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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...

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Autores principales: Rossignol, Daniel A, Rossignol, Lanier W, Smith, Scott, Schneider, Cindy, Logerquist, Sally, Usman, Anju, Neubrander, Jim, Madren, Eric M, Hintz, Gregg, Grushkin, Barry, Mumper, Elizabeth A
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2662857/
https://www.ncbi.nlm.nih.gov/pubmed/19284641
http://dx.doi.org/10.1186/1471-2431-9-21
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author Rossignol, Daniel A
Rossignol, Lanier W
Smith, Scott
Schneider, Cindy
Logerquist, Sally
Usman, Anju
Neubrander, Jim
Madren, Eric M
Hintz, Gregg
Grushkin, Barry
Mumper, Elizabeth A
author_facet Rossignol, Daniel A
Rossignol, Lanier W
Smith, Scott
Schneider, Cindy
Logerquist, Sally
Usman, Anju
Neubrander, Jim
Madren, Eric M
Hintz, Gregg
Grushkin, Barry
Mumper, Elizabeth A
author_sort Rossignol, Daniel A
collection PubMed
description 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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spelling pubmed-26628572009-03-31 Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial Rossignol, Daniel A Rossignol, Lanier W Smith, Scott Schneider, Cindy Logerquist, Sally Usman, Anju Neubrander, Jim Madren, Eric M Hintz, Gregg Grushkin, Barry Mumper, Elizabeth A BMC Pediatr Research Article 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 BioMed Central 2009-03-13 /pmc/articles/PMC2662857/ /pubmed/19284641 http://dx.doi.org/10.1186/1471-2431-9-21 Text en Copyright © 2009 Rossignol et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Rossignol, Daniel A
Rossignol, Lanier W
Smith, Scott
Schneider, Cindy
Logerquist, Sally
Usman, Anju
Neubrander, Jim
Madren, Eric M
Hintz, Gregg
Grushkin, Barry
Mumper, Elizabeth A
Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
title Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
title_full Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
title_fullStr Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
title_full_unstemmed Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
title_short Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
title_sort hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2662857/
https://www.ncbi.nlm.nih.gov/pubmed/19284641
http://dx.doi.org/10.1186/1471-2431-9-21
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