Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using
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(2020) 21:97
RESEARCH ARTICLE
Open Access
Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach Fabian Holzhüter*
and Johannes Hamann
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, Simple consent, Nocebo, Placebo, Shared decision making, Open-label placebo
Strengths and limitations of this study We performed an experimental randomized clinical
trial with high clinical relevance. This study investigated a field of medicine that is
lacking further research. There are weaknesses in the study design (e.g. a
small number of participants). Open-label placebo is an under-researched topic in
medicine [1]
* Correspondence: [email protected] Klinik und Poliklinik für Psychiatrie und Psychotherapie, Klinikum rechts der Isar, Technische Universität München, Möhlstraße 26, 81675 Munich, Germany
Background Shared decision making (SDM) is a widely supported model of doctor-patient-interaction [2, 3] that may lead to benefits in patients’ clinical outcomes [4–6]. There is also an ethical imperative to overcome paternalistic structures and to involve patients in treatment decisions [7, 8]. In this study, 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). Many physicians tend to avoid mentioning side effects and are reluctant because they fear to trouble the patient [10, 11]. This may hinder doctors to engage in SDM.
© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
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