Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.

<h4>Background</h4>Placebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of "open-label placebos" (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarl...

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Main Authors: Tobias Kube, Verena E Hofmann, Julia A Glombiewski, Irving Kirsch
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2021-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0248367
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spelling doaj-b02ec03045564c2fa6f3ec37bb9347922021-06-08T04:30:11ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01163e024836710.1371/journal.pone.0248367Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.Tobias KubeVerena E HofmannJulia A GlombiewskiIrving Kirsch<h4>Background</h4>Placebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of "open-label placebos" (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic.<h4>Methods</h4>In a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis (N = 54) over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter).<h4>Results</h4>The results of the manipulation check confirmed that the augmented clinical encounter was evaluated more positively than the limited encounter, in terms of perceived warmth of the provider. Participants from all treatment groups showed significant symptom reduction from baseline to two weeks later, but OLP had no incremental effect over TAU. Participants benefitted more from OLP when they did not take any other medication against allergic symptoms than when taking medication on demand. When controlling for baseline symptoms, a significant treatment by encounter interaction was found, pointing to greater symptom improvement in the OLP group when the encounter was augmented, whereas the control group improved more when the encounter was limited.<h4>Discussion</h4>The study demonstrates that providing OLP and enhancing the encounter remotely is possible, but their effectiveness might be lower in comparison to previous studies relying on physical patient-provider interaction. The study raises questions for future research about the potential and challenges of remote placebo studies and virtual clinical encounters. The study has been registered as a clinical trial at ISRCTN (record number: 39018).https://doi.org/10.1371/journal.pone.0248367
collection DOAJ
language English
format Article
sources DOAJ
author Tobias Kube
Verena E Hofmann
Julia A Glombiewski
Irving Kirsch
spellingShingle Tobias Kube
Verena E Hofmann
Julia A Glombiewski
Irving Kirsch
Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.
PLoS ONE
author_facet Tobias Kube
Verena E Hofmann
Julia A Glombiewski
Irving Kirsch
author_sort Tobias Kube
title Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.
title_short Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.
title_full Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.
title_fullStr Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.
title_full_unstemmed Providing open-label placebos remotely-A randomized controlled trial in allergic rhinitis.
title_sort providing open-label placebos remotely-a randomized controlled trial in allergic rhinitis.
publisher Public Library of Science (PLoS)
series PLoS ONE
issn 1932-6203
publishDate 2021-01-01
description <h4>Background</h4>Placebos can reduce physical symptoms even when provided with full honesty and disclosure. Yet, the precise mechanisms underlying the effects of "open-label placebos" (OLPs) have remained subject of debate. Furthermore, it is unclear whether OLPs are similarly effective when provided remotely, as is sometimes required e.g. in the current COVID-19 pandemic.<h4>Methods</h4>In a randomized-controlled trial, we examined the effects of OLP plus treatment as usual (TAU) compared to TAU alone on symptom reduction in people with allergic rhinitis (N = 54) over the course of two weeks. Due to the COVID-19 pandemic, OLP was provided remotely (i.e. sent via postal service). To investigate the potential influence of the clinical encounter on the effects of OLP, we manipulated the perception of the virtual clinical encounter, both with respect to verbal and nonverbal factors (augmented vs. limited encounter).<h4>Results</h4>The results of the manipulation check confirmed that the augmented clinical encounter was evaluated more positively than the limited encounter, in terms of perceived warmth of the provider. Participants from all treatment groups showed significant symptom reduction from baseline to two weeks later, but OLP had no incremental effect over TAU. Participants benefitted more from OLP when they did not take any other medication against allergic symptoms than when taking medication on demand. When controlling for baseline symptoms, a significant treatment by encounter interaction was found, pointing to greater symptom improvement in the OLP group when the encounter was augmented, whereas the control group improved more when the encounter was limited.<h4>Discussion</h4>The study demonstrates that providing OLP and enhancing the encounter remotely is possible, but their effectiveness might be lower in comparison to previous studies relying on physical patient-provider interaction. The study raises questions for future research about the potential and challenges of remote placebo studies and virtual clinical encounters. The study has been registered as a clinical trial at ISRCTN (record number: 39018).
url https://doi.org/10.1371/journal.pone.0248367
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