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TORONTO — Patients who underwent the so-called liberation treatmentfor multiple sclerosis experienced no measurable benefit from theprocedure, a study commissioned by the government of Newfoundlandand Labrador found. The results of the small, observational study were announcedWednesday in St. John's by lead investigator Dr. WilliamPryse-Phillips, a professor emeritus of neurology at Newfoundland'sMemorial University. Pryse-Phillips said he had gone into the study hopeful thetreatment might have something to offer his MS patients, butcompleted it convinced the people who had the vein-openingprocedure didn't experience any gains. "I am disappointed. I had hoped. I cannot recommend this therapy onthe basis of these results at this time," he said during a newsconference, the video of which is posted on the Department ofHealth and Community Service's website. The province spent $400,000 on the study, which compared 30patients with MS who had travelled outside the province to have thetherapy and 10 who did not. Participants were subjected to an arrayof tests before the treatment and then at intervals of one month,three months, six months and one year post-procedure. It was an attempt to test a theory that has driven a wedge betweenMS patients and the neurologists and professionals -- includingthose at the MS Society of Canada -- who work to advance the causeof MS sufferers. The theory hails from Italy. Dr. Paolo Zamboni, a vascular surgeonfrom the University of Ferrara, has hypothesized that MS is not aneurodegenerative disease, as has been thought, but a diseaseresulting from collapsed veins in the neck and upper chest. Henamed the condition chronic cerebrospinal venous insufficiency, orCCSVI. Blockages in the veins of MS patients prevent blood from drainingproperly from the brain, and the pooled iron-rich blood damagesbrain tissues, Zamboni suggests. He says opening those blockageswith the balloon procedure used to repair clogged arteries --angioplasty -- offers substantial benefit to MS patients. (Whenapplied to veins, the procedure is called venoplasty.) Zamboni's theory has taken off, particularly in Canada. While clinicians here do not do the unproven procedure, scads of MSpatients have travelled to the U.S., Eastern Europe, and India tohave their veins opened. And enormous pressure has been placed onthe federal and provincial governments, both to fund clinicaltrials and to include the treatment in the items covered byprovincial health-care programs. Newfoundland and Labrador Health Minister Susan Sullivan said basedon the findings of Pryse-Phillips' trial, her province will not becovering the cost of CCSVI treatment going forward. Dr. Andreas Laupacis, who has been periodically assessing thescientific evidence for and against the CCSVI theory for theCanadian Institutes of Health Research, said the study has somestrengths and some weaknesses. If the patients who didn't have venoplasty had been given a shamprocedure -- the equivalent of a placebo in this setting -- theresults would have been stronger, for instance. "I think it's another piece of evidence," said Laupacis, who isexecutive director of the Li Ka Shing Knowledge Institute at St.Michael's Hospital in Toronto. "It's certainly every bit as good a negative bit of evidence as thepositive bits of evidence that people on the other side are haulingout.... But I don't think it's conclusive." Pryse-Phillips said the study was set up so that he didn't knowwhich participants had undergone venoplasty and which had not. Thatis done so any inherent biases a researcher might have cannotinfluence his or her appraisal of how well an intervention hasworked. The study participants were assessed using a combination of tests-- questionnaires which the patients filled out, MRI scans of theirbrains, and a standardized test used to gauge function in MSpatients. Those tests looked at manual dexterity, ability to walkand mental acuity. Pryse-Phillips said he saw no differences among the patients, eventhough those who had received the therapy reported positive resultsin the questionnaires -- things like they felt they had more energyor their balance was better. He noted, though, that even the self-reported gains seemed to tailoff over time, with a drop-off after the three-month check up. Laupacis found that interesting. "It could certainly totally be a placebo effect, the fact that itgoes away in three months. On the other hand, without a kind ofcontrol group, you can't be 100 per cent sure." Pryse-Phillips also noted that by the 12-month check up, about aquarter of the patients who had undergone venoplasty had blockedveins -- either a clot in or the closure of one or more neck veins.But there was no difference, function-wise, in these patients ascompared to the 75 per cent who didn't have the clots or blockages. Pryse-Phillips said under Zamboni's theory, those who experiencedthe closures should have had poorer results than those who didn't. We are high quality suppliers, our products such as TR Fabrics , China Cotton Linen Blend Fabric for oversee buyer. To know more, please visits TR Suiting Fabric.
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