Talk:Cranial electrotherapy stimulation/Archive 1

I
I want one. :)

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hackcanada.com has plans to make a CES. Primitive but it really works. I have it on right now.

I have removed some obvious commercial spam from this page, if the author wishes to edit the article they should refrain from spamming.

The naysayers and the pro-psychiatry movement favor persons with anxiety or depression to be on medication, further supporting the pharmaceutical industry.

The CES has been approved in for the treatment of anxiety and depression as well as sleep disorders. There is no information submitted to the contrary. All is shown (below) is that the CES is a Class 3 type device.

I removed the claims without citation. —Preceding unsigned comment added by 90.216.42.56 (talk) 18:58, 9 September 2009 (UTC)

Mind machines vs Cranial electrotherapy stimulation
Both stimulate brain waves to a certain level......so aren't the two basically the same thing? If that is the case why do CES machines require a prescription in the US while Mind Machines do not? Zachorious 02:55, 3 November 2007 (UTC)


 * I would hazard a guess that it's because CES machines pump electricity into the body (brain) itself, causing both electrical and chemical reactions. Mind machines only indirectly stimulate the brain (though the eyes and ears), and do not pump electricity into the body; thus, they cannot directly cause chemical reactions (though one could argue that they are *almost* directly causing electrical reactions.) As an aside, I've seen CES machines on sale for eBay, no prescription required, so perhaps enforcement isn't taken too seriously. --Lode Runner 22:55, 6 November 2007 (UTC)

You've seen CES machines on ebay? Where? My search found none but a CES guide. What were your keywords when you searched? Also, don't the different brainwave states correspond to different chemical reactions? Or is it the other way around? I would assume that certain alpha wave patterns produce chemical reactions, or at least the opposite. Meaning the different brainwaves produced by mind machines should trigger chemical reactions as well since brainwave states should correspond to chemical reactions. Zachorious 11:45, 11 November 2007 (UTC)
 * Try searching the full name (not just "CES") and check the 'search title and description' box. This reveals one called "AlphaStim" and another cheaper one called "Zed-time". I've come across at least one other, $800+ one that claimed to be able to induce alpha, beta, theta and gamma waves (I remain dubious.) Wouldn't mind knowing what frequencies, power outputs and cranial contact points were specifically used in the studies.


 * It would also be very helpful to know which units the FDA has "cleared to be marketed for the treatment of anxiety, depression, and insomnia". Wikipedia has entire articles for most medicines, so I think it's definitely worth mentioning which CES machines have received FDA approval.


 * As far as the mind machine-induced brainwaves inducing chemical reactions, you are indeed correct. However, the effect is secondary, vs. the primary, direct electrochemical CES reactions.  Many common sensory inputs--listening to certain kinds music, being in a room painted a certain color, whatever--affect brain chemistry as well, so it's probably hard to draw a line and say, well THIS type of brainwave-changing sensory input is drastic enough to require a prescription, but listening to Mozart is ok.   There's too much gray area. I wouldn't be surprised if many daily sensory activities affected brain chemistry more than your average mind machine. I also wouldn't be surprised if some music styles (e.g. techno or some techno derivatives?) duplicate binaural beats without any medical intentions.


 * Even if mind machines affect brain chemistry as much or moreso than CES, the distinctions between medicine and simply perceiving the world around you are a lot blurrier. It's a lot easier to tell someone they need a prescription to clip a strange device to their ears and run an electric current through their head than it is to tell someone they need a prescription to look at a special strobe light or listen to some trance techno. --Lode Runner (talk) 15:21, 17 November 2007 (UTC)

Electrical and Electronic Information Regarding Safety
It's presumed safe, if one has a prescription, to purchase a device used and engineered specifically for electrical stimulation of the brain. However, this is partly a technique of concealment, which is similar to commercial spam, where open information regarding current & voltage of the device, and resistance and receptivity or permittivity of tissues is not explained *at all*. It's also well known that what was considered medically safe in past years, decades, and centuries, has evolved and at times citizens have found that prior practiced medical techniques were not only not safe, but decidedly dangerous.

