CTV.ca The Liberation Treatment: A whole new approach to MS

Updated: Sat. Nov. 21 2009 6:02 PM ET

Amid the centuries-old castles of the ancient city of Ferrara is a doctor who
has come upon an entirely new idea about how to treat multiple sclerosis, one
that may profoundly change the lives of patients.

Dr. Paolo Zamboni, a former vascular surgeon and professor at the University of
Ferrara in northern Italy, began asking questions about the debilitating
condition a decade ago, when his wife Elena, now 51, was diagnosed with MS.

Watching his wife Elena struggle with the fatigue, muscle weakness and visual
problems of MS led Zamboni to begin an intense personal search for the cause of
her disease. He found that scientists who had studied the brains of MS patients
had noticed higher levels of iron in their brain, not accounted for by age. The
iron deposits had a unique pattern, often forming in the core of the brain,
clustered around the veins that normally drain blood from the head. No one had
ever fully explained this phenomenon, considering the excess iron a toxic
byproduct of the MS itself.

Dr. Zamboni wondered if the iron came from blood improperly collecting in the
brain. Using Doppler ultrasound, he began examining the necks of MS patients
and made an extraordinary finding. Almost 100 per cent of the patients had a
narrowing, twisting or outright blockage of the veins that are supposed to
flush blood from the brain. He then checked these veins in healthy people, and
found none of these malformations. Nor did he find these blockages in those
with other neurological conditions.

"In my mind, this was unbelievable evidence that further study was necessary to
understand the link between venous function and iron deposits on the other,"
Zamboni told W5 from his research lab in Ferrara.

What was equally astounding, was that not only was the blood not flowing out of
the brain, it was "refluxing" reversing and flowing back upwards. Zamboni
believes that as the blood moves into the brain, pressure builds in the veins,
forcing blood into the brain's grey matter where it sets off a host of
reactions, possibly explaining the symptoms of MS.

"For me, it was really unbelievable to understand that iron deposits in MS were
exactly around the veins. So probably, it is a dysfunction of drainage of the
veins," Zamboni said.

"This is very important, because iron is very dangerous, because it produces
free radicals, and free radicals are killers for cells. So we need to eliminate
iron accumulation."

Zamboni dubbed the vein disorder he discovered CCSVI, or Chronic Cerebrospinal
Venous Insufficiency, and began publishing his preliminary research in
neurology journals.

He soon found that the severity of the vein blockages were located corresponded
to the severity of the patient's symptoms. Patients with only one vein blocked
usually had milder forms of the disease; those with two or more damaged veins
had more severe illness.

Zamboni found blockages not only in the veins in the neck directly beneath the
brain -- the jugular veins --but in a central drainage vein, the azygos vein,
which flushes blood down from the brain along the spine. Blockages here, he
found were associated with the most severe form of MS, primary progressive, in
which patients rapidly deteriorate. For this form of MS, there currently is no
effective treatment.

As for how these vein abnormalities form, Zamboni isn't sure. He believes,
though, that congenital defects, problems that likely formed before birth, can
be blamed for most of the problems, though this has not been conclusively
proven.

Most neurologists Zamboni initially approached with his findings dismissed
them. But one specialist, Dr. F. Salvi, at Bellaria Hospital in Bologna, was
intrigued by the concept. He began sending Zamboni MS patients for CCVIS
testing, to see if what he was finding was correct. The images of narrowed or
blocked veins, called "strictures," were irrefutable for Salvi.

Focus on a treatment

But Dr. Zamboni had an even more important idea. If key veins of MS patients
were blocked, perhaps he could open them and restore normal blood flow?

Taking a page from standard angiography, in which doctors use balloons to open
up blocked arteries that feed blood from the heart, he enlisted the help of
vascular surgeon Dr. R. Galeotti, also at the University of Ferrara and Santa
Anna Hospital. Three years ago, the team began a study in which they treated 65
MS patients to see if endovascular surgery would restore flow in these vessels
and lessen MS symptoms.

