IT/Buffalo study pub--significant improvement after PTA

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IT/Buffalo study pub--significant improvement after PTA

Postby cheerleader » Fri Aug 12, 2011 10:52 am

NEW published study:
Ferrara/Buffalo treats 15 Italian and American patients with CCSVI using PTA (angioplasty)

Abstract
Objectives
Chronic cerebrospinal venous insufficiency (CCSVI) is associated with multiple sclerosis (MS). The objective of the study was to see if percutaneous transluminal angioplasty (PTA) of duplex-detected lesions, of the internal jugular and/or azygous veins, was safe, burdened by a significant restenosis rate, and whether there was any evidence that treatment reduced MS disease activity.

Design: This was a case-control study.

Materials: We studied 15 patients with relapsing–remitting MS and duplex-detected CCSVI.

Methods
Eight patients had PTA in addition to medical therapy (immediate treatment group (ITG)), whereas seven had treatment with PTA after 6 months of medical therapy alone (delayed treatment group (DTG)).

Results
No adverse events occurred. At 1 year, there was a restenosis rate of 27%. Overall, PTA was followed by a significant improvement in functional score compared with baseline (p < 0.02). The annualised relapse rate was 0.12% in the ITG compared with 0.66% in the DTG (p = NS). Magnetic resonance imaging (MRI) blindly demonstrates a trend for fewer T2 lesions in the ITG (p = 0.081), corresponding to a 10% decrease in the ITG compared with a 23% increase in the DTG over the first 6 months of the study.

Conclusions
This study further confirms the safety of PTA treatment in patients with CCSVI associated with MS. The results, despite the significant rate of restenosis, are encouraging and warrant a larger multicentre double-blinded, randomised study.

http://www.ejves.com/article/S1078-5884 ... 2/abstract
Last edited by cheerleader on Fri Aug 12, 2011 12:05 pm, edited 2 times in total.
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Postby Cece » Fri Aug 12, 2011 11:22 am

a tinyurl link because of the ()s:
http://tinyurl.com/3zsha8p

So this is showing an immediate improvement on MS lesions in the treated group? That is promising. It's not statistically significant but if it can be duplicated in a larger study it would be.
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Postby cheerleader » Fri Aug 12, 2011 12:27 pm

This was a blinded study. The reason for the two groups, immediate treatment and delayed treatment, was to remove any bias in results found after PTA. The MRI techs and statisticians DID NOT know who had been treated.

An important message from Dr. Zamboni regarding the newly published study placed online today. This is the 2nd CCSVI endovascular treatment study undertaken in Ferrara, Italy. The patients were Italian and American. There were two groups, immediate treatment group, and delayed treatment group, The MRI technicians and statisticians were blinded as to who was in which group. This is very important to understand. Angioplasty for CCSVI reduced lesions, reduced gray matter atrophy and reduced relapses. Here's the note from Dr. Zamboni--
___________________________________________________________

Here attached for you, from the site of the European Journal of Vascular Endovascular Surgery, the second treatment study. This study is also known as MS-EVT treatment of American and Italian patients who have traveled from across the Atlantic to be treated.
http://www.ejves.com/article/S1078-5884 ... 2/abstract

The study design is unique in the history of medicine. The patients were operated on in Ferrara, but the results were audited in Buffalo. Patients were divided into two mixed groups of Italians and Americans. The first ITG (immediate treatment group) was operated on immediately, while the second group DTG (delayed treatment group) was treated six months later, allowing us to compare the ITG with DTG. Finally, we compared patients in the second six months, when both groups were operated on. Then, all patients were compared with their original state during the previous year, prior to PTA.

The study is small (we had no money to do more), however, is very strong, certainly stronger than that of 2009 JVS, as it eliminates many of the criticisms of the latter. Particularly--

1. There is a control group for comparison, in practice it as a randomized as possible for use in surgery
2. MRI measures are rigorous, high-standard 3-tesla, comparable and indisputable as completely blind
3. Patients were evaluated by neurologists and neuroradiologists of two centers
4. Statistical analysis was done by an independent statisticians and blinded.

