My TRT docs 2014 Testosterone article

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Testosterone: the Good and the Bad

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Many of ya know, I post articles written by my TRT doc. Here is her recently 2014 testosterone good/bad

Crabapple Internal Medicine
Forrest A. Smith, M.D.
45 W. Crossville Rd, Suite 501
Roswell, GA 30075

770-594-1233
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Dr. Smith's Testosterone: the Good and the Bad



Recently there was published a medical report finding increased risk of heart attack among men taking testosterone supplements. The headlines have made big news, mostly because they are so shocking and because the conclusion flies against known scientific studies indicating improved general health with testosterone replacement therapy. So where is the truth? Is testosterone friend or foe?

The answer must be: it is both. As with any medical treatment, there is a distinction between appropriate dosing and excess. Testosterone has the ability to improve many health parameters. On the other hand, if improperly dispensed and monitored, it may cause harm.

How Common Is Testosterone Deficiency?

Testosterone has multiple metabolic roles. It increases bone strength, reduces fat mass, improves insulin and leptin sensitivity, reduces low-density lipoprotein cholesterol (LDL-C) and triglyceride levels, and increases the high-density lipoprotein cholesterol (HDL-C).

Normal Declines: The concentration of free testosterone gradually declines as men age, due to decreased production as well as higher concentrations of sex hormone-binding globulin. One study found that the mean annual reduction in free testosterone levels was approximately 2%, although this reduction was attenuated among healthier men.[1]

Low T is very common: The exact prevalence of testosterone deficiency (TD) is controversial. Many men have symptoms that might indicate TD. In a study of men at least 45 years old presenting to a primary care setting, the prevalence of a total testosterone level < 300 ng/dL was 38.7%.[2] Less than 10% of these men were receiving testosterone treatment.

What Symptoms Can Indicate TD?

Symptoms of TD are nonspecific and include fatigue, loss of libido, hot flashes, depression, and sleep disturbance,[3] although there is not necessarily a linear association between testosterone levels and symptoms. Men with TD often present with psychological problems especially anxiety and lack of interest in normal life events. Correlation of testosterone levels and overall scores on a psychological health screening tool was not found in one population-based study of 3413 men.[4] Nonetheless, men with TD in this study did have scores indicating higher levels of anxiety.

Consequences of TD

TD has been associated with obesity and higher rates of insulin resistance.[5] A meta-analysis of 12 studies, while noting significant heterogeneity among studies, found an increase in both all-cause and cardiovascular mortality, particularly among older men.[6] A more recent study found a U-shaped association between testosterone levels and mortality among men.[7]

Diabetes is increased in Low T: Beyond the effect of TD on individual patients, the larger consequences of this association are staggering. In a study which assumed a conservative prevalence of TD of 13.4% among middle-aged and older men in the United States, the additional number of cases of diabetes attributable to TD over a 20-year period was 1.1 million.[8] The health consequences of TD were estimated to cost the US economy between $190 billion and $525 billion over 2 decades.

Testosterone and Mental Health

Studies examining the effect of testosterone replacement therapy on mood, well-being, libido, and dysthymia have varied in methodologic rigor, characteristics of the sample population, and outcomes studied. A meta-analysis involving 862 men with low-normal testosterone levels found small improvement in erectile function with no improvement in libido or satisfaction.[12] In aggregate, research has documented improvements in libido and erectile dysfunction and possible improvements in mood. However, not all research has supported the efficacy of TT in improving psychological or quality-of-life outcomes.

Testosterone and Body Composition

Despite decreases in fat mass, at the end of this randomized controlled trial, 47.8% in the testosterone group vs 35.5% in the placebo group had the metabolic syndrome (P = .07).[13] Another study of men with low testosterone and metabolic syndrome or type 2 diabetes treated with 2% testosterone gel vs placebo for 1 year found improvements in insulin resistance, hemoglobin A1c, lipid profiles, and libido. These changes, however, were not accompanied by a decrease in fat mass or waist circumference.[14] A meta-analysis of 8 clinical trials involving 365 men examined the effects of testosterone on bone health. Injectable testosterone, but not other formulations, was found to be weakly effective in increasing bone mineral density; there was insufficient data to determine whether that translated to a decrease in fractures.[15] Most trials lasted less than 1 year and there was substantial heterogeneity. Taken together, studies did demonstrate improvements in fat mass and possible increases in muscle power.

