The realm of personalized medicine, functional medicine, and of course integrative medicine remains rife with pseudoscience and dubious claims. The claims are often couched in scientific terms, as if this is the next step in scientific medicine, just a bit ahead of its time. This is particularly dangerous, as non-experts will have difficulty parsing the often complex claims being made. This is why it is often necessary for expert communities to regulate themselves to ensure some standard of quality – something that has been eroding within medicine for decades, under relentless and successful assault by the overall CAM community.
One practice that, in my opinion, is a good example of this phenomenon is in-office autonomic nervous system (ANS) testing being offered by some practices. ANS testing and diagnosis itself is legitimate, although this is a very complicated area of neurology. “Boutique” versions of many legitimate medical practices have been cropping up, however, such as questionable thyroid testing, fake allergy testing, and other questionable practices.
This particular practice was brought to my attention because of recent local news stories, which were uncritical and essentially amounted to free advertising for the practitioner. But before I get into that, let me give a little background on the ANS and clinical testing in general.
The ANS is part of the nervous system that regulates our overall nervous system activity in specific ways. The sympathetic nervous system reacts to stress or dangers by increasing blood pressure and cardiac function, dilating the pupils, increasing breathing, and increasing sweating. The parasympathetic nervous system is more active when we are in a calm state, and it increases the activity of our gastrointestinal system and glandular secretions while slowing down the heart and reducing blood pressure. These two systems exist in constant balance, adjusting their relative tone moment to moment in order to, for example, maintain a constant blood flow to the brain. It does this by making constant microadjustments in response to changes in position, muscle tone, and even the varying pressures that result from breathing.
Severe disorders of the ANS can result in dramatic symptoms, such as fainting upon standing up because of insufficient sympathetic activity to raise blood pressure to compensate, or severe constipation even to the point of food failing to move through the GI tract. But ANS disorders can also produce more subtle symptoms, such as just feeling dizzy or light-headed, occasional palpitations, or excessive sweating. Diagnosing ANS disorders can be tricky, especially when they are complex or subtle.
Most medical centers will be able to do basic testing. The most common test is a tilt table test, in which blood pressure and heart rate are measured as head position is altered. For more complex testing there are a few autonomic centers in the US (just a few) that can do extensive testing. Even then sometimes the best we can do is document that there is autonomic dysfunction, but may not be able to localize where the problem is coming from. Treatment is mostly symptomatic as most causes of ANS dysfunction are not curable.
If we are going to introduce a new testing method for ANS function (or really anything in medicine) we need to address a few questions. What, exactly, is it measuring, and what is the measured variable a marker for? What is the sensitivity and specificity of the test? And how useful is the information – does it predict the presence of a specific disease or the response to a specific treatment? Research would need to be done to validate any new test with respect to every condition in which it is used.
With that background I read the reporting of Dr. Plotnikoff who is claiming that his ANS testing device is a “gamechanger” for medicine. I could find no published studies by him or his colleagues regarding ANS testing. I was not reassured by his clinic which boasts personalized, functional, and integrative medicine. On his website he specifically claims that people with the following symptoms or disorders will benefit from testing:
Dizziness, Light-headedness, Fainting, Fatigue, Exercise intolerance, Post-exertional fatigue, Chronic pain including firbromyalgia (sic), Persistent, unexplained weight gain, Sleep disturbances of all types, Anxiousness, Heart palpitations, Depressed mood, “Brain fog”, Brain fatigue, Gastrointestinal (GI) symptoms including constipation, nausea, bloating, diarrhea, constipation, and randomly alternating symptoms, Frequent headaches, Falls or near falls, Urogenital dysfunction including urination difficulties and erectile dysfunction, Difficult to diagnose symptoms, Difficult to control blood pressure, diabetes, or hormonal states, Long COVID, Diabetes, Hypertension, Previous heart attack or heart surgery, Postural orthostatic tachycardia syndrome (POTS), Syncope, Anxiety, dysthymia, and/or depression, Neurologic diagnoses including neuropathies, migraines, and/or seizures, Gastroparesis, Traumatic brain injury (TBI), Post-concussion syndrome, Mast Cell Activation Syndrome (MCAS).
That’s a pretty impressive list, especially without any specific scientific research to back it up. The testing itself seems to be just a poor-man’s basic autonomic test, with cardiac monitoring, respiratory monitoring, and blood pressure testing. This might all be useful as part of a basic medical assessment, but claiming that it can diagnose autonomic dysfunction would require some extensive validative testing. The notion that the results of this testing would help, for example, guide treatment of medical entities and distinct as diabetes and seizures is a stretch.
In addition to incredibly overblown claims of using this testing to guide personalize medicine, they also claim that they can diagnose and treat ANS problems directly:
For those with low parasympathetic status (“rest-and-digest”) or excessive sympathetic status (“fight-or-flight”), we provide access to an FDA-approved parasympathetic system activator called GammaCore.
GammaCore is a device used for vagal nerve stimulation. This is a legitimate treatment for very specific conditions, but Plotnikoff’s clinic seems to think it is a panacea for everything listed above. Also, they falsely stated that the device is “FDA-approved”. “Approval” when it comes to the FDA specifically means that it has been tested and found to be both safe and efficacious for a specific disease. That does not appear to be true – the GammaCore website only says that it is “FDA cleared”, which means that the device itself is safe, without any claims for efficacy. This may have been just a sloppy mistake on their part, but it has significant implications. Falsely claiming FDA approval is not a minor thing.
As we can see, they appear to be taking a kernel of real science and medicine but then turning that into a simplified boutique treatment that is good for just about anything, making extremely overblown claims without sufficient evidence, and presenting themselves as the wave of the future. That’s the “functional medicine” marketing BS in a nutshell.