“A surgical treatment pioneered in Europe that was sought out by thousands of desperate people with multiple sclerosis has been categorically debunked by Canadian researchers“.
the Zamboni Baloney
or the ProfAliG and Joan Beal
I agreed to stop this after talking to the CCSVI crew at Manchester MS life:-(It was seen as a conspiracy to deny treatment…but bit by bit the original science was called into question and first and foremost was that many people could not even show that CCSVI existed. So hardly worthwhile doing a blinded clinical trail to see if it should be put to the sword.
This is obviously a release of news .
First we thought maybe it is this
Sadovnick AD, Yee IM, Attwell-Pope K, Keyes G, Kipp L, Traboulsee AL. Patient-Reported Benefits of Extracranial Venous Therapy: British Columbia CCSVI Registry.
Can J Neurol Sci. 2017 Mar 8:1-9. doi: 10.1017/cjn.2017.27. [Epub ahead of print].
Objective Chronic cerebrospinal venous insufficiency (CCSVI) has been hypothesized to be a risk factor for multiple sclerosis (MS). Venoplasty has been proposed as a treatment for CCSVI. The aim of our study was to gain a better understanding of the “real-world” safety and longitudinal effectiveness of venoplasty
Methods: British Columbia residents who self-reported having had venoplasty and consented to participate in the study were interviewed and followed for up to 24 months post-therapy using standardized structured questionnaires
Results: Participants reported procedure-related complications (11.5%) and complications within the first month after the procedure (17.3%). Initially, more than 40% of participants perceived that the venoplasty had had positive effects on their health conditions, such as fatigue, numbness, balance, concentration/memory and mobility. However, this improvement was not maintained over time
Conclusions: Follow-up patient-reported outcomes indicated that the initial perception of the positive impact of venoplasty on the health conditions of MS patients was not sustained over time. In addition, venoplasty was not without associated morbidity.
This is not on the website yet
However in the newspaper it is claimed
the Society for Interventional Radiology’s annual scientific meeting in
Washington, D.C.
The study was conducted on 104 MS patients across the country. All had
narrowing of either their jugular vein, which drains blood from the
brain, or their azygos vein, which drains blood from the spinal cord.
The patients were randomly chosen to receive either an actual venoplasty
treatment. or a “sham” procedure.
In the actual treatment group, doctors inserted a catheter into their
blocked or narrowed veins and then inflated a balloon to push out the
blood vessel’s walls. In the “sham” treatment group, a catheter was
inserted in the vein but no balloon was inflated.
Neither the patients nor the physicians who evaluated them knew who was
receiving the actual treatment or who received the sham procedure,
making the study “double-blinded.”
The patients were evaluated for MS symptoms three days after the
procedure and then at regular intervals for 48 weeks. MRI scans
(magnetic resonance imaging) of their brains were used to look for new
lesions in their myelin, the coating on brain neurons that erodes in MS
patients, leading to symptoms such as numbness, walking difficulties and
muscle weakness.
Patients were asked to evaluate their own symptoms, and to perform a
limb function and cognitive function test called the MSFC (Multiple
Sclerosis Functional Composite).
In all, about 25 per cent of patients saw an improvement in their
symptoms, but they were equally divided among the real and the sham
treatment groups.
As well, by 48 weeks after treatment, the researchers report that
patients’ disability symptoms were back to the baseline established at
the beginning of the study. The brain scans also showed no statistically
significant changes in either group.
So there you have it….. Gold Standard Blinded study. We can wait until they are published to report and put the “nail in the coffin” and “put this baby to bed”.
Apologizes if you find the post insensitive. I realize that people have been charged $10,000-$20,000 for this procedure.
Looking forward to the tweets from Leicester:-(
I can hear the distant sound of a keyboard being bashed ALL IN CAPS 😉
THE LEICESTER FOX!
So twitter land is saying the People were too old to do the trial:-(
Perhpas not the best idea of a background picture
https://twitter.com/zambo57
What other stuff are you cooking up?
Wow! Thank you – to somebodies
Desperate patients taking desperate actions. I believe the National MS Society and the Cleveland Clinic also were sucked into the CCSVI clinical trial.
