Abstract
The use of placebos in clinical research has been a matter of considerable debate in recent years, notably when the World Medical Association published, in 2002, a note of clarification for paragraph 29 of the Helsinki Declaration. Brazil is known for its strong opposition to the flexible use of placebos. Both the Federal Council of Medicine and the National Health Council have published resolutions regulating the use of placebos in Brazil, preventing their use if there is a more effective therapeutic method already in place. The present study reinforces that position and aims to describe the various uses of placebos in clinical research, as well as examining the complex decisions relating to the ethics of their use. Additionally, the authors propose a reflection on the use of placebos through decision-making algorithms based on Brazilian ethical standards.
Placebos; Control groups; Bioethics; Biomedical research; Helsinki Declaration; Methods; Decision support techniques
Key: (Ex) experimental treatment; (T) most appropriate treatment for clinical condition of a specific group of participants; (PT) placebo of T; (PEx) placebo of Ex; (P) Placebo
* The World Health Organization (WHO) considers an adverse drug reaction incidence greater than 10% to be “very frequent”. However, this number cannot be used as an absolute parameter about the fragility of masking, as it is an arbitrary definition.
Notas: (Ex) tratamiento experimental; (T) tratamiento más adecuado a la condición clínica estudiada en un grupo específico de participantes; (PT) placebo de T; (PEx) placebo de Ex; (P) placebo.
* A Organização Mundial da Saúde classifica como “muito comum” a reação adversa à droga cuja incidência seja maior que 10% 15. Contudo, esse valor não pode ser usado como parâmetro absoluto para a decisão sobre fragilização de mascaramento, já que se trata de valor arbitrariamente estabelecido.