Still No Evidence for Effectiveness of ‘Liberation Therapy' for Multiple Sclerosis

Liberation therapy for multiple sclerosis (MS) is an experimental procedure designed to treat chronic cerebrospinal venous insufficiency (CCVI), an unproven theory that claims that narrowing of veins in the neck and chest may cause MS or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord.

To reduce or reverse the effects of the damage caused by narrow veins, liberation therapy involves the use of balloon angioplasty devices or stents to widen narrowed veins in the chest and neck.

Nearly a year ago, the FDA issued a statement warning patients and providers about the potential dangers of unproven treatments for multiple sclerosis, especially the risk of “injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency.”

Specifically, the FDA warned that “death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding” have been associated with the use of liberation therapy, and reminded patients and providers that “angioplasty devices and stents have not been approved by the FDA” for use in treating CCVI.

The lack of reliable evidence of efficacy for liberation therapy (also known as percutaneous transluminal venous angioplasty) — or even lack of evidence that CCVI is a contributing factor in MS – has not prevented the procedure from being used in thousands of patients. A recent article in the National Post noted that leading proponent of liberation therapy, an Italian vascular surgeon named Paolo Zamboni, “published anecdotal results from a small number of patients in an obscure journal in which he claimed improvements when these veins were dilated, and in some cases, kept open with surgical stents.” Despite the paucity of evidence, the article stated that “it is estimated that over 20,000 patients with MS have now undergone this procedure in more than 30 countries.”

No symptom improvement from surgical technique

There continues to be little to no evidence supporting the use of CCVI for patients with MS. A recent clinical trial conducted by SUNY-Buffalo researchers to evaluate “the safety and efficacy of interventional endovascular therapy on the symptoms and progression of multiple sclerosis,” found that liberation therapy does not improve outcomes in patients with MS and can in fact worsen symptoms in some patients.

According to a news release from SUNY-Buffalo, the study’s authors concluded that “while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients.” Based on these results, the authors do not endorse the use of CCVI in the clinical setting and recommend that “endovascular treatment for chronic cerebrospinal venous insufficiency… should only be done in the context of randomized, double-blinded, controlled studies.”

Robert Zivadinov, MD, PhD, FAAN, UB professor of neurology, director of the Buffalo Neuroimaging Analysis Center (BNAC), said that previous studies conducted by university researchers have indicated that CCVI “is more prevalent in MS patients than in healthy controls but the cause or consequence of these venous abnormalities has not been established.”

In this video from SUNY-Buffalo, Zivadinov and colleagues discuss the CCVI and the results of the Prospective Randomized Endovascular Therapy in MS (PREMiSe) trial:

The SUNY-Buffalo researchers presented these findings at the 2013 AAN annual meeting. They reported that patients with MS treated with percutaneous transluminal venous angioplasty experienced more relapses of their disease, increased disease activity as measured by MRI, and more new T2 lesions, compared with patients who received sham treatment.

Zivadinov told Clinical Neurology News that “When you reopened those veins in the neck, I think something happened in reperfusing the brain and re-exacerbating disease activity. The message of this is clear. The majority of patients who are relapsing-remitting should not undergo this treatment.”