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Intervention Studies 2014 B. Therapy Trials Need to Wait. The Landscape has Changed

Kottil W. Rammohan, M.D.

Background: Numerous open label and few blinded studies have been reported on the “liberation” therapy since the original description of the disorder by Dr. Paolo Zamboni in 2008. Although most of these trials report no benefit for this endovascular intervention, Over 30,000 patients with various types and stages of multiple sclerosis (MS) have received the treatment most of them in open label fee-for- service setting. Patients continue to embrace this therapy at considerable cost, often forgoing proven therapies. The disorder has a “cult” following both amongst patients as well as the scientific community. The value of the intervention is yet to be defined and there are no convincing studies that have established value. It is time to step back and examine the real value of this intervention.

Discussion: Sadly, a recent review by the prestigious Cochrane Reviews group identified “no studies that matched the criteria for methodological quality necessary for inclusion in a review. They concluded that there is no evidence to support or refute the efficacy of angioplasty as treatment for CCSVI. Further, they concluded that “well designed and robust studies are warranted”. It is time to pause and examine current evidence and learn past trials. It is time to examine in an unbiased fashion the value of this treatment. It is time to endorse or refute the treatment based on sound clinical trials that can withstand the scrutiny of accepted methodological standards.
The current landscape and the future of this treatment will be discussed in the setting of the ideal clinical trial for this disorder.