Trial finds new MS treatment makes ‘no smidgen of difference’

A major trial study from the University of British Columbia has found that the contentious vein-expanding “Liberation” procedure devised by an Italian doctor is completely ineffective.

A contentious method for treating multiple sclerosis that took the MS world by storm is completely ineffective, suggests a major new trial being touted as the last word on the issue.

A year after 104 patients received either the vein-expanding “Liberation” procedure devised by an Italian doctor or a sham operation, there was essentially no difference in their conditions, the University of British Columbia team reported Wednesday.

Both sets of patients — none of whom knew whether they received the treatment or not — reported “slight” but equal improvements in the first several weeks afterward, and both said those benefits disappeared by the end of 48 weeks, the researchers say.

Doctors measuring symptoms on a different scale were unable to detect any improvement, while MRI scans showed no change in the brain lesions linked to MS.

The federal government, three provinces and the MS Society of Canada agreed to fund the $5.4-million study in 2011 at the height of a furious debate over the procedure and the theory behind it. The issue pitted skeptical neurologists against hopeful patients and then-opposition Liberal politicians, including current Science Minister Kirsty Duncan.

Tony Traboulsee, the UBC neurologist who headed the research, said he considers the long-awaited results “definitive.”

“We now have sufficient evidence that pursuing the Liberation treatment … is not really going to be a good investment of your time and money,” Traboulsee said in an interview. “To have something new to offer people would have been nice. This is not it.”

It seems unlikely, however, the trial will do much to quiet the enthusiasm of the concept’s supporters, who are already voicing doubts about its findings.

The study encompassed too few patients, did not last long enough and shouldn’t be assessed until the end of a “crossover” period when the procedures given the two groups were reversed, said Sandra Birrell, spokeswoman for the Canadian Neurovascular Health Society.

It’s also just one piece of the puzzle amid a plethora of research on the topic, she said.

“Researchers cumulatively build proof or disproof over a period of time,” said Birrell. “A true scientist never, ever would say one study does that.”

The study results have yet to be published in a peerreviewed journal, but were released Wednesday at a Washington, D.C. conference of the Society for Interventional Radiology, a specialty that performs the Liberation treatment.

The saga dates back to 2009 when Paolo Zamboni, an Italian vascular surgeon whose wife has MS, suggested that the illness was linked to “stenosis” or narrowing in neck veins, which he said caused blood to back up on the brain, leaving harmful iron deposits.

To fix what he called chronic cerebrospinal venous insufficiency — CCSVI — Zamboni proposed threading a catheter into those veins and inflating a tiny balloon, a procedure called angioplasty. Highly flattering media coverage in Canada captivated patients here, and Birrell said “thousands” have since undergone the therapy in clinics from the U.S. to Mexico and Bulgaria, many reporting dramatic benefits.

Traboulsee acknowledges the drugs approved now to treat MS — some of which have nasty side-effects — are not nearly effective enough.

But specialists in the field warned from the start that Zamboni’s evidence was wafer thin, and much of the subsequent research has cast further doubt on his ideas.

Pressure from advocacy groups and politicians like Duncan, however, prompted the Canadian Institute for Health Research, the governments of B.C., Manitoba and Quebec and the MS Society to bankroll the UBC research.

The first phase, published in 2013, was a blinded study that found the neck-vein narrowing was equally present in MS patients and healthy controls. The Lancet called it the theory’s “death knell.”

In the just-released second phase, MS patients with vein stenosis were randomly assigned to get the treatment or a sham process that involved inserting the catheter but not inflating the balloon — a sort of placebo.

Patients consented to receive conscious sedation, meaning they had no memory of the process — or clue as to what they underwent, said Traboulsee. The doctors who did the assessments were also blinded to whether patients were treated or not.

Patients responded afterward to the same questionnaire on MS symptoms that Zamboni used in his landmark study on the treatment.

“There was absolutely no difference, no smidgen of a difference” between the placebo and Liberation groups, Traboulsee said.

But one leading advocate of Zamboni’s ideas says such scientists seem more interested in proving CCSVI to be “quack science” than finding out why some patients do so well after the therapy.

“I have met dozens of people who have had remarkable changes following angioplasty … from being wheelchair-bound to walking normally,” said Bernhard Juurlink, a University of Saskatchewan anatomy professor. “This cannot be placebo effect.”