‘Liberation therapy’ ineffective, study finds
TORONTO — A long-awaited Canadian patient trial of a controversial treatment for multiple sclerosis known as “liberation therapy” has concluded the procedure is ineffective and should be avoided.
Liberation therapy involves opening up narrowed veins in the neck, a procedure that an estimated 3,000 Canadians with MS have undergone in clinics outside Canada at a cost of many thousands of dollars each. The therapy is not approved in Canada.
The procedure was first put forward in 2009 by Dr. Paulo Zamboni, who asserted that narrowed veins in the neck could cause iron deposits to create lesions in the brain, leading to multiple sclerosis.
The Italian vascular surgeon dubbed the condition chronic cerebrospinal venous insufficiency, or CCSVI, and cited dozens of cases of patients who improved after he performed the treatment, known as a venoplasty.
But Dr. Anthony Traboulsee, an MS specialist at the University of British Columbia who headed the clinical trial involving 104 Canadians with MS, said researchers found no overall difference in outcomes between patients who received the vein-widening therapy and those who got a sham procedure.
“The major finding was looking at the patient-reported outcome of quality of life and the most important finding of that was that there was no difference at either 72 hours [post-procedure] or at the end of study, week 48, in terms of change in the measurement for either group,” Traboulsee said.
“So both groups looked exactly the same at the end of study, and that was whether we looked at the physical score or the mental composite score or the fatigue scale or the pain scale — all the scales showed exactly the same thing.”
MS is considered an autoimmune disease: the body’s immune system attacks the protective coating around nerve cells, called myelin, impeding the cells’ ability to conduct electrical signals and leading to problems with movement, sensation and cognitive function.
The cause of the disease is unknown. Although there are treatments that can slow its progression, MS has no cure.
Zamboni’s proposed treatment brought hope to MS sufferers worldwide, leading thousands to pursue the scientifically unproven therapy at private clinics in Europe, Mexico and the United States.
Many patients in Canada — which has one of the highest rates of MS in the world — were quick to embrace the procedure and offered online testimonials of its benefits.
Canadian researchers set out to test the therapy by randomly assigning 104 MS patients with narrowed neck veins to receive either a venoplasty, in which a tiny balloon is inserted into the vein and expanded, or a sham procedure, in which the balloon is threaded into the vein, but not blown up.
The study was blinded, meaning neither the patient nor the doctors who assessed them knew which “treatment” they had received.
While the Canadian trial found no “overall” difference between the two groups in quality of life measures or the development of new brain lesions as seen on MRI scans, Traboulsee said about one quarter of patients in each group reported improvements in symptoms.
“When we look on the individuals, we do see that, just like we do in the real world,” he said. “There were patients who reported to me: ‘I know I got it [the real procedure]. I feel better.’
“At about week two, we did see an improvement in the overall population. It doesn’t mean everybody is feeling an improvement.
“It’s about 25 per cent of patients have had an improvement in their quality-of-life scale. But then, by week 48, it starts coming back down to their baseline.”
Traboulsee said he hopes the findings will persuade people with MS not to pursue liberation therapy, which carries potential risks and has led to a few deaths, at least two of them among Canadians who sought the procedure.
But Linda Hume-Sastre, president of the advocacy group CCSVI Ontario, criticized the way the study was carried out, calling it “sham science.”
Hume-Sastre encouraged people with MS to research their treatment options, including liberation therapy.