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Placebo effects in randomized trials of pharmacological and neurostimulation interventions for mental disorders: an umbrella review

Placebo effects in randomized trials of pharmacological and neurostimulation interventions for mental disorders: an umbrella review
Placebo effects in randomized trials of pharmacological and neurostimulation interventions for mental disorders: an umbrella review
There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this research has analyzed evidence across mental disorders. We carried out an umbrella review of meta-analyses of randomized controlled trials (RCTs) of biological treatments (pharmacotherapy or neurostimulation) for mental disorders. We explored whether placebo effect size differs across distinct disorders, and the correlates of increased placebo effects. Based on a pre-registered protocol, we searched Medline, PsycInfo, EMBASE, and Web of Knowledge up to 23.10.2022 for systematic reviews and/or meta-analyses reporting placebo effect sizes in psychopharmacological or neurostimulation RCTs. Twenty meta-analyses, summarising 1,691 RCTs involving 261,730 patients, were included. Placebo effect size varied, and was large in alcohol use disorder (g = 0.90, 95% CI [0.70, 1.09]), depression (g = 1.10, 95% CI [1.06, 1.15]), restless legs syndrome (g = 1.41, 95% CI [1.25, 1.56]), and generalized anxiety disorder (d = 1.85, 95% CI [1.61, 2.09]). Placebo effect size was small-to-medium in obsessive-compulsive disorder (d = 0.32, 95% CI [0.22, 0.41]), primary insomnia (g = 0.35, 95% CI [0.28, 0.42]), and schizophrenia spectrum disorders (standardized mean change = 0.33, 95% CI [0.22, 0.44]). Correlates of larger placebo response in multiple mental disorders included later publication year (opposite finding for ADHD), younger age, more trial sites, larger sample size, increased baseline severity, and larger active treatment effect size. Most (18 of 20) meta-analyses were judged ‘low’ quality as per AMSTAR-2. Placebo effect sizes varied substantially across mental disorders. Future research should explore the sources of this variation. We identified important gaps in the literature, with no eligible systematic reviews/meta-analyses of placebo response in stress-related disorders, eating disorders, behavioural addictions, or bipolar mania.
1359-4184
3915-3925
Huneke, Nathan T.M.
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Amin, Jay
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Baldwin, David S.
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Bellato, Alessio
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Brandt, Valerie
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Chamberlain, Samuel R.
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Correll, Christoph U.
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Eudave, Luis
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Garner, Matthew
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Gosling, Corentin J.
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Hill, Catherine m.
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Hou, Ruihua
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Howes, Oliver D.
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Ioannidis, Konstantinos
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Marzulli, Lucia
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Singh, Satneet
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Solmi, Marco
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Cortese, Samuele
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Huneke, Nathan T.M.
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Amin, Jay
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Baldwin, David S.
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Bellato, Alessio
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Brandt, Valerie
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Chamberlain, Samuel R.
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Correll, Christoph U.
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Eudave, Luis
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Garner, Matthew
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Gosling, Corentin J.
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Hill, Catherine m.
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Hou, Ruihua
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Howes, Oliver D.
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Ioannidis, Konstantinos
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Köhler-Forsberg, Ole
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Marzulli, Lucia
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Reed, Claire
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Sinclair, Julia M.A.
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Singh, Satneet
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Solmi, Marco
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Cortese, Samuele
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Huneke, Nathan T.M., Amin, Jay, Baldwin, David S., Bellato, Alessio, Brandt, Valerie, Chamberlain, Samuel R., Correll, Christoph U., Eudave, Luis, Garner, Matthew, Gosling, Corentin J., Hill, Catherine m., Hou, Ruihua, Howes, Oliver D., Ioannidis, Konstantinos, Köhler-Forsberg, Ole, Marzulli, Lucia, Reed, Claire, Sinclair, Julia M.A., Singh, Satneet, Solmi, Marco and Cortese, Samuele (2024) Placebo effects in randomized trials of pharmacological and neurostimulation interventions for mental disorders: an umbrella review. Molecular Psychiatry, 29 (12), 3915-3925. (doi:10.1038/s41380-024-02638-x).