I think it's reasonable for anyone who is learning about this topic to know what kinds of electrical currents are considered safe for use in cranial stimulation. Presumably, there are some levels of current and voltage, perhaps relating dynamically to frequency, above which danger of extreme numbers of brain cell deaths becomes a valid concern and is generally recognized as *unsafe*, and below which is generally considered safe and would not result in a single brain cell death, with perhaps some values in between. Where are these electrical borders defined in simple to understand units such as voltage, current, and frequency?

Additional areas for improvement of the topic would include the different waveforms used, and how a square wave would have higher harmonic(s) frequencies in addition to the fundamental frequency, versus a perfect sine wave that lacks other harmonics and would be stimulating at only the fundamental frequency. How waveform, frequency, and other generalized electrical 'specifications' such as those in the two paragraphs of mine above may affect CES, would certainly improve the usefulness of the topic.

71.128.192.243 (talk) 20:28, 4 February 2008 (UTC)


 * I've used the device before after some convincing, and it did as advertise. I've been asking around about this device. So far, all i got is that it use electricity and you need to clip the electrode on your earlobes. Every technical questions remain unanswered. 60.50.192.129 (talk) 19:25, 6 August 2011 (UTC)


 * If you don't know what it does (assuming it does anything) or whether it is safe, then I wouldn't f*cking wire myself up to it! Famousdog (talk) 08:56, 8 August 2011 (UTC)

Neutrality
The CES is an FDA approved device for the treatment of several disorders including anxiety and depression. http://www.quackwatch.com/01QuackeryRelatedTopics/ces.html —Preceding unsigned comment added by 24.84.162.80 (talk) 00:10, 23 April 2008 (UTC) "Research conducted in the 20th century has demonstrated that the brain makes use of electrical activity; thus, one can affect mental functions by affecting the organ's electrical activity."

"With the strong arm of the prescription medicine industry backing medication, and the stigma of electrical devices for use on the brain (which many relate to electroconvulsive therapy ) companies that developed such devices had a difficult time receiving financial support for needed research."

"The FDA has cleared several CES units to be marketed for the treatment of anxiety, depression, and insomnia."

Each of these statements is biased and/or unfounded. The first statement is not logically sound. The second statement makes use of unfounded editorialization. The third statement is misleading. The FDA only classifies CES units as Class 3 devices (which may cause harm to users) because it they were grandfathered in due to their use before 1976. (See http://www.fda.gov/cdrh/devadvice/3132.html ) Brw12 (talk) 18:03, 19 February 2008 (UTC) "The first statement is perfectly logical, if worded incorrectly. A car runs on gas, therefore by changing the gas you change the way the car works. That statement says the same thing: The brain works with electricity, so if you change the electricity, you change the way the brain works. -Adam H 02/27/08"


 * Yeah, but there's an important difference. When you're stimulating the brain electrically, you have to work from outside the head; it's possible parts of the brain are shielded against external signals, or that an electrode couldn't limit the signal to a small enough area to achieve a particular effect. Neon  Merlin  02:09, 28 February 2008 (UTC)

POV -- entire is misleading advertising
Overpriced, undermade, unproven, dinky little boxes the size of a cigarette pack with a 9-V battery, marketed for staggering prices.

Grandfathered FDA approval, no actual FDA effectiveness testing
With respect to FDA approval, I this type of device is approved only because a substantially equivalent device was already in use prior to the enactment of medical device regulations in 1976. As such, the vendors of these devices only need to show that their product is not a novel type of device, and they circumvent proper oversight via a grandfather clause loophole.

Grandfathered FDA approval is only Class 3 even as to safety
These devices are Class 3, which have the greatest likelihood of adverse effects or injury to the patient. That said, it's hard to tell just what these devices do, let alone how they could hurt.

Here's what the FDA has to say about Class 3 devices: http://www.fda.gov/cdrh/devadvice/3132.html

Few gold-standards trials found
A few anecdotal reports, unblinded trials, and single-blinded single-center trials conducted by enthusiastic vendors of the "services" were found, and (unsurprisingly) showed favorable effects.

Here's one trial specifying that an effective placebo -- sham treatment -- was used. It concludes that "There is Level 1 evidence from one RCT to suggest that cranial electrotherapy stimulation did not help to improve memory and recall following brain injury"

From http://www.abiebr.com/modules/module6.pdf

---

6.2.4 Cranial Electrotherapy Stimulation and Memory

Cranial electrotherapy stimulation (CES) is the application of less than 1 mA of electric current to the cranium. This application has been used to treat a variety of disorders, including treatment of withdrawal of patients with substance abuse (Michals et al. 1993). The effect of CES for the improvement of memory following brain injury was investigated.

