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Re: Doh! Reversal on some of my last post ihatedrugs

Posted by Larry Hoover on August 31, 2008, at 18:10:50

In reply to Re: Doh! Reversal on some of my last post, posted by ihatedrugs on August 31, 2008, at 17:23:55

> Also about Alpha stim, I've done a little research and the jury is still out on this treatment but I'm also going to talk about it with my dr.

I'm glad you're skeptical about the Alpha-Stim. The research conducted on its efficacy is very weak. The vast majority of the studies are: a) very old (conducted in the early 1970's); b) open (subject to both patient and doctor bias); c) conducted on patients with disorders other than anxiety and depression; d) all of the above. The owner of Alpha-Stim, one Dr. Daniel Kirsch, keeps publishing bizarre and scientifically fallacious articles about how effective his device is, all based on inappropriate meta-analyses of all these poor studies mentioned above.

Alpha-Stim, and its many copycats on the market, are FDA/CDRH Class 3 devices. That puts them in a category that meets the definition "which present a potential, unreasonable risk of illness or injury." Because a similar device was on the market prior to the passing of product safety laws in 1976, any device which can demonstrate that is substantially similar to such device can be marketed without testing or proof of efficacy. That's a so-called "grandfather clause" loophole, a flaw through which all such devices pass. That's also most likely why the device presents risks.....it's never been tested, either for safety or for efficacy.

For the full blurb, see: http://www.fda.gov/cdrh/devadvice/3132.html

Far be it for me to say the device doesn't work, but I have found little convincing evidence that it does.

Lar

 

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poster:Larry Hoover thread:849437
URL: http://www.dr-bob.org/babble/20080822/msgs/849527.html