A vein-expanding procedure does not help multiple sclerosis patients.
According to a new study, “liberation therapy,” an invasive and controversial vein-expanding procedure, does not help multiple sclerosis (MS) patients despite its growing popularity in some regions. Canadian researchers sought to evaluate the efficacy the therapy in which narrowed blood vessels from the brain and spinal cord are expanded via venoplasty procedures.
Proponents of the treatment have endorsed it as a miracle that could significantly reduce symptoms of MS. However, no study has yet been able to bear out the hype, and so researchers from the University of British Columbia set out to debunk — or affirm – the procedure.
To do so, they recruited 104 clinical trial participants for the double-blinded study; all of the patients had to have a catheter inserted into their blocked veins in order to preserve the placebo effect. However, only 49 patients had their veins expanded using small balloons.
After 1 year, patients were assessed in 3 ways: brain imaging, symptom inventories, and patient self-assessments. According to the researchers, there was no statistical difference in all 3 areas in the patients who received the therapy and those who were given the placebo procedure.
“We hope these findings, coming from a carefully controlled, ‘gold standard’ study, will persuade people with MS not to pursue liberation therapy, which is an invasive procedure that carries the risk of complications, as well as significant financial cost,” said Anthony Traboulsee, MD (photo), associate professor of neurology at the University of British Columbia and director of the MS clinic at the Djavad Mowafaghian Centre for Brain Health.
The study is critical, because, despite shaky evidence, the procedure has been in high demand in Canada and parts of Europe. It was first proposed in 2009 by an Italian researcher, Paolo Zamboni, MD. Zamboni argued that Chronic Cerebrospinal Venous Insufficiency (CCVI) was a major factor in nervous system damage in patients with MS. He suggested that 90% of MS patients had CCVI, and asserted that 73% of those patients had symptom abatement with the venoplasty procedure.
However, those results have never been replicated.
In fact, they have been the subjects of increasing skepticism. In 2012, the US Food and Drug Administration (FDA) issued an alert that warned patients the procedure hadn’t been proven scientifically and could potentially cause additional damage.
The following year, a study from Memorial University in Newfoundland discovered that half of the 30 patients who had undergone the procedure reported a subjective benefit at 3 months. Yet, by 12 months post-procedure, objective measures showed no benefit and most of the patients no longer reported any subjective improvement.
The difference between the 2013 study and this new research is that the latter is larger and involves a control group. However, the findings are essentially the same.
Traboulsee said the results should be seen as good news, because they spare patients from having to undergo invasive procedures, and because they come at a time when other therapies are proving highly effective.
“Fortunately, there are a range of drug treatments for MS that have been proven, through rigorous studies, to be safe and effective at slowing the disease progression,” he said, in the press release.
The study results were announced at the annual meeting of the Society for Interventional Radiology, in Washington, DC. Full results will be published in a peer-reviewed journal in the coming months, Traboulsee said.