Individual Studies Table 6.11 The Effect of Cranial Electrotherapy Simulation on Memory Author/ Year/ Country/ Study design/ Score Methodology Outcome Michals et al. (1993) USA RCT D&B = 22 PEDro = 7 A double blind, sham controlled trial was performed on 24 brain-injured patients to evaluate the effectiveness of cranial electrotherapy stimulation (CES) on post-traumatic memory impairment. After a four-week study period, memory performance was measured using subtests from the Wechsler Memory Scale-Revised, California Verbal Learning Test, and Recurring Figures Test.

Results revealed that CES stimulation in brain-injured patients did not improve memory or immediate and delayed recall compared with controls.

Repeated trial effects showed no significant differences between groups.

PEDro = Physiotherapy Evidence Database rating scale score (Moseley et al. 2002). D&B = Downs and Black (1998) quality assessment score. Discussion Michals et al. (1993) studied cranial electrotherapy stimulation and its effect on post-traumatic memory impairment in clinical care patients with closed head injury. Patients received CES or sham CES treatments for 40 minutes daily over a period of four weeks. The group receiving CES treatment did not improve in their memory performance, nor did their immediate or delayed recall improve.

Further, with retesting, both the CES and the sham CES group showed a similarly significant trend with no group performing any better than the other.

These results suggest that CES stimulation in brain-injured patients does not improve memory functioning.

'''Conclusions There is Level 1 evidence from one RCT to suggest that cranial electrotherapy stimulation did not help to improve memory and recall following brain injury'''

The quackwatch write-up is one of the few non-enthusiast sources of information
http://www.quackwatch.com/01QuackeryRelatedTopics/ces.html

Unfortunately, it is limited in scope, rather than covering the area generally, but contains points worthy of including in the article. —Preceding unsigned comment added by 68.166.205.226 (talk) 22:14, 1 May 2008 (UTC)


 * Try taking a look at the linked external review. It's about the only extensive and balanced look at the subject that I've seen. Considers all sides in an objective, scientific light, with a review of the history, research, and notable reviews (including the quackwatch article) with footnoted references. I'm almost tempted to replace the whole article with that one link. 69.248.94.24 (talk) 05:27, 24 May 2008 (UTC)

It is important to note that Quackwatch has published a certified letter from the FDA to HealthPax as proof refuting claims that CES effective treats depression, insomnia and anxiety. This is patently incorrect. If one carefully reads the letter, the FDA reprimands HealthPAX for promoting the use of CES devices for treament of conditions for which it has not received FDA approval. In truth there is a plethora of scientific information documenting CES's effectiveness in treating anxiety, depression and insomnia (Fregni et al 2009). Additionally, FDA Title 21, Code of Federal Regulations, Part 882.5800, describes a CES device as follows: “A cranial electrotherapy stimulator is a device that applies electrical current to a patient’s head to treat insomnia, depression, or anxiety.” —Preceding unsigned comment added by Ravikath (talk • contribs) 15:18, 29 July 2010 (UTC)

This article is very UN-informative
It says nothing about voltage, current, frequency, how the electrodes are constructed and so on. One gets no more info from this article than from reading the name of the therapy ie. CES. 87.59.76.177 (talk) 21:25, 28 September 2008 (UTC)


 * I have to agree. I have a little bit of familiarity with tDCS and tACS, but not CES, so I was expecting a description of what CES is and how it compares & contrasts with other kinds of transcranial stimulation; there's nothing remotely like that aside from a brief mention of 'pulses', which could describe tDCS or tACS equally well! --Gwern (contribs) 03:19 7 December 2014 (GMT)

Metaanalysis
The metaanalysis, reference 2, did not show that CES worked. The article wrongly stated that the metaanalysis did find that CES worked. The metaanalysis only used two blinded trials, grouped trials that were not testing the same thing and took no account of publication bias. The metaanalysis itself said that the topic should be studied further.165.228.172.109 (talk) 04:42, 1 October 2008 (UTC)Andrew Nielsen

