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The last paragraph of the "regulation" section is rather problematic. The titles of the four studies that are referred to (references 27, 28, 29, and 30 in the federal register document) in the quote, would indicate that these studies are not specifically intended to be evaluations of efficacy of CES
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So they recommend NOT abandoning CES, but validating it more rigorously. The original studies did indicate CES was effective despite certain deficiencies. The deficiencies they identified mostly consisted of inadequate screening of control and placebo groups as well as inadequate blinding. But it is
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The reason why the FDA document refers to these studies is that they were cited in public comments submitted to the FDA. It does not appear to be the intent of the FDA to single them out as "evidence for CES as a treatment for
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Regardless of what issues the FDA found with these studies, they are largely irrelevant to any discussion of clinical evidence supporting efficacy of CES for treatment of depressive mood disorders.
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The "regulation" section needs to be updated. The FDA has reclassified CES devices as Class 2 for treatment of insomnia and anxiety. It remains at Class 3 for treatment of depression.
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Price L, Briley J, Haltiwanger S, Hitching R, A Meta-Analyses of
Cranial Electrotherapy Stimulation in the Treatment of Depression, Journal of Psychiatric Research,
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When the FDA was considering changing the category of CES technology in 2012, they held hearings. They were trying to assess what they call "human experience".
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If there is any doubt of what 5 studies would be relevant to a discussion of efficacy of CES for treatment of depressive mood disorders, they could be found at:
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I would suggest that the
Knowledge editors should rethink the editorial consensus on CES regarding depression and probably other conditions as well.
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sources that say that? If so, then we could use them in the article. As it is though, the above wont be sufficient to make us update the article. -
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A particularly terse and adamant testimony was given by
Stephen Xanakis MD Brigadier General US Army Ret. This can be found on youtube at:
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You are welcome. That document is the one that governs how we define acceptable sources for medical content. You should, once you have "
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code is E1399. Now treatment can be billed to insurance. It is an acknowledgement that the treatment is proven to be effective.
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CES is found to be useful, effective, and necessary by professional clinicians working in stressful, front-line situations.
1440:"Randomized double-blind, sham-controlled trials of CES in people with rigorously diagnosed acute depression are needed."
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require that editors disclose their "employer, client, and affiliation" with respect to any paid contribution; see
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Thanks. I am familiar with a lot of the ideas covered here but I will take the time to read it over carefully.
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Excerpts from
Neurological Devices Panel of the Medical Devices Advisory Committee to the FDA found at:
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The
Cochrane review makes it's determination based on 7 studies that were done more than 45 years ago.
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quite feasible to remedy these issues. If they are remedied in new trials, wouldn't that be adequate?
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https://www.massdevice.com/fda-reduces-controls-on-electrical-stimulation-devices-for-anxiety-insomnia/
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to the subject of this article. Relevant policies and guidelines may include
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to the subject of this article. Relevant policies and guidelines may include
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to the subject of this article. Relevant policies and guidelines may include
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column on 28 February 2004. The text of the entry was as follows:
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1427:Maybe it is time for a reset
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