Liberation therapy risks: The United States Food and Drug Administration (FDA) has issued an alert about the use of balloon venoplasty as a treatment for multiple sclerosis (MS). Patients subject to the unproven procedure, also known as “liberation therapy,” to treat so-called chronic cerebrospinal venous insufficiency (CCSVI) are at risk because: “There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS. Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.

The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.

There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients. It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant”

(www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm).

Less than a year after concluding that Italian physician Dr. Paolo Zamboni’s controversial liberation therapy lacked scientific validity and posed risks to patients (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-3665), the Canadian Institutes of Health Research reversed its position and lined-up squarely behind the federal government’s decision to fund CCSVI clinical trials (www.cmaj.ca/lookup/doi/10.1503/cmaj.109-3960).

— Michael Monette, CMAJ

http://www.cmaj.ca/content/184/9/E481.short