Fibromyalgia Lee Bartel PLOS One TEDx

Infomercial in PLOS One links to website selling unproven treatments for fibromyalgia and dementia – Science-Based Medicine

Chirp, chirp. healing crickets.

[Editor’s note: Scott is having a very busy week, and stepping in to help out is Dr. James Coyne with another guest post.]

Bizarrely, the megajournal PLOS One has revealed a paper that is suspiciously comparable to an advertisement. The paper LOOKS prefer it’s reporting on a check of a product that supposedly treats fibromyalgia, but in addition ache, dementia, Parkinson’s disease and extra with simply SOUND: principally just listening to a 40hz tone (pay attention to the sound right here). Nevertheless it’s truly junk science that was in all probability created just to advertise a remedy gadget. Someway this extraordinarily low quality paper obtained by way of PLOS One peer evaluate, despite the fact that it prominently links to an commercial for the gadget. That advertisement is rather more blatantly pseudoscientific, because it leans closely on a flashy, however deceptive promotional TEDx video: “Music Medicine: Sound at a cellular level.”

Be a part of me in a name for a speedy retraction! In this article, I critique the paper and present exactly why it’s obviously junky science, and share my letter sent to the senior editor of PLOS One.

The article presents outcomes of a pre-registered randomized managed trial (RCT) evaluating Sound Oasis Vibroacoustic Therapy System VTS-1000 to a sham remedy.

As reported in PLOS One, the RCT was designed as an important check of the effectiveness of the gadget in treating fibromyalgia. Yet, normal analyses didn’t discover a statistically significance between the lively remedy that is being promoted in the video and a sham remedy constructed as a placebo. Ouch!

Technically speaking, the research found no time-by-treatment interplay. What does that mean? Patients have been assessed with a battery of a minimum of six self-report questionnaires at baseline – earlier than any publicity to the remedy or the sham – and afterwards, post-treatment. In this case, the time-by-treatment analysis confirmed that the before/after variations for sufferers receiving the lively remedy have been no totally different than the outcomes for patients assigned to the sham remedy.

Nevertheless, reporting of the trial emphasized only variations that occurred inside the lively remedy group. The paper went on to declare these results:

provide preliminary proof that gamma-frequency rhythmic vibroacoustic stimulation might decrease fibromyalgia signs and ease associated comorbidities, opening new avenues for further investigation of the consequences of rhythmic sensory stimulation on persistent ache circumstances.

What was not emphasized is that comparable analyses would have shown the same effects for sufferers who acquired the sham/placebo remedy. That may be a huge drawback for any claims for the advertising of the gadget.

Presenting the outcomes in this manner disregards primary guidelines for deciphering a medical trial. Peer reviewers ought to have caught this immediately. Truly, the PLOS One Editor ought to have observed this error in deciphering the trial and not even have sent the paper out for evaluate.

A linked website calls attention to the Clinicaltrials.gov registration of the trial:

Sound Oasis VTS-1000 – Current Medical Trials The medical potential of the VTS-1000 goes past sleep and stress and this is seen in using this potent gadget in three medical trials registered with the U.S. Nationwide Institutes of Well being – (1) Melancholy: https://clinicaltrials.gov/ct2/show/NCT02685982?term=VTS1000&rank=2 (2) Fibromyalgia: https://clinicaltrials.gov/ct2/show/NCT02493348 (3) Temporomandibular Disorder: https://clinicaltrials.gov/ct2/show/NCT02427113?term=TMD+music&rank=1

This use of trial registration as suggesting some sort of endorsement by NIH is misleading. The precise trial registration page for the trial accommodates the standard warning:

The introduction of the article justifies the research with reference to preliminary knowledge regarding ‘a well-established technique’ whereby sensory stimulation delivered to the skin can scale back ache.

Mechano-acoustic vibrations have been extensively used to handle acute ache during orthodontic [26–28] and beauty procedures [29], and is a well-established method in orthopedic follow [30] and physiotherapy to scale back muscle soreness [31–33], low back pain [34], and orofacial pain [35]. Nevertheless, little is understood relating to the appliance of vibroacoustic stimulation in the remedy of continual ache circumstances. Previous medical studies have explored using rhythmic sensory stimulation to treat fibromyalgia [36–38]. Rhythmic sensory stimulation (RSS) broadly refers to using sensory occasions – including vibrotactile, auditory, and visual flickering stimuli – applied in pulsed types with repeated brief, transient stimulus occasions at regular intervals, or in continuous varieties which generate oscillating (e.g., sinusoidal) stimulus patterns [39]

Precise studies of remedy of fibromyalgia are cited in the introduction, but they don’t clearly help the efficacy of rhythmic sensory stimulation to deal with fibromyalgia.

