Too Early to Promote CCSVI

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Summary from Marie Rhodes at Stanford

Postby trrish » Fri Dec 04, 2009 10:24 pm

This is a pretty helpful and balanced summary from the CCSVI Facebook page:

"Hi My name is Marie Rhodes, I am an RN and was the second person treated for CCSVI by Mike Dake MD at Stanford. I have SPMS and got ill with MS in '91. I agreed to be co admin for this facebook page to assist in the overwhelming mail load. I have been at thisisms.com as mrhodes40 for many years and have posted a lot of interesting medical literature for discussion to the TIMS pages over those years as well as becoming interested in this new idea as soon as the CCSVI thread was started by Joan in Dec of '08.

I want to make sure and be perfectly clear from the beginning:

This new idea is, at this point, unproven. Scientific rigor demands more than the currently available data to say with any certainty that this is the cause of MS. Furthermore, it is entirely possible that there will be a combination therapy wherein both a immune suppressant and this surgery are done to maximize healing. At this point it is not known if CCSVI is the start of MS and it will remain as a self perpetuating disease after treatment or if it would go away. I am still on copaxone personally. No one is suggesting you go off of your medications and seek treatment at this time; not enough is known about treatment and whether it will help yet.

However, in spite of the unproven status of this model, the amount of work done already is more rigorous and there is more of it than many suggest. I have repeatedly seen people saying "this is one study" and that is false.

Here are the facts, see what you think:

The research team at the University in Ferrara consists of 8 people. Dr Zamboni is the lead researcher but there is also, importantly, a neurologist on that team as well; Dr Silvi.

All of the studies listed can be accessed at the Foundazione Hilarescere (Dr Zamboni's site). Are are published in regular peer reviewed journals and are legitimate medical research.

The first paper out of Ferrara on this was called "The Big Idea...." This paper described that model and outlined the cytokine similarities between stasis ulcers of the feet caused by venous insufficiency and MS lesions. What this means in lay terms is that the immune system cells that are in the stasis ulcer are the same as the immune system cells seen in MS lesions, and because these stasis ulcers are caused by a blocked vein it suggested that perhaps MS lesions are stasis ulcers in brain tissue. In both stasis ulcers and MS lesions a lot of the damage comes from the immune system itself doing its work to try to heal the area.

In MS lesions it has always been thought that the immune system caused ALL the damage; that it is an overactive system that is attacking healthy tissue and hurting it when immune cells have no reason to be in that tissue. Consequently, the focus has been on knocking out immunity in MS, not in stopping any triggering event, because while a triggering event was suspected, none has ever been proven .

Perhaps CCSVI is our triggering event, or perhaps there is not problem with the immune system and once CCSVI is healed any immune issues will vanish. No one knows at this point.

The second paper was unblinded called "Intracranial Venous Haemodynamics in MS" and it had 89 MS patients and 60 matched controls. In this study the effort was to evaluate everyone and see if they could find a way to see if there was any venous insufficiency in MS patients. What they did was a set of 5 doppler (sonography) studies and looked at them VERY carefully. They were surprised to discover that all MS patients failed at least 2 of these tests. No single test was "the one" that all MSers failed. To the contrary, it was different combinations patient by patient. One might fail test 1 and 3, another person test 1 and 5...or even 2, 4 and 5. No normal person failed more than one test, and most failed none.

The third paper was "Doppler haemodynamics of venous return" and it detailed how all these tests were done and what to look for when assessing cerebral (head) venous return.

The fourth paper was "The Value of Cerebral Doppler Haemodynamics in the assessment of MS" and this time the test was BLINDED.

The 109 MS patients and the 177 controls some of which had neurological disease were assigned a number then tested by a sonographer who didn't know the diagnosis. Could have been a person with ALS or a person with vascular disease or an MSer they were testing, they didn't know. The doppler was done, marked with the patient number and sent to a researcher to read and see if there were test failures and how many for each numbered scan. That researcher doing the interpretation had no idea of the diagnosis and only a meaningless number for reference as to whose scan it was.

When they got all the tests read and interpreted, they unblinded--meaning they looked to see what patient and diagnosis corresponded to the numbered scans.

WHEN THEY DID THAT ONLY THE PEOPLE WITH 2 OR MORE ABNORMALS HAD MS. No control had more than one abnormal test, most had none, even those with other medical conditions. There is no way that the researchers fooled themselves with this method of blinding. This was well blinded.

