New MS treatment highlights need for research

A promising experimental treatment for multiple sclerosis (MS) is drawing much attention around the world and highlighting the importance of efficient and thorough clinical research.

Dr. Paolo Zamboni in Italy began researching iron deposits known to accumulate in the brains of individuals with MS. Until fairly recently it was thought these deposits were an after effect of the disease, but because of the way the iron deposits were clustered around veins he hypothesized there was improper blood drainage through veins at the core of the brain.

Imaging showed nearly 100 percent of MS patients experienced narrowing, twisting or complete blockage of these veins. He discovered that not only was blood not draining properly, but it was reversing and re-entering the brain, where he believed it was causing many problems and symptoms of MS.

He also found that individuals with more than one vein blocked, or with greater degree of blockage, tended to have worse symptoms of MS than those with less vein restriction.

He called this condition chronic cerebrospinal venous insufficiency (CCSVI) and began publishing his findings.

Working on his theory that many of the symptoms of MS may be the result of CCSVI, Dr. Zamboni worked with a vascular surgeon to design a treatment similar to angiography used to clear blocked cardiac arteries. In this treatment for MS, doctors use balloons to open the blocked vessels and allow blood to flow freely out of the brain again.

Research in humans began a few years ago in Europe and was called the Liberation Treatment.

Initial study results seem promising and were published in the Journal of Vascular Surgery in November 2009. While it is not a curative treatment, the study found patients who receive it experienced a decrease in MS attacks, a reduction in brain lesions and improved quality of life. Based on this early success, Dr. Zamboni and colleagues believe the earlier patients are diagnosed and treated, the less damage will be done to the brain.

This makes an interesting story and is fairly typical of many discoveries in medicine. An initial observation, leading to a hypothesis that is then followed up by a treatment based on this hypothesis. Because the initial results have been so promising for an illness that is both severe and without current satisfactory treatment, there has been enormous worldwide interest and many people are ready to put up thousands of dollars and travel to Europe to have the treatment. In spite of these promising results, the research community has been trying to temper the initial enthusiasm with a dose of cautious realism. These findings may be supported by additional research but that research is necessary before this treatment is ready for prime time. Case reports, anecdotal reports of success and even small initial controlled studies are not sufficient to prove that a therapy is effective. Such preliminary findings, however promising, are very often overly optimistic when more study is done.

The desperation of those who see this as their only hope is potent fuel for the placebo effect. Even surgical treatments for severe illness are subject to placebo effects that have to be controlled for. In fact, surgical treatments have the very strongest placebo effects. These are sometimes controlled for with sham operations, where an incision is made but nothing else is done. There are many examples of sham operations producing rather impressive results.

These initial reports about the Liberation Treatment for MS make a good case for additional controlled studies for which volunteers will be required. Results to date are not sufficient to warrant widespread adoption without additional research. This is a very good example of just how important clinical trials are and why participation in them is so important. Should the research prove the treatment's safety and effectiveness, it could be fully funded and available to MS patients in Canada, so the sooner we get the ball rolling, the better it will be for the many people living with this disease already.

 

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