Image: Illustration by Andrew Bannecker

When vascular surgeon Paolo Zamboni reported in December 2009 that inflating a tiny balloon inside twisted veins in the neck provided relief from multiple sclerosis, he created quite a stir. the idea that surgically straightening crooked veins could somehow benefit a degenerative nerve problem was astounding. Physicians were skeptical. Zamboni himself concluded that his findings should be subjected to more rigorous testing. Regardless, many people with MS, which affects at least 250,000 people in the U.S., immediately began clamoring for the unproved treatment. Their demands, amplified through a wide range of social-networking platforms, soon proved impossible to resist. In the past year, for instance, hospitals in California, New York, Italy and Poland have offered the Zamboni treatment—at a cost of $10,000 or more because it is not covered by insurance.

Doctors found themselves playing catch-up every step of the way. Even before Zamboni published his results in the Journal of Vascular Surgery, a post on Patients­LikeMe.com (an online patient community) boasted news of his research, useful links and a dedicated Facebook URL. Community networks traded contact information detailing who would offer the procedure and where. Before-and-after videos were posted on YouTube. Like AIDS activists of 30 years ago but armed with much more powerful communications tools, patients challenged researchers and medical centers to explain why it was taking so long to offer Zamboni’s approach. yet most MS experts believe that undergoing the procedure at the moment is a very risky proposition.

This episode highlights a growing challenge for patients: how to temper enthusiasm for experimental therapies, now widely and effectively marketed through personal testimonials posted online, until evidence shows that the treatments are likely to do more good than harm. “You can never blame people for being excited about something that sounds like good news, especially when they have a serious disease,” says Aaron Miller, a professor of neurology at Mount Sinai School of Medicine and chief medical officer for the National MS Society. “I think these social-media sites can have a positive function in that they allow patients to discuss research and share their experiences.” but, he adds, “they have a very major risk in leading patients to embark on therapeutic courses that are not necessarily appropriate for them or haven’t been established as being scientifically valid.”

A dangerous Game In the case of Zamboni’s work, it is easy to see how patients might be tempted to jump the gun and seek a treatment that initially sounds exciting. After all, the study findings came from a reputable surgeon (though not an MS researcher) publishing in a respected journal. as Daniel Simon, an interventional radiologist in Edison, N.J., says of the work: “It wasn’t Bob’s Journal of MS and Autobody Repair; it was the premier journal of vascular surgery.”

It is also easy to see why racing to get treatment can be a dangerous game to play. In the first place, one study, even a well-done one, does not show that a therapy is ready for prime time. Often in medicine, early positive findings wash away later. And Zamboni himself pointed out that the study had limitations. the small trial was not randomized, double-blinded or placebo-controlled—the combination of which is considered the gold standard in clinical research. Participants also continued to take immune system–modulating therapies known to reduce symptoms.

In the case of MS, as with some other disorders, the difficulty of knowing whether a treatment that seemed to work really did have an effect in a study is compounded by the erratic nature of the disease. the most common form—relapse-remitting MS—has a variable course marked by flare-ups amid symptom-free periods. So it is difficult to know if a certain treatment actually works or was simply taken during a naturally occurring remission. Patients taking placebo have often reported substantial improvements, according to Mount Sinai’s Miller.

By Jenifer GoodwinHealthDay Reporter Latest Neurology News

TUESDAY, Jan. 18 (HealthDay News) — Preliminary research and reports from patients suggest that a controversial treatment for multiple sclerosis can help relieve fatigue and other symptoms, but many physicians remain highly skeptical of the claims.

The debate started in 2009, when Dr. Paolo Zamboni, a vascular surgeon from Italy, published an intriguing study that suggested that a blockage in the veins that drain blood from the brain and spinal cord and return it to the heart might contribute to multiple sclerosis (MS).

Calling it chronic cerebrospinal venous insufficiency, or CCSVI, Zamboni’s theory was that the blockages disrupt the flow of blood from the brain and spinal cord, causing blood to back up and damage the brain and the spinal cord.

Zamboni began surgically treating people with MS with balloon angioplasty to open their veins. Other CCSVI researchers have tried stents, in which a wire mesh is placed in the vein to prop it open.

The methods of Zamboni and the others set off a heated debate among physicians and patients. many MS physicians consider the claims utter hooey. but many people with MS, desperate for relief, pressed for research, and some, unwilling to wait, sought out physicians abroad who’d do the surgery.

