Cerebral Palsy Study Positive,
Despite Contrary Interpretations
A controversy has developed over a misleading study
conducted at McGill University to examine potential benefits of hyperbaric
oxygen therapy in treatment of cerebral palsy. This was not a
placebo-controlled study, as alleged.
All patients did receive increased levels of oxygen under pressure and all
patients improved significantly.
For many years HBOT has been shown to produce
improvement for even severe cases of cerebral palsy and brain-injured
children. High-tech brain scans (SPECT) before, during, and after HBOT has
shown unequivocal improvement to previously damaged and non-functioning
areas of the brain.
A detailed review of this controversy can be found
at the website of the
Ocean Hyperbaric Center, Lauderdale-by-the-Sea, Florida; directed by
Richard A. Neubauer, M.D., a pioneer and preeminent researcher in this
field.
During the McGill study the so-called placebo group
received therapy with pressurized air, which increased brain oxygen by up to
50%, even without added oxygen. It was not a placebo. All cerebral palsy
patients in the study improved, and overall improvement was greater than
with any other form of therapy.
Montgomery D, Goldberg J, Amar M, Lacroix V,
Lecomte J, Lambert J, Vanasse M, Marois P.
Effects of hyperbaric oxygen therapy on children with spastic diplegic
cerebral palsy: a pilot project. Undersea Hyperb Med. 1999
Winter;26(4):235-42.
To quote Dr. P. Marois, one of the researchers in
that study and co-author of the final paper, in an excerpt from his letter
to the editor:
"The main opposition coming
from many researchers (including myself) and the parents of the children
involved in the research is on the abusive interpretation and presentation
of the results by governmental and scientific authorities in Quebec, who are
misleading the public, the press and the scientific community. These
organizations that were involved in financing and directing the research
project as well as some researchers are indeed drawing radical conclusions
from the study and are avoiding to mention two very important facts in their
scientific or public communication:
"First, the rate of
improvement measured in children involved in the research was very
impressive, far more than with any other approved and recognized therapy. In
fact, if you look closely at the results as measured as primary outcome
(GMFM scale) they improved an average of 10 times more in both groups during
the two months of hyperbaric therapy (while all conventional therapies and
medication were ceased) than during the three months follow-up (while all
the therapies and medication were started again). We also saw impressive
improvements in neuropsychological testing and with the parent questionnaire
(PEDI).
"Second, the 1.3 ATM
treatment with air, even if it has been used in many studies in other
conditions (in which the mechanism of action of HBOT was presumed to be very
different) as a placebo treatment, is not an inert treatment or true
placebo. It is a hyperbaric treatment used in certain conditions to save
lives (mountain sickness with pulmonary and cerebral edema) and it increases
the amount of oxygen in the blood and all the physiological liquids by more
than 50%.
"It is certainly not like
"a pill with just sugar in it" as has been stated publicly.
"There are few experts in
hyperbaric oxygen therapy that are familiar with cerebral palsy or the GMFM
scale. If we do not present the improvements on the GMFM scale like they
really are (clinically and statistically very impressive) and if we falsely
state that the 1.3 ATM with air is a real placebo, it is very easy to
mislead everyone, including the scientific community, leading them to
believe that this study only demonstrated that there were some changes in
both groups and that they were certainly related to a placebo effect.
"The research clearly
demonstrated only one thing: that both groups of children involved and
receiving two very different doses of hyperbaric treatment improved
significantly (without any measurable statistical differences between the 2
groups), more than in a natural or a therapeutic environment, more than in
most studies evaluating the effect of intensive therapy."
FETAL
ALCOHOL SYNDROME, MENTAL RETARDATION
A more recent study showed
good benefit in treatment of fetal alcohol syndrome. Fetal alcohol syndrome
(FAS) is the most common nonhereditary cause of mental retardation, with
deficits in general intellectual functioning, learning, memory, attention,
and problem-solving.
After 40 hyperbaric
treatments at 1.5 ATA, a 15-year old patient's performance in 6 of 6
categories of the computer-administered test battery improved. Word
composite (verbal) scores improved from 55% to 73%, memory composite
(visual) scores improved from 38% to 55%, reaction time composites improved
from 1.03 to 0.53 seconds, impulse control composite scores improved from 8
to 5, and visual motor speed scores improved from 18.6 to 19.03. The
patient's subjective symptoms diminished 94%.
Six months after these
treatments, the patient's verbal memory was maintained at 73% without any
other interventions; impulsivity continued to improve, whereas other indices
did not. Thirty-three additional treatments continued to improve test
performance, with verbal memory at 95%, visual memory at 57%, and a 100%
reduction of subjective symptoms. This patient with 15-year-matured FAS,
benefited from a course of hyperbaric oxygen therapy, sustained durable
cognitive improvements, and continued to exhibit further improvement
following an additional 33 treatments.
Stoller KP. Quantification of neurocognitive changes before, during, and
after hyperbaric oxygen therapy in a case of fetal alcohol syndrome.
Pediatrics. 2005 Oct;116(4):e586-91. Epub 2005 Sep 15
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