title: Reconsidering the ethics of sham interventions in an era of emerging technologies.
abstract: BACKGROUND
  Our aim was to ethically evaluate the arguments in favor and against sham interventions, as presented in literature. Two developments underscore the need to reconsider the ethics of sham interventions. First, the number of clinical trials investigating interventions in the field of regenerative medicine are increasing, in which the choice for a placebo requires an invasive intervention. Second, the increased awareness of the lack of systematic research in surgery stresses the need to discuss the necessity and acceptability of sham-controlled clinical trials.
  
  
  METHODS
  A systematic search in Medline was performed, of which 104 articles were considered relevant.
  
  
  RESULTS
  Arguments in favor of a sham controlled design are that it increases the scientific validity and the benefits to society while at the same time the risks and harm can be acceptable. Arguments against sham controls include that they pose unacceptable risks to participants, present difficulties with informed consent, that the use of deceptive tactics is unethical, and that the feasibility of such controls is compromised because of a lack of public support.
  
  
  CONCLUSIONS
  None of the published literature fully rejects sham interventions, and many regard sham interventions acceptable provided the conditions of scientific necessity, reasonable risks, and valid informed consent are fulfilled. Further debate should no longer address whether a sham control is ethically acceptable but rather when these conditions are fulfilled.
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: S.L.Niemansburg-2@umcutrecht.nl.
authors.forename: Sophie L
authors.initials: SL
authors.lastname: Niemansburg
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
authors.forename: Johannes J M
authors.initials: JJ
authors.lastname: van Delden
authors.affiliation: Department of Orthopedics, University Medical Center Utrecht, Utrecht, the Netherlands.
authors.forename: Wouter J A
authors.initials: WJ
authors.lastname: Dhert
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
authors.forename: Annelien L
authors.initials: AL
authors.lastname: Bredenoord
mesh_terms: D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D010342:Patient Acceptance of Health Care; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods; D012107:Research Design; D013514:Surgical Procedures, Operative / Q000941:ethics*
chemical_list: D010919:Placebos