TEST
Caution Urged for Experimental MS Treatment
April 19, 2010 (Toronto) -- People with multiple sclerosis (MS) should not undergo a controversial new treatment that's based on the theory that blocked neck veins can trigger MS, experts say.

Neither the theory nor the treatment -- using angioplasty to open up the narrowed veins -- has been proved in large numbers of people, says Robert Zivadinov, MD, PhD, a researcher at the State University of New York in Buffalo who is studying the approach.

"There are no data at this moment to determine whether this is useful," he tells WebMD.
"If one is contemplating that procedure, it should be done only in the context of a properly controlled trial," says Aaron Miller, MD, chief medical officer of the National Multiple Sclerosis Society and director of the Multiple Sclerosis Center at Mt. Sinai Medical Center in New York.


The research, pioneered by Paulo Zamboni, MD, of Italy's University of Ferrara, has fueled a surge of interest within the MS community; patients are blogging about it and doctors' phone lines are being flooded with requests for more information. Some patients have even traveled to clinics in Italy or Poland, spending thousands of dollars to undergo the unproven treatment.

More than 4,000 people called into a special Internet seminar to hear the doctors speak during the annual meeting of the American Academy of Neurology.

Zamboni says that MS patients who are "rapidly declining" and who have not responded to any other medications might want to appeal to doctors to receive the treatment "under compassionate grounds."

"For these types of patients, the publication of our [research] generated a desperate need to find this type of treatment," he says.

Still, a clinical trial is better as that helps ensure that physicians follow the appropriate procedures, Zamboni says.

MS patients who do enter clinical trials should continue taking the drugs their doctors have prescribed, the experts stress.

"There is no reason to stop treatments," Zivadinov says. "Clinical trials over the last 25 years have clearly shown the advantages of those treatments."

Testing the Theory
Multiple sclerosis is thought to be an autoimmune disease in which the body's immune system mistakenly attacks the brain and spinal cord, causing inflammation and triggering symptoms such as loss of muscle control and vision.

According to Zamboni's theory, blockages in veins leading from the brain cause iron-rich blood to back up into the brain, triggering the inflammation that damages the brain and spinal cord. The condition is dubbed chronic cerebrospinal venous insufficiency (CCSVI).



In his first, small imaging study, all the MS patients had the blockages, while none of the healthy people did.

At the meeting, Zivadinov presented data on the first 500 participants in a new study, 289 of whom had MS. Results were less dramatic, with ultrasounds revealing blockages in 62% of MS patients, 26% of healthy participants, and 45% of people with other neurological disorders.

Miller tells WebMD that the conflicting results of the Zamboni and Zivadinov studies "raise a lot of questions."

Also, the findings do not prove cause and effect, as researchers can't say if the blocked veins cause MS or vice versa.

As for treatment, Zamboni has published a study of 65 patients who underwent an angioplasty procedure to open the blocked veins using a small balloon attached to a catheter inserted though a small incision in the groin. Most of the patients had fewer MS attacks, but the improvement was short-lived for about half.

Additionally, the study lacked any comparison group receiving placebo. Since MS often takes a remitting, relapsing course, it’s not known how many would have improved temporarily anyway, Miller says.

In the U.S., one team of researchers stopped doing procedures to open the blockades after a metal stent -- used to prop open arteries after angioplasty -- migrated to a patient's heart. Another patient died of brain bleeding after the procedure.

Zamboni says stents should not be used to treat these patients.