Controversial No More – Study Shows Much Hyped Multiple Sclerosis ‘Cure’ Doesn’t Work

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[Source: Wikipedia]

[Source: Wikipedia]

Paolo Zamboni didn’t buy into the conventional wisdom that multiple sclerosis was an autoimmune disorder resulting in the wearing away of the nervous system’s cellular insulation: myelin. Instead, the vascular surgeon from Italy was so sure that the root cause of MS was something called chronic cerebrospinal venous insufficiency (CCSVI), a vascular disorder which prevents proper blood drainage from the brain and spinal cord. Unfortunately, Zamboni wasn’t the only one who thought MS was caused by CCSVI. He’d managed to convince a great many patients and a small handful of practitioners to buy into his wisdom, as shaky as its foundation was.

That foundation has now gotten a lot shakier. At this year’s Annual American Academy of Neurology Meeting in San Diego, researchers presented findings of a study designed to evaluate the treatment used by Zamboni and others to treat CCSVI. Their neck venoplasty – freeing up blood flow by inflating balloons in veins coming from the brain – was shown to not only be ineffective in treating MS, the procedure actually made matters worse.

The new study compared the outcomes of nine patients who had undergone Zamboni’s treatment with ten who’d received sham surgeries. Six months after the procedure, the patients receiving the neck venoplasty were worse off – while only one of the sham patients relapsed, four of the patients receiving the treatment had relapsed by follow-up. Furthermore, brain scans showed that whether or not patients received the treatment surgery or the sham did not affect the size or number of MS lesions in the nervous system.

The study, led by Adnan Siddiqui and Robert Zivadinov, both at the University of Buffalo’s School of Medicine and Biomedical Sciences, is admittedly a small one. Nonetheless, it is the first double-blind trial of the procedure. And, considering the dubious evidence that chronic cerebrospinal venous insufficiency causes MS in the first place, it is being taken as a fatal blow to a treatment that experts the world over feel should have been shut down before it was begun.

Paolo Zamboni's controversial treatment for MS had generated much enthusiasm, few results. [Source: Wikipedia]

Paolo Zamboni’s controversial treatment for MS had generated much enthusiasm, few results. [Source: Wikipedia]

It was Zamboni’s own 2009 study, in which he found that CCSVI was present in 100 percent of the study’s MS patients, that generated the enthusiasm in the first place. The study had problems, however, the most egregious being that Zamboni was not blinded to the treated and placebo groups. Regardless, the study put CCSVI and the neck venoplasty treatment on the map as an MS cure, experimental as it might be, and patients desperate for another option flocked to clinics in abiding countries. By 2010, public support for the treatment was strong enough to prompt the US National Multiple Sclerosis Society to designate $2.4 million to research CCSVI, about 7 percent of its budget, despite overwhelming skepticism from clinicians and scientists.

Zamboni’s assertion that MS is a vascular disorder and not an autoimmune one derives from his idea that the accumulation of blood in the brain raises iron to levels that are damaging to the nervous system. A growing number of studies, however, fail to correlate CCSVI and MS, the most recent and damaging coming just this past October.

At the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Lyon, France, data from the largest CCSVI study to date was presented. A total of 1202 individuals with MS were compared to 669 individuals who were either healthy or had some other neurological disorder. They found that the prevalence of CCSVI was the same across all three groups, about 3 percent, and concluded that their data did “not support the role of CCSVI as a potential causal factor in the development of MS.” Unlike Zamboni’s the study was double-blinded – neither the researchers nor the patients knew who was getting the treatment who was receiving the sham surgery.

Just prior to the Congress a similar study had been completed in Canada that had reached similar results. To David Hafler, chairman of the neurological department at the Yale School of Medicine, the $5.5 million the Canadian government used to fund the study could have been better spent. As the told The Globe and Mail, “The debate in the scientific community was brief, swift and is over. The government has squandered precious resources not using peer-review, but instead using emotion and theologic belief and I think shame on the Canadian government for bowing into these pressures.”

Since 2009 over 30,000 MS patients have sought venoplasty to treat their disease. With the Buffalo study, however, that trend may soon subside. In the video below, Dr. Siddiqui (very, very clearly) points out that the study “isn’t the last word,” on CCSVI, but “the first word.” What’s unfortunate is that this “first word” didn’t come sooner, before tens of thousand of patients had sought treatment and millions of dollars had gone to questionable research. But this is what happens when it’s not just the patients who are overcome with wishful thinking.