The 5th paper was the one most people talk about when they talk about Dr Zamboni's study as if it was the only one. This was blinded in the same way as the one above.

In this paper they had 65 MSers and 235 controls, who were cardiovascular patients or people with neuro disease or older people. They tried to find people who might reasonably be thought to develop some kind of blood vessel issues and this could potentially show CCSVI and not be MS patients. Importantly after the blinded doppler part of the study, the MS patients with 2 abnormals were going to be allowed to have venograms, and some of the controls needed venograms too so they could check every one for actual stenosis.

The blinded part came out exactly the same as the previous study--only MS patients had 2 abnormals on doppler. Then they did the unblinded part; venograms on MSers and patients with venous disease who needed one anyway. Only the MS patients had actual stenosis in the neck veins.

There have been other papers since then on related issues such as iron deposits and collateral circulation. Today is Nov. 25 and the Liberation treatment paper is out also--results with very promising results on 65 people whose stensosis was treated with surgery 2 years ago .

There is also a blinded doppler study that should be released this month from Jacobs Neurological in Buffalo on several hundred patients using the Zamboni protocol. Early comments by Dr Guttman, a top US neurologist, are that her work is supporting Zamboni's. A tiny study in Poland, unblinded, By Marion Simka on 8 MS patients was also 100%.

But the question I posed earlier was whether the facts of this work support the often repeated "This is only one study, and only one researcher." Or another comment by a doctor "This work was unblinded. They may have unconsciously "found" it in MS patients because they expect it to be there." Or another comment "There is no way that he can have gotten 100% because nothing is 100% in MS." Do these seem accurate to you?

All of these comments diminish the importance of this new work by pretending it is less well done and far less conclusive than it is IMHO. The totals of patients seen are in the hundreds, not a few dozen as most "preliminary" studies are. The work on the doppler evidence of reflux was rigorously blinded and controlled. I mean that by the time you have included people that are old, people with heart disease, vascular disease and other brain disease, you tried pretty hard to trick yourself into finding "2 abnormals" in people who don't have MS. Also, by the time you have seen a hundred patients with something in research, it is common knowledge that as the numbers go up, your percentage will stay in the same ball park.

At this point in time my opinion is that the first question this new model raises has been to a good degree answered: do people have stenosis if they have MS? The answer is probably yes. Note: this doesn't mean every Tom Dick and Harry at your corder doppler lab can find it! They have to know how to look.

But the important question is does this cause MS and will treatment help? The answer to that question is unproven and really preliminary at this point in time. The results of the liberation procedure out today are very promising, but replication is needed by many more people.

SO that is my initial offering, I hope it answers some questions about CCSVI."
Last edited by trrish on Sat Dec 05, 2009 1:18 pm, edited 1 time in total.
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Thank you so much for your post

Postby mohzi » Fri Dec 04, 2009 10:32 pm

I really appreciate your post. It is pretty much the same stuff that I had read and was aware of. The most interesting thing is that it will probably not take long for the US and Canada to get caught up on the work of Dr. Zamboni and others.
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Postby prof8 » Fri Dec 04, 2009 11:05 pm

Johnson wrote:prof8 - Interestingly, I have a venous angioma too, said to be a "congenital artifact". I was asked about history of head injury though, and I said, with a grin, that I 'couldn't remember. I have taken quite a few blows to the head though'. The neuro' recommended waiting for the "Gamma Knife" to deal with that (15 years ago).


Johnson--wow, your doc. asked you if you had a head injury? Hmmmm...I was in a car accident where I hit the left side of my head on the window. I can't remember which side of the brain my venous angioma is on though. I should go check. I thought they were all congenital and 99% of the time they shouldn't be messed with because they don't cause problems. Cavernous angiomas (another vascular malformation in the brain) are what you have to be careful about since they can hemorrhage. Sometimes a venous angioma is right next to a cavernous angioma. My neurologist says it is not necessarily of any consequence...just like having a birth mark.

Have you seen this website on venous angiomas? Interesting material. Sometimes it is called a Developmental Venous Anomaly (DMV).

http://www.brain-aneurysm.com/dva.html

I was struck by this statement: Regardless, most neurosurgeons regard venous angiomas by themselves as extreme variations of normal venous drainage.