What does it prove

1. Both groups after the PTA had a significant improvement in the MSFC score compared to previous year, with substantial maintenance of EDSS (no disease progression)
2. In the ITG during the first 6 months there were fewer relapses. The percentage has been on an annual basis of 0.16 against 0.66 of the DTG. In fact the DTG in the first six months received only drugs. After surgery, the DTG no longer had more relapses than the ITG, confirming the protective effect of PTA on relapses.
3. ITG T2 lesion load decreased while the DTG increased. After the PTA in the DTG lesion load stabilized during the second six months.
4. Complications were zero, zero thrombosis
5. 27% restenosis
6. ITG had one patient- despite the PTA, who had a recurrence and worsening on the MRI, confirming that the MS-CCSVI can not be handled alone by only interventionist. This article suggests the causes of deterioration after PTA on which new studies are needed.

More results

1. Ahead Zivadinov and all 17 consecutive patients had venography confirmed CCSVI
2. the ITG had an effect more pronounced in brain volume reduction than that of the DTG, a likely anti-edema and anti-inflammatory effect of the PTA.

Key messages

* CCSVI is associated with MS --as the first treatment of the condition changes the clinical parameters of the second
* The modification of parameters in a blinded MRI is totally immune from the placebo effect, then measured the improvements are real
* The treatment is safe in safe hands and can be beneficial
* To say after these two pilot studies, positive treatment studies, epidemiological studies have to wait is not sustainable

Paolo Zamboni, MD
Director, Vascular Diseases Center
University of Ferrara
Last edited by cheerleader on Fri Aug 12, 2011 1:45 pm, edited 1 time in total.
Husband dx RRMS 3/07
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http://ccsviinms.blogspot.com
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Postby MrSuccess » Fri Aug 12, 2011 12:40 pm

reduced lesion load .... is always good news.

anyone know how many pwMS in this study were taking DMD's ?

great news ..... more CCSVI information from Professor Zamboni.




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Postby scorpion » Fri Aug 12, 2011 12:54 pm

cheerleader wrote:This was a blinded study. The reason for the two groups, immediate treatment and delayed treatment, was to remove any bias in results found after PTA. The neurologists DID NOT know who had been treated.

An important message from Dr. Zamboni regarding the newly published study placed online today. This is the 2nd CCSVI endovascular treatment study undertaken in Ferrara, Italy. The patients were Italian and American. The follow up testing was blinded. The neurologists who followed these patients in Buffalo DID NOT know who had been treated with PTA, and who wasn't. There were two groups, immediate treatment group, and delayed treatment group, The MRI technicians and neurologists were blinded as to who was in which group. This is very important to understand. Angioplasty for CCSVI reduced lesions, reduced gray matter atrophy and reduced relapses. Here's the note from Dr. Zamboni--
___________________________________________________________

Here attached for you, from the site of the European Journal of Vascular Endovascular Surgery, the second treatment study. This study is also known as MS-EVT treatment of American and Italian patients who have traveled from across the Atlantic to be treated.
http://www.ejves.com/article/S1078-5884 ... 2/abstract

The study design is unique in the history of medicine. The patients were operated on in Ferrara, but the results were audited in Buffalo. Patients were divided into two mixed groups of Italians and Americans. The first ITG (immediate treatment group) was operated on immediately, while the second group DTG (delayed treatment group) was treated six months later, allowing us to compare the ITG with DTG. Finally, we compared patients in the second six months, when both groups were operated on. Then, all patients were compared with their original state during the previous year, prior to PTA.

The study is small (we had no money to do more), however, is very strong, certainly stronger than that of 2009 JVS, as it eliminates many of the criticisms of the latter. Particularly--

1. There is a control group for comparison, in practice it as a randomized as possible for use in surgery
2. MRI measures are rigorous, high-standard 3-tesla, comparable and indisputable as completely blind
3. Patients were evaluated by neurologists and neuroradiologists of two centers
4. Statistical analysis was done by an independent statisticians and blinded.

What does it prove

1. Both groups after the PTA had a significant improvement in the MSFC score compared to previous year, with substantial maintenance of EDSS (no disease progression)
2. In the ITG during the first 6 months there were fewer relapses. The percentage has been on an annual basis of 0.16 against 0.66 of the DTG. In fact the DTG in the first six months received only drugs. After surgery, the DTG no longer had more relapses than the ITG, confirming the protective effect of PTA on relapses.
3. ITG T2 lesion load decreased while the DTG increased. After the PTA in the DTG lesion load stabilized during the second six months.
4. Complications were zero, zero thrombosis
5. 27% restenosis
6. ITG had one patient- despite the PTA, who had a recurrence and worsening on the MRI, confirming that the MS-CCSVI can not be handled alone by only interventionist. This article suggests the causes of deterioration after PTA on which new studies are needed.

