Health and Community ServicesJune 7, 2012

Multiple Sclerosis Observational Study Results Announced

The Honourable Susan Sullivan, Minister of Health and Community Services, provided an update today on the results of the multiple sclerosis observational study commissioned by the Provincial Government. Minister Sullivan was joined by Dr. William Pryse-Phillips, emeritus Professor of Medicine (Neurology) at Memorial University and lead researcher of the multiple sclerosis observational study. The main objective of the study was to observe whether changes in mental or physical status occurred over a 12-month period in patients with multiple sclerosis who chose to undergo the chronic cerebrospinal venous insufficiency (CCSVI) procedure, also known as the ‘liberation’ procedure.

“In 2010, the Provincial Government committed to take a significant lead role in this country to study and observe the results of the CCSVI procedure put forth by Dr. Paolo Zamboni as a multiple sclerosis treatment option,” said Minister Sullivan. “Although we recognize that this was a small study over a short period of time, through a series of tests over the course of a 12-month period, the physicians involved in the study have concluded that there were no measurable objective medical changes in the observed patients who underwent the CCSVI procedure.”

Physicians involved in the observational study performed preliminary and post-procedural tests and evaluations on 40 participants. This included 30 participants who received the CCSVI procedure and 10 in a control group, who did not. The physician evaluating the study’s participants was blinded as to who had the CCSVI procedure and who did not.

Upon enrolling in the study, the treated subjects were given a series of baseline tests including patient-reported measures of the effect of multiple sclerosis on their daily lives; functional, cognitive and physical testing; MRIs; and, a CT venogram at 12 months. During the study participants were examined at one, three, six and 12 months, and their results were compared to the baseline results.

In the 30 subjects who underwent the CCSVI procedure, no measurable, objective benefit was recordable one year after the procedure. However, participants did self-report notable improvements in physical and psychological well-being in the first three months post-procedure.

“When my colleagues and I first undertook this observational study, we were excited at the prospects of learning more about this theory and contributing to the international data and research on this subject,” said Dr. Pryse-Phillips. “Although we had really hoped our conclusions would support the use of this procedure as a treatment for multiple sclerosis, the findings argue against the validity of the hypothesis that multiple sclerosis is associated with occlusion, or decreased flow, in the cerebral draining veins.”

In September 2010, the Provincial Government announced that it would conduct a Newfoundland and Labrador based observational study of multiple sclerosis patients who had undergone the CCSVI procedure based on the proposed theory and work of Dr. Zamboni. The study was designed and conducted by local neurologists in the province, specializing in multiple sclerosis. The Provincial Government provided $400,000 for the study to be completed. Based on the results of the observational study, the CCSVI procedure will continue to be an uninsured service in this province.

“We undertook this observational study with the intent to further the knowledge-base and research around the CCSVI procedure and the proposed effects it had on individuals with multiple sclerosis,” said Minister Sullivan. “We understand that today’s news may dishearten some people as we all collectively look to find new treatments and cures for this disease. It is important to remember that this study is but one piece of a greater base of research that is being conducted in many parts of the world, and these results do not preclude Newfoundland and Labrador’s involvement in any future national clinical trials involving the procedure.”

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Media contact:

Jennifer Tulk

Director of Communications

Department of Health and Community Services

709-729-1377, 699-6524

JenniferTulk@gov.nl.ca

2012 06 07 12:20 p.m.