Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach

Fabian Holzhüter,Johannes Hamann

doi:10.1186/s12910-020-00541-y

Abstract

BackgroundThorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo (or placebo) effects.MethodsWe conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication.ResultsNo statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill).ConclusionIn this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic.Trial registrationTrial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered.

Highlights

Thorough information of the patient is an integral part of the process of shared decision making
We aimed to investigate whether detailed information about possible adverse effects of treatment options, as it is an obligatory step of Shared decision making (SDM) [9], may induce nocebo effects in patients suffering from depression
There was no hint towards nocebo effects deriving from the kind of information provision

Summary

Introduction

Thorough information of the patient is an integral part of the process of shared decision making. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication. Conclusion: In this study, we were not able detect an effect of informed consent vs simple consent on the emergence of placebo or nocebo effects. We aimed to investigate whether detailed information about possible adverse effects of treatment options, as it is an obligatory step of SDM [9], may induce nocebo (or placebo) effects in patients suffering from depression (i.e. whether the amount of information given to the patient has positive or negative effects on the patient).

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