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Whether placebo controls are methodologically indicated depends on the questions that clinical trials are designed to answer. We argued that placebos were not needed in 2 asthma trials comparing combination therapy with monotherapy and in a third trial comparing 2 dosing regimens of the same inhaled corticosteroid.¹ Temple and Meyer suggest that a placebo might have been warranted to test assay sensitivity in the first 2 trials. However, both these adequately powered studies were designed to test the superiority of the combination therapy to monotherapy. Given that the component treatments in these 2 trials had previously been demonstrated to be effective, we see the potential increase in rigor from including a placebo control as having marginal scientific value. The key ethical question is whether this theoretical increment of rigor justifies the risks of asthma worsening for those randomized to placebo. Temple and Meyer suggest that use of placebo . . . [Full Text of this Article]

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