Wednesday, 30 January 2013

CCSVI treatment: no major effect

#MSBlog: Venoplasty for CCSVI appears not to work! Do we need more data?

Epub: Ghezzi et al; The MS Study Group-Italian Society of Neurology. Endovascular treatment of CCSVI in patients with multiple sclerosis: clinical outcome of 462 cases. Neurol Sci. 2013 Jan 25.

Background: Although it is still debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in MS development, many patients underwent endovascular treatment (ET) of CCSVI. 


Objective: The objective of the study is to evaluate the outcome and safety of ET in Italian MSers. 

Methods: Italian MS centers that are part of the Italian MS Study Group were all invited to participate to this retrospective study. A structured questionnaire was used to collect detailed clinical data before and after the ET. Data from 462 patients were collected in 33 centers. 

Results: ET consisted of balloon dilatation (93 % of cases) or stent application. The mean follow-up duration after ET was 31 weeks. Mean EDSS remained unchanged after ET (5.2 vs. 4.9), 144 relapses occurred in 98/462 cases (21 %), mainly in RR-MS MSers. Fifteen severe adverse events were recorded in 3.2 % of cases. 

Conclusion: Given the risk of severe adverse events and the lack of objective beneficial effects, our findings confirm that at present ET should not be recommended to patients with MS.



"The results of this study are self-explanatory and mirrors our experience with the few MSers from our centre who have had treatment, typically abroad. The results are clear; it is no miracle treatment. What we also need is some symptomatic outcome data and an economic analysis." 

"Whilst we are waiting for the results of prospective blinded trials we do not recommend that any MSer have this procedure outside of a clinical trial protocol. In addition, MSers should not be paying to have the procedure either."

Other posts on CCSVI on this blog:

28 Jan 2013
Chronic cerebro-spinal venous insufficiency (CCSVI) has been proposed as a "congenital malformation" implicated in the pathogenesis of multiple sclerosis (MS). However, numerous studies failed to confirm its presence in ...
26 Jan 2013
SUBJECTS AND METHODS: We assessed flow variables in the ophthalmic artery, central retinal artery, and central retinal vein and measured the diameter of ONe in 46 relapsing-remitting MS patients and 37 healthy controls ...
09 Jan 2013
Google Trends and CCSVI. "Google Trends as an epidemiological tool to study social phenomena continues to fascinate me! The following is the latest update on CCSVI. What do you think?" ...
29 Dec 2012
OBJECTIVE: Chronic cerebrospinal venous insufficiency (CCSVI) was recently described in patients with multiple sclerosis (MS). The hypothesis of the vascular aetiology provides a new approach in the investigation and ...

24 Nov 2012
CCSVI monthly November. Epub: Simka et al. Internal jugular vein entrapment in a multiple sclerosis patient. Case Rep Surg. 2012;2012:293568. doi: 10.1155/2012/293568. Epub 2012. We describe a multiple sclerosis ...
21 Dec 2012
Complications from CCSVI. #MSBlog: complications from jugular vein stenting in MS. Dole┼żal et al. Serious Complication of Percutaneous Angioplasty with Stent Implantation in so Called "Chronic Cerebrospinal Venous ...
27 Oct 2012
CCSVI Monthly October. As the nonsense arrives, whenever there is a contentious post on CCSVI, to keep some balance for those interested, we will go back to the last Saturday of the month with no comments taken.
08 Oct 2012
Background: Chronic Cerebro-Spinal Venous Insufficiency (CCSVI) has been proposed to be associated with Multiple Sclerosis (MS). Zamboni et al reported significant improvement in neurological outcomes in MS patients ...

27 Oct 2012
CCSVI survey results. BLOG readers are sceptical. The survey results on CCSVI have been interesting. When asking Prof G to the post survey, I would have predicted that if all trials were positive the majority of people would ...
17 Oct 2012
In response to someone's comment re comparing CCSVI to Tysabri or Natalizumab. I have embedded the graph. It is clear the trends are very different; Tysabri/Natalizumab dwarfs that of CCSVI. In epidemiological terms we ...
06 Oct 2012
Introduction. An alternative etiology of MS named chronic cerebrospinal venous insufficiency (CCSVI) has recently been proposed by Zamboni et al. By venous ultrasound (US) and venography they found venous stenosis ...
08 Oct 2012
Zamboni P, Bertolotto A, Boldrini P, Cenni P, D'Alessandro R, D'Amico R, Del Sette M, Galeotti R, Galimberti S, Liberati A, Massacesi L, Papini D, Salvi F, Simi S, Stella A, Tesio L, Valsecchi MG, Filippini G. Efficacy and safety ...

