Image: Jean-Marie Charcot's treatment for Parkinson's disease, the "fauteuil trepidant" (translation; shaking chair) or its portable version the shaking helmut. He devised this after observing that Parkinson's patients exhibited reduced symptoms after long carriage rides...lets just say the idea didn't take off. Which goes to show you that not everything you see is what it appears to be.
In short, this study found that there was no clinical improvement in those who participated.
Conversely they found that it may even worsen the disease. There were 20 patients in total in the phase 2 portion of the study: 4 relapses were in the treatment arm and 1 in the placebo/sham-arm, whilst 5 out of 9 patients in the treated arm showed new contrast-enhancing MRI lesions compared to 2 in the placebo/sham-arm.
It is not the first time that worsening disease activity has been noted, and has been reported in 4 other studies. It is thought that re-opening the veins may increase the perfusion of the micro-circulation of the brain, but inadvertently bring in more immune cells worsening the disease activity.
Was this study needed? YES...
A double-blind placebo-controlled clinical trial needed to be done as their was uncertainty about the efficacy of venous angioplasty in CCSVI in MS.
But in order to do such a trial, "clinical equipoise requires that uncertainty exists about the efficacy of an intervention being studied in a clinical trial" - editorial comment.
But as the findings are negative, there is no longer this equipoise.....and further studies of this ilk cannot be justified on ethical grounds alone.
The numbers were small, but for a phase 1/2a interventional study this sample size is adequate. The placebo/sham arm patients still underwent the procedure, wherein an angioplasty balloon was inserted, but not inflated to achieve the dilatation as in the treatment arm. Therefore the risk of complication ~ 4% (4 in every 100) associated with cerebral angiograms still applies to the placebo/sham arm as well.
Infact, the argument works both ways, the authors assertion that angioplasty was performed safely in MS patients is also diminished by the small sample size.