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Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial.

Rossignol DA, Rossignol LW, Smith S, Schneider C, Logerquist S, Usman A, Neubrander J, Madren EM, Hintz G, Grushkin B, Mumper EA - BMC Pediatr (2009)

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: International Child Development Resource Center, Melbourne, FL, USA. rossignolmd@gmail.com

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 = 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.

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Related in: MedlinePlus

Changes compared to baseline on the ABC total score and subscales (percentage change) in the treatment and control groups. *** p < 0.1.
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Figure 3: Changes compared to baseline on the ABC total score and subscales (percentage change) in the treatment and control groups. *** p < 0.1.

Mentions: In the treatment group, the ABC total score significantly improved after 40 sessions (p = 0.0118), see Additional file 1. Improvements in ABC subscales were also observed in the treatment group for irritability (p = 0.0147), stereotypy (p = 0.0124), hyperactivity (p = 0.0211), and speech (p = 0.0155). No significant improvements were observed in the control group on the ABC total score or any of the ABC subscales (p = ns). Analysis of changes in the ABC total score and subscale scores between the treatment and control groups demonstrated no significant changes (p = ns), although there was a trend towards improvement in the treatment group for irritability (p = 0.0976, see Figure 3) and 20/30 (67%) children in the treatment group had an improvement in irritability compared to 9/26 (35%) in the control group (p = 0.0311).


Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial.

Rossignol DA, Rossignol LW, Smith S, Schneider C, Logerquist S, Usman A, Neubrander J, Madren EM, Hintz G, Grushkin B, Mumper EA - BMC Pediatr (2009)

Changes compared to baseline on the ABC total score and subscales (percentage change) in the treatment and control groups. *** p < 0.1.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2662857&req=5

Figure 3: Changes compared to baseline on the ABC total score and subscales (percentage change) in the treatment and control groups. *** p < 0.1.
Mentions: In the treatment group, the ABC total score significantly improved after 40 sessions (p = 0.0118), see Additional file 1. Improvements in ABC subscales were also observed in the treatment group for irritability (p = 0.0147), stereotypy (p = 0.0124), hyperactivity (p = 0.0211), and speech (p = 0.0155). No significant improvements were observed in the control group on the ABC total score or any of the ABC subscales (p = ns). Analysis of changes in the ABC total score and subscale scores between the treatment and control groups demonstrated no significant changes (p = ns), although there was a trend towards improvement in the treatment group for irritability (p = 0.0976, see Figure 3) and 20/30 (67%) children in the treatment group had an improvement in irritability compared to 9/26 (35%) in the control group (p = 0.0311).

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: International Child Development Resource Center, Melbourne, FL, USA. rossignolmd@gmail.com

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 = 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.

Show MeSH
Related in: MedlinePlus