Record type: Review

Abstract

There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this research has analyzed evidence across mental disorders. We carried out an umbrella review of meta-analyses of randomized controlled trials (RCTs) of biological treatments (pharmacotherapy or neurostimulation) for mental disorders. We explored whether placebo effect size differs across distinct disorders, and the correlates of increased placebo effects. Based on a pre-registered protocol, we searched Medline, PsycInfo, EMBASE, and Web of Knowledge up to 23.10.2022 for systematic reviews and/or meta-analyses reporting placebo effect sizes in psychopharmacological or neurostimulation RCTs. Twenty meta-analyses, summarising 1,691 RCTs involving 261,730 patients, were included. Placebo effect size varied, and was large in alcohol use disorder (g = 0.90, 95% CI [0.70, 1.09]), depression (g = 1.10, 95% CI [1.06, 1.15]), restless legs syndrome (g = 1.41, 95% CI [1.25, 1.56]), and generalized anxiety disorder (d = 1.85, 95% CI [1.61, 2.09]). Placebo effect size was small-to-medium in obsessive-compulsive disorder (d = 0.32, 95% CI [0.22, 0.41]), primary insomnia (g = 0.35, 95% CI [0.28, 0.42]), and schizophrenia spectrum disorders (standardized mean change = 0.33, 95% CI [0.22, 0.44]). Correlates of larger placebo response in multiple mental disorders included later publication year (opposite finding for ADHD), younger age, more trial sites, larger sample size, increased baseline severity, and larger active treatment effect size. Most (18 of 20) meta-analyses were judged ‘low’ quality as per AMSTAR-2. Placebo effect sizes varied substantially across mental disorders. Future research should explore the sources of this variation. We identified important gaps in the literature, with no eligible systematic reviews/meta-analyses of placebo response in stress-related disorders, eating disorders, behavioural addictions, or bipolar mania.

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Accepted/In Press date: 2024
Published date: 24 June 2024
Additional Information: Publisher Copyright: © The Author(s) 2024.

Identifiers

Local EPrints ID: 492813
URI: http://eprints.soton.ac.uk/id/eprint/492813
ISSN: 1359-4184
PURE UUID: dc0c765f-99eb-410e-bf10-ee3e44aa7545
ORCID for Jay Amin: ORCID iD orcid.org/0000-0003-3792-0428
ORCID for David S. Baldwin: ORCID iD orcid.org/0000-0003-3343-0907
ORCID for Alessio Bellato: ORCID iD orcid.org/0000-0001-5330-6773
ORCID for Samuel R. Chamberlain: ORCID iD orcid.org/0000-0001-7014-8121
ORCID for Matthew Garner: ORCID iD orcid.org/0000-0001-9481-2226
ORCID for Ruihua Hou: ORCID iD orcid.org/0000-0001-6127-1478
ORCID for Claire Reed: ORCID iD orcid.org/0000-0003-1385-4729
ORCID for Julia M.A. Sinclair: ORCID iD orcid.org/0000-0002-1905-2025
ORCID for Samuele Cortese: ORCID iD orcid.org/0000-0001-5877-8075

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Date deposited: 15 Aug 2024 16:30
Last modified: 12 Dec 2024 03:08

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Contributors

Author: Nathan T.M. Huneke
Author: Jay Amin ORCID iD
Author: Alessio Bellato ORCID iD
Author: Valerie Brandt
Author: Samuel R. Chamberlain ORCID iD
Author: Christoph U. Correll
Author: Luis Eudave
Author: Matthew Garner ORCID iD
Author: Corentin J. Gosling
Author: Catherine m. Hill
Author: Ruihua Hou ORCID iD
Author: Oliver D. Howes
Author: Konstantinos Ioannidis
Author: Ole Köhler-Forsberg
Author: Lucia Marzulli
Author: Claire Reed ORCID iD
Author: Satneet Singh
Author: Marco Solmi
Author: Samuele Cortese ORCID iD

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