Overview of Results of Randomized Clinical Trials in Heart Disease

WHEN Daniel1requested 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."