Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
Daniel A Rossignol1 email, Lanier W Rossignol1 email, Scott Smith1 email, Cindy Schneider2 email, Sally Logerquist2 email, Anju Usman3 email, Jim Neubrander4 email, Eric M Madren5 email, Gregg Hintz6 email, Barry Grushkin7 email and Elizabeth A Mumper8 email
1International Child Development Resource Center, Melbourne, FL, USA
2Center for Autism Research and Education, Phoenix, AZ, USA
3True Health Medical Center, Naperville, IL, USA
4Edison, NJ, USA
5Princess Anne Medical Associates, Virginia Beach, VA, USA
6Therapeutic Pathways, East Troy, WI, USA
7Biognosys, Nanuet, NY, USA
8Rimland Center, Lynchburg, VA, USA
BMC Pediatrics 2009, 9:21doi:10.1186/1471-2431-9-21
Published: 13 March 2009
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.
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).
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 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
May 17, 2009
Hyperbaric Treatment for Children With Autism
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."