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http://www.elixa.com/CES/CESfaq.htm schreef:
Q. What research is there as to the safety and effectiveness of CES?
A. There are approximately 1,000 articles on CES therapy many of which are listed in four reviews put out by the Foreign Service Bulletin of the United States Library of Congress. This is in addition to the wealth of physiological and bio-engineering data on electrosleep and electroanesthesia in animals. As of this writing there are more than 100 research studies on CES in humans and 18 experimental animal studies. The efficacy of CES has been clinically confirmed through the use of 28 different psychometric tests. The significance of CES research for treating anxiety has also been reconfirmed through meta-analyses conducted at the University of Tulsa and at the Department of Health Policy and Management , Harvard University School of Public Health. The full body of research can be accessed at this website.
Dat klinkt erg positief
http://www.onemedplace.com/blog/archives/567 schreef:
There are several proposed mechanisms of action through which CES is believed to operate—the effects are possibly mediated through a direct action in several brain areas including the limbic system, the hypothalamus or the reticular activating system. Fisher-Wallace has received an FDA 510(K) clearance for the device. It is available in the U.S. by prescription only. CES devices are sold over the counter in Europe and other parts of the world.
Tegen apathie ? Zie voor wat terughoudendheid:
http://www.quackwatch.org/01QuackeryRelatedTopics/ces.html
http://www.cochrane.org/reviews/en/ab006341.html
http://en.wikipedia.org/wiki/Cranial_electrotherapy_stimulation
Betreffende FDA-clearances maken allemaal gebruik van de 1976-overgangsregeling, de z.g. grootvaderverklaring, die inhoudt dat er niet hoeft te worden getest op effectiviteit. De fabrikanten zien kennelijk geen reden zien deze situatie te veranderen, maar leggen de tekst zo uit dat het lijkt of hun apparaat wel degelijk goed is:
http://www.alleviahealth.com/regulatory.htm schreef:
According to the FDA, cranial electrotherapy stimulator (Regulation No.882.5800) is a grandfathered class III neurological device “…that applies current to a patient’s head to treat insomnia, depression, or anxiety.” Both the Alpha-Stim 100 and the Alpha-Stim SCS have been classified as cranial electrotherapy stimulators. The Alpha-Stim FDA's 510 (k) Premarket Notification Number for these applications is K903014.
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Grandfathered class III devices are not considered investigational by the FDA and therefore an Investigational Device Exemption (IDE) is not required for clinical use or research trails with any Alpha-Stim products or CES devices in general.
http://www.aetna.com/cpb/medical/data/400_499/0469.html schreef in 2007:
Aetna considers cranial electrical stimulation (also known as electrosleep, electrotherapeutic sleep, cerebral electrotherapy, transcranial electrotherapy, transcerebral electrotherapy, craniofacial electrostimulation, and electric cerebral stimulation as well as the Liss Body Stimulator that is used to treat alcoholism) experimental and investigational for the treatment of neuropsychological indications (alcoholism, chemical dependency, dementia, depression, headaches) or any other indications because its effectiveness has not been established.
CES