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

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 (N5160) 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) -21.10, P=0.272) or unpleasantness ratings (t(146)= -20.05, 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.