Testosterone Replacement Therapy

Effects of Testosterone Treatment in Older Men

The so called double-blind randomized controlled trial (RCT) is accepted by medicine as the gold standard objective scientific methodology, and provides the highest strength of evidence for the effectiveness of a treatment.[1-4]
 
An accumulating body of evidence shows that treating hypogonadal men with testosterone therapy provides a number of wide-ranging benefits beyond mere relief of symptoms, including improvements in muscle mass, insulin sensitivity, fat mass (both total body fat and visceral fat), endothelial function, blood pressure, lipid profile and bone mineral density.[5, 6]
 
Recent clinical practice guidelines state that testosterone therapy is safe if treatment and monitoring are appropriately executed [7-9], and the totality of available evidence to date does not support alleged concerns regarding risk of cardiovascular disease [10] and prostate cancer.[11] Despite this, opponents state that the clinical benefits and potential long-term risks of testosterone therapy have not been adequately assessed in large RCTs, and that therefore a general policy of testosterone replacement in all older men with age-related decline in testosterone levels is not justified.[12]
 
To address the lack of large RCTs on testosterone therapy, the US National Institute of Health has funded The Testosterone Trials, which is a coordinated set of 7 large double-blind RCTs. Here I report the first results from The Testosterone Trials,  which were released February 18, 2016.[13]
 
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Effects of long-term testosterone treatment on weight loss and waist size in obese men - is TRT the next obesity treatment?

Testosterone, historically believed to be important only for male reproduction and sexuality, has over the past decades transformed from niche hormone to multi-system player.[1] A rapidly accumulating body of research is showing that testosterone is an important metabolic hormone with marked effects on energy metabolism and body composition.[2]
 
In USA, 36% of the adult population are obese (BMI >30), (affecting a similar proportion of men and women) [3], and obesity prevalence is escalating worldwide. According to the McKinsey Global Institute (MGI) report “Overcoming obesity: An initial economic analysis”, obesity is “one of the top three preventable social burdens (along with smoking and violence/war/terrorism) generated by human beings” imposing an estimated annual global direct economic burden amounting to 2 trillion USD.[4] 
 
Obesity treatments with comprehensive lifestyle modification and/or drugs are notorious for their poor long-term efficacy and inability to achieve long-term weight loss maintenance.[5-9] Even with continued lifestyle treatment, significant weight regain occurs.[7, 9, 10] And obesity drugs have side effects which limit their long-term and widespread use. [11, 12] Therefore, new interventions are urgently needed to combat this alarming preventable threat to society. 
 
Here I summarize a recent study that investigated the effects of long-term testosterone treatment – up to 8 years - on weight loss and waist size in 411 testosterone deficient men with obesity classes I-III.[13]
 
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Critical Update of the 2010 Endocrine Society Clinical Practice Guidelines for Hypogonadism

In 2010, the Endocrine Society published a Clinical Practice Guideline “Testosterone Therapy in Adult Men With Androgen Deficiency Syndromes”, which addressed important issues regarding the diagnosis and treatment of male hypogonadism.[1] 
 
Since publication of this Guideline, several high-quality trials have been conducted, warranting an update of the 2010 recommendations in several areas, especially that of testosterone therapy in men with the metabolic syndrome, type 2 diabetes, sexual dysfunction, and frailty.
 
In addition, many of the previously stated contraindications to testosterone therapy – including severe lower urinary tract symptoms (LUTS) and untreated obstructive sleep apnea (OSA) - have been reexamined in recent trials.
 
Here I summarize the results of a recent systematic analysis of the latest high-quality studies, which call for some important updates of the 2010 Endocrine Society Clinical Practice Guidelines for Male Hypogonadism.[2] 
 
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Effects of Testosterone Therapy for 3 Years on Subclinical Atherosclerosis Progression in Older Men

Clinical practice guidelines rely heavily on results from randomized controlled trials (RCTs), which is the gold standard for medical research. RCTs produce evidence considered to be of the highest quality. Because RCTs are resource intensive and costly, they are typically of relatively short duration, commonly lasting for around one year. 
 
