Talk:Pulsed electromagnetic field therapy
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PEMF Article
[edit]This article is full of unproven medical claims, they were made entirely by one or two people and upon trying to find any sources for the page my searching has indicated that they have been pulled from thin air. I'm putting up a neutrality flag, but I may suggest this article is deleted if this isn't cleaned up. Previous unsigned comment by 205.250.105.229(talk) 19:24, 20 September 2009
- I could find no unproven claims in this article. All facts were cited using credible sources. Please be specific about which facts require verification. Previous unsigned comment by Kcfrankl(talk|contribs) 21:07, 23 September 2009 (UTC)
- 205.250.105.229(talk)--are you User Verbal (talk|contribs)?
- Critical thinking scientists, university and college students are usually NOT forbidden the knowledge of electromedicine, and are usually NOT blocked from accessing the Pub Med or nytimes web sites to search for double blind medical studies and information on various (proven) forms of electromedicine. The search for such things can best be performed making use of the Google search engine when using the site:website-name search item. FYI the PubMed site is run by the US NIH and so is supposedly a WP:RS, and so too is the nytimes.
- For example searches that you should read the results from include the following:
- Are there any key reasons why it was that you could not find this information for yourself?
- What in your background and experience prompted you immediately to think that this form of treatment method was quackery? The blind following of monopolistic tycoons who would rather narrow the breadth of human thinking to solutions provided only by corporations that they own and control is a bad plan.
- Since many of the references of the article are from peer reviewed scientific journals, what reliable articles / sources are there that contradict or are critical of the ones cited in the current version of the article that would validate your claims of neutrality or invalid claims / sources?
- In November 2008 some user known as Oldspammer inserted the following text (bounded by the horizontal lines) into the Electromagnetic therpay talk page:
Old information, newly found:
1995 Salzburg
... 30 male participants...
For spinal cord-injured men with Stage II pressure ulcers, active non-thermal pulsed electromagnetic energy treatment significantly improved healing.
and
The effect of diapulse therapy on the healing of decubitus ulcer.
1993 Jan-Jun;30(1-2):41-5 Comorosan S, Vasilco R, Arghiropol M, Paslaru L, Jieanu V, Stelea S.
The effect of pulsed high peak power electromagnetic field (Diapulse) on treatment of pressure ulcers is under investigation. 20 elderly patients, aged from 60 to 84, hospitalized with chronic conditions and bearing long-standing pressure ulcers, are subjected to Diapulse sessions (1-2 daily), parallel to conventional treatment. 5 patients undergo conventional therapy, serving as control and 5 others follow conventional+placebo Diapulse treatment. All patients were daily monitored, concerning their clinical status and ulcers' healing. After a maximum 2-weeks treatment, bulge healing rate was, as follows: 85% excellent and 15% very good healing under Diapulse therapy; in the placebo group, 80% patients show no improvement and 20% poor improvement; in the control group, 60% patients show no improvement and 40% poor improvement of ulcers. This investigation strongly advises for Diapulse treatment as a modern, uninvasive therapy of great efficiency and low social costs in resolving a serious, widespread medical problem.
However, the following contradits the not just one of above statements, but both by saying the opposite thing seemingly about exactly these previous two studies:
Updated 2006 by PMID: 16625564 2001 Electromagnetic therapy for the treatment of pressure sores.
Flemming K, Cullum N.
...MAIN RESULTS: A total of two eligible RCTs were identified for inclusion in this review. The first of these studies (Comorosan 1993) was a three armed study comparing electromagnetic therapy, electromagnetic therapy in combination with standard therapy, and standard therapy alone. The second study (Salzburg 1995) was a comparison between electromagnetic therapy and sham therapy on 30 male patients with a spinal cord injury and a grade two or grade three pressure sore.
Updated as follows:
2006 updates previous PMID: 11279778... Two RCTs were identified for inclusion in the original review (total of 60 participants). One was a three-armed study comparing electromagnetic therapy with electromagnetic therapy in combination with standard therapy, and with standard therapy alone, on 17 female and 13 male with grade II and III pressure ulcers. The other study compared electromagnetic therapy with sham therapy in 30 male participants with a spinal cord injury and a grade II or grade III pressure ulcer. Neither study found a statistically significant difference between the healing rates of pressure ulcers in people treated with electromagnetic therapy compared with those in the control group.
... However, the possibility of a beneficial or harmful effect cannot be ruled out, due to the fact that there were only two included trials both with methodological limitations and small numbers of participants. Further research is recommended.
The contradiction is that opposite things are being stated--the new study about both the older ones.
What was the level of "statistical significance" used as a threshold in these different studies? I ask this because one of the cited studies says "85% excellent and 15% very good healing." Was there supposed to be instantaneous healing of 100%? Were these significance levels set by US-based medical insurance companies?
In the Pub-Med search for >Pulsed Electromagnetic wound< 177 records were found. I checked a few of these and all said that PEMF was found significantly beneficial and one said that "most recent studies" said this.