17 Oct 2012
Google trends: CCSVI a waning social phenomenon. "These latest Google trend figures are reassuring and continue downward. I sincerely hope the off-license use of procedures to treat CCSVI are waning as fast." "CCSVI .
14 Oct 2012
This is one of the trials by protagonists of CCSVI. It appears that the Canadian Government has pledged to do a trial of 100 MSers, but this trial is being led by a CCSVI sceptic. Will the results be definitive. If positive, will we ...
8 minutes ago
CCSVI Research: Now Pigs?-Save the Pigs! Habib CA, Utriainen D, Peduzzi-Nelson J, Dawe E, Mattei J, Latif Z, Casey K, Haacke EM MR imaging of the yucatan pig head and neck vasculature. J Magn Reson Imaging.
16 Sep 2012
Research: CCSVI papers back after the Summer holiday. After 2 months of essentially nothing in terms of papers published nothing, now the periodical "Neurological Research" gives the journal over to CCSVI topics. Morovic ...

12 Sep 2012
Only one subject, a control, satisfied the Zamboni definition of CCSVI; however, 19 patients and 13 controls had abnormalities as defined by Zamboni, the difference largely caused by a higher prevalence in patients of internal ...
25 Aug 2012
This study looks at MSers and finds some with criteria compatible with the theory of CCSVI and some that do not. Likewise there are healthy individuals with CCSVI and some without. Where there is ultrasonic CCSVI there can ...
28 Aug 2012
The graph below compares the search volume index of alemtuzumab to CCSVI. To make the graphs readable I had to do a log conversion of the search volumes, which are given by week. To do the log conversion I simply ...
10 Aug 2012
RESULTS: CCSVI was present in 28 (18.9%) of the MS patients, in 2 (10%) of CIS patients, in 11 (6.4%) of the controls, and in 2 (5%) of the OND patients. A significant association between MS and CCSVI was found with an ...

22 Jul 2012
I sincerely hope the off-license use of procedures to treat CCSVI are waning as fast." "CCSVI remains predominantly an Italian and Canadian phenomenon. The UK and USA don't make the top 10." "Once the dust has settled ...
31 Aug 2012
Research: Clinical Improvement after Venoplasty of CCSVI. Epub: Hubbard D et al. Clinical Improvement after Extracranial Venoplasty in Multiple Sclerosis. Journal of Vascular and Interventional Radiology Epub online 28 ...
28 Jul 2012
CCSVI Monthly July. Yet again nothing! Do you think it is time to wind-up this monthly post? Reactions: Posted by MouseDoctor at 02:00 · Email ThisBlogThis!Share to TwitterShare to Facebook · Newer Post Older Post Home ...
11 May 2012
FDA Safety Communication CCSVI. FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients The FDA today issued a safety communication about CCSVI ...

31 May 2012
BACKGROUND AND PURPOSE: CCSVI has been reported to occur at high frequency in MS. Its significance in relation to MR imaging parameters also needs to be determined, both in patients with MS and HCs. Therefore ...
16 Jun 2012
Twenty-nine patients with clinically definite relapsing-remitting MS underwent percutaneous transluminal angioplasty for CCSVI, outside a clinical relapse. All the patients were regularly observed over at least two years before ...
30 Jun 2012
Yes. beside the couple of offerings that Prof G has served up there is nothing to report this month. Maybe people just want to see what the clinical studies show. Maybe the scientific interest is waning. Maybe it is time to kick ...
02 Jun 2012
To systematically review the ultrasonographic criteria proposed for the diagnosis of chronic cerebrospinal venous insufficiency (CCSVI). The authors analyzed the five ultrasonographic criteria, four extracranial and one ...

