marcstck wrote:So much potentially vital information has been lost due to the lack of long-term tracking of CCSVI treatment patients. Of the 30,000 patients treated, we only know the outcomes of a tiny percentage. It's really a shame…
centenarian100 wrote:NZer1 wrote:Who looked comfortable and who looked very uncomfortable and was cut short in the staged PR interview, WHY?
Is someone in bed with Dr. Zivadinov?! DUN DUN DUUUUUUN!
PREMiSe is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS performed with Institutional Review Board approval in a rigorous fashion in the U.S. with significant safeguards in place to ensure careful determination of risks and benefits. All screening, diagnostic, interventional and follow-up procedures and visits were performed at no cost to the patients.
"The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients,” explained Zivadinov.
The trial enrolled 30 MS patients. Phase 1 was a safety trial, involving 10 MS patients and Phase II involved a total of 20 MS patients, who were randomized to receive treatment or placebo. Researchers found no difference in clinical symptoms, brain lesions as determined on MRIs or quality of life outcomes between MS patients who underwent balloon angioplasty to correct CCSVI and those who did not receive the treatment.
• In phase 2, improvement was observed also in treatment (p=0.02) and sham (p=0.04) arms at month 1 but did not reach >75% restoration of the venous outflow compared to baseline. No differences in VHISS improvement (Venous Hemodynamic insuffiency Severity Score) were detected between phase 2 treated and sham groups (p=0.894).
If I took a pill (say Fampridine for example) and the effects wore off, I would take another pill. And the drug maker can explain its because the half-life of the checmical in my system.Cece wrote:"The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients,” explained Zivadinov.
Ernst wrote:I was going to ask if Buffalo trial is published.. but it isn't yet? Im also wondering why unpublished and small trial, with no correction with blood flow, is so much in media? Study result is used as an proved evidence against CCSVI.. absolutely horrible. Why positive studies, are not in media.. like blinded study from Italy which was recently published and result was very clear that CCSVI is related to MS? Quess this is going to be long war..
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