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Re: EMSAM-Day 5-Too early??

Posted by SFY on April 24, 2006, at 13:03:36

In reply to Re: EMSAM-Day 5-Too early?? pederspd, posted by RobertDavid on April 23, 2006, at 0:21:11

> May I also ask if you know if your experience was similar to others in the study? The study showed that only 3.5% more people dropped out taking EMSAM vs placebo. That would suggest very few had enough side effects to quit. Do you have any insight regarding that?

Don't get me wrong, I'm not an Emsam doubter. (In fact, it's going to be my next step if my current meds regimen doesn't pan out.) But I don't think we should minimize the ocurrence of side effects (and interpreting statistics correctly will help us all to better understand study results).

In the study earlier cited, 7.1% of Emsam users dropped out due to adverse effects versus 3.6% of placebo users. 7.1% is not 3.5% higher than 3.6% but nearly 100% higher since nearly twice as many people on Emsam dropped out than those on placebo.

If we had a total sample size of 1000 in the study, then 71 Emsam users and 36 placebo users would have dropped out. Thus 35 more or 97% more Emsam users than placebo users dropped out due to adverse reactions. If it were only 3.5% more than there would have been only 1 (0.035 x 36) more person dropping out which was clearly not the case.

Thus Emsam's side effects (or at least their severity leading to discontinue treatment) are noticeably greater than those encountered with placebo.




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