MS patients did not benefit from CCSVI intervention, landmark pilot study of ‘liberation treatment’ finds:

Procedure is safe but does not improve MS outcomes, a finding that the UB investigators call “surprising and unexpected”

Greating from Croatia, home of the one of last bastions against CCSVI hoax.

http://www.hindawi.com/crim/surgery/2012/293568/

Case Reports in SurgeryVolume 2012 (2012), Article ID 293568, 5 pagesdoi:10.1155/2012/293568
Case Report

Internal Jugular Vein Entrapment in a Multiple Sclerosis Patient

Marian Simka, Eugeniusz Majewski, Marek Fortuna, and Maciej Zaniewski

Department of Vascular Surgery, EuroMedic Medical Center, Street Kościuszki 92, 40-519 Katowice, Poland
Received 16 June 2012; Accepted 16 September 2012
Academic Editors: I. Harirchi, H. Kawai, and G. Santori

Copyright © 2012 Marian Simka et al.
“…
We treated the 57-year-old female patient, with clinically defined MS, presenting with EDSS (extended disability severity score): 5.5 and MSIS-29 (multiple sclerosis impact scale-29): 103 points [11, 12]. She was given the diagnosis of CCSVI according to Doppler sonography results.
…
The patient was followed up 10 months after the endovascular procedure. Her neurological status remained unchanged.
…
Yet, control Doppler sonography revealed totally collapsed middle part of the left IJV in the supine position, with no flow through the vein detected.
…
According to the above-described sonographic findings, patient qualified for surgical decompression of the vein. Anatomic relationships were checked sonographically and locations of jugular vein and compressing muscle were marked on the skin before the procedure (Figure 4(a)). Surgical exploration revealed atypical OH, which was obviously squeezing the vein.
…
Transection of pathological muscle—performed in general anesthesia—resulted in widening of the vein (Figure 4(c)) and normal blood flow was restored
…
Still, neurological assessment performed 2 months after the operation has shown a slight deterioration of clinical status: EDSS was 6.5 and MSIS-29 was 110 points.
…”

??????

Is this poor woman a guinea pig or something? Two unnecessary procedures, lot of pain (and money) and dr. simka is still wondering:

“Of note, despite successful decompression of the vein, we did not observe clinical improvement in this patient. However, it is already known that only a subset of MS patients benefits from restoration of proper venous outflow after endovascular treatment for CCSVI [29, 30]. Patients with more severe disability, like our patient, were less likely to improve. Besides, clinical status in MS patients typically fluctuates and perhaps a longer followup, instead of 2 months, was needed to evaluate our patient properly. It is also likely that the worsening, perhaps temporary, was due to general anesthesia. Undoubtedly, results of the treatment of a bigger group of MS patients presenting with muscular compressions of IJVs should be prospectively evaluated in order to understand actual clinical meaning of such an entity.”

What a ‘Doctor’, and all this publiched in Academic Journal with Academic Editors?!

Best regards, Mladen.

p.s: (for those with good stomach) here is how dr. Marian Simka ‘cure’ MS patient:
http://www.hindawi.com/crim/surgery/2012/293568/fig4/

Lyon. 12th October, 2012. The CoSMo study, recently concluded, highlights that 97 % of people suffering from MS does not have the CCSVI (Chronic Cerebrospinal Venous Insufficiency). In the remaining 3 %, the CCSVI can be verified with a percentage which is totally equivalent observed both in healthy controls, in patients suffering from MS and in patients suffering from other neurological diseases. No difference is encountered between the CIS (Clinically Isolated Sindrome) with respect to relapsing-remitting, either secondary or primary progressive MS forms. In the CCSVI diagnosis no risk factors, like age and gender, were highlighted. These, in summary, are the results of the CoSMo study, promoted and financed by AISM (Italian Multiple Sclerosis Society) and presented to ECTRIMS, (European Committee for Treatment and Research in Multiple Sclerosis).
 
CoSMo “Observational Study of the prevalence of CCSVI in Multiple Sclerosis in Other Neurodegenerative Diseases (OND)” is the largest observational and multicentric study, with double-blind reading performed to date, with an investment of 1.5 million euros: 1767 case analysed, 35 neurological centres involved and 26 trained sonologists covering the whole country, 3 international expert for the centralised reading of the exams. A 2-year lasting work to achieve the completion of the study. The final evaluation of the CoSMo study has been performed on 1165 patients affected by MS, compared with 376 healthy controls and with 226 patients affected by other neurological diseases.
 
The mechanism of centralised blinded reading, competent and free from any biased judgement connected to the interaction with the person examined, combined with the wide multicentricity, the numbers of samples analysed and with the widest database of examined subjects (which remains at the complete disposal of the whole scientific community) are the strengthpoints and unicity of this study, and ensure its scientific reliability.

….

Read more here:
http://www.medpagetoday.com/MeetingCoverage/ECTRIMS/35292

Largest CCSVI Study Fails to Support Theory:

The largest study to date testing the venous-obstruction theory of multiple sclerosis failed to support it, leading the Italian Multiple Sclerosis Society to declare the theory dead.

