DrSclafani answers some questions

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

Postby 1eye » Mon May 17, 2010 7:24 pm

I am reposting this her because I am half-serious, and really I think it is a clever way to get myself treated, using myself as a control.

I would like to volunteer myself as a subject for a test of CCSVI vs progression. I have recently completed a trial that tested my progression at three-month intervals for more than two years. It was a trial of MBP8298.

The standard nine-hole peg test, walking, and PASAT tests were used throughout. I was examined on this quarterly basis by neurologists. My results are probably obtainable, through the company that made Dirucotide, and they also included MRIs I think every six months.

So (since I have continued to progress since then, and was in the placebo group) the comparison can be made of any effect Liberation treatment has on my progression.

The experimenters can decide ahead of the test, what peg, walking, and/or PASAT performance level will be acceptable as evidence I have or have not progressed, and these same tests can be repeated indefinitely.

This evidence will be anecdotal, but very compelling, since it will be directly comparable to my performance on a study in which Dr. Freedman was directly involved.

Experimenters will be able to see if my performance with CCSVI treatment exceeds my performance on placebo for long enough to eliminate the placebo effect, if it has any bearing on anything. It may not be possible to get all the data from BioMS, but I do think I know of at least one person who also may agree to become a subject.

I have been on no DMDs for at least five years. I will not try to influence the results.
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Postby Cece » Mon May 17, 2010 7:48 pm

newlywed4ever wrote:MORE Importantly! I agree with you about a study using fake venoplasty by not inflating; I cringed when I read that post.

Yeah, I wouldn't want to be in that study, and I was the one who thought it was noteworthy enough to bring up here.

I'm in favor of randomized trials if that's what it takes to get this accepted but I'd rather it not be necessary. And I don't know that it is. As far as I can google, angioplasty has never been subjected to randomized trials yet it has been in use for thirty years.
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Postby NZer1 » Mon May 17, 2010 7:51 pm

Thanks for the update Dr. and others.
I have received Squeakycats first questionnaire and I hope it will be of use. Something that can be flicked around the globe at nil cost would be of so much more benefit. Some kind of adjust for error could happen. The use of expensive (MRI) type testing would not be practical for this trial. The same goes for anything that is dependant on the skills of the questioner or if there was a need for a Neuro or anyone who may have a bias.
ALSO wondering how you will go D.r with Satellite clinics around the globe :lol: New Zealand is a fantastic destination or ideal as a new central base, with easy access to rejuvenating your body, mind and soul! :lol: :lol:
Enjoy and thanks
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Postby Cece » Mon May 17, 2010 7:58 pm

Donnchadh wrote:First of all, as someone who actually underwent the balloon procedure, it would be very difficult to partially inflate a balloon just enough for a MSer to perceive it and at the same time not be enough to relieve the stenosis.

I think I misrepresented the study at first; when I found the full quote from CureIous, it sounds as if the patients would be out under general anesthesia during the procedures. Which actually adds another layer of concern to the whole thing.
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Postby girlgeek33 » Mon May 17, 2010 8:01 pm

Reading all the postings about randomized trials and sham surgeries it occurred to me, can't we just do studies without needing to have such things? What is the highest percentage of any "placebo" effect? From the number of people I have communicated with that have had the liberation procedure, almost everyone has significant improvements. If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough. There are so many of us, we would be lining up for these studies, well we already are, most seem to get on every list possible. I guess what I'm asking is that if significant results show in these types of studies, isn't that enough for the scientific community? Especially if we are talking about quality of life. That's what all of us with MS really care about!
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Postby Cece » Mon May 17, 2010 8:04 pm

girlgeek33 wrote:What is the highest percentage of any "placebo" effect?

35% is the number to beat...also apparently the more effort you go to for a treatment, the higher the placebo effect (and travelling in order to get surgery is a fairly high effort)....

drsclafani wrote:i think designing trials is going to have to take this into consideration. How can we remotely follow up without losing patients to followup

We need an angel investor with lots of frequent flyer miles.
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Postby girlgeek33 » Mon May 17, 2010 8:22 pm

Cece wrote:
girlgeek33 wrote:What is the highest percentage of any "placebo" effect?

35% is the number to beat...also apparently the more effort you go to for a treatment, the higher the placebo effect (and travelling in order to get surgery is a fairly high effort)....


Thanks CeCe...

