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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

Absolute change compared to baseline on the mean CGI overall functioning score in the treatment and control groups as rated separately by physicians and parents. * p < 0.001; ** p < 0.05.
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Figure 2: Absolute change compared to baseline on the mean CGI overall functioning score in the treatment and control groups as rated separately by physicians and parents. * p < 0.001; ** p < 0.05.

Mentions: After 40 sessions, the mean physician CGI score for change in overall functioning compared to baseline significantly improved (p = 0.0008) by 1.13 points in the treatment group (2.87 ± 0.78, score of 4 = "no change") compared to 0.38 points in the control group (3.62 ± 0.75), see Figure 2. Furthermore, 9/30 (30%) children in the treatment group had a "very much improved" or "much improved" rating compared to 2/26 (7.7%) in the control group (p = 0.0471). An improvement on the CGI scale (score of 1, 2, or 3) was noted in 24/30 (80%) children in the treatment group compared to 10/26 (38%) in the control group (p = 0.0024). Conversely, 16/26 (62%) children in the control group had a "no change" or "minimally worse" score (CGI score of 4 or 5) compared to 6/30 (20%, all 6 had a score of 4) in the treatment group (p = 0.0024). In the control group, two children received a score of 5 ("minimally worse"), whereas none received this score in the treatment group (p = 0.211). No child received a score worse than 5 in either group. Examination of the physician CGI subscales demonstrated that more children improved in the treatment group compared to the control group in receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); a trend towards improvement was also observed in activity level (p = 0.0545).


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)

Absolute change compared to baseline on the mean CGI overall functioning score in the treatment and control groups as rated separately by physicians and parents. * p < 0.001; ** p < 0.05.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Absolute change compared to baseline on the mean CGI overall functioning score in the treatment and control groups as rated separately by physicians and parents. * p < 0.001; ** p < 0.05.
Mentions: After 40 sessions, the mean physician CGI score for change in overall functioning compared to baseline significantly improved (p = 0.0008) by 1.13 points in the treatment group (2.87 ± 0.78, score of 4 = "no change") compared to 0.38 points in the control group (3.62 ± 0.75), see Figure 2. Furthermore, 9/30 (30%) children in the treatment group had a "very much improved" or "much improved" rating compared to 2/26 (7.7%) in the control group (p = 0.0471). An improvement on the CGI scale (score of 1, 2, or 3) was noted in 24/30 (80%) children in the treatment group compared to 10/26 (38%) in the control group (p = 0.0024). Conversely, 16/26 (62%) children in the control group had a "no change" or "minimally worse" score (CGI score of 4 or 5) compared to 6/30 (20%, all 6 had a score of 4) in the treatment group (p = 0.0024). In the control group, two children received a score of 5 ("minimally worse"), whereas none received this score in the treatment group (p = 0.211). No child received a score worse than 5 in either group. Examination of the physician CGI subscales demonstrated that more children improved in the treatment group compared to the control group in receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); a trend towards improvement was also observed in activity level (p = 0.0545).

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