (89.9%; N = 9351) at 40 clinical centers who were still taking study pills (conjugated equine estrogens plus medroxyprogesterone [CEE + MPA] or placebo) when the estrogen plus progestin intervention (Women's Health Initiative) was stopped. Surveys were mailed 8 to 12 months after the stop date. Logistic regression was used to model vasomotor symptoms and pain or stiffness symptoms as functions of former treatment and baseline symptoms, adjusted for appropriate covariates. Main Outcome Measures: Symptoms (vasomotor or pain and stiffness) and management strategies. Results: Respondents' mean (SD) age at trial stop date was 69.1 (6.7) years. They averaged 5.7 years of taking study pills. Moderate or severe vasomotor symptoms after discontinuing study pill use were reported by 21.2% of former CEE + MPA and 4.8% of placebo group respondents overall and by 55.5% and 21.3%, respectively, with these symptoms at baseline (randomization). Compared with respondents in the former placebo group, moderate or severe vasomotor symptoms (adjusted odds ratio [AOR] 5.82; 95% confidence interval [CI], 4.92-6.89) and pain or stiffness symptoms (AOR, 2.16; 95% CI, 1.95-2.40) were more likely in respondents in the former CEE + MPA group. Both vasomotor symptoms (AOR, 5.36; 95% CI, 4.51-6.38) and pain or stiffness symptoms (AOR, 3.21; 95% CI, 2.90-3.56) also were more likely in women with these symptoms at baseline. Women reported a wide range of strategies to manage symptoms. Conclusions: More than half of the women with vasomotor symptoms at randomization to active CEE + MPA also reported these symptoms after discontinuing use of the study pills. However, these participants did not include women who were unwilling to be randomized or who had stopped taking the study pills earlier. These findings should be considered when advising women to treat menopausal symptoms with hormone therapy for as short duration as possible. Investigation of alternative strategies to manage menopausal symptoms is warranted.

AB - Context: Little is known about women's experiences after stopping menopausal hormone therapy. Objective: To describe women's symptoms and management strategies after stopping the intervention in a large estrogen plus progestin trial. Design, Setting, and Participants: Cross-sectional survey of 8405 women (89.9%; N = 9351) at 40 clinical centers who were still taking study pills (conjugated equine estrogens plus medroxyprogesterone [CEE + MPA] or placebo) when the estrogen plus progestin intervention (Women's Health Initiative) was stopped. Surveys were mailed 8 to 12 months after the stop date. Logistic regression was used to model vasomotor symptoms and pain or stiffness symptoms as functions of former treatment and baseline symptoms, adjusted for appropriate covariates. Main Outcome Measures: Symptoms (vasomotor or pain and stiffness) and management strategies. Results: Respondents' mean (SD) age at trial stop date was 69.1 (6.7) years. They averaged 5.7 years of taking study pills. Moderate or severe vasomotor symptoms after discontinuing study pill use were reported by 21.2% of former CEE + MPA and 4.8% of placebo group respondents overall and by 55.5% and 21.3%, respectively, with these symptoms at baseline (randomization). Compared with respondents in the former placebo group, moderate or severe vasomotor symptoms (adjusted odds ratio [AOR] 5.82; 95% confidence interval [CI], 4.92-6.89) and pain or stiffness symptoms (AOR, 2.16; 95% CI, 1.95-2.40) were more likely in respondents in the former CEE + MPA group. Both vasomotor symptoms (AOR, 5.36; 95% CI, 4.51-6.38) and pain or stiffness symptoms (AOR, 3.21; 95% CI, 2.90-3.56) also were more likely in women with these symptoms at baseline. Women reported a wide range of strategies to manage symptoms. Conclusions: More than half of the women with vasomotor symptoms at randomization to active CEE + MPA also reported these symptoms after discontinuing use of the study pills. However, these participants did not include women who were unwilling to be randomized or who had stopped taking the study pills earlier. These findings should be considered when advising women to treat menopausal symptoms with hormone therapy for as short duration as possible. Investigation of alternative strategies to manage menopausal symptoms is warranted.

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Ockene JK, Barad DH, Cochrane BB, Larson JC, Gass M, Wassertheil-Smoller S et al. Symptom experience after discontinuing use of estrogen plus progestin. Journal of the American Medical Association. 2005 Jul 13;294(2):183-193. https://doi.org/10.1001/jama.294.2.183