A controversial theory about the cause of multiple sclerosis that has given new hope to thousands of patients suffered a setback as two new studies for the first time threw doubt on the findings.
Pioneered by Italian physician Paolo Zamboni, the theory suggests that MS is a vascular disorder caused by vein blockages that lead to a buildup of iron in the brain, rather than an autoimmune disease, and can be treated by a simple surgical procedure - angioplasty. While the procedure has yet to undergo clinical trials in Canada, MS patients here have shelled out thousands of dollars for the unproven and experimental treatment in countries such as India and Poland. Last week, Saskatchewan Premier Brad Wall announced his province would finance clinical trials, despite caution expressed by other premiers, the MS Society of Canada and others in the medical community.
New research from Germany and Sweden that provides the first negative medical evidence on Dr. Zamboni's theory could bolster the campaign of critics. The studies, published Monday in the Annals of Neurology, found no unusual blockages in the veins of MS patients compared with control groups.
"These two papers should add a note of caution for MS patients and physicians who are contemplating interventions for possible venous abnormalities based on the findings of [Dr.]Zamboni. At this time, the theory must be considered unconfirmed and unproven," said Stephen Hauser, the journal's editor and chair of the department of neurology at the University of California, San Francisco.
That doesn't discourage Perry Goodyear of Grand Bank, Nfld., who is heading to the United States in October for treatment. He was diagnosed with MS in 2003, and has been unable to walk, is easily tired and barely has the use of his left arm.
"They're going to do whatever they can to run it down anyway. It doesn't discourage me, not a bit, because I've done a lot of research on it. I know that it works. I've had a lot of friends that have had amazing results," the 37-year-old said.
The first study, out of Germany, involved 56 MS patients and 20 healthy patients. Scientists did ultrasound testing and other imaging exams and found blood flow was normal in all, except for one MS participant. A smaller study out of Sweden that involved 21 MS patients and 20 healthy patients used magnetic resonance imaging to compare blood flow and reached a similar conclusion.
"In this quite small study we find no support for venous vascular surgical treatment and we are not able to confirm the Italian theory," lead researcher Peter Sundstrom of Umea University in Sweden said.
Dr. Zamboni's study of the degenerative condition involved 65 patients, who underwent angioplasty to clear blockages. Many in the medical community have been skeptical of his work because it is preliminary, with a small sample size, and has been heavily promoted before going through the rigorous research process.
Yet hundreds of MS patients, including a few Canadians, have travelled to India, Poland, Bulgaria and a few other countries for the surgery. Most say they have increased energy and mobility, but others have described little change. The treatment has led to injury in some cases.
Saskatchewan, the province at the forefront of Canadian efforts to introduce a treatment, is not backing down from its plan to offer clinical trials, despite the negative studies. The province has the highest rate of MS in the country. Other governments aren't allowing access to treatment, since it hasn't been well studied.
"The medical community is a bit divided on this right now. But that doesn't stop us from offering to financially back a clinical trial," said Kathy Young, a spokeswoman for Mr. Wall. "Our Premier, because of where we are per capita with this disease, felt he really needed to take a stand here. We know there will be science on both sides of this, but we will be led by the experts."
Researchers from the University of Saskatchewan, the University of British Columbia and the Vancouver Coastal Health Research Institute had teamed up to conduct diagnostic testing of MS patients. Lindsay Machan, an associate professor in radiology at UBC and one of the researchers, said the money from Saskatchewan will allow for both diagnostic testing and clinical trials for patients from that province.
Dr. Machan said the German and Swedish studies are not surprising given that controversial theories often lead to conflicting data in the medical community that get sorted through as more research and larger studies are conducted. The studies may temper enthusiasm about Dr. Zamboni's theory, but won't kill it, he said.
"Many people feel that it's worth pursuing further studies, because we're seeing these patients who seem to be having some very impressive improvements," Dr. Machan said. "That tells us that at the very least we need to investigate this thoroughly."
With a report from Patrick White