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A Harvard Specialist shares his Ideas on testosterone-replacement therapy

It might be stated that testosterone is the thing that makes men, men. It gives them their characteristic deep voices, big muscles, and body and facial hair, differentiating them from women. It stimulates the development of the genitals , plays a role in sperm production, fuels libido, and contributes to regular erections. Additionally, it fosters the creation of red blood cells, boosts mood, and assists cognition.

Over time, the "machinery" which produces testosterone gradually becomes less powerful, and testosterone levels begin to fall, by about 1 percent a year, beginning in the 40s. As guys get in their 50s, 60s, and beyond, they may start to have signs and symptoms of low testosterone like reduced libido and sense of vitality, erectile dysfunction, decreased energy, decreased 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" referring to the testicles). Yet it is an underdiagnosed issue, with just about 5 percent of these affected receiving treatment.

But little consensus exists about what constitutes low testosterone, when testosterone supplementation makes sense, or what dangers patients face.

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 has developed specific expertise in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment plans he uses with his patients, and why he believes experts should reconsider the potential connection between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

What symptoms and signs of low testosterone prompt the typical person to see a physician?

As a urologist, I tend to see guys because they have sexual complaints. The main hallmark of reduced testosterone is low sexual libido or desire, but another may be erectile dysfunction, and any guy who complains of erectile dysfunction must get his testosterone level checked. Men can experience other symptoms, such as more trouble achieving an orgasm, less-intense orgasms, a much lesser amount of fluid from ejaculation, and a sense of numbness in the penis when they see or experience something that would usually be arousing.

The more of the symptoms there are, the more probable it is that a man has low testosterone. Many physicians often dismiss these"soft symptoms" as a normal part of aging, however, they're often treatable and reversible by decreasing testosterone levels.

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

Not exactly. There are quite a few medications that may lessen sex drive, such as the BPH medication finasteride (Proscar) and dutasteride (Avodart). Those drugs can also decrease the amount of the ejaculatory fluid, no wonder. But a decrease 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 is more of a struggle to get a good erection.

How do you determine whether or not a person is a candidate for testosterone-replacement treatment?

There are just two ways that 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 perfect. Generally men with the lowest testosterone have the most symptoms and guys with maximum testosterone possess the least. However, there are a number of guys who have reduced levels of testosterone in their blood and have no symptoms.

Looking purely at the biochemical numbers, The Endocrine Society* considers low testosterone for a entire testosterone level of less than 300 ng/dl, and I believe that is a sensible guide. However, no one really agrees on a few. It is similar to diabetes, in which if your fasting sugar is over a certain level, they will say,"Okay, you've got it." With testosterone, that break point isn't quite as apparent.

*Notice: The Endocrine Society recommends clinical practice guidelines with recommendations for who should and should not receive testosterone treatment. For a check that complete Recommended Reading copy of these instructions, log on to www.endo-society.org.

Is total testosterone the right point to be measuring? Or if we are measuring something different?

This is just another area of confusion and good discussion, but I don't think it's as confusing as it appears to be in the literature. When most doctors learned about testosterone in medical school, they learned about overall testosterone, or all of the testosterone in the human body. However, about half of the testosterone that's circulating in the bloodstream is not readily available to cells. It's tightly bound to a carrier molecule known as sex hormone--binding globulin, which we abbreviate as SHBG.

The available part of overall testosterone is called free testosterone, and it's readily available to the cells. Though it's only a small fraction of this overall, the free testosterone level is a pretty good indicator of low testosterone. It is not ideal, but the significance is greater than with testosterone.

Endocrine Society recommendations summarized

This professional organization recommends testosterone treatment for men who have

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

Therapy Isn't Suggested for men who have

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

Do time of day, diet, or other elements influence testosterone levels?

For years, the recommendation has been to receive a testosterone value early in the morning because 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 demonstrated little change in blood testosterone levels in men 40 and older within the course of the day. One reported no change in typical testosterone until after 2 p.m. Between 6 and 2 p.m., it went down by 13%, a small amount, and probably not enough to affect diagnosis. Most guidelines nevertheless say it is important to do the evaluation in the morning, but for men 40 and over, it probably does not matter much, provided that they get their blood drawn before 6 or 5 p.m.

There are some rather interesting findings about diet. By way of example, it seems that individuals who have a diet low in protein have lower testosterone levels than males who consume more protein. But diet has not been studied thoroughly enough to create any clear recommendations.

Exogenous vs. endogenous testosterone

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

Within four to six months, all of the guys had heightened levels of testosteronenone reported some side effects during the year they had been followed.

Because clomiphene citrate is not accepted by the FDA for use in men, little information exists about the long-term ramifications of taking it (such as the risk of developing prostate cancer) or whether it's more capable of boosting testosterone than exogenous formulas. But unlike exogenous testosterone, clomiphene citrate preserves -- and potentially enriches -- sperm production. That makes drugs such as clomiphene citrate one of only a few choices for men with low testosterone that wish to father children.

Formulations

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

The oldest form is an injection, which we use since it is inexpensive and because we faithfully get good testosterone levels in nearly everybody. The drawback is that a person needs to come in every few weeks to find a shot. A roller-coaster effect may also happen as blood testosterone levels peak and then return to baseline. [Watch"Exogenous vs. endogenous testosterone," above.]

Topical treatments help maintain a more uniform level of blood testosterone. The first form of topical treatment has been a patch, but it has a very high 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 usage.

The most commonly used testosterone preparation in the United States -- and the one I start almost everyone off with -- is a topical gel. Based on my experience, it has a tendency to be consumed to great degrees in about 80% to 85 percent of guys, but leaves a significant number who do not consume sufficient for this to have a favorable impact. [For details on several different formulations, see table ]

Are there any drawbacks to using dyes? How long does it take for them to work?

Men who begin using the implants need to return in to have their testosterone levels measured again to make sure they're absorbing the right amount. Our target is the mid to upper range of normal, which usually means around 500 to 600 ng/dl. The concentration of testosterone in the blood really goes up quite fast, in just a few doses. I usually measure it after two weeks, though symptoms may not change for a month or two.

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