Reversion
I have just reverted a series of edits by Jmarksberry2288 that had the effect of changing this from an article with a reasonably skeptical tone to an article that asserts that the effectiveness of CES is proven and that the technique is a recognized form of therapy. That is false: there is, as far as I can see, not a single reliable source (in the sense of WP:MEDRS) that can be cited to support the effectiveness of this treatment. All that exist are old papers, speculative papers, and pilot studies. Looie496 (talk) 22:09, 16 March 2011 (UTC)


 * A paper's being "old" is no reason per se not to accept (or reject) its conclusions, but Jmarksberry2288 would have to provide links to online versions of these articles, or more complete citations, so that other editors could verify the methodology employed (if any) in these studies. Famousdog (talk) 10:34, 17 March 2011 (UTC)


 * Just reverted all of Jmarksberry2288's changes again. This editor seems to not want to engage. Famousdog (talk) 11:30, 18 March 2011 (UTC)


 * I support that. I would have done it myself but didn't want to leave the impression that I am the only one who has serious problems with those changes. Looie496 (talk) 16:52, 18 March 2011 (UTC)

"Effectiveness" Section is Biased and Misleading.
Looking at the studies under the "effectiveness" section of the article, one would think CES is superior to established, first-line treatments for depression, anxiety and pain. However, in 2012 the FDA reviewed research that has been carried out on CES devices and concluded that: "among studies that reported a clinical benefit of CES, few can be considered rigorous, high quality clinical studies." For example, the FDA found that only 12.8% (5 of 39) of the studies used the DSM criteria to diagnose depression, anxiety or insomnia. I suspect that the FDA's debunking included many of the studies listed in this article. These studies seem likely to have been inserted by someone affiliated with a CES company, and a lot of them should probably be deleted. I simply edited this section by inserting some of the evidence the FDA used in their report for maintaining CES device as "Class III" medical devices (the lowest categorization that is still legal).

ThinkItThrough90 (talk) 21:00, 25 July 2013 (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.

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..

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

Moved to talk
I can't tell what this is trying to say. Sandy Georgia (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."


 * 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 and than again  and than again. 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 . 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 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)
 * 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)

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)
 * I've nothing to add: it's fine as is. Don't copy and paste text from copyrighted publications into Wikipedia (you replicated some text from the abstract) as it creates problems of WP:COPYVIO/WP:PLAGIARISM. Alexbrn (talk) 15:29, 7 August 2015 (UTC)

User:Alexbrn When you say "I have nothing to add", is that in reference to my most recent suggestion, or to the current content? The current content is actually copied and pasted from the review itself; so, that would violate the same standard you are referring to. ColumbiaLion212 (talk) 16:02, 7 August 2015 (UTC)
 * The text we have is fine as is. It is not copied from the article. Alexbrn (talk) 16:10, 7 August 2015 (UTC)


 * would you please respond on your Talk page so we can finish the COI discussion? thanks Jytdog (talk) 15:45, 7 August 2015 (UTC)

Recent edit
Previous edit was mimicking general format on Transcranial direct-current stimulation. Noting WP:MEDMOS in next edit. Let me know. Jppcap (talk) 21:10, 18 September 2015 (UTC)
 * Sure will fix the article in question. Doc James  (talk · contribs · email) 20:58, 19 September 2015 (UTC)

(Following copied from user talk pages; NPOV issues should be discussed here.)

 * Unexplained Removal of sourced

Alexbrn

You removed sourced content from the Food and Drug Administration that speaks to safety and effectiveness of CES devices in multiple indications for no justified reason. The Cochrane review only reviewed literature specific to acute depression, and no other indication, making it limited in its scope and making the FDA citation a novel addition. I am restoring the content. Please discuss with me on talk page before making unjustified edits.

