Evidence map›Paper›PMID 26393486›Full record

SynthesisTranslational psychiatry2015

Predictors of placebo response in pharmacological and dietary supplement treatment trials in pediatric autism spectrum disorder: a meta-analysis.

A Masi, A Lampit, N Glozier, I B Hickie, A J Guastella

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Translational psychiatry, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 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

34 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
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  5. Pooled it
  6. Trial
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  14. Arbaclofen in Children and Adolescents with Autism Spectrum Disorder: A Randomized, Controlled, Phase 2 Trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2017
    Trial
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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

5 authors.

A MasiAutism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
A LampitRegenerative Neuroscience Group, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
N GlozierAutism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
I B HickieAutism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
A J GuastellaAutism Clinic for Translational Research, Brain and Mind Centre, Central Clinical School, Faculty of Medicine, University of Sydney, Camperdown, NSW, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Large placebo responses in many clinical trials limit our capacity to identify effective therapeutics. Although it is often assumed that core behaviors in children with autism spectrum disorders (ASDs) rarely remit spontaneously, there has been limited investigation of the size of the placebo response in relevant clinical trials. These trials also rely on caregiver and clinical observer reports as outcome measures. The objectives of this meta-analysis are to identify the pooled placebo response and the predictors of placebo response in pharmacological and dietary supplement treatment trials for participants with a diagnosis of ASD. Randomized controlled trials (RCTs) in pediatric ASD, conducted between 1980 and August 2014, were identified through a search of Medline, EMBASE, Web of Science, Cochrane Database of Systematic Reviews and clinicaltrials.gov. RCTs of at least 14 days duration, comparing the treatment response for an oral active agent and placebo using at least one of the common outcome measures, were included. Analysis of 25 data sets (1315 participants) revealed a moderate effect size for overall placebo response (Hedges' g=0.45, 95% confidence interval (0.34-0.56), P<0.001). Five factors were associated with an increase in response to placebo, namely: an increased response to the active intervention; outcome ratings by clinicians (as compared with caregivers); trials of pharmacological and adjunctive interventions; and trials located in Iran. There is a clear need for the identification of objective measures of change in clinical trials for ASD, such as evaluation of biological activity or markers, and for consideration of how best to deal with placebo response effects in trial design and analyses.

Indexed as

Autism Spectrum DisorderDietary SupplementsOutcome Assessment, Health CareChildHumansPlacebo EffectPrognosisPsychotropic DrugsRandomized Controlled Trials as TopicPsychotropic Drugs

Identifiers

PMID26393486
PMCPMC5068810

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.