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


Journal

Molecular psychiatry
ISSN: 1476-5578
Titre abrégé: Mol Psychiatry
Pays: England
ID NLM: 9607835

Informations de publication

Date de publication:
24 Jun 2024
Historique:
received: 01 02 2024
accepted: 19 06 2024
revised: 17 06 2024
medline: 25 6 2024
pubmed: 25 6 2024
entrez: 24 6 2024
Statut: aheadofprint

Résumé

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.

Identifiants

pubmed: 38914807
doi: 10.1038/s41380-024-02638-x
pii: 10.1038/s41380-024-02638-x
doi:

Types de publication

Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

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Auteurs

Nathan T M Huneke (NTM)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. n.huneke@soton.ac.uk.
Southern Health NHS Foundation Trust, Southampton, UK. n.huneke@soton.ac.uk.

Jay Amin (J)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Southern Health NHS Foundation Trust, Southampton, UK.

David S Baldwin (DS)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Southern Health NHS Foundation Trust, Southampton, UK.
University Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.

Alessio Bellato (A)

School of Psychology, University of Nottingham Malaysia, Semenyih, Malaysia.
Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.

Valerie Brandt (V)

Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
Clinic of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hanover, Germany.

Samuel R Chamberlain (SR)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Southern Health NHS Foundation Trust, Southampton, UK.

Christoph U Correll (CU)

Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, Germany.
Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA.
Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA.

Luis Eudave (L)

Faculty of Education and Psychology, University of Navarra, Pamplona, Spain.

Matthew Garner (M)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.

Corentin J Gosling (CJ)

Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
Université Paris Nanterre, DysCo Lab, F-92000, Nanterre, France.
Université de Paris, Laboratoire de Psychopathologie et Processus de Santé, F-92100, Boulogne-Billancourt, France.

Catherine M Hill (CM)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Department of Sleep Medicine, Southampton Children's Hospital, Southampton, UK.

Ruihua Hou (R)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

Oliver D Howes (OD)

Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
H Lundbeck A/s, Iveco House, Watford, UK.
Institute of Clinical Sciences (ICS), Faculty of Medicine, Imperial College London, London, UK.

Konstantinos Ioannidis (K)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Southern Health NHS Foundation Trust, Southampton, UK.

Ole Köhler-Forsberg (O)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Psychosis Research Unit, Aarhus University Hospital-Psychiatry, Aarhus, Denmark.

Lucia Marzulli (L)

Department of Translational Biomedicine and Neuroscience (DIBRAIN), University of Studies of Bari "Aldo Moro", Bari, Italy.

Claire Reed (C)

Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.

Julia M A Sinclair (JMA)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

Satneet Singh (S)

Southern Health NHS Foundation Trust, Southampton, UK.

Marco Solmi (M)

Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.
Department of Mental Health, Ottawa Hospital, Ottawa, ON, Canada.
Ottawa Hospital Research Institute (OHRI) Clinical Epidemiology Program, University of Ottawa, Ottawa, ON, Canada.
School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.

Samuele Cortese (S)

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
Solent NHS Trust, Southampton, UK.
DiMePRe-J-Department of Precision and Regenerative Medicine-Jonic Area, University "Aldo Moro", Bari, Italy.
Hassenfeld Children's Hospital at NYU Langone, New York University Child Study Center, New York, NY, USA.

Classifications MeSH