Evidence map›Paper›PMID 19284641›Full record

Trial reportBMC pediatrics2009

Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial.

Daniel A Rossignol, Lanier W Rossignol, Scott Smith, Cindy Schneider, Sally Logerquist, Anju Usman, Jim Neubrander, Eric M Madren, Gregg Hintz, Barry Grushkin and 1 more

Erratum issued Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00335790 (A Prospective, Randomized, Double-Blind, Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children), which is not on this map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT00335790 nacompletednot on this map

A Prospective, Randomized, Double-Blind, Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children

TypeinterventionalSponsorInternational Hyperbarics AssociationRan2006 to 2007Enrolled60ConditionsAutismArmsHyperbaric Therapy
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 97 citations in OpenAlex.

  1. Hyperbaric oxygen therapy for people with autism spectrum disorder (ASD).The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Trial
  3. Review
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  5. Oxygen and the Spark of Human Brain Evolution: Complex Interactions of Metabolism and Cortical Expansion across Development and Evolution.The Neuroscientist : a review journal bringing neurobiology, neurology and psychiatry · 2024
    Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Hyperbaric oxygen therapy for children with autism spectrum disorder.Canadian family physician Medecin de famille canadien · 2017
    Review
  18. Review
  19. Review
  20. Complementary and Alternative Therapies for Autism Spectrum Disorder.Evidence-based complementary and alternative medicine : eCAM · 2015
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

Daniel A RossignolInternational Child Development Resource Center, Melbourne, FL, USA. rossignolmd@gmail.com
Lanier W Rossignol
Scott Smith
Cindy Schneider
Sally Logerquist
Anju Usman
Jim Neubrander
Eric M Madren
Gregg Hintz
Barry Grushkin
Elizabeth A Mumper
Center for Autism and Related Disorders · USChild Development Center · QAPathways Behavioral Services · USTrinity Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism.

methods62 children with autism recruited from 6 centers, ages 2-7 years (mean 4.92 +/- 1.21), were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm) and 24% oxygen ("treatment group", n = 33) or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29). Outcome measures included Clinical Global Impression (CGI) scale, Aberrant Behavior Checklist (ABC), and Autism Treatment Evaluation Checklist (ATEC).

resultsAfter 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008), receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); 9/30 children (30%) in the treatment group were rated as "very much improved" or "much improved" compared to 2/26 (8%) of controls (p = 0.0471); 24/30 (80%) in the treatment group improved compared to 10/26 (38%) of controls (p = 0.0024). Mean parental CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0336), receptive language (p = 0.0168), and eye contact (p = 0.0322). On the ABC, significant improvements were observed in the treatment group in total score, irritability, stereotypy, hyperactivity, and speech (p < 0.03 for each), but not in the control group. In the treatment group compared to the control group, mean changes on the ABC total score and subscales were similar except a greater number of children improved in irritability (p = 0.0311). On the ATEC, sensory/cognitive awareness significantly improved (p = 0.0367) in the treatment group compared to the control group. Post-hoc analysis indicated that children over age 5 and children with lower initial autism severity had the most robust improvements. Hyperbaric treatment was safe and well-tolerated.

conclusionChildren with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air.

trial registrationclinicaltrials.gov NCT00335790.

Indexed as

Hyperbaric OxygenationAutistic DisorderChildChild, PreschoolDouble-Blind MethodFemaleHumansMalePsychiatric Status Rating ScalesTreatment Outcome

Identifiers

PMID19284641
PMCPMC2662857
OpenAlexW2166813309

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.