At last, researchers have found the truth about using angioplasty to treat CCSVI in people with multiple sclerosis. They have found it is not effective and say it is not recommended.
The research team included Dr Paolo Zambini, the doctor who first proposed there was a link but now accepts that he was mistaken.
CCSVI, or chronic cerebrospinal venous insufficiency to give its full name, is characterized by restricted venous outflow from the brain and spinal cord. Its treatment, by venous percutaneous transluminal angioplasty (PTA). This uses balloons to enlarge veins so that more blood flows out of the brain and spinal cord, and so restore normal blood flow.
However, it has been controversial on two fronts. The first is whether CCSVI is associated with MS. And, second, whether its treatment by PTA is beneficial in people with MS.
Researchers in Italy have conducted a clinical trial, and its report states that the PTA procedure did NOT improve the participants’ functioning or reduce their brain lesions.
In conclusion, researchers said that venous PTA cannot be recommended in patients with MS. It has proven to be largely ineffective technique, although safe.
CCSVI trial explained
Researchers published their study in the journal JAMA Neurology. The title is “Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis A Randomized Clinical Trial.”
The objective of the trial was to determine the efficacy and safety of venous PTA in patients with MS and CCSVI.
The Brave Dreams trial was a multicentre, randomized, double-blind, sham-controlled, parallel-group trial to evaluate the efficacy and safety of venous PTA in patients with MS and CCSVI in extracranial or extravertebral veins.
It analyzed 177 patients with relapsing-remitting MS; 62 were ineligible, including 47 (26.6%) who did not have CCSVI on colour Doppler ultrasonography screening. A total of 115 patients were recruited in the study timeframe. All patients underwent a randomized, double-blind, sham-controlled, parallel-group trial in six MS centres in Italy. The trial began in August 2012 and concluded in March 2016; data was analyzed from April 2016 to September 2016.
Patients were randomly allocated (2:1) to either venous PTA or catheter venography without venous angioplasty (sham).
An end to the CCSVI controversy?
Controversy has raged since 2009, when Zamboni, from the University of Ferrara in Italy, put forward the idea that CCSVI may contribute to nervous system damage in MS. He also published results from a study which demonstrated that CCSVI was present in all the individuals with MS who he examined.
In truth, however, not everyone with MS has CCSVI. Further, although considered a safe procedure, the angioplasty treatment does not help with MS symptoms. This well-regulated double-blind clinical trial says so – and so, now, does Dr Zamboni.
As far as I am concerned, this puts the whole issue of CCSVI treatment for MS to rest. But I am sure some diehards will attempt to keep the controversy going.
I have always been highly skeptical of claims that the treatment could help relieve MS symptoms. This trial proves the claims to be wrong. Zamboni admits he was wrong. Enough said.
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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.
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