Antonios and Pierre:
some continuation on your points/questions...
(a) why is the study delayed... very frustrating indeed!, for investors and for vasomedical... The explanation I was given (and I believe it is true) is that they have to screen 10-12 patients to be able to enter 1 in the study. This because they need a "positive" exercise test by EKG criteria. But also because the patients cannot be unstable. Lastly the patients cannot cross over, for a whole year, to the real EECP treatment. Many patients don't like the idea that they could be in the placebo group for weeks, then not be able to benefit from EECP for a year... Another factor is most likely the fact that these patients come from "famous" centers, where there are already "bezillions" of research protocol for angina patients, and therefore these centers have an inside "competition" for getting their patients into this or that research protocol... I therefore understand the delay, but still don't like it!
(b) suspicious cardiologists, ? placebo effect?: there is NO doubt in my mind that there will be a "placebo" effect, on 2 counts: (1) the natural history of coronary artery disease is characterized by spontaneous improvement of angina, and we should see an improvement in the low inflation group and (2) patients most likely get a real psychological "boost" from having all this attention, and their lower limbs "softly massaged" for 35 sessions, in the "placebo" low inflation group... But then again: we do have stress reduction clinics which don't use pills, sometimes yoga, acupuncture... Are those "placebo" effects... or are these techniques really working? I think they are, in some patients.
My understanding, therefore, is that EECP HAS to have a BIG "placebo" effect associated with a REAL improvement of exercise tolerance, etc...
Why are cardiologists "suspicious" about EECP?... Remember that some are making a lot of dough, proposing PTCA to some patients and getting > 1500$ for a PTCA, lasting at most 2 hours... Better than what they could make with one prescription for EECP (a consultation fee)which probably runs in the 150$ range... and then, you can bet that about 10% of patients will need another procedure whithin 6 months...
Why, therefore, would a cardiologist push EECP?... It would eat into their income real bad!... that is my take in the situation.
There is definitively NO evidence that EECP does NOT work.... In fact, the published literature shows that EECP appears to be 40% effective in severe cases, and > 90% effective in mild cases (one blocked vessels).
I hope the above helps in the understanding of the ongoing EECP saga! |