More results

1. Ahead Zivadinov and all 17 consecutive patients had venography confirmed CCSVI
2. the ITG had an effect more pronounced in brain volume reduction than that of the DTG, a likely anti-edema and anti-inflammatory effect of the PTA.

Key messages

* CCSVI is associated with MS --as the first treatment of the condition changes the clinical parameters of the second
* The modification of parameters in a blinded MRI is totally immune from the placebo effect, then measured the improvements are real
* The treatment is safe in safe hands and can be beneficial
* To say after these two pilot studies, positive treatment studies, epidemiological studies have to wait is not sustainable

Paolo Zamboni, MD
Director, Vascular Diseases Center
University of Ferrara


While I admit these results are interesting how in the world can you make these "key points" after all the recent studies show no correlation between CCSVI and MS??

* CCSVI is associated with MS --as the first treatment of the condition changes the clinical parameters of the second
* The modification of parameters in a blinded MRI is totally immune from the placebo effect, then measured the improvements are real
* The treatment is safe in safe hands and can be beneficial
* To say after these two pilot studies, positive treatment studies, epidemiological studies have to wait is not sustainable



Because of this trial of 15 people????? This is some of the crap that makes me believe CCSVI has become more about the being right then about PWMS. Ok, well screw the other studies. Case closed I guess. By the way this study was done by neurologists but I guess in this case it does not matter.
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Postby Cece » Fri Aug 12, 2011 12:58 pm

It is a good study with the ITG and DTG group. I wish there was funding to have had a placebo group although whether it's worth the sham shenanigans is debatable.

* The modification of parameters in a blinded MRI is totally immune from the placebo effect, then measured the improvements are real

I have to disagree with this. The placebo in drug tests have shown an improvement in the placebo group even on MRI lesions.

(The 'regression to the mean' effect also gets lumped into placebo because drug trials typically choose patients with highly inflammatory MS and much greater disease activity than normal. These patients then regress toward the mean or naturally calm down closer to average disease activity, because they had abnormal amounts of disease activity at the start of the trial. So we do not know the true numbers for placebo effect in MS but it would be somewhere between 0-30% reduction in MS lesions.)

Scorpion, the most recent negative imaging study had 18 pwMS in it, that's a small study too. The research is best described as preliminary, still, even now. And MRIs are expensive to include in research design.
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Postby cheerleader » Fri Aug 12, 2011 1:54 pm

MrSuccess wrote:reduced lesion load .... is always good news.
anyone know how many pwMS in this study were taking DMD's ?


All of the pwMS/CCSVI treated were on DMDs before, during and after, for consistancy. What was interesting was that the delayed group (DTG) continued to have more relapses and new lesions while on DMD medication, while the treated group had less of both. Here's Zamboni on this---

2. In the ITG during the first 6 months there were fewer relapses. The percentage has been on an annual basis of 0.16 against 0.66 of the DTG. In fact the DTG in the first six months received only drugs. After surgery, the DTG no longer had more relapses than the ITG, confirming the protective effect of PTA on relapses.
3. ITG T2 lesion load decreased while the DTG increased. After the PTA in the DTG lesion load stabilized during the second six months.


After clarification from Dr. Zivadinov, I've edited my note, but it remains incorrect in Scorpion's copied version....the neurologists were not blinded as to the ITG and DTG and controls, but the MRI technicians and statisticians were. Apologies, I misinterpreted that section of the paper. This is the first controlled study, as normals were used.
The duplex prevalence of CCSVI in MS was 100%, whereas, in eight normal subjects used as controls in the CVIMS studies, the prevalence was 0%.7,9 Of the 16 patients, 15 met the inclusion/exclusion criteria and agreed to participate (eight from Italy and seven from Buffalo).

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Postby MrSuccess » Fri Aug 12, 2011 2:19 pm

as always ..... I am very satisfied with the integrity and honesty of Dr.Zamboni and all other CCSVI investigators .

In this great report ..... Dr.Zamboni includes the frustrating news that one
of the subjects actually got worse.

In his CCSVI report , Dr.Simka , recorded some difficulties in cathetor[sp] removal.

Note : No effort was made to " cover up ".

This is a substantial advancement in CCSVI .



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Postby frodo » Fri Aug 12, 2011 6:27 pm

scorpion wrote:While I admit these results are interesting how in the world can you make these "key points" after all the recent studies show no correlation between CCSVI and MS??


