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A Harvard Specialist shares his thoughts on testosterone-replacement therapy

A meeting with Abraham Morgentaler, M.D.

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

Over time, the testicular"machinery" which makes testosterone gradually becomes less powerful, and testosterone levels start to fall, by approximately 1% per year, starting in the 40s. As men get into 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, reduced muscle mass and bone density, and nausea. Taken together, these signs and symptoms are often called hypogonadism ("hypo" significance low functioning and"gonadism" referring to the testicles). Researchers estimate that the illness affects anywhere from two to six million men in the United States. Yet it is an underdiagnosed issue, with just about 5% of those affected undergoing therapy.

Various studies have shown that testosterone-replacement therapy may provide a vast range of benefits for men with hypogonadism, such as enhanced libido, mood, cognition, muscle mass, bone density, and red blood cell production. But little consensus exists on what constitutes low testosterone, when testosterone supplementation makes sense, or what dangers patients face. Much of the current debate focuses on the long-held belief that testosterone may stimulate prostate cancer.

He has developed particular experience in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment strategies he uses with his own patients, and he thinks specialists should rethink the potential connection between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

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

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 guy who complains of erectile dysfunction must get his testosterone level checked. Men may experience other symptoms, such as more difficulty achieving an orgasm, less-intense orgasms, a much lesser quantity of fluid out of ejaculation, and a sense 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 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 exactly. There are a number of drugs that may lessen sex drive, including the BPH drugs finasteride (Proscar) and dutasteride (Avodart). Those drugs can also decrease the quantity of the ejaculatory fluid, no wonder. However a decrease in orgasm intensity normally does not go along with treatment for BPH. Erectile dysfunction does not usually go together with it , though certainly if somebody has less sex drive or less attention, it's more of a challenge to have a fantastic erection.

How can you determine whether a man 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 one is by characteristic symptoms and signs, and the correlation between those two methods is far from perfect. Normally guys with the lowest testosterone have the most symptoms and guys with highest testosterone have 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* believes low testosterone for a total testosterone level of less than 300 ng/dl, and I think that's a sensible guide. However, no one really agrees on a number. It's similar to diabetes, in which if your fasting glucose is over 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 should not receive testosterone treatment.

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

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

The available portion of total testosterone is known as 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 significance is greater than with testosterone.

Endocrine Society recommendations summarized

This professional organization urges testosterone therapy for men who have

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

Therapy is not Suggested for men who've

  • Breast or prostate cancer
  • a nodule on the prostate which can be felt during a DRE
  • a PSA greater 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 symptoms
  • class III or her latest blog 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 begin 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 mature over the course of the day. One reported no change in typical testosterone till after 2 p.m. Between 2 and 6 p.m., it went down by 13 percent, a modest amount, and probably insufficient to affect diagnosis. Most guidelines still say it is important to perform the test in the morning, but for men 40 and over, it likely doesn't matter much, as long as they obtain their blood drawn before 6 or 5 p.m.

    There are a number of very interesting findings about diet. By way of instance, it seems that individuals who have a diet low in protein have lower testosterone levels than males who eat more protein. But diet has not been researched thoroughly enough to make any clear recommendations.

    Within this article, testosterone-replacement therapy refers to the treatment of hypogonadism with adrenal gland -- testosterone that's produced outside the body. Based upon the formulation, treatment can cause skin irritation, breast enlargement and tenderness, sleep apnea, acne, decreased sperm count, increased red blood cell count, along with additional side effects.

    Preliminary studies have 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 nitric oxide, in men. Within four to six months, each one the men had increased levels of testosteronenone reported any side effects during the year they were followed.

    Because clomiphene citrate is not accepted by the FDA for use in males, little information exists regarding the long-term ramifications of carrying it (such as the risk of developing prostate cancer) or whether it is more effective at boosting testosterone than exogenous formulations. But unlike adrenal gland, clomiphene citrate maintains -- and potentially enriches -- sperm production. This makes medication such as clomiphene citrate one of only a few options for men with low testosterone who want to father children.

Formulations

What forms of testosterone-replacement therapy are available? *

The oldest form is an injection, which we use since it's inexpensive and because we reliably get fantastic testosterone levels in almost everybody. The drawback is that a man needs to come in every few weeks to get a shot. A roller-coaster effect can also happen as blood glucose levels peak and return to baseline. [See"Exogenous vs. endogenous testosterone," above.]

Topical therapies help preserve a more uniform amount of blood glucose. The first form of topical therapy has been a patch, but it has a quite high rate of skin irritation. In one study, as many as 40% of people that used the patch developed a reddish area on their skin. That limits its use.

The most widely used testosterone preparation from the United States -- and the one I start almost everyone off with -- is a topical gel. The gel comes from miniature tubes or in a special dispenser, and you rub it on your shoulders or upper arms once a day. According to my experience, it has a tendency to be absorbed to good degrees in about 80% to 85 percent of men, but leaves a substantial number who don't consume enough for this to have a positive effect. [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 begin using the implants need to come back in to have their own testosterone levels measured again to make certain they are absorbing the right quantity. Our target is that the mid to upper assortment of normal, which usually means around 500 to 600 ng/dl. The concentration of testosterone in blood actually goes up quite fast, within several doses. I usually measure it after two weeks, even though symptoms may not alter for a month or two.

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