Food allergies affect about 32 million people in the US alone. They can be a significant burden on quality of life and carry the risk of anaphylaxis, which can be fatal if not treated promptly. Living in fear of a deadly reaction results in significant anxiety, and requires vigilant avoidance which is disruptive to social behavior.
The standard management of food allergies is identification of the specific foods that trigger a reaction, avoidance of those foods, and education into the emergency use of epinephrine injections (epi-pens). Gradual desensitization is also a treatment option, either with injection or oral consumption of gradually-increasing doses of the allergen (oral immunotherapy, OIT). Most allergic responses are due to sensitivity of the IgE antibodies. Desensitization works by building IgG antibodies to the offending allergen, which neutralizes the allergen before a significant IgE response can occur. There are some risks to this approach, and it should only be performed under the supervision of a trained clinician.
Still there is a large unmet need in terms of effective cures for food allergies that allow people to live a normal life without fear of a deadly allergic reaction to a common food. Just as nature abhors a vacuum, unmet medical needs attract enthusiastic but dubious gurus and practitioners. One such dubious treatment is the Allergy Release Technique (ART), which was invented by Amy Thieringer, a certified health and life coach. She promotes the treatment as “holistic” but it is really just a repackaging of real treatments with a garnish of worthless pseudoscience.
She also promotes her treatment by referring to a recent clinical study:
Boston Children’s Hospital and Boston University have published a collaborative pilot study in The Journal of Alternative and Integrative Medicine on the A.R.T. process, which clinically validates the transformative results of Amy’s work.
Except that it doesn’t. Let’s take a look at that study, which unfortunately follows an all-too-familiar pattern. To call this a “pilot” study is being generous. The study looks at 20 subjects total, 10 receiving ART and 10 receiving standard medical care. The study is also retrospective, and potential clients were contacted by e-mail, letters, or phone. This isn’t even a sequential case series – subjects were self-selected. The authors acknowledge:
…this was not a randomized prospective study so some families who opted to participate in ART might differ in motivation or other variables that might affect allergy progression…Finally, ART was delivered by an experienced provider who may have developed special rapport with participants, perhaps affecting outcomes.
I wonder if having a “health coach” as a cheerleader affected the outcome. The standard management in this study involved diagnosis, avoidance, and education without any medical intervention designed to reduce the allergic response. The ART intervention group involved desensitization to minute and gradually increasing amount of food allergen. Wait a minute – that’s OIT. That is an evidence-based intervention shown to decrease allergic response. But it was combined with cognitive behavioral therapy (CBT) to reduce anxiety. That is a second evidence-based already established intervention. So what’s new?
Each week, using a galvanometer device (Bioscan system, International Health Technologies) with accompanying software (Bioscan MSA 141) to measure the electrical resistance between one of two acupuncture points on the fingers of one hand (in Chinese acupuncture, points Nervous system NE-1b* and Allergy (upper toxicity), AL-1b*) and an electrode held in the other hand (skin conductance) when allergens are placed on a metal plate on the galvanometer or highlighted in the software library.
Tapping up and down the patient’s spine after allergen or electromagnetic exposures, using the side of the practitioner’s hand while patients take deep, slow inhalations and exhalations.
This is worthless medical theater. So we have two proven interventions one quack intervention and one magic theater. I wonder which components of this intervention had any effect. The study results, as worthless as they are given the severe limitations mentioned above, were also not impressive. The only real significant finding was that the SPT wheal diameter (size of the skin reaction after a prick test with the allergen) was decreased in the treatment group compared to standard care. However, SIgE and TIgE antibody titers were not different between the two groups. Anxiety levels were also not different, but reported quality of life was improved in the ART group. This mixed outcome is common when investigating essentially useless interventions.
This small retrospective study proves absolutely nothing. I would not even use it as evidence of safety, given the self-selective nature of the recruitment process. There were no food challenges in the standard treatment group, and no records of allergic reactions during the study duration of four years. The authors further acknowledge:
However, additional investigation is necessary to confirm these advantages and to understand the immunologic mechanisms, including which of the ART components are driving the effects.
But do we really? I think we can guess which of the ART components are driving the effects (if they are even real). Is it what amounts to a version of oral immunotherapy (a proven treatment), or the tapping along the spine?
I have no problem studying fringe treatments, but the medially trained authors on this study are being naïve. A pilot study should be used solely to get an idea of safety and help design studies that are rigorous and powerful enough to draw actual conclusions regarding safety and efficacy. But that is not what happens in the alternative medicine world. Rather, pilot studies like this, which are almost guaranteed to be positive, or are misinterpreted as positive, are used for promotion. The later more rigorous studies generally are never done. If they are, and they are almost always negative, the results are ignored and believers move on to less rigorous “pragmatic studies” that show what they want. Studies like this are not used to determine “if” a treatment works, only for promotion. That is what is happening here.
The authors conclude:
The efficacy and effectiveness of ART should continue to be investigated using larger samples, a prospective design, disaggregating individual ART components, and comparing ART to OIT.
I do not see any trials registered in clinicaltrials.gov to perform an actual clinical trial as above (this study was published in 2019). I have contacted one of the authors to inquire about any future plans for study without any response yet (I will add an addendum if they respond). Meanwhile desperate parents and children will continue to pay for a dubious treatment requiring weekly visits for two years or more, with the disclaimer:
As you consider the A.R.T. process, it is important to understand that successful outcomes are only possible with clients who are committed, active participants.
It’s always good to build in an excuse blaming the patient when a treatment does not work as hoped. This should not be considered a benign intervention. The authors also made pains to point out that OIT should not be administered by someone who is not qualified, and that ART does not follow standard safety protocol for OIT.