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MS treatment has patients seeking surgery–but more testing is needed

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TORONTO—Like electrical wires, neurons are insulated. But in multiple sclerosis (MS), the insulation (called myelin) is stripped or worn down, slowing conduction along the axons—the wires of the nervous system. MS is widely considered to be an autoimmune disease, in which the myelin is attacked by the body’s own T cells. But Paulo Zamboni, director of the Vascular Diseases Center at the University of Ferrara in Italy, thinks a blockage in the veins that drain blood from the brain is the part of the problem. In his pilot study, published December 2009 in The Journal of Vascular Surgery, MS patients who had such blockages (called chronic cerebrospinal venous insufficiencies) fixed surgically, including Zamboni’s wife, showed a significant improvement.

News of the treatment traveled fast and MS patients around the world, eager for a remedy, began asking for the experimental procedure. But doctors outside the study remain skeptical. The main limitation to Zamboni’s pilot trial is that it was "open-label," meaning patients knew they were receiving the treatment and so did the researchers. And when hopes are high in both parties, bias can occur. But despite doctors’ cautionary words about Zamboni’s preliminary findings, some patients have journeyed to clinics in Poland and beyond and paid more than $10,000 for the procedure.

Zamboni’s controversial treatment, which he presented here as an invited speaker April 14 at the American Academy of Neurology’s annual meeting, highlights the need for properly designed clinical trials in which patients are randomly assigned to treatment and placebo groups and both patients and researchers are unaware of who has received treatment or placebo. Promising results from open-label pilot studies can prompt patients, desperate for a cure, to seek out risky and costly experimental treatments that might not work as expected.

Image: iStockphoto/dpmike

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  1. 1. scientific earthling 8:07 pm 04/16/2010

    Must we always have blind tests and designed experiments?

    Collecting statistics from the results can also help assess results. In manufacturing chemistry design experiments are the only way to prove the effect and interaction of variables on a process according to the experts. However data from manufacturing processes, where the process variables change (some operators have their special settings – they actually get better results) will also give us information about the effect of the variable and its interaction with other variables.

    Remember as the variables increase the number of experiments increment exponentially.

    Blind trials deprive some of those taking part in the trial of benefits if the procedure is beneficial. The placebo effect also has the opposite effect if the member of a blind trial has a strong suspension he/she has received a placebo.

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  2. 2. cheerleader 2:10 pm 04/17/2010

    What is not reported is that Dr. Zamboni is not the only vascular surgeon to find this correlation. Other interventional radiologists and surgeons across the globe are finding a 90-100% correlation between MS and CCSVI when patients are tested by venography. There is a pattern of venous insufficiency found in the majority (70%) of primary progressive MS patients tested by doppler as part of the blinded Jacobs Neurological Institute Study. The health ministry of Kuwait is now testing and treating all of their MS patients, based on this evidence. And patients are clamoring to be tested and treated, because time equals brain in this horribly debilitating and progressive disease. A plea to vascular doctors around the globe–please study the venous return of the jugular and azygos veins–now.

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  3. 3. bridgetparsons 2:54 pm 04/17/2010

    Putting the MS issue aside,this blockage is a vascular problem.As with any blockage it is causing problems.If the benefit of it is a reduction in MS symptoms,well thats a bonus.Time will tell if the ins and outs of the role that the blockage plays is MS.Yes,that requires more research.The blockage side of vascular.Repair the vascular side of it and research the MS correlation over time.Iam on a medication for my Ms.You can’t tell me that everything is known about the long term effects of this medication.Unblocking a blockage is a medical procedure.Short and simple.Long termeffects of it is better quality of life.It’s a win, win deal.

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  4. 4. Bev B. 2:55 pm 04/17/2010

    I’m asking that doctors out of Loma Linda Hospital take a look at this and on compationate grounds start treating people, just a Jesus would do.

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  5. 5. Bev B. 3:02 pm 04/17/2010

    My prayer is that Interventional Radiologists and Vascular Specialists out of well respected Loma Linda Hospital will do what is right and on compationate grounds and follow Kuwait and treat all people with CCSVI, today, just as Jesus would do. There is so much evidence already published, surely we don’t need more, or to wait for everyone to do their own research before doing the right thing.

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  6. 6. SamanthaG 3:03 pm 04/17/2010

    Because of the preliminary dramatic correlation between CCSVI and MS, I believe it is vital to carry on research concurrently with patient treatment. Patient treatment can also provide important data including objective measures of possible improvements (MRI, EVP, EDSS improvements), thus contributing to the data pool. Dr. Zamboni’s patients are far enough along for placebo effect to be less enduring, and the use of objective assessment tools can aid in confirming the status of their health outside of subjective reporting. Doctors can learn valuable information from both direct patient care as well as under research protocols.

