Placebo in Surgical Research: A Case-Based Ethical Analysis and Practical Consequences.
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.
Department of Legal Medicine and Bioethics, Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; National Institute of Legal Medicine, 042122 Bucharest, Romania.
Sorin
0000-0003-4130-9402
S
Hostiuc
Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, 020021 Bucharest, Romania.
Irina
I
Rentea
University of Medicine and Pharmacy, 800216 Galați, Romania; Galați Psychiatry Hospital, 800216 Galați, Romania.
Eduard
0000-0003-4247-6202
E
Drima
Department of Surgery, Faculty of Medicine, Carol Davila University of Medicine and Pharmacy, 020021 Bucharest, Romania.
Ionut
0000-0002-6950-9599
I
Negoi
D035843:Biomedical Research / Q000941:ethics*; D006801:Humans; D010919:Placebos / Q000008:administration & dosage / Q000627:therapeutic use; D018570:Risk Assessment; D013514:Surgical Procedures, Operative / Q000379:methods*
D010919:Placebos