A controversial condition coined and championed by Italian doctor Paolo Zamboni as the key to treating multiple sclerosis doesn't appear to exist, according to a new study published in a leading Canadian medical journal. But the veinoplasty procedure, used to treat the non-existent condition known as chronic cerebrospinal venous insufficiency, may yet help some people with MS.
The idea that CCSVI, which refers to blocked or abnormal neck veins, plays a pivotal role in MS has been a controversial, hotly debated topic for the last five years in Canada, which has one of the world's highest rates of the disease. The theory was developed by Zamboni, an Italian vascular surgeon, and brought to public attention by media reports, including in The Globe and Mail. Thousands of Canadians have travelled overseas and payed $20,000 or more to have veinoplasty, a procedure to prop open the neck veins to promote blood flow.
The new study, published in the Canadian Medical Association Journal on Monday, examined 120 patients with MS and 60 healthy controls and found no meaningful difference in vein abnormalities between the groups. The authors, led by Dr. Fiona Costello at the University of Calgary, conclude that their findings "revealed significant methodologic concerns" about the proposed diagnostic criteria for CCSVI that "challenge their validity."
It's just the latest in a slew of scientific papers that have cast serious doubt on the existence of a condition that supposedly interferes with normal blood flow and leads to an accumulation of iron in the brain. Many studies have found that venous abnormalities are quite common in healthy people and that many who have MS don't have venous malformations.
Despite the doubt surrounding Zamboni's original hypothesis, there is a burning question the studies haven't answered: Why do so many MS patients report feeling better after undergoing the veinoplasty procedure?
The possibility exists that somehow, vein-widening surgery is an effective treatment option for a subset of patients, said Dr. Anthony Traboulsee, MS Society of Canada Research Chair and associate professor at the University of British Columbia. He was part of a survey that asked 100 people about their experiences getting the vein-widening treatment overseas. About half of respondents said they noticed an improvement in symptoms, while half didn't.
"Something is happening to people, a certain proportion of people," he said. "The easiest thing to do is discount it all as a placebo effect."
Traboulsee and other researchers across Canada are on a mission to answer the question of whether the positive effects are real.
Plenty of anecdotal evidence of the success of vein-widening surgery exists online, thanks to outspoken advocates who use social media to share news and raise awareness.
But what's missing are the randomized controlled trials that can take anecdotes and see if they stand up to evidence-based scrutiny.
Traboulsee is part of a four-centre trial (Vancouver, Winnipeg, Montreal, Quebec City) that will eventually study 100 MS patients. Half will receive the treatment and half won't. No one in the study, including the researchers, will know who received what.
After a year of observation, the researchers will analyze the data and report their findings, which could be late next year or sometime in 2016.