Basic Science Fibromyalgia Lee Bartel PLOS One Tech TEDx

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

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

Chirp, chirp. therapeutic 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 just like 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 more with just SOUND: principally just listening to a 40hz tone (take heed to the sound right here). However it’s truly junk science that was in all probability created just to promote a remedy gadget. One way or the other this extraordinarily low high quality paper obtained by means of PLOS One peer evaluate, regardless that it prominently links to an advertisement for the gadget. That commercial is far more blatantly pseudoscientific, as it leans heavily on a flashy, but deceptive promotional TEDx video: “Music Drugs: Sound at a mobile degree.”

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

The article presents results of a pre-registered randomized managed trial (RCT) comparing Sound Oasis Vibroacoustic Remedy 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. But, commonplace analyses did not discover a statistically significance between the lively remedy that’s being promoted within the video and a sham remedy constructed as a placebo. Ouch!

Technically talking, the research discovered no time-by-treatment interaction. What does that mean? Patients have been assessed with a battery of no less than six self-report questionnaires at baseline – before any exposure to the remedy or the sham – and afterwards, post-treatment. On this case, the time-by-treatment evaluation showed that the earlier than/after variations for sufferers receiving the lively remedy have been no totally different than the results for sufferers assigned to the sham remedy.

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

provide preliminary evidence that gamma-frequency rhythmic vibroacoustic stimulation might lower fibromyalgia signs and ease related comorbidities, opening new avenues for further investigation of the consequences of rhythmic sensory stimulation on persistent pain circumstances.

What was not emphasized is that comparable analyses would have shown the identical 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 results in this means disregards primary guidelines for deciphering a medical trial. Peer reviewers should have caught this instantly. Truly, the PLOS One Editor should have observed this error in deciphering the trial and never even have despatched the paper out for assessment.

A linked web site 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 that is seen in using this potent gadget in three medical trials registered with the U.S. National Institutes of Health – (1) Melancholy: https://clinicaltrials.gov/ct2/show/NCT02685982?term=VTS1000&rank=2 (2) Fibromyalgia: https://clinicaltrials.gov/ct2/show/NCT02493348 (three) 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 actual trial registration web page for the trial accommodates the standard warning:

The introduction of the article justifies the research on the subject of preliminary knowledge regarding ‘a well-established method’ whereby sensory stimulation delivered to the pores and skin can scale back ache.

Mechano-acoustic vibrations have been extensively used to deal with acute ache during orthodontic [26–28] and cosmetic procedures [29]and is a well-established method in orthopedic follow [30] and physiotherapy to scale back muscle soreness [31–33]low again pain [34]and orofacial pain [35]. Nevertheless, little is understood relating to the appliance of vibroacoustic stimulation within the remedy of continual pain circumstances. Previous medical research 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 – utilized in pulsed varieties with repeated brief, transient stimulus occasions at regular intervals, or in steady types which generate oscillating (e.g., sinusoidal) stimulus patterns [39]

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

The Dialogue section concedes a scarcity of established believable mechanism by which the remedy ought to work:

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

The Dialogue part makes an attempt to neutralize the shortage of differences between lively and sham remedy by raising the likelihood that perhaps the management/comparison group isn’t really a sham, but 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 aspect of a advertising strategy selling unproven medical units to persons who consider they are suffering from well being circumstances which are poorly understood and that have poor outcomes within typical evidence- and science-based drugs.

The advertising campaign leaves sufferers and their households with the impression that a medical gadget that’s on the market has been confirmed powerful and that it is comparable to what is being utilized in prestigious hospitals.

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

The American Medical Affiliation 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 selling an unproved medical system with a hyperlink to a buying cart permitting cost and residential supply to be arranged. No value to the company for the advertisement, solely cost of the Article Processing Prices (APCs).

We must ask how senior PLOS administration and lax editorial and assessment 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 text.

The article

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 summary 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 focused on whether or not rhythmic sensory stimulation would promote vital modifications in fibromyalgia and related symptoms, and whether remedy results would differ between two distinct remedy parameters.

A complete of 50 patients who had been recognized with fibromyalgia have been randomly assigned to 2 check teams.

One group acquired vibrotactile stimulation from a steady sine wave single-frequency stimulation (40 Hz) for 30 minutes, 5 days per week, over 5 weeks, concomitant with traditional care. The second group accomplished the same remedy protocol however acquired a special stimulation, consisting of random and intermittent complicated wave gamma-range vibrotactile stimulation.

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

What might be seen as a clever however uncool spinning of the outcomes:

Results indicated that there were 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 within the conclusion. The seemingly good news is nice for advertising the system, but ought to have brought about the reviewers and editor to cry foul.

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

Primary research design

The presentation of the technical particulars of the research is linked to an image of the system being marketed and even links to where it may be bought.

Individuals enrolled in the research have been randomly assigned to one among two research arms (Fig 1). Both teams acquired 25 periods of 30-minute rhythmic sensory stimulation over 5 weeks concomitant with typical care. Group one acquired vibrotactile stimulation from a continuous 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. Within the preliminary trial research protocol, the stimulation delivered to group two was meant as a sham stimulation, nevertheless, cautious spectral evaluation 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 Remedy System VTS-1000) with a built-in low-frequency transducer situated on the middle again region and stereo speakers situated at ear degree (S1 Fig).


