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:ColumbiaLion212 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)

User:Doc James please provide an explanation. User:Alexbrn please provide an explanation, as well. You made the same reversion edits.— Preceding unsigned comment added by ColumbiaLion212 (talk • contribs) 19:46, 23 July 2015 (UTC)

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.

The biggest one is that its impact factor is less than one. Doc James (talk · contribs · email) 21:25, 23 July 2015 (UTC)

User:Doc James you have casually deflected my many points. Please address each point carefully, as they are essential to the integrity of this page. Why is a post 2010 journal considered "old", and a 1995 meta-analysis is not?

What Wikipedia standard puts an objective evaluation criteria for impact factor? It seems as if you're doing this arbitrarily. I've debunked your arguments, yet you seem to lack impartiality in accepting knowledge validated by a reputable secondary source.

User:Doc James please provide an explanation. 166.171.187.211 (talk) 21:47, 23 July 2015 (UTC)

Agree that 1995 meta analysis is old and have removed it . Doc James (talk · contribs · email) 22:09, 23 July 2015 (UTC)

User:Doc James What basis allows you to disallow a reputable, secondary source? Can you explicitly reference an objective reliability evaluation criteria that relegates secondary sources based on impact factor? If not, there are no grounds to delete sourced content on. ColumbiaLion212 (talk) 23:31, 23 July 2015 (UTC)

You need consensus. I disagree with you that it is a reputable secondary sources as the impact factor of the journal is so low. The Cochrane review is both newer and has a much higher reputation for fact checking, and impact factor. Doc James (talk · contribs · email) 23:35, 23 July 2015 (UTC)

ColumbiaLion212 please do finish the conversation we are having about conflict of interest on your Talk page. Thanks. Also, you are new to Wikipedia - please stop arguing so fiercely here. The Journal of Psychosocial Nursing and Mental Health Services article is not a review; it is an editorial. per WP:MEDRS we do not source health content to editorials. This is not a wild west - we follow policies and guidelines here. Please slow down and talk and learn how things work here. Thanks. Jytdog (talk) 23:38, 23 July 2015 (UTC)

Request for Clarification

Cranial Electrotherapy Stimulation is a technology category that is in the public domain (all CES tech that I’m aware of is out of patent), so there are no companies or private interests that control or exclusively benefit from Cranial Electrotherapy Stimulation, and those companies that do make CES devices are very small, unlike the giant pharmaceutical companies that produce competing products. Indeed, one of the obstacles that CES companies have faced is the overwhelming influence of competitors that often use well-placed, influential surrogates to disseminate misinformation about CES.

Following is my assessment of content on the page that is grossly misleading:

There is insufficient evidence to determine whether or not CES with alternating current is safe and effective for treating depression.[6]

[6] Kavirajan HC, Lueck K, Chuang K. Alternating current cranial electrotherapy stimulation (CES) for depression. Cochrane Database Syst Rev. 2014 Jul 8;7:CD010521. Review. PMID 25000907

This extremely misleading statement is supported (in citation) by a published literature review, not a clinical trial, and the publisher of this review is a small undergraduate teaching college within the University of Bristol.

In a 2010 literature review, published in a much more respected journal, Journal of Psychosocial Nursing and Mental Health Services, the conclusion is reached: “To date, whether used alone or in conjunction with pharmaceutical agents, CES has been shown to be an effective and economical therapy for mild to moderate depression.”

Gunther M1, Phillips KD. J Psychosoc Nurs Ment Health Serv. 2010 Nov;48(11):37-42. doi: 10.3928/02793695-20100701-01. Epub 2010 Jul 22.Cranial electrotherapy stimulation for the treatment of depression.

More importantly, there are at least two well-controlled clinical trials that have been published in respected peer-reviewed journals that provide statistically significant evidence of CES safety and effectiveness in treating depression:

Krupitsky et al. The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence 27:1-6, 1991

J Affect Disord. 2014 Aug;164:171-7. A Clinical Trial of Cranial Electrotherapy Stimulation for Anxiety and Comorbid Depression, doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.

I attempted to add this evidence to the page, yet it was repeatedly deleted.

Critics of CES research may point to the fact that subject sizes for most studies are not large when compared with drug studies, but CES study subject sizes are typical of non-invasive medical device studies. Drug studies need to be much larger because drug therapy is a chemical intervention and causes much more serious side effects. Critics may also point to the fact that CES studies examine varying patient populations and that device brands used in the studies have slight variance in electrical output. Varying patient populations are more representative of the real world, and the variance in output of different device brands is too small to skew data. The three most important aspects of studies – quality of controls, statistical significance and rigorous peer review – are soundly met in the studies listed above. In short, the Effectiveness section of this page should not be allowed to mislead the reader into thinking that there is a complete lack of evidence when in fact there is sufficient evidence

Another sentence on the page which, left alone, is very misleading:

The exact mechanism of action of CES is unclear.[9]

9. Rosa MA, Lisanby SH (2012). "Somatic treatments for mood disorders". Neuropsychopharmacology 37 (1): 102–16. doi:10.1038/npp.2011.225. PMC 3238088.PMID 21976043.

