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NEUROLOGY 2005;65:S59-S65
© 2005 American Academy of Neurology

Neurology supplements are not peer-reviewed. Information contained in Neurology supplements represent the opinions of the authors and are not endorsed by nor do they reflect the views of the American Academy of Neurology, Editor-in-Chief, or Associate Editors of Neurology.

Ethical aspects of placebo groups in pain trials

Lessons from psychiatry

Elna M. Nagasako, PhD and Donna A. Kalauokalani, MD, MPH

From the Washington University School of Medicine, St. Louis, MO (Dr. Nagasako), and University of California Davis, Department of Anesthesiology and Pain Medicine, Sacramento, CA (Dr. Kalauokalani).

Address correspondence and reprint requests to Dr. Elna M. Nagasako, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8021, St. Louis, MO 63110; e-mail: nagasake{at}msnotes.wustl.edu

Placebo control use in clinical research is contentious in areas where effective treatments already exist. Determination of appropriate standards for placebo use is especially difficult in areas such as pain treatment and psychiatry, in which substantial placebo responses can occur. Debates are characterized by three common themes: (a) whether the state of existing treatments forbids placebo use, (b) whether the nature of the condition being treated and the level of additional risk permit placebo control use, and (c) whether methodological concerns are sufficient to justify placebo use. A review of these themes in the psychiatric research literature suggests possible strategies for analysis of this issue in the area of pain research.


Publication of this supplement was supported in part by an educational grant from Pfizer Inc to the Office of Professional Education, University of Rochester School of Medicine and Dentistry.

Disclosure: The sponsor has provided the authors with an honorarium for their participation in this project.







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