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The End for CCSVI

A new study published in The Lancet provides the most definitive evidence to date that chronic cerebrospinal venous insufficiency (CCSVI), a hypothetical syndrome of narrowed veins draining the brain that some believe is the true cause of multiple sclerosis (MS), is not associated with MS.

In a science-based world, this study would be yet one more nail in the coffin of this failed hypothesis. But that’s not the world we live in.

CCSVI background

CCSVI was first proposed in 2009 by Italian vascular surgeon, Dr. Paolo Zamboni – that multiple sclerosis (MS) is caused by chronic blockage of the veins that drain the brain. The current scientific consensus is that MS is a chronic autoimmune disease, and the pathology is caused by primary inflammation. Dr. Zamboni believes that the venous anomalies he has discovered are the primary cause and the inflammation is secondary.

That is a fairly radical hypothesis, up there with the notion that bacterial infection and not stress causes gastric ulcers. Of course the latter hypothesis turned out to be true. As more and more research was done on H. pylori, the evidence pointed increasingly in the direction of a correlation and causation, and the consensus of scientific opinion followed the evidence.

The story for CCSVI has been quite different. The evidence has been mixed at best, and mostly negative. Zamboni initially claimed a nearly 100% correlation between MS and narrowing of the cerebral veins. If true this could potentially change our understanding of MS and lead to new treatments. The MS research community received the claims, as they should, with intense skepticism. Many in the patient community, however, saw the claims as a ray of hope.

The key to any new claim in science is replication – do the results hold up when independently replicated? So far, no one has replicated Zamboni’s near-100% results, but that aside, what has the follow up research shown about CCSVI?

In 2011 I reviewed the major replications to date, seven of them, mostly negative. The largest study at the time did find some correlation between CCSVI and MS, but half of MS patients in the study did not have CCSVI and many subjects with other neurological disease or healthy controls also had CCSVI. So it appears that CCSVI does not always cause MS, and MS patients do not always have CCSVI. While the study left the door open for some relationship, it certainly did not support Zamboni’s claims to have found “the” cause of MS.

Since my 2011 review, additional replications have been devastatingly negative for the CCSVI hypothesis. A 2013 study of 1767 subjects (with MS, another neurological disease, and healthy controls) was dead negative – no association between MS and CCSVI. This study used ultrasound criteria similar to Zamboni’s.

A recent meta-analysis of 9 studies (included out of 19 identified) did show a correlation between CCSVI using ultrasound criteria and MS, but the data did not establish causation. The results, in my opinion, reveal the weakness in the meta-analysis approach because it can potentially include early false positive data skewing the outcome. A best-evidence analysis is a better approach – looking at the pattern in the research, which clearly shows that later, larger, more rigorous studies (as with the latest one above) tend to be more negative.

The Lancet study

The new Lancet study by Traboulsee et al., including 177 subjects, 79 with multiple sclerosis, 55 siblings, and 43 unrelated controls from three centers in Canada is not the largest study of CCSVI and MS. However the study is large enough, and it does have the advantage of comparing ultrasound investigation of the venous system with full dye catheterization, which is the gold standard.

The results of this study are also completely negative – no correlation between CCSVI and MS. They found that:

Catheter venography criteria for chronic cerebrospinal venous insufficiency were positive for one of 65 (2%) people with multiple sclerosis, one of 46 (2%) siblings, and one of 32 (3%) unrelated controls (p=1•0 for all comparisons). Greater than 50% narrowing of any major vein was present in 48 of 65 (74%) people with multiple sclerosis, 31 of 47 (66%) siblings (p=0•41 for comparison with patients with multiple sclerosis), and 26 of 37 (70%) unrelated controls (p=0•82).

It’s interesting that about 2/3 of people had greater than 50% narrowing, meaning that such narrowing is a common occurrence and it not necessarily correlated with any disease. This study suggests that Zamboni was simply making an incidental finding of a common benign anatomical variant that is neither pathological nor related to MS. Those meeting the strict criteria for CCSVI by catheter examination, on the other hand, were rare – 2-3% of all subjects.

