Journal of Advanced Practice Nursing
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What Nurses Should Know About Low T, Chelation, and Integrative Medicine

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By John Watson

In the age of fake news, illicit Internet pharmacies, and proposed rollbacks to healthcare regulations, it is perhaps not surprising that clinics offering unsubstantiated or poorly administered medical treatments seem to be on the rise.

Integrative Medicine Storms Academia's Ivory Tower

For many of the physician contributors to the blog Science-Based Medicine (SBM), which takes aim at unfounded medical practices and beliefs, the continued rise of integrative medicine (IM) represents one of the most exasperating trends in contemporary healthcare. IM is roughly defined as the combining of conventional and what used to be called complementary and alternative medicine (CAM), though there is wide variability in that definition.

"Some clinics just offer acupuncture, for example, and others offer the complete buffet dinner of nonsense," said SBM contributor Mark A. Crislip, MD, an infectious disease specialist in Portland, Oregon. "Their defining characteristic is pseudomedicine and -science."

SBM's managing editor, David H. Gorski, professor of surgery and oncology at the Wayne State University School of Medicine in Detroit, Michigan, suggested that IM misleads by building upon established health practices.

"Integrative medicine is very good at co-opting certain science-based modalities, such as nutrition, exercise, and lifestyle changes, which they identify as somehow being alternative or integrative, when in reality it's just medicine," he said.

From this relatively straightforward foundation, IM incorporates a host of other therapies of decidedly unclear scientific value, such as reiki, homeopathy, and reflexology. Because these unproven therapies are placed alongside established health interventions, critics argue, patients are led to believe that the entirety of what IM offers is valid.

Critics of IM see its embrace by institutional academic health as purely economically motivated. Estimates from a decade ago were that US adults spent nearly $34 billion annually out of pocket on CAM, numbers that are surely higher in today's environment where these practices have become even more mainstream.

To IM proponents who state that even if these therapies haven't shown overwhelming efficacy in randomized trials, patients nonetheless physically benefit via a sort of placebo effect that enhances relaxation and improves state of mind, Dr Crislip offers a stiff rejoinder.

"When you offer worthless therapies for money, that's fraud in the real world," he said. "Fortune tellers convicted of defrauding people of their money because they're possessed by evil demons just have to open an integrative medicine clinic and cruise. They'll never get punished."

Chelation's Unlikely Institutional Support

In the 1950s, chelation therapy (the process by which heavy metals are removed from the blood) began to be used by some to treat atherosclerotic disease. Then considered an alternative treatment, it arguably breached the mainstream when the $30 million Trial to Assess Chelation Therapy (TACT) was funded by the National Center for Complementary and Integrative Health at the National Institutes of Health (NIH).

TACT was initially mired in controversy due to allegations of impropriety with the patient-consent process,. When the results were eventually published, they attributed chelation therapy using ethylene diamine tetra-acetic acid to a modest reduction in the risk for cardiovascular problems in patients with a history of myocardial infarction. Critics have catalogued a host of potential flaws with TACT's design and accused it of spinning a negative result into a positive one.

"There's the naturopath use of chelation therapy, where they often claim that many diseases or chronic illnesses are due to undefined toxins that are heavy metals," Dr Gorski said. "Never mind that it can be potentially dangerous. It can cause hypocalcemia or hypomagnesemia and also cause death due to cardiac arrest, including in one 5-year-old child who was being treated for autism back in 2005. Basically, it's all risk and no benefit."

Criticism of chelation's institutional support looks unlikely to die down any time soon, as this past fall it was announced that the NIH is funding a $37 million TACT follow-up study in diabetics with cardiovascular disease.

"Low T" Brings High Returns

The FDA approves testosterone replacement only for men who have low testosterone from disorders of the testicles, pituitary gland, or brain that cause hypogonadism. However, critics argue that the pervasive direct-to-consumer "low T" advertising campaign has taken advantage of disease-mongering to extend treatment indications to often ambiguous symptoms associated with the normal aging process, such as decreased sense of vigor.

"The advertisers are doing their job -- increasing sales by distortion of the truth without actually lying, but exaggerating, overemphasizing, or highlighting the connection between hypogonadism and vague symptoms," said Bradley D. Anawalt, MD, chief of medicine at the University of Washington Medical Center, Seattle, and an expert in male reproductive endocrinology.

It's been a successful strategy. In the last decade, prescriptions for testosterone have increased by 10- and 40-fold in the United States and Canada, respectively, with annual US sales alone now thought to exceed $2 billion. As testosterone replacement clinics are often cash operations in which it is difficult to track sales, these numbers may underestimate the true scale of the rise.

"They have also reduced hypogonadism to a diagnosis made by a blood test alone; that is incorrect," said Dr Anawalt. "Male hypogonadism is defined by specific symptoms and/or signs (objective findings) of male hypogonadism, plus a low blood testosterone concentration measured on at least two occasions in the early morning (7-10 AM) with an accurate blood test."

Patients seeking out these clinics run the risk of being treated by practitioners who may not have the experience or interest to diagnose the true underlying causes of their symptoms, which may include depression, diabetes, or other common chronic diseases. Testosterone therapy has also been linked with an increased risk for venous thromboembolism and myocardial infarction, among other adverse outcomes.

"It is helpful for men to know that daily exercise has many of the same benefits that are being advertised about testosterone therapy for 'low T,' including increased muscle and leanness, improved bone mass and strength, and for some men there is improved sexual function," Dr Anawalt said.



 
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