John E. Nelson, MD, PhD
Nelson JE. "Pilot" Studies. Ann Intern Med. 1989;111:188-189. doi: 10.7326/0003-4819-111-2-188_2
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Published: Ann Intern Med. 1989;111(2):188-189.
To the Editor: The study of megestrol acetate in the treatment of cachexia associated with human immunodeficiency virus (HIV) infection by Von Roenn and colleagues (1) and their reasons for doing a nonrandomized, nonblinded, and uncontrolled study deserve further comment (2).
Dr. Von Roenn puts the cart before the horse in stating (3) that "a potential benefit, without undue toxicity, must be shown before a placebo-controlled study is appropriate." The reason for doing a blinded and controlled trial is to determine if the proposed treatment is "beneficial and without undue toxicity." A reasonable hypothesis, and not previous proof of benefit,
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