The amazing thing about a placebo is that it tends to help people ,when in theory it shouldn't. It must be that the people in the study felt more positive about their predicament - and, after all, they had no idea whether they were going to get the device on or off -
and just the positive brain chemicals engendered by hope caused their heart to work better. The difference in heart volume may still be enough to make a difference in people's lives.
Thr results actually support my speculation in another thread that the 'non-responders' dilute the effect . That is, 'non-responders' (I believe) must have already had conventional CRT fitted - and , although the lead has not malfunctioned, for some unknown reason they were not helped. It would have been unreasonable to expect that as many would be helped as much as people who had not even been able to have conventional CRT fitted at all because of, say, acute lead failure. The fact that a reasonable percentage of non -responders were helped by WiSE is still positive. However, because the effect is not as good in the non-responders, and so they dilute the result, it was decided to submit only the other groups for FDA approval in the first instance . At least , this is my understanding. I would very much appreciate anyone else contributing any ideas. At any rate ,after I have examined the results more carefully, I intend to send questions to Andrew Shute. If his answers contradict my speculations, I will post.
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