Dr Traboulsee is extremely biased and completely compromised as a scientist when it comes to CCSVI research because he has accepted large sums of money from the MS pharmaceutical companies for at least a decade. His 2013 paper on CCSVI and MS notes that “He has received honoraria or travel grants from Biogen, Teva Canada Innovation, Roche, Merck/EMD Serono, and Chugai Pharmaceuticals”. He was a co-author of a recently published paper of a drug trial and his conflicts of interest included “receiving fees for serving on an advisory board from Biogen Idec, consulting fees from Chugai Pharmaceutical and Teva Pharmaceuticals, lecture fees from Sanofi Genzyme, and grant support from Biogen Idec, Sanofi Genzyme, Chugai Pharmaceutical, and Teva Pharmaceuticals. Given the MS drug companies could potentially lose hundreds of billions of dollars on MS drug sales if CCSVI treatment proved effective for MS, in combination with the fact that Dr Traboulsee has been “on the take” from those same companies, this research cannot be taken seriously. Do we take research, which comes from researchers “on the take” from tobacco companies and which “debunks” the cancer/smoking relationship, seriously?Of course not! Anytime research is seriously compromised by large and blatant financial conflicts ofinterest, it must be ignored.
sorry I am more incline to ignore your rants.
I think you are barking up the wrong tree…how many neurologists that are known for MS do not have such a conflicts of interests statement? Yes None…..Look at ProfG, look at DrK. Look at ECTRIMS and the conflicts, they are longer than the abstracts being presented.
If you think they are happy to throw $5.4 dollars of tax payers money down the toilet to fix a clinical trial you are wrong.
I think you do the neurologists a dis-service. If you are going to complain the CCSVI should have been up in arms before the study started
It is abit late after the result is known
I have not had such pharma money, check out my conflicts, but I would not have gone near such a trial as it was obvious it was going to be a waste of time and money. You just have to read the literature, but because of the nay sayers they (neuros and MS Societies) are pushed into doing the trials.
Check this: http://onlinelibrary.wiley.com/doi/10.1002/ana.22085/epdf
Conflicts minimal, all hands-on work done by non-conflicted "vascular" colleagues seven (!) years ago.
Ha ha, a desperate bit of whataboutery from anon 10.33 there.
CCSVI is dead and good riddance.
Few questions MD. Why did Traboulsee et al choose majority of patients in the trial with disease over 20 years (i.e. SELECTION BIAS by choosing SPMS patients)? Drug trials for RRMS never do this and rarely choose patients that have had the disease over 10 years when recruiting. Even Zamboni already stated it does not work in more advanced cases of MS.
Was there a measurement of restenosis, which, according to Zamboni, is around 50%? Why were these patients not repeat angioplastied if they restenosed? How did they or did they check the flow/perfusion over the extremely short trial of 48 weeks to see if pt had continued reperfusion throughout trial?
Traboulsee was a very odd choice to lead this study. He not only has a conflict of interest with Pharma (inevitable for research neurologist it seems) but also has a complete lack of experience in vascular surgery, although he did work with IR. My hat is off to him, however, as it is his reputation on the line.
I can see MD by your enthusiasm on the topic that you are anxiously awaiting the upcoming the Brave Dreams trials available in the near future.
I lost enthusiasm for this topic years ago, when I saw the writing on the wall.
Clinical trials are about volunteers and the criteria were pre selected 18-65 as is usual.
The key here was that the people fulfilled the criteria of CCSVI, remember many studies can't even confirm CCSVI criteria in many people with MS. This is perhaps where your selection bias arrives. I have not seen the publication and I was not there at the so we can wait until the last post once the publication surfaces.
Perhaps you should look at the criteria for the Zamboni trial
BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis) (BRAVE-DREAMS)NCT01371760
Criteria 18-65. RR and SPMS. Was there mention of retreatment. A short trial of 48 weeks…come now the claims are for intstant succeess.
Yes we wait for the Brave Dreams it was marked as completed in december 2015 and data analysed by May 2016 late enough to get a late breaker at ECTRIMS but where is the data. We'll be calling Ben Goldacre soon:-)
Changes marked after the trial was completed change from
10-20 Italian centres
445 relapsing remitting (RR)+ 234 secondary progressive (SP), overall 679 MS patients will be randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.
