Monday, February 19, 2007

When Is A Trial Not A Trial - 1

EoR has been hearing advertisements on commercial radio calling for volunteers for "clinical trial seven six eleven" being run by John Charlick. Listeners are warned about "heart attacks" and "breathlessness" due to diabetes 2. Someone claims he lost weight and "got his life back". Listeners are then urged to telephone "to take part" in the trial with a promise of "no drugs, no side effects and great results!". That last claim seems very strange for a trial - the purpose of a trial is to determine whether there are any side effects, and what results, if any, are achieved. On further investigation, it seems to be another magic machine that can cure a huge range of diseases. You only become part of a "trial" in the sense that you're using a device that has no proof that it works.

Now, before you go clicking on links to visit that site, be aware that most pages include this statement:

By reading this page, you agree to the terms of our Website Usage Agreement.

Of course, to know about that, you've already read the webpage and consequently agreed to this bizarre agreement:

If you choose to read the contents of this web site or to subscribe to this site, you agree that the entire contents of this web site are owned by Biological Control Systems Pty Ltd (ABN 009 297 830) and are not for copying, resale, distribution or representation to any third party. You agree the web site contents represents the opinions of individuals provided in open conversation and should not be relied upon to make scientific, medical, legal or purchase related decisions or judgments and you agree to make your own investigations as to the true facts of the matter. You agree that the information on this site does not represent the view or beliefs of MEDEC Australasia, MEDEC Systems International or its distributors. You agree to receive information by email which is also subject to these conditions. You can unsubscribe at any time but will not have full site access or emails sent to you. If you unsubscribe at any time you agree that this agreement remains in force ad infinitum.

So, you've agreed to enthrall yourself to Biological Control Systems Pty Ltd for all eternity. You've also agreed not to "represent" this site to anyone else. Eor is boldy defying that requirement by even discussing the site here or, even worse, including excerpts for your reading (which, of course, is legally allowable under fair use provisions). He seriously doubts that any court is going to approve of such a contract in perpetuity enforced by one party only. He will, however, satisfy the injunction to "make your own investigations". That should keep them happy.

Even worse, there's that "agreement" that you accept that there is nothing scientific on the site, that it is all opinion and, even worse, it doesn't even represent the "views or beliefs" of the company. Nor should it be used "to make scientific, medical, legal or purchase related decisions or judgments". Which sits rather strangely on a site purporting to provide scientific, medical, legal and purchase related information. In other words, you should ignore everything on the website, presumably.

For a site that is so relentlessly "scientific" with all its supposed studies and proof, that's a worry.

So how does the PERT machine work? Well, it's based on the Chinese view of energy (don't bother clicking on the link, even though the site doesn't appear to have been updated since 2004 that page is devoid of content and "under construction"). You might wonder How PERT works? (nothing - page under construction). It has something to do with energy and human body (nothing - page under construction). It's due to the invisible energy (invisible page under construction!). So why do we need to use PERT? (nothing - page under construction).

Luckily, one of the pages provides a bit more information (and it's full of graphs and scientificky-looking things too! Cool!):

How does it work?

Well, when I lie on the mat, it gives me about half a watt of energy increase each time I lie on the mat. This happens for the first 60 days so, and so therefore I gained approximately 30 watts of internal or biological energy. This is the energy that makes us live; it's the organs, the blood, the nervous system. It's this energy which is the fundamental difference between the energy and rejuvenation of a young child and that of myself or someone older. Aging is a decrease in the person's energy, and this causes less healing and less health, and virtually all the symptoms and illnesses of aging caused by this.

Now, in giving me more energy, PERT increased the dissolved oxygen in my blood. It also increased my hemoglobin, the blood circulation and the lymphatic fluid, also known as interstitial fluid, was also increased in circulation. That's the liquid you get when you have swollen legs and limbs, such as in old age or sometimes in cancer therapy when the lymph glands are removed. So my body is humming, it's feeling better, and it works better.

There are even graphs on the page proving that your internal batteries lose power as you age, and so you get sicker and eventually die when the lights flicker and go out. If you haven't got the right wattage to fend off various illnesses (they appear to have different levels) then you will succumb to that illness. Why, however, does the graph that shows male and female energies (male energies are higher than female, for some unexplained reason), both fall to zero (presumably, this is the "energy" equivalent of death in old age) at exactly the same point? Where were these data points obtained? By what measuring method? Females, on average, live longer than males. But not according to this graph. Or maybe they just go on for longer with zero invisible Chinese "biological energy"?

How do we know that this is real science, and not just another woo machine that measures amazingly improbable things and delivers it with a hefty dose of woo-filled spin?

