39592
document
Hyperbaric treatment for children with autism : a multicenter , randomized , double-blind , controlled trial . 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 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 .
39593
Intervention_Physical
hyperbaric treatment
39594
Intervention_Physical
slightly pressurized room air
39595
Outcome_Other
efficacy
39596
Outcome_Mental
Clinical Global Impression ( CGI ) scale
39597
Outcome_Mental
Aberrant Behavior Checklist ( ABC )
39598
Outcome_Mental
Autism Treatment Evaluation Checklist ( ATEC
39599
Outcome_Mental
CGI
39600
Outcome_Mental
overall functioning
39601
Outcome_Mental
receptive language
39602
Outcome_Mental
social interaction
39603
Outcome_Mental
eye contact
39604
Outcome_Mental
parental CGI scores
39605
Outcome_Mental
overall functioning
39606
Outcome_Mental
receptive language
39607
Outcome_Mental
eye contact
39608
Outcome_Mental
ABC
39609
Outcome_Mental
total score , irritability , stereotypy , hyperactivity , and speech
39610
Outcome_Mental
ABC total score and subscales
39611
Outcome_Mental
ATEC , sensory/cognitive awareness
39612
Outcome_Mental
overall functioning , receptive language , social interaction , eye contact , and sensory/cognitive awareness
39613
Participant_Age
children
39614
Participant_Condition
autism
39615
Participant_Sample-size
62
39616
Participant_Age
children
39617
Participant_Condition
autism
39618
Participant_Age
ages 2-7 years ( mean 4.92 +/- 1.21 )
39619
Participant_Age
Children
39620
Participant_Condition
autism