And this theoretically, one or more veins comprising the angioma can spontaneously "clot off" (thrombose), leading to local venous hypertension (back pressure buildup in the region's venous system)

I just got to thinking if I had abnormalities of venous draining in my brain maybe it was going on in my jugulars too. So CCSVI made a lot of sense.
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Postby Johnson » Fri Dec 04, 2009 11:35 pm

prof8 - seems like another piece in the 30,000++ piece puzzle.

I don't think it would matter all that much which side you remember (or not) banging your head in a car crash, it matters where your brain impacts your skull case, and I would think, where any congenital weaknesses might lie. It is entirely possible to suffer cerebral haemorrhage from a "whip-lash" injury.

I had not heard of cavernous angiomae. Just a reminder to myself that I do not know near as much as I would like to think that I do. Grin. I will peruse your link anon.

I can think of three occasions particularly when I might have had such a blow to the head - one a car crash, one falling through a rotted floor of a barn, and once when I refused to fight, and got beat up for my altruism.

The "extreme variation in normal venous drainage" really caught my attention too. Hey, neurologists don't know everything either... Qu'elle surprise!
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Re: Too Early to Promote CCSVI

Postby seeva » Sat Dec 05, 2009 3:40 am

mohzi wrote:I would just like to make a couple of comments.

1.) Dr. Zamboni never said this was cure. The media did. I have an email from him that says "we have just completed an experimental phase. The next step consisting in extending the diagnosis and treatment of CCSVI to patients with MS will require time."

2.) Dr. Zamboni has been very hesitant to use stents, due to the risk. It is my understanding, he has only put a stent in one person. In the trials he used Angioplasty, excluding one patient.

3.)Dr. Zamboni's clinical trial, show no help for SP and PP after six months. Most likely due to the placebo effect.

4.)Dr. Zamboni is not doing the liberation procedure now. In his papers, he repeatedly states there are many areas where more research is needed, including his own procedure.

4.) Dr. Simka, as of December 1st has only done 5 of these procedures. His email to me states, "We have performed liberation procedure in 5 patients, and other 10patients will be operated on in December."

5.) Dr. Dake has stopped doing the stents for now. They are preparing a clinical trial. There has been many ethics questions regarding stenting patients without a clinical trial here in the US.

6.) MS Clinics all over have been bombarded with people wanting their Veins checked. Only a few people in the world are trained to read the blockage and flow that they are reporting in the CCSVI trial.

7.)As much as I hate my MS and the drugs I take, I believe it is irresponsible to promote the Liberation Procedure without telling everything. And promoting it before clinical trials are done on thousands of people.

8.) I feel desperate many days also and wonder if there is every an end, but reality is reality. I read somewhere, "My Serenity is in direct proportion to my expectations." Promoting and selling CCSVI is sad and giving many people a false hope of a quick fix. Let's wait a year and see where it is, hopefully it will give new treatment methods.

HI Member my name is SEEVA from AUSTRALIA, I want to contact DR.SIMKA POLAND.Please let me know his contact details.
REGARDS
SEEVA :roll:
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Re: Summary from Marie Rhodes at Stanford

Postby mohzi » Sat Dec 05, 2009 9:56 am

trrish wrote:This is a pretty helpful an balanced summary from the CCSVI Facebook page:

"Hi My name is Marie Rhodes, I am an RN and was the second person treated for CCSVI by Mike Dake MD at Stanford. I have SPMS and got ill with MS in '91. I agreed to be co admin for this facebook page to assist in the overwhelming mail load. I have been at thisisms.com as mrhodes40 for many years and have posted a lot of interesting medical literature for discussion to the TIMS pages over those years as well as becoming interested in this new idea as soon as the CCSVI thread was started by Joan in Dec of '08.

I want to make sure and be perfectly clear from the beginning:

This new idea is, at this point, unproven. Scientific rigor demands more than the currently available data to say with any certainty that this is the cause of MS. Furthermore, it is entirely possible that there will be a combination therapy wherein both a immune suppressant and this surgery are done to maximize healing. At this point it is not known if CCSVI is the start of MS and it will remain as a self perpetuating disease after treatment or if it would go away. I am still on copaxone personally. No one is suggesting you go off of your medications and seek treatment at this time; not enough is known about treatment and whether it will help yet.

However, in spite of the unproven status of this model, the amount of work done already is more rigorous and there is more of it than many suggest. I have repeatedly seen people saying "this is one study" and that is false.

Here are the facts, see what you think:

The research team at the University in Ferrara consists of 8 people. Dr Zamboni is the lead researcher but there is also, importantly, a neurologist on that team as well; Dr Silvi.

