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Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia

Locher, Cosimaa,*; Frey Nascimento, Antjea; Kirsch, Irvingb; Kossowsky, Joea,c; Meyer, Andread; Gaab, Jensa

doi: 10.1097/j.pain.0000000000001012
Research Paper
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Research on open-label placebos questions whether deception is a necessary characteristic of placebo effects. Yet, comparisons between open-label and deceptive placebos (DPs) are lacking. We therefore assessed effects of open-label placebos and DPs in comparison with no treatment (NT) with a standardized experimental heat pain paradigm in a randomized controlled trial in healthy participants. Participants (N = 160) were randomly assigned to NT, open-label placebo without rationale (OPR-), open-label placebo with rationale (OPR+), and DP. We conducted baseline and posttreatment measurements of heat pain threshold and tolerance. Apart from the NT, all groups received an application of a placebo cream. Primary outcomes were planned comparisons of heat pain tolerance and the corresponding intensity and unpleasantness ratings. Objective posttreatment pain tolerance did not differ among groups. However, for subjective heat pain ratings at the posttreatment tolerance level, groups with a rationale (OPR+ and DP) reported diminished heat pain intensity (t(146) = −2.15, P = 0.033, d = 0.43) and unpleasantness ratings (t(146) = −2.43, P = 0.016, d = 0.49) compared with the OPR-group. Interestingly, the OPR+ and the DP groups did not significantly differ in heat pain intensity (t(146) = −1.10, P = 0.272) or unpleasantness ratings (t(146) = −0.05, P = 0.961) at the posttreatment tolerance level. Our findings reveal that placebos with a plausible rationale are more effective than without a rationale. Even more, open-label placebos did not significantly differ in their effects from DPs. Therefore, we question the ubiquitously assumed necessity of concealment in placebo administration.

Supplemental Digital Content is Available in the Text.In a standardised heat pain paradigm randomized controlled trial with healthy participants, open-label placebos did not significantly differ from deceptive placebos, regarding subjective intensity and unpleasantness ratings.

aDepartment of Psychology, Division of Clinical Psychology and Psychotherapy, University of Basel, Basel, Switzerland

bProgram in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS), Boston, MA, USA

cDepartment of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Harvard Medical School (HMS), Boston, MA, USA

dDepartment of Psychology, Clinical Psychology and Epidemiology, University of Basel, Basel, Switzerland

Corresponding author. Address: Department of Clinical Psychology and Psychotherapy, University of Basel, Missionsstrasse 62a, 4055 Basel, Switzerland. Tel.: +41 (0)61 267 03 85. E-mail address: cosima.locher@unibas.ch (C. Locher).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.painjournalonline.com).

Received May 12, 2017

Received in revised form June 19, 2017

Accepted July 03, 2017

© 2017 International Association for the Study of Pain
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