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

Moveable shopper system (Sound Oasis Vibroacoustic Therapy System VTS-1000) outfitted with a built-in low-frequency transducer situated at the center back area and two stereo audio system situated at ear degree. Supply: 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 comparison management 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 roughly 33 Hz and 45 Hz, and a secondary pitch peak at approximately 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. Each sound burst was separated by intervals generated by a random quantity generator producing numbers between 1-10. Every digit had an equivalent of 250 milliseconds; in order that no 1 represented 250 milliseconds, quantity 2 represented 500 milliseconds, quantity three represented 750 milliseconds, and so on. These numbers have been used to find out the intervals between every sound onset all through the trial. The monitor was produced by arranging sound bursts separated by the random intervals till one minute of fabric was generated. This first minute of fabric was repeated four extra occasions, however every of these 5 equivalent segments was set to a unique tempo; the first minute performed at 120 bpm, the second at 110, the third at 115, the fourth at 125 and the fifth 130.

Competing Pursuits

A competing interest statement discloses a battle of interest, however an effort to handle it by holding 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 potential battle of curiosity as he has served as a paid scientific advisor to Somerset Group and Sound Oasis, and receives restricted royalties from the Somerset Group for the Sonic Help collection and from Sound Oasis on the gross sales of the Vibroacoustic Therapy System VTS-1000 gadget. To manage this potential battle of interest, L.B. was not concerned in patient recruitment, consenting, or knowledge collection process, and had no direct position within the knowledge analysis course of. This does not alter our adherence to PLOS ONE policies on sharing knowledge and supplies.

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

The web site

A click on on one of many hyperlinks within 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’ve been visiting this website over a number of weeks and the “! Just one left in inventory” has been there each time.

The gadget is described as:

Clinically Proven, Doctor Developed Sounds…The revolutionary Vibroacoustic Remedy System uses clinically proven, physician developed sounds and vibration that will help you sleep, loosen up and renew your physique – naturally! Vibroacoustic remedy techniques, costing several hundreds of dollars, have been successfully used in hospitals and clinics all over the world. Now you’ll be able to take pleasure in this similar therapeutic know-how at a fraction of the worth. Sound remedy offers soothing music with clinically confirmed brainwave entrainment for efficient stress discount, rest and therapeutic.

Vibroacoustic research and Dr. Bartel’s TEDx speak

The webpage allows a customer to click on 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 performed by means of Vibroacoustic units may help reduces the symptoms of Fibromyalgia ache, Alzheimer’s Disease, Parkinson’s Disease, Melancholy, and improve blood circulate.

The video is a basic instance of a well-polished TEDx speak pitch. Lee Bartel’s requisite moment 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 simply as inevitably a cricket would walk into the honey home and would go chirp chirp chirp… it didn’t take very long earlier than 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 many years until I found the precept of entrainment in physics, how one rhythmic vibrating object will synchronize with one other and so I used that concept and started creating music to affect your brainwaves music…

A dreamy, glad lady who has just had her pain 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 improvements in an Alzheimer’s and a fibromyalgia patient utilizing this Vibroacoustic Remedy System. Within the example of the fibromyalgia patient:

We gave her a prescription of 23 minutes of 40 Hertz sound stimulation two occasions every week for 5 weeks on this gadget…and what we found after 5 weeks was that she had stopped utilizing all her medicine. She’s reported that she might sleep a lot better and she or he was less depressed. The chiropractor checked her neck and shoulders and she or he 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 after which the pain circuits so the idea can be in our assumption was that 40 Hertz sound stimulation would restore this connectivity and she or he demonstrated that there were constructive results.

The TEDx speak ends with a rousing promise of this powerful music drugs on the mobile 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 impression cells in your body. That stimulating cells with sound can scale back the danger and influence of well being issues like Alzheimer’s and Parkinson’s and fibromyalgia and melancholy. But what I do foresee now in the not-too-distant future is that when a physician encounters something 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 need to tell him instantly.

Pricey Dr. Heber:

I’m writing to request a formal investigation of an article that appeared in PLOS One. I consider that a immediate retraction can be within the interest of the status 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 Illness.

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 signs. PLOS One. 2019 Mar 1;14(3):e0212021.

The PLOS One article stories a RCT by which no differences have been discovered between the lively remedy of rhythmic sensory stimulation of 40 Hz Vibroacoustic Therapy 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 outcomes

present preliminary proof that gamma-frequency rhythmic vibroacoustic stimulation might lower fibromyalgia signs and ease associated comorbidities, opening new avenues for additional investigation of the consequences of rhythmic sensory stimulation on continual ache circumstances.

The PLOS One article accommodates a picture of the gadget that’s being marketed direct to shoppers and the caption to the picture is redundant with one other link going on to a product web page where the VTS-1000 Vibroacoustic Remedy System is offered for $399.99, but with the admonition that there’s only one system left in inventory.

The web site additionally prominently shows a TEDx speak with outlandish claims that I recommend you view.

The PLOS One article is an infomercial, a part of a crass advertising of an unproven medical system to weak patients and their families 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 these with FDA approval. PLOS One is now within the place of selling an unproven gadget for the relatively low value of APCs.

I hope the journal will respond promptly to this alert. I acknowledge that policing the standard of articles in a megajournal with ~20,000 articles revealed per yr is a formidable process. However just a few, and even one articles displaying a number of breakdowns in editorial and peer assessment can have substantial impression on authors and lay and professional perceptions of the trustworthiness of the journal. A immediate investigation to find out whether or not this article ought to be retracted or merely have a correction could possibly be an essential step in limiting any injury. I apparent favor a retraction.

Please let me know if I can provide further info.

Sincerely,
James C. Coyne, PhD


Notice
Because of Paul Ingraham of PainScience.com for editorial assistance. I highly advocate his science-based fibromyalgia tutorial.