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  7. 7. prairiewalker 3:23 pm 04/17/2010

    For those seeking more information, see for a thorough listing of the publications on CCSVI.

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  8. 8. redcloud 3:49 pm 04/17/2010

    I absolutely disagree on wasting time for more research.
    WHY PEOPLE SO IGNORANT ON others who is suffering.
    None of the medications is to cure the MS so is CCSVI! Each pill is good for one thing that;s why I take 5 different of them everyday. Well maybe CCSVI will be helpful on one other symptom that pills can never do! I honestly have no expectations from doctors who is against to CCSVI only until their sons or daughters will have MS. I tried for months my doctors said no, none of my trial requests were responded. Yes, I am in pain, can not walk, can not talk WHO CARES!! Another human being, I lost that trust long time ago. A t least don’t let kids suffer because of your negligence of doing your duty as doctors.

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  9. 9. curmudgeonine 4:14 pm 04/17/2010

    Dr. Zamboni also urged governments to allow people to be treated for compassionate reasons.

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  10. 10. Retired Naval Officer 6:05 pm 04/17/2010

    The issue becomes very straightforward if it is looked at from a non MS or Neurologists point of view.
    1. CCSVI is a newly found venous condition that is real. The Zamboni & Buffalo studies to date are sufficient to prove that.
    2. The primary indications of CCSVI are the same as MS symptoms. That is fatigue, numbness, balance and gait issues, optic neuritis, etc.
    3. The confirmational tests for CCSVI are safe for patients. The protocols for their use in this application will improve as tthey get more use, but there is no patient safety issue with dopler US or venography.
    4. Venous angioplasty by IR specialists is a known safe and effective treatment for CCSVI stenosis.

    So how could anyone rationally argue against treating people suffering with CCSVI now?

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  11. 11. lavmac56 11:57 pm 04/17/2010

    I think asking Loma Linda for their help is a wonderful idea!

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  12. 12. lavmac56 11:58 pm 04/17/2010

    I think contacting Loma Linda is a wonderful idea!

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  13. 13. zhenya 8:44 am 04/18/2010

    Why this theory makes perfect sense can be summarized by the publications. What I can say, as someone who had the procedure, is that I feel a variety of improvements just a few days later. Balance improvement came same day. The procedure was safe and relatively simple, i do not see ANY reasons why this should be denied to desperate patients. I realize that many just want to write off people with MS however this is real and it does work.

    Although several IRs have laughed at me, when the last one went in with a catheter venogram it was quite evident that stenosis was not in one but both jugular veins. I, and other who have endeavored to do this, are feeling dramatically better. A disease with no hope finally has hope.

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  14. 14. graciesnan 12:04 pm 04/18/2010

    This year marks my 33rd year with this being the first thing I think about when I wake up and the last thing I think about at night, so far I have remained ambulatory but that is slowly slipping away to the point where I see arehabilatation theratist tomorrow to get the best fit in a wheelchair. Powers that be out there, I am all out of wait!!!!!!!!!!!! I don’t need the life perserver after I’ve drowned!!

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  15. 15. galileoX 9:33 pm 06/7/2010

    I understand the reticence to accept Dr. Zamboni’s treatment. However, medical progress is sometimes made at a snail’s pace partly because established vested interests feel threatened. This seems a simple procedure that I would seek were I suffering from MS. The big drug companies might not be happy. There are times to think outside the box as Darwin did.

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  16. 16. mazzalupi 5:00 am 01/25/2011

    A Nobel worthy breakthrough with a simple mechnical fix. Perfect. Reminds me of another Nobel worthy discovery, that of H. Pylori (the culprit behind many stomach ulcers) which also struggled for many years to see the light of day.

    How many other cureable conditions are being kept under the thumb of some of pseudo-scientists using some autoimmune or other broad based, wishy washy, catch-all phrase like inflammatory bowel disease?

    I hope that the scientific community takes note of Dr. Zamboni’s discovery from the point of view that he has simply discovered a pattern which didn’t require any advanced medical knowledge – the cause was right there for everyone to see using good ‘ol scientific observation techniques.

    If it were not for all this – political, personal pride, corrupt, greedy, "everything is genetic" and "the body is so dumb that it’s attacking itself" thinking – we probably would have had several other important finds by now.
    What’s more, with today’s advanced computerized scanning, it’s almost criminal that we aren’t scanning and analyzing vast amounts of patient data for physical abnormalities/patterns. Who knows, perhaps Google will make the next significant discovery in medicine?!

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  17. 17. colros 9:47 am 01/25/2011

    Zamboni’s "CCSVI" is junk science and his "liberation" treatment is a very profitable scam. No one, including MS patients, has increased intracerebral pressure or "reflux" causing brain pathology due to blocked neck veins. See my blog for details:

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