11 Nov 2009
Recently, evidence has emerged – and widely publicised – that a condition called “chronic cerebro-spinal venous insufficiency (CCSVI)” may play a role in the pathogenesis of multiple sclerosis (MS). Paolo Zamboni ...
17 May 2012
It's amazed me from the beginning that even skeptics of the theory of ccsvi agree to the need for clinical trials when the crucial point of the entire situation is that not long ago shared total obscurity along with the thousands of ...
10 Jun 2012
CCSVI: News of Negative trial. You may be have heard that trial data is emerging from Canada..in the press (ugh this is not where we should be hearing about this, science using the media for publicity is normally bad ...
21 Mar 2012
Search volume index. Region, Ranking. Italy, 1. Canada, 0.755. Serbia, 0.58. Croatia, 0.35. Norway, 0.275. Denmark, 0.245. Netherlands, 0.205. Ireland, 0.19. Finland, 0.155. Sweden, 0.135. City, Ranking. Cagliari (Italy), 1 ...

55 comments:

  1. There's always a summer job to be had, I hear cherry picking can be quite lucrative.

    Regards as always.

    ReplyDelete
    Replies
    1. 462 patients were collected in 33 centers - more than a punnet of cherries. Maybe a hundred punnets? More than enough to assess whether or not the treatment works. In my opinion this works is definitive. With a drug like penicillin it would only take about 3 patients with pneumonia to show penicillin was effective. Let's face it CCSVI and its treatment is the big farce to hit the field of MS in the last 50 years. It's time to move on to greener pastures or revisit ones that have been neglected by this irritating distraction.

      Delete
    2. I wonder just what it will take to convince you Andy. The cherry picking comment is unfair and if anything can be increasingly applied to the believers.

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    3. The only reason this observational study got published is because it is against CCSVI. Let's see why it is of the lowest quality:

      1.It is an observational study. Patients had the treatment somewhere and Italian neurologists gave them questionnaires to complete.
      2.The venous pathologies encountered are not mentioned.
      3.The number of different places/doctors that performed angioplasties are not mentioned.
      4.The patient cohort consisted of all types of MS. 28.8% were SPMS 23.1% were PPMS. MORE THAN HALF of the patients were in progressive phase (I wonder what would the result of any DMT be in a similar cohort!)
      5.Post treatment MRI was available for only 171 out of 462 cases (37%).
      6.Pre treatment relapse rate is NOT mentioned, so no comparison can be made.
      7.The fact that half of the patients consistently reported subjective improvement is not mentioned in the abstract.

      Professors and MDs, this study is not worth the paper printed upon, neither the hard disk space saved in. Why do you feed your readers with it?

      Delete
    4. Of course some might suggest that you consider it "lowest quality" because it disagrees with your deeply held views. You are one who no matter the weight of evidence it will never be good enough to change your mind. If 99 papers out of 100 come out against CCSVI you will choose to believe the 1 that agrees with you and i guess that will never change.

      Delete
    5. Be honest MD2, would you sign your name on a study like the above?

      Delete
    6. To add to VV's list, it would have been good if post-treatment sonography had been performed. Restenosis is so high (in angioplasty in general, which is why stents were developed) that it would be useful to analyze the data excluding MSers who restenosed.

      The premise being tested is that relieving extracranial obstructions will benefit MS disease course or MS symptoms; it does not seem correct to include data from MSers whose extracranial obstructions remained or may even have been worsened as seen in some of the adverse outcomes such as clotting.

      Delete
    7. I would think this would bet sensible to have an exclusion criteria like this but will it mean all are excluded?. I think the brave dreams trial is examination after 12 months but the perceived benefit lasts three based on other studies, so will brave dreams miss out if it is indeed a 12 month end point.

      Delete
    8. I would have liked to see a 3 month assessment for that reason.
      I see both sides (pro and negative on CCSVI) wanting definitive answers.

      Delete
  2. I quess we just havo to wait plasebo controlled trials. Now there are two kinds of data; a) vascular experts: CCSVI treatment is promising and b) neurology: CCSVI is useless, and it doesn't exist. I put my money to first one, vascular experts know what they are doing, and neurology doesn't like CCSVI at all, and are doing "science" with emotion :)

    ReplyDelete
    Replies
    1. It is good to know that neuros have emotions, I suspect it will be "ire" when they read this comment

      Delete
  3. There are indeed 2 types of data, negative and positive, and the evidence for CCSVI seems to be stacking up firmly in the negative grouping as more and more studies are being reported.

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    Replies
    1. Sir Mousedoctor2, its not about numbers - how many studies or how many people are in study. Its about quality and expertise. Poor study (like Cosmo, lots of critique by Italian vascular experts) gives false results. Doppler has been big problem and thats why there has been talk about multimodal research. I know that this very important research direcetion, and maybe after couple of years even neurologists realize it.

