The ethics of placebo-controlled trials--a middle ground.

Abstract

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.2–5 Recently, the debate has become polarized. One view, dubbed “placebo orthodoxy” by its opponents, is that methodologic considerations make placebo-controlled trials necessary.6–11 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.10–14 The latest revision of the Declaration of Helsinki, . . .