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Wednesday, June 27, 2012 1:21 AM | Ken Torbert Volg link

The US Food and Drug Administration (FDA) is warning patients and physicians that a controversial experimental procedure for treating multiple sclerosis (MS) has been associated with serious injuries and deaths. Moreover, the agency notes that the benefits of the procedure have not been proven.



Medical News and Perspectives |

FDA Warns About the Risks of Unproven Surgical Therapy for Multiple Sclerosis


Bridget M. Kuehn

JAMA. 2012;307(24):2575-2576. doi:10.1001/jama.2012.6399

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The US Food and Drug Administration (FDA) is warning patients and physicians that a controversial experimental procedure for treating multiple sclerosis (MS) has been associated with serious injuries and deaths. Moreover, the agency notes that the benefits of the procedure have not been proven.





Image not available.


Some patients with multiple sclerosis, a disorder that causes demyelination (shown here), are turning to an unproven surgical treatment that is associated with serious risks, according to US health authorities.





The so-called liberation procedure uses balloon angioplasty or stenting to widen blood vessels that drain the brain and spinal cord. Its use in MS is based on a theory advanced in 2009 by Paolo Zamboni, MD, of the University of Ferrara in Italy. Using evidence from imaging to support his claim, Zamboni argued that patients with MS may have chronic cerebrospinal venous insufficiency (CCSVI), which leads to iron buildup in the central nervous system and an immune or inflammatory reaction (Singh AV and Zamboni P. J Cereb Blood Flow Metab. 2009;29[12]:1867-1878). But subsequent studies have produced conflicting findings, with several groups reporting they were unable to replicate the findings of Zamboni and his colleagues. Meanwhile, others have questioned the biological plausibility of the theory.




A recent review of the evidence on CCSVI and MS concluded that the CCSVI theory isn't consistent with the evidence and that surgical procedures intended to fix this problem shouldn't be undertaken outside a clinical trial (Awad AM et al. Ther Adv Neurol Disord. 2011;4[4]:231-235). The review noted that various biological assays have not consistently detected CCSVI in patients and that there is no histopathological evidence of venous abnormalities in patients with MS.




“We couldn't find a strong biological rationale to associate CCSVI with MS,” said one of the review's coauthors, Olaf Stüve, MD, section chief of neurology at the Dallas Department of Veterans Affairs (VA) Medical Center and associate professor at the University of Texas (UT) Southwestern Medical Center in Dallas, in an interview.


http://jama.jamanetwork.com/article.aspx?articleid=1199148#.T-pBM_0hAxp.facebook