The study also found that ultrasound examination did not correlate well with catheter examination, showing that this technique has poor sensitivity and specificity. This calls into question all previous studies that relied upon ultrasound examination.

Conclusion

The notion that CCSVI causes MS has always been a dubious hypothesis. It seems implausible that decades of research showing MS to be an autoimmune disease would all be wrong, and that a vascular surgeon who is not an MS specialist would discover the true vascular cause of MS.

Despite this lack of plausibility, the hypothesis was seriously researched. Early results did not replicate Zamboni’s original claims (calling the quality of the data into question), but did give mixed results with an aggregate small positive correlation. This pattern of results, however, is consistent with the null hypothesis that there is no real phenomenon here.

Furthermore, the largest, highest quality, and most definitive studies tended to be negative. This latest study, while not the largest, is of high quality, using a definitive technique for venous examination. It shows no correlation between CCSVI or venous narrowing with MS, and further shows that ultrasound studies are not reliable, partly explaining the mixed results.

Many patients suffering from MS and not responding to established treatment, however, want CCSVI to be real and to offer them a treatment. This has led to CCSVI taking on a life of its own, separate from the scientific data. Once that occurs, the data loses its ability to convince those caught in the narrative of CCSVI. Any negative data can be dismissed as a conspiracy. There are always convenient villains to be found and plugged into the narrative – Big Pharma, insurance companies, greedy doctors, and in this case, MS doctors protecting their turf.

The story of CCSVI is not yet over, even though it should be. One approach to a new medical hypothesis is to see if the underlying theory is correct – does CCSVI exist and does it correlate with MS? The other approach is to conduct treatment trials to see if treating CCSVI improves outcomes in MS.

There is a procedure of venous angioplasty, called the liberation procedure, for alleged CCSVI. A recent systematic review found:

There is currently no high level evidence to support or refute the efficacy or safety of percutaneous transluminal angioplasty for treatment of CCSVI in people with MS. Clinical practice should be guided by evidence supported by well-designed randomised controlled trials: closure of some of the gaps in the evidence may be feasible at completion of the six ongoing clinical trials.

My summary – the evidence we have so far is mostly negative, consistent with the null hypothesis, but on its own is not iron-clad evidence for lack of efficacy. This is sufficient, in my opinion, to condemn the liberation procedure as a treatment. Being generous, most scientists recommend that the procedure should not be performed outside of a clinical trial.

Further clinical trials are underway, including one by Traboulsee, the lead author in the current Lancet study. So it seems we will have to wait at least two more years for the current clinical trials to conclude before we can officially close the book on CCSVI. This will likely, unfortunately, lead to CCSVI moving to the fringe (much like chelation therapy) rather than fading into history.

Posted in: Neuroscience/Mental Health

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44 thoughts on “The End for CCSVI

  1. goodnightirene says:

    “This will likely, unfortunately, lead to CCSVI moving to the fringe (much like chelation therapy) rather than fading into history.”

    If only the “fringe” would stay on the fringe–instead of insinuating itself into every nook of (real) medicine!

    1. Broken Link says:

      My neighbor has MS, and he has been a strong local advocate for Zamboni’s treatment. He had one ultrasound in Canada, apparently showing a blockage. So, he flew to India to have the surgery, and a repeat ultrasound showed no blockage, so he came back without the surgery. Undaunted, he went on to a US clinic which performed the surgery.

      Because the study indicates that the narrowing is very common, it is now much easier to understand my neighbor’s varying results.

      1. windriven says:

        “Undaunted, he went on to a US clinic which performed the surgery.”

        And did the surgery cure his muscular sclerosis?

        1. Broken Link says:

          No. He claims that he has better circulation in his feet, but certainly no miracle cure.

  2. Albert Macfarlane says:

    The van Zuuren review of ongoing clinical trials of percutaneous venoplasty cited in this article identified 6 randomised trials underway in June 2012. I cannot get past the firewall in this paper, but since that date, a trial led by Siskin in New York has been abandoned, a trial at Prince Alfred Hospital in Sydney, Australia has not been funded, and the Albany trial has reported negative results in abstract form (Am Acad Neurology 20 March 2013). Correct me if I am wrong, but publication of an interim analysis before trial numbers are achieved virtually precludes continuation of the trial. The fourth trial is presumably the Canadian study led by Traboulsee. Where are the two remaining trials and has there been any update since June 2012 ?

