Testosterone supplementation: Looking at controversial studies

We begin another new year.  Have you started to pursue your dream for this year? If so, are you allowing yourself to feel good while you dream so those exciting ideas can flow to you?

A colleague under my medical direction recently refused to prescribe testosterone therapy because of the large study last year which concluded that it doubles heart attack risk in older men. That intrigued me. After so many years of proven benefits and safety with testosterone, it was suddenly taboo. Or was it? In this article I’ll shed light on the conflicting scientific data and look at some details of that study. In a subsequent article I’ll explain the many benefits of testosterone, the indications for its use, and the parameters for its safe use. Then I’ll cover dosing and methods of administration (not only injections). Finally I’ll go over the tests you’ll need for hormone balancing and some decision-making tips for testosterone replacement therapy.

The testosterone therapy controversy

First let me point out that at the 2013 annual meeting of the Endocrine Society, speakers from the international endocrinology community praised testosterone therapy to mitigate symptoms associated with aging-related declines in male hormones.  Likewise, at the 22nd Annual Congress on Anti-Aging Medicine, sponsored by the American Academy of Anti-Aging Medicine held in December 2013 (which I personally attended), speakers cited overwhelming evidence of the benefits of testosterone therapy in hypogonadism (low blood testosterone levels) and how it reduces the risk of myocardial infarction among other illnesses. For nearly 50 years the medical literature has clearly shown us the beneficial effects of testosterone replacement for millions of males and females.

The controversial study published Jan 29, 2014 in PLOS ONE is entitled, “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men.” Because PLOS (Public Library of Science) ONE is an online peer-reviewed scientific journal with a “publish first, judge/critique later” methodology, once its claim that testosterone therapy doubles heart risk in older men hit the news, it stuck in the minds of most all of us. But is this really true? Were these researchers’ conclusions correct? Now months after it was released to the public scientists have further analyzed it and now see it to be a manipulation of data and not a representation of a causal relationship between testosterone therapy and heart attacks. Let’s look at some details.

According to their report, Finkle, et al examined the health care records of 55,593 men who were prescribed testosterone therapy and compared them to men who were prescribed Viagra® or Cialis®. They concluded that those with pre-existing heart disease doubled their expected heart attack rate within the first 90 days after getting a prescription for testosterone. I have read this study and it is extremely technical with statistical methodologies. I look to some of my colleagues to point out some of the problems with this study’s conclusions:

  1. Retrospective database analyses (in contrast to prospective, randomized controlled clinical trials) allow for any researcher to manipulate the data—in this case to show that testosterone therapy is the cause of increasing non-fatal myocardial infarctions.
  2. They compared heart attacks in the treatment group after just 90 days of initiating testosterone. Could testosterone really have caused heart attacks to occur in just three months? More probably it is attributable to other confounding factors and underlying heart disease.
  3. This study did not adequately control for important multi-factorial variables, though many are mentioned yet are not explained in body of the report. Does the supplemental material referred to address these covariates in an unbiased way? For example, which of these men had low testosterone levels (i.e. hypogonadism) prior to starting therapy? What epigenetic factors (e.g. lifestyle, environment, and other cardiovascular disease risk variables) were considered which would preclude testosterone therapy? Were lethargic, obese, hypertensive and diabetic men considered alongside those men who exercise, consume nutrient rich food, are happy and involved in their care? What about measuring serum tests (e.g. cardio-lipid profile), EKG, exercise tolerance and muscle-to-fat ratios which would give us more information about heart attack risk? And were the testosterone types, doses and methods of administration all lumped together? Testosterone taken by mouth significantly increases cardiovascular disease risk, but injected and transdermal routes do not. [1]
  4. The comparison with Viagra®/Cialis® users further invalidates this study according to critics. That’s because these drugs induce vasodilation [2] (which lowers cardiovascular disease risk) so this cannot be a valid control group.
  5. Did they receive methyl testosterone (the synthetic prescription version) or a compounded (and identical to human) testosterone? In the words of Jonathan Wright, M.D. at the Tahoma Clinic, “…bio-identical testosterone improves muscle mass and strength, rebuilds bone, strengthens the heart and blood vessels, lowers total cholesterol and blood sugar, raises HDL (“good”) cholesterol, lowers blood pressure, lessens the chances of blood clots, improves tissue oxygenation, improves the health of a non-cancerous prostate gland—and that’s all before we get to testosterone’s positive effects on libido and your sex life.” [3] He points out the big difference he sees clinically between bioidentical testosterone (compounded in your local pharmacy) and methyl testosterone that comes from a drug company.

In my next article I’ll share with you the many studies I’ve come across in the real peer-reviewed literature prior to January 2014 that have shown us the safety and efficacy of testosterone therapy in men and women who need and deserve it.

To feeling good for health,

Michael Cutler, M.D.
Easy Health Options

[1] Borst SE, Shuster JJ, Zou B, Ye F, Jia H, Wokhlu A, Yarrow JF. Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis. BMC Med. 2014 Nov 7;12:211.
[2] http://circ.ahajournals.org/content/110/19/3149.full
[3] http://www.tahomaclinicblog.com/bioidentical-testosterone/

Dr. Michael Cutler

By Dr. Michael Cutler

Dr. Michael Cutler is a graduate of Tulane University School of Medicine and is a board-certified family physician with more than 20 years of experience. He serves as a medical liaison to alternative and traditional practicing physicians. His practice focuses on an integrative solution to health problems. Dr. Cutler is a sought-after speaker and lecturer on experiencing optimum health through natural medicines and founder of the original Easy Health Options™ newsletter — an advisory on natural healing therapies and nutrients. His current practice is San Diego Integrative Medicine, near San Diego, California.