Liberation therapy was seen to be an ineffective treatment — both in the short and long term — in a Canadian study in people with multiple sclerosis (MS), its researchers reported, advising patients not to assume the procedure’s risks or cost.
Lindsay Machan, a radiology professor at the University of British Columbia (UBC), presented results of his team’s study during the March 4-9 annual meeting of the Society for Interventional Radiology in Washington, D.C.
Liberation therapy, a controversial angioplasty procedure, stems from the belief that MS patients have chronic cerebrospinal venous insufficiency (CCSVI), a condition of compromised blood flow in veins flowing away from the central nervous system. Since 2009, thousands of patients have had their neck veins dilated through this one-time operation, which aims to improve blood flow between the brain and the heart, and clear out iron deposits.
However, there is no clear evidence of the relationship between CCSVI and MS, and Canadian doctors have refused to perform this surgery on the grounds it is unnecessary and potentially dangerous — prompting some patients to seek the treatment in the United States, Latin America and Eastern Europe.
Machan’s $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 — enrolled 104 participants with MS who were randomly assigned to receive the liberation procedure or a sham operation that mimics the procedure but with no actual surgery. Doctors performed the procedure on either the jugular vein, which transports blood from the brain, or the azygos vein, which transports blood from the spinal cord.
All participants had a catheter inserted into their blocked veins, but only 49 patients underwent actual blood vessel surgery, in which blood vessels were opened up by inflating a small balloon. Since the study was double-blinded, neither the patients nor the physicians who evaluated them knew who was receiving the actual treatment or the sham procedure.
One year after surgery, doctors assessed patients’ blood vessels using brain imaging, MS symptoms and self-reported evaluations. Although patients in both groups reported slight improvements, doctors’ analyses found no difference in MS symptoms between sham and liberation therapy groups — neither at three days after the procedure nor one year later.
Brain assessment using magnetic resonance imaging also showed no improvement in the treatment group compared to sham group, not after six months or one year later. Together, these findings show liberation therapy to be ineffective in treating blood vessel anomalies in MS patients.
“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,” UBC neurology professor Anthony Traboulsee said in a news release. “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.”
It’s not the first time researchers address the possible relationship between CCSVI and MS. In 2013, another study, supported by the MS Society of Canada, showed that MS patients and healthy people have similar degrees of blood vessel narrowing.
“Despite the negative findings of that diagnostic study, many patients wanted to know if the venous dilation procedure could help,” Machan said. “We were committed to meticulously evaluating this treatment with robust methods and patient-focused outcomes.”