[Source: ubcommunications via YouTube]

Discussion — 22 Responses

  • Maria Smith April 1, 2013 on 11:24 am

    He never said it was a cure you idiot! Do your homework before blabbing your uninformed, clearly ignorant opinion. How on earth did you get a job as a journalist? aren’t you supposed be thorough and 100% informed and have all your bases covered before writing anything?
    You’re an idiot, go back to school.

    • Peter Murray Maria Smith April 1, 2013 on 2:02 pm

      Thank you Maria for pointing out my liberal use of the word “cure.” It would have been more accurate to say Zamboni’s “treatment” to relieve MS symptoms does not work. I apologize for upsetting you so much.

      • Lori Batchelor Peter Murray April 3, 2013 on 11:41 am

        It worked for me! Even my neurologist has documented my improvements with neurological testing–not bad for someone with secondary/progressive MS who was NEVER supposed to improve! You can see my before/after videos on lorimayb’s channel on youtube–if you try to say it’s just “placebo”, maybe you should check how long placebos last–so far mine is over 2 years!
        Walk a mile in my shoes
        http://www.youtube.com/watch?v=yrH9GH0N4ck

        1 year “Angioversary”

  • Michael Mohammadi April 1, 2013 on 12:31 pm

    If Italy’s court was so brazen to throw climate scientists in jail for not predicting how bad earthquakes would be, I wonder what they’ll do to this guy!

    • Michael Mohammadi Michael Mohammadi April 1, 2013 on 12:32 pm

      Maria: You realize he said “cure” and was careful to note that it was experimental treatment? Reading and comprehension are your friend….

      Great article, Peter.

  • Richard Cook April 1, 2013 on 1:25 pm

    oopsie!

  • Ellen Ward April 1, 2013 on 2:37 pm

    Peter [no relationship, I hope],
    You left out the key finding of the study, at least as reported on the MedPage summary of the findings, since there is no published paper:

    “In addition to the lack of apparent clinical improvement in patients undergoing the procedure relative to controls, there was **NO** sign that the venoplasty improved blood flow.” [emphasis added]

    Since the WHOLE point of the procedure is to improve blood flow, the study seems to be saying that even an experienced interventional radiologist such as Dr. Siddiqui has problems identifying and fixing the problems in the beginning.

    Dr. Zamboni has neither said that CCSVI is THE cause of MS, nor that venoplasty is a cure. He points out very clearly the limitations of his studies and has repeatedly said the procedure should only be done as a part of a clinical trial.

    Further, it wasn’t that Dr. Zamboni didn’t “buy” the conventional wisdom of MS as an auto-immune disease, he saw that from the beginning, it was characterized as being periventicular, something that he, as a vascular surgeon was very familiar with. He is enough of an academic that when he first saw mention of this, he flew to Paris to personally review Charcot’s notes on MS.

    Every IR who has done significant numbers of procedures sees that there are very real differences in the veins of people with MS that impair cerebral and spinal blood flow. They also see how difficult it is to image these problems making one of the major challenges of treatment finding the problems and then fixing them.

    The Buffalo study is a good first step. It is unfortunate that so many have been treated outside of clinical trials, but if your brain were slowly slipping away, I think you would be at the head of the line to see if this procedure could help given the relatively low risk of intervention and the utter failure of existing therapies.

    The benefits of proper treatment are immediate, on the table, and commonly reported by those who have had the procedure. These include: immediate relief from MS fatigue, immediate improvements in balance, immediate relief from constant choking when eating or drinking, greater tolerance to heat, improvements in vision, improvements in bladder control, relief from headaches and migraines.

    It would appear that these common signs of MS may well be signs of venous insufficiency and correcting the impaired blood flow provides immediate relief. Whether these changes will also have an impact on lesions, atrophy, and other neurological signs of MS is still an open question. Many who have been treated have seen improvements in these areas, but the evidence is strictly anecdotal at this point.

    I find your tone amusing. It shows how difficult it is for new ideas to be accepted or even viewed objectively.

    Ed Murray

    • ericet Ellen Ward April 2, 2013 on 5:25 am

      I agree with Mr Murray a 100%, thank you.