  3. Frederick Cossette says:

    Thank for that, My mother had MS. She was diagnosed in 1999, but MS was doing is work for at least 10 years before diagnosis ( it took a while to be sure). She was lucky, she had only a ‘light’ version of MS. She was then diagnose with Amyotrophic Lateral Sclerosis, unrelated with MS ( her neurologist was totally surprised, 2 neurological syndrome like that is rare). She die in the night of November 1 2009. Anyway, So i’m always curious about those neurological condition. And there is so much Pseudo-science, and false miracle cure. I like when on is nail to the ground. because people take risk, and burn money for nothing. all because the big Ego of one ( of for his wallet). I remember that Tv new report about ‘why’ the method was not founded by or canadian health care . Biased report with no critical view. That ‘method’ always sounded fishy to me. now we have stronger evidence.

  4. Kel says:

    As a person with MS I am so glad this dubious idea is finally getting debunked. Unfortunately those of us with any chronic disease will always have to keep our guards up against so many forms of quackery, as if just dealing with the disease isnt hard enough. I recently had a nurse practitioner (who I went to for my annual exam and birth control prescription) tell me that I should give up all sugar, most carbs and especially gluten because she saw a documentary that claimed those things cause autoimmune disease. I moved to a different state earlier this year and finding science-based health care providers is proving to be next to impossible.

  5. Marion says:

    Never heard of CCSVI before. To be honest, it sounds like one of the least implausible causes of any disease. It’s not like claiming a disease is caused by not enough people holding candles over the patient’s stomach & chanting.

    Of course, we know it IS implausible, because it contradicts the mountains of evidence.

    It IS such a shame that a person, especially if they are a scientist, act very unscientific & refuse to give up on their pet hypothesis no matter how many times it is proved wrong.

    I can’t begin to tell you how many mathematical paths I’ve had to abandon in trying to prove certain desired theorems.

    1. Young CC Prof says:

      Exactly! On the face of it, the hypothesis had some level of biological plausibility. So, researchers tested it. It doesn’t work. Next hypothesis, please!

      But no, 20 years down the line, people are still going to be going on about this.

  6. Dave says:

    Isn’t it Helicobacter Pylori, not Clostridium Pylori?

    1. Dave says:

      …or perhaps Steve meant Campylobacter, but I believe this is deprecated, no?

      1. windriven says:

        I’m sure he meant Campylobacter. The organism is now known as H pylori but at least us old timers get the original which, I think, was Campylobacter pyloridis. I thought to send him a note on this myself but he a Gorski are touchy about relatively insignificant corrections.

        1. Dave says:

          “Touchy” is a word I’d never think of applying to Steve, having consumed most of his output in the last several years. I suppose it depends on the import of the niggle… but he seems pretty balanced and good-natured to me :-)

  7. lilady says:

    I believe Dr. Novella meant the H. pylori bacterium, not the C. jejuni bacterium, as a cause of ulcers.

    A prior infection with Campylobacter jejuni has been implicated in the onset of arthritis and the onset of GBS:

    http://www.cdc.gov/nczved/divisions/dfbmd/diseases/campylobacter/

    Are there long-term consequences?

    Most people who get campylobacteriosis recover completely within two to five days, although sometimes recovery can take up to 10 days. Rarely, Campylobacter infection results in long-term consequences. Some people develop arthritis. Others may develop a rare disease called Guillain-Barré syndrome that affects the nerves of the body beginning several weeks after the diarrheal illness. This occurs when a person’s immune system is “triggered” to attack the body’s own nerves resulting in paralysis. The paralysis usually lasts several weeks and requires intensive medical care. It is estimated that approximately one in every 1,000 reported Campylobacter illnesses leads to Guillain-Barré syndrome. As many as 40% of Guillain-Barré syndrome cases in this country may be triggered by campylobacteriosis.

