Reply to K. Jackson et al and W. Leppert
We thank Jackson et al and Leppert for the opportunity to respond to their concerns regarding our article.
Our main point of contention is the belief, on the part of Jackson et al, 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. This issue is particularly emphasized by the high placebo response rate (27%) demonstrated in our blinded, randomized controlled trial.