Placebo in Surgical Research: A Case-Based Ethical Analysis and Practical Consequences

Abstract

Placebo is a form of simulated medical treatment intended to deceive the patient/subject who believes that he/she received an active therapy. In clinical medicine, the use of placebo is allowed in particular circumstances to assure a patient that he is taken care of and that he/she receives an active drug, even if this is not the case. In clinical research placebo is widely used, as it allows a baseline comparison for the active intervention. If the use of placebo is highly regulated in pharmacological trials, surgery studies have a series of particularities that make its use extremely problematic and regarded less favorably. The purpose of this paper is to present three famous cases of placebo use in surgical trials and to perform an ethical analysis of their acceptability using the Declaration of Helsinki as a main regulatory source.