The author of the source (Dr. Lisanby) has a documented conflict of interest with CES. Dr. Lisanby recused herself from the 2012 FDA Panel on CES Reclassification as a result of having a conflict of interest – she has financial ties to Transcranial Magnetic Stimulation, a competing technology. Interestingly, Transcranial Magnetic Stimulation is listed in the See Also section of the Cranial Electrotherapy Stimulation page, along with Trancranial Direct Current Stimulation, another competing technology. In short, Dr. Lisanby’s review is an inappropriate citation for a statement which misleads readers into thinking that the way CES works is a complete mystery. It is not a mystery.

The mechanism of action of most brain related interventions, whether drug or device, are never completely clear, because the brain is so complex and imaging is only beginning to tell the whole story. But the way CES works is by no means a complete mystery. There is very strong evidence, published in respected journals, that CES stimulates the production of serotonin and other neurochemicals responsible for reducing and eliminating depression, anxiety and insomnia:

Liss. S. and B. Liss. Physiological and therapeutic effects of high frequency electircal pulses. Integrative physilogical and behavioral science 31:88-94, 1996

Shealy et al. Cerebralspinal fluid and plasma neurochemicals: response to cranial electrical stimulation. J. Neurol. Orthop. Med. Surg. 18: 94-97, 1996

Shealy et al. Depression: a diagnostic, neruochemical, profile & threapy with cranial electrical stimulation. J. Neurol. Orthop. Med. Surg. 10: 319-321, 1989

2005Gilula MF, Kirsch DL. (2005). Cranial electrotherapy stimulation review: a safer alternative to psychopharmaceuticals in the treatment of depression.Journal of Neurotherapy, 9(2), 2005.doi:10.1300/J184v09n02_02

Kennerly, Richard. QEEG analysis of cranial electrotherapy: a pilot study. Journal of Neurotherapy (8)2, 2004.

My efforts to provide this research have been met with repeated deletion.

The page as it stands right now seems intentionally designed to make readers think that Cranial Electrotherapy Stimulation is a risky, unproven technology. Not only is there sufficient evidence, but CES is prescribed by thousands of doctors, many at the top of the psychiatric field. The New York City Health and Hospitals Corporation recently approved the device for use in its 11 hospitals – including Bellevue, Jacobi and Metropolitan Hospitals. The page should reflect the scientific evidence and broad clinical support the technology has behind it.

Sincerely

ColumbiaLion212 (talk) 19:00, 21 July 2015 (UTC)ColumbiaLion212

Effectiveness Section

User:Alexbrn You reverted my edit from 20:50, 6 August 2015 without giving a reason in the edit summary. You simply stated that you reverted to a prior edit. The reason I made the edit was because the article was citing the objective of the summary, not the author's actual conclusions, which is what I directly quoted for the article.

Could you please explain your reasoning for the edit? Or elaborate on why you think your original edit summary was sufficient?

ColumbiaLion212 (talk) 21:24, 6 August 2015 (UTC)

The prior text was a fairer summary of the article, and not a copy & paste WP:COPYVIO like what what you attempted. Alexbrn (talk) 21:32, 6 August 2015 (UTC)

User:Alexbrn What is fairer, to use your language, is rather subjective, however. Let's collaborate. The purpose of the study was to "assess the effectiveness and safety of alternating current cranial electrotherapy stimulation (CES) compared with sham CES for acute depression." The result of the study was that "There are insufficient methodologically rigorous studies of CES in treatment of acute depression. There is a need for double-blind randomized controlled trials of CES in the treatment of acute depression." If you have read the review, you would see that there was significant evidence, but rather, that the evidence was considered not rigorous enough. The author never concluded that there is insufficient evidence, but rather that the evidence is not rigorous enough. Those are two different conclusions, and my edit was an effort to accurately reflect the outcome of the study, not the purpose of it.

I'm a little unclear on why you referenced a copyright violation page. Could you direct me to a specific part of the article that discourages what I tried to do? I want to adhere to all rules, and would appreciate further clarification. ColumbiaLion212 (talk) 22:11, 6 August 2015 (UTC)

User:Alexbrn Could you please reply to my earlier post? It'd be nice to reach consensus. I think a fair interpretation of the content is the following: "After reviewing over 250 CES studies, a 2014 Cochrane Review determined that no studies met inclusion criteria for review. As a result, it was determined that there is a lack of rigorous studies to determine effectiveness of CES for the treatment of acute depression." ColumbiaLion212 (talk) 15:24, 7 August 2015 (UTC)