  • Beth April 1, 2013 on 4:43 pm

    Look at the conflict of interest here. These researchers are on pharma’s payroll. If MSer’s are healthier, no more drug money. There are many flaws in this study. Significant data was thrown out. There are thousands of people who have remarkable improvement in their symptoms. Many say their lesions are fading away and have no new ones since venoplasty. Is it just for people with an MS diagnosis? No. About 30 other neuro type issues have been treated with venoplasty with success. Is it a cure? So far, not for everybody. But it certainly helps many people live a more productive life. Isn’t all about helping people? An oxygen deprived brain is not a healthy brain. I had several benefits from venoplasty. One of my jugular veins was 70% blocked. You can’t say that is normal. If you had MS or another neuro type issue, I will bet you you’d try this treatment. It’s not expensive, only a 1% chance of a problem and only takes about an hour. Truly worth it!

    p.s. It is not fun at all being a cash cow to the medical profession. We’ve been lied to for years. We have died from dangerous drugs. We are not going to take it anymore. The autoimmune theory has not been proven for 150 years. People shouldn’t be treated for something nobody understands? That’s insane. The drugs are immune modulators and we need our immune system to fight off bacteria in the body. Oh, yes, look into Lyme disease and MS. Some say MS is Lyme. Another out of the box theory.

    • User Beth April 2, 2013 on 5:29 am

      Thanks Beth
      As a sufferer with PPMS, I also have been prescribed drugs by differing MD“S
      I am turning to the paleo diet,as with that I am not subjecting my body to yet more harm from these cocktails of medicines
      I am no Doctor, so frankly I do not understand half of what you are talking about!I am just one of the 2 million MS sufferers. I do agree with
      I do thank a few commentators and especially Beth
      I refuse to drop tabs all day long and in some cases I ACTUALLY FEEL WORSE

      Thanks for your many varied but precise views
      http://www.nectareal.com

  • ericet April 2, 2013 on 5:21 am

    I had the it done and it worked for me for 3 months. The Germain doctor who did my 14 minute operation told me that the 109 patients before me all had blocked veins. I don’t give much credit to this study because they are talking about ONLY 9 patients… If had the money I would do it again. It might not be the cause of MS but maybe it is. Time will tell but for me having one vein blocked at 50% and the other at 60% is NOT normal no matter what… if it re-blocks 3 months after it’s like any other surgery that happens but I don’t believe this study of 9 patients…

  • vahid April 2, 2013 on 2:25 pm

    I have MS for over 30 years and I did the procedure , it took about 90 min and I also do exercises and write down everything , when I did the procedure I broke all my previous records , in walking, balancing, lifting my legs and I know a lot of people who had the same experiences.
    This is not a placebo effect , this is real thing but now MS patients are fighting with the big pharmaceutical guys which is worse than the disease. CCSVI It’s very low risk so I suggest to MSers do a good research on the issue Now they know a lot more about the CCSVI and MS and they are a lot more places that they do the procedure.
    Also the lesion on your brain I am very skeptical about them, I remember when I have so many lesions that it was diagnose as too numerous to count and I still could run. But I see people with 3 lesions and they are on wheelchair and I see people with 25 or more lesions and feeling relatively OK

    • Ian Kidd vahid April 3, 2013 on 2:31 am

      Yes, this all sounds very suspicious indeed to me. Business interests putting the squeeze on or small minds clamping shut, either way the sufferers are the losers when the truth gets deliberately obfuscated in the manner that this “study” seems to have done.

    • Lori Batchelor vahid April 3, 2013 on 11:48 am

      Vahid,
      I hear you–the treatment was easier than having my wisdom teeth out!

      It worked for me! Even my neurologist has documented my improvements with neurological testing–not bad for someone with secondary/progressive MS who was NEVER supposed to improve! You can see my before/after videos on lorimayb’s channel on youtube
      Walk a mile in my shoes
      http://www.youtube.com/watch?v=yrH9GH0N4ck

      1 year “Angioversary”

      • vahid Lori Batchelor April 3, 2013 on 12:34 pm

        WOW I just saw the videos Lori, unbelievable this is amazing
        there is no way any drugs in the market that can have that kind of effect. I am not there yet but slowly and gradually I am getting better everyday, it’s a process instead of progressively getting worse , you are progressively getting better.
        good luck Lori keep doing what you doing ,vahid

  • Onlyjoined Foraccess April 3, 2013 on 6:33 am

    I knew as soon as I saw the headline that it’d upset people; so many are firmly wedded to the idea that CCSVI is the Holy Grail for MS patients.

    Well no thanks! No way am I buying into it AT LEAST until it’s ready for prime-time, which this obviously is NOT. I have absolutely ZERO intention of being surgically experimented upon. For one thing, the stents used in CCSVI are meant for use in the chest, NOT the neck, a supple structure that has to flex and all directions. And whether or not the procedure seems to benefit some patients, it would have to be repeated over and over as the stents very predictably reoccude.

