Abstract
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We thank Jackson et al1 and Leppert2 for the opportunity to
respond to their concerns regarding our article.3
Our main point of contention is the belief, on the part of Jackson
et al,1 that unblinded, nonrandomized, prospective audits can give a
true indication of the efficacy or toxicity of a drug. Open-label studies
do not meet the specific scientific definition of control. The gross
underestimation and overestimation of effects in uncontrolled trials,
especially studies that involve small numbers of participants, have
been well documented.4 This issue is particularly emphasized by the
high placebo response rate (27%) demonstrated in our blinded, randomized
controlled trial.