Tuesday, July 09, 2024 5:07:27 PM
But I agree, the standard deviation over 100% means the data points are really scattered -- the curse of the underpowered clinical study.
It's absurd to think that the ActiPatch group would use more opioids than the placebo group (and wake up from pain more often during sleep). But they did.
I think Ilfeld saw the high standard deviation and realized that the ActiPatch wasn't working as well for some indications, so he cherry-picked three indications and started a new SofPulse study in April 2023.
I don't see a reason for him to publish this ActiPatch study. At the very least, I think he will wait for the SofPulse study to end and see if he got better numbers, although that sample size is even smaller (only about 35 per arm).
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