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Dr. Salvi and Dr. Zamboni published in a Neurology journal
Posted: Wed Jun 13, 2012 1:45 pm
by Cece
http://www.functionalneurology.it/index ... ce=message
Functional Neurology
Salvi F.,Bartolomei I.,Buccellato E.,Galeotti R.,Zamboni P.
Venous angioplasty in multiple sclerosis: neurological outcome at two years in a cohort of relapsing-remitting patients
Original Article, 55 - 59
An open study was conducted with the aim of reporting long-term clinical outcome of endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis (MS).
Twenty-nine patients with clinically definite relapsing-remitting MS underwent percutaneous transluminal angioplasty for CCSVI, outside a clinical relapse. All the patients were regularly observed over at least two years before the first endovascular treatment and for at least two years after it (mean post-procedure follow up 30.6±6.1 months). The following clinical outcome measures were used: annual relapse rate and Expanded Disability Status Scale (EDSS) score. All the patients were observed intensively (mean 6 hours) on the day of the endovascular treatment to monitor for possible complications (bleeding, shock, heart attack, death).
We compared the annual relapse rate before and after treatment (in the two years before and the two years after the first endovascular treatment) and the EDSS score recorded two years before versus two years after the treatment.
Overall, 44 endovascular procedures were performed in the 29 patients, without complications. Thirteen of the 29 patients (45%) underwent more than one treatment session because of venous re-stenosis: 11 and two patients underwent two and three endovascular treatments respectively.
The annual relapse rate of MS was significantly lower post-procedure (0.45±0.62 vs 0.76±0.99; p=0.021), although it increased in four patients. The EDSS score two years after treatment was significantly lower compared to the EDSS score recorded at the examination two years before treatment (1.98±0.92 vs 2.27±0.93; p=0.037), although it was higher in four patients.
Endovascular treatment of concurrent CCSVI seems to be safe and repeatable and may reduce annual relapse rates and cumulative disability in patients with relapsing-remitting MS. Randomized controlled studies are needed to further assess the clinical effects of endovascular treatment of CCSVI in MS.
EDSS scores improved in 25 out of 29 patients. Relapse rates were lower. The usual caveats apply (no control group, relatively small sample size) but this is very promising. The conclusion is that CCSVI endovascular treatment seems to be safe and repeatable, that it may reduce relapse rates and cumulative disability, and that randomized controlled studies are needed.
Re: Dr. Salvi and Dr. Zamboni published in a Neurology journ
Posted: Thu Jun 14, 2012 1:09 am
by CureOrBust
I always feel that the four who did not respond have been neglected. Probably because I would clearly sit in that group.
Do we know if the four that did not respond (actually worsened) were in the group requiring more than one treatment? Any discussion on these specific cases?
Re: Dr. Salvi and Dr. Zamboni published in a Neurology journ
Posted: Thu Jun 14, 2012 1:45 am
by Robnl
And which veins were treated??
Re: Dr. Salvi and Dr. Zamboni published in a Neurology journ
Posted: Sat Jun 16, 2012 4:07 am
by MarkW
Robnl wrote:And which veins were treated??
Robnl, the whole paper is online (the pdf button below the abstract). You could say they under treated some subjects but research protocols mean that you must follow the protocol not look for stenosis in any veins or use a balloon sized to suit the subject. IVUS was not used so under treatment could have occurred. Excellent results in such a study and discussion focussed on treating CCSVI syndrome in IJV/AZ veins rather than treating MS.
Kind regards,
MarkW
Try this url for whole paper:
http://www.functionalneurology.it/commo ... 1ead753ee5
Re: Dr. Salvi and Dr. Zamboni published in a Neurology journ
Posted: Sun Jun 17, 2012 10:02 am
by 1eye
Even the title says "in MS". "MS" is the context. The symptoms (relapses, EDSS) are the important features measured in drug trials for "MS". This paper describes treatment for CCSVI, but the aim and the results are treatment of "MS".
The four who got worse, it was their "MS" that got worse. The whole study, and other bigger blinded RCTs must be conducted before significant numbers of neurologists will take it seriously.
Those opposed to use of the procedure have shown (with notable exceptions) unwillingness to cooperate, tunnel-vision in reporting, and a tendency to emphasize results that are interpreted to show no patient benefit, as though they were preferable to more positive ones.
These negative results, no matter how small or how often contradicted, have been fixed on by governments, and the neurologists and MS Societies who advise them. They have been used to drag as many feet as possible.
I expect no scientific progress or broad consensus among scientists to come in my lifetime, because of the proven association of CCSVI with "MS", and also because of accusations of placebo, unfair and even dishonest behaviour, greediness, short-sightedness, carelessness, and worse, coming from the deniers of CCSVI theory. The polarization of the opposing pieces of turf is this war is unprecedented in my small experience. That probably makes drug dealers, bankers, and stock brokers happy.
Re: Dr. Salvi and Dr. Zamboni published in a Neurology journ
Posted: Sun Jun 17, 2012 1:31 pm
by Cece
If it is possible to do research on CCSVI on its own in patients who do not have additional diagnoses, that would be helpful. When it is research on CCSVI and all the patients have MS, then it is research on CCSVI in MS, and that is trickier. MS is a difficult enough disease to study as it is, with all our different presentations and highly individual disease courses. I agree that to avoid muddying the waters, the researchers should collect data that is specific to CCSVI symptoms, not to MS symptoms. An exception would be of MRIs looking for lesions, because there was some research indicating a reduction on brain lesions on MRI in 12 out of 13 patients treated for CCSVI in that study, and brain lesions on MRI is a well-accepted research measurement of MS, and tbat could lead to quicker acceptance of CCSVI treatment.
I expect scientific progress in my lifetime, and in this decade! We've made some ground already. It is to our advantage that venous malformations and blood flow are real and observable.
Re: Dr. Salvi and Dr. Zamboni published in a Neurology journ
Posted: Thu Jun 21, 2012 11:56 am
by 1eye
Cece wrote:I expect scientific progress in my lifetime, and in this decade! We've made some ground already. It is to our advantage that venous malformations and blood flow are real and observable.
And so are CSF measurements. The science is expensive and of necessity sometimes a lot slower than we would like. Complicating that is the wealth of those opposing it. I don't expect my lifetime to last long enough, but I hope those of most of the people on this forum do. Good luck with it.
I hope I outlive the decade. I have believed in a lot of nonsense before, so this is nothing new.