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To the Editor: Concerns about the validity of observational data provided justification for the WHI randomized clinical trials (RCTs). Results from several of these trials, including the one by Dr Howard and colleagues,¹ have now been published and are being interpreted as providing evidence that dietary modification,¹ hormone therapy,² and calcium/vitamin D³ are not efficacious. This conclusion is premature and results in part from failure to consider the limitations of RCTs.

Of the women screened for participation in the WHI (a small fraction of all women aged 50-79 years in the United States), only 18% were randomized to one of the clinical trials, and the most common reason for exclusion was refusal to participate.⁴ Because participation entailed substantial burdens and lifestyle changes that could be at odds with strongly held personal beliefs, women who agreed to participate are likely to differ from women who declined. For example, there are significant . . . [Full Text of this Article]

Scott K. Aberegg, MD, MPH
scottaberegg@hotmail.com
Division of Pulmonary and Critical Care Medicine
Ohio State University College of Medicine and Public Health
Columbus

David T. Majure, MD, MPH
Johns Hopkins Medical Institutions
Baltimore, Md

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