I examined Google search result information of EM therapy and found that FDA and medicare approved EM therapies for various things was not being covered by "for profit" US-based medical insurance carriers. It is explained in PDF documents from various carriers that one of the cited reasons why healthcare insurance policy coverage is denied for EM therapies was this particular Cochrane review study. These customer policy manuals claim that this particular study sufficiently demonstrated that EM therapies are completely experimental in nature, and statistically likely to provide no useful treatment.
In light of the contradition of the many Pub-Med reliable source studies and this one negative Cochrane review (that seems to mischaracterize the authors of both its subject studies), what should go into the article: the negative point of view of US medical insurance companies, or the actual studies themselves?
The negative studies about EM fields usually involve things like power lines--completely different than the therapy applications.
I suggest that the individual PEMF studies speak for themselves, and that the summary of the studies seems to have gotten things backwards somehow?--Why?--Who knows? So the WP article should be revised in light of this information to at least more carefully qualify the points of view. It also should be mentioned in the article that most US-medical insurance companies currently do not support the use of these FDA and Medicare approved therapes mainly because of this particular Cochrane review study. Oldspammer (talk) 19:24, 21 November 2008 (UTC)
- With this in mind, I now say that there are fake Cochrane Reviews of prior studies that present diametrically opposing conclusions to the very studies supposedly being reviewed--I do not trust these because they are being used by US for-profit medical insurance companies to deny claims based soley on the claim by these Cochrane authors that after 30 years that the treatment method is experimental, even though in 2004 or so it was approved by US Medicare / Medicaid (See these search results). 99.224.61.118 (talk) 09:13, 5 October 2009 (UTC)
Pulsed Electromagnetic Field Therapy "unproven"?
[edit]The fact is that PEMF is widely used and approved by the FDA. There are many studies showing that it's effective. To say that it's "unproven" because it's not used is both poor logic and factually incorrect.
User:Verbal is making a claim that PEMF is "unproven". This claim needs to be justified. --Dyuku (talk) 22:44, 18 November 2009 (UTC)
- Please provide references from WP:RS for your claims that it is a widely used mainstream treatment.
- I never made such a claim. --Dyuku (talk) 18:18, 19 November 2009 (UTC)
- It is not my claim.
- And neither is it mine. What I said was that "PEMF is widely used and approved by the FDA", which is factual. What you're doing OTOH is obvious POV pushing, breaking Wikipedia rules. --Dyuku (talk) 18:18, 19 November 2009 (UTC)
- Dyuku wrote "What I said was that 'PEMF is widely used and approved by the FDA', which is factual." No, that is not factual. The FDA has never approved PEMF as medical treatment, and every time any company has tried to claim that their PEMF device treats any medical condition, the FDA has gotten injunctions against them for unproven claims. All that the FDA has done is to examine the likelihood of harm being caused by using PEMFs, and has determined that the risk of harm is low. That is nothing like being "approved by the FDA". Bricology (talk) 01:06, 26 August 2021 (UTC)
- Please feel free to suggest alternative wording. We should not mislead our readers. Do you have an interest in PEMF treatments? Verbal chat 22:52, 18 November 2009 (UTC)
- I have an interest in all non-invasive, non-toxic therapies. What about you? --Dyuku (talk) 18:18, 19 November 2009 (UTC)
- I have an interest in building an encyclopaedia. Please address the article and how you feel it could be improved. See WP:TALK. Verbal chat 22:14, 19 November 2009 (UTC)
- I have an interest in all non-invasive, non-toxic therapies. What about you? --Dyuku (talk) 18:18, 19 November 2009 (UTC)
- Please provide some substance for your claim that Pulsed Electromagnetic Field Therapy is "unproven". See WP:V. --Dyuku (talk) 18:09, 20 November 2009 (UTC)
- Sorry, Dyuku, that's not the way reality works. The burden of proof rests upon the claimant, not the skeptic. People are claiming that PEMF therapy is efficacious. The onus is on them to prove that it does work. Bricology (talk) 04:53, 8 July 2021 (UTC)
- I have included some academic journal references validating the effectiveness of PEMF Therapy. Anyone that believes otherwise, please review these articles before deciding to undo the changes. Thanks. —Preceding unsigned comment added by 97.77.51.116 (talk) 02:03, 11 June 2010 (UTC)
Deletion of a peer-reviewed study
[edit]Why did 'Verbal' delete the peer-reviewed study by Thomas et al? What's wrong with it? --Dyuku (talk) 22:49, 18 November 2009 (UTC)
- I didn't "delete" the study,
- You deleted the ref. --Dyuku (talk) 18:34, 19 November 2009 (UTC)
- I reverted what I feel is your WP:UNDUE presentation.