  8. I meant H. pylori. Corrected now.

  9. Alessandro Rasman says:

    ‘Narrowing’ is a generic term that was used by the Canadian TVs to understand the concept of CCSVI among the common people. Already many studies with MRV (Zivadinov) had shown that the sectional areas and diameters of the veins with CCSVI are not different from the healthy ones. But the stenosis of CCSVI, clarified by dozens of studies, are not due to a narrowing of the wall but rather to the presence of intraluminal obstacles and external compressions, especially the first, not detectable with the measurement of the diameter of the vessel. Moreover, the difference in the section according to the Zamboni’s criteria, is not detected in the supine position in which it is executed venography, but by subtracting the area in the supine position from the sitting position. Many patients with CCSVI have huge differences of this parameter, which was not measured in the BC’s study.

    1. WilliamLawrenceUtridge says:

      That’s quite the statement, but is it backed by any published research?

      The problem is, without this being clearly laid out from the beginning, proponents can keep making claims along these lines – you didn’t correct for X, you forgot to include Y. It moves the goalposts, when the ultimate goal is not to test an intervention but rather to prove it (really, to justify the treatment irrespective the evidence).

      Another option not reflected in your post is that CCSVI is unrelated to MS, and the “liberation” procedure is ineffective.

  10. Shawn says:

    Is there a difference between this liberation treatment as curing MS and it temporarily alleviating some of the symptoms of MS?

    Knowing someone who spent the money on this treatment, she regained her balance and fine motor control for over a year before it started to deteriorate. Clearly not a cure. Clearly not the cause. We all agree.

    Is it possible it interacts with some symptoms of MS (balance, ultimately) on some sub-group of MS patients, making it occasionally helpful for specific patients in the short term, temporarily, but utterly useless to others? I’ve seem to have seen some studies like that.

    1. WilliamLawrenceUtridge says:

      MS has a tremendously variable course, and its symptoms are similarly quite variable. This is why carefully controlled clinical trials with proper matching, randomization and follow-up are necessary. They take time, but they can definitively answer the question “does the treatment help, or is it due to the natural waxing and waning of symptoms?”

      It could be subgroup interactions, it could be merely the natural course of the disease.

      1. Mark Mattingly says:

        I got a diagnosis of MS in 1999 after over 10 years of various problems. Since then I have tried to keep up with the research. This follows the course of most of the cures/causes of MS. I truly appreciate your work to help sort things out. Very good trials are the only way to go with MS and unfortunately each one takes years.

        MS sparked my interest in alternative cures and how worthless testimonials are in determining anything. Everything seems to work when the course of the disease is in remission. Relapses and recovery are always determined to be better, because of… Sounds a lot like homeopathy. Take something if you get better its the cause. If you don’t, you will in time. Just imagine how bad you would have been if not taking the remedy.

  11. Shawn says:

    I’ve had supporters tell me that Dr. Z never said it was a casual. That he only said it was somehow associated, and they personally believe it just alleviates the symptoms. Steve posted to the study which I looked up before. He doesn’t say there is a casual relationship.

    Are there place where he did say that? And can someone make sure I understand the end of this article? It’s saying there maybe therapeutic benefits, right? But we don’t know. And there are not strong indications.

    1. Zachary Stansfield says:

      The abstract of Zamboni’s article linked to here argues that MS is “strongly associated” with CCSVI and that “[t]he location of venous obstructions plays a key role in determining the clinical course of the disease.” This certainly sounds like he was trying to argue for a causal relationship.

      The end of Dr. Novella’s piece pretty clearly argues that there is little reason to believe that CCSVI is associated with MS and that the likelihood of therapeutic benefit based upon this (diminishingly weak) hypothesis is low.

  12. Marzia says:

    I know there’s a big study now in Italy, named “Brave dreams”, studying the results of the surgical procedure.

    http://clinicaltrials.gov/ct2/show/NCT01371760

  13. Kim Nault says:

    I am a patient with CNS lupus and RRMS and I’m so delighted to see Dr Bamboni’s quackery theory (which is subjective, on account of his wife has MS and who was also CCSVI patient of his) debunked. The other quackery red flag for me was that Bamboni’s subjective theory and trial, did not include comprehensive neurological evaluations (to include the FSS and EDSS ratings), including MRI of the patients before and after CCSVI. I’m not a scientist, but from what I know about my CNS disease processes (plural) and the current therapies available to me, CCVSI is not immunomodulating therapy period, end of story. Buh bye snake oil.