The Discussion part concedes a scarcity of established plausible mechanism by which the remedy should work:

There isn’t a consensus relating to the mechanisms underlying the consequences of sensory stimulation on ache.

The Dialogue part attempts to neutralize the shortage of variations between lively and sham remedy by raising the likelihood that perhaps the management/comparability group isn’t actually a sham, however another poorly understood lively, efficient remedy.

(Deja vu: We frequently see this argument when acupuncturists can’t find differences between lively and sham acupuncture.)

Nevertheless, the linked TEDx speak claims robust scientific help for cartoonish, simplistic explanations of miraculous results in some dramatic case examples.

The PLOS One article is an infomercial, a key component of a advertising strategy selling unproven medical units to individuals who consider they are affected by health circumstances which are poorly understood and that have poor outcomes inside typical evidence- and science-based drugs.

The advertising marketing campaign leaves sufferers and their households with the impression that a medical system that is for sale has been proven powerful and that it is comparable to what is being used in prestigious hospitals.

The advertising campaign provides no indication that remedy of debilitating, complicated, and poorly understood medical circumstances ought to be carried out beneath medical supervision.

The American Medical Association advises towards medical journals accepting direct-to­-consumer ads for medical units, even when the units are permitted by the US Food and Drug Administration.

The AMA doesn’t even contemplate what we discover in this PLOS One article: A spun medical trial instantly promoting an unproved medical gadget with a link to a buying cart allowing cost and residence supply to be arranged. No value to the corporate for the advertisement, solely cost of the Article Processing Prices (APCs).

We should ask how senior PLOS management and lax editorial and evaluation processes permit readers to be misled and exploited by a journal publishing such infomercials as peer-reviewed scientific articles, not paid ads.

However let’s immediately get this article retracted. See my letter to the Senior PLOS One Editor on the finish of this article.

The article

Janzen TB, Paneduro D, Picard L, Gordon A, Bartel LR. “A parallel randomized controlled trial examining the effects of rhythmic sensory stimulation on fibromyalgia symptoms.” PLOS One. 2019 Mar 1;14(three):e0212021.

The abstract provides the essential design for the research:

A double-blind, two-arm parallel randomized controlled trial investigated the consequences of gamma-frequency rhythmic sensory stimulation on fibromyalgia. We have been in whether or not rhythmic sensory stimulation would promote vital modifications in fibromyalgia and related symptoms, and whether or not remedy effects would differ between two distinct remedy parameters.

A total of 50 sufferers who had been recognized with fibromyalgia have been randomly assigned to two check groups.

One group acquired vibrotactile stimulation from a continuous sine wave single-frequency stimulation (40 Hz) for 30 minutes, five days per week, over five weeks, concomitant with normal care. The second group accomplished the identical remedy protocol however acquired a unique stimulation, consisting of random and intermittent complicated wave gamma-range vibrotactile stimulation.

The two groups have been evaluated earlier than and after for self-reported fibromyalgia signs, pain severity and interference, melancholy symptoms, quality of life and sleep quality.

What could possibly be seen as a clever but uncool spinning of the results:

Results indicated that there have been statistically vital modifications from baseline to post-treatment in measures of fibromyalgia symptom severity, ache interference, melancholy, and sleep high quality. Nevertheless, remedy outcomes did not differ considerably between groups.

The spin turns into specific in the conclusion. The seemingly excellent news is great for advertising the system, but ought to have prompted the reviewers and editor to cry foul.

These findings present preliminary evidence that gamma-frequency rhythmic vibroacoustic stimulation might lower fibromyalgia symptoms and ease associated comorbidities, opening new avenues for further investigation of the consequences of rhythmic sensory stimulation on continual ache circumstances.

Primary research design

The presentation of the technical details of the research is linked to a picture of the gadget being marketed and even links to the place it can be bought.

Members enrolled in the research have been randomly assigned to certainly one of two research arms (Fig 1). Both teams acquired 25 periods of 30-minute rhythmic sensory stimulation over five weeks concomitant with traditional care. Group one acquired vibrotactile stimulation from a steady single-frequency sine wave at 40 Hz that was amplitude modulated on an 11-second cycle plus isochronous auditory stimulation with a 160 Hz tone amplitude modulated at 40Hz. Group two acquired vibrotactile stimulation from randomly intermittent sounds consisting of complicated wave gamma-range noise with pitch peaks at 33 Hz and 45 Hz. In the initial trial research protocol, the stimulation delivered to group two was meant as a sham stimulation, nevertheless, careful spectral analysis of the stimulus carried out after research completion revealed that this was not the case. The stimulation was delivered by way of a transportable shopper gadget (Sound Oasis Vibroacoustic Therapy System VTS-1000) with a built-in low-frequency transducer situated at the center back region and stereo speakers situated at ear degree (S1 Fig).


