More MS news articles for July 2001

Health Canada Clarifies requirements Applying to Hyperbaric Oxygen Chambers and Notes No Evidence Supporting Usefulness in MS

http://www.mssociety.ca/en/research/CAT010713.htm

Medical Update Memo
JULY 13, 2001

Summary

Health Canada has issued a bulletin clarifying the legal requirements governing the importation, sale and use of hyperbaric oxygen (HBO) treatment facilities. The bulletin also states that Health Canada has not received any conclusive information to support the use of HBO chambers to treat any neurological conditions such as multiple sclerosis, cerebral palsy or migraine. There have been claims for a number of years that breathing oxygen under increased pressure in an HBO chamber improves the signs and symptoms of MS. However, according to the new publication Multiple Sclerosis: The Guide to Treatment and Management, six separate controlled double-blind studies found no positive effect on any objective outcome measure of the disease process.

Details

Health Canada has issued a bulletin clarifying the legal requirements governing the importation, sale and use of hyperbaric oxygen (HBO) treatment facilities. The bulletin notes that HBO chambers are Class 3 medical devices and to legally sell an HBO chamber in Canada, the manufacturer must obtain a medical device licence from Health Canada.

The bulletin also states that Health Canada has not received any conclusive information to support the use of HBO chambers to treat any neurological conditions such as multiple sclerosis, cerebral palsy or migraine. Because of the lack of scientific information, HBO chambers are not licensed for treatment of these conditions.

The use of HBO chambers and other medical devices for investigative purposes is permitted as long as research is carried out in an ethical and controlled manner by qualified investigators. Health Canada investigational use provisions require submission by the manufacturer of a risk analysis, an acceptable study protocol, informed patient consent forms and evidence of ethics committee approval.

Health Canada recognized uses

HBO therapy is allowed to be used for medical conditions where there is reliable scientific evidence of effectiveness. Such conditions include:

Decompression sickness
Air or gas embolism
Carbon monoxide poisoning
Smoke inhalation
Gas gangrene
Crush injury Acute traumatic ischemia  (reduction in blood supply to a part of the body)
Burns
Radiation damage
Severe anemia
Some kinds of serious or chronic infection

MS and HBO treatments

There have been claims for a number of years that breathing oxygen under increased pressure in an HBO chamber improves the signs and symptoms of MS. However, according to the new publication Multiple Sclerosis: The Guide to Treatment and Management, six separate controlled double-blind studies found no positive effect on any objective outcome measure of the disease process. The single exception was minimal bladder improvement in some participants. The studies took place in the United States, Canada, Great Britain and the Netherlands and used a variety of assessments including magnetic resonance imaging, laboratory procedures and clinical examination. There are risks to HBO therapy including blindness, seizures and lung problems.

Disclaimer

The Multiple Sclerosis Society of Canada is an independent, voluntary health agency and does not approve, endorse or recommend any specific product or therapy but provides information to assist individuals in making their own decisions.

Multiple Sclerosis Society of Canada
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© 2001 Multiple Sclerosis Society of Canada