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A Harvard Specialist shares his thoughts on testosterone-replacement Treatment

It could be stated that testosterone is what makes men, guys. It gives them their characteristic deep voices, large muscles, and body and facial hair, distinguishing them from girls. It stimulates the development of the genitals at puberty, plays a role in sperm production, fuels libido, and leads to normal erections. Additionally, it boosts the production of red blood cells, boosts mood, and assists cognition.

Over time, the testicular"machinery" which makes testosterone slowly becomes less powerful, and testosterone levels start to drop, by approximately 1% per year, starting in the 40s. As men get in their 50s, 60s, and beyond, they might start to have symptoms and signs of low testosterone such as lower libido and sense of vitality, erectile dysfunction, decreased energy, decreased muscle mass and bone density, and nausea. Taken together, these signs and symptoms are often referred to as hypogonadism ("hypo" significance low functioning and"gonadism" referring to the testicles). Researchers estimate that the condition affects anywhere from two to six million men in the United States. Yet it's an underdiagnosed issue, with only about 5% of these affected receiving treatment.

Various studies have shown that testosterone-replacement therapy can provide a vast range of benefits for men with hypogonadism, including enhanced libido, mood, cognition, muscle mass, bone density, and red blood cell production. Much of the current debate focuses on the long-held belief that testosterone can stimulate prostate cancer.

Dr. Abraham Morgentaler, an associate professor of surgery at Harvard Medical School and the director of Men's Health Boston, specializes in treating prostate ailments and male sexual and reproductive difficulties. He's developed specific experience in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment strategies he uses with his own patients, and he thinks experts should reconsider the potential connection between testosterone-replacement treatment and prostate cancer.

Symptoms and diagnosis

What symptoms and signs of low testosterone prompt the average man to see a doctor?

As a urologist, I tend to see men because they have sexual complaints. The main hallmark of reduced testosterone is reduced sexual libido or desire, but another may be erectile dysfunction, and any man who complains of erectile dysfunction must possess his testosterone level checked. Men may experience other symptoms, such as more difficulty achieving an orgasm, less-intense orgasms, a smaller amount of fluid from ejaculation, and a feeling of numbness in the penis when they see or experience something that would normally be arousing.

The more of these symptoms there are, the more likely it is that a man has low testosterone. Many physicians tend to dismiss these"soft symptoms" as a normal part of aging, but they are often treatable and reversible by normalizing testosterone levels.

Aren't those the same symptoms that men have when they're treated for benign prostatic hyperplasia, or BPH?

Not exactly. There are a number of drugs which may reduce libido, such as the BPH medication finasteride (Proscar) and dutasteride (Avodart). Those drugs may also reduce the quantity of the ejaculatory fluid, no wonder. But a reduction in orgasm intensity usually does not go along with therapy for BPH. Erectile dysfunction does not ordinarily go together with it either, though certainly if somebody has less sex drive or less interest, it's more of a struggle to have a fantastic erection.

How can you determine whether a person is a candidate for testosterone-replacement treatment?

There are just two ways we determine whether someone has reduced testosterone. One is a blood test and the other one is by characteristic symptoms and signs, and the correlation between those two methods is far from ideal. Normally men with the lowest testosterone have the most symptoms and men with maximum testosterone possess the least. But there are some guys who have reduced levels of testosterone in their blood and have no symptoms.

Looking purely at the biochemical amounts, The Endocrine Society* believes low testosterone to be a total testosterone level of less than 300 ng/dl, and I believe that is a sensible guide. But no one quite agrees on a number. It is similar to diabetes, where if your fasting glucose is over a certain level, they will say,"Okay, you've got it." With testosterone, that break point is not quite as apparent.

*Notice: The Endocrine Society publishes clinical practice guidelines with recommendations for who should and shouldn't receive testosterone treatment. For a complete copy of the guidelines, my link log on to www.endo-society.org.

Is complete testosterone the ideal point to be measuring? Or should we be measuring something different?

