Evidence map›Paper›PMID 33170261›Full record

Trial reportJAMA network open2020

Effect of Sodium Benzoate vs Placebo Among Individuals With Early Psychosis: A Randomized Clinical Trial.

James G Scott, Andrea Baker, Carmen C W Lim, Sharon Foley, Frances Dark, Anne Gordon, David Ward, Drew Richardson, George Bruxner, K Martin Beckmann and 10 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA network open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% of its field
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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Article
  7. Review
  8. Review
  9. Add-on Sodium Benzoate andSchizophrenia bulletin open · 2024
    Article
  10. Review
  11. Article
  12. Review
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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

20 authors at 13 institutions in 2 countries.

James G ScottQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Andrea BakerQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Carmen C W LimQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Sharon FoleyEmotional Health Unit, Mater Hospital, South Brisbane, Australia.
Frances DarkMetro South Mental Health, MacGregor, Australia.
Anne GordonMetro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Australia.
David WardMetro North Mental Health, Royal Brisbane and Women's Hospital, Herston, Australia.
Drew RichardsonWest Moreton Mental Health Service, Ipswich, Australia.
George BruxnerMetro North Mental Health, Caboolture and Redcliffe Hospitals, Caboolture, Australia.
K Martin BeckmannSchool of Medicine, Logan Hospital, Griffith University, Meadowbrook, Australia.
Sean HatherillMetro South Addiction and Mental Health Services, Logan Hospital, Meadowbrook, Australia.
Stephen StathisQueensland Children's Hospital, South Brisbane, Australia.
Krystal DixonMental Health and Addiction Services, Sunshine Coast Hospital and Health Service, Birtinya, Australia.
Alexander E RyanQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Brett C McWhinneyDepartment of Chemical Pathology, Pathology Queensland, Royal Brisbane and Women's Hospital, Herston, Australia.
Jacobus P J UngererDepartment of Chemical Pathology, Pathology Queensland, Brisbane, Australia.
Michael BerkInstitute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Deakin University, Geelong, Australia.
Olivia M DeanInstitute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Deakin University, Geelong, Australia.
Sukanta SahaQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
John McGrathQueensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
Queensland Centre for Mental Health Research · AURoyal Brisbane and Women's Hospital · AUGriffith University · AUPark Centre for Mental Health · AUThe University of Queensland · AUAarhus University · DKBarwon Health · AUDeakin University · AULogan Hospital · AUMater Health Services · AUMetro South Health · AUQueensland Health · AURedcliffe Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: There is evidence that sodium benzoate (BZ) may be an effective adjunctive treatment for schizophrenia. The clinical efficacy of BZ has been investigated in chronic schizophrenia; however, the efficacy of this agent has not been studied in individuals with early psychosis. Objective: To examine the clinical efficacy of the adjunctive use of BZ for symptoms in people with early psychosis. Design, Setting, and Participants: Using a placebo-controlled double-masked parallel-group design, this randomized clinical trial was conducted from August 2015 to July 2018. Participants aged between 15 and 45 years experiencing early psychosis were enrolled from 5 major clinical sites in Queensland, Australia. Data analysis was conducted from October 2018 to February 2020. Interventions: Participants were randomized 1:1 (50 participants in each group) to receive 500 mg of sodium benzoate twice daily or placebo for 12 weeks. Main Outcomes and Measures: The primary efficacy outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks. The key secondary efficacy measures were (1) the Clinical Global Impression score, (2) the Hamilton Depression Rating Scale for depression, (3) functioning as assessed by the clinician-rated Global Assessment of Function, and (4) the Assessment of Quality of Life Scale. The PANSS subscale scores and impact on selected amino acid concentrations were also assessed. Results: The study comprised 100 participants with a mean (SD) age of 21.4 (4.1) years, of whom 73 (73%) were male individuals. The mean (SD) baseline PANSS score was 75.3 (15.4). We found no improvement in total PANSS score in the BZ group compared with the placebo group. The end result of least-squares mean difference (SE) for total PANSS was -1.2 (2.4) (P = .63). There were no differences in any subscales of the PANSS, any secondary measures, nor any amino acid concentrations. The dose of BZ was well tolerated without any clinically significant treatment-emergent adverse event differences between BZ and placebo groups. Conclusions and Relevance: In this randomized clinical trial, there was no evidence that adjunctive use of 500 mg of BZ twice daily is an effective treatment for individuals with early psychosis. Trial Registration: anzctr.org.au Identifier: ACTRN12615000187549.

Indexed as

AdolescentAdultAntifungal AgentsAustraliaCase-Control StudiesDrug Therapy, CombinationFemaleHumansMalePlacebosPsychiatric Status Rating ScalesPsychotic DisordersQuality of LifeSchizophreniaSodium BenzoateTreatment OutcomeAntifungal AgentsPlacebosSodium Benzoate

Identifiers

PMID33170261
PMCPMC7656289
OpenAlexW3104299557

What OpenQuestion holds

Textmetadata
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.