"The recent Quebec, Canada study on the effectiveness of hyperbaric oxygen as a treatment modality for children with cerebral palsy, reported in the prestigious British medical journal, The Lancet (2/24/01), has reaffirmed the positive effects of hyperbaric therapy," concludes J. Michael Uszler, M.D., internationally recognized expert on functional brain imaging.
These findings are completely opposite to the official interpretation given in the study, and widely reported in the press. Dr. Pierre Marois of Quebec, one of the 15 physicians who participated in the study, has publicly announced that "the conclusions of the study were sabotaged and the way people are interpreting the results is a fraud." Rather than producing a "negative effect", as first reported, the study produced a positive result.
The study, a randomized multi-center trial from Quebec conducted under the auspicies of Jean-Paul Collet, Professor of Clinical Research, compared two sets of children with cerebral palsy, 3-12 years of age. In the study, 111 children received 40 treatments over a two month period. One half the children received pressurized oxygen at 1.75 ATA. Treatments were conducted at several locations using both monoplace and multiplace chambers.
The statistics of the study demonstrated that both groups of children improved in all areas over the course of the study without any significant difference between the two types of treatment, with the exception that the group receiving the increased oxygen tension improved more rapidly and to a higher degree in many of the measurements. Furthermore, "all results, in both groups, were still evident three months after the intervention, without regression," the Quebec study reported.
Dr. Richard Neubauer, Director and Founder of the Ocean Hyperbaric Center in Florida, and an author and international lecturer on hyperbaric oxygenation, is excited about the results of the study. He believes it is an outstanding study and opens new doors to the possibility that lower supplements of oxygen may be effective in helping children with cerebral palsy. "If it can be scientifically proven that lower levels of oxygen in compressed air will help children with cerebral palsy almost as much as higher levels of pressurized oxygen," said Dr. Neubauer, "it would mean that hundreds of thousands of additional children could be treated each year . . . the majority of the world's children with cerebral palsy will never have access to hyperbaric conditions."
Although the study confirmed the oxygen therapy significantly helped all of the children, the protocol of the study opened its findings to debate.
Dr. Paul G. Harch, Clinical and Research Director, Louisiana State University, School of Medicine, Hyperbaric Medicine Fellowship, a well respected physician in hyperbaric medicine, who agrees the study was highly positive, questions whether 1.75 ATA may have been too high a pressure for the children in the monoplace chamber group. "It approaches the 2 atmosphere cutoff where improvement in chronic brain injury is infrequently seen in hyperbaric oxygen therapy. Although Marois reports that many Canadian children with cerebral palsy are frequently treated with 1.75 ATA, Harch states, "the use of 1.75 ATA atmosphere of pure oxygen for 60 minutes for forty treatments, is a protocol never before used in a clinical study of the use of hyperbaric oxygen for cerebral palsy."
Dr. Philip James, Director of the Hyperbaric Trust in the UK, and internationally known author and speaker, is concerned that the control group received hyperbaric air at 1.3 ATA, originally referred to as the "placebo" of the study. Despite the surprisingly positive effects in the 1.3 ATA control group, James feels the 1.3 ATA oxygen caused at least a 25% rise in the rate of the children's metabolism rate. "The findings would have more validity if the control group had not been given any additional oxygen," said James.
The evidence of the Quebec study confirms hyperbaric therapy may be an effective and safe way to improve the functioning abilities of many children with cerebral palsy. To prove this fact without a doubt, and to determine if lesser amounts of oxygen will help children with cerebral palsy, however, will take further study under more tightly controlled testing conditions.
There will be a major international conference in Boca Raton, Florida, July 26th - 28th, 2001, to further substantiate the effects of hyperbaric oxygenation in cerebral palsy and the brain injured child. Speakers from all over the world, including China, Russia, Cuba, South America, United Kingdom, Canada, and the United States, will be presenting new information and techniques on this non-invasive form of treatment. The goal is to glean the necessary information to validate and substantiate hyperbaric treatment for cerebral palsy children as a viable therapy to gain medical acceptance and obtain insurance coverage.