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Testosterone Replacement Therapy
Off-Label Prescriptions and Alternative Treatments

Are you taking questionable treatments?
Are you taking questionable treatments?

In an article about alternative medicine, Dr. James Hamblin of Atlantic Magazine said this. "...there are really only three kinds of medicine: medicine that is proven to work, medicine that is proven not to work, and medicine that has not been conclusively studied."

The same can be said for supplements and treatments used by the health and fitness community. Some things have been proven to work, some are worthless and a whole lot of stuff hasn't been conclusively studied.

So what happens when you have a product that's been extensively studied for one thing, but promoted to the world for something else? When you're talking about pharmaceutical drugs, it's called "off-label use." That's when a drug officially tested and approved, is prescribed by a physician to an unapproved age group, in unapproved dosages or to treat a disease or condition that wasn't part of the drug approval study.

Off-label use is generally legal, but there are health risks involved for the patient and potential legal risks for the doctor. One of the more famous cases of off-label use were the drugs fenfluramine and phentermine. Prescribed together, they were known as fen-phen and doctors promoted their use as a way to lose weight.

The doctors were right. The two drugs taken together did help people lose weight. What the doctors didn't know what that they also caused potentially fatal pulmonary hypertension and heart valve problems. The deadly side effects were only revealed years after the drug combination had become wildly successful in off-label prescriptions. Thousands of people were harmed, many died and the drug company Wyeth paid over $13 billion in damages.

In the health and fitness world there are dozens of "off-label" prescriptions being promoted, many with potential side effects as bad or worse than fen-phen. One of the more prominent are treatments for low testosterone. With the arrival of gels that are easy to apply, doctors have been prescribing testosterone replacement for a wide range of symptoms including low energy, fatigue, depression, erectile dysfunction, bone loss and a reduced libido.

Clinic's promoting "Low-T Treatments" run ads that imply a little testosterone will make a 60 year old man look and feel like a 30 year old. The reality is that as of 2014, researchers have not been able to definitively link low testosterone levels to mood, low physical vigor or fatigue.

More troubling are the potential risks. In 2009 a trial called Testosterone in Older Men with Mobility Limitations was abruptly halted because of potential cardiovascular events. 209 men were in the study, with approximately half receiving testosterone and half getting a placebo. An astonishing twenty-three men receiving testosterone suffered a heart attack or stroke, compared to only five in the control group.

Those results are reminiscent of what happened with hormone replacement therapy for post-menopausal women. Doctors originally believe that taking estrogen and progestin would reduce the risk of heart disease and millions of women were prescribed the treatment. However, in 2004 after the completion of a massive study into the therapy, researchers discovered hormone replacement therapy actually does more harm than good for the majority of women over the long term.

That doesn't mean there aren't women who benefit, but it's a much smaller group than originally thought.

Heart attacks and stroke aren't the only concern. Testosterone therapy may also increase the risks of prostate cancer. Treatment for advanced prostate cancer involves starving the body of testosterone, so it's believed increasing those levels may fuel tumor growth.

According to The Endocrine Society, men should only be prescribed testosterone after two consecutive blood tests that confirm "unequivocally low serum testosterone levels." Currently it's estimated between 25 and 40 percent of patients receiving testosterone replacement therapy were never given a blood test. With the rise of Low-T and Anti-aging clinics, many physicians seem more concerned with the promise of profits than the benefit to their patients.

Ignore the marketing hype. Before starting something like testosterone replacement therapy, make sure you have a clinical (and blood test verified) diagnosis that confirms your need.

UPDATE: 9/15/2015

There's a remarkably simple reason why many men have low testosterone levels; too much fat. The fat cells in a man's belly convert testosterone into estrogen. The more fat cells, the greater the rate of conversion.

In the European Male Aging Study they found that three out of four men with low testosterone were overweight. The more overweight you are, the more likely you are to have low testosterone.

Want to increase your levels of testosterone? Drop some of the fat you're carrying around.

UPDATE: 5/24/2017

In the February 21st, 2017 issue of JAMA and JAMA Internal Medicine the results of several testosterone studies were published. Here’s what they found.

Testosterone did NOT improve memory or cognitive function in men who suffered cognitive impairment. It also did NOT improve overall vitality or physical function.

Testosterone DID increase hemoglobin levels and corrected anemia in 126 of the anemic men. It was also associated with increases in bone density and strength.

To see the benefits, researchers said treatment should be considered for men with levels below 320 ng/dl. Follow up is critical and patients should be retested every 6 months to see if the therapy is improving or sustaining the appropriate levels.

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10/5/2014
Updated 9/15/2015
Updated 5/24/2017