Researchers at the University of British Columbia and Vancouver Coastal Health say they’ve debunked the one-time medical procedure (known as “liberation therapy”), citing lack of proof that the therapy actually achieves the dramatic health improvements it promises.
“We didn’t think [liberation therapy] was going to cure MS but we were hoping it would help improve the symptoms in maybe a subset of people,” Dr. Tony Traboulsee told Global News.
He’s a UBC associate professor of neurology and director of the MS Clinic at the Djavad Mowafaghian Centre for Brain Health.
“We thought we could design a good quality study that would give definitive answers – to get very clear answers – in terms of safety and benefit of this type of approach.”
To test the validity of the procedure, researchers enrolled over 100 participants and divided them into two groups. The first group underwent a “sham” procedure — the surgical equivalent of a placebo. While all of the participants had a catheter inserted into their blocked veins, only 49 had their vessel walls opened up by a small inflated balloon, a procedure known as venoplasty.
After a year, researchers revisited the patients and found that the venoplasty group’s results were statistically the same as those who had the placebo procedure. This was measured by brain imaging, standard assessments of MS symptoms and the patients’ own self-assessments.
Participants in both groups also underwent MRI scans of their brains to count the number of new lesions in their myelin.
Researchers checked in with the participants after six months and at the one-year mark and found no difference between the groups.
The use of venoplasty as a treatment for MS began with Dr. Paolo Zamboni of Italy. He claimed the narrowing of the veins in the neck could be causing iron to build up in the brain and spinal cord, triggering the autoimmune response.
He originally called his theory chronic cerebrospinal venous insufficiency (CCSVI) and alleged that it increased the risk of having MS by 43.
Zamboni also claimed that several dozens of his patients improved as a result of the procedure.
When news of his procedure spread to Canada and Europe, many MS patients requested to try the therapy. However, almost all Canadian physicians refuse to perform it, citing lack of evidence of its workings. Turned-away patients then travelled to the U.S., Latin America or Eastern Europe to undergo the treatment.
“We have a lot of treatments for MS that seem to slow down the disease and maybe stop it, but it doesn’t reverse the damage they have – it doesn’t get rid of that pain, that fatigue and memory problems,” Traboulsee said. “So when Dr. Zamboni published in 2009 that his treatment could improve those symptoms in a large number of people, naturally it created a lot of excitement.”
Since 2009, thousands of MS patients have undergone liberation therapy, the study points out.
“With people with multiple sclerosis, the medications we use – their pain doesn’t go away,” Traboulsee adds. “So something that had the promise – the potential to improve pain, to improve quality of life – we couldn’t ignore that.”
But what pushed Traboulsee and his team to look into the procedure was two-fold: first, the fact that Zamboni’s liberation therapy promised great results and second, they wanted to meet the public demand for more insight.
“I think what really pushed us [to look into liberation therapy] was the compelling early results,” says Traboulsee. “The fact that something could possibly help patients and improve their symptoms – that is such an unmet need in the work we do.”
Traboulsee hopes that these findings will persuade people with MS to not pursue liberation therapy. Instead he hopes patients will stick to the range of drug treatments for MS that have been proven (through rigorous studies) to be safe and effective at slowing the progression of the disease.
This isn’t the first time researchers looked in to liberation therapy and its claims.
Two studies – one in 2013 by McMaster University and the other in 2014 by the University of Calgary – found no evidence that blood flow was impaired or blockage in the veins in the neck or head existed in MS patients.
Their findings, they said, contradicted Zamboni’s theory as well as his liberation therapy treatment.
For Angelica Asis, acting director of research at the MS Society of Canada, the findings of Traboulsee’s study are good news.
“I think people living with MS want clarity,” she told Global News. “They want answers about both CCSVI as a potential cause for MS, but also venoplasty treatment. I think that with any treatment there comes risks but also potential benefits so people always try to weigh those two together. So having important research that’s being done in this area allows them to be informed and educated before making these types of big treatment decisions.”
But when it comes to people living with MS and their decisions, Asis says the MS Society of Canada always respects the autonomy in their decision-making.
“Ultimately it is their decision,” says Asis. “Everyone has a different journey so they have to consider their own personal choices, their background and health history. They need to consult with their health care team in order to have the information that they need to make the best decision for themselves.”
According to the MS Society of Canada, 100,000 Canadians are affected by the disease. Canada is also the country with the highest rate of MS in the world.
MS is an autoimmune disease that attacks the myelin – a protective coating around the nerves essential to transmitting impulses to the nerve fibres – and causes damage to the nerves and myelin. It affects the brain, spinal cord and optic nerves.
Symptoms often include extreme fatigue, weakness, vision problems, tingling, impaired sensation and bladder problems, among others.
Global News reached out to Zamboni for comment but did not receive a response in time for publication.
Traboulsee’s team presented their findings Wednesday at the Society for Interventional Radiology’s annual meeting in Washington. They say their next steps are to publish their findings.
With files from Carmen Chai