To perform a clinical trial of angioplasty for CCSVI in patients with MS, researchers must first demonstrate that patients with MS have an increased risk of CCSVI, compared with normal controls or patients with other neurologic diseases. Dr. Comi’s study, however, found no difference among the three patient groups. “If we … decide to operate for this condition, then we should theoretically operate also on the normal controls,” said Dr. Comi.
“There is no rationale for a trial exploring the efficacy of the liberation therapy,” and a randomized trial of an endovascular procedure in patients with MS would be unethical, Dr. Comi commented. “The risk to treat patients is that the adverse effect of the intervention would overcome all the potential advantages,” he concluded.
—Erik Greb