In their informative assessment of 13 years of aortocoronary bypass surgery, DeBakey and Lawrie (p 837), dispute the necessity of prospective randomized studies for the evaluation of surgical diagnostic and therapeutic techniques. They point out that certain time-honored criteria, particularly clinical experience, have proved reliable in assessing therapeutic value. They state, "The insistence on prospective randomized studies reflects a naive obsession with this research tool."
In support of their statement, DeBakey and Lawrie could easily invoke the testimony of the past. Many great advances in medicine have been made without the benefit of controlled trials. The latter, in fact, is a mixed blessing. One shudders, for instance, to think what might have become of insulin had a controlled prospective trial reported a few deaths from hypoglycemic shock when this complication was unknown. Insulin might have been declared too toxic for human use. One also wonders about the number of fatalities
Vaisrub S. Random Thoughts on Randomization. JAMA. 1978;239(9):858. doi:10.1001/jama.1978.03280360054021
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