Despite the skepticism, U.S. researchers began investigating venous blockage. in June, the National Multiple Sclerosis Society announced $2.4 million in funding for CCSVI studies, most of which are trying to answer the basic question of whether there is actually a link between venous blockages and MS.

Among those conducting CCSVI research is Dr. Michael Dake, a professor of cardiothoracic surgery at Stanford University School of Medicine.

Dake followed 30 people with MS who had stents implanted to open their veins. Two months after surgery, they reported feeling 50% less fatigued than before surgery, Dake said. they continued to be less fatigued at the one-year mark, even improving slightly from where they were two months after surgery, he said.

People who saw the most benefit were those with the relapsing-remitting form of MS, in which periods of remission, when the person feels relatively good, are followed by MS flares, Dake said.

People with more aggressive or more advanced forms of MS, including primary and secondary progressive MS, reported about a 40% drop in fatigue two months after the surgery, but the effect did not last at the one-year mark, Dake said.

MS is believed to be an autoimmune disease in which the body’s immune system attacks myelin, or the substance that insulates nerve fibers of the central nervous system. The damage disrupts nerve signals traveling to and from the brain, which can lead to numbness, movement difficulties and blurred vision. Other symptoms can include fatigue and cognitive problems, sometimes described by those with MS as being in a fog.

Vein opening is unlikely to help regenerate damaged myelin, which causes the movement difficulties, Dake said, but opening blocked veins looks like it may help alleviate fatigue, at least in people with relapsing-remitting MS.

“It’s a stretch to think opening up veins is going to deal with or reverse an injury that is due to demyelinating plaque, whereas the symptoms that are more general, such as fatigue and brain fog that are much more related to an obstruction in venous outflow from the brain — those could potentially be reversed,” he said.

Dake was scheduled to present his findings this week at the International Symposium on Endovascular Therapy in Miami Beach.

He cautioned that his research was not a randomized, controlled, clinical trial but rather a review of his clinical experience with 30 patients.

Therein lies the problem with CCSVI and its treatments, said Dr. Lily Jung, medical director of the neurology clinic at the Swedish Neuroscience Institute in Seattle.

“There is no clear evidence that MS has anything to do with blocked veins, and to then jump to therapy for blocked veins is premature,” Jung said.

The research done on CCSVI has not consistently established that people with MS are more likely to have venous blockage than are healthy people or those with other neurological diseases, Jung said. nor is it known when venous blockage occurs during the course of the disease or why such a blockage, if it occurs, would cause symptoms of MS.

Until much more is learned, Jung warned people against seeking treatment for CCSVI because of the danger of complications. According to the National Multiple Sclerosis Society, a Canadian man with MS died after seeking angioplasty in Costa Rica, and another had to have emergency open heart surgery to retrieve a stent that dislodged.

“It is not ready for prime time,” Jung said. “We need to first establish how firm the basis for the theory is and, secondly, have a widely accepted agreement about how to diagnose CCSVI before you try treatment for it,” she said.

Dr. James Benenati, president of the Society of Interventional Radiologists, described MS as a heterogeneous disease — meaning that not every person with MS has venous blockages, and not every person with venous blockages has MS. And that, he said, makes the research more difficult.

Benenati said he plans to begin offering the treatment to MS patients at Baptist Cardiac & Vascular Institute in Miami as part of a research study.

“My feeling and the society’s feeling is we don’t have enough data yet to say 100% yes or no,” Benenati said. “But to basically condemn something because there isn’t good data at this time is premature — and not very scientifically sound, either. my own feeling is it is going to pan out to be something of great value.”

In the meantime, not everyone with MS seems willing to wait for the lengthy clinical trials to be completed. “We’re getting a huge number of calls on this,” Benenati said. “It can be overwhelming.”

Copyright © 2011 HealthDay. All rights reserved.

SOURCES: Michael Dake, M.D., professor, cardiothoracic surgery, Stanford University School of Medicine, Stanford, Calif.; James Benenati, M.D., medical director, peripheral vascular laboratory, Baptist Cardiac & Vascular Institute, Miami; Lily Jung, M.D., medical director, neurology clinic, Swedish Neuroscience Institute, Seattle; presentation, Jan. 17, 2011, International Symposium on Endovascular Therapy, Miami Beach