The web site “The Thinking Mom’s Revolution” (TMR) has partnered with a company known as AMD (A Major Difference). AMD is the seller of an ionic foot bath called the Ion Cleanse® and according to the company’s marketing, this foot bath has the ability to improve the symptoms and/or behavior of children with autism. The basic model is currently available for the price of $1,995.00 USD.
In partnership with TMR, AMD has conducted a study with the goal of investigating the effect of using the Ion Cleanse® on the severity of symptoms of children with autism. Rather than submitting this study to a peer-reviewed journal, the study has been posted on the TMR blog. I will leave it to you to figure out why.
The foot bath operates with the help of a power supply which produces a small potential difference across the water in the bath and this difference induces a small electrical current. According to AMD, this current results in the excretion of “toxins” from the body through the feet of the subject. After a certain period of time, the water in the bath changes color and many foot bath advocates argue that this change in color is a result of the excreted “toxins.” The amount of time spent with feet in the bath can vary, but the company recommends no longer than 45 minutes for children.
Before I get into the details of the study, it is worth noting that there is currently no plausible evidence or explanation, be it based in chemistry or human physiology, for why placing one’s feet in a foot bath with a small electric current would cause the excretion of toxic substances through the skin of the feet.
On its web site, AMD provides some “research” materials which include a document from their “lead engineer” describing how the foot bath supposedly works. The document itself is thin on details and draws from chemistry and science textbooks. Essentially, they describe the chemical reactions that result when an electric current is placed in water. This current results in small changes to the water’s pH, which as scientists know is a measure of how acidic or alkaline the water is. The pH can be any value between 0 and 14, where 7 indicates a neutral solution, anything lower than 7 indicates an acidic solution and anything above 7 indicates a basic (alkaline) solution. It seems that the company’s rationale for how the foot bath works is that placing one’s feet in a more alkaline solution (higher pH) will result in diffusion (movement) of some molecules across the skin of the feet, which draws out the so called toxins. As mentioned previously, there is no evidence to show that this is true. However if it were true, there are still many unanswered questions. Why would this process cause the excretion of bad molecules and not good ones? Secondly, as explained in the document, they ran the foot bath for 15 minutes and measured the pH at different times to see how the pH changed. At the start of the experiment, they measured a pH of 7.3. At the end of the 15 minutes, the pH was 7.7. To be fair, they ran the foot bath in opposite polarity for 30% to show that the pH would go down. Based on this, let’s assume that had it been running with the same polarity for the entire 15 minutes that the resulting pH would be 7.9. So in 15 minutes, the electric current increased the pH of the water by 0.6. If we extrapolate out to 45 minutes (and generously assume that the increase is always linear), then the pH after this time would increase by 1.8 for a final value of 9.1. Now what happens if the operator begins with water that has a pH of 6? After 45 minutes, the pH would be 7.8. None of this is terribly impressive when you consider that the pH of normal water can be anywhere between 6 and 8.5. To illustrate how unimpressive this is, here is a visual:
If AMD’s explanation were true, then it would follow that one could just go swimming in a pool of water that has a high pH and see even more dramatic removal of “toxins” and other molecules from the body, given that the amount of diffusion would be proportional to the surface area of skin exposed to the water. The document also goes on to define diffusion, rate of diffusion and osmosis, but there is no evidence or explanation as to how this applies to the foot bath. I don’t know why they bothered including these; they essentially just regurgitated the textbook definitions. My guess is that they wanted some sort of sciencey-sounding explanation that would convince laypeople that there is a scientific justification for how the bath works.
There is also no evidence that removing “toxins” from the body has any benefit for people with autism. I could go on, but the point is that even if AMD’s explanation was true, there would be a host of other inconsistencies in the basic science of how the foot bath supposedly improves symptoms of autism.
For the sake of argument, let’s assume that there may be some unknown mechanism by which the foot bath can improve the symptoms of autism by considering the study conducted by AMD and TMR.
