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March 18, 1983

Controlled Clinical Trials-Reply

Author Affiliations

University of Texas Health Sciences Center Houston

JAMA. 1983;249(11):1434-1435. doi:10.1001/jama.1983.03330350016008

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In Reply.—  I thank Dr Spodick for his supporting view with regard to my editorial in The Journal. Although we agree on most points, I would reiterate my criticisms of large, multicentered, randomized clinical trials for reperfusion therapy in cases of acute myocardial infarction, which make such trials frequently uninterpretable and, therefore, a waste of limited research funds.

  1. 1. Preselection, medical-surgical crossovers, data attrition, and, finally different characteristics of randomized groups despite randomization make the final data questionable in many if not most such trials.

  2. 2. Mortality is a remote and non-specific end point that provides little insight into mechanisms or actual effects of therapy. That is, the therapy may benefit the problem for which it was intended, but other factors of selection or side effects, which may be investigated or solved as separate problems, obscure these benefits by increasing mortality nonspecifically.

  3. 3. In our experience, admission left ventricular ejection