This Is MS Multiple Sclerosis Community: Knowledge & Support

link to Siskin review

link to Dake review
bottom line, we need multidisciplinary coorperation for studies....because that's the right thing to do.
cheer

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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

We need multidisciplinary cooperation but will we get it? 'Total lunacy.' There's not much to build on when one side thinks the other side is insane. The dismissal of the concept of CCSVI as outrageous does not make sense to me. The brain is an organ like any other.

When he asks what the endovascular treatment is really affecting, flow or something else, what else could it be but flow? I am not sure I understand that question and he considers it a fundamental one.

Does looking for evidence that the trajectory of disease progression is altered after CCSVI treatment not include QOL improvements?

The neurologists have stated that the improvements from CCSVI venoplasty are placebo. Dr. Dake wishes to study this, to see if it is true. That is the "something else."

Jeff's improvements of reversal of brain atrophy, relief of night time spasms, bladder issues and apnea would point to relief that isn't due to placebo, according to Dr. Dake (ie: they are involuntary bodily responses) but this will never be published, due to the lack of an IRB when he was treated. Dr. Dake is trying to get his study approved, and he needs the neurologists to submit their parameters for an acceptable proof of a successful treatment. So far, they are refusing to engage. Quality of life improvements will always be considered placebo, sad to say, Cece...
cheer

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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

It is really a shame that some Neuro's are closed minded.

We recently went and saw a MS "Specialist", I asked about CCSVI, after my wife was told there was nothing they could do for her. The responce was don't waste the 20K, it is just a shame...

How do these people sleep at night?

Would placebo result in the "relief of night time spasms"? Does placebo work while you are asleep? That is one of the improvements I have experienced. That said, I didn't know it until my wife told me that the spasms were much better while I was asleep. Certainly, “I feel better” or “I am less tired”, is difficult to quantify. But is that the same as someone else seeing the difference? I think not.

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Chuck

Mr. Success cannot see how CCSVI can involve a placebo arm in any future Trial. It is one thing to ask test subjects to ingest one pill or another .... now compare that process .... to having your body cut open .... and a wire fished through your veins ... and through your heart ........

Not to mention numerous times inside an MRI machine .......

It would take one hell of a healthy volunteer to accept those conditions.

And all of that is needless ..... as there are no shortage of people willing to undertake this procedure.

Of interest ..... is the recent mention of "soft" vs "hard " .... MS symptoms. The so-called soft MS symptoms are truly ..... not proof.


It is the " hard " MS symptoms that are the tale of the tape.

You cannot fool or dupe qualified trained professionals ....with respect to your hard MS symptoms.

If you can ........ you need a new doctor or other medical professional ........ as their observational ability's .... are harming you.



Mr.Success

We are talking hard and soft MS symptoms but there are also hard and soft CCSVI symptoms. A hard CCSVI symptom would be improvement of flow through the vein after CCSVI venoplasty. Dr. Dake's trial will be looking at this. It is quantifiable. Curses upon the neuros of Stanford or whoever it is who is holding up his fully funded trial.

As for QOL symptoms being placebo or indistinguishable from placebo...carotid artery stenting is similar to ccsvi venoplasty, it's just the other side (blood inflow to the brain instead of blood outflow). In a quick search of carotid artery stent trials, QOL is listed as a secondary outcome measure.

Dr. Hubbard's study has QOL as a primary outcome measure:
http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=1

Dr. Siskin's trial has QOL as a primary outcome measure:
http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=2

Dr. Mehta's trial, interestingly, does not, neither primary nor secondary:
http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=5

Dr. Simka's trial includes the MSIS and FSS (fatigue severity scale):
http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=6

Dr. Zamboni's trial includes some QOL measures as secondary outcomes:
http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=7

QOL is measureable and particularly in a sham trial, it can be distinguished from placebo by comparing the two arms.

I just wish all the research was done, rather than still beginning. C'mon guys...we've been at this for years now.

What is of primary urgent extreme importance to me, and I'm sure to many others on this forum, is to know that our kids will not get "MS"/CCSVI. They have seen what it has done to me since they were babies, and they are scared. This war of words hurts them the most, and for that I get very angry. When will all these grown-up doctors and would-be scientists start acting their age, start thinking about something besides $$$$, and set a better example for the future generation?

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"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

I don't mean to be a nay sayer about the importance of QOL...obviously, to anyone with MS or anyone who loves someone with MS, it's all about QOL. Jeff's most horrific MS symptom was fatigue that left him unable to work or drive or stay up for more than 2 hours at a time. That was the first thing that remitted, and has remained gone for 28 months now. But as Cece said, there are "hard" and "soft" proofs of efficacy and fatigue relief is considered "soft." Because neurologists believe pwMS are highly suggestable and your disease waxes and wanes. They do not trust what you report yourself.

Getting the neurologists to specify WHAT THEY NEED to see as proof of efficacy of venoplasty has been impossible. That is why Dr. Dake wrote this editorial. He has seen the relief of fatigue and spasms that Jeff had in those he treated for vena cava syndrome....and no one called it placebo in those patients. He sees it as the result of successful venoplasty.

Hard proof in MS drug trials is reversal of brain atrophy, healing of lesions, lack of new lesions and similar evidence on MRI. That's what the neuros want to see, but they are also insisting pwMS stay on their drugs duing venoplasty studies...and you can bet any MRI changes will be credited to the drugs. It is an impossible situation. Catch 22.