I also have to wonder, at what point does common sense factor into science? Like someone needing a wheelchair pre-liberation, able to rely on only a cane post liberation. Absence of a headache that a patient lived with every day for years. Or as in my case, no need for sleeping pills post liberation. Anecdotal, placebo, whatever. In our great numbers showing such significant changes has to make an impact on those in science...

And while I'm on my soapbox... They have never been pushed to prove the things they so quickly blame on our MS. Like fatigue. They have never had any scientific reason to understand why fatigue was experienced by many with MS. for a long time, it was not accepted as a symptom of MS. And then there it was, readily accepted and listed as a symptom of MS. And there have been other symptoms too, they aren't MS and then a few years later, they list it as a symptom because, who knows, enough MSers report to have the symptom? I developed severe migraines last year. No tests were run to see if anything new was going on, it was chalked up to MS, without even batting an eye. So many of us live with the frustration of what is a symptom of MS, what is a side effect of medication and what is just something else going on because of life or god forbid, some other new health condition! How did it become so acceptable to just write off so much to MS without doing anything about it?!

Okay, so do we have rights as a whole group to demand all sorts of studies as to why they feel they can lump any symptom we have into MS and not allow us to get the proper treatment we deserve? (yeah, I'm venting...)
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Postby Cece » Mon May 17, 2010 8:30 pm

girlgeek33 wrote:If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough.

I think this is exactly what Dr.S concluded, many pages back: if the pilot studies come back with overwhelming results, then no need for the randomized trials.
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Postby girlgeek33 » Mon May 17, 2010 8:34 pm

Cece wrote:
girlgeek33 wrote:If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough.

I think this is exactly what Dr.S concluded, many pages back: if the pilot studies come back with overwhelming results, then no need for the randomized trials.


Yeah, I recall him saying that. But everyone still keeps bringing up the others. I was very impressed that Dr. S will be doing his study as a safety study. And others don't necessarily sound like the studies they may start up are along these lines...
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Postby costumenastional » Mon May 17, 2010 10:45 pm

drsclafani wrote:
That collateral is significant because it indicates that there is an outflow obstruction. I do not think it is that large by the way. In another ten years it might be large.....but by then you would possibly be EDSS 5. I think one reason the collateral flow is so impressive is because the catheter tip is directly into the orifice of the collateral. It will push the contrast through the path of least resistsance.

unfortunately the views of the outflow at the confluens are just not the best.
Nor is the imaging of the Azygous vein (spelled correctly, i might add!) partaicularly good. Image quality is weak and the view is not a profile view of the arch of the azygous.

I am very impressed with the "waist" on the balloon of the upper jugular. I wasnt expecting that!

let us know how your next doppler looks

s


Thank you doctor!

Well, this is what was happening without the tip being directly into the orifice of the collateral. Same thing but as you predicted not so impressive this time. I guess that is what made them look into it.
I dont know if the "waist" is what causes that reflux you see there and the flow to go in the colateral. In fact i dont even know if it s the same side we are talking here. Xrays confuse me. I should ask while i was there but there was no time to look at my cds cautiously.

Image

LEFT JUGULAR? i guess...

Image

with the tip into the collateral...

Image

BALLOONING THE CONFLUENCE OF LEFT (?) JUGULAR.

Image

This IS the left jug simply cause i remember the pain :)

I am sorry but all captions of the azygous ballooning are terrible. I only remember that it hurt like hell and since they ballooned it i breath better!!! Also my heart dont go crazy like it used to sometimes pre op(!?)

For what it s worth here is my epicrisis:

Pre op doppler:
Highly advanced stenosis of both of the jugular veins with a minimum diameter of Left - 0.03 mm and Right - 0,3mm, V. Vertebralis sin. -2.5mm, V. Vertebralis dex. -3.2mm

Invasive diagnostic and therapeutic procedures performed:
Venography: V. Jugularis dex (i think this means right), -30% stenosis in the confluence, V. Jugularis sin (left) annuli in two areas, one near the bulbous and one near the confluence. V Azygous withhighly advanced stenosis. PTA and balloon dilation angioplasty was contucted with a 9/12 mm balloon on both jugular veins and 12/40 balloon on the Azygous.

