The Ethics of Placebo-Controlled Trials -- A Middle Ground

doi:10.1056/NEJM200109203451211

Volume 345:915-919		September 20, 2001		Number 12

The Ethics of Placebo-Controlled Trials — A Middle Ground

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Editorial
by Huston, P.

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The first placebo-controlled trial was probably conducted in1931, when sanocrysin was compared with distilled water forthe treatment of tuberculosis.¹ Ever since then, placebo-controlledtrials have been controversial, especially when patients randomlyassigned to receive placebo have forgone effective treatments.²^,³^,⁴^,⁵Recently, the debate has become polarized. One view, dubbed"placebo orthodoxy" by its opponents, is that methodologic considerationsmake placebo-controlled trials necessary.⁶^,⁷^,⁸^,⁹^,¹⁰^,¹¹ The otherview, which might be called "active-control orthodoxy," is thatplacebo orthodoxy sacrifices ethics and the rights and welfareof patients to presumed scientific rigor.¹⁰^,¹¹^,¹²^,¹³^,¹⁴ Thelatest revision of the Declaration of Helsinki, although controversial,¹⁵^,¹⁶embraces . . . [Full Text of this Article]

Placebo Orthodoxy

Active-Control Orthodoxy

A Middle Ground

A Case Example

Conclusions

References

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