All of the studies listed can be accessed at the Foundazione Hilarescere (Dr Zamboni's site). Are are published in regular peer reviewed journals and are legitimate medical research.

The first paper out of Ferrara on this was called "The Big Idea...." This paper described that model and outlined the cytokine similarities between stasis ulcers of the feet caused by venous insufficiency and MS lesions. What this means in lay terms is that the immune system cells that are in the stasis ulcer are the same as the immune system cells seen in MS lesions, and because these stasis ulcers are caused by a blocked vein it suggested that perhaps MS lesions are stasis ulcers in brain tissue. In both stasis ulcers and MS lesions a lot of the damage comes from the immune system itself doing its work to try to heal the area.

In MS lesions it has always been thought that the immune system caused ALL the damage; that it is an overactive system that is attacking healthy tissue and hurting it when immune cells have no reason to be in that tissue. Consequently, the focus has been on knocking out immunity in MS, not in stopping any triggering event, because while a triggering event was suspected, none has ever been proven .

Perhaps CCSVI is our triggering event, or perhaps there is not problem with the immune system and once CCSVI is healed any immune issues will vanish. No one knows at this point.

The second paper was unblinded called "Intracranial Venous Haemodynamics in MS" and it had 89 MS patients and 60 matched controls. In this study the effort was to evaluate everyone and see if they could find a way to see if there was any venous insufficiency in MS patients. What they did was a set of 5 doppler (sonography) studies and looked at them VERY carefully. They were surprised to discover that all MS patients failed at least 2 of these tests. No single test was "the one" that all MSers failed. To the contrary, it was different combinations patient by patient. One might fail test 1 and 3, another person test 1 and 5...or even 2, 4 and 5. No normal person failed more than one test, and most failed none.

The third paper was "Doppler haemodynamics of venous return" and it detailed how all these tests were done and what to look for when assessing cerebral (head) venous return.

The fourth paper was "The Value of Cerebral Doppler Haemodynamics in the assessment of MS" and this time the test was BLINDED.

The 109 MS patients and the 177 controls some of which had neurological disease were assigned a number then tested by a sonographer who didn't know the diagnosis. Could have been a person with ALS or a person with vascular disease or an MSer they were testing, they didn't know. The doppler was done, marked with the patient number and sent to a researcher to read and see if there were test failures and how many for each numbered scan. That researcher doing the interpretation had no idea of the diagnosis and only a meaningless number for reference as to whose scan it was.

When they got all the tests read and interpreted, they unblinded--meaning they looked to see what patient and diagnosis corresponded to the numbered scans.

WHEN THEY DID THAT ONLY THE PEOPLE WITH 2 OR MORE ABNORMALS HAD MS. No control had more than one abnormal test, most had none, even those with other medical conditions. There is no way that the researchers fooled themselves with this method of blinding. This was well blinded.

The 5th paper was the one most people talk about when they talk about Dr Zamboni's study as if it was the only one. This was blinded in the same way as the one above.

In this paper they had 65 MSers and 235 controls, who were cardiovascular patients or people with neuro disease or older people. They tried to find people who might reasonably be thought to develop some kind of blood vessel issues and this could potentially show CCSVI and not be MS patients. Importantly after the blinded doppler part of the study, the MS patients with 2 abnormals were going to be allowed to have venograms, and some of the controls needed venograms too so they could check every one for actual stenosis.

The blinded part came out exactly the same as the previous study--only MS patients had 2 abnormals on doppler. Then they did the unblinded part; venograms on MSers and patients with venous disease who needed one anyway. Only the MS patients had actual stenosis in the neck veins.

There have been other papers since then on related issues such as iron deposits and collateral circulation. Today is Nov. 25 and the Liberation treatment paper is out also--results with very promising results on 65 people whose stensosis was treated with surgery 2 years ago .

There is also a blinded doppler study that should be released this month from Jacobs Neurological in Buffalo on several hundred patients using the Zamboni protocol. Early comments by Dr Guttman, a top US neurologist, are that her work is supporting Zamboni's. A tiny study in Poland, unblinded, By Marion Simka on 8 MS patients was also 100%.

But the question I posed earlier was whether the facts of this work support the often repeated "This is only one study, and only one researcher." Or another comment by a doctor "This work was unblinded. They may have unconsciously "found" it in MS patients because they expect it to be there." Or another comment "There is no way that he can have gotten 100% because nothing is 100% in MS." Do these seem accurate to you?

