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Monday, November 14, 2011 11:50 PM | CCSVI in Multiple Sclerosis Volg link

Dr. Zamboni is the feature of a new book, "Sogni Corragiosi"  (Bravest Dreams) published in Italy by Mondadori.  (I will let you know when/if the English version is available).  Written by reporter Marco Marozzi of La Repubblica.  Here is a google translation of a feature article in the Friday edition of The Republic Magazine.  It tells the story of how Dr. Zamboni began his ground-breaking work.

http://www.ccsvi-sm.org/?q=node%2F1124

Il Venerdì di Repubblica

The challenge of the Italian surgeon who dreams of beating multiple sclerosis

by Alex Saragosa

A surgeon was struck by a neurological disease, which makes it difficult to work. While fighting his illness, his wife falls victim to a disease similar to his. His life seems destroyed, but the man did not give up, studied, experimented and finally, between the skepticism of many, identifies a possible treatment for his wife. The real story is the story, extraordinary, the "Zamboni cure" is told by journalist Marco Marozzi  of the Republic  in the book Brave Dreams (Penguin, pp. 336, Euro 18). "I heard about the care of friends, affected by the disease," said Marozzi. "But I decided to write because, following the story, I was surprised to encounter the difficulties that those who find a new method to see their efforts recognized by the medical powers.

It all starts in the nineties, when the vascular surgeon Paolo Zamboni of the University of Ferrara, then working in Sassari, is suffering from a rare neurological disorder that makes it difficult to move and his wife is diagnosed with multiple sclerosis, a disease that affects three million people in world and 58 000 in Italy. Zamboni is able to control his illness, and devoted himself to that of his wife. Multiple Sclerosis can manifest itself with very different symptoms - from blindness to chronic fatigue, loss of balance to paralysis - acute and alternate periods of months or years of remission. Approximately 30-40 percent of cases, progresses to disability.

It is believed that multiple sclerosis is an autoimmune disease that is caused by an attack of lymphocytes to the brain tissue, mistaken for invaders. So is treated with drugs that reduce the aggressiveness of the immune system. These, however, can only alleviate the symptoms and slow the progression of the disease, but do not cure it.

Zamboni discovered that several researchers have speculated in the past a role in multiple sclerosis, defects in the venous circulation that drains blood from the brain. As of 2005, with the use of Doppler ultrasound,  he scanned dozens of sick and discovered that more than half had defects in blood flow through the veins of the neck. In 2007, 65 selected patients, had narrow blood vessels dilated, using a balloon catheter. The intervention is successful in 44 cases and thirty have a rapid improvement. The book cites many examples Marozzi. Noam Hirsch, of Bologna, summarizes his rebirth: "The beast has been stopped."

The treatment, which must be repeated because the veins tend to close again, appears to reduce symptoms, ward off relapses and slow down the deterioration. "My guess," said Zamboni "is that the chronic cerebrospinal venous insufficiency, or CCSVI, increases blood from pooling in the brain, causing microhemorrhages, and that they are to cause the symptoms of multiple sclerosis. This is not the  sole cause of the disease, but I think it is often an important factor.

In 2009, the surgeon is called in the U.S., where they begin testing, while countries such as Serbia, Jordan and Kuwait are beginning to offer therapy in hospitals. And so do private clinics all over the world, including Italy (costs from 4 to 20 000 euros). The Italian public health, however, choose to wait. On June 8, 2010 the Board of Health states: "To date the effectiveness of any therapeutic procedure is certainly not proven vascular." In practice, because the health service will provide an intervention must be first demonstrated the correlation between cerebrospinal venous insufficiency and multiple sclerosis. This causes the uprising of thousands of patients.

"I understand them," says Professor Mario Battaglia, president of the IMF, the Foundation has since 1998 supported the AISM, Italian Multiple Sclerosis Association, "but just in the interests of patients we must be cautious. Multiple sclerosis, for the complex nature symptoms, is very subject to the placebo effect. And do not forget that almost all patients operated on have continued to take prescribed medication: to be assessed if the improvements are derived from either therapy. " The operation of expansion is not a panacea (about one third do not experience improvements) and is not without risks, especially if, to keep open the veins, using bare-metal stents, which may break or cause thrombosis: two operated on died from it and others have risked their lives.

"I am very conscious of the placebo effect" Zamboni says, "so I posted on my office just two years after surgery on patients, I wanted to be sure that the results were lasting. Dilatation of the veins, if done properly and without using stents, has almost no side effects. Of low efficiency, and with many side effects,  are rather the drugs now used for multiple sclerosis.

On the correlation between CCSVI and multiple sclerosis have come out in the meantime dozens of studies. With very different results: some deny the relationship, while others confirm the 80 percent (study of 710 Italian-Canadian patients, coordinated by the neuroradiologist Stefano Bastianello, University of Pavia). An analysis of data obtained from the eight best studies came to the conclusion that the CCSVI is 13.5 times more common in MS patients than in healthy people. But IMF and Aism say this is not enough: "The methodologies used do not allow to reach a firm conclusion," says Gianluigi Mancardi, professor of neurology at the University of Genoa. "Therefore Aism and its foundation are in the process of the COSMOS study, a correlation study on a sample of two thousand people, composed of multiple sclerosis and other neuropathologies and healthy people. The method used is the most rigorous, the double-blind, that is, who evaluates the tests do not come from those who know the ultrasound images. We have trained thirty workers, supervised by three experts in the highest level. The results, scheduled for next summer, will make us understand the extent to CCSVI and multiple sclerosis are related 

So the COSMO study will be the final word ? Zamboni, who initially worked on the project, then abandoned it,  saying that his methodological instructions were not considered. To complicate matters, Giancarlo Comi, a neurologist at San Raffaele in Milan, one of the most critical of researchers Zamboni, gave early results of his study in October at ECTRIMS,  stating that the examination of the first third of the sample of COSMO showed positive results of CCSVI in less than 10 percent of MS cases. "Anticipating the results of a study is incorrect" stated Zamboni "because it affects the rest."

But how is it that scientific research leads to results which are so discordant? "Unlike the arteries," explains Dr. Robert Catalini, president of the Italian Society of Ultrasound Vascular Ultrasound, "the venous Doppler ultrasound is used little and has no standard procedures, except those designed by Zamboni. It is a difficult test. The veins are smaller and more irregular than arteries, the results vary even if the person has been drinking recently, and depend on its location, how they breathe. I made a hundred tests and, in fact, I saw many possible venous malformations. But it was hard to tell if it really affects the circulation, because, if a vein is narrow, usually the blood passes by a collateral vein. In short, the results depend on the interpretation of who performs the tests. 

Zamboni, meanwhile, has started to recruit patients for a research study, called Brave Dreams, hence the title of the book by Marozzi, conducted with the help of Emilia Romagna. The surgeon will treat about three quarters of 700 patients with multiple sclerosis and CCSVI, while the rest will suffer only a mock dilation treatment, to evaluate the placebo effect. Patients will be followed for one year. "It takes two milia euros, but if all goes as we hope, by 2013-2014, we have final results." 

  • Title: Sogni coraggiosi
  • Author: Marco Marozzi
  • Edition: Mondadori
  • Collana: Ingrandimenti
  • Date of publication: Giugno 2011
  • ISBN: 8804614307
  • ISBN-13: 9788804614302
  • Pages 200
  • Price 18 euro