Currently there are only a few placebo-controlled RCTs investigating the effects of testosterone therapy for a duration of 3 years [1-4], and medical societies have long been urging for more long-term trials evaluating the safety and efficacy of testosterone therapy.[5-7]
 
On August 11th 2015 a notable 3-year long RCT was published in JAMA (Journal of the American Medical Association), which attracted a lot of attention.[8] While interpreted by many as showing that testosterone therapy does not confer any benefits on atherosclerosis, sexual function and quality of life, a closer look at the data actually shows two important positive results…
 
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Normalization of testosterone level is associated with reduced risk of heart attack, stroke and mortality in men

The effect of testosterone replacement therapy on cardiovascular outcomes such as heart attack and stroke are controversial and have been generating heated discussions among clinicians as well as researchers. This, coupled with biased media sensationalism blowing up the supposed “dangers” of testosterone therapy has created great confusion among suffering men, who could gain tremendous health benefits from testosterone therapy.[1]
 
Here I report the results of a new study that examined the relationship between normalization of total testosterone levels with testosterone therapy and cardiovascular events as well as all-cause mortality, in patients without a previous history of heart attack and stroke.[2] This notable study was published in the European Heart Journal on August 6th, 2015.
 
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Long-term testosterone treatment with different testosterone preparations - provocative results on diagnosis and adherence

Due to lack of consistent clear-cut guidelines for diagnosis and treatment of testosterone deficiency, there is a lot of confusion among both health professionals and suffering men. The multiple different testosterone preparations available further add to the complexity of testosterone treatment.

This article presents the intriguing results from a notable study that analyzed effects of testosterone therapy with seven different testosterone preparations in symptomatic men who had previously been denied treatment because of “normal” baseline testosterone levels.[1]
 
The results are quite provocative and highlight several important practical issues relating to diagnosis and treatment of hypogonadism…
 
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Risk of Blood Clots in Men Receiving Testosterone Therapy?

Venous thromboembolism is a blood clot that forms in a vein deep inside a part of the body; it mainly affects the large veins in the lower leg and thigh. 
 
Blood clot formation (venous thromboembolism) has been suggested to be one main risk with testosterone replacement therapy. In 2014, both the US Food and Drug Administration (FDA) [1] and Health Canada [2] implemented a requirement for manufacturers to add a warning about the potential risks of venous thromboembolism and deep vein thrombosis to the label of all testosterone products.
 
However, until recently there were no comparative studies examining an association between testosterone replacement therapy and venous thromboembolism. Here we report the results of a recent case-control study - published July 20th 2015 - that specifically examined the risk of venous thromboembolism associated with testosterone therapy in middle-aged and older men.[3]
 
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Provocative New Research on Testosterone, Prostate Cancer and BPH/LUTS

The number one concern among clinicians worldwide and reason for not prescribing testosterone is the fear that it will cause prostate cancer and/or worsen benign prostatic hyperplasia (BPH, age-associated prostate gland enlargement that can cause urination difficulty).

This article is a summary of a recent presentation by Dr. Khera at The Annual European Association of Urology (EAU) Congress held in March 2015.
 
The EAU is Europe’s largest annual event for medical health care professionals, showcasing the latest medical research findings in the andrology and urology fields.
 
In this presentation, Dr. Khera debunks the popular widespread myth that testosterone supposedly is harmful for the prostate, and presents provocative new testosterone research…
 
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Testosterone Replacement Therapy and Hormonophobia – Cardiovascular risk, the Media, and the Authorities

One of the most controversial and debated issue related to testosterone replacement therapy is its effects on cardiovascular risk and related clinical outcomes.
 
In this video presentation, Dr. Morgentaler clarifies misperceptions of testosterone replacement therapy and cardiovascular disease risk, which have created unwarranted concerns and distorted public discussion of testosterone replacement therapy as a medical treatment.
 
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Video Summary of Testosterone Replacement Therapy and Cardiovascular Risk

One of the most controversial and debated issue related to testosterone replacement therapy is its effects on cardiovascular risk and related clinical outcomes.
 
In the February 2015 issue of Mayo Clinic Proceedings a comprehensive medical review paper, written by Dr. Abraham Morgentaler and his coauthors of the Androgen Study Group – www.AndrogenStudyGroup.org - was published.[1]
 
The aim of the review was to analyze all available studies on testosterone replacement therapy and cardiovascular effects, and to clarify the grossly misleading conclusions from two recent studies that caused a tremendous media scare.
 
In this 8 minute video, Dr. Morgentaler presents the key results from this comprehensive analysis…
 
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Dr. Pierce's Medical Organization Affiliations

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