Hyperbaric Oxygen Therapy for Children with Cerebral Palsy:A Multicenter Placebo Controlled Randomised Clinical Trial

I have access to your bulletin board and read several notes on the Canadian Study on CP. I would like to let your readers know that one of the researchers disagrees with the results that were presented by Dr. Collet. I received a news paper report from Montreal and had it translated into English. It should be published on your board to let your subscribers know that HBOT does help those with CP and the Montreal study was not completed fairly.

Here is the article.

LaPresse 12 Oct 2000

Dr. Marois accuses the Quebec Health Minister of sabotaging the results so they would not have to pay for Cerebral Palsy treatments. The most recent Quebec study on the effectiveness of Hyperbaric Oxygen Treatment should have shown 'spectacular' results. In Dr. Marois' opinion, who is one of the researchers involved with the study last fall says, "The results from the researchers and the financing group for the study have not reached the same conclusion." The first group of kids received oxygen at 1.75 atmospheres of pressure while the second group received air at 1.3 ata of pressure. The study showed no difference between the two groups but both of them have shown progress. Up to now we have heard only Dr. Jean-Paul Collet's, Health and Research Resources and Quebec's Health and Social Services version of the study, saying that the treatments had no therapeutic effect on the condition of the children's mobility. In other words the positive effect found during the study was only a 'psychological effect'.

Other Version

'Thus, all other researchers involved with the study would have testified otherwise', says Dr. Marois. According to him the children involved with the study have shown a progress of 3% in two months in comparison to three months of conventional therapy with a progress of 0.3%. 'Its ten times the progress in less time. In some kids the results were almost miraculuous', replies Dr. Marois. 'Some kids started to talk, others were able to walk for the first time and some were able to sit', adds Dr. Marois. The difference in interpretation comes when considering the children given 1.3 atmospheres of air in the second group.

For Dr. Collet, this group of children received what he considers a 'Placebo' and had an inert effect. We could compare the two groups and conclude that the positive effect noticed in both groups wasn't therapeutic.

For Dr. Marois, the second group was not a placebo, but rather a lower dosage of hyperbaric oxygen. We cannot conclude to the inefficiency of the treatment but rather that even a lower dosage of hyperbaric oxygen showed great progress. Dr. Marois accuses Health and Research Resources and the Minister of Health of forging the research so they would not have to pay for treatments. 'All of the processes have been sabotaged by Health and Research Resources who abused their power to keep researchers away from their conclusion. It formed its own committee composed of people who were bias against the effect of the treatment and told them that it was a placebo effect based on no scientific evidences'.

The only way to find out, according to Dr. Marois, would be to start a new study with one pilot group with no treatment, a second group on a placebo, a third who would receive hyperbaric oxygen, a fourth on hyperbaric air and a fifth on oxygen only.

This is a direct translation from the French newspaper LaPresse. It lends some insight into why the report had been presented so negatively. Dr. Marois should be thanked by the community of parents and adults with Cerebral Palsy.

David Zuratsky

ACADEMIA MOVES TO PRESERVE THE STATUS QUO IN THE TREATMENT OF CEREBRAL PALSY

111 children studied

Written by Tom Fox and Claudine Lanoix

Toronto-Canada In an effort to address the growing enthusiasm for Hyperbaric Oxygen therapy in the treatment of Cerebral Palsy, researchers here discounted the role of hyperbaric oxygen in the significant improvement seen in this study. Instead researchers, holding firm in their support of their study design, preferred to explain the significant-but equal-improvements in two groups as resulting from the increased intimacy between the parent and child and the participation in the study. The two things that researchers fail to realize is that the parents of special needs children in most cases have an unparalleled intimacy with their children and if it was possible for these children to improve significantly through intimacy the condition of these children would already have had substantial improvement. The fact is patients with cerebral palsy treated with hyperbaric oxygen are experiencing significant improvement. Parents are seeing this and this is why they continue pursue this relentlessly for their children.

In presenting this study in Toronto, the results which demonstrated significant improvement as acknowledged by Dr.. Michel Vanasse in his presentation were misconstrued as not leading to marked improvements in children with cerebral palsy by reports in the popular press. To the contrary if one examines taped records of the meeting you will find Dr.Vanasse, pediatric neurologist and member of the research team saying, " There is scientific evidence that this treatment ( hyperbaric oxygen) is useful in the treatment of Cerebral Palsy. Cerebral Palsy, a term used to describe a plethora of conditions that have resulted from damage to the brain and is traditionally a stable condition. The importance in the advance of a treatment of this condition and its impact on the families with children affected by CP cannot be understated and the true results of the study cannot be covered up.