- By quoting directly from the abstract? This is bizarre. --Dyuku (talk) 18:34, 19 November 2009 (UTC)
- Please feel free to propose other ways of incorporating this study. Verbal chat 23:02, 18 November 2009 (UTC)
- Originally, this was just a ref. You deleted the ref. Your editing of this article is not helpful, and demonstrates bias. --Dyuku (talk) 18:34, 19 November 2009 (UTC)
- Please see WP:NPA and WP:AGF, and use this talk page to address the article, not other editors. Verbal chat 22:12, 19 November 2009 (UTC)
- Originally, this was just a ref. You deleted the ref. Your editing of this article is not helpful, and demonstrates bias. --Dyuku (talk) 18:34, 19 November 2009 (UTC)
- Please explain why you deleted the ref for Thomas et al study. --Dyuku (talk) 18:16, 20 November 2009 (UTC)
FALSE CLAIMS
[edit]WE HAVE MADE SEVERAL ATTEMPTS TO ADDRESS ERRONEOUS CLAIMS(DIRECT BOLD LIES) MADE BY THE EQUIPMENT SELLER LISTED UNDER 'EXTERNAL LINKS'-'PEMF TECHNOLOGY'
ALL CLAIMS, UL, CE, CE 2A, ISO CERTIFIED MANUFACTURER, AS WELL AS FDA REGISTERED MEDICAL DEVICE MANUFACTURER ARE ALL UNTRUE AND TO DATE, UNPROVABLE. THEY EVEN HAD A BOGUS FDA NUMBER ON A PIECE OF SALES LITERATURE LEADING BUYERS TO BELIEVE IT WAS IN THE PROCESS OF APPROVAL. I HIRED AN FDA LAWYER, BEN ENGLAND, TO DO THIS RESEARCH WITH THE FDA. THEY WERE UNABLE TO VALIDATE ANY OF THE ABOVE CLIAMS.
THIS GROUP IS USING YOU, WIKIPEDIA, TO LURE UNSUSPECTING BUYERS SAYING THAT THEIR EQUIPMENT IS RECOMMENDED BY WIKIPEDIA THEREFORE PROVING THEIR EQUIPMENT IS VALIDATED BY A REPUTABLE SOURCE.
THIS TYPE OF MARKETING, USING WIKIPEDIA AS YOUR PERSONAL SALES SITE, CERTAINLY WEAKENS WIKIPEDIA'S REPUTATION.PulsedPowerTechnologies (talk) 02:48, 14 April 2010 (UTC)
"real physical entity"
[edit]This edit restores text that, in my opinion, falls afoul of basic academic plagiarism standards by presenting the words of the source in the voice of the article, in effect asserting that one of the editors here originated the text. This sentence is far beyond the threshold of being a generic description. Attributing the statement and putting it in quotation marks would address this issue, but the relevance of the statement has not been established. Additionally, electromagnetic fields have never been perceived as somehow "not real", making it unclear what exactly the sentence and citation are adding to the article. Accordingly, I have removed it again. Please address these points before restoring this material. - 2/0 (cont.) 05:20, 25 January 2011 (UTC)
Confusion over various "magnetic therapies" - which are scientific medicine and which are not
[edit]It seems that many of the editorial debates may source a bit from confusion over the various types of therapies purported to use magnetic fields in some way. Magnetic fields are not magic - they work in a very specific way. Putting a magnetic under your skin will not attract blood haemoglobin to increase circulation, but rubbing it on your skin might have some effect, because a changing magnetic field creates some active responses in the body.
So magnet therapy, which typically is advertised with static fields, is completely bunk. But this, Transcranial magnetic stimulation (TMS is being used noninvasively for certain mental illness) and MRI, which again use dynamic fields, are real with well-observed effects.
Of course, unscrupulous companies may prey on this confusion, as many hawkers of wares with purported health benefits do. So just watch out especially with the commercial vendor sites, as noted (in a less-tactful manner) above. SamuelRiv (talk) 19:10, 2 September 2011 (UTC)
This article needs a rescuing
[edit]At first I was skeptal of this article then I double checked the med references.. They seem good. Then I looked at all the deletes and thought GRRRR then I double checked the deletes and coundy them all copy and pasted from elsewhere. BIGGER GRRRRR. So yeah... I think it looks cleaner now then from when before you started. PEFT helps heal bones according to the FDA? Thats fine with me. Treating depression? Whatever, so long as it is sourced. BUt I dont think you need to throw the baby out with the bath water just yet. Just keep an open cynical and honest mind when editing and it will be just fine. — Preceding unsigned comment added by 1zeroate (talk • contribs) 01:50, 16 December 2013 (UTC)
HC license
[edit]Looks like the license is real: http://webprod5.hc-sc.gc.ca/mdll-limh/information.do?companyId_idCompanie=138354&lang=eng Of course that's not much of a useful statement for content. LeadSongDog come howl! 05:50, 26 November 2014 (UTC)
nanosecond pulsed electric fields
[edit]User:DrConcern - here is what is going on:
- you added content here cited to just a patent.
- I reverted here citing [[W{SPS]]
- yuo restored here adding a ref
- I reverted here noting the ref is WP:PRIMARY and the content violates WP:PROMO and I cited WP:MEDRS and also provided you with notification about MEDRS on your Talk page here
- you restored again here adding another PRIMARY source and not addressing the WP:PROMO violation at all.
