.

[Johnson]

That is my biggest concern about the Buffalo blind trial. If they have the same surgery except the balloon, who is to say there is no improvement to be expected? Maybe I am oversimplifying, but back to the plumbing analogies, aren't they snaking the drain? If they clear some minor obstruction with the catheter and someone feels better, is that placebo?

Exactly! There are known to be membranes and stuck valves and such, and they could skew the results significantly. I would think that the only way to be certain would be to use IV ultra-sound. I would think that they would want to do shams on some of the "non-MS" group that have CCSVI, and see if there is a change in the CCSVI presentation in them.

Combinations and permutations...

[CureIous]

That is my biggest concern about the Buffalo blind trial. If they have the same surgery except the balloon, who is to say there is no improvement to be expected? Maybe I am oversimplifying, but back to the plumbing analogies, aren't they snaking the drain? If they clear some minor obstruction with the catheter and someone feels better, is that placebo?

Exactly! There are known to be membranes and stuck valves and such, and they could skew the results significantly. I would think that the only way to be certain would be to use IV ultra-sound. I would think that they would want to do shams on some of the "non-MS" group that have CCSVI, and see if there is a change in the CCSVI presentation in them.

Combinations and permutations...

All the more reason to make veno the gold standard with a little g and not all caps eh? That being said, my own septum flap doohicky wasn't cleared when the stent was put in 8/2009, only when the specific spot was angioplastied 4/2010, admittedly though that would not have alleviated my ccsvi in and of itself (trying not to put too much into the 4/2010 thing as it was for a specific non/ccsvi reason for the most part).
That may have something to do with the larger diameter of the right side (vs my left) , compared with the "skinniness" of the cath+balloon (whether a stent is on it or not). Very interesting thoughts though. This kind of begs the question "how scientific can the scientific study get?", unless things can be definitively, and categorically included or excluded. At what point will enough be enough? (evidence that is).

And once again, we are back to the stark reality, that without sham surgeries to include/exclude the placebo effect, or at least mute it somewhat, all results are arguable, oh except for the "no ccsvi in ms" studies from Germany and Switzerland. wink wink.

Mark.

[Johnson]

he said:

she said:

I wrote:

Combinations and permutations...

All the more reason to make veno the gold standard with a little g and not all caps eh? That being said, my own septum flap doohicky wasn't cleared when the stent was put in 8/2009, only when the specific spot was angioplastied 4/2010, admittedly though that would not have alleviated my ccsvi in and of itself (trying not to put too much into the 4/2010 thing as it was for a specific non/ccsvi reason for the most part).
That may have something to do with the larger diameter of the right side (vs my left) , compared with the "skinniness" of the cath+balloon (whether a stent is on it or not). Very interesting thoughts though. This kind of begs the question "how scientific can the scientific study get?", unless things can be definitively, and categorically included or excluded. At what point will enough be enough? (evidence that is).

And once again, we are back to the stark reality, that without sham surgeries to include/exclude the placebo effect, or at least mute it somewhat, all results are arguable, oh except for the "no ccsvi in ms" studies from Germany and Switzerland. wink wink.

Mark.

But Mark, how do you know that reparation of the septum/flap/doohicky might not have put that vascular canal back into order? There must be a trial!

To satisfy intellectual and scientific curiosity, sham surgeries are great, but to we who live a life in hell (to varying degrees) every day, who cares? If sham surgeries are what it takes to satisfy the health care providers in Canada, many more will suffer needlessly. As a compassionate species, should we care if someone has relief of the horror for 10 days, or ten weeks, or ten years? I paid my 10 grand (equals six months in Mexico!) for 2 months of diminishing relief, and I did not have a sham surgery. It was real, and my relief was real - unless all of the doubt has instilled in me a nocebo effect. I don't have the freedom to have that real surgery (again), and follow-up at home, because someone wants sham surgeries. Then, someone will cry "hoax!", because those EAE mice have free jugular flow, but are still messed up.

The stark reality is that people are suffering while people who are not dick around with semantics.

This is getting goofy.

/rant

[CureIous]

he said:

she said:

I wrote:

Combinations and permutations...

All the more reason to make veno the gold standard with a little g and not all caps eh? That being said, my own septum flap doohicky wasn't cleared when the stent was put in 8/2009, only when the specific spot was angioplastied 4/2010, admittedly though that would not have alleviated my ccsvi in and of itself (trying not to put too much into the 4/2010 thing as it was for a specific non/ccsvi reason for the most part).
That may have something to do with the larger diameter of the right side (vs my left) , compared with the "skinniness" of the cath+balloon (whether a stent is on it or not). Very interesting thoughts though. This kind of begs the question "how scientific can the scientific study get?", unless things can be definitively, and categorically included or excluded. At what point will enough be enough? (evidence that is).

And once again, we are back to the stark reality, that without sham surgeries to include/exclude the placebo effect, or at least mute it somewhat, all results are arguable, oh except for the "no ccsvi in ms" studies from Germany and Switzerland. wink wink.

Mark.

But Mark, how do you know that reparation of the septum/flap/doohicky might not have put that vascular canal back into order? There must be a trial!

To satisfy intellectual and scientific curiosity, sham surgeries are great, but to we who live a life in hell (to varying degrees) every day, who cares? If sham surgeries are what it takes to satisfy the health care providers in Canada, many more will suffer needlessly. As a compassionate species, should we care if someone has relief of the horror for 10 days, or ten weeks, or ten years? I paid my 10 grand (equals six months in Mexico!) for 2 months of diminishing relief, and I did not have a sham surgery. It was real, and my relief was real - unless all of the doubt has instilled in me a nocebo effect. I don't have the freedom to have that real surgery (again), and follow-up at home, because someone wants sham surgeries. Then, someone will cry "hoax!", because those EAE mice have free jugular flow, but are still messed up.