This is the problem....and why we may need to separate CCSVI studies from MS. The MS specialists are intrasigent. (Cece, I add to your curses.)

One eye...for your kids, here's what we're doing for our son- Vitamin D supplements, fruit and veg, exercise, sunshine, laughter, lots of love and prayer. And if he shows signs of MS, a trip to our favorite IR.

_________________
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

so who decides ? Who decides if your quality of life has improved ?

Do you really care if your doctor does or does not share your opinion ?

Using an mri of your head as a " MS Scoreboard " .... seems a rather weak method. True. The mri ..... will show changes.

Bottom line for Mr.Success ...... are the - MEASURED - improvements [-or not -] .... of any of the so-called " hard " symptoms .

These are : Timed walks . Hand to eye coordination skills . Memory tests. Balance. ALL of these cannot be faked . Either you can or you can't.

I accept ..... but give little weight to ..... I sleep better. [ prove it ]

Not saying I don't accept your opinion ...... just saying.... where is the evidence ?


Mr.Success

I have switched neuro’s in the last couple months. My old one knew about CCSVI and was neither supportive or particularly critical. I have not mentioned it to the new one yet. My next MRI is next month and I am looking forward to what it shows, good or bad, or no change at all.

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Chuck

The placebo effect can indeed have powerful and lasting influences on patients, because the effect is not just in "someone's imagination", but is actually a physiological phenomenon in which the body actually changes based on a strong belief by the patient that they have been treated. As long as this belief is maintained, the effect has been shown to be, in some cases, as powerful as any medication.

Here's a link to a fascinating article about the use of sham surgery in the treatment of Parkinson's Disease, which profiles a patient who was wracked by that extremely disabling disease, and underwent experimental brain surgery (yes, his skull was drilled open, his brain exposed, but no actual treatment was done) as part of a double blinded study. His disease went into remission for a full year after the surgery, even though it turned out he was part of the placebo group:

http://journals.lww.com/neurologynow/Fu ... ks.15.aspx



The fact is that the placebo effect is very real, very powerful, and is not purely the product of wishful thinking on the part of the patient. I'm not saying that what we're seeing in the treatment of CCSVI is placebo, but certainly placebo plays some role, as it does in any treatment for any disease. Suggesting that the results of venous angioplasty may in part be due to the placebo effect is not an accusation that some patients are engaged in self-delusion, but rather is an expression of a scientific reality.

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Marc
www.wheelchairkamikaze.com

It grinds me that neurologists speak of snake oil when commenting on CCSVI. Snake oil costs a couple of dollars per bottle and it does nothing, except maybe give you a little buzz from the alcohol content. The disease modifying drugs that the neuros peddle cost $20,000 to $40,000 per year and also do nothing insofar as slowing the progression of the disease. And the DMDs can make you sick or even kill you. Given that, snake oil sounds like a good deal by comparison.

that's a very informative post , Marc. I read the whole article.

I guess having CCSVI treatment compared to / with brain surgery & Parkinson's is more or less ....... a step forward ?

Did the Neuro community scream and shout from the rooftops , when this was proposed as a fix ? Or a test for a placebo effect ?

The more we know ...... the more confusing ..... it all gets .

but all things aside ...... there is a HUGE difference between a exploritory tube snaking through your veins [ I understand most patients are awake ] versus ..... having a hole drilled in your head .... fully sedated .

given a choice ........ I know which one I would take ......

Any idea how many other patients got the placebo drill ?

There is always an exception to every rule. Evaluating the results on the basis of ONE Parkinson's patient ....... strikes me as unreliable.

As we know ....... there are numerous CCSVI treated patients now available to establish some hard facts.

I look forward to gleaning the reports.



Mr.Success

As horrifying as it sounds, many brain surgeries are performed with the patient conscious. I believe it's so the surgeons can ask the patient what they are experiencing as they probe the brain, to make sure that they are in the right area. Not sure about the Parkinson's surgery in question, but it wouldn't surprise me to find out that the patient was not knocked out.

According to the article, one third of the patients involved in the study were given the sham skull opening. Not sure how big the entire study was, but the final results showed that the drug didn't have any greater effect than the sham surgery, so if this one patient is any example, his experience probably isn't all that anomalous.

The fact that MS patients are awake during venoplasty would make the argument for a strong placebo effect more plausible, since they can be sure that a procedure has been done on them. There have been studies that show that the more trouble at patient needs to go through to procure a treatment, and the more elaborate the treatment, the higher the chances of placebo affecting the patient's perceived outcomes.

As an example of the power of placebo, in one study, two groups of headache sufferers were both given the same placebo pill. One group was told price of the pill was $.50, and the other that each pill cost five dollars. The group that was told that each pill was five bucks reported a much higher degree of pain relief.

It's a fascinating topic, and for whatever reason, MS is known as one of the "poster children" for the placebo effect.

Unfortunately, practically all of the outcomes regarding CCSVI treatment are self-reported (self-reported outcomes skew hard towards the positive), and of the thousands of people treated, we only have a relative handful of reports to go on. What's desperately needed are quantifiable pre-and post-treatment examinations by a blinded third-party. That's really the only way to nail down what's actually going on here…

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Marc
www.wheelchairkamikaze.com