The study detailing those results will be published in the Journal of Vascular
Surgery on Nov. 24. But preliminary results, already released, show patients
had a decrease in the number of new MS attacks, a big reduction in the number
of brain lesions that define MS, and improved quality of life. The only time
symptoms returned for the patients was when the veins re-narrowed.

Because the surgery freed the blood flow, the team dubbed the procedure "The
Liberation Treatment."

Zamboni's sense is that the earlier patients are diagnosed and treated, the
more function they will preserve, and the less damage the improper blood flow
will do to the brain.

"Because MS is a progressive disease and strikes young people, if we lose time,
there are a lot of young people that will progress without possibility to get
back. This is very heavy for me," he says.

Zamboni has also been studying the prevalence of CCSVI with a team at the
University of Buffalo in New York, in collaboration with Dr. Robert Zivadinov.
That study, to be published in January, has looked at 16 MS patients, including
eight from the U.S and eight from Italy. All have been found to have blocked
veins of CCSVI, just as Zamboni described, and all eventually underwent the
Liberation Treatment.

Relief for patients

One of those patients was Buffalo resident Kevin Lipp. Lipp had MS for over a
decade, and as part of the study, discovered he had five blocked veins in his
neck. After undergoing the Liberation Treatment 10 months ago, he says he
hasn't had a single new MS attack.

Zamboni emphasizes that the Liberation Treatment does not make people in
wheelchairs walk again. Rather, it seems to stop the development of further MS
attacks, and in some cases, improves movement and decreases the debilitating
fatigue that are the hallmarks of MS.

The foundation that has sponsored Zamboni's research, the Hilarescere
Foundation, also urges cautious restraint.

"We can't give the illusion to patients that this is a guaranteed treatment and
it is easy. This is not right. And we have never done this," says Hilarescere
President Fabio Roversi-Monaco. "We don't say this is a cure for M.S. We only
say that research is advancing, and there is encouraging data but we are
waiting for more conclusions."

Dr. Zivadinov in Buffalo is now starting a new study, recruiting 1,600 adults
and 100 children, half of them MS patients. He plans to use ultrasound and MRI
scans to confirm if those with MS also have CCSVI and if their family members
have the abnormalities too.

Prof. Mark Haake, a neuro-imaging scientist at McMaster University and Wayne
State University in Detroit is also intrigued by Zamboni's findings. He has
long been seeing iron deposits in the brains of MS patients using a specialized
MRI analysis called SWI - specific weighted imaging. When he saw Zamboni's
initial publications, he immediately contacted the Italian doctor and began
collaborating.

Population studies under way

Haake too is initiating a study, asking neurological centres across North
America and Europe to take some extra MRI scans of the neck and upper chest of
MS patients. The scans can then be electronically sent to his research team for
analysis. He believes this grassroots approach could spur larger and more in
depth studies. He's hoping he can engage MS specialists and vascular surgeons,
interventional radiologist around the world to study the theory and then move
to diagnosing and treating MS patients quickly.

"I think patients do play a role, because there are millions and millions of
dollars donated to MS Societies and a lot of money set aside by the government
to study MS research and right now, 99.9 per cent of that money goes somewhere
else," he told W5.

"So the patients need to speak up and say 'We want something like this
investigated, at least at an early stage, to see if there is credence to this
theory.' Even if it is 10 or 20 per cent of these people who can be helped,
that needs to be investigated," says Haacke.

Haake's research is being done with no funding; he's unwilling to wait the nine
months to a year needed to get formal research funding applications approved.
Urgency, he says, is needed in finding the answer to the question of whether
Dr. Zamboni is right.

"Certainly, I continue my battle because I am fully convinced that this is the
right thing for the patient," he says.

The MS Societies of Canada and the U.S. are reticent to support Zamboni's
theories. They maintain that: "Based on results published about these findings
to date, there is not enough evidence to say that obstruction of veins causes
MS... It is still not clear whether relieving venous obstructions would be
beneficial."