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Overview of Results of Randomized Clinical Trials in Heart DiseaseI. Treatments Following Myocardial Infarction
Salim Yusuf, MRCP, DPhil;
Janet Wittes, PhD;
Lawrence Friedman, MD
JAMA. 1988;260(14):2088-2093.
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WHEN Daniel1 requested that he and his compatriots be served pulse and water while Nebuchadnezzar's other young servants be served the king's food and wine, he was inaugurating the first recorded clinical trial. Today we would criticize Daniel's attempt to demonstrate the superiority of his simple diet. He failed to assign the two diets at random; neither the experimental subjects nor the eunuchs who were to measure the ten-day outcome, fairness of countenance, were blinded to the treatment; and the sample size, four subjects on the experimental diet and a larger unspecified number on kingly fare, was too small to be likely to detect a difference in outcome. Despite, or perhaps because of, the faulty design, the results supported Daniel's hypothesis. "And at the end of ten days their countenances appeared fairer, and they were fatter in flesh, than all the youths that did eat of the king's food."
. . . [Full Text PDF of this Article]
Author Affiliations
From the Clinical Trials Branch (Drs Yusuf and Friedman) and Biostatistics Research Branch (Dr Wittes), Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, Bethesda, Md.
Footnotes
The opinions expressed in this article are entirely those of the authors and do not necessarily reflect the position of any institution.
Reprint requests to Room 5C-08, Federal Building, Clinical Trials Branch, National Heart, Lung, and Blood Institute, Bethesda, MD 20892 (Dr Yusuf).
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