The stark reality is that people are suffering while people who are not dick around with semantics.

This is getting goofy.

/rant

Thanks. But you are seriously preaching to the choir here. I'll tuck my head back in the foxhole here and stay out of it then.

Anectdotal is anectdotal is anectdotal, whether we say "not a placebo effect" quietly, or shout it from the rooftops. The people with the equipment and the know how and the facilities are the ones who need convincing. They hold the reins, not us, whether we like it or not, that's how it is.

Sorry for "dicking around with semantics".

[NHE]

Then, someone will cry "hoax!", because those EAE mice have free jugular flow, but are still messed up.

Let's not forget that an EAE mouse is really screwed up to begin with. So much so that it is a poor model for MS.

Not only do they have a high susceptibility to EAE, but they also develop prolific cancers as well as spontaneous myopathy making it a model for muscular dystrophy.

NHE

[Johnson]

Mark,

I was not referring to you in my semantics comment. My shrinking brain makes things harder and harder to elucidate. I had concern that my comments might be misconstrued as being directed at you. You ought to have seen it before I remedied the quote tags. I really ought to withdraw into my own foxhole again... Sorry.

NHE,

I think you bolstered my point on the mice. Thanks.

[PCakes]

The stark reality is that people are suffering while people who are not dick around with semantics.

i read this as a direct shot at health care.. and could not agree more.. How do they sleep? Family and friends question legal / criminal ramifications. They ponder the ultimate costs to our healthcare systems. Will the mounting proof of efficacy aid or hinder our cause?

[bluesky63]

I haven't been involved in this thread, so maybe I should just stay underground i the first place, but . . .

What I have failed to understand from the get-go is why everyone is so deeply concerned about the placebo effect when it comes to CCSVI and not with other MS treatments -- other drugs, other invasive treatments (did people write articles about placebo effect and suggest sham cell stem treatments?), etc.

In my many years of receiving newsletters and updates from the MS Society, this is the only issue that has been so systematically shredded. Others are either promoted, with fatalities and side effects glossed over, even with tiny sample size, unclear results, etc, or (in the case of questionable efficacy or downright flakiness) ignored.

So it's not the placebo effect itself that I care to discuss. It's why CCSVI gets unique treatment.

[PCakes]

What I have failed to understand from the get-go is why everyone is so deeply concerned about the placebo effect when it comes to CCSVI and not with other MS treatments -- other drugs, other invasive treatments (did people write articles about placebo effect and suggest sham cell stem treatments?), etc.

So it's not the placebo effect itself that I care to discuss. It's why CCSVI gets unique treatment.

EXACTLY!!!! ..

although dialogue and debate is healthy and, at least for me, broadens the scope of understanding and ability to discuss these roadblocks with our doctors.

(p.s. on your treatment!)

[concerned]

MS drugs have to undergo double-blinded controlled studies I think, even if they don't test that much better than placebo. I imagine it would be difficult to do a sham stem-cell treatment but I don't really know.

ALSO: I've never been personally affected by any other treatments or whatever before, if I was, I'd probably voice my skepticism about them as well. That's just my way.

[codefellow]

So it's not the placebo effect itself that I care to discuss. It's why CCSVI gets unique treatment.

I can see some of the fuzzy logic. If a drug does not work or causes problems, you can stop taking it. How does one undo a surgery? So it makes some sense to hold the Liberation treatment to a different standard. Hopefully our friends in Buffalo can breach this wall.

[Cece]

If a drug does not work or causes problems, you can stop taking it.

Unless there are permanent problems like lipoatrophy or death from PML that can't be undone by stopping the drug?

[Drury]

Cece just said what I wanted to say.

I will add that I cannot think of a single MS drug that does not have a significant amount of risk attached to it and that includes steroids.

Drury

[BooBear]

Cece just said what I wanted to say.

I will add that I cannot think of a single MS drug that does not have a significant amount of risk attached to it and that includes steroids.

Drury

Absolutely indisputable. Whether it's PML, increased risk of suicide, liver damage, kidney damage, thyroid damage, and much more, reversal is difficult if not impossible if these conditions occur as a result of the current MS regimens (and absolutely inclusive of steroids, as I can attest to).

What I don't understand is why the industry wants to treat a surgical procedure as they would a drug trial. This is easy enough, gang- get 200 MS patients. Test and treat half for CCSVI. Do nothing with the other half. Give MRIs, blood tests, etc. for both groups. Follow for two years. Report results. It does not have to be this difficult.

I liken sham surgeries to Nazi-era experiments. What monster puts a MS patient on a table, performs an invasive procedure (or pretends to) and refuses to treat a condition that they see? Is this really what we have come down to as a society in the name of science? Or profits? Shameful.

For the love of Pete, treat those that want it and let them move on. Venous compression (via CCSVI or anything else) is a real condition that deserves treatment.

[codefellow]

I liken sham surgeries to Nazi-era experiments.

That's a bit harsh, IMHO. INFORMED CONSENT makes all the difference.
I think we need these studies, but I agree that if you wish to take a risk on an unproven procedure and you are a consenting adult with all your mental faculties, and you are willing and able to pay for it yourself or can get your personal insurance to cover it, that is a highly personal decision between you and your doctor.