Retrospective Study Idea

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

Retrospective Study Idea

Postby Rokkit » Fri May 28, 2010 10:05 am

Take 100 of Simka's patients as they pass the 6 month or 1 year mark. Take another 100 MS patients who've not been treated for CCSVI. All 200 must have been followed previously by a neurologist and have a record of EDSS assessment.

Let several neurologists, blinded as to CCSVI treatment status, assess each member of the entire group for EDSS. Average the scores for each patient and compare to previous.
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Postby fogdweller » Fri May 28, 2010 11:39 am

Good idea. Studies like this are relatively cheap, and can come in with results fast.
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Postby Brightspot » Fri May 28, 2010 1:02 pm

I amazed that no body seems to be jumping on the fact that there are now several hundred people around the globe who have been treated. Surely most of them had been followed by neuros and other doctors and had many tests and procedures pre treatment. It does seem an obvious way to go forward.
Has anyone heard of a proposal like this being put forward anywhere?
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Re: Retrospective Study Idea

Postby frodo » Fri May 28, 2010 11:08 pm

Rokkit wrote:Take 100 of Simka's patients as they pass the 6 month or 1 year mark. Take another 100 MS patients who've not been treated for CCSVI. All 200 must have been followed previously by a neurologist and have a record of EDSS assessment.

Let several neurologists, blinded as to CCSVI treatment status, assess each member of the entire group for EDSS. Average the scores for each patient and compare to previous.

It is a good idea. The problem is that the 200 non treated controls should remain untreated until the study finishes. Maybe a variation of the study in which people passes from one group to the other little by little would be also a possibility.
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Postby se1956 » Sat May 29, 2010 1:17 am

Good idea.
Let's add the self assessed MSIS value. Then one can compare the MSIS values from the patients with the neuro EDSS values and get an idea how much palcebo effect is there.

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Postby Billmeik » Sat May 29, 2010 8:48 am

so all of simka's patients have an mri don't they? Or is that just a picture of the veins.

comparing mri's would be huge. I guess dake's patients are all hitting the 1 year mark and will get the 1 year follow up mri. Those comparisons are hard to neuros while edss stuff is soft.
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MRIs, placebo, controls, progression

Postby 1eye » Sat May 29, 2010 5:01 pm

There are more than one variable. There are the facts that all these cases have had various doctors, stents vs. no stents, dilation in different places, etc. There is so much difference from one case to the next because it is a disease that can attack in many different ways. Somebody needs to study the set of presenting symptoms and see if there is any commonality to that, and whether there is any correlation between MS symptom and vein problem. Dr. Simka has said that the most common feature he has seen is a valve problem.

There could be a questionnaire to do with prominent symptoms, and prominent reversals.

But to me the hardest problem is that everybody with MS has to be treated. What we have now is research in Canada that's depending on donations, people that have enough money paying for treatment with a variable price, which may or may not include the cost of a trip to India or somewhere else overseas from where they live, and no agreed upon standard of care for a disease that we know very little about.

It is congenital but it continues and may morph into MS or something worse at various times during human lifetimes.

We have venoplasty with balloons that can be used sometimes to restore venous flow and that will sometimes result in significant restoration of the damage it causes.

Since MS symptoms have never been addressable in this way before and the prognosis for the majority of MS sufferers has been bleak, and this treatment, though it is unpredictable, has had a lot of very good results, most MS victims will want it. But the most common thing MS does to people is to make it impossible for them to earn an income (after they have become Secondary Progressive). Secondary Progressive MS (and Primary Progressive MS) has a problem: Paulo Zamboni said these patients do not benefit as much (hardly at all) from the procedure.

There have been dramatic exceptions. The users of stents have been able to maintain better patency. Zamboni says that the azygous vein is associated with this more disabling form of MS, and they seem to be harder to assess and work on. So all in all I think we still have a long way to go in studying this disease.

It will be less profitable to sell MS drugs if all of the less severe cases (who have a better chance at successful recovery) are treated. But these are also the ones being prescribed the expensive drugs, so this may (may) result in less insurance claims. And it has been said that at least progression can be stopped for the more disabled.

But the MS drugs that *were* so expensive, were the reason there was money around for putting a lot of investment into treating people at earlier disease stages. The most affected, with the least hope of improvement, will be the persons who have the least earning power, and so the least ability to pay.

So what will they do? What will governments, and charities, do? I think it is critical that it is determined whether this treatment stops progression or not. The easiest way to find this out might be to ask the patients themselves, the ones who had converted to SPMS *before* treatment, if they think, after one year (or more if they can be found) that their disease progression has stopped, or is starting to reverse itself. This self assessment is I believe, as valid as any, after one year.

Placebo, I think, can be discounted also, after one year. MRIs are going to be written about by the people running the tests. And self-assessed items like these do not benefit from controls. I think the reason controls are ever needed in MS is that the disease is so unpredictable. Otherwise we would have enough data on its natural history after 150 years, to be able to know how controls would fare after 1 year of no treatment.

My other statement is that I think EDSS can be self-assessed, or at least, does not need a neurology appointment. It is very straightforward and descriptive, so that it is obvious if a person can walk 50 yards without any support, needs bilateral support, or not, etc.
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Postby emess2 » Sun May 30, 2010 8:32 pm

How many of you have not made adjustments to your life in an attempt to improve your circulation since learning of Zamboni's findings?

I've adjusted my supplements, added some peppermint tea each day, sleep on an inclined bed, have acupuncture treatments and an external application as well. All these are designed to promote circulation.

My point is that I can't be part of a control group that hasn't been liberated. They have to find a group who ignores their vascular health to make a proper control. Is that really possible anymore?

"Science" of the era of our neurologists is dead. Our ability to communicate with each other has killed it. They will never be able to prove or disprove the effectiveness of CCSVI treatment based on their old-fashioned scientific method.

Unless, of course, a group of us agrees to ignore our circulation and vascular health in order to give them a control group. Any martyrs out there?

Our anecdotal evidence may be all we ever get. Let's keep speaking openly and honestly to each other and keep supporting that portion of the medical community that is willing to act now.

I fear that 20 years from now, we'll still have no 'scientific' proof, even if we've all but eliminated MS. I'm not a co-operative guinea pig and I'm not waiting for them to find some.
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Postby NZer1 » Mon May 31, 2010 2:08 pm

This thread hits the nail on the head, where the investigation goes from here needs very careful thought, not just doing things because its available.
MAKE A PLAN that will benefit as many as possible.
Please read Cheerleaders thread "Treating CCSVI--multi-factoral care"
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