He called for a prospective randomised controlled trial, performed by unbiased physicians with one sham arm (with percutaneous transluminal angioplasty for the subclavian vein) which would have independent blinded follow-up in order to settle the issue.
Dr. Reekers suggests an unbiased physician but would that be akin to an inexperienced physician? I have heard several CCSVI IRs discuss that there is a learning curve to CCSVI. He also suggests unwarranted subclavian vein angioplasty for the sham arm. There is a possibility of harm there for that sham group. If a subclavian vein is damaged, it might reroute via collaterals to the internal jugular vein, further reducing the MS patient's cerebrospinal drainage.
Dr. Siskin wrote:He also argued that “I do not remember any of the pioneers of many of our other procedures waiting until all the questions were answered before performing procedures such as subintimal angioplasty, chemoembolization, radioembolization and uterine fibroid embolization on patients.” He told delegates that his group was currently enrolling into a prospective randomised, blinded trial to evaluate angioplasty as a treatment for CCSVI in multiple sclerosis patients. “I am aware of several other trials getting underway,” he noted.
Gary Siskin told Interventional News: “Interventional radiology has achieved its success as a specialty by constantly looking for new solutions to old problems, and this newly described entity is just another example of that. Many prominent members of our specialty have found preliminary success with treating this condition, which has provided the basis and impetus for further research. The difficulty in finding objective parameters of success and the possibility of discovering that angioplasty is not bringing about the success that patients are looking for should not stop our specialty from performing well designed clinical trials to answer this question. Patients suffering with multiple sclerosis deserve this.”
nicely said, Dr. Siskin!