Study had insufficient power to investigate safetyBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8146 (Published 03 December 2012) Cite this as: BMJ 2012;345:e8146
- Jacques E Rossouw, medical officer1,
- JoAnn E Manson, professor of medicine2,
- Andrew M Kaunitz, professor of obstetrics and gynecology3,
- Marcia L Stefanick, professor of medicine4
- 1National Heart, Lung, and Blood Institute, Bethesda, MD, USA
- 2Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
- 3University of Florida College of Medicine-Jacksonville, FL, USA
- 4Stanford University School of Medicine, Stanford, CA, USA
There are several concerns about the robustness of Schierbeck and colleagues’ findings.1 The open label design means that the trial could not control for placebo effect, and knowledge of active treatment could have led to differential ascertainment of outcomes.
The composite outcome of mortality, myocardial infarction, and heart failure was not prespecified in the design paper, …
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