WikiGuy1980 (talk) 15:13, 19 July 2016 (UTC)
 * Oh don't edit-war: that way blocking lies. I think we have a WP:V issue here, since this (primary) source is talking about how "controls" will provide assurance, not the safety/effectiveness of CES itself. Alexbrn (talk) 15:16, 19 July 2016 (UTC)


 * Alexbrn The FDA citaiton is a secondary source. It is a position statement by a major health organization. General and special controls themselves can not be determined safe or effective; they help ensure both for the devices themselves. The FDA specifically indicates that the CES devices are considered safe and effective, with general and special controls. That is the exact language, and you are misinterpreting this for unclear reasons. You also falsely claimed that the source is a primary source when it is clearly a secondary source. WikiGuy1980 (talk) 16:07, 19 July 2016 (UTC) — Preceding unsigned comment added by WikiGuy1980 (talk • contribs) 16:02, 19 July 2016 (UTC)

Apologies, as I did not sign my last additionWikiGuy1980 (talk) 16:07, 19 July 2016 (UTC)
 * It's a primary source for what the FDA does (obviously), which is how it was cast in your edit. As I say, it's a bit of a stretch from a statement about the effect of controls in the future, to the safety and effectiveness of CES now. We've a very strong source (Cochrane) for that detail without having to perform such contortions. (Hmm, I have a strange sense of d&eacute;j&agrave; vu here). Alexbrn (talk) 16:30, 19 July 2016 (UTC)

Why did you change article again?
Why do you keep changing it? Looks like you are imposing your own opinion. What is the problem with US National Library of Medicine National Institutes of Health as a source? Please explain. — Preceding unsigned comment added by Jeanmb1 (talk • contribs) 14:10, 22 January 2018 (UTC)

Doc James: I don't see value added by your edits as you keep reverting to your version without compromise nor good explanation. You also ignore highly cited references that were added, enriching the content. I am reverting back to my version and expect and explanation for changes. You mentioned having a problem with primary sources, when there is no such requirement in Wikipedia. Jeanmb1 (talk) 09:41, 23 January 2018 (UTC)
 * Hi Jeanmb; folks will be happy to discuss content with you but there are matters that should be addressed first. Would you please respond at your talk page? Thanks. Jytdog (talk) 13:29, 23 January 2018 (UTC)

Thank you but I don't see any active discussion on my talk page. Jeanmb1 (talk) 19:10, 24 January 2018 (UTC)
 * Click here to see what Jytdog is talking about, on your talk page, from yesterday. -Roxy, Zalophus californianus. barcus 19:14, 24 January 2018 (UTC)

An RfC
RFC: Should FDA and a dozen serious academic journals be overridden by a single article that, literally, says nothing about the subject? See the section titled "Recent edits." Verdana ♥ '''Bold 08:36, 12 July 2018 (UTC)

Responses

 * See WP:MEDRS as already explained to you. I leave it to somebody else to remove the tag. -Roxy, the dog. barcus 08:47, 12 July 2018 (UTC)


 * The RfC statement is not neutral nor is it competent.
 * With regard to the FDA, these devices were grandfathered in, when the the part of FDA law that governs medical devices was amended in 1976. The FDA is required to look back and reclassify such already-marketed devices, and there has been heavy lobbying over that (just as there has been heavily lobbying on this page, as you can can see from the list at the top of this page). As of 2012 what the FDA actually had to say about these devices is here: “FDA believes the available valid scientific evidence does not demonstrate that CES will provide a reasonable assurance of effectiveness for the indication of ‘insomnia, depression, anxiety.’”
 * The answer to the question outside of the FDA -- dealing with the refs the OP actually brought, is yes -- the refs were almost entirely primary sources which are not OK per MEDRS. The "single article" is a Cochrane review, which is OK per MEDRS.
 * The article does need to be updated but not with a bunch of woo sourced to refs that fail MEDRS.Jytdog (talk) 14:39, 12 July 2018 (UTC)


 * (bot-summoned) Procedural close RfC statement is not only non-neutral (see Requests_for_comment), it also fails to clearly state what are the options to choose from or to link to a contested diff. I suspect insiders already know what is going on, but the point of an RfC is to bring in outsiders; let them know quickly what is happening. Tigraan Click here to contact me 07:13, 16 July 2018 (UTC)
 * (summoned by bot) Yes - Even leaving aside the non-neutral phrasing of the RfC, an examination of the sources in question leads me to conclude that, yes, the "one source" meets WP:MEDRS, as well as being the most up-to-date and reliable review that we have. The "ten sources", however, do not meet WP:MEDRS so far as I can see (indeed, some of them were specifically referenced in the Cochrane review without changing its conclusions), and the "one source" version should therefore stand. Anaxial (talk) 18:41, 17 July 2018 (UTC)
 * Close this. It's not a proper RfC. -- BullRangifer (talk) PingMe 04:30, 21 July 2018 (UTC)


 * I have closed the RfC . As noted by other editors, it is not a proper RfC. Looie496 (talk) 15:29, 21 July 2018 (UTC)

Fine and useful as it is in 2020
The current content and refs will help my child care colleague to make a decision re (not) using such devices.

