Placebo and Nocebo: Legal and Ethical Implications for Nursing Practice
Styliani Kotrotsiou
General Department, University of Thessaly, Larissa, Greece.
Sotirios Tozios
Nurse School Teacher, Lesvos, Greece.
Dimitrios Theofanidis *
Department of Nursing, School for Health, International Hellenic University, Thessaloniki, Greece.
*Author to whom correspondence should be addressed.
Abstract
Aim: The purpose of this discussion paper is to contemplate on the placebo and nocebo phenomena providing legal, ethical and clinical implications for nursing practice.
Methodology: This is a critical review for which a selection of key references were used based on a critique of placebo and nocebo that provided a balanced discussion and evaluation of the strengths, weakness and notable features of the both terms.
Results and Discussion: From a legal point of view, there is a clear reference to the informed consent of the patient involved in the investigation, the way it is carried out and the conditions to be met for the conduct of a clinical study. In Greek legislation, the rights of the hospital patient are determined ex lege and the protection of the study participants by specific ministerial decisions. With regard to the moral aspect of the use of placebo, the Helsinki Declaration refers in specific articles to medical research which should promote respect for human beings and the protection of health. More recently rather than denying the patient essential treatment by using placebo, a new drug is tested against a drug which is known to be effective to check if the new drug is more effective or not.
Conclusions: The term ‘placebo’ refers to a pseudo-drug or procedure i.e. an inert treatment while ‘nocebo’ is a phenomenon where the symptoms of a condition unjustifiably worsen when the patient is dissatisfied with a treatment.
There are many views on the appropriateness of the existence and use of the placebo method. From a moral point of view, one could argue that it would be unfair to use it in some cases. Yet, in the authors’ view, there should be a balance between conflicting opinions and whether these relate to ethics, religion or science per se. Neither the abolition nor the excessive and irrational use of placebo would in any way serve the direct interests of mankind.
Keywords: Placebo, nocebo, legal, ethical