To the Editor: Nearly all of the patients in
the trial by Dr Lazarus and colleagues1
were previously receiving controller therapy with ICs. In addition to the
fact that one third of the trial participants were randomized to placebo for
16 weeks, all participants entered a 6-week "placebo runout" phase at the
conclusion of the trial in which controller therapy was withdrawn or withheld.
Several placebo-controlled trials have indicated that such patients
experience worsening of asthma symptoms when randomized to placebo,2- 4 which was confirmed
by the results of this trial. Placebo-controlled clinical trials are ethically
controversial whenever patients risk forgoing proven effective therapy as
a result of randomization to placebo.
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