Doppler post op:
Lying position: V Jugularis sin diameter 5mm and V Jugularis dex diameter 4.3mm
Sitting position:V Jugularis sin diameter 2.5mm and V Jugularis dex diameter 2mm

Just a notice: i dont get it. I mean the doppler results. It is obvious that most of my stenoses were not highly advanced after all. I just dont understand how the doppler measurements are so different before and after. And this happened to many patients while i was hospitalized.
Also, i have the impression that injecting the dye may help the surgeon recognize were the problem is, but watching its flow it is very difficult to imagine that such tight stenoses may exist. The docs assistant told me he could see perfect blood flow. Then Dr Petrov came and found 4 places with problems. All i want to say, and please, correct me if i am wrong, is that the gold standard wouldnt be so gold if some surgeons were not so cabable. I do not think that the dye indicates the real chronic problem of the blood flow and sadly it might take years until diagnosis methods are perfected. And for now, all they do is stopping scientists from taking this further...

Sorry for the size of the post dear dr Sclafani.
Last edited by costumenastional on Tue May 18, 2010 1:31 am, edited 2 times in total.
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Postby JOJOB » Tue May 18, 2010 1:25 am

Very interesting indeed !!!
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Postby JOJOB » Tue May 18, 2010 2:01 am

Hello Dr Sclafani,

I have myself a question to ask you.

I had a doppler in Paris with DR...., He did not find anything specially wrong with my jugulars except for the valve not working properly in my left jug. He told me to sleep in the inclined position. He also told me to come back to him in the next few months to have my azygous veins checked as he thought that a problem could be there.
In the meantime I have contacted an interventionist radiologist who believes in CCSVI and he programmed an MRV without any dye for the week after next. Is there any particular thing I should ask when they do it ? I have an appointment later with the dr, but it seems unlikely to me that the problem will be detected if it is lower down the azygous veins. If my understanding is correct, the only real method of finding anything is to have a catheter venogram. I would really appreciate if you could give me any guidance.
Thank you in advance.

For info: MS diagnosed 2005, 15 lesions on the brain plus one particularly annoying lesion at the top of the spinal cord that has been the subject of the last 4 relapses.
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Postby markus77 » Tue May 18, 2010 3:11 am

hey doc,

just a few questions. i had the procedure in poland a few weeks ago. i received a stent on one side and angioplasty on the other. when is it possible for me to start lifting weights again? i was told to take it easy for 3 weeks. also what is the best sleeping position? does sleeping on your side affect the blood flow?

thank you sir for your time
STAY REAL MY FRIENDS

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Postby girlgeek33 » Tue May 18, 2010 5:17 am

JOJOB wrote:Hello Dr Sclafani,

I have myself a question to ask you.

I had a doppler in Paris with DR...., He did not find anything specially wrong with my jugulars except for the valve not working properly in my left jug. He told me to sleep in the inclined position. He also told me to come back to him in the next few months to have my azygous veins checked as he thought that a problem could be there.
In the meantime I have contacted an interventionist radiologist who believes in CCSVI and he programmed an MRV without any dye for the week after next. Is there any particular thing I should ask when they do it ? I have an appointment later with the dr, but it seems unlikely to me that the problem will be detected if it is lower down the azygous veins. If my understanding is correct, the only real method of finding anything is to have a catheter venogram. I would really appreciate if you could give me any guidance.
Thank you in advance.

For info: MS diagnosed 2005, 15 lesions on the brain plus one particularly annoying lesion at the top of the spinal cord that has been the subject of the last 4 relapses.


You may want to ask why he ordered the MRV without dye. Most seem to be getting with & without contrast...
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Postby fogdweller » Tue May 18, 2010 7:20 am

girlgeek33 wrote:Reading all the postings about randomized trials and sham surgeries it occurred to me, can't we just do studies without needing to have such things? What is the highest percentage of any "placebo" effect? From the number of people I have communicated with that have had the liberation procedure, almost everyone has significant improvements. If safety studies and studies to measure lesions and measure degree of symptoms are all done, can't the significance of the results be enough. There are so many of us, we would be lining up for these studies, well we already are, most seem to get on every list possible. I guess what I'm asking is that if significant results show in these types of studies, isn't that enough for the scientific community? Especially if we are talking about quality of life. That's what all of us with MS really care about!


I am confused too. I was involved in doing a study with an endovascular device. We did not do sham surgeries. We just randomized the patients. Of course, our results were totally objective ... amount of ischemic dead tissue in the heart per subsequent x-ray like device. Not subjective like symptoms of MS. However, for a safety study I don't see why you would even do radomization.

I really have trouble with sham surgery in any guise from an ethics standpoint.
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