The interpretation given to me was supplied by accredited PERT medical personnel. These are usually medically qualified people who understand and have practiced the PERT system. So from my readout, generally it is very good and I have the energy of a 30 year old, but I have a little bit of an issue with my stomach. This may be an infection of some sort, so I have had some tests done.

Yes: the magic mat works because the magic measuring machine says so. It doesn't just measure known physical concepts like electricity, it can also measure invisible, unknown energies as well:

Another graph that is produced by the Biograph is this one. It's a correlations graph. Looking at the first bar chart, this is Yin, which is female, and Yang, which is male. Ideally they should meet at the 50% region here. Because I have an excess of Yang, which is male, that might indicate that I am too stressed or too angry or too male about life and I need to do something to bring that back to balance.

"Half a watt of energy increase" (or any other amount) is also a meaningless statement, since Watts are not a measure of energy (real, or the "woo" energy that these devices supposedly measure) but are a measure of power. P=W/t (power is the time rate of doing work, P=power, W=work, t=time). An interesting discussion about how many watts the human body uses is available at Physics Forums. As this page makes clear, the harder you work (cycling harder, running up stairs) the more power you use. Mr Charlick could presumably extend his power reserves and his life indefinitely if he lies very very still on his magic mat and never moves.

EoR also wonders why you can't just recharge your batteries by sticking your fingers in a light socket? Wouldn't that cure all diseases? Immediately. It would certainly give you an instant energy boost.

There's also a published Bulgarian study of Therapeutic efficiency of pulsating energy resonance therapy (PERT) in patients with vertebral diseases. The study is fairly low grade in terms of rigourousness. There were only 42 patients. These were further subdivided into three groups. There were only 10 controls in total. One of the subgroups only had one control! The study was not double-blind (the operators knew whether the machine was on or not).

There are a lot of graphs of how effective PERT was, but these really don't show anything clear at all. Some seem to indicate a greater affect above placebo than others, but all show a range of values for PERT at each data point (only three data points are shown). No range is shown for the placebo response. If the range for that is also assumed to be similar, then the results for PERT and placebo are pretty much the same in all cases.

For someone who has conducted over 3000 "trials" with his "Space therapy" that mimics "exercise and acupuncture", there are only 36 case histories on the website, even though the site assures us that all reports are online. Some of these case histories are from people who may be considered to have a vested interest in the product (John Charlick, Ivor Charlick, Julia Charlick, and Michael Nobbs). Some of these case histories also indicate that the PERT machine does not deliver any benefit, such as the case of Lewis Lowther:

At the time of writing Lewis has declined to continue to use PERT due to the cost and lack of clinical improvement over the 12 weeks Trial.

It's an interesting trial where the participants are made to pay to take part.

Sometimes, the machine doesn't work because you're already 100% healthy (if it doesn't work, it's classed as a "side effect"!):

On few occasions PERT may not stir a response at all from the individual. This though is a very rare occurance as for nothing to happen, the person using PERT is presumably 100% healthy and functioning at its peak. Unfortunately there are not more examples of ths happening, as if there were it would mean that there was a larger percentage of the population out there that are as healthy as physically possible.

EoR finds the clumsy grammar of that statement heavy going, but it seems to be saying that if more people are healthy the percentage of healthy people is higher. Or something.

There are some wonderful stories on the site (though they are anecdotal, thirdhand or self-reported, rather than clinical trials). For example, the young man with Susac Syndrome for which the doctors sent him home to die (as doctors seem so prone to do with virtually all diseases), until his community banded together to get a PERT machine which miraculously cured him completely. Further information about Susac Syndrome points out:

The symptoms appear to remain stable (monophasic) with little or no progression. The syndrome is thought self-limiting; that is, improvement is spontaneous although in some cases there may be residual dysfunction.

The report is very unclear, but it appears that the patient was also on anti-inflammatories. Whether either of these, or neither of them, resulted in the resolution is unproven. Nonetheless, the reporter (an attendee at a PERT seminar) praised the machine as the source of the cure.

Also unclear is the reference to the community banding together to support the cost of his treatment: "one million dollars". Is that the cost of the PERT machine? One million dollars for anti-inflammatories seems unlikely. No prices for the miracle machine appear on the website.

EoR found a total of zero records at PubMed for "pulsating energy resonance therapy".

Mr Charlick also appears at Conscious Living seeking participants for his trial, which is described, twice, as "complimentary". EoR suspects that is a lie.

Mr Charlick also runs Biological Control Systems which appears to be an air conditioning cleaning company, though "We are looking to leave this lucrative part of our business to concentrate on a reduced number of core activities". EoR is always suspicious when someone wants to get rid of something "lucrative".

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