Clicking in the (S1 Fig) took the reader to a photo of the gadget prominently displayed at the end of the article and links to the gross sales web page.

Moveable shopper gadget (Sound Oasis Vibroacoustic Remedy System VTS-1000) outfitted with a built-in low-frequency transducer situated at the middle back region and two stereo audio system situated at ear degree. Source: https://www.soundoasis.com/products/sleep-sound-therapy-systems/vibroacoustic-therapy-system/

The intervention

The sound stimulus delivered to group one consisted of a steady single-frequency sine wave at 40 Hz that was amplitude modulated on an 11-second cycle, plus isochronous auditory stimulation with a 160 Hz tone amplitude modulated at 40 Hz with secondary pitch peaks at 120 Hz and 200 Hz (Fig 2). The monitor has a 1-second fade-in and a 13-second fade-out, with an output degree of -12.7db.

The comparability control condition

The second monitor, administered as stimulation to group two, comprised of randomly intermittent sounds consisting of complicated wave gamma-range noise with pitch peaks at approximately 33 Hz and 45 Hz, and a secondary pitch peak at roughly 95 Hz (Fig 3). The sound was generated from a single hit on a percussion instrument (gran cassa), which generated a sound burst with a period of 500 milliseconds. Every sound burst was separated by intervals generated by a random quantity generator producing numbers between 1-10. Each digit had an equivalent of 250 milliseconds; in order that no 1 represented 250 milliseconds, quantity 2 represented 500 milliseconds, number 3 represented 750 milliseconds, and so on. These numbers have been used to decide the intervals between every sound onset throughout the trial. The monitor was produced by arranging sound bursts separated by the random intervals until one minute of fabric was generated. This primary minute of material was repeated four extra occasions, but every of these 5 similar segments was set to a special tempo; the first minute played at 120 bpm, the second at 110, the third at 115, the fourth at 125 and the fifth 130.

Competing Pursuits

A competing curiosity assertion discloses a conflict of curiosity, however an effort to handle it by protecting the conflicted writer out of key selections.

Authors T.B.J., D.P., L.P., and A.G. declare that no competing pursuits exist. L.B. declares a possible conflict of interest as he has served as a paid scientific marketing consultant to Somerset Group and Sound Oasis, and receives limited royalties from the Somerset Group for the Sonic Help collection and from Sound Oasis on the sales of the Vibroacoustic Remedy System VTS-1000 gadget. To manage this potential conflict of interest, L.B. was not involved in affected person recruitment, consenting, or knowledge collection process, and had no direct position in the info analysis process. This doesn’t alter our adherence to PLOS ONE insurance policies on sharing knowledge and supplies.

Perhaps LB was not concerned in these actions, as said. However how can we clarify the alignment of the spinning of the null outcomes in the PLOS One article with the wants of an advertising campaign for a ‘powerfully’ efficient gadget? I don’t assume this declaration lets the authors off the hook for a nonstandard interpretation of the results.

The website

A click on one of the links in the PLOS One article takes one to the product web page for the VTS-1000 Vibroacoustic Therapy System, simply as pictured in the article, however with pricing and a full range of equipment.

I have been visiting this website over a couple of weeks and the “! Only one left in stock” has been there each time.

The system is described as:

Clinically Proven, Doctor Developed Sounds…The revolutionary Vibroacoustic Therapy System uses clinically confirmed, physician developed sounds and vibration to allow you to sleep, loosen up and renew your body – naturally! Vibroacoustic remedy methods, costing several hundreds of dollars, have been successfully used in hospitals and clinics all over the world. Now you possibly can take pleasure in this similar therapeutic know-how at a fraction of the worth. Sound remedy offers soothing music with clinically proven brainwave entrainment for efficient stress reduction, rest and healing.

Vibroacoustic research and Dr. Bartel’s TEDx speak

The webpage allows a visitor to click on instantly to a TEDx speak pitch for these merchandise:

Dr. Lee Bartel’s TEDx speak at Collingwood, Ontario provides a superb overview of the current state of vibroacoustic medical analysis. Dr. Bartel explains how scientifically developed sound played via Vibroacoustic units might help reduces the symptoms of Fibromyalgia ache, Alzheimer’s Disease, Parkinson’s Illness, Melancholy, and improve blood movement.

