Wednesday, March 27, 2013

BNAC research : A Tale of Two Studies


March 27, 2013 at 2:43pm

There have been two venoplasty studies undertaken by the University of Buffalo and recently released/publicized.  I thought it might be good to compare them, side by side.  Because the conclusions and results are worlds apart, and there needs to be an explanation.

Dr. Robert Zivadinov is the lead investigator in both studies.

PREMiSe Study Phase #1  Cine/CSF Study  
Published in the Journal of Vascular Radiology March 2013
No publicity  
Discussed at International Society for Neurovascular Disease Conference

PREMiSe Study Phase #2
Poster/Publicity at American Academy of Neurology  March 2013
Press conferences, videos, lots of news coverage all over the world.

Both are Venoplasty studies in mainly RRMS patients.  

PREMiSe study phase 1--Dr. Robert Galleotti, treating IR 
has worked with Dr. Zamboni for many years, has treated hundreds of CCSVI patients
an expert in venoplasty for CCSVI.  Venous drainage is improved >75%


"Improved venous parenchyma drainage"  Lower number of lesions on MRI for treated patients, less relapses.  
More studies are warranted!  PTA is good for the brain.


PREMiSe study phase 2-- Dr. Adnan Siddiqui, treating IR, relatively new to CCSVI venoplasty
Venous drainage is NOT improved to marker of >75%.  In fact, it is only improved to 50%!  (meaning treatment was a failure!!!)
 Headlines read, Liberation Therapy may make MS worse!
Nine patients treated, showed 19 new lesions on MRI.  PTA is bad.


 "more sizable changes in venous outflow [were] associated with increased disease activity primarily noted on MRI,"  Dr. Zivadinov and his colleagues concluded.


How are we to know what to believe? 
Is venoplasty helpful or harmful?  Is this about experience in the treating IR?  
Is this about how research is framed for the different audiences of vascular vs. neurological conferences?  

If phase 2 of PREMiSe did not reach a restoration of <75% venous flow, as it was supposed to....is this trial a failure?  

Because one study shows the venoplasty for CCSVI reduces lesions, relapses and improves CSF and venous drainage when flow is restored to <75%.

while the other study shows the exact opposite.
Which is the truth?

Does anyone want to answer this?
Joan

2 comments:

  1. yeah, they get mixed up in their own lies..and why the univ of buffalo and not harvard? i mean why so little interest? and how can they ignore the thousands of people for whom the ccsvi treatment worked?

    ReplyDelete
  2. Thankyou for doing this with truths

    ReplyDelete