  14. Malcolm McClimont says:

    I am not a doctor or a scientist but this I know that CCSVI worked for my daughter. After suffering episode after episode and being reduced to a very low quality of life my daughter underwent the CCSVI procedure. Nearly 4 years later she is still free of all her symptoms apart from a bit of numbness under her feet and she has lost some strength in her hands. She has had another 2 angioplasties in that time when she felt the symptoms start to return. Her veins have stayed open the last 18 months.
    At the start her neuro said it was dangerous and that she had experienced the placebo effect. How can a myoclonic jerk disappear over night? Her neuro said that she would need to live with this for the rest of her life. He then said that it was the tysabri working. My daughter went off all drugs and then he said she would suffer an horrific episode. Over 3 years later he didn’t believe my daughter’s MRI so he ordered her to have another. It was the same result: no new lesions on the brain in all that time and all lesions on her spine have disappeared. He now says that her MS is stable. My daughter is now at university and enjoying a fantastic life. I personally know other MSers who are back living a high quality of life.
    It is my opinion, when the dust settles there will be many angry people with MS who will go on to suffer a lot of physical damage and they will blame the neurological discipline for this.

    1. Harriet Hall says:

      I’m really glad your daughter is doing so well, and I understand why you attribute it to the surgery, but I’m afraid you can’t really “know” that it worked for her. MS has an unpredictable course with remissions and relapses, so the only way to tell if a treatment really works is to do a controlled trial. If any significant percentage of MS patients had a favorable response to the surgery, it would have shown up in the trials. There is always a small possibility that a tiny minority of patients will respond in numbers too small to make a blip in the statistics, but if so, we would have no way to predict who those few were. We would have to operate on a whole lot of people unnecessarily to help those few, and in toto it would likely do more harm than good, and it would not be ethical to operate on everyone just because of a few anecdotal reports when the controlled studies are negative. It might be that when the dust settles, there will be a lot of angry people who will resent having been persuaded into surgery they didn’t need.

    2. Malcolm McClimont says:

      There is anecdotal evidence in over 30 000 cases where people have undergone CCSVI. In 1/3 of the cases there has been a very good result, in 1/3 some benefit and in 1/3 no benefit whatsoever. I know that double blinded studies are required to satisfy evidence based medicine but the anecdotal evidence is highly significant. This is far better strike rate than any of the MS drugs.
      In my view there may be another neurological disease called CCSVI and it may include people who have diseases other than MS. There are a lot of people who have gained a benefit in brain fog, fatigue, bladder/ bowel problems and other symptoms.

      1. WilliamLawrenceUtridge says:

        Those sorts of figures suggest it’s an inert treatment. And worthless if 60,000 people have been treated and the missing 30,000 all died from it. The anecdotal evidence is at best hypothesis generating that requires careful testing. Only quacks, the greedy and ignorant think research stops there.

        Based on pure random numbers, at any random time, a third are likely to improve, a third remain unchanged, and a third get worse, simply due to natural fluctuations in symptoms. If people seek the liberation procedure when symptoms are at their worst (a common occurrence), then simply due to regression to the mean people will tend to feel better (because when it’s actually at the worst, it’s likely to get better simply because extremes tend to move towards the center – like an exceptionally tall father having a shorter child).

      2. Harriet Hall says:

        The whole point of evidence-based medicine is that anecdotal evidence can’t be assumed to be “highly significant.” Where did you get these figures from? Were the 30,000 cases collected and studied systematically? How were “good results” defined? How do you know 1/3 wouldn’t have improved without treatment? After all, this is a relapsing/remitting disease.

