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Nocebo vs. placebo: the challenges of trial design in analgesia research.
Clin Pharmacol Ther. 2015 Feb; 97(2):143-50.CP

Abstract

The placebo effect in randomized clinical trials appears to have increased thereby contributing to problems of demonstrating statistically reliable effects of treatments that directly target biological mechanisms. The shortcomings of randomized clinical trials are currently discussed along with potential improvements of trial designs. In this review we explain how utilizing knowledge from the placebo and nocebo mechanisms literature could improve the information that can be obtained from randomized clinical trials. We present three major challenges in randomized clinical trials: (i) increasing placebo effects, (ii) variability of the placebo effect, and (iii) risk of un-blinding. We then explain how recent placebo and nocebo studies of effects of verbal suggestion, expectancy, and emotions may improve understanding and discussion of increasing placebo effects, account/control for large parts of the variability of placebo effects, and suggest ways to improve blinding in future trials.

Authors+Show Affiliations

Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Aarhus, Denmark.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

25670519

Citation

Vase, L, et al. "Nocebo Vs. Placebo: the Challenges of Trial Design in Analgesia Research." Clinical Pharmacology and Therapeutics, vol. 97, no. 2, 2015, pp. 143-50.
Vase L, Amanzio M, Price DD. Nocebo vs. placebo: the challenges of trial design in analgesia research. Clin Pharmacol Ther. 2015;97(2):143-50.
Vase, L., Amanzio, M., & Price, D. D. (2015). Nocebo vs. placebo: the challenges of trial design in analgesia research. Clinical Pharmacology and Therapeutics, 97(2), 143-50. https://doi.org/10.1002/cpt.31
Vase L, Amanzio M, Price DD. Nocebo Vs. Placebo: the Challenges of Trial Design in Analgesia Research. Clin Pharmacol Ther. 2015;97(2):143-50. PubMed PMID: 25670519.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nocebo vs. placebo: the challenges of trial design in analgesia research. AU - Vase,L, AU - Amanzio,M, AU - Price,D D, Y1 - 2015/01/09/ PY - 2014/09/19/received PY - 2014/10/28/revised PY - 2014/11/04/accepted PY - 2015/2/12/entrez PY - 2015/2/12/pubmed PY - 2015/4/9/medline SP - 143 EP - 50 JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. VL - 97 IS - 2 N2 - The placebo effect in randomized clinical trials appears to have increased thereby contributing to problems of demonstrating statistically reliable effects of treatments that directly target biological mechanisms. The shortcomings of randomized clinical trials are currently discussed along with potential improvements of trial designs. In this review we explain how utilizing knowledge from the placebo and nocebo mechanisms literature could improve the information that can be obtained from randomized clinical trials. We present three major challenges in randomized clinical trials: (i) increasing placebo effects, (ii) variability of the placebo effect, and (iii) risk of un-blinding. We then explain how recent placebo and nocebo studies of effects of verbal suggestion, expectancy, and emotions may improve understanding and discussion of increasing placebo effects, account/control for large parts of the variability of placebo effects, and suggest ways to improve blinding in future trials. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/25670519/Nocebo_vs__placebo:_the_challenges_of_trial_design_in_analgesia_research_ L2 - https://doi.org/10.1002/cpt.31 DB - PRIME DP - Unbound Medicine ER -