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Deceptive Research—Reply

Deceptive Research—Reply In reply We appreciate the commentary by Dr Miller regarding the use of deception in placebo research. The recent study by Scott and collaborators1 was designed to avoid deceptive statements while still obtaining clinically relevant data on the neurobiology of placebo effects. The design used was developed after extensive consultation and input from the investigational review board at our institution and the ethics specialists at the board. It consisted of the use of both active and inactive drug administrations in a parallel design (subjects could receive one or the other, but not both). The informed consent specifically described that the subjects could receive either an inactive or active drug. Furthermore, the adverse effects described in the consent form were those corresponding to the active drug. Perhaps the point of confusion resides on the phrasing used in page 222 of the article, in the “Experimental Design” subsection of the “Methods” section, “Actual pharmacological agents were not administered in these studies,” when it should have read “Actual pharmacological agents were not administered to these subjects” instead. The data contained in this article only describe the responses to the placebo intervention and not those to the active drug. Dr Miller and collaborators have recently published a perspective on the topic of placebo research, with an emphasis on avoiding deception when manipulating expectancies through inactive (placebo) interventions.2 Procedures suggested in their article included the following: (1) prior review and approval by an independent ethics committee; (2) disclosure that the study involves the use of deception; and (3) debriefing the participants at the conclusion of research participation. Points 1 and 2 are addressed earlier for the specific example of Scott et al.1 We also had originally planned to debrief the subjects regarding our interest in the study of placebo effects in addition to those of active drugs. Because of the parallel design used, the ethics review did not deem that a debriefing session was necessary. My colleagues and I also would like to make 2 additional points regarding the use of deception and disclosure in placebo studies. There is substantial literature, including the article being commented on, demonstrating that the administration of a placebo can indeed modulate endogenous mechanisms promoting analgesia and a number of other physiological effects. Depending on the actual description of the procedure to the subjects, it cannot be immediately assumed that deception is indeed taking place when it is suggested that a particular sham procedure may induce a physiological response. It is now very well described at psychophysical and neurobiological levels that there are indeed physiological effects as a consequence of placebo administration. The other comment regards point 2. Emphasizing a specific interest in the study of placebo effects during informed consent procedures is likely to introduce a substantial bias in the data, as this impacts the volunteer's interpretation of the study and its purpose. This type of disclosure prior to the performance of the studies would make the results substantially less relevant to clinical trials and practice where placebo effects are embedded in the active treatment effects. Like Dr Miller, we are very much interested in the ethical conduct of research and finding a good balance between ethics and the quality and the generalizability of the research conducted. Correspondence: Dr Zubieta, Department of Psychiatry, University of Michigan Medical School, Molecular and Behavioral Neuroscience Institute, 205 Zina Pitcher Pl, Ann Arbor, MI 48109 (zubieta@umich.edu). Financial Disclosure: None reported. References 1. Scott DJStohler CSEgnatuk CMWang HKoeppe RAZubieta JK Placebo and nocebo effects are defined by opposite opioid and dopaminergic responses. Arch Gen Psychiatry 2008;65 (2) 220- 231PubMedGoogle ScholarCrossref 2. Miller FGWendler DSwartzman LC Deception in research on the placebo effect. PLoS Med 2005;2 (9) e262.http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020262. Accessed July 16, 2008PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of General Psychiatry American Medical Association

Deceptive Research—Reply

Archives of General Psychiatry , Volume 65 (10) – Oct 6, 2008

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References (2)

Publisher
American Medical Association
Copyright
Copyright © 2008 American Medical Association. All Rights Reserved.
ISSN
0003-990X
eISSN
1598-3636
DOI
10.1001/archpsyc.65.10.1226
Publisher site
See Article on Publisher Site

Abstract

In reply We appreciate the commentary by Dr Miller regarding the use of deception in placebo research. The recent study by Scott and collaborators1 was designed to avoid deceptive statements while still obtaining clinically relevant data on the neurobiology of placebo effects. The design used was developed after extensive consultation and input from the investigational review board at our institution and the ethics specialists at the board. It consisted of the use of both active and inactive drug administrations in a parallel design (subjects could receive one or the other, but not both). The informed consent specifically described that the subjects could receive either an inactive or active drug. Furthermore, the adverse effects described in the consent form were those corresponding to the active drug. Perhaps the point of confusion resides on the phrasing used in page 222 of the article, in the “Experimental Design” subsection of the “Methods” section, “Actual pharmacological agents were not administered in these studies,” when it should have read “Actual pharmacological agents were not administered to these subjects” instead. The data contained in this article only describe the responses to the placebo intervention and not those to the active drug. Dr Miller and collaborators have recently published a perspective on the topic of placebo research, with an emphasis on avoiding deception when manipulating expectancies through inactive (placebo) interventions.2 Procedures suggested in their article included the following: (1) prior review and approval by an independent ethics committee; (2) disclosure that the study involves the use of deception; and (3) debriefing the participants at the conclusion of research participation. Points 1 and 2 are addressed earlier for the specific example of Scott et al.1 We also had originally planned to debrief the subjects regarding our interest in the study of placebo effects in addition to those of active drugs. Because of the parallel design used, the ethics review did not deem that a debriefing session was necessary. My colleagues and I also would like to make 2 additional points regarding the use of deception and disclosure in placebo studies. There is substantial literature, including the article being commented on, demonstrating that the administration of a placebo can indeed modulate endogenous mechanisms promoting analgesia and a number of other physiological effects. Depending on the actual description of the procedure to the subjects, it cannot be immediately assumed that deception is indeed taking place when it is suggested that a particular sham procedure may induce a physiological response. It is now very well described at psychophysical and neurobiological levels that there are indeed physiological effects as a consequence of placebo administration. The other comment regards point 2. Emphasizing a specific interest in the study of placebo effects during informed consent procedures is likely to introduce a substantial bias in the data, as this impacts the volunteer's interpretation of the study and its purpose. This type of disclosure prior to the performance of the studies would make the results substantially less relevant to clinical trials and practice where placebo effects are embedded in the active treatment effects. Like Dr Miller, we are very much interested in the ethical conduct of research and finding a good balance between ethics and the quality and the generalizability of the research conducted. Correspondence: Dr Zubieta, Department of Psychiatry, University of Michigan Medical School, Molecular and Behavioral Neuroscience Institute, 205 Zina Pitcher Pl, Ann Arbor, MI 48109 (zubieta@umich.edu). Financial Disclosure: None reported. References 1. Scott DJStohler CSEgnatuk CMWang HKoeppe RAZubieta JK Placebo and nocebo effects are defined by opposite opioid and dopaminergic responses. Arch Gen Psychiatry 2008;65 (2) 220- 231PubMedGoogle ScholarCrossref 2. Miller FGWendler DSwartzman LC Deception in research on the placebo effect. PLoS Med 2005;2 (9) e262.http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020262. Accessed July 16, 2008PubMedGoogle ScholarCrossref

Journal

Archives of General PsychiatryAmerican Medical Association

Published: Oct 6, 2008

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