CCSVI: Part 1
How an Italian vascular surgeon created a media and scientific firestorm.
In 2009, an Italian vascular surgeon, Paolo Zamboni, created a media and scientific firestorm when he proposed that the primary cause of MS was disordered venous drainage. He identified five patterns of venous obstruction in patients with MS using ultrasound as a diagnostic tool. He reported results that would be amazing for any medical study: 100 percent of patients with MS were found to have venous drainage insufficiency on at least two of the five parameters he identified, a condition he termed “Chronic Cerebrospinal Venous Insufficiency (CCSVI).” In contrast, zero percent of healthy controls were found to have these venous abnormalities. By extension, he also proposed that the treatment for MS was an interventional procedure to relieve these obstructions—a procedure he flamboyantly referred to as “The Liberation Procedure.”
Dr. Zamboni’s publication set off a frenzy of debate and controversy, with some people hailing it as the cure for MS, while others dismissed his results almost immediately. The topic became very popular in social media and “non-believers” were often subject to vigorous criticisms.
These initial studies suffered from several problems (which Dr. Zamboni recognized and absolutely acknowledged). The biggest of these is that his studies were not blinded. This means that the evaluating ultrasound technician knew whether they were evaluating patients with MS or healthy controls. It also meant that the patients who received the liberation procedure knew they were getting the treatment. In blinded studies of similar procedures, study subjects receive either the proposed treatment or a sham treatment, and they, as well as the study investigators, are unaware of which they receive until the conclusion of the trial.
If study investigators or subjects are aware of which treatment is being given, there is a possibility that human psychology will interfere and a response to a treatment will be seen, simply because everyone wants or expects this to be the case. For this reason, the most valid scientific studies are referred to as double blinded studies. This is supposed to remove the powerful element of human psychology from studies and allows the medication and/or procedure to be independently evaluated. I have met some patients who reported near immediate relief of symptoms they had for many decades after getting the Liberation Procedure. While it is always nice to hear that people are feeling better, the nature of the lesions that cause MS make it difficult to imagine any procedure that could reverse years of neurological damage.
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