Friday, 31 August 2012

Research: Clinical Improvement after Venoplasty of CCSVI.

Purpose: This study proposed to prospectively evaluate safety and clinical changes in outpatient endovascular treatment in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI).

Materials and Methods: Two hundred fifty-nine patients with MS were followed with the Multiple Sclerosis Impact Scale (MSIS-29) before and for 1and 6 months after treatment of extracranial internal jugular vein and azygos vein stenoses and occlusions using venous angioplasty, as well as stent placement in 2.5% of patients. Before treatment, the patients were tested with magnetic resonance (MR) venography and flow quantification.

Results: We found statistically significant improvements in the MSIS-29 scores (P < .01) at both 1 and 6 months. At 1 and 6 months, 67.9% and 53.6% were improved on the physical scale, respectively, and 53.0% and 44.4% were improved on the psychological scale, respectively. Women showed greater improvement than did men on the physical scale at 6 months (P = .01). Patients with primary progressive MS (PPMS) showed less improvement than did those with relapsing-remitting MS (RRMS) on the psychological scale at 1 month, and venoplasty treatment of more vein sites versus fewer vein sites showed greater improvement on the physical scale at both 1 and 6 months. Fifteen patients (6.3%) reported recurrent symptoms after clinical improvement and were treated again. There was one serious adverse event, a deep venous thrombosis at the catheter insertion site, which resolved with treatment.

Conclusions :Endovascular treatment of CCSVI in patients with MS appears to be a safe procedure resulting in significant clinical improvement.

Well you can all read and so the conclusions say it all. This is not a clinical trial but a retrospective look at people who have had venoplasy and 70% felt better at 1 month after treatment.

Therefore if the trials ongoing look at one month then it should be a breeze to show an effect. But at 6 months only 50% better or no effect/worse. If one looks at 12 months then maybe it is going to be touch and go. The BRAVE DREAMS trial of Zamboni is baseline and 12 months, maybe months too far.

We need to see data from placebo controlled trials. The pro-side should be confident and say "bring it on". Let us hope it works.

This study is by David Hubbard of the Hubbard Foundation, which investigates the vascular component of neurological disorders, such as Chronic Cerebrospinal Venous Insufficiency. So no conflict of interest in showing CCSVI as a disease entity then :-)

No comments: