Placebo and nocebo effects in randomized controlled trials: The implications for research and practice

Sanderson, C; Hardy, J; Spruyt, O; Currow, DC

Placebo and nocebo effects in randomized controlled trials: The implications for research and practice

Sanderson, C

Hardy, J Spruyt, O Currow, DC

Permalink

Publication Type:: Journal Article
Citation:: Journal of Pain and Symptom Management, 2013, 46 (5), pp. 722 - 730
Issue Date:: 2013-11-01

Closed Access

	Filename	Description	Size
	1-s2.0-S0885392413001103-main.pdf	Published Version	102.01 kB	Adobe PDF	View/Open

Copyright Clearance Process

Recently Added
In Progress
Closed Access

This item is closed access and not available.

Full metadata record

Field	Value	Language
dc.contributor.author	Sanderson, C https://orcid.org/0000-0001-5423-5778	en_US
dc.contributor.author	Hardy, J	en_US
dc.contributor.author	Spruyt, O	en_US
dc.contributor.author	Currow, DC https://orcid.org/0000-0003-1988-1250	en_US
dc.date.available	2012-12-18	en_US
dc.date.issued	2013-11-01	en_US
dc.identifier.citation	Journal of Pain and Symptom Management, 2013, 46 (5), pp. 722 - 730	en_US
dc.identifier.issn	0885-3924	en_US
dc.identifier.uri	http://hdl.handle.net/10453/117429
dc.description.abstract	Placebo and nocebo effects are known to contribute significantly to the response to symptom control, including analgesia. Clinical trial methodologies using placebo controls are designed to identify the magnitude of these effects in the research context. An adequately powered, randomized, double-blind, placebo-controlled trial of ketamine in cancer pain has recently been reported, which demonstrated no net clinical benefit for ketamine over and above that of placebo. Rates of placebo and nocebo responses were high. The setting of a clinical trial provides an opportunity to quantify the nonpharmacologic aspects of patient responses to analgesia, raising important clinical and ethical issues for practice. The findings of the ketamine study are analyzed in the context of a methodological discussion of placebo and nocebo effects, what is known about the biological and psychological bases for each of these, and their implications for a clinical trial design in the palliative care setting. Along with reviewing the use of ketamine after this negative trial, clinicians need to remain aware of the strength and significance of both placebo and nocebo responses in their own practices and the biopsychosocial complexity of why and how patients actually respond to pain management strategies. The results of this study strongly reinforce the importance of the therapeutic relationship and the context of care. © 2013 Published by Elsevier Inc. on behalf of U.S. Cancer Pain Relief Committee. All rights reserved.	en_US
dc.relation.ispartof	Journal of Pain and Symptom Management	en_US
dc.relation.isbasedon	10.1016/j.jpainsymman.2012.12.005	en_US
dc.subject.classification	Anesthesiology	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Pain	en_US
dc.subject.mesh	Analgesics	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Placebo Effect	en_US
dc.subject.mesh	Biomedical Research	en_US
dc.subject.mesh	Outcome Assessment (Health Care)	en_US
dc.subject.mesh	Randomized Controlled Trials as Topic	en_US
dc.subject.mesh	Outcome Assessment, Health Care	en_US
dc.title	Placebo and nocebo effects in randomized controlled trials: The implications for research and practice	en_US
dc.type	Journal Article
utslib.citation.volume	5	en_US
utslib.citation.volume	46	en_US
utslib.for	1110 Nursing	en_US
utslib.for	11 Medical and Health Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Students
utslib.copyright.status	closed_access
pubs.issue	5	en_US
pubs.publication-status	Published	en_US
pubs.volume	46	en_US

Abstract:

Placebo and nocebo effects are known to contribute significantly to the response to symptom control, including analgesia. Clinical trial methodologies using placebo controls are designed to identify the magnitude of these effects in the research context. An adequately powered, randomized, double-blind, placebo-controlled trial of ketamine in cancer pain has recently been reported, which demonstrated no net clinical benefit for ketamine over and above that of placebo. Rates of placebo and nocebo responses were high. The setting of a clinical trial provides an opportunity to quantify the nonpharmacologic aspects of patient responses to analgesia, raising important clinical and ethical issues for practice. The findings of the ketamine study are analyzed in the context of a methodological discussion of placebo and nocebo effects, what is known about the biological and psychological bases for each of these, and their implications for a clinical trial design in the palliative care setting. Along with reviewing the use of ketamine after this negative trial, clinicians need to remain aware of the strength and significance of both placebo and nocebo responses in their own practices and the biopsychosocial complexity of why and how patients actually respond to pain management strategies. The results of this study strongly reinforce the importance of the therapeutic relationship and the context of care. © 2013 Published by Elsevier Inc. on behalf of U.S. Cancer Pain Relief Committee. All rights reserved.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/117429