Effects of TT on the Prostate

A 2010 systematic review and meta-analysis by Fernández-Balsells and colleagues[16]evaluated the adverse effects of TT. The methodologic quality of the 51 included studies varied from low to medium, with follow-up periods from 3 months to 3 years. TT was not associated with a significant difference in the risk for prostate biopsy or prostate cancer. A more recent review in 2014 reached a similar conclusion and went beyond this previous report.[17] It found no significant association between the incidence of prostate nodules, prostate biopsy, or prostate cancer among different formulations of TT, and the duration of treatment failed to significantly change this conclusion.

Testosterone and Cardiovascular Disease

This same meta-analysis[16] raised concern about CV risk associated with TT. Therapy was found to have no significant effect on mortality or on prostate or CV outcomes. This study followed the early discontinuation of a small trial of 209 community-dwelling men (average age, 74 years) with multiple comorbidities after 23 cardiovascular events were recorded in the TT group -- a much higher number than the 5 that occurred in the placebo group.[18] Despite recommendations by the Data and Safety Monitoring Board to halt the trial because of this higher rate of adverse events, the researchers were careful to note that the small size of the trial and the unique population studied prevented drawing broader inferences about the safety of TT.

VA Study: Cardiovascular Risk

A number of subsequent studies have further raised concerns about CV risk with TT. A Veterans Affairs cohort study[19] assessed the association between TT and all-cause mortality, myocardial infarction (MI), or stroke among male veterans with multiple comorbidities undergoing coronary angiography. The researchers further sought to determine whether this association was modified by underlying coronary artery disease. The use of TT in men was found to be associated with an approximately 30% higher risk for death, MI, or ischemic stroke. In an interview with heartwire, senior investigator Dr. Michael Ho (Veterans Affairs Eastern Colorado Health Care System) was careful to note that although an association was found, "it's not causal, given the observational nature of the study." Other researchers have said that the featured study has multiple flaws that make its conclusions essentially meaningless as the study assess did not test testosterone levels of patients before and during therapy. Unfortunately, this study grabbed the headlines despite the poor quality of the research.

Systematic Review: Cardiovascular Risk

A systematic review and meta-analysis of placebo-controlled randomized trials published in 2013 found an odds ratio of 1.54 (95% CI, 1.09-2.18) for CV events associated with TT.[20]Half of the trials were sponsored by pharmaceutical companies and the effect of therapy varied with the source of funding, but not with baseline testosterone levels. A higher risk for CV events was found in trials not funded by the pharmaceutical industry (8% in nonsponsored trials vs 4% in sponsored trials).

Cohort Study: Cardiovascular Risk

Early in 2014, results from the largest cohort study to date provided more fodder for concerns about CV risk with TT in men with and without pre-existing cardiac disease.[21] In all subjects, the post-/pre-prescription acute nonfatal MI rate ratio for TT prescription was 1.36 (95% CI, 1.03-1.81). Among all men aged 65 years and older, there was a 2-fold increase in the risk for MI in the 90 days after filling an initial TT prescription. The risk declined to baseline in the 91-180 days after initial TT prescription among those who did not refill their prescription. Risk was similarly increased in younger men with pre-existing diagnosed heart disease. The researchers concluded: "Given the rapidly increasing use of testosterone therapy , the current results, along with other recent findings, emphasize the urgency of the previous call for clinical trials adequately powered to assess the range of benefits and risks suggested for such therapy."

Mechanisms for CV Risk With TT

The results of these analyses suggest that an association between TT and adverse CV events does indeed exist, despite several limitations with some of the research. There are a number of plausible biological mechanisms that could potentially explain this increase. Proposed mechanisms of risk include excessive dosing, elevated estrogen, elevated red cell counts and But there is also some evidence that low endogenous testosterone levels may also be positively associated with cardiovascular events.[24]

Putting It All Together

I have presented here the dry data from multiple studies and meta-analyses on testosterone therapy as reported on Medscape February 2014. Unfortunately, there are many flaws in most of the studies so conclusions may be controversial. However, we have also noted the strong data supporting the use of testosterone: men with low testosterone are twice as likely to have insulin resistance or diabetes and replacement therapy improves these metabolic parameters.

