HYPERBARIC TREATMENT FOR CHILDREN WITH AUTISM: a multicenter, randomized, doubleblind,
controlled trial
Daniel A. Rossignol1§, Lanier W. Rossignol1, Scott Smith1, Cindy Schneider2, Sally Logerquist2,
Anju Usman3, Jim Neubrander4, Eric M. Madren5, Gregg Hintz6, Barry Grushkin7, Elizabeth A.
Mumper8
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 eyecontact (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.
Conclusions
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