Suits allege Stanford University, physician harmed patients by breaking rules for ethics, safety and medical research in performing CCSVI surgeries outside of a clinical trial.

http://www.businesswire.com/news/home/20121010006553/en

SAN FRANCISCO–(BUSINESS WIRE)
Today two men announced lawsuit filings (docket #112CV218823) against Dr. Michael Dake and Stanford University (Stanford) for performing experimental surgeries on them for purported CCSVI, a controversial theory hypothetically linked to multiple sclerosis (MS), outside of an approved clinical trial.

“I trusted Dake’s medical opinion – in no small part because of Stanford’s prestigious reputation – and wound up as a guinea pig for his experiments”

Plaintiffs Oliver Zahn and Mark Wittwer allege that Dake abandoned fundamental policies for medical research and patient consent when he conducted experimental surgery to insert arterial stents in their veins, according to their complaints. They also allege that Stanford failed to protect patients by allowing Dake’s unapproved experiments to continue outside of a clinical trial, despite the recognized, life-threatening risks associated with Dake’s procedures and a lack of evidence to support any benefit from the treatment, court documents state. As a result, both men now suffer permanent and life-altering injuries…..

Best regards,
Mladen..

“The diagnosis of CCSVI was assigned by using specific color Doppler ultrasonographic criteria. Cerebral blood volume (CBV), cerebral blood flow (CBF), and mean transit time were assessed with dynamic susceptibility contrast material–enhanced magnetic resonance imaging in normal-appearing white matter (NAWM) in 39 patients with MS. Of these, 25 had CCSVI and 14 did not. Twenty-six healthy control subjects were also evaluated, and of these, 14 had CCSVI and 12 did not”

More than half of the healthy controls had “CCSVI”!!!
How can a subjective observer continue their support for the theory of CCSVI and MS, much use “Liberation Therapy” to treat people that suffer from MS
Dr. Novella wonders if the overwhelming evidence that fails to show a connection between CCSVI and MS will put a stop to clinics that promote “Liberation Therapy” and the research attempting to replicate Zamboni’s flawed hypothesis. He concludes sadly that it will live on as an alternative therapy. But what might help is if Dr. Zamboni admits his original work was incorrect.

The conclusion: CCSVI is not associated with more severe lesion burden or brain atrophy in patients with MS or Healthy controls.

Baracchini C, Atzori M, Gallo P.
Department of Neuroscience-SSPNRR, Stroke Unit, First Neurology Clinic, University of Padova, via Giustiniani, 5, 35128, Padua, Italy.

A condition called “chronic cerebrospinal venous insufficiency” (CCSVI) has been
postulated to play a role in the pathogenesis of multiple sclerosis (MS). This
hypothesis implies that a complex pattern of extracranial venous stenosis
determines a venous reflux into the brain of MS patients, followed by increased
intravenous pressure, blood-brain barrier breakdown and iron deposition into the
brain parenchyma, thus triggering a local inflammatory response. In this review,
we critically analyze the scientific basis of CCSVI, the current literature on
the relationship between CCSVI and MS, as well as the ultrasound methodology that
has been claimed to provide evidence of impaired cerebral venous drainage. We
show that no piece of the CCSVI theory has a solid supportive scientific
evidence. The CCSVI appears to be a rather alien condition and its existence
should be definitely questioned. Finally, no proven (i.e., based on strict
scientific methodology and on the rules of evidence-based medicine) therapeutic
effect of the “liberation” procedure (unblocking the extracranial venous
obstruction using angioplasty) has been shown up to date.

PMID: 22569567 [PubMed - as supplied by publisher]

http://www.sciencedirect.com/science/article/pii/S2211968X1200006X

Fact or fiction: Chronic cerebro-spinal insufficiency
• Claudio Baracchini, ,
• Paolo Gallo
• Department of Neurological Sciences, University of Padua, Via Giustiniani 5, 35128 Padova, Italy
• Available online 19 April 2012.

Conclusions

Ultrasound investigation of intracranial and cervical veins is highly operator dependent owing to the wide anatomic and physiological variability of these vessels. Therefore a study of cerebral venous drainage requires very experienced neurosonographers, but most importantly, blinding algorithms are mandatory in assessing MS patients especially during venographic verification of ultrasound findings; these were completely omitted in Zamboni’s studies. To this day, a scientifically sound validation of each of the five criteria proposed by Zamboni for the diagnosis of CCSVI is missing, not to mention their combined application. Concurrently, there is growing evidence which rejects the role of CCSVI in the pathogenesis of MS and which suggests that the proposed CCSVI criteria are questionable due to miscitation, manipulation of known data and methodological flaws. Thus, any potentially harmful interventional treatment such as transluminal angioplasty and/or stenting should be strongly discouraged, not only for the lack of any evidence, but also for the risk of serious peri-procedural complications.