Canadian study casts doubt on liberation treatment for MS patients
One expert says report not conclusive, but ‘ it’s another piece of the evidence’
I am disappointed. I had hoped. I cannot recommend this therapy on the basis of these results at this time. DR. WILLIAM PRYSE- PHILLIPS
LEAD INVESTIGATOR OF STUDY
TORONTO — Patients who had the so- called liberation treatment for multiple sclerosis experienced no measurable benefit from the procedure, a study commissioned by the government of Newfoundland and Labrador found.
The results of the small, observational study were announced Wednesday in St. John’s by lead investigator Dr. William PrysePhillips, a professor emeritus of neurology at Newfoundland’s Memorial University.
Pryse- Phillips said he had gone into the study hoping the treatment might have something to offer his MS patients, but completed it convinced the people who had the vein- opening procedure didn’t experience any gains.
“I am disappointed. I had hoped. I cannot recommend this therapy on the basis of these results at this time,” he said during a news conference.
The province spent $ 400,000 on the study, which compared 30 patients with MS who had travelled outside the province to have the therapy and 10 who did not. Participants were subjected to an array of 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 between MS patients and the neurologists and professionals — including those at the MS Society of Canada — who work to help MS sufferers.
The theory originates from Italy. Dr. Paolo Zamboni, a vascular surgeon from the University of Ferrara, has hypothesized that MS is not a neurodegenerative disease, as has been thought, but a disorder resulting from collapsed veins in the neck and upper chest. Blockages in the veins of MS patients prevent blood from draining properly from the brain, and the pooled iron- rich blood damages brain tissues, Zamboni suggests. He says opening those blockages with the balloon procedure used to repair clogged arteries — angioplasty — offers substantial benefit to MS patients.
Zamboni’s theory has taken off, particularly in Canada. While clinicians here do not do the unproven procedure, many MS patients have travelled abroad to have their veins opened.
Newfoundland and Labrador Health Minister Susan Sullivan said based on the findings of Pryse- Phillips’ trial, her province will not cover the cost of the treatment.
Dr. Andreas Laupacis, who has been assessing the scientific evidence for and against the CCSVI theory for the Canadian Institutes of Health Research, said the study has strengths and weaknesses.
If the patients who didn’t have veins opened had been given a sham procedure — the equivalent of a placebo in this setting — the results would have been stronger, for instance.
“I think it’s another piece of evidence,” said Laupacis, who is executive 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 the positive bits of evidence that people on the other side are hauling out.... But I don’t think it’s conclusive.”
Pryse- Phillips said he saw no differences among the patients, even though those who had received the therapy reported positive results in the questionnaires — such as having more energy or better balance.
He noted that even the selfreported gains seemed to tail off, with a drop- off after the three- month checkup.