In the presentation of this study to professionals at the start of the general session on Saturday September 23, 2000, members of the research team were applauded and congratulated by their peers for a well designed study, but their presentation was punctuated by misunderstanding of the hyperbaric environment. In fact those presenting were quick to point out that none of the members presenting this study were specialist in hyperbaric medicine. The truth is that despite the attempt to provide an adequate placebo this study design provided a placebo that was not inert. Because of the variances in patients afflicted with CP the study design would have been better to use the individual patient as a control for themself .

It is true that many parents are spending thousands of dollars on the treatments, based on anecdotal reports that time spent in hyperbaric chambers helps diminish spasticity and increase functional ability. Despite the inability of researchers to explain the significant improvement in their study subjects, the abundence and availability of anecdotal reports continues to grow empirically. The term the lack to the "scientific evidence" and the absence of placebo controlled randomized double blind studys are often used by clinicians as an excuse to discount patient requests for the therapy. In the case of the study from Quebec, a study costing the Quebec tax payers approximately 2.4 million dollars, it was the inability of researchers to approach this subject without preconceived ideas and designed a study with inert controls that provided a study that was less than a landmark. Once the study yields results with significant improvement, the investigators should have the moral courage to present their finding to their peers without fear of repercussions. Instead the members of the research team presented conclusions that at best could be considered astute teleological thinking.

Despite the reports to the contrary in periodicals such as the Montreal Gazette, landmark studies and research have been performed by Machado et al from Brazil, Harch-Gottlieb from the United States, and Montgomery et al from Canada. The rationale for delivering high levels of oxygen to the brain via hyperbaric oxygen is to reanimate parts of the brain believed to have been damaged by lack of oxygen in the womb or at birth. Future studies may find that this reanimation is not so much different from the mechanism of action demonstrated by Dr. Robert Marx in irradiated tissue.

To date non of the studies by researchers specializing in hyperbaric medicine we can find makes claims of "tickling" the brain tissue back into action as claimed by Dr. Peter Rosenbaum, chief of staff at Toronto's Bloorview MacMillan Centre for children with disabilities. It is no doubt this "doesn't make a lot of sense" as says Dr. Rosenbaum. Quite honestly this quote doesn't make sense to a lot of us in hyperbarics.

Quite honestly the expenditure of 2.4 million dollars in this study directed by Dr.Jean-Paul Collet of Montreal falls quite a bit short of what we have become to expect as customary of the scientific community of Canada. His representation of the breathing media of the placebo group as equivalent to the air pressure in a plane demonstrates the chief investigator had a poor understanding of hypobaric versus hyperbaric environment. Infact most airplanes maintain cabin pressurization at less than 6000 feet which is significantly lower than the change of the equivalent of 1/3 of an atmosphere. The results demonstrate clearly significant improvement of two groups of patients with cerebral palsy treatment with different doses of hyperbaric oxygen. We feel the conclusions promoted by the FRSQ are illogical given the traditionally stable patient group treated and are meant to stem the tide of the growing enthusiasm for hyperbaric therapy in the treatment of children with cerebral palsy.

An overview of Collet's findings, which have been submitted for publication in the British medical journal The Lancet, were later presented to a group of parents attending the family forum session of the American Academy for Cerebral Palsy and Developmental Medicine. This presentation followed a shameful presentation by Dr. Wayne Evans of Toronto General Hospital. In this carefully orchaestrated presentation, Dr. Evans sensationalized and misrepresented the safety of the hyperbaric industry as a whole in an attempt to discourage families from seeking this type of therapy for their children. Despite the excellent saftey record in the United States and Canada over the past 30 years of continuous operation, Dr. Evans devoted 24 minutes of an 1 hour presentation to the review of fire and explosions. Drawing on examples from Milan Italy and Japan, Dr. Evans presentations was illprepared and not truly representative of the professionalism seen in the hyperbaric community as a whole. In our opinion, the Undersea and Hyperbaric Medical Society would be less than appreciative of this negative representation of their industry .

The one true statement that was echoed by all members of the research team was that they were not sure why both groups improved, but significant improvement was demonstrated in both groups. It is ashame that this group of researchers could not interpret these findings so that more children could benefit from the early intervention and use of hyperbaric oxygen therapy as an adjunctive treatment and experience improvement in their quality of life through its use.