This is another area of confusion and good debate, but I do not think that it's as confusing as it appears to be from the literature. When most doctors learned about testosterone in medical school, they heard about total testosterone, or all of the testosterone in the human body. But about half of their testosterone that's circulating in the bloodstream isn't available to cells. It's closely bound to a carrier molecule called sex hormone--binding globulin, which we abbreviate as SHBG.

The available portion of total testosterone is known as free testosterone, and it's readily available to cells. Nearly every lab has a blood test to measure free testosterone. Though it's only a little fraction of this total, the free testosterone level is a fairly good indicator of low testosterone. It is not perfect, but the significance is greater than with total testosterone.

This professional organization urges testosterone therapy for men who have both

Therapy is not Suggested for men who have

  • Breast or prostate cancer
  • a nodule on the prostate that may be felt during a DRE
  • a PSA higher than 3 ng/ml without additional evaluation
  • that a hematocrit greater than 50% or thick, viscous blood
  • untreated obstructive sleep apnea
  • severe lower urinary tract infections
  • class III or IV heart failure.

Do time daily, diet, or other elements affect testosterone levels?

For many years, the recommendation has been to get a testosterone value early in the morning since levels start to fall after 10 or 11 a.m.. However, the information behind that recommendation were attracted to healthy young men. Two recent studies showed little change in blood glucose levels in men 40 and mature over the course of this day. One reported no change in average testosterone until after 2 Between 6 and 2 p.m., it went down by 13%, a small amount, and probably insufficient to affect diagnosis. Most guidelines nevertheless say it is important to do the evaluation in the morning, but for men 40 and over, it likely doesn't matter much, provided that they get their blood drawn before 5 or 6 p.m.

There are a number of very interesting findings about diet. By way of instance, it appears that individuals that have a diet low in protein have lower testosterone levels than males who consume more protein. But diet hasn't been researched thoroughly enough to create any clear recommendations.

Exogenous vs. endogenous testosterone

Within the following article, testosterone-replacement therapy refers to the treatment of hypogonadism with exogenous testosterone -- testosterone that's produced outside the body. Depending upon the formulation, treatment can cause skin irritation, breast tenderness and enlargement, sleep apnea, acne, decreased sperm count, increased red blood cell count, along with other side effects.

Preliminary research has proven that clomiphene citrate (Clomid), a drug generally prescribed to stimulate ovulation in women struggling with infertility, may boost the creation of natural testosterone, also known as endogenous testosterone, in men. Within four to six weeks, all of the men had increased levels of testosterone; none reported any side effects during the year they were followed.

Because clomiphene citrate isn't accepted by the FDA for use in males, little information exists regarding the long-term ramifications of carrying it (such as the probability of developing prostate cancer) or if it's more capable of boosting testosterone compared to exogenous formulas. But unlike exogenous testosterone, clomiphene citrate maintains -- and potentially enriches -- sperm production. That makes drugs like clomiphene citrate one of only a few choices for men with low testosterone who wish to father children.

Formulations

What forms of testosterone-replacement therapy can be found? *

The earliest form is the injection, which we use because it's inexpensive and since we faithfully become good testosterone levels in nearly everybody. The disadvantage is that a man needs to come in every few weeks to find a shot. A roller-coaster effect may also happen as blood glucose levels peak and return to baseline.

Topical therapies help maintain a more uniform amount of blood glucose. The first form of topical therapy has been a patch, but it has a quite large rate of skin irritation. In one study, as many as 40% of men who used the patch developed a reddish area in their skin. That restricts its use.

The most commonly used testosterone preparation from the United States -- and also the one I start almost everyone off with -- is a topical gel. There are two brands: AndroGel and Testim. According to my experience, it has a tendency to be absorbed to good degrees in about 80% to 85 percent of men, but leaves a significant number who don't consume sufficient for this to have a positive effect. [For details on various formulations, see table below.]

Are there any downsides to using gels? How long does it require them to work?

Men who start using the implants need to come back in to have their testosterone levels measured again to be sure they're absorbing the proper amount. Our goal is that the mid to upper range of normal, which generally means approximately 500 to 600 ng/dl. The concentration of testosterone in the blood really goes up quite quickly, in just several doses. I usually measure it after 2 weeks, although symptoms may not change for a month or two.

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