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A Harvard Specialist shares his thoughts on testosterone-replacement Treatment

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

Over time, the "machinery" which makes testosterone gradually becomes less powerful, and testosterone levels start to fall, by about 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 like lower 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 working and"gonadism" referring to the testicles). Yet it is 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 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 strategies he utilizes his own patients, and why he thinks specialists should rethink the possible connection between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

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

As a urologist, I have a tendency 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 should get his testosterone level checked. Men can experience other symptoms, such as more trouble achieving an orgasm, less-intense orgasms, a lesser quantity of fluid from ejaculation, and a sense of numbness in the manhood when they see or experience something that would normally be arousing.

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

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

Not precisely. There are a number of drugs which may reduce libido, including the BPH drugs finasteride (Proscar) and dutasteride (Avodart). Those drugs can also reduce the quantity of the ejaculatory fluid, no question. But a reduction in orgasm intensity normally doesn't go together with treatment for BPH. Erectile dysfunction does not ordinarily go along with it , though certainly if somebody has less sex drive or less attention, it is more of a struggle to get a good erection.

How do you decide if or not a person is a candidate for testosterone-replacement treatment?

There are just two ways we determine whether somebody has low testosterone. One is a blood test and the other is by characteristic signs and symptoms, and the correlation between these two approaches is far from ideal. Normally guys with the lowest testosterone have the most symptoms and men 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 at the biochemical numbers, The Endocrine Society* considers low testosterone to be a total testosterone level of less than 300 ng/dl, and I think that's a reasonable guide. But no one quite agrees on a number. It's not like diabetes, where if your fasting glucose is above a certain level, they'll say,"Okay, you've got it." With testosterone, that break point is not quite as apparent.

*Notice: The Endocrine Society recommends clinical practice guidelines with recommendations for who should and should basics not receive testosterone treatment. For a navigate to these guys complete 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 another area of confusion and great debate, but I don't think that it's as confusing as it is apparently from the literature. When most physicians learned about testosterone in medical school, they learned about overall testosterone, or all the testosterone in the body. But about half of their testosterone that is circulating in the blood is not available to the cells. It is closely bound to a carrier molecule known as sex hormone--binding globulin, which we abbreviate as SHBG.

The biologically available part of overall testosterone is known as free testosterone, and it is readily available to the cells. Even though it's just a little fraction of the overall, the free testosterone level is a fairly good indicator of reduced testosterone. It's not perfect, but the significance is greater compared to total testosterone.

Endocrine Society recommendations outlined

This professional organization recommends testosterone therapy for men who have

Therapy Isn't Suggested for men who have

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

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

    For years, the recommendation was to get a testosterone value early in the morning because levels begin to drop after 10 or even 11 a.m.. However, the data behind this recommendation were drawn from healthy young men. Two recent studies showed little change in blood glucose levels in men 40 and older over the course of this day. One reported no change in average testosterone till after 2 p.m. Between 2 and 6 p.m., it went down by 13 percent, a modest sum, and probably not enough to affect identification. Most guidelines still say it is important to perform the test in the morning, however for men 40 and above, it likely doesn't matter much, provided that they obtain their blood drawn before 5 or 6 p.m.

    There are a number of rather interesting findings about diet. By way of example, it seems that individuals that have a diet low in protein have lower testosterone levels than men who eat more protein. But diet hasn't been researched thoroughly enough to make any clear recommendations.

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

    At a recent prospective study, 36 hypogonadal men took a daily dose of clomiphene citrate for at least three months. Within four to six months, all the guys had heightened levels of testosteronenone reported any side effects during the entire year they were followed.

    Since clomiphene citrate is not accepted by the FDA for use in males, little information exists about the long-term effects of carrying it (including the probability of developing prostate cancer) or whether it is more capable of boosting testosterone than exogenous formulations. But unlike adrenal gland, 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 want to father children.

    What kinds of testosterone-replacement treatment are available? *

    The oldest form is the injection, which we use since it is cheap and because we reliably become good testosterone levels in nearly everybody. The disadvantage is that a person should come in every few weeks to get a shot. A roller-coaster effect may also happen as blood testosterone levels peak and then return to baseline.

    Topical treatments help preserve a more uniform level of blood testosterone. The first form of topical therapy was a patch, but it has a quite large rate of skin irritation. In 1 study, as many as 40 percent of men who used the patch developed a red area on their skin. That limits its use.

    The most widely used testosterone preparation from the United States -- and also the one I begin almost everyone off -- is a topical gel. The gel comes in tiny tubes or within a special 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 degrees in about 80% to 85 percent of guys, but that leaves a significant number who don't absorb enough for it to have a positive effect. [For specifics on various formulations, see table ]

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

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

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