Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Thursday, March 09, 2017

From "Definitive" To Cursory

"We now have sufficient evidence that pursuing the Liberation treatment ... is not really going to be a good investment of your time and money."
"To have something new to offer people would have been nice. This is not it."
"There was absolutely no difference, no smidgen of a difference [between placebo and Liberation groups in research trial]."
Dr. Tony Taraboulsee, neurologist, University of British Columbia
Dr. Anthony Traboulsee, medical director of the University of British Columbia Hospital MS Clinic, believes this research should officially close the file on 'liberation therapy.'
Dr. Anthony Traboulsee, medical director of the University of British Columbia Hospital MS Clinic, believes this research should officially close the file on 'liberation therapy.' (Martin Dee/University of British Columbia/Canadian Press) 
"Researchers cumulatively build proof or disproof over a period of time. A true scientist never, ever would say one study does that."
Sandra Birrell, spokeswoman, Canadian Neurovascular Health Society

"I have met dozens of people who have had remarkable changes following angioplasty ... from being wheelchair-bound to walking normally."
"This cannot be placebo effect."
Dr. Bernhard Juurlink, anatomy professor, University of Saskatchewan
The miracle cure for the treatment of multiple sclerosis that spread like frantic wildfire through the community of MS sufferers who met the skepticism of doubters with the defiance of those who will grasp at hope wherever it present itself, has now been given the definitive thumbs-down, in the wake of research headed by Tony Traboulsee who has advised the waiting public that the "Liberation" treatment pioneered by Italian vascular surgeon Paolo Zamboni in 2009 belongs in the annals of wishful thinking.

The study results were revealed at a Washington, D.C. conference of the Society for Interventional Radiology, a medical specialty that performs the Liberation treatment, in advance of publication in a peer-reviewed journal. Dr. Zamboni's theory and his confidence in its utility resulted from his firm belief that multiple sclerosis was an outcome from a narrowing in neck veins -- stenosis -- causing blood to flood the brain, leaving behind iron deposits. Dr. Zamboni named his discovery chronic cerebrospinal venous insufficiency; CCSVI.

And his solution to what he diagnosed was to thread a catheter into the veins to enable the inflating of a tiny balloon, much as is done when arteries leading to the heart become clogged through arteriosclerosis, stopping the free flow of blood to the heart. The procedure is called angioplasty, commonly performed for heart patients, to stretch open the arteries clogged with cholesterol, fatty deposits that stop the arteries from their vital work, and impairing the heart.

Media described ecstatic patients, free for the first time from the debilitating effects of the disease after having undergone the new procedure in special therapy clinics around the world that opened to provide the Liberation treatment in the U.S., Mexico and Bulgaria, where the results were astonishingly dramatic. Specialists in the field were less than impressed, however. They warned that the evidence presented by Dr. Zamboni was insubstantial, and research supported that skepticism.

hi-ms-trials
For years, people with MS have been travelling around the world and paying thousands of dollars for an unproven procedure to widen their neck veins. (CBC)

In Canada, advocacy groups and politicians pressed for research to be carried out to determine whether Dr. Zamboni's claims had merit, or not. What resulted was that the Canadian Institute for Health Research, the MS Society and the governments of British Columbia, Manitoba and Quebec undertook to fund the research, carried out at the University of British Columbia. The study's first phase was a blinded study finding that the neck-vein narrowing was present equally among both MS patients and healthy controls.

A finding that the influential science journal The Lancet characterized as the theory's "death knell". What has now been released is the second phase of the study, where MS patients with vein stenosis were assigned randomly to receive the treatment, or unknown to themselves, a sham process instead, involving insertion of the catheter, but not completing the process by inflating the balloon. Patients had no idea which process they were subjected to, and nor did the doctors who assessed the results know which patients were treated and which not.

Dr. Juurlink of the University of Saskatchewan is an advocate of the Zamboni theory and methodology, and he stated his opinion that the trials appeared geared to proving CCSVI represented "quack science", rather than being carried out in the spirit of neutral scientific investigation, planning to fairly judge the outcome. Left out of the equation, as far as he is concerned is how it is that some patients find such amazing relief once the therapy has been performed on them.


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