Thanks @Jytdog for defending the article, as per above! Zezen (talk) 06:17, 13 September 2020 (UTC)

Recent edits
Dude: I overwrote your one-citation declaration that CES doesn't work with references to 10+ academic studies that say it does--a conclusion backed by the FDA in 1979.

You reverted that change.

The single study you reference does not refute any of the evidence; it performed no research itself, nor nor did it review current research. In fact, it is not really a study at all. All this one source did in its single-page literature review was to declare that ALL of the many research studies on CES "do not meet the inclusion criteria for this review. Therefore we conclude that insufficient evidence exists to..."

It actually said nothing at all, other than that it refused to look at the research published in the academic journals this Wikipedia article references:
 * Journal of Clinical Psychiatry
 * Journal of Nervous and Mental Disease
 * Annals of the New York Academy of Science
 * Journal of Neurotherapy
 * Integrative Psychological and Behavioral Science
 * Neuropsychopharmacology
 * Brain and Behavior
 * Neuroscientist
 * Neurobehavioral Toxicology and Teratology
 * Journal of the Psychiatric Clinics of North America
 * American Journal of Electromedicine
 * Current Opinion in Psychiatry
 * Publications of the University of Tulsa, Oklahoma
 * Annals of Internal Medicine

The above research—and much more—convinced the FDA to declare in 1979, that:
 * Controlled studies demonstrate that CES is effective in treating anxiety, headaches, fibromyalgia, smoking cessation, and drug withdrawal symptoms.

Yet you replaced all of that here because ONE outfit published an article saying that none of these studies meets its high review standards, even though they met the standards of the FDA.

Finally, your single citation was from Cochraine Reviews, an outfit that seems to exist to prove that accepted medical treatments don't work. They were recently busted for scientific fraud when they published a paper declaring that Ritalin doesn't help ADHD. The outfit smells like scientology.

This is outrageous.

If you want to pursue this, take it to arbcom. Don't revert it again. The only way you could win there is if you have an admin friend who will rubber stamp anything you write. That may very well happen, as I've seen it happen before in years past. I have heretofore remained silent at these travesties because until now, I was, per WP rules, too young to be editing here. Verdana ♥ Bold 10:50, 10 July 2018 (UTC)
 * Please focus on content. See WP:FOC.
 * Your edits were not OK because the sourcing was not OK. Please see WP:MEDRS - I left a note on your talk page providing guidance on editing about health and medicine. Jytdog (talk) 14:21, 10 July 2018 (UTC)
 * Why were they "not okay"?
 * The guidelines say we take FDA and other established sources seriously. My sourcing was the FDA and a dozen serious academic journals. Yours was a single literature review that said nothing except to reject ALL published evidence in the last 40 years as not meeting their standards for a literature review. They then conclude that the topic is unsubstantiated because there is no literature about it. This is beyond ridiculous. We're obviously going to arbcom, but first, I'd like to hear your answer. Verdana ♥ Bold 12:30, 11 July 2018 (UTC)
 * Why were they "not okay"? See WP:MEDRS as already explained to you. -Roxy, the dog. barcus 13:01, 11 July 2018 (UTC)

I think the comments in the article on the Cochrane review are inaccurate and misleading. The review states:

7 full-text articles excluded. 1 had only active comparator groups and placebo; 3 used sham treatment that did not produce superficial electrical tingling sensation, resulting in poor blinding; 1 trial did not specify diagnostic criteria for depression; 2 trials on chronic and/or refractory depression.

However, all evaluations were double blind randomized studies. Statistical tests were applied to data sets, p-values indicated adequate degree of statistical significance. The issues cited are really more technicalities rather than serious flaws. Thus, to say the studies were seriously lacking in rigor would be inaccurate and misleading.

