(RxWiki News) The U.S. Food and Drug Administration (FDA) is warning of possible risks associated with liberation therapy, an unproven multiple sclerosis (MS) treatment.
Liberation therapy is used to treat chronic cerebrospinal venous insufficiency (CCSVI), a disorder that some suspect is a contributing factor in the development of MS. The FDA issued an alert upon learning of both damaging and fatal results from the non-FDA-approved treatment.
"Exercise caution when considering unproven treatments."
CCSVI is a condition characterized by the narrowing of veins in the neck and chest. This narrowing makes it more difficult for blood to drain from the brain and upper spinal cord back to the heart. Although studies linking MS to CCSVI have proven inconclusive, some researchers believe CCSVI causes or contributes to MS.
The underlying cause of MS is unknown. MS is a progressive, immune-mediated disorder in which the brain and spinal cord nerve fibers and nerve fiber lining are injured.
The damage results in disruption of nerve signals and creates major and immobilizing neurological symptoms.
In liberation treatment, balloon angioplasty devices or stents widen the narrowed veins. Devices and stents have not been approved by the FDA to treat CCSVI.
The FDA has received reports of death, stroke, detachment and movement of the stents, damage to treated veins, blood clots, cranial nerve damage, and abdominal bleeding resulting from the treatment.
"Patients should realize that in order to be demonstrated to be effective, treatments must be subjected to several randomized clinical trials." says Nancy D. Chiaravalloti, PhD, Director of Neuropsychology & Neuroscience Research at Kessler Foundation. "These research studies provide the most solid scientific evidence supporting or refuting the efficacy of a given treatment. Particularly in treatment such as this, where the risks are considerable, the treatment must have solid research data supporting its potential effectiveness."
The FDA issued a warning letter in February to a group conducting a study of liberation therapy without the proper approval. The researchers voluntarily ended their study.
The FDA encourages anyone experiencing complications from CCSVI treatment to report to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
