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

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Abstract

Background: Several 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.

Methods: 62 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).

Results: After 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

Published: 13 March 2009

BMC Pediatrics 2009, 9:21 doi:10.1186/1471-2431-9-21

Received: 20 January 2009

Accepted: 13 March 2009

This article is available from: http://www.biomedcentral.com/1471-2431/9/21

© 2009 Rossignol et al; licensee BioMed Central Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BMC Pediatrics 2009, 9:21 http://www.biomedcentral.com/1471-2431/9/21

Page 2 of 15

(page number not for citation purposes)

5 and children with lower initial autism severity had the most robust improvements. Hyperbaric

treatment was safe and well-tolerated.

Conclusion: Children 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 Registration: clinicaltrials.gov NCT00335790

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