All of these comments diminish the importance of this new work by pretending it is less well done and far less conclusive than it is IMHO. The totals of patients seen are in the hundreds, not a few dozen as most "preliminary" studies are. The work on the doppler evidence of reflux was rigorously blinded and controlled. I mean that by the time you have included people that are old, people with heart disease, vascular disease and other brain disease, you tried pretty hard to trick yourself into finding "2 abnormals" in people who don't have MS. Also, by the time you have seen a hundred patients with something in research, it is common knowledge that as the numbers go up, your percentage will stay in the same ball park.

At this point in time my opinion is that the first question this new model raises has been to a good degree answered: do people have stenosis if they have MS? The answer is probably yes. Note: this doesn't mean every Tom Dick and Harry at your corder doppler lab can find it! They have to know how to look.

But the important question is does this cause MS and will treatment help? The answer to that question is unproven and really preliminary at this point in time. The results of the liberation procedure out today are very promising, but replication is needed by many more people.

SO that is my initial offering, I hope it answers some questions about CCSVI."


Thank you so much, that is sort of what I was trying to say in my very first post.
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Re: Thank you so much for your post

Postby trrish » Sat Dec 05, 2009 12:04 pm

mohzi,

I really support what you said in your opening post. Which doesn't change the fact that I, like you, really look forward to finding out what happens with trials. I tend to be cautiously optimistic on MS stuff, probably because I've been disappointed a few times. I just stopped using Tysabri, after two years, and started LDN. Tysabri was good to me, from an MRI and relapse point of view. But it didn't do that much for my day-to-day wellness. The LDN has done more for me in day-to-day wellness that any single "official" disease-modifying treatment I've tried - and it's only been a few weeks. Again, I'm cautiously optimtistic about the LDN. For the moment, I'm really happy about it, though the insomnia is something to manage for me, still.

On MS stuff, I've always gone with my gut. My gut says that CCSVI helps/will help some people. It remains to be seen what the extent of that will be.

mohzi wrote:I really appreciate your post. It is pretty much the same stuff that I had read and was aware of. The most interesting thing is that it will probably not take long for the US and Canada to get caught up on the work of Dr. Zamboni and others.
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Postby Billmeik » Sat Dec 05, 2009 12:54 pm

I wonder if there is such thing as irresponsible skepticism?


Can it be harmful to condescend to a patient?


By not assuming that MS patients are grownups who will feel better if they know if they have ccsvi can a doctor do psychological harm?


While this is dangerous territory, where only pioneers tread...I think it would be counter productive to post 'no pioneer' signs.


'don't try ths lightly' might be better.
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Postby trrish » Sat Dec 05, 2009 1:17 pm

I'm not sure what post you are referring to with the "no pioneer" signs. For the record, I don't have any problem with others pioneering. I feel like I've been a pioneer of sorts by following the MS-Diet, supplementing, trying Tysabri, and Novantrone. And now LDN. And inclining my bed! :-)

I'm not planning on pioneering this particular thing, but I'm glad others are.

On the condescending to a patient thing, I don't know if you could say it does harm. Perhaps temporarily. I think when that happens, you need to find a new dr. I remember when I asked my mainstream neuro clinic about LDN. He laughed me out of the office and told me to stop "reading things on the internet". I switched drs. New guy said "people who do well on LDN probably never really had MS". Found a "holistic neurologist" who said, "yes, I'll prescribe that for you". I keep up my relationship with the mainstream guys so I can still get my MRI's and all that covered.

Billmeik wrote:I wonder if there is such thing as irresponsible skepticism?


Can it be harmful to condescend to a patient?


By not assuming that MS patients are grownups who will feel better if they know if they have ccsvi can a doctor do psychological harm?


While this is dangerous territory, where only pioneers tread...I think it would be counter productive to post 'no pioneer' signs.


'don't try ths lightly' might be better.
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All of us are right

Postby mohzi » Sun Dec 06, 2009 12:35 am

MS is a personal battle for each of us. I just have to weigh the facts for myself and make my decision. I sure understand why some people would run and get a CCSVI treatment. During a horrible attack 3 and half years ago, I would of been first in line. So I do understand.

Billions of dollars in research and we had drugs with horrible side effects that are about 30% to 40% effective. We can get about a 67% effectiveness if we want to risk our life on PML. Hopefully after the Buffallo trials we will all know more.
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