The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone Therapy
Authors: Francine Grodstein, JoAnn E. Manson, Meir J. Stampfer, Walter C. Willett
Journal: Annals of Internal Medicine (2004)

Letters4 May 2004The Discrepancy between Observational Studies and Randomized Trials of Menopausal Hormone TherapyFrancine Grodstein, ScD, JoAnn E. Manson, MD, DrPH, Meir J. Stampfer, MD, DrPH, and Walter C. Willett, MD, DrPHFrancine Grodstein, ScDFrom Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA 02115., JoAnn E. Manson, MD, DrPHFrom Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA 02115., Meir J. Stampfer, MD, DrPHFrom Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA 02115., and Walter C. Willett, MD, DrPHFrom Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA 02115.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-140-9-200405040-00026 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:In their article on the discrepancy between observational studies and randomized trials of menopausal hormone therapy, Col and Pauker (1) correctly recognized that differences in socioeconomic status or other risk factors ("healthy user effect") between postmenopausal hormone users and nonusers are unlikely to substantially explain differences in the coronary heart disease (CHD) findings from the Nurses' Health Study (NHS) (2) and the Women's Health Initiative (WHI) trial (3). They noted, as we have (4), that any such effects would also alter findings for other diseases, especially stroke. The nearly identical results from the NHS and WHI for ...References1. Col NF, Pauker SG. The discrepancy between observational studies and randomized trials of menopausal hormone therapy: did expectations shape experience? Ann Intern Med. 2003;139:923-9. [PMID: 14644895] LinkGoogle Scholar2. Grodstein F, Manson JE, Colditz GA, Willett WC, Speizer FE, Stampfer MJ. A prospective, observational study of postmenopausal hormone therapy and primary prevention of cardiovascular disease. Ann Intern Med. 2000;133:933-41. [PMID: 11119394] LinkGoogle Scholar3. Manson JE, Hsia J, Johnson KC, Rossouw JE, Assaf AR, Lasser NL, et al . Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003;349:523-34. [PMID: 12904517] CrossrefMedlineGoogle Scholar4. Grodstein F, Clarkson TB, Manson JE. Understanding the divergent data on postmenopausal hormone therapy. N Engl J Med. 2003;348:645-50. [PMID: 12584376] CrossrefMedlineGoogle Scholar5. Stampfer MJ, Willett WC, Colditz GA, Rosner B, Speizer FE, Hennekens CH. A prospective study of postmenopausal estrogen therapy and coronary heart disease. N Engl J Med. 1985;313:1044-9. [PMID: 4047106] CrossrefMedlineGoogle Scholar6. 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 Scholar7. Mikkola TS, Clarkson TB. Estrogen replacement therapy, atherosclerosis, and vascular function. Cardiovasc Res. 2002;53:605-19. [PMID: 11861031] CrossrefMedlineGoogle Scholar8. Herrington DM, Espeland MA, Crouse JR, Robertson J, Riley WA, McBurnie MA, et al . Estrogen replacement and brachial artery flow-mediated vasodilation in older women. Arterioscler Thromb Vasc Biol. 2001;21:1955-61. [PMID: 11742870] CrossrefMedlineGoogle Scholar9. 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 Scholar Author, Article, and Disclosure InformationAffiliations: From Brigham and Women's Hospital and Harvard School of Public Health, Boston, MA 02115. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoA Prospective, Observational Study of Postmenopausal Hormone Therapy and Primary Prevention of Cardiovascular Disease Francine Grodstein , JoAnn E. Manson , Graham A. Colditz , Walter C. Willett , Frank E. Speizer , and Meir J. Stampfer 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 Nananda F. Col and Stephen G. Pauker Metrics Cited ByHormone Therapy Use and Risk of Chronic Disease in the Nurses' Health Study: A Comparative Analysis With the Women's Health InitiativeWomen and Coronary Artery DiseaseIndividualizing Hormone Therapy to Minimize Risk: Accurate Assessment of Risks and BenefitsMenopause and Hormone Replacement TherapyEffectiveness of Valsartan for Treatment of Hypertension: Patient Profiling and Hierarchical Modeling of Determinants and Outcomes (the Preview Study)Gender-specific characteristics of atherosclerosis in menopausal women: risk factors, clinical course and strategies for preventionPolycystic ovary syndrome and metabolic syndromeSystematic review: Hormone therapy and cardiovascular disease: a systematic review and meta-analysisPrevalence and correlates of hormonal therapy among Israeli women in the post-WHI era 4 May 2004Volume 140, Issue 9Page: 764-765KeywordsAtherosclerosisCongenital heart diseaseEstrogensHormonal therapyHormonesMenopauseObservational studiesRandomized trialsRelative riskStroke ePublished: 4 May 2004 Issue Published: 4 May 2004 CopyrightCopyright © 2004 by American College of Physicians. 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