Liberation or placebo effect? MS surgery

MONTREAL – Miracle cures are not a common occurrence but in the world of multiple sclerosis, the hopes of patients and their loved ones have never been as high as they are right now. The excitement stems from what is being touted as a circulation-improving surgical procedure that seems to promise remarkable results. With dramatic testimonials pitted against a skeptical scientific and regulatory community, the question is whether or not poor vein drainage from the head to the heart is a cause of MS and whether dilating the veins, known as "the liberation treatment," is helpful. We take a hard look at the evidence.

Tell me about multiple sclerosis

Multiple sclerosis is a degenerative neurological disease in which the body’s own immune system turns against itself, damaging the nerves of the brain and spinal cord. The exact cause is unknown; however, research suggests that environmental and genetic factors are at play. For instance, the disease is more prevalent in certain regions, namely Scandinavia, Scotland, northern Europe and Canada, while in the U.S., it occurs more commonly in whites than in other racial groups.

When MS strikes, the covering that protects the body’s nerves – known as the myelin sheath – erodes; and as the disease progresses the nerves may be destroyed. Multiple areas of scarring known as sclerosis, which are viewable on MRI imaging as plaques, can develop, causing the nerve signals between the brain and the rest of the body to slow down or even stop. These short-circuits are what cause the symptoms of MS.

The disease does not affect everyone in the same way, but common symptoms include numbness and fatigue, along with loss of vision, balance, speech and muscle control. The disease is unpredictable: intense flare-ups might be followed by remission. It usually hits between the ages of 20 and 40, and is more common in women than in men.

What are the various types of MS?

In one kind of MS, known as the relapsing-remitting variant, periods of bad symptoms are followed by remission. During relapse, a person will experience loss of function or even new symptoms, while in remission, these partially or fully disappear.

The most severe form of the disease is primary progressive, which causes gradual deterioration. People with secondary-progressive MS originally had the relapsing-remitting form but no longer have periods of remission.

How is MS treated?

Drugs known as disease-modifying therapies target the underlying cause of the disease by reducing the inflammation in the nervous system, which causes symptoms. And steroids are often used to shorten the duration of disease flare-ups.

What is the new theory about the cause of MS?

Going against long-held medical thought, Dr. Paolo Zamboni has postulated that MS stems from a narrowing or blockage in the veins that drain blood from the brain, known medically as CCSVI, or chronic cerebrospinal venous insufficiency. Zamboni thinks this impaired flow of blood from the brain builds up pressure, and that the resulting collection of blood may cause MS symptoms.

The study

Zamboni P, Galeotti R, Menegatti E, et al. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg 2009 Dec;50(6):1348-58.

What is our understanding of this treatment?

The research that has generated all this interest in a surgical approach to MS has been the unique product of an Italian research team. The first studies used an ultrasound test to show that while non-MS patients had normal circulation in their veins, all of the MS patients had blockages. Furthermore, their testing procedure was reported to be 100 per cent accurate in distinguishing MS from non-MS patients simply on the basis of measuring blood flow.

This led to the second phase of research, which asked if performing a dilation of these narrowed veins through percutaneous transluminal angioplasty, PTA, might improve MS symptoms. The results were impressive. Patients with relapsing-remitting MS experienced some impressive, though possibly not sustained, benefits from the treatment of their CCSVI.

How sound was this research?

Unfortunately, all of the Zamboni studies are severely limited, making it impossible to draw firm conclusions about the connections between blocked veins and MS and, in turn, the benefits of the procedure. The early ultrasound studies were problematic in that the findings have never been confirmed by other labs and it is unclear if the ultrasonographer was biased by knowledge of which of the patients being studied had MS.

The PTA work did not use a control group. As a result, it is likely – given what we know about the placebo effect in MS patients who enter studies of novel treatments – that all of the benefits were the result of the powerful belief in the treatment, rather than anything related to improved blood flow.

The supposed connection between CCSVI, if that condition actually exists, and MS, breaks down on a number of other fronts, including the fact that patients who have impaired blood flow in their veins as a result of surgeries, for example, don’t develop MS. Similarly, vessels tend to narrow as we age and yet MS is not a disease of older individuals. The blocked vein theory of MS is so out of keeping with our understanding of the disease that it might be compared to fixing a burned out car radiator by changing the tires of a car.

What’s next for research?

In order for a treatment to merit endorsement and funding by government agencies, it has to be proven safe and effective, and provide more benefit than just the psychological boost associated with the placebo effect of a highly touted procedure. If the connection between vein obstruction and MS is confirmed, double-blind studies will need to be conducted to tease out any real benefit to the course of the disease.

Conducting these studies will take time and create delays that will invariably be a source of frustration for hopeful MS sufferers and their loved ones.

Unfortunately, a rigorous scientific approach is the only way to ensure that a well-intentioned but likely ineffective treatment is not used to take advantage of a susceptible group of patients.

– The material provided in HealthWatch is designed for general educational purposes only and does not pertain to individual cases. The information included should not replace necessary medical consultations with your own doctor or medical professional.