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A Harvard expert shares his Ideas on testosterone-replacement Treatment

It might be said that testosterone is the thing that 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 aids cognition.

As time passes, the testicular"machinery" which produces testosterone gradually becomes less powerful, and testosterone levels start to drop, by about 1 percent per year, beginning in the 40s. As guys get in their 50s, 60s, and beyond, they may start to have symptoms and signs of low testosterone such as reduced libido and sense of energy, erectile dysfunction, decreased energy, decreased muscle mass and bone density, and anemia. Taken together, these signs and symptoms are often referred to as hypogonadism ("hypo" meaning low functioning and"gonadism" speaking to the testicles). Yet it is an underdiagnosed issue, with just about 5% of these affected receiving treatment.

Various studies have revealed that testosterone-replacement therapy may offer a vast selection of benefits for men with hypogonadism, including improved 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 diseases and male reproductive and sexual problems. He has developed particular experience in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his perspectives on current controversies, the treatment strategies he uses with his own patients, and why he believes specialists should rethink 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 see a doctor?

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

The more of the symptoms you will find, the more probable 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 very same symptoms that guys have when they are treated for benign prostatic hyperplasia, or BPH?

Not precisely. There are quite a few drugs that may lessen sex drive, such as the BPH medication finasteride (Proscar) and dutasteride (Avodart). Those drugs may also decrease the amount of the ejaculatory fluid, no question. But a decrease in orgasm intensity normally doesn't go together with therapy for BPH. Erectile dysfunction does not ordinarily go along with it either, though certainly if somebody has less sex drive or less interest, it's more of a challenge to get a good erection.

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

There are two ways that we determine whether someone has reduced testosterone. One is a blood test and the other is by characteristic symptoms and signs, and the correlation between those two approaches is far from ideal. Generally men with the lowest testosterone have the most symptoms and guys with maximum testosterone have the least. But there are a number of guys who have low 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's a reasonable guide. However, no one really agrees on a few. It's not like diabetes, in which if your fasting sugar is above a certain level, they will 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 important source should not receive testosterone therapy. For a complete copy of the guidelines, log on to www.endo-society.org.

Is complete testosterone the ideal thing to be measuring? Or if we are measuring something else?

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

The biologically available portion of total testosterone is called free testosterone, and it is readily available to the cells. 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 correlation is greater compared to total testosterone.

Endocrine Society recommendations summarized

This professional organization recommends testosterone treatment for men who have

Therapy Isn't recommended for men who've

  • Breast or prostate 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 elements affect testosterone levels?

For many years, the recommendation has been to get a testosterone value early in the morning since levels start to drop after 10 or even 11 a.m.. But the data behind this recommendation were attracted to healthy young men. Two recent studies showed little change in blood glucose levels in men 40 and older within the course of the day. One reported no change in average testosterone till after 2 p.m. Between 6 and 2 p.m., it went down by 13%, a modest amount, and probably insufficient to affect diagnosis. Most guidelines still say it is important to do the evaluation in the morning, however for men 40 and above, it likely does not matter much, as long as they get their blood drawn before 6 or 5 p.m.

There are a number of very interesting findings about dietary supplements. For example, it seems that those who have a diet low in protein have lower testosterone levels than men who consume more protein. But diet has not been studied thoroughly enough to create any clear recommendations.

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

Preliminary research has shown that clomiphene citrate (Clomid), a drug generally prescribed to stimulate ovulation in women struggling with infertility, can foster the production of natural testosterone, termed endogenous testosterone, in men. Within four to six weeks, all of the men had heightened levels of testosteronenone reported some side effects throughout the year they were followed.

Because clomiphene citrate is not accepted by the FDA for use in males, little information exists about the long-term effects of taking it (including the probability of developing prostate cancer) or if it's more capable of boosting testosterone compared to exogenous formulas. But unlike adrenal gland, clomiphene citrate maintains -- and potentially enriches -- sperm production. This makes medication such as clomiphene citrate one of just a few options 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 because it's cheap and since we faithfully become good testosterone levels in nearly everybody. The disadvantage is that a man should come in every couple of weeks to find a shot. A roller-coaster effect can also occur as blood testosterone levels peak and return to baseline. [Watch"Exogenous vs. endogenous testosterone," above.]

Topical treatments help preserve a more uniform level of blood testosterone. The first kind of topical treatment has been a patch, but it has a very high rate of skin irritation. In 1 study, as many as 40% of people that used the patch developed a reddish area in their skin. That limits its use.

The most widely used testosterone preparation from the United States -- and the one I start almost everyone off -- is a topical gel. Based on my experience, it tends to be consumed to great levels in about 80% to 85% of guys, but that leaves a substantial number who do not absorb enough for this to have a positive impact. [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 certain they're absorbing the proper quantity. Our target 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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