Thursday, January 22, 2015

New blinded study finds CCSVI associated with MS, and NOT found in normals

While CCSVI studies lead by neurologists claim they can't seem to find CCSVI, or conversely, they find it in everyone---

Here are the details of a recent blinded study lead by vascular specialists utilizing correct diagnostic protocols.  It was undertaken at Sapienza Hospital in Rome and lead by Dr. Luciana Tromba.   It's all about specificity and sensitivity of the study, which is reflected in their method and p values.  I'll explain below the abstract.
http://phl.sagepub.com/content/30/1/52.short


We enrolled 112 patients with multiple sclerosis and 67 healthy subjects from 20 to 67 years of age. All the patients underwent Duplex and color-Doppler sonography of the neck vessels, transcranial colour duplex sonography, M-mode study of the valve system and of venous abnormalities. Subjects were positive for chronic cerebrospinal venous insufficiency when at least two of five hemodynamic criteria of the Zamboni protocol were fulfilled

No healthy subjects were positive for chronic cerebrospinal venous insufficiency, while in the sample of patients affected by multiple sclerosis the diagnosis was made in 59.8% of cases (p < 0.0001)

I want to point out that very, very small p value number, that number which is smaller than .0001 means these scientists are very sure about their results.  In statistics, the p value is the number which reflects the testing of a hypothesis. The smaller the p value, the larger the significance of results.

What this means is that the study found a significant difference between normals and people with MS, and this is backed up scientifically.  It is not random, or chance.  This was a highly specific, highly detailed study.


The first criterion was the most frequent in patients affected by multiple sclerosis and chronic cerebrospinal venous insufficiency (respectively 54.4% and 76.1%, p < 0.001). The second, third and fourth criteria were never present in healthy subjects but were detected in patients with multiple sclerosis. The positivity of the second criterion was associated with diagnosis of chronic cerebrospinal venous insufficiency in 100% of cases. The third criterion had a prevalence of 52.2% in the subgroup of chronic cerebrospinal venous insufficiency patients. It was positive in 36 multiple sclerosis patients and was associated with chronic cerebrospinal venous insufficiency diagnosis in all cases except one.

This highly detailed study looked at all the CCSVI diagnostic criteria in those with MS and normals and saw very dramatic results.  This leads them to the conclusion---

Chronic cerebrospinal venous insufficiency is a haemodynamic condition strongly associated with multiple sclerosis and is not found in normal controls. The addition of M-mode ultrasound to the diagnostic protocol allows improved observation of venous valve abnormalities.

Again, this study was blinded, followed the correct Zamboni protocol, looked at blood flow (or hemodynamics) using M mode ultrasound.  M mode stands for "motion", and this ultrasound shows problems with delayed blood flow caused by issues inside the veins, like webs or problems with valves.

And the researchers found CCSVI in pwMS, and not in normals.

Dr. Zamboni has always stated that CCSVI is about blood flow, not just how veins look, or measuring stenosis.   As he has said numerous times, "CCSVI is about flow, not architecture."

When scientists work with him, utilize his protocol, they find CCSVI in MS.  That's what scientific replication is about.  It is not about agendas, conflicts of interest, or p values that show no specificity.  It is not about ignoring his protocol, casting aspertions, or creating new measurements for stenosis never before seen in vascular journals, like the Traboulsee study at UBC, which I believe was scientific misconduct.
http://ccsviinms.blogspot.com/2014/12/scientific-misconduct.html

This exploration of CCSVI is far from over, despite the "death knell" editorials by neurologists.   Thanks to the vascular researchers willing to do the hard work.

Joan