Wednesday, June 06, 2007

End Pain Forever. Maybe.

Australia. Land of myriad miracle devices. Such as the ENAR (Electro Neuro Adaptive Regulator), recently given nationwide publicity on A Current Affair ("Space-Age Pain Relief" - does that mean it uses outdated 1950s technology?).

A device designed for Russian astronauts can relieve chronic pain, according to a Macquarie University study.

They probably mean cosmonauts. It's also interesting that it's being touted now, when the study was conducted in 2005. Maybe they need a boost in sales.

As the segment mentioned a number of times, this device would "end pain forever". There was also the obligatory personal testimony, provided by a man who stated he'd been in pain for many years, and confined to a wheelchair for the last few years. After three and a half minutes with the amazing ENAR he says he no longer needed the wheelchair and got up and walked! And he's been fine ever since!

Well. EoR's convinced. Especially since the segment also touted scientific proof, provided by a study conducted at Macquarie University. Few actual details of the study were given, but it was done at a university! What more do you need to know?

There was a brief rebuttal from a skeptical doctor, expressing disbelief that such a handheld device would replace prolapsed discs, or reverse arthritis. But that man walked! It must be true! There's proof!

"I know it's nice to have a study that claims you've got these results," says Dr Rose. "But it's got to be statistically provable otherwise you can't really take anything from it."

No! No! A$1400 for pain relief "forever"? Surely that's not too much to ask for a little electronic zapper that will "end pain forever"? Who cares if some Big Pharma shill wants to poo-poo this miracle of modern science! It's only scientists who want statistically significant results. Statistically insignificant results are what's needed for marketing!

The ENAR FAQ provides some fascinating information about how this device "works":

ENAR/SCENAR technology interactively stimulates the body working with Reflex Bio-feedback to find and treat ‘Asymmetries’. These asymmetries are signs of difference that indicate nerve energy problems associated with injury, pathology and disease.

"Asymmetries"? How are these asymmetries located and measured? Answering "by the ENAR" is not acceptable. An article by Ellen Hodgson Brown, JD ("who has written nine books on alternative health care") explains the ENAR combines "Western electrical biofeedback with Eastern energy medicine" and "The device works on diseases and dysfunctions of every sort, by acting systemically on the energy field of the body".

The ENAR website provides copious proof of this machine's effectiveness. Such as a report from New Scientist. Well, if New Scientist are reporting on it, it must work! Surely? Actually, since the New Scientist report is about electrical currents in wound healing and the ENAR is being promoted for total pain relief, and specifically debilitating pain such as arthritis, it has no relevance whatsoever. Unless the inability to walk is caused by wounds.

Of course, this is how these devices are promoted. Any research, even if it's only vaguely related, no matter how small the study, no matter what statistical significance it may or may not have, is proudly displayed as proof of the device itself being scientifically plausible. That conclusion is not indicated. But what about that Macquarie University study? Isn't that proof? The only proof, in fact (the FAQ makes reference to other studies worldwide, but no details are provided - the only study that is being pushed so heavily is the Macquarie University study with repeated statements such as "DRAMATIC and SUSTAINED" - Pubmed returns no publications relating to the ENAR).

As this promotional article explains:

Paul Keetley was aware that he would have to deal with scepticism about any claims that he might make for the ENAR, particularly from Australia's Therapeutic Goods Authority, so he took early steps to get Macquarie University's Centre for Health & Chiropractic to carry out a randomised control pilot study using a patient group suffering from chronic neck pain.

If Mr Keetley really thought the TGA would be difficult to deal with he's living under a delusion. The TGA seem quite happy to register almost any magical device, as long as the promoters don't make too extravagant claims about it. And even if they do, that's okay until someone lodges a complaint.

It's good to know, however, that the ENAR has been tested by chiropracters. EoR can't think of a more worthy group of people to conduct the study (unless it be homeopaths). The use of chiropracters might also explain the "assymetries" this device detects, since chiropracters are also so beloved of such "asymmetries". The relevant people are Associate Professor Rod Bonello, described as "senior academic and founder of Chiropractic studies at Macquarie University". Among his publications is a paper on "Cancer and Chiropractic" in the prestigious Sydney College of Chiropractic Gazette. EoR would love to see that paper. His ENAR work only gets listed under "Poster Presentations". So, not only is it a small scale trial, it's apparently not even published. The student who actually conducted the study is Andrew Vitiello (inventor of the Chiropak - something that sounds to EoR like some horrible newage Deepak Chopra device).

The ENAR works with positive and negative electrodes. The device, which is the size of a mobile phone, is switched on and applied to the point of pain. "We followed participants over six weeks and measured things like pain intensity, functional capabilities, quality of life and neck disability," explains Vitiello. "We treated them intensively and then left them alone." Results showed that people who received the TENS therapy were no better off than if they received no therapy at all. People who received the ENAR therapy found that not only had their pain levels improved so had their functional capabilities and quality of life.

EoR is amazed that an electrical device works with both positive and negative electrodes. Cool, eh?

Mr Vitiello also states proudly:

I am juggling a few balls but I am excited about doing these things because it helps build the profile of Macquarie University, especially in a field we haven’t classically been involved in. We are now in the front line of clinical trials as the only University in the world who is testing the ENAR.

Which rather begs the question, why is no other university interested in this magic machine so soundly based on science and with such miraculous results?

Since the study apparently remains unpublished to date, readers need to rely on this document for details. Nine patients were treated with the ENAR, seven with TENS (Transcutaneous Electro Neuro Stimulation), and eight were treated using a switched off ENAR. Patients were treated for 12 weeks, and asked weekly about their pain levels. Various conclusions, and various graphs are then presented purporting to show that TENS and the sham treatment were the same (implying, of course, that TENS has no effect at all), while the ENAR dramatically and sustainably reduced pain.

There are, however, many problems with this study.

  • It is unpublished

  • The numbers were so small that statistical errors are bound to be exaggerated

  • The ENAR works by electrical stimulation - was it not possible that those receiving the sham treatment (a switched off ENAR) were aware of this?

  • The Visual Analog Scale runs from 0 to 10, but the first graph (Pre/Post Treatment VAS Scores) only shows a scale from 0 to 4.5, exaggerating any differences (the largest difference recorded is only 0.5 to 3.5). While a continuous graph is shown from the three data points, VAS scores at the ten intervening treatments are not reported.

  • There are further graphs presented, though the greatest differences seem to appear in self-reported assessments, such as the Change in Patient Specific Functional Scores after Six Months graph.

  • There is no information what other treatments the subjects were receiving, if any.

  • The conclusion ("There is no doubt ENAR works") is unwarranted and unsupported. ENAR may work. It may not.

  • Even so, the final paragraph of the report falls back on the lack of evidence by a call to testimonials and newage cliche: "There is a fast growing list of Western anecdotal case reports that suggest it might well be a quantum leap forward in therapy."

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