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Trialling Bioflow -

The Peninsula Arthritis Study


“Randomised, controlled trial of magnetic bracelets
for relieving pain in osteoarthritis of the hip and knee”
by Harlow, Greaves, White, Brown, Hart and Emst.


What:   Studied magnetic devices for pain relief of hip and/or knee osteoarthritis.
When:  Reported 16th December, 2004 in the British Medical Journal, after a 2-year trial.
Who:    Conducted at local GP clinics in Devon, UK, by the Peninsula Medical School of Exeter University, on behalf of the respected UK Arthritis Research Campaign (now Arthritis Research UK).
How:    The researchers randomly split the trial group of 194 older people into three, using a Bioflow Classic wristband, a weaker magnet in the Bioflow case or a plain steel washer placebo in the same case.  They were tested for pain at the start, at 4 weeks and at 12 weeks, using WOMAC objective tests. Unblinding was tested by questioning at the end of each patient’s trial.
Results: The Bioflow wearers gained significant pain relief beyond that of both the ordinary magnet and placebo users, who had similar results.


Summary

The Peninsula Medical School of Exeter University supervised a trial on 194 general practice clinic patients, testing the basic Bioflow Classic wristband CRP unit (an ultra-high-power bi-polar magnet system).  The trial is so far unique because it used both an ordinary powerful magnet and a steel washer as dummies.  It took place during 2002 and 2003 and was published in the prestigious British Medical Journal in December 2004.

The trial found that pain from osteoarthritis of the hip and knee decreased significantly when wearing a Bioflow magnetic bracelet, comparable with typical arthritis pain-relief drugs.  The ordinary magnet and the steel washer placebos made little difference to the pain (the magnet gave slightly better results).  Note that the Bioflow CRP unit is VERY much more powerful than the other magnet, as well as being bi-polar.  

The results from the genuine Bioflow CRP bracelets were similar to those found in trials on typical drugs used for arthritis pain relief, but without showing the side effects normally found with drugs.  The UK Arthritis Research Campaign, which commissioned and funded the study, said about the Bioflow CRP bracelets studied:

“Results appear to show that magnets do reduce pain in people with hip and knee osteoarthritis, although it is still unclear how.  As they are quite cheap and safe, people with osteoarthritis might want to consider wearing them as part of their self-help regime”.


You can find the abstract of the report on the BMJ’s website (subscription for full report) or at the NCIB website in full.

Is the trial valid?

The researchers took extraordinary pains to make the trial valid.  Neither the participants nor the medical staff knew who had which kind of bracelet.  The participants were aged from 45-80 (when arthritis is most common), of both sexes and had no previous familiarity with magnetic bracelets.  144 other volunteers did not satisfy the strict criteria. The 194 finally participating are enough to ensure that the results are unlikely to be more that slightly wrong just by chance.  

Compliance with instructions was unusually high, with most participants wearing their bracelet 24-7. Before the trial, samples of the bracelets were tested by the National Physical Laboratory and found to be to specification, and afterwards the bracelets were recalled and checked.  Each participant was questioned afterwards to find whether they had discovered anything which would disqualify them—only one had. Every likely anomaly was looked for and checked, and no significant problems were found.  So we have to conclude that if the trial was run again, say in a different area than Devon, similar results would almost certainly be found.  It’s a valid trial.

So what can we conclude?

In  this study and others which had a successful conclusion, the key to getting good pain relief seems to be using very strong magnets and having both poles against the skin alongside each other - called bipolar or flux changing.  (This bipolar effect appears to make less difference over ordinary strong magnets when treating skin lesions and ulcers, where the area to be treated is at the skin surface, not below it.)

Also, for most causes of pain the stronger the magnet, the better the results seem to be. It does seem that the closer the treatment system gets to electromagnotherapy in hospitals, the better the results—which makes sense, I suppose.  Which must be why the Bioflow CRP system, with its deliberate mimicry of hospital equipment in flux changing and power, seems to do so well.

The future

It’s early days yet.  Much more research is needed, especially into how it all works.  

One of the problems in trialling magnetic therapy is staying objective.  A key difficulty in any double-blind trial is preventing both the patient and the researcher from knowing whether the patient is using the placebo or the real thing.  When the appliance is a powerful magnet, it’s all too easy to find out accidentally!  

One significance of the Peninsula Bioflow trial was that the researchers used a weaker plain magnet (not bipolar) as one of the placebos, based on previous research showing that ordinary wristband magnets have never been shown clinically to be effective.  So finding out that the placebo magnet in the wristband actually was a magnet did not nullify the trial.  None of the trial’s participants discovered that they were wearing a different magnet in a Bioflow case, so the trial was valid.

Where now?  We need more trials like that on the Bioflow CRP System, to find out just how effective static magnets are on different conditions.  Also, and especially, we need to see clear evidence from modern trials on the ordinary magnets used by most suppliers.  And we need some fundamental research, to find out why magnetic therapy works at all.  I have my own ideas, from my reading and from observation, but that isn’t evidence; it’s informed speculation.

The big question is: who will pay for such research and trials? Certainly not the drug multinationals who fund most medical research.  Full medical trials are very expensive — it costs several million dollars to do the early trials on a new drug and although magnotherapy doesn’t need to undergo such rigorous contraindication testing (it’s well-proven as harmless), full trials will still cost more than anyone can afford to pay except for international pharmaceutical companies. I’ve heard that the charity-funded Peninsula trial cost over £87,000, even with most of the staff involved giving their time for free, which they certainly would not in commercial trials!

Meanwhile, and until more trials are completed, one system at last has some medical backing: the Bioflow CRP wristband.

Misapplication and Fakery

The problem is, most other magnetic wristband sellers are claiming that the trial results apply to their products, too — in the face of plenty of evidence that it just isn’t so.  They make two claims, usually implicit rather than stated outright:

  1. The kind of bracelet called in the trial the ‘standard bracelet’ is the same as their own product, or
  2. Their product has the same or greater magnetic flux than the ‘standard bracelet’.  

The ‘standard bracelet’ is a Bioflow Classic.  It has the flux changing effect of a bipolar design and a vast magnet 15-30 times the size and power of the magnets in nearly all other products.  So if you see a claim that a bracelet, strap, mattress or any other magnetic appliance is proven by medical trial, look for the evidence that these conditions apply.  You may see a claim that the magnet matches the power of the trial magnet—ask whether the power was actually measured at the wrist, as the trial did, or quoted as a magnet supplier’s best figure of internal flux.  It’s not at all the same!  And if their magnets aren’t placing both north and south poles of a very powerful magnet close together on your wrist, the trial results don’t apply to their product.  It would need a different trial to see whether their own system worked, and in many such trials researchers have never achieved positive results.

Unfortunately, the medical team, by research convention, didn’t name the brand being tested and despite showing a diagram of the CRP’s unique field pattern and quoting Ecoflow (the maker’s name then) as the first reference, they left it open for spurious claims to look true at a quick glance.  And people do tend to believe what they’re told if it’s in print, don’t they?

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