Opening up narrowed veins from the brain and spinal cord is not effective in treating patients with multiple sclerosis (MS), according to a new study led by the University of British Columbia in Canada. Thousands of people with MS have undergone the procedure since 2009.
All 104 participants in the study had a catheter inserted into their blocked veins, but only 49 had their vessel walls pushed out by inflating a small balloon in the procedure known as venoplasty. A year later, the results in the venoplasty group were statistically the same as those in the sham-procedure group, as measured by brain imaging, standard assessments of MS symptoms, and patients’ self-assessments.
The findings were presented at the annual scientific meeting of the Society for Interventional Radiology in Washington, D.C.
Using venoplasty as an MS treatment was first advanced 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 the disorder chronic cerebrospinal venous insufficiency (CCSVI) and cited several dozen cases of patients who improved after undergoing venoplasty that he performed.
All of the 104 subjects in the new study had MS and narrowing of the jugular vein, which drains blood from the brain, or of the azygos vein, which drains blood from the spinal cord. The study was double-blinded.
The subjects were put under minor sedation, and all of them had a catheter threaded through an incision in the groin to the area of vessel narrowing. For those receiving the actual treatment, the balloon was inflated once or twice; for those receiving the sham procedure, the catheter simply remained in the narrowed area for the same amount of time (approximately one minute).
The researchers found no statistically significant difference between the treatment group and the sham group with regard to patient symptoms––either as reported by the patients or as determined by physicians––three days after the procedure and one year later. Both groups showed slight but equal improvements a year later in the patients’ own assessments; physician assessments showed no improvement in either group.
Magnetic resonance imaging (MRI) of the subjects’ brains was used to count the number of new lesions in their myelin. Again, the researchers found no difference between the treatment group and the sham group at six months and one year later.
“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 lead investigator Dr. Anthony Traboulsee. “Fortunately, there is a range of drug treatments for MS that has been proven through rigorous studies to be safe and effective at slowing disease progression.”
Source: University of British Columbia; March 8, 2017.