Talk:Cranial electrotherapy stimulation

Moved to talk

I can't tell what this is trying to say. SandyGeorgia (Talk) 02:30, 22 February 2015 (UTC)

In its announcement made on June 12, 2014, FDA "has determined that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices. In this action, FDA is withdrawing the proposed rule and proposed order to call for PMAs for CES devices. FDA plans to issue a proposed order in the future for the reclassification of the CES device into class II."

In preparation to the 2012 Neurologic Devices Panel, FDA conducted its own CES literature review of the selected 39 papers, of which "some reported a beneficial effect of CES treatment on depression, anxiety and insomnia while others demonstrated no effect." FDA noted that "among studies that reported a clinical benefit of CES, few can be considered rigorous, high quality clinical studies."

References

these devices have been on the market for a long time, and when devices ~really~ came under FDA regulation in 1976 the FDA had to decide what to do with existing devices, including CES devices. (they had to do a similar thing with the effectiveness of drugs already on the market, following the passage of the Kefauver Harris Amendment in 1962). The FDA was meant to move pretty swiftly to classify pre-existing devices but that has gone very, very slowly. One reason is that the manufacturers of some pre-existing devices have fought like crazy and sued to keep their devices on the market and not have to conduct clinical studies, as spending significant money on research was never in their business models. So the FDA announcement in 2014 saying it would treat them as Class II (no PMA required so no new clinical studies required) was a "win" for them... it is still not clear what kind of claims manufacturers will be able to make about their devices. Jytdog (talk) 20:27, 18 July 2015 (UTC)

I've just reverted the addition of what apppears to be a proposed rule change, which was even cherry picked to omit that it mentions that CES would be considered okay only alongside certain "controls". Overall, it seems a rather flimsy source, certainly in comparison to the Cochrane review which was removed (I restored it). Alexbrn (talk) 16:33, 22 July 2015 (UTC)

Cochrane review

Yes the 2014 Cochrane review was removed in this edit [1] and than again [2] and than again [3]. The "Journal of Psychological Nursing" is a much lower quality source and older. Hum. User:Doc James please provide an explanation. Doc James (talk · contribs · email) 21:18, 22 July 2015 (UTC)

The Journal of Psychological Nursing is a monthly, peer reviewed publication. That does not fit the description of a "low quality source." Furthermore, it speaks to CES (both direct current and alternating current devices) broadly, whereas the Cochrane review only references alternating current devices. Therefore, the Cochrane Review is only providing a partial assessment that is being broadly applied to the entire category of cranial electrotherapy stimulation. The information from the Journal of Psychological Nursing is novel because it discusses the major branch of CES devices that the Cochrane Review does not address. ColumbiaLion212 (talk) 19:23, 23 July 2015 (UTC)ColumbiaLion212

User:Doc James please provide an explanation.

User:Alexbrn please provide an explanation, as well. You made the same reversion edits.

This is the source [4]. It looks like an editorial maybe rather than a proper review article. I see no were described in the paper the methods they used to systematically look at the literature so likely they did not.

This source also does not mention direct or alternating current. And it is getting a little old. And the impact factor of the journal is really low at 0.873 [5] so yes I would say not a good source for all those reasons. Doc James (talk · contribs · email) 19:53, 23 July 2015 (UTC)

The Journal of Psychosocial Nursing and Mental Health Services is a recognized journal indexed in MEDLINE/PubMed; CINAHL; SCOPUS; EMBase; EMCare; ProQuest; British Nursing Index; PsycINFO; Current Contents/Social & Behavioral Sciences; Science Citation Index; Social Sciences Citation Index; Journal Citation Reports, Science; and Journal Citation Reports, Social Sciences.

Coincidentally, the Cochrane review reference is also from pubmed, which recognizes the same journal that I am trying to reference. It seems arbitrary that you will establish such a double-standard.

Furthermore, you assert that the journal review, which was published THIS DECADE is "old." Does that, by your standards (and wikipedia standards) mean the 1995 meta-analysis is "old" as well? If so, it is not a proper reference to standard.

The source does not refer to alternating or direct current because the literature reviewed contained both alternating and direct current devices. That is why it spoke broadly on cranial electrotherapy stimulation, not just the alternating current aspect of it. The cochrane review speaks solely on alternating current devices, which makes it misleading to apply that knowledge broadly to all CES devices.

User:Doc James please provide an explanation. User:Alexbrn please provide an explanation, as well. I would like to know your reasoning since you have not replied yet.