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Wednesday, March 28, 2012 10:16 PM | Ken Torbert Volg link

28th March 2012 - A procedure to treat a condition called CCSVI in people with multiple sclerosis (MS) should only be carried out as part of clinical trials, according to the National Institute for Health and Clinical Excellence (NICE).


The decision has been welcomed by an MS charity and the doctor behind the first CCSVI procedures carried out in the UK.


Evidence review


The surgical technique, called percutaneous venoplasty, aims to improve blood flow from the brain by using inflatable balloons to widen narrow veins in the neck. This can improve the drainage of oxygen-depleted blood from the brain. It has been suggested that there could be a link between these narrowed veins (called chronic cerebrospinal venous insufficiency, or CCSVI) and the progression of MS.


The link between CCSVI and MS was first put forward by an Italian doctor called Paolo Zamboni whose wife had MS. He suggested that MS can be caused by blockages in the veins draining blood from the brain and that, by clearing these blockages, symptoms of the disease could be eased.


In the latest research on the effectiveness of the procedure reported to the Society of Interventional Radiology in the US this week, researchers found it can "produce significant, short-term improvement in physical and mental health."


However, the researchers from the Albany Medical Center in the US found the procedure was less effective in secondary progressive MS than primary progressive and relapsing-remitting MS.


They say more research is needed to "rigorously evaluate" CCSVI treatment and which patients it may benefit.


NICE says it is uncertain how many people with MS have CCSVI compared with the general population. It is also unclear what the link is between CCSVI and MS.


NICE also says several of the studies it reviewed did not report how well the procedure worked.


NICE CCSVI final guidance


NICE says more evidence is needed on the safety of the procedure and the impact on quality of life in the long term.


In a statement, Professor Bruce Campbell, chair of the independent committee that develops NICE’s interventional procedures guidance says: "Multiple sclerosis can be a distressing and disabling condition with a lack of effective treatments. This means that it is really important to find out whether percutaneous venoplasty is clinically effective and safe for use in the NHS. Based on the existing evidence, we believe that clinicians should only consider offering percutaneous venoplasty as a treatment option for people with MS who fit the diagnostic criteria for CCSVI, as part of structured clinical trials.


"This is so that we can learn more about whether venoplasty works and if so for how long. Further research could also investigate the relationship between MS and CCSVI, as this is very unclear at present."



More:


28th March 2012 - A procedure to treat a condition called CCSVI in people with multiple sclerosis (MS) should only be carried out as part of clinical trials, according to the National Institute for Health and Clinical Excellence (NICE).


The decision has been welcomed by an MS charity and the doctor behind the first CCSVI procedures carried out in the UK.


Evidence review


The surgical technique, called percutaneous venoplasty, aims to improve blood flow from the brain by using inflatable balloons to widen narrow veins in the neck. This can improve the drainage of oxygen-depleted blood from the brain. It has been suggested that there could be a link between these narrowed veins (called chronic cerebrospinal venous insufficiency, or CCSVI) and the progression of MS.


The link between CCSVI and MS was first put forward by an Italian doctor called Paolo Zamboni whose wife had MS. He suggested that MS can be caused by blockages in the veins draining blood from the brain and that, by clearing these blockages, symptoms of the disease could be eased.


In the latest research on the effectiveness of the procedure reported to the Society of Interventional Radiology in the US this week, researchers found it can "produce significant, short-term improvement in physical and mental health."


However, the researchers from the Albany Medical Center in the US found the procedure was less effective in secondary progressive MS than primary progressive and relapsing-remitting MS.


They say more research is needed to "rigorously evaluate" CCSVI treatment and which patients it may benefit.


NICE says it is uncertain how many people with MS have CCSVI compared with the general population. It is also unclear what the link is between CCSVI and MS.


NICE also says several of the studies it reviewed did not report how well the procedure worked.


NICE CCSVI final guidance


NICE says more evidence is needed on the safety of the procedure and the impact on quality of life in the long term.


In a statement, Professor Bruce Campbell, chair of the independent committee that develops NICE’s interventional procedures guidance says: "Multiple sclerosis can be a distressing and disabling condition with a lack of effective treatments. This means that it is really important to find out whether percutaneous venoplasty is clinically effective and safe for use in the NHS. Based on the existing evidence, we believe that clinicians should only consider offering percutaneous venoplasty as a treatment option for people with MS who fit the diagnostic criteria for CCSVI, as part of structured clinical trials.


"This is so that we can learn more about whether venoplasty works and if so for how long. Further research could also investigate the relationship between MS and CCSVI, as this is very unclear at present."



http://www.webmd.boots.com/news/20120328/nice-more-research-needed-on-ccsvi-for-ms