The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone Therapy
Authors: Nananda F. Col, Stephen G. Pauker
Journal: Annals of Internal Medicine (2004)

Letters4 May 2004The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone TherapyNananda F. Col, MD, MPP, MPH and Stephen G. Pauker, MDNananda F. Col, MD, MPP, MPHFrom Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120; and Tufts-New England Medical Center, Boston, MA 02111.Search for more papers by this author and Stephen G. Pauker, MDFrom Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120; and Tufts-New England Medical Center, Boston, MA 02111.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-140-9-200405040-00027 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:Despite mounting evidence concerning the risks of hormone therapy, the NHS authors still believe that it is cardioprotective if initiated in newly menopausal women without atherosclerosis. However, NHS data show that the cardioprotective effect was the same among women in their 50s and 60s (relative risk, 0.71 vs. 0.66) and among women with and without CHD risk factors (1). Grodstein and colleagues' argument hinges on one statistically insignificant subgroup analysis of WHI women within 10 years of menopause (relative risk, 0.89; 65 CHD cases). Of note, subgroup analysis of WHI women 50 to 59 years of age yielded ...References1. Grodstein F, Stampfer MJ, Manson JE, Colditz GA, Willett WC, Rosner B, et al . Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med. 1996;335:453-61. [PMID: 8672166] CrossrefMedlineGoogle Scholar2. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408-12. [PMID: 7823387] CrossrefMedlineGoogle Scholar3. Sheifer SE, Manolio TA, Gersh BJ. Unrecognized myocardial infarction. Ann Intern Med. 2001;135:801-11. [PMID: 11694105] LinkGoogle Scholar4. Stamler J, Pick R, Katz LN, Pick A, Kaplan BM, Berkson DM, et al . Effectiveness of estrogens for therapy of myocardial infarction in middle-age men. JAMA. 1963;183:632-8. [PMID: 13983325] CrossrefMedlineGoogle Scholar5. Marmorston J, Moore FJ, Hopkins CE, Kuzma OT, Weiner J. Clinical studies of long-term estrogen therapy in men with myocardial infarction. Proc Soc Exp Biol Med. 1962;110:400-8. [PMID: 14470097] CrossrefMedlineGoogle Scholar6. The coronary drug project.. Design, methods, and baseline results. Circulation. 1973;47:I1-50. [PMID: 4570454] MedlineGoogle Scholar7. Bailar JC. When research results are in conflict [Editorial]. N Engl J Med. 1985;313:1080-1. [PMID: 2995809] CrossrefMedlineGoogle Scholar8. Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, et al . Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001;135:939-53. [PMID: 11730394] LinkGoogle Scholar9. Holm P, Andersen HL, Andersen MR, Erhardtsen E, Stender S. The direct antiatherogenic effect of estrogen is present, absent, or reversed, depending on the state of the arterial endothelium. A time course study in cholesterol-clamped rabbits. Circulation. 1999;100:1727-33. [PMID: 10525493] CrossrefMedlineGoogle Scholar10. Mikkola TS, Clarkson TB. Estrogen replacement therapy, atherosclerosis, and vascular function. Cardiovasc Res. 2002;53:605-19. [PMID: 11861031] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120; and Tufts-New England Medical Center, Boston, MA 02111. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoUnrecognized Myocardial Infarction Stuart E. Sheifer , Teri A. Manolio , and Bernard J. Gersh Estrogen in the Prevention of Atherosclerosis Howard N. Hodis , Wendy J. Mack , Roger A. Lobo , Donna Shoupe , Alex Sevanian , Peter R. Mahrer , Robert H. Selzer , Chao-ran Liu , Ci-hua Liu , Stanley P. Azen , and The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone Therapy: Did Expectations Shape Experience? Nananda F. Col and Stephen G. Pauker The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone Therapy Francine Grodstein , JoAnn E. Manson , Meir J. Stampfer , and Walter C. Willett Metrics 4 May 2004Volume 140, Issue 9Page: 765-766KeywordsCongenital heart diseaseEstrogensHormonal therapyHormonesMedical risk factorsMenopauseObservational studiesRandomized trialsRelative riskStatistical data ePublished: 4 May 2004 Issue Published: 4 May 2004 Copyright & PermissionsCopyright © 2004 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...