This Is MS Multiple Sclerosis Community: Knowledge & Support

Forgive this question. I just can't figure out what I'm missing here.
It seems to me that there are only two big things that need to be shown for CCSVI to hit the mainstream.

1) Is there a correlation between narrow veins and MS?
2) Does opening (and keeping open) the veins stop MS progression?

Lets assume Buffalo’s numbers are already out and we all agree on the first one.

For the second, I know there are studies being planned, and it seems it will take a year or 18 mos for everything to play out.

For instance, imagine a study where a group of 50 MS patients get a baseline MRI and have their veins opened, (I think the control group is irrelevant, but imagine 50 of them if you like) and then we watch the "liberated" for a year. 50 liberated people times 12 mos gives us 600 “liberated MS patient months” (minus the re-stenosers of course, who by definition are no longer showing the effect of open veins). One year later we do another MRI to confirm no progression for the liberated...that took a year.

Instead, why couldn't they take the black market MS crowd with their already open veins and start adding up “liberated MS patient months”? Jeff gets us 10, Marie 9, Lew, Sharon, Wonky, Rhonda… I realize you can’t hand-pick them, but you can get your 600 MS patient months right now, today (or Wed, after the Buffalo announcement). Add up Zamboni and Dake and Simka and Queen Noor, and count up the months up to 600. Compare progression in those 600 liberated months to 600 average MS months, as measured by an MRI. Why couldn’t someone add up the months of patients who have managed to get their veins open and check if there is any progression. I’m not talking improvement, relief of symptoms, etc., just flat-out progression or no progression on an MRI. There is no placebo effect or operator error involved when comparing a before and after MRI. There is either change, or there is not. Is there a reason that data can’t be gathered immediately? Is there a reason it would not be conclusive?

Once it is established that "open veins" equals "no progression," it becomes the top drug out there and the free market can take over the task of finding the best way to open veins, w/ production of vein-specific stents, dissolving stents, figuring out risk of stent vs. risk of repeat balloon, etc.,

Sorry, but that sounds WAY too reasonable for our regulation- laden world....

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41 years old, dx 1998, current EDSS 6.5

http://www.medterms.com/script/main/art ... ekey=24053
Retrospective study: In medicine, a study that looks backward in time, usually using medical records and interviews with patients already known to have a disease.

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my approach: no meds so far - just balanced whole foods (partial 'paleo', much less outright elimination), science, supplements, & bloodwork
my regimen - www.thisisms.com/ftopict-2489.html
www.whfoods.com, www.nutritiondata.com

I think the conclusive question is:

Is there any report so far of a case that had an exacerbation or noticeable progression without having vein problems any more?

(That is, without restenosis or remaining vein problems after procedure like in Rici's case.)

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"There is only one good, knowledge, and one evil, ignorance." Socrates

Thanks, Jimmy! I wonder though, in addition to having it be a retrospective study (thanks for the cool new word ) is there an issue with taking 100 patients who got their veins opened on Jan 8 (one month ago), and counting their 100 total relapse-free months with open veins, the same way that you would count the 10 relapse-free months of 10 patients who got their veins opened in April (10 mos ago). Does that make sense? Are all relapse-free months equal? Or is there something about the 10th or 20th month of open veins that is more telling than the first? I realize month 1 and month 20 are different if you are judging the risk or effectiveness of a particular method (angio/stent/etc.) in keeping veins open over time, but if your goal is just to show a correlation between open veins and no progression, can't we just add any ol' relapse-free month out there?



Yes, EXACTLY!



Yeah, I agree that old fashioned horse sense is not the medical establishment's strong point, but when you can add up hundreds and hundreds and thousands of relapse-free months, and cannot find one single instance where someone had open veins and MS progression at the same time... it seems a new level of medical regulation silliness, even for them.

There are a lot of difficulties with doing a study the way you suggest, many of which would prevent it from being either conclusive or definitive.

One practical problem is that just getting the medical records for a large number of people scattered across the globe would be a huge undertaking, and not always possible even if you tried. There are various privacy laws that would have to be worked through, plus "simple" problems like records being stored in different formats at different medical centers, different MRI protocols, etc. So such as study would still be fairly costly and time-consuming, though obviously not as much as a prospective study.

Another problem is that CCSVI intervention isn't yet standardized, nor are the procedures used to even identify blocked veins. Did all of the patients have MRIs done just prior to the procedure, and again at roughly the same interval afterwards? Comparing 6--month MRIs for some patients with 12-month MRIs for others could be difficult.

Another really big problem is that the MS patients who have already had CCSVI intervention are almost by definition not "typical". That's why well-controlled clinical trials usually start by collecting a large group of "similar" patients, and then randomly assigning them into treatment and control groups, to avoid leting patients self-select. How does this mattter? Well, what kind of MS patient signs up for an invasive, experimental, unproven therapy, especially if it involves paying a lot of money out-of-pocket? I would expect many of these patients have already tried existing medications and found them ineffective. They may have more advanced or intrusive MS symptoms than "typical", leading them to be more willing to try something adventurous. Point is, they aren't typical by any stretch of the imagination, and these differences make it nearly impossible to find a truly comparable control group to compare them against.


No, not all months are equal. As a simple example, post-surgical complications are likely to be most prevelant right after a procedure, so combining data from 100 1-month intervals would grossly overstate the surgical risk. I think there is also some debate over whether or not the stress of surgery itself has any impact on relapse rate, so again you'd risk adding that confounding factor to the analysis.

I think it would be very interesting to do a retrospective study as you suggest, but I think the best you could hope for would be for it to add a bit more interest among the medical community. Due to the reasons listed above, such studies tend to be subject to a lot of (often valid) criticism, which prevents them from being accepted as very conclusive.

Note that there is a third very important question to be answered before CCSVI treatment becomes widespread, and that is whether or not CCSVI can be safely and effectively treated. It's tough to answer that question without long-term studies.

/Scut

The main problem(s) with that - MRI's do NOT confirm much of anything, and they definitely do NOT show progression or no progression.

**And yes, MRIs are often read very differently by different radiologists and neuros.
**And different MRI equipment gives different results.
**And lesions often come and go on their own - sometimes over a very short time.
**And some patients are dx'd with MS with no lesions showing in the first place.
**And lesions don't necessarily correlate with MS symptoms, exacerbations, progression, severity, or anything else.

In fact, Secondary Progressive MS is characterized by the fact that a patient no longer has exacerbations, but is progressively going downhill, and shows no active lesions. And it's often mentioned that Primary Progressive MS presents with few or no lesions in the 1st place. And a patient's "progression" is only evaluated by an educated guess - there's no test for it.

Bottom line is that, although CCSVI seems to be a widespread phenomenon in MS, it's also an extremely complex, individual problem, and its treatment is so new that no one has the slightest idea how many different approaches will come out of this exciting new research or how effective each one will be. It's even too early to assume that "no progression" will be the ultimate outcome of treatment. It might happen, but even then it may not happen for everyone.
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Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS or MS symptoms except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)