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Hbot; preliminary study with no control group
Topic Started: Jul 6 2009, 09:25 PM (232 Views)
kwombles
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There are several problems with this study.

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18005455


The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study

Daniel A Rossignol,1 Lanier W Rossignol,1 S Jill James,2 Stepan Melnyk,2 and Elizabeth Mumper3,4


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AngelaSodee
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WooFightingWarriorPrincess (The Pink One)
Kim, would you care to explain a bit further? :) Pretend we are your students, use small words!
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kwombles
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I will do. :-) Sometime this afternoon or early evening, promise. First I must run around like a chicken with my head cut off. Hah! Will explain later.
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kwombles
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First problem: no control group. We don't know if children without autism are less likely to have oxidative stress; we don't really know that children with autism in general have it because the studies that have found it have been small studies with similar problems to this one.
Second problem: sample size. Too small to be statistisically significant, nor was there any attempt to have a representative sample. Therefore, you can't extrapolate out past these 18 kids.
Third problem: The parental evaluation of clinical outcomes. As the authors themselves note: "The use of parent-rated scales and the fact that parents were not blinded to the type of therapy given to their child might have introduced some bias. Furthermore, there was no placebo or control group. Therefore, the improvements found in this open-label study could be due merely to chance or to the natural development of the children. In addition, it is possible that any clinical improvements observed could have occurred as a result of the increased close interaction between the child and parent/caregiver, or motivation and/or enthusiasm that may have developed in the parent/caregiver during the course of the treatments. Because this was a pilot study, the sample sizes were small which makes it difficult to make adequate and meaningful comparisons between the 2 different pressures and oxygen concentrations used. Due to these issues, a larger double-blind, prospective study that includes a control group and more objective outcome measures is warranted."


On many levels, it would be wrong if this study was used as anything other than a preliminary study which basically says this: well, gee, the parents were going to do it anyway so let's see if it changes oxidative stress levels (the argument behind the HBOT therapy). Huh, it didn't change it but the parents' perception that their children got better. Never mind they are psycholigcally invested in seeing improvement. 40 sessions at 30 minutes to 2 hours. 100 to 300 dollars a session. A keen desire to see the child improve and checklists filled out by parents rather than third party blind obersvers rating. Lots of holes in this study. And yet it will be touted as proof that it helps the children.

Makes me very angry.


"Eighteen children with autism, ages 3–16 years, underwent 40 hyperbaric sessions of 45 minutes duration each at either 1.5 atmospheres (atm) and 100% oxygen, or at 1.3 atm and 24% oxygen."
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