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In Reply: Dr Shapiro postulates that detection bias in women who developed vaginal bleeding after randomization to CEE + MPA may have led to an overestimate of their HRs for CHD. Several considerations argue against this interpretation.

If women developed persistent bleeding, the clinic gynecologist was unblinded, but not the participant or clinic staff. Even if some participants correctly guessed randomization status, the central adjudication of hard outcomes was done by blinded adjudicators. A greater likelihood of CHD identification in the CEE + MPA group is plausible only if there was both differential unblinding and an expectation of harm. To the contrary, during the initial years of the study when most of the excess CHD events occurred, the expectation was that hormone therapy would reduce the risk of CHD. After participants were warned of an excess risk at about 3 years of follow-up, this expectation changed. This warning was in response to the excess . . . [Full Text of this Article]

Jacques E. Rossouw, MD
rossouwj@nih.gov
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
Bethesda, Maryland

Ross L. Prentice, PhD; Andrea Z. LaCroix, PhD; LieLing Wu, MSc
Fred Hutchinson Cancer Research Center
Seattle, Washington

JoAnn E. Manson, MD, DrPH
Harvard School of Public Health
Boston, Massachusetts

David Barad, MD
Albert Einstein College of Medicine
New York, New York

Vanessa M. Barnabei, MD, PhD
Medical College of Wisconsin
Milwaukee

Marcia Ko, MD
Mayo Clinic
Scottsdale, Arizona

Karen Margolis, MD
University of Minnesota
Minneapolis

Marcia Stefanick, PhD
Stanford University
Palo Alto, California

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