#ISNVD 2016: Thanks to Kerri of CCSVI Australia for these tweets:
Helen Kavnoudias:"Randomised, double-blinded, controlled (w/ sham) study of PTA for extracranial vein stenosis in 28 patients w MS.
Dr. Kavnoudias: in Australia pressure was put on government not to allow treatment in public hospitals outside a trial.
Does angioplasty make a difference, is there placebo effect? Control with sham was used to test placebo.
Kavnoudias: allowed two procedures per patient, and treated restenosis as part of protocol.
All placebo patients received procedure at year one. Patients given Midazolam and had no recollection of procedure--to maintain sham end of study.
Kavnoudias: reflux in 7 patients, 21/28 had valve involvement, 22 had 2-3 stenoses.
Restenosis - complicates the data. 3 restenosed within 6 months. Balloon angioplasty may not be a solution in itself for everyone.
One person relapsed, was in the control arm and was on immunomodulators.
The procedure is relatively safe. Few mild adverse events
Kavnoudias: Improvement in EDSS is trending to significance at p=.08. Needs larger sample size.
Cognitive test showed significant differences in treatment vs control group.
15% increase in Quality of Life self-test. There was no increase in QOL for patients in placebo group. No placebo effect shown.
PICTURED: Paolo Zamboni, Robert Zivadinov, Carol Schumacher & Helen Kavnoudias after Annette Funicello presentations.