I have reverted again. Do not restore this without discussing it here. Please see the edit warring notice on your talk page. Jytdog (talk) 19:43, 2 September 2016 (UTC)
Hi there Jytdog this is all new to me as you know I wish to add the nsPEF section, I understand that you see it as [WP:PROMO] as the refs are the inventors, I have nothing to do with them but know the potential of the new technology - I have added another ref. What do you want me to do to meet approval? DrConcern (talk) 21:20, 2 September 2016 (UTC)
- [1] please do not re-add this...[2]by RexxS covers your question above...--Ozzie10aaaa (talk) 22:04, 2 September 2016 (UTC)
- Thanks for finally starting to talk - I was afraid we would have to block you. DrConcern if there are no sources that comply with WP:MEDRS then we don't discuss it. Wikipedia is for communicating accepted knowledge to the public, not what is cutting edge. Jytdog (talk) 22:20, 2 September 2016 (UTC)
- I realize that this may all confuse everyone, but there are two possible kinds of "accepted knowledge" here: the accepted knowledge about what treatments work (or are used anyway), and the accepted knowledge about what kind of research has been happening recently. We can't say anything about treatment efficacy on the basis of a single animal study, but we might be able to create a ==Research directions== section that mentions the fact that research into whether nsPEF might be useful for cancer treatment has been going on since ~2004 "with the goal of fighting cancer cells", to quote this book. There are several books that mention this subject, e.g. [3][4][5]. WhatamIdoing (talk) 00:27, 16 September 2016 (UTC)
- Thanks for finally starting to talk - I was afraid we would have to block you. DrConcern if there are no sources that comply with WP:MEDRS then we don't discuss it. Wikipedia is for communicating accepted knowledge to the public, not what is cutting edge. Jytdog (talk) 22:20, 2 September 2016 (UTC)
I've gone through this article and removed each claim of effectiveness that isn't referenced to a source which meets the standard of WP:MEDRS. Single case studies, trials and experiments on animals are insufficient to support claims that a particular treatment has a biomedical effect. It is equally unacceptable to write "PEMF therapy may offer some benefit in the treatment of ...". Suggesting that there may be benefit does not relieve the requirement for a MEDRS source. At best it could be reported as a claim. --RexxS (talk) 16:55, 18 November 2016 (UTC)
- There may be some utility to PMC 4292325, PMID 21786259, PMID 26042793, PMID 27086866. LeadSongDog come howl! 16:35, 16 February 2017 (UTC)
Delayed- and non-union fractures
[edit]"Delayed- and non-union fractures" are mentioned in their own section, but there is no definition given for this medical term, not even a link. David Spector (talk) 12:47, 7 September 2018 (UTC)
Neutral point of view; polarization of points of view
[edit]There appears to be some hysteria going on in this Talk page (fortunately, not so much in the article). There is even an entry in all capitals, which on the Web is considered rude.
You may have personal biases for or against a particular medical technology or research field, but you are not to bring such bias with you when you act as a WP editor. It is against WP policy. If you cannot resist having a strong opinion or belief, perhaps it is best to refrain from editing what you consider to be a misleading article or an unfair discussion.
WP is an attempt to summarize human knowledge, and our policies are there to guide its tone and content so that it stays useful. In this case, the field of bioenergy has been around, off and on, since the late 1800s. While it may have had no rational basis in its early days, the field has gained legitimacy in recent years, and no one would deny the benefits of modern devices such as Transcranial magnetic stimulation, which was first available in 1985 and which applies strong magnetic fields to the head, to name just one well-known example. David Spector (talk) 13:03, 7 September 2018 (UTC)
Sentence removed
[edit]I have removed the sentence "New high tech PEMF device called Theraphi delivers its frequency therapy via non-thermal plasma." from the Wellness devices section, for the following reasons:
- The website cited is a primary source, which is forbidden by the WP:MEDRS policy.
- The biased or marketing term "high tech" is used, contrary to WP policy.
- The term "frequency therapy" is vague, typical of do-nothing devices marketed without any medical rationale.
- There is no reference to any research that would validate the effects of the device.
- The term "non-thermal plasma" is misleading. A "plasma" is a hot gas, a unique state of matter.
David Spector (talk) 13:33, 7 September 2018 (UTC)
- no, you didn’t. Roxy, the dog. wooF 14:34, 7 September 2018 (UTC)
The gatekeepers and poorly sourced information needs to be addressed
[edit]Firstly , it is incorrect and misleading to conflate PEMF with every electromedical device one can think of. Tumor Treating Fields are not pulsed electromagnetic therapy. Low field magnetic stimulation is something different from a pulsed electromagnetic field therapy. The first paragraph is also clearly biased with the words "in an attempt" The food and drug safety administration do not give clinical medical approval to things used in the medical practice that only "attempts" to work but rather they give approval to things PROVEN to work. Citation 1 doesn't even list the device in question as a PEMF device. But then again that first paragraph attempts to paint everything pertaining to electronic devices in medicine as PEMF and that is factually incorrect and unethical.
