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
percent 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
percent 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 percent 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."
More information
The National Multiple Sclerosis Society has more on
CCSVI.