    And before you hotheads accuse me of being an apologist for Big Pharma (as if only YOU are astute enough to see behind the curtain of vested interests), what about the ethics of pushing unproven, unnecessary surgeries?

    Anyway, I’m not suggesting taking ANYTHING for MS that comes from the big pharmaceutical companies. I take LDN, which works well for me and BTW makes no significant profits for anyone because it’s compounded from an inexpensive generic. It helps me, costs almost nothing, and it does ZERO harm. Beat that!

    • Lori Batchelor Onlyjoined Foraccess April 3, 2013 on 11:45 am

      It worked for me! Even my neurologist has documented my improvements with neurological testing–not bad for someone with secondary/progressive MS who was NEVER supposed to improve! You can see my before/after videos on lorimayb’s channel on youtube–if you try to say it’s just “placebo”, maybe you should check how long placebos last–so far mine is over 2 years!
      Walk a mile in my shoes
      http://www.youtube.com/watch?v=yrH9GH0N4ck

      1 year “Angioversary”

      • Onlyjoined Foraccess Lori Batchelor April 3, 2013 on 1:24 pm

        LDN’s been working for me for almost 9 years.

        • vahid Onlyjoined Foraccess April 3, 2013 on 2:16 pm

          that,s great that is working for you since is very inexpensive drug in the market unfortunately it didn’t work for me I tried it for 6 months.

  • Robert Schreib April 13, 2013 on 5:12 pm

    A recurring theme in MS research is that subjecting MS patients to controlled dosages of medical bee venom gives their immune systems something to gnaw on so it doesn’t attack healthy tissue. But the FDA apparently will never approve of this approach due to a tiny percentage of the population that can go into anaphylactic shock when exposed to bee venom in any dosage, however small. Maybe if they put into liquor, like the southerners who drink snake venom, they could ingest it and get the same effect?

  • loseraspie April 23, 2013 on 7:59 pm

    The only way to reverse MS is by having The Liberation Treatment/Angioplasty Stem Cell Therapy. It’s a simple five step process. For proof that this works y’all can read “CCSVI as the Cause of Multiple Sclerosis: The Science Behind the Controversial Theory” by Marie A. Rhodes. The book is available on Amazon.com .

    1. The doctors collect bone marrow from your hip bone like if you have Bone Cancer. When your bone marrow is collected you’re under anesthesia. Most patients don’t find that having their bone marrow collected hurts. On the other hand, some patients are sore when the needle is inserted into their hip bone. Step 1 is normally 30 minutes.

    2. Stem Cells are then processed via a state-of-the-art, CE approved Point-of-Care technique. Your stem cells are available usually in less than one hour. Stem Cell Processing takes place in a lab.

    3. A venous catheter is inserted into a vein in your right arm or your left arm. After this happens Mannitol is introduced via an IV for 20 minutes. Mannitol is a safe drug that’s used to open the blood-brain barrier which will allow the passage of your stem cells and other neurotrophic factors into the brain canal and the spinal canal. Then the stem cells are slowly introduced into the catheter so that they are thoroughly allowed to mix with your blood as they enter your body. You aren’t required to undergo anesthesia for Step 3.

    4. The procedure is done with a balloon tipped catheter in which autologous stem cells are used. Doctors are guided with X-Ray scanning. As soon as the catheter hits the affected vein it is then widened with the catheter. This only takes 90 minutes. After Step 4 is completed the patient will spend 2 hours or 3 hours in the recovery room so the doctors can make sure that the entry site isn’t bleeding.

    5. The balloon tipped catheter is inserted into the femoral vein. The catheter is guided through the heart and the stem cells are then released into the the pulmonary artery. 30% – 50% of the stem cells are indirectly brought into the brain arteries. There is zero chance of embolic complications.

  • Denise Baillie April 25, 2013 on 7:29 am

    Peter Murray -you, sir, are an idiot!! ‘They’ completely dismissed Dr. Zamboni’s pilot study as being clinically insignificant because he only successfully treated 65 people. Then ‘they’ jump all over this piece of garbage touting it as gospel truth that proves CCSVI treatment doesn’t work even though it only covers 30 people and NOT ONE had their CCSVI treated!!! Read the f***ing study! They didn’t make any change in the bloodflow in any of the 19 they said they tried to treat! OF COURSE A TREATMENT DOESN’T WORK IF YOU DON’T F***KING DO IT!!!!!!!!!!!!!! Try to get just a modicum of journalistic integrity before you spew any more of this vomitus!