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Symptom Experience After Discontinuing Use of Estrogen Plus Progestin
Judith K. Ockene, PhD, MEd;
David H. Barad, MD, MS;
Barbara B. Cochrane, PhD, RN;
Joseph C. Larson, MS;
Margery Gass, MD;
Sylvia Wassertheil-Smoller, PhD;
JoAnn E. Manson, MD, DrPH;
Vanessa M. Barnabei, MD, PhD;
Dorothy S. Lane, MD, MPH;
Robert G. Brzyski, MD, PhD;
Milagros C. Rosal, PhD;
Judy Wylie-Rosett, EdD;
Jennifer Hays, PhD
JAMA. 2005;294:183-193.
Context Little is known about womens experiences after stopping menopausal hormone therapy.
Objective To describe womens 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 Affiliations: Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester (Drs Ockene and Rosal); Departments of Obstetrics and Gynecology and Womens Health (Dr Barad) and Epidemiology and Population Health (Drs Wassertheil-Smoller and Wylie-Rosett), Albert Einstein College of Medicine, Bronx, NY; Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Wash (Dr Cochrane and Mr Larson); Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, Ohio (Dr Gass); Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass (Dr Manson); Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee (Dr Barnabei); Department of Preventive Medicine, State University of New York, Stony Brook (Dr Lane); Department of Obstetrics and Gynecology, University of Texas Health Science Center, San Antonio (Dr Brzyski); and Department of Medicine, Baylor College of Medicine, Houston, Tex (Dr Hays).
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