The authors state in their conclusion, "There is a need for double‐blind randomized controlled trials of CES in the treatment of acute depression." If no further investigation is warranted because "the evidence for use in acute depression is not sufficient to justify it" as stated in the article, then why do the authors recommend further more rigorous evaluations? — Preceding unsigned comment added by 2601:249:601:5F00:F82A:DFA:F40C:BB82 (talk) 19:01, 4 March 2019 (UTC)

The FDA seems to have a rather low opinion of CES. How about other countries? Health Medical Service in the UK conducted the largest study to date with 161 subjects comparing cost-effectiveness of CES versus CBT for treatment of moderate to severe generalized anxiety disorder:

This reference seems to suggest that CES might be approved for use in the HMS system.

Write up of the study can be found at: PMID: 31103808 DOI: 0.1016/j.jad.2019.04.020  — Preceding unsigned comment added by 2601:249:603:B930:F5A5:1B70:F571:64DF (talk) 13:20, 1 October 2020 (UTC)

CES does have a Healthcare Common Procedure Coding System (HCPCS) code with the Centers for Medicare & Medicaid Services. So it is covered under Medicare/Medicaid as of Jan 1, 2020. The code is K1002. — Preceding unsigned comment added by 2601:249:603:B930:F5A5:1B70:F571:64DF (talk) 15:07, 1 October 2020 (UTC)

FDA Document / More current content
In the section on Regulation, there is a comment:

"In December 2019, the FDA announced that there is no valid evidence for CES as a treatment for depression, and request new trials to be made."

To support this statement a quote from the FDA document reads:

"FDA concluded that the four studies published after January 1, 2016, through November 1, 2019, did not contribute sufficient information in the form of valid scientific evidence to demonstrate that the subjects met the criteria for any recognized depressive disorder, as defined in DSM-5."

This is a comment on a rather minor limitation of 4 papers that were reviewed. On reading through the FDA document, there do not siseem to be any statements that amount to a definitive determination on efficacy of CES for depression. That was not the purpose of this document. The document is merely stating that the hazard classification of CES devices is being changed from Class 3 to Class 2. That is actually a less severe hazard level.

With regards to the use of CES for treatment of depressive disorders, a more recent paper ought to be cited:

Price L, Briley J, Haltiwanger S, Hitching R, A Meta-Analyses of Cranial Electrotherapy Stimulation in the Treatment of Depression, Journal of Psychiatric Research, https://doi.org/10.1016/j.jpsychires.2020.12.043.

The conclusion of this paper states:

"CES is an effective tool for the treatment of depression and may be a useful adjunctive to other ongoing treatments including pharmacotherapy and psychotherapy for depression.

CES for depression was significantly more effective than wait-list and sham-treated comparator groups.

The effectiveness of CES as an adjunctive treatment is yet to be systematically explored. Since the clinical benefit that might arise from the combination of CES with other interventions could be a step forward in depression treatment, further investigation is pressing."

Depression is a serious problem for millions of people. Better treatment options are definitely needed. It is appropriate for this article to contain current information on efforts to improve the prognosis for patients suffering with depression.

Finally, the comment referred to above is misleading and should be removed from the article. 2601:249:603:B930:E169:62A4:EB03:247F (talk) 14:28, 7 January 2021 (UTC)
 * I note that the third author of that meta-analysis works for the company that makes the only FDA approved CES device, and that the conclusion does not say what you say it says. -Roxy the inedible dog . wooF 16:46, 7 January 2021 (UTC)


 * What is there was copy/pasted out of a section called "highlights". True, technically, that's not the conclusion. It is still a conclusion that could be drawn from this study.


 * As for the employers of the authors, 3 of them seem to be PhD psychologists. If a psychologist is an expert on CES, it is not too surprising that they work for Electromedical Products. That in itself would not be a conflict of interest I do not think. 2601:249:603:B930:C115:A0CC:CFC0:1CAE (talk) 23:34, 7 January 2021 (UTC)
 * We wont be making any changes to the article based on a conclusion that could be drawn from this study. -Roxy the inedible dog . wooF 15:26, 8 January 2021 (UTC)

So you refuse to incorporate a reference to this paper, published in a respected peer reviewed journal on a topic that is relevant to the content of your article? 2601:249:603:B930:649B:3447:2115:6FE5 (talk) 20:20, 8 January 2021 (UTC)
 * It isn't my article. -Roxy the inedible dog . wooF 20:58, 8 January 2021 (UTC)