title: Ethical problems arising from the use of placebo in clinical trials with drugs for migraine. Their analysis by the moral deliberation method.
abstract: BACKGROUND
  Migraine is characterised as episodes of headache plus a variety of accompanying symptoms. Its pharmacological control remains unsatisfactory for some patients. The use of placebo in drug clinical trials on migraine commonly leads to numerous ethical uncertainties.
  
  
  METHODS
  The purpose of this paper is to illustrate how the deliberation method helps in analysing the issues and finding solutions to selected ethical problems. Ethical decisions that try to solve conflicts arising from placebo use in clinical trials may be adopted using the moral deliberation method. Thus, the conflict is systematically assessed by identifying the following: Relevant facts; Values in conflict; Duties, or in other words, possible courses of action. Moral duty is following the optimal course of action. To identify this, it is recommended to state extreme courses of action, then intermediate courses of action, and then to proceed to the optimal course(s) of action.
  
  
  CONCLUSIONS
  In this paper, the application of this method is shown in several conflicting situations arising in two placebo-controlled clinical trials with drugs under development for the prophylaxis and acute treatment of migraine.
authors.affiliation: Servicio de Farmacología Clínica, Hospital Universitario La Paz, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Frías
authors.forename: J
authors.initials: J
authors.lastname: Pascual
authors.forename: J
authors.initials: J
authors.lastname: Lahuerta
authors.forename: D
authors.initials: D
authors.lastname: Gracia
authors.forename: R
authors.initials: R
authors.lastname: Dal-Ré
mesh_terms: D000328:Adult; D026688:Bioethical Issues; D002986:Clinical Trials as Topic / Q000941:ethics*; D005260:Female; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy* / Q000517:prevention & control*; D009014:Morals; D010919:Placebos / Q000627:therapeutic use*
chemical_list: D010919:Placebos