My experience

I now have hundreds of men in my practice receiving testosterone replacement. Most of the time, these men are self-referred after being inadequately treated by their primary physician. The truth is: most physicians do not have training and experience in the intricacies of TT.

When treating hypogonadism (low T), the diagnosis must be made with laboratory testing along with symptomatology and physical exam. Replacement may be done with injectables or compounded creams which are customized to the individual. The goal is to achieve for each man the optimal level of testosterone to maximize his health. Additional prescriptions include an aromatase inhibitors to block the expected increase in estrogen levels. Also, HCG is prescribed. This natural hormone is FDA-approved for infertility. Its use in Testosterone replacement therapy is to stimulate the testicles encouraging continued endogenous hormone production and inhibiting shrinkage.

Close monitoring of hormone levels, CBC, PSA and other appropriate tests will insure proper dosing and avoidance of adverse effects. For example, the reported cardiovascular risks in some medical studies are due to incorrect or incomplete testing. When using topical hormones, for example, it is mandatory to monitor salivary levels not blood. Most physicians are familiar only with blood testing; however, serum levels grossly underestimate tissue levels when creams are used. In at least one study of the pharmaceutical gels, because the researchers were prescribing doses to reach “normal” serum testosterone levels, the actual tissue levels were up to 10-fold safe levels. When levels are too high there can be excess estrogen and dihydrotestosterone (DHT). High testosterone can also raise red blood cell counts making blood more viscous and leading directly to blood clots, heart attack and stroke. Thus, a complete blood count needs to be checked every 6 months. Routine blood donations can control hematocrit levels.

The health benefits of optimizing reproductive hormones are clear and have been well documented in various studies. The cardiovascular risks are largely avoidable through appropriate management by a skilled physician.

Dr. Mercola, a respected integrative web-based physician, states “Well over 100 studies were reviewed, and the authors 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 correlated with the degree of testosterone deficiency. Testosterone therapy has been shown to relax coronary arteries and improve ability of patients with congestive heart failure to exercise. Testosterone therapy has been shown to lower blood sugar in diabetics and to lower body mass index in obese patients. Finally, studies have associated lower testosterone levels with thicker walls of some of the major blood vessels. This thickening increases the risk of atherosclerosis thus leading researchers to conclude that low levels of testosterone increase the risk for atherosclerosis.



All of these factors point to the conclusion that optimal testosterone levels decrease the risk of cardiovascular disease. Testosterone therapy can be an excellent way to help men to enhance their quality of life and decrease their risk of multiple diseases, as shown in many studies. Importantly though, the therapy should not be undertaken lightly and should be properly monitored by a hormone specialist that is well versed in the risks of therapy and the treatment of possible side effects for patients to have optimal benefits from the therapy."



Please Note: Above statements are not written by Health Realizations nor the opinion of Health Realizations


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- See more at: Testosterone: the Good and the Bad

[Rrexy]

Very interesting read.........

[lovbyts]

Thanks for posting that. I saw the commercial just this morning and thought what a bunch of BS.

[17chester6]

The article cited mentions that if one is using topical TRT then testing serum levels (blood testing) is not accurate and salivary testing is required. Really? I have not seen any reliable evidence based studies that rely on salivary testing.

[lovbyts]

The article cited mentions that if one is using topical TRT then testing serum levels (blood testing) is not accurate and salivary testing is required. Really? I have not seen any reliable evidence based studies that rely on salivary testing.

That sounds very backwards. I would think blood testing would be a LOT more accurate than saliva testing. Doesn't make any sense.

[BallSak]

Pretty good write up. Thanks.

Of course, since your Dr is a she, I had to look her up to see if she's hot. Cuz I get jealous of such things.

[17chester6]

That sounds very backwards. I would think blood testing would be a LOT more accurate than saliva testing. Doesn't make any sense.

But that is what I said! Salivary testing is not accepted in mainline medical circles. No peer reviewed studies in recognized medical journals that I have seen rely on salivary tests.

[kelkel]

Great write up by your Doc! Keep them coming. See if you can find out more from her on the salivary / gel testing. Maybe she has a study she can pass on.
Wish more doc's were this up on hormones.