So if Traboulsee was following the Zamboni lead and started their trial in good faith
They would not changing the patient selection group criteria midway through the trial.
Changed to
5-8 Italian centres
360 relapsing remitting (RR) MS patients will be randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.
It also changes from a phase III to an N/A, what does this mean?
It is no longer blinded? We have to wait and see.
Italian placebo controlled trial will be published quite soon, so it will be interesting to see results. In italian study, selected patients are relapsing with shorter disease history. I believe that is is important factor.
Reason why Im very positive to CCSVI concept, is my wife's condition after treatment. She was "early case" when treated, but had many MS symptoms (fatigue, weakness, balance issues, heat intolerance). After her operation 2010 all her symptoms improved or disappeared and benefits have lasted now almost 7 years. Was it placebo or better blood flow? I believe latter option. But we need more studies, especially related to blood flow. Study publshed last year was very interesting and researchers measured improved perfusion after jugular vein operaton with early cases, but not patients with longer disease duration.
Thanks for your insight
But it is the weight of evidence we need to see.
I can't comment on the trial as I am not party to what has been done and who has been recruited, I suspect what ever happens it is not going to startling as it has been a long time waaiting for the information to surface and there have been quite a few meetings since may 2016 when the data was indicated to be analysed by.
To the person who sent the link to the pdf. Generally links without description ends up in spam. I have had a read and decided not to post. It is not relevant, except I note that you claim people making decisions were not expert
However as to Brave Dreams the question is Does Zamboni (and the trial) have any credibility?
Just realised I can't spell its ccsv-i not ccvs-i aliG pic
Zamboni already talked to the world so sensationalist of the technique CCSVI when decided "launch it," which for me already appeared that she would actually a great trap.
It can even exist vascular diseases, even more on the inflammation on the walls vessel for example, and not obstructions vessel linked to MS.
Otherwise everyone who had obstruction venous would have consequently MS, and this is not what happens.
Why is there so much hate surrounding Dr Zamboni's research? I thought doctors and scientists were supposed to look for answers where others failed. Canadians and Italians wasting research money, that is ridiculous.
Do we follow the theory that the only research that is worth funding is Pharma backed in which there are fortunes to be made. The difference is that by the time pwMS reach the SPMS stage most professionals will have retired. Not nice comments.
The "hate" though dislike may be a better term is due to the fact that after Dr Zamboni's original report, a number of shall we say opportunistic clinics sprang up around the world offering "Liberation therapy" at, of course significant cost. Dr Zamboni, it would seem has encouraged this, maybe not overtly but there it is.
All the evidence now is that the original findings have not been replicated and the procedure is of no use except for a short-term placebo effect and a lightening of the wallet for people who are understandably desperate for any treatment that may alleviate their condition.
Any theory is worth investigating, pharma backed or not but it must be replicated and due to the cost of running clinical trials in many cases this will involve partnering with pharma, maybe regrettable but that's how it is.
If 10,000 dollars is a significant cost to you, how do you explain MS drugs that cost a minimum of 2000.00 a month equaling a minimum of 24,000 dollars a year? That is a cheap one, most in Canada cost between 30,000 and 60,000 a year?? Can you explain why that doesn't upset you? Especially when UBC University in Vancouver Canada where Traboulsee works has proven that the first line of drugs (so the 24,000 a year drugs) are NOT effective in slowing or delaying the disease progression? Also I do not believe you can comment on the UBC study either as it is will not be complete until September 2017, and many in the study are speaking out now that they had great results and can't figure out why their data was not used, and some have not even been evaluated from the procedure yet. Do not ruin your good name on this bad study!!
Please keep in mind science is ongoing, and people used to have to go to Africa for heart surgery because no one believed in it. It is the naysayers that may come out looking just a bit naive. Take note Heart surgery saves many lives every day but it was met with the same angst as CCSVI has been. It is not dead we have 2 better designed studies coming soon. And as a scientist you know as well as I that science can always be improved and needs to be rewritten, just on the fact that our brains have a lymphatic system (immune system) Thanks for all you try to do.