The Use and Abuse of Placebo in Clinical Trials.

Abstract

This article particularly looks at the advantages and disadvantages of the use of placebos in the evaluation of new drugs when a standard drug is already available. Placebos make blinding possible and in that way help to control measurement bias when assessing the outcome of a trial. Several considerations need to be made when deciding whether to use a placebo. There are legal aspects, registration requirements, commercial interests, medical issues and scientific aspects. A placebo can and should be used in all research when the condition of the patient is not life-threatening and when there are no irreversible consequences of placebo treatment, even if a standard drug is available, but obviously only after informed consent. Insufficient evidence is provided if a placebo group is omitted when assessing a new drug versus standard drug. Obviously, this causes a conflict between the ethical aspects on one hand and the scientific aspects on the other, but if placebo groups are not used it will slow developments in medicine and reduce therapeutic possibilities.