The video is a basic example of a well-polished TEDx speak pitch. Lee Bartel’s requisite second of epiphany was extracting honey on a farm in western Canada. Honey sticking to belts made them:

Go squeak squeak squeak to drive me nuts and just as inevitably a cricket would stroll into the honey home and would go chirp chirp chirp… it didn’t take very lengthy before what started as a kind of a random chirp would synchronize with the squeak on the belt. Why this was occurring was a query that lingered in my head for very a few years until I discovered the precept of entrainment in physics, how one rhythmic vibrating object will synchronize with one other and so I used that idea and began creating music to have an effect on your brainwaves music…

A dreamy, glad lady who has simply had her ache and fatigue relieved.

Years later, Bartel would uncover a single pitch of 40 HZ would scale back ache in fibromyalgia and Alzheimer’s signs.

The video provides detailed medical examples of seeming miraculous, enduring enhancements in an Alzheimer’s and a fibromyalgia affected person using this Vibroacoustic Remedy System. Within the instance of the fibromyalgia affected person:

We gave her a prescription of 23 minutes of 40 Hertz sound stimulation two occasions every week for five weeks on this gadget…and what we found after 5 weeks was that she had stopped using all her treatment. She’s reported that she might sleep a lot better and she was less depressed. The chiropractor checked her neck and shoulders and she had extra mobility.

The consequences of the sound stimulation on a affected person with are given a easy rationalization:

Analysis exhibits that fibromyalgia has connectivity points between elements of the brain and then the ache circuits so the idea can be in our assumption was that 40 Hertz sound stimulation would restore this connectivity and she demonstrated that there have been constructive results.

The TEDx speak ends with a rousing promise of this powerful music drugs on the cellular degree being built-in into routine, typical drugs.

I couldn’t have foreseen that the concept came from this cricket might start to create sound which may influence cells in your body. That stimulating cells with sound can scale back the danger and influence of well being problems like Alzheimer’s and Parkinson’s and fibromyalgia and melancholy. However what I do foresee now in the not-too-distant future is that when a physician encounters one thing like Alzheimer’s or Parkinson’s or melancholy they could take out their prescription pads and write a prescription for sound stimulation and that’s music drugs on the mobile degree [Applause] [Music] [Applause] [Music]

The letter

I’ve written to Dr. Joerg Heber ([email protected]) Editor-in-Chief of PLOS One. If readers share my considerations, they could want to inform him instantly.

Pricey Dr. Heber:

I’m writing to request a proper investigation of an article that appeared in PLOS One. I consider that a immediate retraction can be in the interest of the fame of the journal and would shield shoppers from the advertising of a dubious unproven medical system claiming dramatic results of a 40 Hz sound on Fibromyalgia pain, Alzheimer’s Disease, and Parkinson’s Disease.

The article is

Janzen TB, Paneduro D, Picard L, Gordon A, Bartel LR. A parallel randomized managed trial analyzing the consequences of rhythmic sensory stimulation on fibromyalgia symptoms. PLOS One. 2019 Mar 1;14(three):e0212021.

The PLOS One article studies a RCT in which no variations have been found between the lively remedy of rhythmic sensory stimulation of 40 Hz Vibroacoustic Remedy System and a cleverly constructed sham remedy. Despite this being a null trial, the article focuses on the within-differences for the lively remedy (no totally different than in the sham group) and declares the results

provide preliminary evidence that gamma-frequency rhythmic vibroacoustic stimulation might decrease fibromyalgia signs and ease associated comorbidities, opening new avenues for further investigation of the consequences of rhythmic sensory stimulation on continual ache circumstances.

The PLOS One article incorporates an image of the system that’s being marketed direct to shoppers and the caption to the picture is redundant with another hyperlink going immediately to a product web page the place the VTS-1000 Vibroacoustic Remedy System is obtainable for $399.99, however with the admonition that there’s just one system left in stock.

The website also prominently displays a TEDx speak with outlandish claims that I recommend you view.

The PLOS One article is an infomercial, part of a crass advertising of an unproven medical gadget to weak patients and their households fighting managing complicated and poorly understood medical circumstances for which typical evidence- and science-based drugs don’t supply a lot hope of aid.

AMA advises towards medical and scientific journals accepting ads for medical units, even those with FDA approval. PLOS One is now in the place of selling an unproven gadget for the relatively low value of APCs.

I hope the journal will reply promptly to this alert. I acknowledge that policing the quality of articles in a megajournal with ~20,000 articles revealed per yr is a formidable activity. However just a few, or even one articles displaying a couple of breakdowns in editorial and peer evaluate can have substantial impression on authors and lay and skilled perceptions of the trustworthiness of the journal. A prompt investigation to decide whether or not this article must be retracted or merely have a correction could possibly be an necessary step in limiting any injury. I obvious favor a retraction.

Please let me know if I can provide further info.

Sincerely,
James C. Coyne, PhD


Notice
Thanks to Paul Ingraham of PainScience.com for editorial help. I highly advocate his science-based fibromyalgia tutorial.

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