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Volume 348:645-650 February 13, 2003 Number 7
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Understanding the Divergent Data on Postmenopausal Hormone Therapy
Francine Grodstein, Sc.D., Thomas B. Clarkson, D.V.M., and JoAnn E. Manson, M.D., Dr.P.H.

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 by Solomon, C. G.
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Recent findings from clinical trials examining the relation between postmenopausal hormone therapy and coronary heart disease1,2 have appeared to be widely divergent from the results of earlier observational studies. In randomized clinical trials, subjects are randomly assigned to treatments, thereby minimizing possible differences between the groups in lifestyle or health-related factors. In observational studies, by contrast, subjects who choose to take a given agent may be very different from those who do not. Although apparent discrepancies in results have raised questions about the validity of observational data, it is useful to explore both the methodologic and the biologic issues that . . . [Full Text of this Article]

Methodologic Issues

Confounding Bias, or "Healthy User" Effect

Compliance Bias

Incomplete Capture of Early Clinical Events

Biologic Differences

Hormone Regimen

Characteristics of the Populations

Conclusions


Source Information

From the Channing Laboratory (F.G., J.E.M.) and the Division of Preventive Medicine (J.E.M.), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, and the Department of Epidemiology, Harvard School of Public Health (F.G., J.E.M.) — both in Boston; and the Comparative Medicine Research Center, Wake Forest University School of Medicine, Winston-Salem, N.C. (T.B.C.).

Address reprint requests to Dr. Grodstein at the Channing Laboratory, 181 Longwood Ave., Boston, MA 02115.


Related Letters:

Postmenopausal Hormone Therapy
Krieger N., Grodstein F., Manson J., Clarkson T. B.
Extract | Full Text | PDF  
N Engl J Med 2003; 348:2363-2364, Jun 5, 2003. Correspondence

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