The University of Southampton
University of Southampton Institutional Repository

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
Huneke, Nathan T.M.
d1be843a-7aab-4978-9b4d-5bcc69b178a7
Amin, Jay
692a8880-70ff-4b64-a7e9-7d0d53449a30
Baldwin, David S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Bellato, Alessio
0ee4c34f-3850-4883-8b82-5717b74990f7
Brandt, Valerie
e41f5832-70e4-407d-8a15-85b861761656
Chamberlain, Samuel R.
8a0e09e6-f51f-4039-9287-88debe8d8b6f
Correll, Christoph U.
d1a6c4a7-3911-4ffb-9d9d-4d70f6b574b1
Eudave, Luis
f736791a-8a5f-4d3f-b273-9354922d160c
Garner, Matthew
3221c5b3-b951-4fec-b456-ec449e4ce072
Gosling, Corentin J.
4b27a1d3-18fb-4be5-b199-e44aaa66c8b2
Hill, Catherine m.
172dc851-574e-4815-9c5e-4de4dae9fc35
Hou, Ruihua
470bdcbc-93a9-4dad-aac5-26d455c34376
Howes, Oliver D.
91cd1cc1-58d0-4743-928f-e0b971cfd6a5
Ioannidis, Konstantinos
82240a24-3153-45bb-bfaf-c6df9cd4f261
Köhler-Forsberg, Ole
0e3198bb-cf2a-4a91-ab26-721cb666906a
Marzulli, Lucia
3f554484-1473-4d8b-b01c-1b01ba64c834
Reed, Claire
465b9fe5-083a-41a3-81e4-c6b1f2efce7b
Sinclair, Julia M.A.
be3e54d5-c6da-4950-b0ba-3cb8cdcab13c
Singh, Satneet
a33d0576-f7ff-44ba-b3f8-f3e564e43c76
Solmi, Marco
2022a2e4-774d-4811-b1db-b6dbfedbd10d
Cortese, Samuele
53d4bf2c-4e0e-4c77-9385-218350560fdb
Huneke, Nathan T.M.
d1be843a-7aab-4978-9b4d-5bcc69b178a7
Amin, Jay
692a8880-70ff-4b64-a7e9-7d0d53449a30
Baldwin, David S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Bellato, Alessio
0ee4c34f-3850-4883-8b82-5717b74990f7
Brandt, Valerie
e41f5832-70e4-407d-8a15-85b861761656
Chamberlain, Samuel R.
8a0e09e6-f51f-4039-9287-88debe8d8b6f
Correll, Christoph U.
d1a6c4a7-3911-4ffb-9d9d-4d70f6b574b1
Eudave, Luis
f736791a-8a5f-4d3f-b273-9354922d160c
Garner, Matthew
3221c5b3-b951-4fec-b456-ec449e4ce072
Gosling, Corentin J.
4b27a1d3-18fb-4be5-b199-e44aaa66c8b2
Hill, Catherine m.
172dc851-574e-4815-9c5e-4de4dae9fc35
Hou, Ruihua
470bdcbc-93a9-4dad-aac5-26d455c34376
Howes, Oliver D.
91cd1cc1-58d0-4743-928f-e0b971cfd6a5
Ioannidis, Konstantinos
82240a24-3153-45bb-bfaf-c6df9cd4f261
Köhler-Forsberg, Ole
0e3198bb-cf2a-4a91-ab26-721cb666906a
Marzulli, Lucia
3f554484-1473-4d8b-b01c-1b01ba64c834
Reed, Claire
465b9fe5-083a-41a3-81e4-c6b1f2efce7b
Sinclair, Julia M.A.
be3e54d5-c6da-4950-b0ba-3cb8cdcab13c
Singh, Satneet
a33d0576-f7ff-44ba-b3f8-f3e564e43c76
Solmi, Marco
2022a2e4-774d-4811-b1db-b6dbfedbd10d
Cortese, Samuele
53d4bf2c-4e0e-4c77-9385-218350560fdb

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. (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.

Text
s41380-024-02638-x - Version of Record
Available under License Creative Commons Attribution.
Download (1MB)

More information

Accepted/In Press date: 2024
Published date: 24 June 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

Catalogue record

Date deposited: 15 Aug 2024 16:30
Last modified: 05 Oct 2024 02:16

Export record

Altmetrics

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

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×