Also the second sentence speaking to the many various FDA approved devices that can preform PEMF is not relavnt to the therapy itself. Does add and value to the article about PEMF therapy to know that several of these devices have been approved by the ministry of health or the EU or some other organization? Is the article about PEMF or its approval in various nations. This is to say nothing about the citation being kind of weak.
Speaking of citations please check on citation 4 because all I got was page not found. Even so even if true , I fail to see the relevance of a singular company selling consumer devices being warned about something they should of known better than to do. Is this an article about PEMF therapy in the legitimate medical setting or is it about less than trust worthy consumer products. It should not try to be both. What a doctor prescribes should not be confused with what you can buy from uncle Larrys garage and if uncle Larry gets in trouble for it, that doesn't invalidate the doctors medically approved therapy.
Citations 5 and 6 seem to of been placed so close together in an attempt to promote invalidation. Citation 5 states that the rats conclusively grew more bone matter better at the points of breaking. Citation 6 clearly states that the therapy maybe effective in human adults but more evidence is required for conclusive recommendations. So the question becomes do medical doctors use this for troublesome broken bones or in compression breaks , that sort of thing , or are they not used for this in humans? The two citations seem more supportive of the therapy for broken bones than not but the two sentences seem to indicate that not much is known about it and that evidence is lacking and that the therapy is lacking efficacy. Clearly , in the next heavily cited section of the history of PEMF therapy , the main use has been for improved bone repair in troublesome slow healing or non healing broken bones both in animals and women.
So why are the citations and conclusion of the citations swinging back and forth in contradictions?
Lastly, their is the limited research section. In double checking citations I found a bunch of research studies both past concluded and currently ongoing related to PEMF and various conditions. The research section doesn't speak to sham devices and the difficulty of applying placebo effect. No explanation of what was studied in regards to depression or the findings of the study. Just that a study happened here's the citation moving on. Was it spesific frequencies of magnetic fields studied or was it random? Was it advised as adjunctive? Was it studied with differnt kinds of depression or just the regular general catch all depression? Who knows but glossing over and moving on we come to post operative pain. A new device was approved this year for post operative pain but after checking the citation this seems to just apply to one singular device and not the therapy itself of which it is demonstrated that multiple other kinds of devices from other manufactures can also provide adjunctive treatment for post operative pain. The question becomes , were they all approved this year or was it just the one device or was it the therapeutic application of the PEMF modality itself for post operative pain? I read that plastic surgeons regularly utilize PEMF therapy for pain and swelling but that isn't mentioned at all here but it is in other wiki articles. Almost as though it were purposefully omited.
Looking closer it really isn't clear. In fact the whole article is unclear marrying itself to every bioelectro medical field it can and claiming ineffectiveness in almost every way. At no point is it ever explained in the article what PEMF is. Is it a modality of adjustable low frequency magnetic field induction? Is it solid state magnets with ac or dc current running through them? Is it magical magnetic pixie fairys that grant healing wishes? At no point what so ever, does this article ever properly explain what a Pulsed Elctro Magnetic field is. The starter in your car engine has an electromagnetic field, does that make it a PEMF therapy device too? What are the distinctions between professional and non proffesional personal use? What I mostly get out of this article is that PEMF therapy is used to cure everything , cures nothing, and mostly used to mend broken bones that are having trouble mending.
Is the WPMEDRS being followed here? Is the article neutral or biased? Is the article full of general information about PEMF warning letters (that lack proper or use broken citation) and wellness devices sold as yoga mats and electro massage or is it about the biomedical nature of whatever PEMF is? Are the citations mainly from the abstracts or from the whole rat infested articles. Did any of the citations come from predatory journals?
If another attempt to clean this article up is made will the watcher gatekeepers allow it or will it remained revised back into what they want it to say?
174.83.7.90 (talk) 09:27, 13 October 2019 (UTC)
The food and drug safety administration do not give clinical medical approval to things used in the medical practice that only "attempts" to work but rather they give approval to things PROVEN to work.
Complete nonsense. The FDA specifically does not link approval to use a device with any consideration of efficacy, and merely considers whether a device poses a risk. These devices are completely devoid of medical evidence of working, and the only thing that's unethical is attempting to promote them as if they had any useful effect on any condition.- When a manufacturer falsely claimed that their device could be used to treat cerebral palsy and spinal cord injury – for which there is no reliable evidence – the US FDA quite properly warned them. I can see that you wouldn't want that sort of information coming to the attention of the desperate folks who pay money for these useless devices in the vain hope of some relief from their conditions. It's disgusting that avaricious charlatans manage to make their living from this sort of predation, and the shills supporting their efforts have no place on Wikipedia.
- The most that "approval" of these devices admits is that they make be used as part of a broader regimen as "general wellness devices" without safety concerns. That means very little when faced with the complete lack of evidence of any value for these devices in treating anything.
