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The second phase of the study will randomize 20 MS patients to undergo either venous angioplasty or a “sham angioplasty” (i.e. a catheter will be inserted but there will be no inflation of the balloon). The treatment will be blinded in such a way that neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed.

Here is the relevant phrase from the press release. I await enlightenment as well.

Nicknewf, here is my understanding of how the Buffalo procedure works.

EVERYONE goes under general anesthesia for the procedure.

The first 10 who ALL got the procedure (already done) ... then they make sure there are no bad results in 30 days (safety). This is the stage we're in right now. Waiting for those 30 days - which I believe ends right at the end of July.

THEN

The other 20 patients are randomized into 10 get the procedure, 10 go under general anesthesia and don't get the procedure. THERE is the blinding ...

AFTER THAT, they are followed by the IRs and neurologists, and see if the 10 who actually got the procedure display benefits, display short term improvements followed by losses (could be described as either restenosis or placebo) or get worse,

And then compared against the 10 who didn't get the procedure either get worse, display placebo improvements from thinking they got the procedure, or nothing happens.


IF the study displays benefits ... then it will be offered to a larger group (which I believe isn't a trial at that point but were people who participated in UB's study of doppler and things like that) ...

That's my understanding.

Thanks Cece and CCSVIhusband - tick tock, tick tock

All in the name of science and saving lives..

I already feel for the controls, am so thankful for their generosity and pray they will be released from their duty and treated as soon as possible.

General anaesthetic is not to be taken lightly and will they awake with a groin incision?

..

ohhh..for ... the.. love.. of ..god!!!... stop this!! please!! ..blah blah blah ..

Jimmylegs.. how about a 'great ccsvi debate' sticky?

joge wrote:Thank you all for your information.

This is a good start, but critics will say: It's only done on 20 patients... So I'm afraid we also have to wait for the results of a second trial.

What do you think?

I think trial#1 the safety trial will show veinplasty to be safe. To be sure, we already knew, but why not have the same monkeys do the safety as the monkeys who will be doing most everybody else soon?

Trial #2, the efficacy trial will show that there is no placebo effect to be concerned with.

This is I think 20 people, half sham, and there will likely be 10 who can tell, with the other 10 (over days to months) showing marked improvements, so they will be able to tell as well. Proving the improvements are not placebo.

Soon after, it will be announced that the procedure will be done unblinded on 100 more. The results will have shown that it is better to go in on the left side, and also to take what Dr. Zamboni says at face value. There will be later changes to the best practices established in this and other trials. After the 100, the deluge.

That's what I think.

What will happen is a whole nother can of sardines.

CCSVIhusband wrote:Nicknewf, here is my understanding of how the Buffalo procedure works.

EVERYONE goes under general anesthesia for the procedure.

Severql of the comments on this thread seem to confuse general; anesthesia with sedation. Sedation for a procedure might be something that we lay people would consider ansethesia--you feel no pain, you have no memory of what happened, etc. You don't need to be "put to sleep" to remember nothing, and feel no pain. I think I had both my hernia operations done under deep sedation, and I know I had both colonoscopies I have had done under sedation, and I remember nothing about any of those procedures.

However, ansethesia involves up to 10 drugs and a patient who is truely unconscious. If a patient is under light sedation for a procedure, for example most angioplasties, he is even responsive, and the Dr. may ask him/her to cough, turn his head, etc. Yet there are drugs that are administered that produce amnisia, so the patient does not remember.

I have not been able to find out, but it is my guess that sedation with or without amnisia, is what is used since that is generally what is used for angioplasty, and that would be sufficient to blind this study since they are inserting the catheter in everyone.

General anesthesia also involves some serious risks, and I doubt an IRB would approve its use in placebo subjects.

Also, anesthisia requires the constant presence and vigilance of an anesthisiologist, a very significant expense added to each procedure that is probably not necessary.

Fogdweller.. thank you!.. this makes much more sense!

I found out the tranquilizer I use as a sleeping pill (very rarely) is also a date-rape drug. No, I just heard that it is. Not up to either, plus not interested. I hear you don't have any memory afterwards with that drug , but after I wake, I can remember everything. Except what year it is. And maybe a few others, I forget.

1eye wrote:I found out the tranquilizer I use as a sleeping pill (very rarely) is also a date-rape drug. No, I just heard that it is. Not up to either, plus not interested. I hear you don't have any memory afterwards with that drug , but after I wake, I can remember everything. Except what year it is. And maybe a few others, I forget.

What exactly is it that you don't remember>

fogdweller wrote:Severql of the comments on this thread seem to confuse general; anesthesia with sedation.

Thank you for the clarification on the two.

I remember someone saying they had the liberation under a 'twilight sleep' sort of sedation, this could be something like that?

Also I was thinking that if we apply Siskin's clinical findings that a third of the patients he's treated have big improvements, a third have small improvements and a third have no improvements, then if that holds true in the Buffalo randomized trial, we should see 2/3rds of the 20 treated patients (both safety and trial combined) have improvements, so about 14 of them. If the placebo effect holds true at 30%, in the sham treatment group, we should expect about 3 or 4 people to claim improvements. So if we see figures like 66% of the treated group improved and 30% of the sham treatment group improved, those would fit with what Siskin has found clinically.

Please note this as my prediction for when results are released.

this is all really stupid.

concerned wrote:this is all really stupid.

I do not think this post adds anything to the conversation.

Cece wrote:

concerned wrote:this is all really stupid.

I do not think this post adds anything to the conversation.

I don't think that one does either.
I'm just saying I'm not interested in people making wild accusations about me, instead of adding anything to the conversation anymore.

P.S. - I said this is ALL stupid, not just your "side"


EDIT: Cece, I didn't mean your post or the thread as per the OP's intentions was stupid, just all the people trying to draw all the skeptics into fights like that.