Evidence map›Paper›PMID 38035741›Full record

ArticleBMJ open2023

Placebo effects in mental health disorders: protocol for an umbrella review.

Nathan Tm Huneke, Jay Amin, David S Baldwin, Samuel R Chamberlain, Christoph U Correll, Matthew Garner, Catherine M Hill, Ruihua Hou, Oliver D Howes, Julia Ma Sinclair and 2 more

Abstract read
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Nathan Tm HunekeClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK n.huneke@soton.ac.uk.ORCID 0000-0001-5981-6707
Jay AminClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.
David S BaldwinClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.
Samuel R ChamberlainClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.
Christoph U CorrellPsychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, USA.
Matthew GarnerClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.
Catherine M HillClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.
Ruihua HouClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.
Oliver D HowesDepartment of Psychosis Studies, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
Julia Ma SinclairClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.ORCID 0000-0002-1905-2025
Marco SolmiDepartment of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-4877-7233
Samuele CorteseClinical and Experimental Sciences, University of Southampton Faculty of Medicine, Southampton, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGiven the high prevalence of mental health disorders and their significant socioeconomic burden, there is a need to develop improved treatments, and to evaluate them through placebo-controlled trials. However, the magnitude of the placebo response in randomised controlled trials to test medications may be substantial, affecting their interpretation. Therefore, improved understanding of the patient, trial and mental disorder factors that influence placebo responses would inform clinical trial design to better detect active treatment effects. There is a growing literature exploring the placebo response within specific mental health disorders, but no overarching synthesis of this research has been produced to date. We present a protocol for an umbrella review of systematic reviews and/or meta-analyses in which we aim to understand the effect size and potential predictors of placebo response within, and across, mental health disorders. METHODS AND ANALYSIS: We will systematically search databases (Medline, PsycINFO, EMBASE+EMBASE Classic, Web of Knowledge) for systematic reviews and/or meta-analyses that report placebo effect size in clinical trials in patients with mental health disorders (initial search date 23 October 2022). Screening of abstracts and full texts will be done in pairs. We will extract data to qualitatively examine how placebo effect size varies across mental health disorders. We also plan to qualitatively summarise predictors of increased placebo response identified either quantitatively (eg, through meta-regression) or qualitatively. Risk of bias will be assessed using the AMSTAR-2 tool. We aim to not only summarise the current literature but also to identify gaps in knowledge and generate further hypotheses. ETHICS AND DISSEMINATION: We do not believe there are any specific ethical considerations relevant to this study. We will publish the results in a peer-reviewed journal.

Indexed as

Mental DisordersMental HealthHumansPlacebo EffectReview Literature as TopicSystematic Reviews as TopicPSYCHIATRYSLEEP MEDICINESystematic Review

Identifiers

PMID38035741
PMCPMC10689367

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.