The Ethics of Placebo-Controlled Trials — A Middle Ground

The first placebo-controlled trial was probably conducted in 1931, when sanocrysin was compared with distilled water for the treatment of tuberculosis.1 Ever since then, placebo-controlled trials have been controversial, especially when patients randomly assigned to receive placebo have forgone effective treatments.25 Recently, the debate has become polarized. One view, dubbed “placebo orthodoxy” by its opponents, is that methodologic considerations make placebo-controlled trials necessary.611 The other view, which might be called “active-control orthodoxy,” is that placebo orthodoxy sacrifices ethics and the rights and welfare of patients to presumed scientific rigor.1014 The latest revision of the Declaration of Helsinki, . . .