        1. Malcolm McClimont says:

          This will be my last post. In Australia there has been over 700 CCSVI procedures done. This statistic is very easy to verify as there are only a few IRs who have been performing the procedure. If you do your research you will find that there are doctors like Michael Arata who have done over 2000 CCSVI procedures. I believe CCSVI is being performed in over 30 countries.
          It amazes me that there is such negative rhetoric from scientists and those in the neurological discipline. From my perspective this group has done everything in their power to close CCSVI down. This group are crying out for double blinded trials but at the same time they are doing there best to close these trials down. From my point of view I find this most dangerous.
          In Melbourne, Australia, there is a Double Blinded Trial at the Alfred Hospital where 80 MSers and 80 controls are involved. At this stage 30 people have either undergone the trial or been in the control group. The money required for this trial is $450 000 (Australian). The money raised by the CCSVI Australia group has run out. And the trial may fold. I find this disappointing. Groups like MS Australia and Australian neurologists have been so close minded. To discuss and crow about incomplete trials is not very scientific.
          Have you ever wondered why there are so many people who are so passionate about this procedure. The answer is this: it has helped them get their life back and they want this for other MSers. I pose this question to some of your readers. If in years to come it is proven that that CCSVI leads to a positive treatment to people with neurological disorders what are you going to say to the MS patients whose health has deteriorated needlessly. Science and Medicine can be an absolute ass!!

          1. WilliamLawrenceUtridge says:

            This will be my last post.

            Our hearts will go on.

            In Australia there has been over 700 CCSVI procedures done. This statistic is very easy to verify as there are only a few IRs who have been performing the procedure. If you do your research you will find that there are doctors like Michael Arata who have done over 2000 CCSVI procedures. I believe CCSVI is being performed in over 30 countries.

            So what? Are any of these treatments performed within the context of a clinical trial? If not, they are completely useless in terms of answering the question “does the procedure work”. As useless as testimonials found on nearly every CAM website everywhere. They enrich the practitioners and impoverish the patients but add nothing to our knowledge of CCSVI.

            It amazes me that there is such negative rhetoric from scientists and those in the neurological discipline. From my perspective this group has done everything in their power to close CCSVI down. This group are crying out for double blinded trials but at the same time they are doing there best to close these trials down.

            Given the strong indications that MS is an immunological condition, it’s not surprising that neurologists see them as an unpromising avenue of research that puts patients at risk with little promise for a successful treatment.

            In Melbourne, Australia, there is a Double Blinded Trial at the Alfred Hospital where 80 MSers and 80 controls are involved. At this stage 30 people have either undergone the trial or been in the control group. The money required for this trial is $450 000 (Australian). The money raised by the CCSVI Australia group has run out. And the trial may fold. I find this disappointing.

            Given the trend towards negative findings as more results accumulate, it’s rather unsurprising that there is little interest in further investment.

            Groups like MS Australia and Australian neurologists have been so close minded. To discuss and crow about incomplete trials is not very scientific.

            You may be projecting “crow” onto the article, I read Dr. Novella’s posts as disinterested. And again, in a climate of limited resources for scientific funding, the pursuit of more promising avenues is simply rational management of resources into the most promising areas.

            Have you ever wondered why there are so many people who are so passionate about this procedure.

            Because it provides hope from an unexpected direction for a condition that is hitherto intractable, frustrating and unpredictable? The latter point is also why nearly any dramatic treatment is likely to be perceived as a success in the absence of good controls or outright death of the patient.

            If in years to come it is proven that that CCSVI leads to a positive treatment to people with neurological disorders what are you going to say to the MS patients whose health has deteriorated needlessly. Science and Medicine can be an absolute ass!!

            What happens if the liberation procedure does nothing but expose patients to the not-inconsiderable risk of major surgery including anesthesia? The key point is whether CCSVI is proven to be such a treatment. That point has not yet been reached. You are promoting hope over science and reason, to the detriment of patients no matter the outcome. If CCSVI is real, the pursuit of treatments without evidence interferes with the process of testing it. If it is not real, it’s risk without benefit (and again, interferes with the process of testing it. Unethical either way.

