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Captopril and Digoxin in Mild to Moderate Heart Failure-Reply

Bertram Pitt, MD; Sidney Goldstein, MD
JAMA. 1988;259(24):3557-3558. doi:10.1001/jama.1988.03720240019014.
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In Reply.  —In response to the letter by Dr Zatuchni regarding our recent publication in JAMA, we agree with the difficulties in assessing end points in clinical trials for congestive heart failure. Treadmill exercise testing and New York Heart Association classification constitute the universally accepted end points in clinical trials. Improvements in these parameters were in fact the basis of approval in 1982 by the Food and Drug Administration for the use of captopril in the treatment of heart failure refractory to treatment with digitalis and diuretics.Because of the subjective nature of the assessment of exercise tolerance and functional class, the validity of the conclusions rests on double-blinding the investigation in addition to randomly allocating treatments to patients. The random allocation of treatments allows the chance distribution of "whim and will" among the treatment groups and is the prerequisite for making statistical inferences from the study. Clearly, measuring exercise


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