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Drs Hansen and Stein raised the question as to the validity of using historical controls to assess a new therapeutic modality. The authors are very well aware of the merit and pitfalls of concurrent randomized studies. In many situations, the circumstances do not permit a concurrent randomized control, or, if the historical control is very much compatible with the studied groups, historical control may be the only valid background. For example, in the successful treatment of gestational choriocarcinoma with the chemotherapy, the initial treatment of Wilms tumor with chemotherapy and radiotherapy during the postoperative period, and even radiotherapy for stage I and stage II Hodgkin disease, there were no concurrent randomized controls. In addition, the effect of digitalis on congestive heart failure, the effect of adrenal steroids on adrenal crisis, and the effect of insulin on diabetic coma are all examples. To go a step further, when a
Li MC. Fluorouracil as an Adjuvant to Colorectal Cancer Surgery-Reply. JAMA. 1976;236(22):2488. doi:10.1001/jama.1976.03270230012007
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