      Delete
    2. I suspect that you will only believe the studies that agree with you and dismiss those that don't as being "poor quality".
      The CCSVI lobby has been crying out for studies to be done (at great expense which in my opinion would have been better spent elsewhere) and therefore should accept the findings (positive or negative) as the evidence mounts. However I expect that this may be false hope on my behalf if experience with the MMR/Autism lobby is anything to go by.

      Delete
    3. I believe that venous experts know veins and how to measure flow for example. In Italy, there is really a war between neurologists and vascular experts - I have red now many articles where vascular specialists say what went wrong in COSMO. So my choise is expertise in this field.

      Delete
    4. The study talks against CCSVI treatment but doesn't describe a single case! What was treated? How was it treated? What was left untreated? CCSVI treatment is not like taking aspirin (either way MD). Each patient needs a unique approach.

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    5. In my opinion CCSVI is still very beginning and as time and research goes on, there will be developments with procedure tehcniques too. I have had same thoghs like VV, there are differences between cliniques. I saw couple of lectures (INSVD 2012 conference) and it was eye-opener, that there is still lots of work to do with research.
      I know quite many operated and have seen impressive results (my wife included), especially people whos MS in not so progressed. I know also people with high EDSS, results are now so good, sometimes zero.
      Angioplasty should be done in early phase.

      (sorry for language errors)

      Delete
    6. You may not be surprised, but I'm with Erkki and VV all the way on this one.She's looking a bit despondent at not getting her chance to sing, but I'm sure the 'Fat Lady' will get over it.
      Regards as Always.

      Delete
  4. I do wonder sometimes whether it's worth putting up any more posts about CCSVI as they always generate more heat than light.

    ReplyDelete
    Replies
    1. Whats wrong with good conversation? :)

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    2. It so frequently goes round in circles. it's deja vu all over again! ;-)

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    3. Yes yes, absolutely :)

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    4. I think you should go on posting about it. Whether we like it or not, it is a kind of treatment that MSers currently choose. It is part of the research going on about MS. I use this blogg to keep me updated on the research that is going on in the field of MS so it should be part of your posts. But then again... I don't think you should give it more room than any other field of MS-research. And maybe it might be an idea going back to switching off comments when it comes to this kind off stuff.

      Thank you very much for the great work you are doing with this blogg!
      Ingrid

      Delete
    5. I usually do switch them off, I messed up at the weekend but could not get to a computer to switch them off, ProfG often forgets, or is he stirring it, but it is going to be a debate we will have again in the comming year or so. Hopefully we will seen blinded trial results reporting, if some of the bloggers are correct then next month at a CCSVI meeting we could see some, however I guess we will hear about it on the blogosphere as I will not be there. If I was a roving reporter I would think it interesting to be a fly on the wall.

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    6. if the heats too hot get outta the kitchen

      Delete
    7. I was wrong about what's being reported at ISNVD with the PREMiSe trial. The presentation is titled, "Comparison of IVUS to gold standard catheter venography for detection of extra-cranial venous abnormalities indicative of CCSVI: results of the PREMiSe study. Yuval Karmon (USA)"

      The last part says, "Results of the PREMiSe study," but it's not the full results, only the diagnostics (IVUS versus flouroscopy).

      Delete
    8. http://www.eventscribe.com/2013/ISETCIO/assets/pdf/52589.pdf

      No moobs, I swear
      Dr. Dake's pdf from the ISET conference has a slide titled, "Recent developments to follow in 2013." The PREMiSe trial has "Results unblinded this week with outcomes to be presented in the near future." It's a small pilot study but it's the beginning of the randomized controlled studies that we'll see over the next few years.

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    9. Why are they unblinding part of the study an advertising reason or for assessing safety or has the study been so ace that it is not ethical to carry one...oh boy.

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    10. No, that's the whole study. It began in june 2010 and was supposed to follow patients for two years. The whole study is unblinded/finished but the data analysis is now underway.

      If it went well, maybe BNAC will undertake a larger trial. If it went poorly, we move the goal post? :)

      Delete
  5. MS drugs no major effect other than lining pockets of ones making commissions and shares in the MS drugs , The truths of whats going on

    ReplyDelete
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    1. What has this post got to do with MS drugs..nothing so maybe your comments need to go into "unrelated comments"

      You may think MS drugs are crap and maybe some of them are for certain things, but two wrongs do not make a right. To to suggest something is rubbish does not mean the alternatives are good, far from it, as it a weak line of argument to take. At least VV said why he thought the study was no good rather than blaming the findings on his toenails. I am sorry for being curt but this has got boring, hands up who has shares in any Ms drug on the market in teach G..non that I know of.

