Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

Abstract Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search...

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Autores principales: Melina von Wernsdorff, Martin Loef, Brunna Tuschen-Caffier, Stefan Schmidt
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Lenguaje:EN
Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/fc7b321d49f943bf89c27a9f7c114ce4
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spelling oai:doaj.org-article:fc7b321d49f943bf89c27a9f7c114ce42021-12-02T12:11:50ZEffects of open-label placebos in clinical trials: a systematic review and meta-analysis10.1038/s41598-021-83148-62045-2322https://doaj.org/article/fc7b321d49f943bf89c27a9f7c114ce42021-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-83148-6https://doaj.org/toc/2045-2322Abstract Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I 2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.Melina von WernsdorffMartin LoefBrunna Tuschen-CaffierStefan SchmidtNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-14 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Melina von Wernsdorff
Martin Loef
Brunna Tuschen-Caffier
Stefan Schmidt
Effects of open-label placebos in clinical trials: a systematic review and meta-analysis
description Abstract Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I 2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.
format article
author Melina von Wernsdorff
Martin Loef
Brunna Tuschen-Caffier
Stefan Schmidt
author_facet Melina von Wernsdorff
Martin Loef
Brunna Tuschen-Caffier
Stefan Schmidt
author_sort Melina von Wernsdorff
title Effects of open-label placebos in clinical trials: a systematic review and meta-analysis
title_short Effects of open-label placebos in clinical trials: a systematic review and meta-analysis
title_full Effects of open-label placebos in clinical trials: a systematic review and meta-analysis
title_fullStr Effects of open-label placebos in clinical trials: a systematic review and meta-analysis
title_full_unstemmed Effects of open-label placebos in clinical trials: a systematic review and meta-analysis
title_sort effects of open-label placebos in clinical trials: a systematic review and meta-analysis
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/fc7b321d49f943bf89c27a9f7c114ce4
work_keys_str_mv AT melinavonwernsdorff effectsofopenlabelplacebosinclinicaltrialsasystematicreviewandmetaanalysis
AT martinloef effectsofopenlabelplacebosinclinicaltrialsasystematicreviewandmetaanalysis
AT brunnatuschencaffier effectsofopenlabelplacebosinclinicaltrialsasystematicreviewandmetaanalysis
AT stefanschmidt effectsofopenlabelplacebosinclinicaltrialsasystematicreviewandmetaanalysis
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