The most common comments we hear from men on testosterone are, “I got my life back!”. “My energy is great!” “My sex drive is back.” “I’m building muscle.” “I got off of Lipitor.” “My diabetes is under control.” After 10 years of prescribing testosterone to thousands of men, and witnessing the improvements, and quoting the studies supporting improved quality of life and protection from heart attacks; imagine my surprise when the headline news was to the contrary. In November 2013, Vigen et al published opposing results from a retrospective study which followed 8,709 men. They reported testosterone therapy increased heart attacks by an absolute risk difference of 5.8percent (95 percent CI -1.4 percent to 13.1 percent). It made all the headlines and I recalled 2002 when the WHI study in women hit the media before we saw the results. Our phones started ringing. I got a hold of the study and started to examine it very carefully.
Fortunately, I was not the only one examining the study. By the time I finished reviewing the study, the word was out. It was not a valid study. The editor of JAMA received requests for a formal retraction of the study from 29 societies including Endocrinology and Andrology, 160 distinguished researchers and clinicians, 8 emeritus professors, >60 full professors, 9 journal editors, and Dr. Abraham Morgantaler from Harvard Medical School. Their position was that there was “gross data mismanagement and contamination” rendering the study “no longer credible”. Some issues with this study included grossly sub-therapeutic testosterone levels, 40 percent loss to follow-up and a mistaken inclusion of 9 percent women!
The second wave of media attention followed the PlosOne retrospective review of 55,000 charts (Finkle WD et al, 2014) reporting an increased non-fatal myocardial infarction (MI) risk within the first 90 days of therapy, with a higher risk in men with a history of cardiovascular disease. The pre-treatment MI rate was 3.48/1000 person-years. The post-treatment MI rate was 4.75/1000 person-years, an increase of 1.27/1000 person-years. Dr. Morgantaler reported limitations including no control group, unverified events (13 percent) and an apple-to-oranges comparison with a group on Viagra. In addition, data available beyond 90 days, remains unreported without explanation. His conclusion was that the “study was non-informative”.
These flawed studies in the media remind us of the once predominant thought that “Cancer of the prostate is activated by testosterone injections.” That conclusion was based on a single patient.
A large body of literature from past decades supports testosterone’s positive effects on blood sugar, body fat, cholesterol, Alzheimer’s, bone density, arthritis and acute angina. In December of 2013, a review of over 100 articles in JAHA concluded that low levels of testosterone are associated with higher rates of mortality and cardiovascular- related mortality, higher rates of obesity and diabetes. Additionally, the severity of disease correlates with the degree of testosterone deficiency.
Shores MM et al reported testosterone therapy reduced mortality rate from 20.7 percent to 10.3 percent (p< .0001) over 4 years in 1,031 men over the age of 40 with initial testosterone levels below 250 ng/dL. Muraleedharan, V. et al reported that testosterone therapy reduced mortality in 581 male diabetics from 19.2 percent to 8.4 percent over 5.8 years. English et al reported a statistically significant increase in time to ischemia on a treadmill test in 46 men randomized to testosterone gel or placebo. Caminiti, G. et al reported that testosterone improved functional capacity in men with congestive heart failure. Amory JK et al reported a 10 percent increase in bone density with testosterone over 40 months compared to placebo. And the data goes on.
At age 50, testosterone levels have declined by approximately 50 percent. This decline is accompanied by symptoms and disease. Most compelling is a study of over 11,000 men ages 40-70, which reported that a testosterone level over 564 ng/dL was associated with a 41 percent decrease in all-cause mortality over 7 years. When men are restored to these optimal levels, energy, sexual function, stamina, joint pain, mental clarity, muscle mass and mood are significantly improved. Although, a well-designed randomized controlled trial is needed; a review of the current literature on disease and quality of life supports the most common statement we hear, “I got my life back!”
Sangeeta Pati, MD, is the Medical Director of The Institute For Restorative & Regenerative Medicine in Orlando. She is the recognized international medical authority and physician educator on bio-identical hormones. She is presenting a CME/CEU Workshop on Hormone Restorative Therapy for Men & Women-Science & Case Applications on September 27th in Orlando.
