Pictured: The white areas represent MS scarring. MS causes extensive damage and scarring throughout the brain and spinal cord leading to permanent disability.
Opening up narrowed veins from the brain and spinal cord is not effective in treating multiple sclerosis (MS), according to a study led by the University of British Columbia and Vancouver Coastal Health.
The conclusions about so-called “liberation therapy,” which thousands of people with MS have undergone since 2009, represent the most definitive debunking of the claim that MS patients could achieve dramatic improvements from a one-time medical procedure.
“We hope these findings, coming from a carefully controlled, ‘gold standard’ study, will persuade people with MS not to pursue liberation therapy, an invasive procedure that carries the risk of complications, as well as significant financial cost,” said Dr. Anthony Traboulsee, a UBC associate professor of neurology and director of the UBC Hospital MS Clinic at the Djavad Mowafaghian Centre for Brain Health. “Fortunately, there are a range of drug treatments for MS that have been proven through rigorous studies to be safe and effective at slowing disease progression.”
The study had some people undergo a “sham” procedure, the surgical equivalent of a placebo. All 104 participants had a catheter inserted into their blocked veins but only 49 had their vessel walls pushed out by inflating a small balloon, known as venoplasty.
A year later, the venoplasty group’s results were statistically the same as those in the sham group, as measured by brain imaging, standard assessments of MS symptoms and the patients’ own self-assessments.
The findings from the $5.4-million study, jointly funded by the Canadian Institutes of Health Research, the MS Society of Canada, and the provinces of British Columbia, Manitoba and Quebec, were presented today at the Society for Interventional Radiology’s annual scientific meeting in Washington, D.C. The researchers are now preparing an article to be published in a peer-reviewed journal.
Using venoplasty as an MS treatment was first put forward by Dr. Paolo Zamboni of Italy, who asserted that narrowing of the veins in the neck could be causing iron to accumulate in the brain and spinal cord, triggering an autoimmune response. He called his theory chronic cerebrospinal venous insufficiency (CCSVI), and cited several dozen cases of patients who improved after undergoing venoplasty performed by him.
Many patients in Canada and Europe, upon learning of those anecdotal results through the news media, asked for imaging of their veins and subsequent venoplasty. But almost all Canadian physicians, citing the lack of supporting evidence, would not perform it, prompting some patients to seek the treatment in the U.S., Latin America and Eastern Europe.
This is the second study, led by the UBC and Vancouver Coastal Health team and involving researchers from across Canada, that aimed to seek more evidence on the CCSVI theory. The first study, published in The Lancet in 2013 and supported by the MS Society of Canada, sought to determine if narrowed veins was a distinct feature of MS and found that narrowing was just as common in people without the disease.
“Despite the negative findings of that diagnostic study, many patients wanted to know if the venous dilation procedure could help,” said Dr. Lindsay Machan, a UBC associate professor of radiology who presented the findings at today’s interventional radiology conference. “We were committed to meticulously evaluating this treatment with robust methods and patient-focused outcomes.”