A “clinical trial” of foot bath “detoxification”

A “clinical trial” of foot bath “detoxification”

One of the most reliable indicators of a quack clinic that I know of (besides its offering homeopathy and reiki) is the inclusion of “detox foot bath” treatments on its roster of services. Detox foot baths, whatever the brand, are of a piece with other “detoxification” pseudoscience involving the feet, such as Kinoki foot pads. Basically, the idea is that you can some how remove toxins through the soles of your feet using either a nice mineral bath with a weak electrical current passed through it or a foot pad. Inevitably, nasty looking stuff is seen apparently coming out of the feet. In the case of the foot pads, it’s in the form of some sort of brownish black stuff on the pad; in the case of the footbath, the water turns brown. These color changes are presented as evidence that “toxins” have been pulled from the body through the soles of the feet, and those selling these devices make videos like this:

It’s all utter nonsense, of course. Indeed, “detox” foot pads and foot baths are among the very silliest treatments used in alternative medicine there are. First, the skin on the soles of the feet is thing and relatively impermeable, covered as it is with a layer of cells and keratin. But what about the color change? For the “detox footbath,” that’s easy. As I’ve described on more than one occasion, thanks to the minerals in the water and some basic physics and chemistry of electrolysis that lead to the corrosion of the electrodes, the water will change color whether feet are in the bath or not. Similarly, I’ve described how “detox footpads” turn black when exposed to warm moisture like steam (or like the bottoms of stinky feet). “Foot detox,” whether due to detox foot pads or detox foot baths, are a brilliant scam to bilk the gullible.

No wonder the merry band of antivaccine quacks and propagandists over at that wretched hive of scum and antivaccine quackery Age of Autism like it enough to advertise—get this!—a clinical trial of the IonCleanse System from A Major Difference (AMD). I’ve mentioned this system before and how AMD has jumped feet first (if you’ll excuse the term) into autism quackery. I learned of this “clinical trial” from AoA yesterday in this post about Therapy House LLC Clinical Trial Enrolling Participants in Pittsburgh for IonCleanse. I took a look at the protocol. Let’s just say that it’s not exactly rigorous, as you’ll see. First, however, see the genesis of this study. First AMD brags about having sold over 13,000 units in 39 countries, demonstrating once again that gullibility knows no nationality. Then, we learn:

In December of 2014, AMD was approached by The Thinking Moms’ Revolution to do a parent evaluation of the IonCleanse by AMD as it relates to children with ASD. The first of the 2-part study completed in April of 2015. This evaluation proved enormously successful and has paved the way for a wave of interest in the autism community.

Ah, yes, the Thinking Drinking Moms’ Revolution (TMR), that coffee klatch of affluent suburban women who love wine and quackery (including homeopathy) but really, really hate vaccines. No wonder they like the IonCleanse footbath. Rather amusingly, the “first of the 2-part” study referred to above was not published in anything resembling a peer-reviewed biomedical journal. Rather, it was posted on the TMR blog as The Thinking Moms’ Revolution Study – IonCleanse® by AMD Treatment Effectiveness for ASD.

Basically, from what I can tell, this “part one” was a single arm “study” (I really, really have to use scare quotes, because what TMR posted and a real clinical study are related only by coincidence), unblinded, with repeated measures. There’s nothing resembling a statistical analysis. I was half-tempted to show this post to one of our statisticians at the cancer center, but I decided that I didn’t want to cause harm by inducing relentless, unstoppable laughter that could cause her to pass out, particularly at the part that says:

The efficacy of treatments using ionic detoxification footbath technology has been validated through the TMR-ATEC Survey. Observed results, combined with mathematical analysis, have shown clearly that detoxification is an essential element in the autism recovery process.

And:

These results establish high confidence that continued use of the IonCleanse® Detoxification Footbath System can be used as an effective tool in the treatment of Autism Spectrum Disorder (ASD).

Um, no. It shows nothing of the sort. Moreover, this new study is not likely to show anything of the sort either. For instance:

Of the 30+ participants, 50% will be randomly selected to receive the IonCleanse by AMD sessions, and 50% will be part of the control group that will receive no therapy. Pre and post evaluations will be performed for all 30 participants, and the evaluators will be blind as to which children received treatment and which did not. The parents of the children and the children cannot be blinded as they will observe the water which may change color during actual therapy. The blinding of the evaluators as to the therapy/no therapy should be sufficient to assure a valid conclusion. Each patient will have total of 32 treatments. The pre-evaluation testing will be done within 7 days of beginning therapy and post-evaluation will be completed with 7 days of the last treatment.

After 60 days, success will be considered a significant reduction in ASD symptoms as determined by a repeat of the entry requirements assessment and a comparison of the treated patients to the control patients. For purposes of this study a greater than 25% overall reduction ASD symptoms will be clinically significant.

But how will this be determined? Thusly:

Data from the study will be collected at the study site, and provided to sponsor for data analysis. A simple analysis comparing pre procedure symptoms with post procedure symptoms will be performed, and a statically difference in measurement will be considered a success.

Let’s see. The bit about not being able to blind the parents or children is risible in the extreme, as it would not be that difficult to make a sham device that replicates the color change in the water in the control group. So, no, the blinding of the evaluators as to therapy/no therapy is not sufficient. Moreover, no study would ever pass institutional review board (IRB) muster (at least not with a decent IRB) without a decent plan for statistical analysis. Nothing resembling that exists here. Nor does anything resembling a plan to make sure that the two groups (control and IonCleanse) are comparable in terms of age, autism severity, comorbidities, etc., another very important basic part of any randomized clinical trial because if the groups aren’t comparable biases can creep in and affect the results.

Then there’s the issue of ethics. The common rule and federal regulations regarding the protection of human research subjects emphasize a higher standard to protect vulnerable populations, and children are a vulnerable population, particularly special needs children like autistic children. So what does AMD have to say about this? Not a lot:

The study is considered under FDA regulations as non-significant risk clinical trial. The trail will comply with FDA regulations by having the approval of a qualified Institutional Review Board.

Um, no. You don’t get to choose whether your study is a “non-significant risk” study. As the FDA points out, it is the IRB that determines whether a study is a “non-significant risk” study or not. I suppose I should be happy that this will be approved by an IRB, but given how antivaccine warriors like Mark and David Geier have set up their own IRBs to approve unethical studies, I’d be very interested in knowing what IRB AMD plans on using.

This study is a perfect example of what Harriet Hall likes to refer to as “Tooth Fairy science.” Basically, it’s doing research on a phenomenon before establishing that that phenomenon exists. As she likes to continue the analogy, you can measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can even get all kinds of good data that is reproducible and statistically significant. Yes, you think you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists. In this case, it hasn’t been determined that these foot baths can pull toxins out of the body through the feet; quite the opposite, in fact. It also hasn’t been established that these unnamed “toxins” have anything to do with autism.

As I said early on, one of the surest indicators of quackery in a clinic is its inclusion of something like the IonCleanse foot bath. The purpose of this study isn’t really to determine efficacy or safety of the IonCleanse in treating autism. The design of the study virtually guarantees that it will find a positive result. That’s because it’s a marketing tool to produce more IonCleanse Ambassadors and sell more IonCleanse devices.

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