CCSVI in multiple sclerosis: is it the end?

DEAR EDITOR,

Eight years ago, Paolo Zamboni, an Italian vascular surgeon, created a firestorm in the MS community with his hypothesis that MS, believed to be an autoimmune disease, could have a vascular connection. His research has shown that patients with MS had restricted venous flow from the brain and spinal cord, a condition he named chronic cerebrospinal venous insufficiency (CCSVI). His small observational study (65 patients assessed) demonstrated that PTA of venous strictures in patients with CCSVI is safe and, especially in patients with relapsing-remitting course of the disease, positively influenced the clinical status and quality of life of MS patients [2].
Zamboni’s theory propelled wide-ranging research and the creation of a multidisciplinary society: the International Society for Neurovascular Disease to promote research on neurovascular pathologies. However, a study conducted by neurologists did not demonstrate association of CCSVI with MS [5].
MS neurologists, official gatekeepers of the disease, dismissed and even mocked Zamboni’s theory and the scientific integrity of his research. Nonetheless, thousands of Italians with MS (the incidence of MS in Italy is high) spurred by anecdotal reports of improvements spread on social media, sought such a treatment. Many patients with MS who did not improve after standard pharmacological treatment or presented with contraindications for such a therapy, were at least interested in relieving symptoms of MS or improving quality of life. They also demanded that venoplasty for MS should be covered by the Italian healthcare system, as it is for other vascular pathologies. Reported responses to CCSVI treatment were as varied as the MS population itself – some patients experienced lasting benefits in terms of renewed energy, better balance, and improved bladder control [3]. In others, early improvements vanished with time, while some patients did not improve, or even experienced complications. There were three fatalities associated with this treatment reported in the literature [4]
MS patients called for a randomised double-blinded placebo-controlled trial performed in a similar manner to those aimed at testing new drugs. Recently a long-awaited Italian clinical trial investigating the safety and efficacy of venous percutaneous transluminal angioplasty (PTA) for the treatment of patients with multiple sclerosis (MS) has been published. Zamboni was principal...


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