Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
BMC Pediatrics 2009, 9:21 doi:10.1186/1471-2431-9-21
Daniel A. Rossignol, Lanier W. Rossignol, Scott Smith, Cindy Schneider, Sally Logerquist, Anju Usman, Jim Neubrander, Eric M. Madren, Gregg Hintz, Barry Grushkin, Elizabeth A. Mumper
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
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