No benefits to MS ‘liberation therapy,’ local study discovers
A $5.4-million study led by University of B.C. and Vancouver Coastal Health researchers has shown that opening up narrowed neck veins is useless as a multiple sclerosis (MS) treatment.
Thousands of Canadian MS patients have gone to the U.S. for the angioplasty procedure since an Italian doctor, Paolo Zamboni, announced in 2009 that the procedure provided benefits. But study co-leader Dr. Anthony Traboulsee, a UBC neurology professor, said any relief perceived by those who have the procedure should be viewed as nothing more than a placebo effect.
The results of the four city (Vancouver, Winnipeg, Montreal, Quebec City) study of the so-called “liberation therapy” should serve as definitive debunking of Zamboni’s claims, Traboulsee said.
Zamboni contended that MS patients had a higher prevalence of vein stenosis (narrowing) which caused iron to accumulate in the brain and spinal cord. A previous study on that claim showed that MS patients and healthy controls actually have the same prevalence of vasoconstriction and such physiology is not unique to those with MS.
About 100,000 Canadians have MS and ever since Zamboni coined the term chronic cerebrospinal venous insufficiency (CCSVI) and recommended opening the blocked neck veins, thousands of patients have paid between $10,000 and $20,000 to get it done in the U.S. and other countries.
Canadian doctors have always been dubious. Traboulsee and his co-researchers presented their findings Wednesday at the annual scientific meeting of the Society for Interventional Radiology in Washington, D.C. because they felt they should not wait for publication in a medical journal.
Traboulsee said when the results of the new study are published in several months, it will show that some participants perceived slight benefits that were not borne out on either imaging or neurological evaluations.
That suggests there was a placebo effect offering fleeting relief of symptoms.
There were 104 participants in the study funded by the Canadian Institutes of Health Research, the MS Society of Canada and three provinces — B.C., Manitoba and Quebec. After minor sedation, all participants had a catheter inserted through an incision in their groin that was then threaded up to the narrowed blood vessel — either the jugular or azygos.
In half the participants, a balloon was inflated to prop open the vessel while in the other half, the catheter remained in the area for the same duration — about a minute, with no vein dilation.
Almost a year later, there was a crossover; the next time, participants got the procedure they didn’t have the first time.
Traboulsee said in a teleconference that while the procedure was safe, there was no statistically significant difference in outcomes between the two procedures, one of which was a sham. Symptoms were measured by doctors and reported by patients three days after the procedures and again one year later. At six months and again at one year after the procedures, researchers conducted MRI imaging of participants’ brains to count the number of brain lesions.
Marilyn Lenzen, a 57-year old North Vancouver resident who was diagnosed with MS 17 years ago, said she was enthusiastic about joining the study since there are so many unanswered questions (causes and treatments) about a disease which is a “ticking time bomb” inside all those with it.
She said since the angioplasty procedure has never been offered in Canada, several other MS patients she knows went elsewhere to get it, in desperation.
“Many of them said they had immediate positive results but they didn’t last. I even know someone who committed suicide because she was so disappointed after she had paid to have the procedure and saw no benefit,” she said.
Lenzen said she went to UBC at least 15 times in the two-year study period, for ultrasounds, MRIs and repeated assessments.
“It was a very well-designed study and I had high hopes that this would help. But for my symptoms, which include burning pain in my feet, fatigue and brain fogginess, there’s been no change.”
The mother of two said she’s tried many different prescription drugs developed for MS, none of which have alleviated her symptoms and all of which produced unwanted side effects. The latest drugs cost as much as $60,000 a year, which is unaffordable to her since she lives on a disability pension.
Lenzen said the fact there appeared to be a small placebo effect shows that the scientist who figures out a way to “bottle that” should win a Nobel Prize.