      Delete
  6. Ben Goldacre has shown what really is happening with clinical trials You are NOT professionals at all CON ARTISTS

    ReplyDelete
    Replies
    1. I know this is SPAM as it has all the hallmarks but I can't be bothered to go into spam to remove it. I have a collection of yours in there

      Why are we not professionals and con artists? What is the basis for this comment. Indeed we have a paper on the go with your hero Ben Goldacre as we speak commenting on pharma. These posts are like a magnet for you, but we have heard this enough, you have made your point I am not professional ok...if I am not professional I would tell you to *@~~#### off, so there we have it:-)

      Delete
    2. Why am I nasty?
      I have been insulted and I ask a sensible question and get a response that answers nothing. Therefore who is nasty?

      Delete
    3. The insults given are to the person who wrote am afraid Mousedoctor is wrong again quoted Why are we not professionals and con artists? What is the basis for this comment. Indeed we have a paper on the go with your hero Ben Goldacre as we speak commenting on pharma. These posts are like a magnet for you, but we have heard this enough, you have made your point I am not professional ok...if I am not professional I would tell you to *@~~#### off, so there we have it:-)
      Thats nasty what was said above the TRUTHS were said an this was the reaction

      Delete
  7. could you trace the ISP of that particular troll and get your students to inundate him/her and get them to sod off that way- very satisfying, I'd have thought!

    ReplyDelete
    Replies
    1. Tell me how to do it and I will.

      I did spend an entertaining few days writing repeatedly to one of our trollers, who sent their email by mistake. Be careful, Google is very unforgiving as once it is sent it is sent as you will note by some of my unfinished posts. After that the trolling stopped.

      It is interesting how easy it can be to track people down, especially in US. For another, within 15 minutes of a search I had pictures of their bedroom...scary stuff. Amazing what people put on websites.

      Delete
    2. I concur MD, picture's of my Daughters bedroom would probably not get past the moderators,probably breaching health and safety :-)

      Regards

      Delete
    3. Just as well it was not your daughter but tell her to take down pictures, if there are anyway, and clean up the room. I remember her from the trip to Manchester.

      If only there were moderators we would not get the 50+ moobs spam per day

      Best wishes

      Delete
    4. I would put money on it if this person is spamming and talking tosh she is most definitely not one of those who attended Manchester, not sure what moobs are ?
      I have, by the way she writes a very good idea who she is and quite frankly, I sympathise with you.

      Regards

      Delete
    5. Sorry MD, stick wrong end of *shuffles backwards out of the room, apologising as I go *
      btw If your spammer is who I suspectit is she's a nutter.

      Regards

      Delete
    6. Actually most spam is "you are so ace, blah, blah blah...visit my website blah blah". Luckily the spam filter gets most of them

      Interesting re nutter we both agree on their sex...but suppose it there was 50:50 chance on that.

      Delete
    7. AC, I post as Cece over at TiMS. I've been reading here for months for the MS research posts.

      Delete
  8. The CCSVI nutters have already destroyed "This is MS" and now it looks like they are trying to slither thier way onto this site. I think it is best to shut them down before they can continue to spread their mis-information.

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    1. My sentiments exactly.

      Delete
    2. Get a grip and put things into perspective, it's not all about hero worship and only choosing to listen to your side of the argument. Have a look how politics work in the more advanced societies of the world. Whilst I agree with stopping trolling ths is a fluid subject and evolution will play it's part. That said,
      Regards as Always.

      Delete
  9. ones running this site are very nasty sick individuals who need help

    ReplyDelete
    Replies
    1. ".....who need help"

      Any suggestions how you can help them? It is not good form to suggest there is a problem without proposing a solution? If you have no solution to propose I suggest not making making any comments.

      I suspect the corollary is correct - you are the one that is very nasty and sick and needs the help. I suggest you arrange to see a psychiatrist and stop reading this blog.

      Delete
    2. Here here, will the nutter just go away......
      signed the unprofessional one

      Yes we need help but not in the way you suggest, we spend all of our time removing useless spam posts, If we did not get them then maybe we would not need help get help to do

      Delete

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