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Liberation Therapy: Hype or Hope?

New MS treatment

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Liberation Therapy: Hype or Hope?

A controversial new procedure is giving those with MS hope. Debates are raging whether percutaneous transluminal angioplasty, or liberation therapy, is helpful.

A controversial new procedure is giving those with multiple sclerosis (MS) new hope. Government, health agencies, and health providers, however, are debating whether percutaneous transluminal angioplasty (PTA) is truly helpful. At present they can’t even agree about funding for research into the procedure that has been dubbed “liberation therapy.”

PTA is much like conventional angiography, in which a catheter is fed into the venous system to detect blockages. In PTA the catheter reaches the narrowed blood vessels, usually the internal jugular and azygous veins, and a tiny balloon is inflated to widen the diameter of the veins, allowing better blood flow.

This “liberation” of blood flow is where the treatment gets its name, though it’s often thought to refer to liberation from symptoms or from the disease itself.

Because the treatment is unavailable in this country, many Canadians with MS are funding their own overseas trips to get it. While there is some early evidence that PTA is effective, it’s the hope of a cure—or even just improved ability to function—that is leading MS sufferers to lobby for access to the treatment on home ground.

Promising study

PTA was developed by Italian vascular surgeon Paolo Zamboni, who published his study in the December 2009 Journal of Vascular Surgery. He performed the procedure on 65 patients, all of whom had chronic cerebrospinal venous insufficiency (CCSVI), narrowing of the blood vessels that drain the head, a condition that can be present in MS.

Zamboni reasoned that the body compensates for CCSVI by developing an alternate network of leaky blood vessels. The result, he believes, is a buildup of iron in the brain, triggering an immune response that destroys healthy tissue.

Study subjects who had the relapsing and remitting type of MS showed improved physical performance and better quality of life measures. His results were not as positive for those with the steadily progressing type of MS.

Scientists not convinced

Many in the scientific community are advising a cautious approach to liberation therapy. Some point to flaws in Zamboni’s study. First, his study sample was small; second, it was an open-label study, meaning subjects knew they were getting the treatment, as did those who administered it. This method is less reliable than a double-blind study because it does not eliminate the power of suggestion.

A study published in Annals of Neurology (2010) examined a group of 76 subjects, 56 with MS and 20 without. It found that only one subject with MS showed signs of narrowed cerebral blood vessels.

“Our results challenge the hypothesis that cerebral venous congestion plays a significant role in the pathogenesis of MS,” concluded researchers. This study, like Zamboni’s, also used a small study group.

Last August the Canadian Institutes of Health Research (CIHR) convened a meeting of top medical MS authorities from around the world to weigh the evidence on the procedure. In a press release, CIHR president Dr. Alain Beaudet announced the group’s conclusion that it is too early to recommend Canadian studies on the treatment.

“There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is any link between blocked veins and MS,” stated Beaudet.

Government bickering

Enormous demand for PTA is putting pressure on government and health agencies that are divided over whether to begin funding research into the procedure. Last summer, Liberal MP Dr. Kirsty Duncan addressed a letter to the federal health minister asking for immediate research into the effectiveness of PTA.

“We believe there is a moral obligation to offer clinical trials to MS patients so that they have access to the imaging necessary to identify a venous malformation and access to the treatment that could possibly stop the progression of their disease in its tracks,” wrote Duncan.

Federal health minister Leona Aglukkaq declined the request, stating her government had decided not to fund research based on the CIHR’s recommendations.

Despite the thumbs down given by the CIHR and the federal government, the Saskatchewan provincial government has indicated a willingness to fund research into the treatment.

Last September the provincial government of Newfoundland and Labrador announced they will fund a study to follow outcomes of patients who travel outside Canada for the treatment.

Living with MS

Kerry Smith knows the reality of life with MS. The 49-year-old artist, writer, and stay-at-home father has been dealing with the disease since 1993. It started with the loss of vision in one eye, and while his sight returned gradually over the following year, Smith has been plagued with relapses that leave him with severe fatigue and dizziness.

Over the years, Smith declined conventional drugs and treatment, choosing instead to follow therapies that he researched on his own. For example, when vision problems returned, he chose a “massive intake” of beet and carrot juice as well as grapeseed extract. He also sought the care of a homeopathic doctor and practised regular meditation.

He dealt with his constant dizziness by following the spiritual practice of whirling dervishes, as described by philosopher Joseph Campbell. Smith rationalized, “I can’t ride my bike; I’m having difficulty walking. I thought I better get used to being dizzy, so I started spinning twice a day. It made it easier to navigate and do things, and I was actually able to start riding my bicycle again.”

But in May 2009 Smith was experiencing a relapse with crushing fatigue that didn’t seem to be abating. Then he heard about Zamboni’s procedure. “I got very, very excited because, finally, something made sense to me.”

In June 2010, after attempts to obtain the treatment in Canada, Smith made the trip to Poland. The procedure, which took about 50 minutes, resulted in immediate improvement. “I had almost 100 percent relief. I felt brilliant,” says Smith.

The following day, while sightseeing, he ran to catch up with one of his fellow travellers. “I realized that I’d just run 100 metres at top speed and that I could run another 500 metres easily. It made a huge, huge difference.”

For Smith, the effects of the treatment have not lasted and he plans to return to Poland for another treatment. He remains positive about the procedure, though he doesn’t see it as a cure. “I would endorse the treatment because what it does, if nothing else, is it gives people hope. It gave me a great deal of hope.”

Continued study needed

The MS Society of Canada seems to be walking the line between endorsing the treatment and rejecting it. In a public message dated September 10, 2010, president and CEO Yves Savoie addressed “what has been perceived to be the MS Society of Canada’s negative stance on CCSVI.”

He noted that the MS Society of Canada, in partnership with the US National MS Society, has put $2.4 million toward studies into the subject.  Zamboni himself, speaking at an MS conference in Sweden, said the treatment should only be performed in the context of a clinical trial and that he does not support "medical tourism."

With online petitions, chat groups, and blogs many Canadians continue to call for immediate access to PTA. However, the wheels of government are turning slowly and cautiously. It remains to be seen whether the treatment is too good to be true, or whether it is one way to provide better quality of life to people with MS.

MS in brief

Multiple sclerosis is a chronic disease that affects the nervous system. Although what exactly causes it is not known, it’s thought to be an autoimmune disease. Heredity appears to play a role in some cases, since it has a 15 percent higher incidence in those with a close relative who has MS.

MS occurs most often in young adults ages 20 to 40, and is more common in people who have spent their early years in a cold climate. There is some speculation that vitamin D offers protection against the disease, increasing the risk for those in less sunny areas.

Another theory blames some sort of viral trigger such as Epstein-Barr. A study published in Current Neurology and Neuroscience Reports found that 99 percent of those with MS tested positive for the Epstein-Barr virus.

MS causes nerve cells to lose their protective cover, called myelin, interfering with their ability to transmit messages. The result is a constellation of symptoms including muscle weakness, fatigue, loss of vision, and odd sensations—prickling, burning, creeping, for example—in the face, limbs, or trunk.

Like other chronic degenerative diseases, MS can range in severity from mild impairment to inability to control basic physical functions. In some cases the disease comes and goes in what can be extremely debilitating flare-ups; in other cases, there can be a gradual, steady decline in ability to function. Factors such as stress, infection, and postpartum can trigger
a relapse.

Up until now, treatment for MS has consisted of medications to suppress the immune system, to reduce muscle spasms, and to treat symptoms such as fatigue and depression.

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