- If you couldn't find the source for reference 4, you didn't look very hard. I found it in the FDA archives in a few seconds at:
- I've updated the citation, but here's an extract of the relevant parts of what it says
and so on. This is a clear example of false advertising for this sort of device and is very relevant to this article, although I can see why you'd prefer the public not to be made aware of these fraudulent practices.The Food and Drug Administration (FDA) has learned that your firm is marketing the BioMove 3000, BioMove 5000, Curatron 2000 HT, Curatron 2000 XP, Curatron 2000PC, and Curatron Ultra-Power 3-D Pulsed Electro-Magnetic Field Therapy (PEMF) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act). Under section 201(h) of the Act, 21 U.S.C.§ 321(h), these products are devices, because they are intended for use in the diagnosis of disease or other conditions or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. As explained below, these devices are being marketed without the required clearance or approval in violation of the Act. ... your firm was advised that the setting called “spinal cord injury” was not an indication under the proposed indications for use or cleared under the predicate device and that data to support the safe and effective use for specific ailments was required. ... comparative claims regarding the device being the best and easiest stroke rehabilitation system in the world requires clinical data
"Is this an article about PEMF therapy in the legitimate medical setting or is it about less than trust worthy consumer products"
Of course it can't be an article about "PEMF therapy in the legitimate medical setting" because PEMF therapy has no legitimate medical setting. It doesn't work. Lying on a yoga mat that has a small low-frequency signal passed through coils inside it doesn't do anything more than the placebo effect and if you are claiming that you have evidence of effectiveness beyond that, let's see it cited here."the main use has been for improved bone repair in troublesome slow healing or non healing broken bones both in animals and women"
No it hasn't. The conclusions from the Cochrane Review, which assessed "the effects of electromagnetic stimulation for treating delayed union or non‐union of long bone fractures in adults", were:
Do you have any equally reliable source that contradicts the conclusion insufficient to inform current practice? Where's your evidence of "improved bone repair in troublesome slow healing or non healing broken bones"? What MEDRS-compliant sources do you have that reliably show bone repair and healing due to PEFT?There was no reduction in pain found in two trials. No study reported functional outcome measures. One trial reported two minor complications resulting from treatment. ... Though the available evidence suggests that electromagnetic field stimulation may offer some benefit in the treatment of delayed union and non‐union of long bone fractures, it is inconclusive and insufficient to inform current practice.
- Citation 5 (Boopalan 2009) supported the sentence "The mechanism of osteogenesis is not clear." Citation 6 (Griffin 2011) supported the following sentence "While PEMF therapy is claimed to offer some benefit in the treatment of fractures, the evidence is inconclusive and is insufficient to inform current clinical practice." So you're talking complete nonsense when claiming that they
"seem to of[sic] been placed so close together in an attempt to promote invalidation"
. That's how we cite text on Wikipedia. But I share your dissatisfaction with using Boopalan, PRJVC; Chittaranjan, Samuel B; Balamurugan, Ramadass; Nandakumar, NS; Sabareeswaran, A; Mohanty, Mira (August 2009). "Pulsed electromagnetic field (PEMF) treatment for fracture healing". Current Orthopaedic Practice. 20 (4): 423–428. doi:10.1097/BCO.0b013e318198e8b2.{{cite journal}}
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ignored (|display-authors=
suggested) (help) as it's an old rat-study published in Current Orthopaedic Practice, a journal insufficiently notable to even have a Wikipedia article. So I've removed it. - In fact the entire article is based on the reliable sources that editors have been able to find, so if it's stating "ineffectiveness in almost every way", that's because the sources are telling us that PEFT is ineffective in almost every way. What reliable sources do you have that show otherwise? The question is not "what doctors do?"; it's actually "what do these devices do?" and the answer, according to the sources, is "nothing". What you ought to be getting from the sources and hence the article is that folks will try anything to try to regain health, whether or not there's any evidence that it will do anything for them.
"At no point is it ever explained in the article what PEMF is."
So find some reliable sources that explain what PEMF is. That's how we write articles."Is it a modality of adjustable low frequency magnetic field induction?"
Are you aware of what complete pretentious crap that is? A modality? Where do you get that PR-buzztalk from? A transformer is "a modality of adjustable low frequency magnetic field induction", but we don't go around recommending folks lie on top of power supplies to cure cerebral palsy."In double checking citations I found a bunch of research studies both past concluded and currently ongoing related to PEMF and various conditions"
You mean:- https://www.oarsijournal.com/article/S1063-4584(13)00851-0/fulltext - "Current evidence of low and very low quality suggests that low frequency (≤100 Hz) pulsed subsensory threshold electrical stimulation produced either through PEMF/PES vs sham PEMF/PES is effective in improving physical function but not pain intensity at treatment completion in adults with knee osteoarthritis". We currently state "A 2013 review found that evidence was of very low quality, there might be a benefit for improved function, and there was no evidence for benefit for pain." What's wrong with that? Should we remove the word "very"?
- https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152432.pdf - "We have ... determined the device is substantially equivalent ... to legally marketed predicate devices ... that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. ... CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading". So the ActiPatch was allowed to be marketed and our article says so. What's wrong with that?
