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A Harvard expert shares his thoughts on testosterone-replacement therapy

It might be stated that testosterone is what makes guys, men. It gives them their characteristic deep voices, large muscles, and facial and body hair, differentiating them from women. It stimulates the growth of the genitals at puberty, plays a role in sperm production, fuels libido, and leads to normal erections. It also boosts the creation of red blood cells, boosts mood, and aids cognition.

As time passes, the testicular"machinery" which produces testosterone gradually becomes less powerful, and testosterone levels begin to fall, by approximately 1% a year, starting in the 40s. As men get into their 50s, 60s, and beyond, they might begin to have symptoms and signs of low testosterone like lower sex drive and sense of energy, erectile dysfunction, diminished energy, reduced muscle mass and bone density, and anemia. Taken together, these symptoms and signs are often referred to as hypogonadism ("hypo" meaning low working and"gonadism" speaking to the testicles). Yet it's an underdiagnosed problem, with only about 5 percent of these affected receiving treatment.

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 problems. He's developed specific expertise in treating low testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment plans he utilizes his own patients, and why he thinks experts should reconsider the possible link between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

What symptoms and signs of low testosterone prompt that the typical person to find a doctor?

As a urologist, I have a tendency to observe guys because they have sexual complaints. The primary hallmark of low testosterone is low sexual libido or desire, but another may be erectile dysfunction, and some other man who complains of erectile dysfunction should get his testosterone level checked. Men can experience other symptoms, such as more trouble 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 often discount those"soft symptoms" as a normal part of aging, however, they're often treatable and reversible by decreasing testosterone levels.

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

Not exactly. There are a number of medications which may reduce libido, such as the BPH drugs finasteride (Proscar) and dutasteride (Avodart). Those drugs can also decrease the quantity of the ejaculatory fluid, no question. However a decrease in orgasm intensity normally does not go along with treatment for BPH. Erectile dysfunction does not ordinarily go together with it , though surely if a person has less sex drive or less attention, it is more of a challenge to have a good erection.

How do you determine if or not a person is a candidate for testosterone-replacement therapy?

There are two ways we determine whether somebody has reduced testosterone. One is a blood test and the other one is by characteristic signs and symptoms, and the correlation between those two methods is far from perfect. Normally men with the lowest testosterone have the most symptoms and men with maximum testosterone possess the least. However, 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 entire testosterone level of less than 300 ng/dl, and I believe that's a sensible guide. But no one really agrees on a few. It's not like diabetes, where if your fasting sugar is above a certain level, they'll say,"Okay, you've got it." With testosterone, that break point isn't quite as clear.

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

Is total testosterone the ideal thing to be measuring? Or should we be measuring something different?

Well, this is just another area of confusion and good debate, but I do not think it's as confusing as it is apparently in the literature. When most doctors learned about testosterone in medical school, they heard about total testosterone, or all of the testosterone in the body. However, about half of the testosterone that is circulating in the bloodstream is not readily available to the cells.

The available part of overall testosterone is known as free testosterone, and it is 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 testosterone.

This professional organization recommends testosterone therapy for men who have

  • Low levels of testosterone in the blood (less than 300 ng/dl)
  • symptoms of low testosterone.

Therapy is not Suggested for men who have

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

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

    For many years, the recommendation was to get a testosterone value early in the morning since levels begin to drop after 10 or even 11 a.m.. However, the information behind that recommendation were drawn from healthy young men. Two recent studies demonstrated little change in blood testosterone levels in men 40 and mature over the course of the day. One reported no change in typical testosterone till after 2 p.m. Between 6 and 2 p.m., it went down by 13 percent, a modest amount, and probably insufficient to influence diagnosis. Most guidelines still say it's important to perform the evaluation in the morning, but for men 40 and above, it likely does not matter much, as long as they get their blood drawn before 5 or 6 p.m.

    There are some rather interesting findings about dietary supplements. For example, it appears that those that have a diet low in protein have lower testosterone levels than men who eat more protein. But diet has not been studied thoroughly enough to make any recommendations that are clear.

    In the following guide, testosterone-replacement treatment refers to the treatment of hypogonadism with adrenal gland -- testosterone that is manufactured outside the body. Depending upon the formula, therapy can lead to skin irritation, breast tenderness and enlargement, sleep apnea, acne, decreased sperm count, increased red blood cell count, and additional side effects.

    In a recent prospective study, 36 hypogonadal men took a daily dose of clomiphene citrate for at least three months. Within four to six weeks, all of the men had heightened levels of testosterone; none reported any side effects during the year they were followed.

    Because clomiphene citrate is not approved by the FDA for use in men, little information exists about the long-term effects of taking it (including the risk of developing prostate cancer) or whether it is more effective at boosting testosterone than exogenous formulas. But unlike adrenal gland, clomiphene citrate preserves -- and possibly enhances -- sperm production. That makes drugs such as clomiphene citrate one of just a few choices for men with low testosterone that wish to father children.

    What forms of testosterone-replacement therapy are available? *

    The earliest form is the injection, which we use since it's inexpensive and because we faithfully get fantastic testosterone levels in nearly everybody. The disadvantage is that a man should come in every couple of weeks to get a shot. A roller-coaster effect can also occur as blood glucose levels peak and return to baseline. [Watch"Exogenous vs. endogenous testosterone," above.]

    Topical treatments help maintain a more uniform level of blood glucose. The first form of topical therapy has been a patch, but it has a quite large rate of skin irritation. In 1 study, as many as 40% of men who used the patch developed a red area in their skin. That restricts its use.

    The most commonly used testosterone preparation from the United States -- and the one I start almost everyone off -- is a topical gel. There are two brands: AndroGel and Testim. The gel comes from miniature tubes or in a unique dispenser, and you rub it on your shoulders or upper arms once a day. According to my experience, it tends to be absorbed to great levels in about 80% to 85% of guys, but that leaves a substantial number who do not absorb sufficient for this to have a positive impact. [For details on various formulations, see table below.]

    Are there any downsides to using gels? How much time does it require them to get the job done?

    Men who start using the implants need to come back in to have their own testosterone levels measured again to make certain they're absorbing the proper quantity. Our goal is the mid to upper assortment of normal, which usually 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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