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Placebo and nocebo effects in randomized controlled trials: the implications for research and practice.
J Pain Symptom Manage. 2013 Nov; 46(5):722-30.JP

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.

Authors+Show Affiliations

Calvary Health Care Sydney, Kogarah, New South Wales, Australia; CareSearch, Flinders University, Bedford Park, South Australia, Australia. Electronic address: christinersanderson@gmail.com.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23523360

Citation

Sanderson, Christine, et al. "Placebo and Nocebo Effects in Randomized Controlled Trials: the Implications for Research and Practice." Journal of Pain and Symptom Management, vol. 46, no. 5, 2013, pp. 722-30.
Sanderson C, Hardy J, Spruyt O, et al. Placebo and nocebo effects in randomized controlled trials: the implications for research and practice. J Pain Symptom Manage. 2013;46(5):722-30.
Sanderson, C., Hardy, J., Spruyt, O., & Currow, D. C. (2013). Placebo and nocebo effects in randomized controlled trials: the implications for research and practice. Journal of Pain and Symptom Management, 46(5), 722-30. https://doi.org/10.1016/j.jpainsymman.2012.12.005
Sanderson C, et al. Placebo and Nocebo Effects in Randomized Controlled Trials: the Implications for Research and Practice. J Pain Symptom Manage. 2013;46(5):722-30. PubMed PMID: 23523360.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo and nocebo effects in randomized controlled trials: the implications for research and practice. AU - Sanderson,Christine, AU - Hardy,Janet, AU - Spruyt,Odette, AU - Currow,David C, Y1 - 2013/03/22/ PY - 2012/07/17/received PY - 2012/12/04/revised PY - 2012/12/18/accepted PY - 2013/3/26/entrez PY - 2013/3/26/pubmed PY - 2014/5/16/medline KW - Placebo KW - cancer pain KW - ketamine KW - nocebo KW - randomized controlled trial methodology SP - 722 EP - 30 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 46 IS - 5 N2 - 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. SN - 1873-6513 UR - https://www.unboundmedicine.com/medline/citation/23523360/Placebo_and_nocebo_effects_in_randomized_controlled_trials:_the_implications_for_research_and_practice_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(13)00110-3 DB - PRIME DP - Unbound Medicine ER -