It is clear at this point that the other studies were flawed. In fact, negative results published to date are inconsistent among them, going from finding no CCSVI in any patient to find CCSVI in nearly every patient including healthy people.

Besides, performing wrongly a test in a study can lead to a negative bias, while performing specially well the test will not introduce a positive bias. At this point I think we can consider the results of Zivadinov the correct results and any other study that contradicts this as a lack of expertise of the doctors performing the tests.
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Postby scorpion » Fri Aug 12, 2011 6:39 pm

frodo wrote:
scorpion wrote:While I admit these results are interesting how in the world can you make these "key points" after all the recent studies show no correlation between CCSVI and MS??


It is clear at this point that the other studies were flawed. In fact, negative results published to date are inconsistent among them, going from finding no CCSVI in any patient to find CCSVI in nearly every patient including healthy people.

Besides, performing wrongly a test in a study can lead to a negative bias, while performing specially well the test will not introduce a positive bias. At this point I think we can consider the results of Zivadinov the correct results and any other study that contradicts this as a lack of expertise of the doctors performing the tests.


:roll:
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Postby cheerleader » Fri Aug 12, 2011 10:15 pm

frodo wrote:
Besides, performing wrongly a test in a study can lead to a negative bias, while performing specially well the test will not introduce a positive bias. At this point I think we can consider the results of Zivadinov the correct results and any other study that contradicts this as a lack of expertise of the doctors performing the tests.


Dr. Zivadinov has another study coming out next week. Venography, CCSVI found in 17 pwMS. Zivadinov is still not stating what CCSVI is (whether cause or effect) but he is finding it, researching it and publishing. And yes, Frodo is right, his ultrasound specialist has worked with Zamboni and gets most of the protocol. The TCD/Esaote protocol is still a stumbling block, but venography is the gold standard, and that's where CCSVI is found.
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Postby frodo » Sat Aug 13, 2011 1:01 am

scorpion wrote:
frodo wrote:
scorpion wrote:While I admit these results are interesting how in the world can you make these "key points" after all the recent studies show no correlation between CCSVI and MS??


It is clear at this point that the other studies were flawed. In fact, negative results published to date are inconsistent among them, going from finding no CCSVI in any patient to find CCSVI in nearly every patient including healthy people.

Besides, performing wrongly a test in a study can lead to a negative bias, while performing specially well the test will not introduce a positive bias. At this point I think we can consider the results of Zivadinov the correct results and any other study that contradicts this as a lack of expertise of the doctors performing the tests.


:roll:


Should I explain you slowly the argument?
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Postby se1956 » Sat Aug 13, 2011 1:50 am

Dr. Zivadinov uses the right  threshold values for the CCSVI criterias because in his earlier (also blinded) study he got a difference between healthy and pwMS.

If one uses wrong  threshold values one can get nearly everything between nobody and everyone has CCSVI.

If these results (significant improvement in functional score and reduced lesion load) can be duplicated in a larger study, again with blinded data analysis, this might be a real breakthrough.

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Postby scorpion » Sat Aug 13, 2011 6:11 am

frodo wrote:
scorpion wrote:
frodo wrote:
scorpion wrote:While I admit these results are interesting how in the world can you make these "key points" after all the recent studies show no correlation between CCSVI and MS??


It is clear at this point that the other studies were flawed. In fact, negative results published to date are inconsistent among them, going from finding no CCSVI in any patient to find CCSVI in nearly every patient including healthy people.

Besides, performing wrongly a test in a study can lead to a negative bias, while performing specially well the test will not introduce a positive bias. At this point I think we can consider the results of Zivadinov the correct results and any other study that contradicts this as a lack of expertise of the doctors performing the tests.




:roll:


Should I explain you slowly the argument?




Nope I got it. Any studies not showing positive results are flawed. Pretty simple concept.
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Postby Cece » Sat Aug 13, 2011 6:23 am

If you genuinely believe that, you must not think much of us.

I've seen studies going both ways. I've seen studies that don't have much to do with CCSVI (such as this latest genetics study) interpreted as if they do.

Someone recently pointed out that the idea that CCSVI is common in healthy controls is at odds with the idea that CCSVI is not present in anyone.

I respect anyone's choice to hold off on CCSVI treatment unless and until it becomes mainstream standard-of-care. I felt the science was strong enough and the risk small enough that it was worth it to me but that is a private decision between a pwMS, their doctors, and their message boards.... :D
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