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

Reprinted with permission granted by the International Hyperbaric Association, The following is an excerpt from the article that appeard in the PressurePoint March/April 2009-08-18 Newsletter.

Dan Rossignol, M.D., article is the top ranked study in the journal BMC Pediatrics.

Daniel A Rossignol*1, Lanier W Rossignol1, Scott Smith1, Cindy Schneider2, Sally Logerquist2, Anju Usman3, Jim Neubrander4, Eric M Madren5, Gregg Hintz6, Barry Grushkin7 and Elizabeth A Mumper8

Published: 13 March 2009

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

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).

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 equals 0.0008), receptive language (p less than 0.0001), social interaction (p equals 0.0473), and eye contact (p equals 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 equals 0.0471); 24/30 (80%) in the treatment group improved compared to 10/26 (38%) of controls (p equals 0.0024).

Mean parental CGI scores significantly improved in the treatment group compared to controls in overall functioning (p equals 0.0336), receptive language (p equals 0.0168), and eye contact (p equals 0.0322). On the ABC, significant improvements were observed in the treatment group in total score, irritability, stereotypy, hyperactivity, and speech (p less than 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 equals 0.0311).

On the ATEC, sensory/cognitive awareness significantly improved (p equals 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.

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.

Click for larger image.

Above: Absolute change compared to baseline on the mean CGI (Clinical Global Impression) overall functioning score in the treatment and control groups as rated separately by physicians and parents. *less than 0.001; **less than 0.05

Click for larger image.

Above: Changes compared to baseline on the ABC (Aberrant Behavior Checklist) total score and subscales (percentage change) in the treatment and control groups.***p is less than 0.1

Click for larger image.

Above: Changes compared to baseline on the ATEC (Autism Treatment Evaluation Checklist) total score and subscales (percentage change) in the treatment and control groups.**p is less than 0.05

Below: Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

Click for larger image.