          2. Harriet Hall says:

            “If in years to come it is proven that that CCSVI leads to a positive treatment to people with neurological disorders what are you going to say to the MS patients whose health has deteriorated needlessly. ”

            A bit of history is in order. In 1939 an Italian surgeon devised an operation for angina that improved blood flow to the heart by tying off the internal mammary artery. The success rate was astounding: 3/4 of all patients improved, and 1/3 were cured. The operation became popular and was performed everywhere until 2 decades later, when 2 sham surgery trials showed that patients improved just as much when the chest was opened and closed without doing anything inside. The operation was abandoned. What did doctors say to the angina patients who underwent the risk and expense of surgery and developed complications from an operation that was completely useless?

            “Have you ever wondered why there are so many people who are so passionate about this procedure.”
            We needn’t wonder any more: we long ago asked and answered the question of why so many people come to believe an ineffective treatment has helped them. Especially in MS, with its unpredictable course of remissions and exacerbations. We have a heavy responsibility as scientists to do what is in the best interest of the patient, not what “seems” to work and what they “want” to believe in.

            There is strong evidence from multiple studies that Zamboni’s hypothesis about the relationship of MS and venous insufficiency is wrong. Isn’t it irresponsible to continue to spend money and put patients at risk for a failed hypothesis?

  15. Harriet is correct. You can never know from an individual case if something “worked” or not. That is the post-hoc-ergo-propter-hoc logical fallacy. But it is the most common response we get – hey, it worked for me (or for a loved one).

    So did blood letting. And purging, and every other worthless therapy until they were studied scientifically.

    That is the one point I wish we could really get across to the broader public – anecdotes are not reliable evidence.

    1. WilliamLawrenceUtridge says:

      Malcolm might be interested in Shawn’s testimonial that the procedure didn’t help. Perhaps his daughter hasn’t (yet had a relapse), perhaps it is a cure, but at this point you simply can’t tell.

  16. Mrs. Beasley says:

    Dear Mr. McClimont,

    So glad that your daughter’s twisted and stenosised jugular veins were successfully opened in order to keep her blood and hope flowing. I too was fortunate enough to find stenosed jugular veins which helped to explain all of my stroke like symptoms I have experienced since dx with MS and has given me the hope and determination to keep my veins open in order to delay my MS progression.
    It is unfortunate that so many clinicians that take care of MS patients have been so defensive and surprisingly angered in regards to this ‘new theory’ that it has created mistrust and alienation from their patients and families. They are missing an opportunity to give hope and energy to another human being to start or continue to eat well, avoid toxic air, and exercise to keep their blood moving.
    For those clinicians that feel the need to burst your patients bubble when asked about this new theory, or for your newly dx MS patients, please stop yourself and try something new.
    1. If you believe that this new theory is a shame, hoax, quackery, snake oil, etc. keep your mouth shut. Your thoughts and beliefs aren’t ‘evidenced based’ and it only makes you look like a jerk.
    2. If possible, advise your patient on the theory before they find out on their own. Most of you have children. Wouldn’t you rather hear from them that the principal from the Jr. High will be calling soon? It always helps to get good/bad news early so one can process new information which enables one to make smarter decisions.
    3. Not sure what to say? All you need to say is something like “….I would strongly recommend that you begin an exercise regiment that includes 30 minutes x 3 days/week of aerobic exercise because if this new theory proves to help MS pts avoid long term disabilities, it sure as heck wouldn’t hurt to try.” I don’t care if my dx. mangled jugular veins have anything to do with my MS, all I care about is now I have some ‘common-sense-based-evidence’ that has given me hope, energy, and drive to run, eat well, and look forward to a better future than I envisioned before this CCSVI.

    Have a nice day all.

    1. WilliamLawrenceUtridge says:

      Your thoughts and beliefs aren’t ‘evidenced based’ and it only makes you look like a jerk.

      There is a difference between “this idea hasn’t been tested in clinical trials” and “this idea doesn’t make sense given what we know of the etiology of the medical condition”. The liberation procedure appears to be the latter. MS doesn’t appear to be caused by blood congestion, it appears to be autoimmune, so attempting to treat it with increased blood flow just doesn’t make sense. Doctors are perfectly right in pointing this out and wanting it to be tested – false hope is a bad thing, it wastes time, money and in some cases lives. Much like the liberation procedure, which consistently fails testing and has actually killed some people.

