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A Harvard Specialist shares his thoughts on testosterone-replacement therapy

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 fosters the production 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 approximately 1 percent a year, starting in the 40s. As guys get into their 50s, 60s, and beyond, they might begin to have signs and symptoms of low testosterone like lower libido and sense of vitality, erectile dysfunction, diminished 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.

But little consensus exists about what constitutes low testosterone, when testosterone supplementation makes sense, or what risks patients face. 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 expertise in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his perspectives on current controversies, the treatment plans 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 man to see a doctor?

As a urologist, I tend to observe guys since they have sexual complaints. The main hallmark of reduced testosterone is reduced sexual desire or libido, but another can be erectile dysfunction, and any man who complains of erectile dysfunction should get his testosterone level checked. Men may experience other symptoms, such as more difficulty achieving an orgasm, less-intense climaxes, a much lesser quantity of fluid out of ejaculation, and a sense of numbness in the manhood 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 precisely. There are quite a few medications 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. However a reduction in orgasm intensity usually does not go together with therapy for BPH. Erectile dysfunction does not ordinarily go together with it either, though certainly if somebody has less sex drive or less attention, it is more of a challenge to get a fantastic erection.

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

There are just two ways that 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 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 entire 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's 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 is not quite as clear.

*Notice: The Endocrine Society publishes clinical practice guidelines with recommendations why not find out more for who should and should not receive testosterone treatment.

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

Well, this is just another area of confusion and great discussion, but I don't think it's as confusing as it is apparently in the literature. When most physicians learned about testosterone in medical school, they learned about total testosterone, or all of the testosterone in the body. However, about half of the 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 available portion of overall 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 pretty good indicator of reduced testosterone. It's not ideal, but the correlation is greater compared to total testosterone.

Endocrine Society recommendations outlined

This professional organization recommends testosterone treatment for men who have both

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

Therapy is not Suggested for men who have

  • 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 analysis
  • 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 has been to receive a testosterone value early in the morning since levels start to fall after 10 or even 11 a.m.. But the information behind this recommendation were drawn from 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 percent, a small amount, and probably insufficient to affect diagnosis. Most guidelines still say it is 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 a number of rather interesting findings about diet. For example, it seems that those that have a diet low in protein have lower testosterone levels than men who consume more protein. But diet hasn't been researched thoroughly enough to create any clear recommendations.

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

    Preliminary studies have proven 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 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'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 like clomiphene citrate one of only a few choices for men with low testosterone who want to father children.

Formulations

What forms of testosterone-replacement therapy are available? *

The earliest form is the injection, which we use because it's inexpensive and since we faithfully become fantastic testosterone levels in almost everybody. The drawback is that a person should come in every few weeks to get a shot. A roller-coaster effect may also happen as blood glucose levels peak and then 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 percent 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 also the one I start almost everyone off -- is a topical gel. The gel comes in miniature tubes or within a unique dispenser, and you rub it on your shoulders or upper arms once a day. Based on my experience, it tends to be consumed to great levels in about 80% to 85 percent of guys, but that leaves a significant number who do not absorb enough for this to have a positive effect. [For details on various formulations, see table below.]

Are there any downsides to using dyes? How long does it require them to get the job done?

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

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