[Ethical controversies on the use of placebo as control treatment in clinical trials in neurology].
Under certain circumstances, the best design to answer a therapeutic question is to conduct a randomized, blinded, placebo-controlled clinical trial. This paper suggests and comments the most controversial aspects of placebo use in clinical research in neurology. It also aims to provide criteria and alternatives, with a multidisciplinary approach (bioethics, research methodology and clinical neurology).
Use of placebo as control treatment mainly affects four of the seven usually recognized requirements to consider a clinical trial as ethical: social or scientific value of the research, scientific validity, benefit/risk balance and informed consent. These four aspects are considered separately within the context of clinical trials with drugs in Neurology. The main questions at stake, ethical conflicts and possible options are stressed.


CONCLUSIONS
The use of placebo-controlled clinical trials in Neurology is subject to many ethical controversies. Nevertheless, there are ethical reasons that justify study designs that use placebo, provided that the rights and safety of participants are adequately safeguarded. We need to increase our understanding of the concept of equipoise and recognize the benefit society obtains with research, thus requiring joint assessment of the benefit/risk ratio of a given clinical trial. Likewise, accurate information on the real risks and benefits of patients taking part in placebo-controlled clinical trials should be collected.
Lahuerta
J
J
Departamento Médico, Glaxo SmithKline, S.A., Tres Cantos (Madrid). jld23465@gsk.com
Gutiérrez Rivas
E
E
Frías
J
J
Gracia
D
D
Dal-Ré
R
R
D000465:Algorithms; D002986:Clinical Trials as Topic / Q000941:ethics*; D004358:Drug Therapy; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent; D009462:Neurology; D015990:Placebo Effect; D010919:Placebos; D018570:Risk Assessment
D010919:Placebos