  17. Mrs. Beasley says:

    Geez Bill, why do you have to be so crabby? As a graduate from Google University Medical school, I learned that as of today there is still no known cause or cure for MS and that we are only given one life. So if I decide to forgo the $30,000 a year injections that are made of Chinese Hamster Ovary cells that made me sick like I was in the 1st trimester of a pregnancy that lasted 2 years and left me too tired and weak to be a productive tax paying member of our society and I am now lucky enough to find my neck veins mangled, I’m going with the common sensical option that has given me my one and only life back. And saving everyone money to boot! Take care.
    Btw, False Hope? What is that? Never heard of it.

    1. WilliamLawrenceUtridge says:

      “False hope” is when a doctor says “this will cure you, that’ll be $60,000″ and when you ask for how they know it will work, they respond with “in my experience…”

  18. Olia says:

    I regretted that I opened this website with so much “scientifically” proven negative rubbish against Liberation procedure by Dr Zamboni. I have done my procedure during my MS relapse in 2010 and trust me All I cared about then to have some quality life and to offer my children less care about their disabled mother! My consultant neurologist prescribed me £30,000 worth drags ( profitable for pharmacutical industry business ) with plenty of side effects and I chosen to damp it all and went for Liberation Procedure and guess what? From day 1 after procedure and For the 3rd year I am as healthy as never before, enjoying my life, seeing my children happy too! Whoever closes the gate of hope for any sick person should only pray that he / she will never get illness of the one they deprive of cure! Best wishes.

    1. windriven says:

      “I regretted that I opened this website with so much “scientifically” proven negative rubbish against Liberation procedure by Dr Zamboni.”

      Sadly, you wallowed in your regret long enough to write your comment. I am confident saying that all of us here are unreservedly happy for the remission of your symptoms. I am just as confident that most of us here doubt that the ‘liberation procedure’ had anything to do with it. That is because we here are all about negative rubbish and we absolutely delight in negative rubbish that is scientifically proven.

      If I were to show you a score of other MS patients who had the procedure without benefit, if I were to show you clear evidence that there is no scientific basis to even believe that it COULD work, it wouldn’t make a bit of difference in your mind. You feel better and you are convinced the procedure is responsible.

      This column is about science based medicine, it is about having substantial evidence of benefit before subjecting patients to a potentially dangerous procedure. It is not about Olia thinks this helped her so it must be the one true cure.

    2. WilliamLawrenceUtridge says:

      Question:

      Were you given the liberation procedure for free? Because if not – doesn’t that suggest that profits can be made elsewhere beyond Big Pharma?

      Also, how long was the distance between you relapses in the past? Did you carefully track your symptoms to note differences between them?

      Multiple sclerosis is notoriously labile, your experience may have nothing to do with the procedure.

  19. James says:

    MS treatment is a multbillion-dollar market. Stakes are high. Arguments are fierce.

    Imagine that giant cake shrinking by 1/3 and you get the picture.

    http://www.fool.com/investing/general/2013/02/14/whos-1-in-this-multibillion-dollar-market.aspx
    http://www.fool.com/investing/general/2013/10/24/a-changing-of-the-guard-in-multiple-sclerosis-trea.aspx

  20. Bob says:

    I have MS. I tend to believe the theory of genetic/epigenetic interactions with endogenous viruses as a cause of MS. That to me makes a lot epidemiological sense: oligoclonal bands in the CNS, ethnic variations, equatorial proximity, blood biomarkers, effectiveness of interferon and glatimere acetate, hereditary associations, autoimmune implications, and common age of onset. If the above research continues to yield positive data, it could mean that a cure would be still be extremely difficult. I feel a bit jaded about that, really.

    Upon first reading about ccsvi, I was intrigued. I understand the controversy to be really about patient rights to a noncosmetic questionable surgery to treat an obscurely defined venous condition unassociated with a chronic relapsing disease. If this were a drug, there would be no controversy. The FDA would say, no way. But, thinking like an insurance company, I would celebrate. If $10k here and there reduces $50k annual for drugs per patient, then it is a huge win (considering that the drugs have little proof of long term outcomes, anyway). That is billions of dollars in savings!

    Interesting times. I have no answers.

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