- https://www.sciencedirect.com/science/article/pii/S0278584616301117?via%3Dihub - "low-strength transcranial pulsed electromagnetic field (tPEMF) stimulation has been purported as a promising strategy for such treatment-resistant depression (TRD). The mode of action of this new technique is however largely unknown. ... Weak magnetic fields influence divergent neurobiological processes. The antidepressant effect of tPEMF may be specifically attributable to its effects on local brain activity and connectivity." Our article states "Use of pulsed electromagnetic field therapy has been studied for depression". How much more can anybody read into that source?
- https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf - "We have ... determined the device is substantially equivalent ... to legally marketed predicate devices ... that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. ... CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading". So the RecoveryRx was allowed to be marketed and our article says so. What's wrong with that?
Is the WPMEDRS being followed here?
Yes.- If you want to "clean up" the article, feel free to bring your sources here and suggest the article text that you feel they support. If you bring MEDRS-compliant sources and accurately summarise them them, your contributions will be gratefully received. If you just bring a load of hagiographic marketing blurb, supported by nothing more than hearsay and rat-studies, you're unlikely to find much consensus for its inclusion. If you disagree with the use of any of the sources currently in the article, please explain what your objections to them are. You've already pointed to one old animal study that should never have been in the article, and I'm grateful to you for that. --RexxS (talk) 15:21, 13 October 2019 (UTC)
Description as "bogus" in short description
[edit]I think the current short description for pulsed electromagnetic field therapy risks breaking WP:NPOV. There's clearly quite weak evidence for this being effective, and several applications are definitely unapproved for lack of proof of effectiveness, but a blanket label of "bogus" for the whole thing seems too much, unless there is a high-quality cite to back this up.
There is quite clearly controversy about effectiveness, so I have changed the short description "medical treatment of disputed effectiveness". -- The Anome (talk) 17:59, 15 October 2019 (UTC)
- I dont feel that we should describe a device of no efficacy for anything to actually be a medical device. -Roxy, the dog. wooF 19:51, 15 October 2019 (UTC)
- Also : There's no controversy. Roxy, the dog. wooF 20:04, 15 October 2019 (UTC)
- There are lots of medical treatments for which there are little or no evidence for effectiveness; effectively folk medicine carried on by medical practitioners. (This is one of the things the evidence-based medicine movement seeks to counter.) To describe something as a medical treatment is not an endorsement or statement of efficacy. Some of these things are FDA approved as medical devices; therefore they are medical devices by fiat, whether or not they actually work. -- The Anome (talk) 20:11, 15 October 2019 (UTC)
- Actually the FDA only approves them as "general well-being devices", on a par with yoga mats. Like so many fringe treatments, nobody has been able to produce evidence of effectiveness beyond folks subjectively feeling better for a while, and there is no plausible mechanism at work. The tiny sliver of possible evidence was described in a review as "low or very low quality", so we really shouldn't suspend our scepticism about the healing potential of pulses of low frequency radio waves, especially given the earning potential of such devices to a gullible public. --RexxS (talk) 21:21, 15 October 2019 (UTC)
- I see Roxy the dog has now removed the word "medical" from the short description. I think that's definitely an improvement. -- The Anome (talk) 22:22, 15 October 2019 (UTC)
- Actually the FDA only approves them as "general well-being devices", on a par with yoga mats. Like so many fringe treatments, nobody has been able to produce evidence of effectiveness beyond folks subjectively feeling better for a while, and there is no plausible mechanism at work. The tiny sliver of possible evidence was described in a review as "low or very low quality", so we really shouldn't suspend our scepticism about the healing potential of pulses of low frequency radio waves, especially given the earning potential of such devices to a gullible public. --RexxS (talk) 21:21, 15 October 2019 (UTC)
- There are lots of medical treatments for which there are little or no evidence for effectiveness; effectively folk medicine carried on by medical practitioners. (This is one of the things the evidence-based medicine movement seeks to counter.) To describe something as a medical treatment is not an endorsement or statement of efficacy. Some of these things are FDA approved as medical devices; therefore they are medical devices by fiat, whether or not they actually work. -- The Anome (talk) 20:11, 15 October 2019 (UTC)
- Also : There's no controversy. Roxy, the dog. wooF 20:04, 15 October 2019 (UTC)
Why is this not spam?
[edit]@Roxy the dog: Um... addition of stuff like On 2/3/2017 the FDA Cleared the first PEMF Device
here has been reverted again and again, but there are still such passages in the article: search for "wearable" and "clear" in the article. Have they been overlooked, or is there a reason why they do not constitute spam? I cannot tell the difference. --Hob Gadling (talk) 22:19, 29 December 2021 (UTC)
- It does seem to be a case of stuff being overlooked. I wasn't able to concentrate this morning or be useful on this page, but I think you are correct, there is much stuff to be scrutinised, and probably removed as promotional / just plain wrong / silly, let's see. -Roxy the dog. wooF 15:21, 30 December 2021 (UTC)
Riddled with issues - request to clarify extremely non-specific and meaningless claims, and my other concerns.
