Thursday, 9 March 2017

MS in the NEWS. CCSVI is a waste of your money

#MS research #CCSVI is debunked

"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 Liberation Therapy for multiple sclerosis to widen narrowed veins from the brain was devised by Dr Paolo Zamboni. The narrowing was found in 100% of people with MS and not with healthy people and there were some miraculous cures claimed on youtube.
You could get treatment without bothering with Neuros and scammers sold the procedure to prey on people desparate solutions (These snake oil pelders should be drummed out of business they are not doctors but conmen!). 
The Neurological fraternity was slow to respond and it became an internet hit and people demanded research and access to the treatment. The UK resisted investigation into this but the Canadian and Italian MS Socoieties got sucked into spending millions of dollars on this.
Slowly neuros woke up to social media and started to cast doubts. These people were chastised and ProfG and DrK took the brunt of the wrath of some people and worse we have been bedevilled by certain trolls...yep you know who you are...so do we!


I was told that I was being insensitive because of the artwork I created such as the Zamboni on thin ice
the Zamboni Baloney

                           or the ProfAliG and Joan Beal 
 (CCSVI supporter who created a damming cicular about ProfG
                        and singer for one of ProfGs birthday presents)

I agreed to stop this after talking to the CCSVI crew at Manchester MS life:-(
Who knows what heights in Comic Genius I could have reached?

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. 
However, the Canadians have apparently indeed wasted their time and $5.4 million (apparently jointly funded by the Canadian Institutes of Health Research, the MS Society of Canada and the provinces of British Columbia, Manitoba and Quebec) and done a blinded trial (source the guardian) and surprise it appears that the results show the idea was a dead duck. Surprise, Surprise:-(.



This is obviously a release of news . 
We can put flesh on the news release once we see the paper.  

First we thought maybe it is this

Sadovnick ADYee IMAttwell-Pope KKeyes GKipp LTraboulsee 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

This doesn't look like a trial and essentially says we followed people who had done the procedure, but with time there was no benefit. So saying CCSVI is not worth the cash!.

However in the newspaper it is claimed

"They performed the vein-widening venoplasty procedure on 49 people, inserting a catheter and inflating their veins with a small balloon and a “sham” operation on 55 others, who just had the catheter insertion. Neither the patients nor the researchers knew which people had undergone which operation"

So MD2 has done some digging and it turns out it is a meeting report. So the findings have yet to be published, but were presented Wednesday on the trial NCT01864941 at 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".

If it it is, it will be the last time I will bother with this subject as a bit of science?
Maybe VV (vasilis vasilopoulos) can come back for a Swansong and give us his/her take on the story. (Indeed you could do a guest post when the paper surfaces if you want to email).
If you can't remember, VV was a nemesis to TeamG (in my opinion more so than DrDre-no offense intended Bruv), and posed some hard hitting questions in his/her defense of CCSVI phenomenon.
VV even took part in our first Question Time at the First Research Day, giving his answers to your questions ( I kept them secret from the panel)...I can't remember the question but his response "next question" showed us what he/she thought about some current neurological approach..it got a good laugh from the panel (not broadcast).
VV even formed part of our brain training memory game, if you can stretch back to 2012

Today I reveal

vasilis vasilopoulos (person on the left is picture of a vasilis vasilopoulos from the internet..not the VV) thinks (light bulb = idea = think), doctors (money=change=to doctor), sometimes (catfish=sum, newspaper = times), talk (Robert Kennedy = Ted Kennedy = Ted talk = talk),  rubbish (Shiite Cleric= shite = crap =rubbish).  

What association did you use to remember this? 
At least I think that was the order:-).
    
There are still people doing this procedure, it is your money, it is your risk, but medical advice would be do not waste your money as there is no evidence for benefit.  

Apologizes if you find the post insensitive.  I realize that people have been charged $10,000-$20,000 for this procedure.

19 comments:

  1. Looking forward to the tweets from Leicester:-(

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    1. I can hear the distant sound of a keyboard being bashed ALL IN CAPS ;-)

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    2. 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?

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  2. Desperate patients taking desperate actions. I believe the National MS Society and the Cleveland Clinic also were sucked into the CCSVI clinical trial.

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  3. 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.

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    1. 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.

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    2. 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.

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    3. Ha ha, a desperate bit of whataboutery from anon 10.33 there.
      CCSVI is dead and good riddance.

      Delete
  4. 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.

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    1. 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.

      Delete
  5. 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.

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    1. 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

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  6. However as to Brave Dreams the question is Does Zamboni (and the trial) have any credibility?

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  7. Just realised I can't spell its ccsv-i not ccvs-i aliG pic

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  8. 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.

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  9. 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.

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    1. 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.

      Delete

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