James K. Rone, MD, FACP, FACE

Should Women Take Testosterone Replacement or Have Testosterone Pellets Implanted?

July 20, 2012

Tags: Testosterone, Hormone Replacement in Women

THIS IS AN EMAIL I SENT TO A PERSONAL FRIEND WHO ASKED ME WHAT I THOUGHT ABOUT A FRIEND OF HERS, A YOUNG PRE-MENOPAUSAL WOMAN, MOTHER OF A TODDLER, WHO WAS “FEELING GREAT” AFTER HAVING TESTOSTERONE PELLETS IMPLANTED.

I have reviewed the Endocrine Society’s clinical practice guidelines from 2006 for androgen (testosterone) therapy in women. These guidelines—as I told you—advised against diagnosing and treating testosterone deficiency in women. Their basis for that position was a lack of understanding of what the normal ranges of testosterone levels are for women at different points in their lives, known inaccuracies in available testosterone blood tests, and a lack of studies demonstrating safety over many years. That is, what might be safe for a week or a month or a year, might not be safe for 5 years or 10 years or 20 years.

The accuracy of testing is important—what we’re saying is that the testosterone blood tests physicians use everyday aren’t accurate enough, especially at the lower levels that are normal in women, to be trusted for identifying women who need treatment and monitoring that therapy once started to be sure enough but not too much is given. I don’t know about what testing XXXX, for example, has add, but many of these types of clinics (that prescribe testosterone and other hormones outside the recommendations of mainstream endocrinology—HRC Medical would be an example) use saliva testing. There is even less confidence among physicians as to the accuracy and usefulness of saliva testing than blood testing.

The following summarizes the Endocrine Society’s safety concerns that need further study before testosterone therapy is recommended in women:

(1) Endometrium (uterine lining)—endometrial hyperplasia, which can led to uterine cancer, SEEMS UNLIKELY in women taking testosterone, but the endometrium should be monitored in adequate long-term research studies to be sure.

(2) Breast—too much testosterone has been shown to cause breast atrophy (shrinkage); testosterone does not directly promote breast cancer, but some breast pre-cancerous lesions have the enzyme aromatase that converts testosterone to estrogen (estrogen does promote breast cancer); therefore the possibility exists that aromatization of exogenous (outside) testosterone and other androgens “could contribute to breast cancer risk for women taking them.” Actual research done in this area is as yet inconclusive and of limited quality.

(3) Cardiovascular and metabolic function—the guidelines essentially state that research is needed as to the safety of testosterone treatment in women with respect to cholesterol issues, diabetes risk, and heart disease and stroke risk.

(4) Skin and voice—it is well established that testosterone can cause facial and body hair growth in women, acne, baldness, and a deepening of the voice. No studies have been done looking at these effects in women taking testosterone in doses that maintain “normal” levels for greater than 1 year.

I think I need to emphasize that there is a very different philosophy with which I and these guidelines approach this issue, compared to you and XXXX and your friends and colleagues. I emphasize this, to point out the potential weaknesses of our assertions—namely, I and the guidelines, and most physicians follow a Hippocratic philosophy that states that we will “first do no harm.” That is, we will not give any therapy that has not been proven effective AND safe. By safe, I mean that the benefits clearly outweigh the risks—because there are ALWAYS risks. Anything that is strong enough to help is strong enough to hurt. Furthermore we need to establish exactly who should be treated, and how that treatment should be monitored for effectiveness and safety.

I and these guidelines are not saying that there might not be some benefit to testosterone supplementation in some women. I am certainly not saying that XXXX, for example, doesn’t feel better when she takes testosterone. What I am saying is that it has not been established to our satisfaction who needs this therapy to avoid real medical harm, how much should be given and how it should be monitored, and that it doesn’t do more harm than good over years and years.

I know nothing about the provider prescribing to XXXX—I will be so bold, however, as to say that there are practices that are more concerned about billing people who understandably want to feel better than they are about safety and the other issues I have discussed.

I hope this helps. I am trying to emphasize that there are no absolute right answers here. There a lot of uncertainties, and the differences are in the way we deal with the uncertainties—ignore them, or be scared off by them—truthfully the “right answer” is probably somewhere in the middle. You might take another look at The Thyroid Paradox because it talks about many of the same issues regarding the use of thyroid hormone. In the case of thyroid hormone I do treat more often than most first-do-no-harm physicians do. I do that based on many years of experience and contemplation, which I have not applied to the testosterone-in-women question, so I am ethically obligated to go along with what the mainstream guidelines say. See?

All real medicine boils down to managing uncertainty. That is, accepting the possibility of error. Malpractice lawyers fail to grasp that—but that’s another story. With regard to testosterone therapy in women—especially otherwise healthy young women—I am counseling that we should err on the side of safety, and not do it, despite the possibility of denying the patient something that might help them feel better, and enjoy other benefits. XXXX and her provider, on the other hand, are erring on the side of feeling better. Just remember: cocaine makes people feel good, but most of us don’t advocate its use for that purpose.

Best,

jkr

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