[edit]"The result of the signaling processes is to instruct skeletal cells to synthesize structural extracellular matrix and signaling molecules and enhance the ability of skeletal tissues to respond to changing physicochemical environments and biomechanical demands, and facilitate healing." What is "instructing" the cells supposed to mean? This is not a scientific term, and has absolutely no precise definition in medical science. This is an encyclopedia, and should use precise and verifiable claims, while claims like this one are de facto meaningless, and only serve to create an impression of the therapy's effectiveness on the readers. Not only is the claim meaningless and extremely unlikely to come from any medical expert or a ediligent Wikipedian, it is eerily similar to the narration employed by sellers of pseudo-scientific medical devices - e.g. on neshealth.com the site's owners write "[it enables you to] see the information the body needs to return to its original blueprint" about PEMFT "wellness devices", and "These provide corrective information to the body-field" about their so-called "infoceuticals" they claim to be "imprinted with with proprietary bio-information". "The result of the signaling processes is to instruct" - the result is that what exactly instructs the cells? The magnetic field itself or something else? What even is a signaling process? Cause it's definitely not a medical or a scientific term. "signaling molecules" - molecules cannot be signaled, as they are, you know, a few atoms. I have yet to encounter a single-molecule biological system. Molecules can be used for signaling when they are parts of complex biological or technological systems, but they themselves cannot be recipients of any information. I know this may sound like a nitpick, but this is an encyclopedic article about medical science, and this phrase also serves as an example of how poorly the paragraph was written. "enhance the ability of skeletal tissues to respond" - very dubious claim, would be hard to prove that the cells gain any enhanced abilities as a result
"While PEMF therapy is claimed to offer some benefits in the treatment of fractures, the evidence is inconclusive and is insufficient to inform current clinical practice. PEMFs is generally not among the guidelines to treat bone and osteochondral defects. Notwithstanding, there is strong evidence for ELF-PEMF treatment." Those statements are contradictory, as ELF-PEMF is a type of PEMF. The line is a slightly altered copypaste from the cited Ehnert et al. 2019. The original line reads "Notwithstanding, here we show that there is strong evidence for ELF-PEMF treatment." The conclusion is not only formed based on one article only, it literally is the view of the article's authors copy-pasted to Wikipedia. The article itself cites only all five existing in-vivo trials performed on humans, and those trials would all most likely be classified as low quality evidence, with small sample sizes, confounding factors, and conflicts of interests. I could access 4 of the 5 studies, and found the following. One of the studies was conducted by EBI, LLC (a Zimmer Biomet company), and Zimmet Bionet manufactures a PEMF device (Biomet® EBI® Bone Healing System), which is a very significant conflict of interest. One of the studies had only 34 participants, and one had 45, which doesn't allow for any solid generalised conclusions. One study has concluded that conservative management of non-union is effective, which can explain why people attribute efficacy to PEMF devices. Even if the one study I couldn't access was flawless, it wouldn't be enough to use for clinical practice or to make any definitive claim. There is absolutely no good reason for claiming any significant clinical relevance, and the conclusion is not supported by any reputable organisations. At best, if there is no better evidence to the contrary, we could conclude that there is some evidence suggesting potential efficacy of ELF-PEMF, but that the findings are low quality and inconclusive. But the wording "strong evidence" is absolutely unacceptable - just because the authors of the study claim their evidence is strong, it doesn't mean it's the truth.
The depression section should include any information on the status of research. I am expecting that there isn't any conclusive evidence, and if that's the case it would be good to write exactly that. Sadly, at the moment I don't have any more time to go through the literature.
Big parts of the article are also unclear. The "Use" section for example uses very complex and potentially difficult to untangle sentences. This is a lesser concern, but I just feel that the syntax was very confusing and it would be best to reword that.
About the numerous mentions of the FDA, I have no idea how all this works, because I am not from the USA and I'm unfamiliar with how this entity operates. However, it definitely seems like it could be an attempt to use the FDA's authority to legitimise the therapy, and to suggest that there exists evidence for it being legitimate and effective. Even claims that are factually true can be used for malicious purposes, and it's worth debating which of them should be included. To me it seems like this warrants further investigation of the claims and very conservative wording that avoids suggesting more than is said explicitly. Another thing - is being cleared by FDA research? Should it be there? The document cited seems to prove that the device is at least equivalent to some previous devices, so that is in a sense some rudimentary research, but the clearing itself seems to be more of a bureaucratic thing, not a research thing. For me, it would made more sense to cite this document, but instead write a summary of FDA's relevant findings in the article. Idk if that would be considered relevant or anything, but the current thing is even worse in my opinion.
I don't feel comfortable editing the article myself, as a new Wikipedian, but I really believe that it needs a massive overhaul. The current state of this article is extremely bad, with dubious or nonsensical claims, and an obvious bias. Contco (talk) 00:04, 26 December 2022 (UTC)
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