Placebos and paradoxes in psychiatric research: An ethics perspective

The use of placebos in clinical trials, particularly in research with menta lly ill people, has emerged as a subject of considerable controversy. We fi rst outline rthical aspects of the primary scientific arguments for and aga inst placebo use in research. Three examples of paradoxical aspects of the ethical use of placebos are discussed: involvement of relatively more vulne rable populations, use of apparently "less than standard" therapy, and the omission of information in placebo comparisons. In the current scientific a nd regulatory context, placebo use in psychiatric research may be necessary for scientific reasons, and when certain conditions are present, it may be justified on ethical grounds. Four key recommendations to facilitate the e thical use of placebos in research trials are presented. We conclude that p lacebo trials should be undertaken only after careful evaluation of alterna tive scientific strategies and, as with all human research, with great resp ect and genuine consideration for the individuals who choose to participate in these protocols. (C) 2001 Society of Biological Psychiatry.