The study involved one group of 24 children (28 initially, 4 dropped out). The children underwent “cleansing” sessions with the foot bath for at least 15 minutes every other day. The severity of symptoms throughout the study was assessed by having parents fill out an ATEC survey at the beginning of the study, at 30 days, 60 days, 90 days, and 120 days. The ATEC is a survey that is used to track the effects of treatment by going through a checklist of different behaviors and indicating whether they are present. A lower score indicates fewer symptoms.
There is a clear reduction in ATEC scores across the majority of the participants after 30 days of using the foot bath. Therefore, the foot bath must be the cause, right? Unfortunately, it is not so simple.
When parents are observing symptoms in their children and they know that their children are undergoing an intervention, it is natural that they will be more inclined to look for improvements. Given this, it is difficult to determine whether the reported improvement is really due to the intervention or due to parents’ optimism. This is especially so when parents fill out the ATEC both before and after the intervention. They are also astutely aware of how their child performed on the initial assessment, making it less likely for a negative outcome to be reported. This is analogous to the fish oil experiment explained by Ben Goldacre at 5:25 of this TED Talk:
Secondly, some high functioning children with autism eventually lose their diagnosis as they age. There is no way to account for any natural improvement in this study.
Finally, the study does not account for any variation that may be due to the limitations of the ATEC study itself. It is easy to see how some of the criteria on the ATEC survey might be vulnerable to variations over time, depending on the mood of the child. It’s also evident that some points are quite subjective. For example, here are some ATEC criteria that may be open to interpretation or vary depending on mood:
- Can follow some commands
- Asks meaningful questions
- Ignores other people
- Uncooperative and resistant
- Prefers to be left alone
- Shows no affection
- Indifferent to being liked
- Indifferent if parent(s) leave
This is not to say that the ATEC test is not useful. It is extremely difficult to accurately and consistently compare symptoms of ASD over many subjects.
The point is that all of the issues mentioned above could have been largely addressed if there was a control group to compare to. Give another group of children a placebo foot bath with Ion Cleanse branding and have parents report the symptoms. In this case, if there really is improvement that is due to the foot bath, it would be observed in the foot bath group and not the control group.
I found another study in the literature, not funded by AMD, that investigated if the foot bath had any effect on the levels of toxic metals in the body. The conclusion:
we found no evidence to suggest that ionic footbaths help promote the elimination of toxic elements from the body through the feet, urine, or hair.
It is obvious that there is astronomical doubt as to the ability of the foot bath to improve symptoms of ASD given the available evidence and the fact that there is no plausible scientific explanation for how it works.
Out of curiosity, I joined the Ion Cleanse Facebook page. The page is full of Ion Cleanse users posting pictures of their foot baths after their sessions. Others jump in to speculate as to the contents of the colored water, even though the color is due to the chemical reaction of the foot bath components in the water and nothing to do with an actual detox.
In the group, it was announced that AMD is doing another study with TMR looking at the Ion Cleanse’s effect on ATEC scores. As far as I could tell, this second study has the exact same design as the one discussed above. I have no idea why they would bother doing a second study with the same design instead of just doing one study that has a control group… I will leave the guessing to you.
I decided to chime in:
One of the page admins replied, and based on their comment I can only assume they were an employee of AMD:
I then pointed out that a money-back guarantee does not account for a placebo effect. For example, if the observed improvement is actually due to parents’ optimism and not due to the foot bath, is it really ethical to charge parents $2,000+ for a placebo? After raising this ethical question, I was banned from the group. (Sadly, I was banned before nabbing screen shots of the rest of the conversation) I suppose they took my question as an implication that they were taking advantage of desperate parents of children with autism.
This is certainly a legitimate question. When searching for the Ion Cleanse on Google, there is an ad proudly proclaiming that over 11,000 units have been sold. At $2,000+ a pop, that is at least 22 million dollars charged to parents for an unproven device with no scientific plausibility.
A very legitimate question indeed…