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Randomized Controlled Trial
. 2020 Oct 14;21(1):97.
doi: 10.1186/s12910-020-00541-y.

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

Fabian Holzhüter  1 , Johannes Hamann  2
Affiliations
Randomized Controlled Trial

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

Fabian Holzhüter et al. BMC Med Ethics. .

Abstract

Background: Thorough 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.

Methods: We 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.

Results: No 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).

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. This finding is contrary to most assumptions and publications about this topic.

Trial registration: Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered.

Keywords: Informed consent; Nocebo; Open-label placebo; Placebo; Shared decision making; Simple consent.

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Conflict of interest statement

There is no conflict of interest we can proclaim.

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