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Hormone Replacement Therapy: Looking at it with fresh eyes

By Jeffrey Pearson, D.O.,


(Part 2)

Regarding heart disease, the past studies were horrible in design, for both women and men. Physicians had long assumed that it was estrogen that protected women against heart attacks based upon observation. Looking at men and women under the age of 50 who presented to the local hospital emergency department with complaints of chest pain, most of the time, men did have a heart attack whereas the women did not. Hence the reason for why so many physicians ignored women’s complaints of chest pain because “women can’t get heart attacks.”

It was assumed that women were protected by estrogen’s ability to improve HDL and through other mechanisms. In an attempt to prove this, the Heart Estrogen/Progesterone Replacement Study (HERS) was undertaken and the reported results shocked everyone by noting that there was no protective effect noted in the women who took HRT versus those who did not.

The investigators scared literally thousands of women from taking their HRT. This was a poorly designed study, however, with one big glaring fact: the average age of menopause in American women is 52 years of age (some sooner, some later); the average age of women in the HERS was nearly 67 years of age! In other words, they had already developed blockages in their coronary arteries by the start of the study.  Incidentally, when they look at the women who began HRT immediately after menopause, a cardio protective effect was noted.

It’s a similar story for men. Physicians thought that testosterone replacement would induce heart attacks because too high levels can cause polycythemia (increase in number of red blood cells). The problem with many of these studies is that they, too, were poorly done. Some had their conclusions of danger published despite their data indicating the contrary (substituting their beliefs of what they expected, rather than what really happened). How bad were some of these studies? In one large retrospective study that purportedly emphasized the cardiovascular dangers of testosterone, only patients’ charts were reviewed – not a single patient was examined/tested – AND, a lot of the “male” patients turned out to be women!

Fortunately, more recent studies in both men and women have vindicated the cardiovascular safety of HRT at therapeutic dosages.

So, how does one know if he or she needs HRT? The diagnosis in women is fairly straightforward – if a woman has stopped having menstrual flows and has complaints of hot flashes, poor sleep, mood changes, etc. – then it’s obvious and no laboratory testing   is required.

Different story for men as they do require laboratory testing for testosterone levels. Be aware that many people (physicians included) are unaware that so-called “normal” testosterone levels provided by a laboratory are not normal biological levels – they’re statistical normals. [This is how laboratory normals are established: a lab analyzes hundreds of thousands of patients who pass through their doors for testing. They take the mean (a type of average) and then go out 2 standard deviations on either side of the mean to create their normal range This large group represents 95% of the patients who submitted for a particular test.]

You may have noted that normal ranges vary from laboratory to laboratory. For example, the current “normal range” for total testosterone from LabCorp is 264-916 ng/dl.  For Quest Labs, it’s 250-1100 ng/dl.  If a male patient’s total morning testosterone was 400, this would be considered to be normal by both labs and their insurance companies would decline to pay for a testosterone prescription. The problem with this is that a man’s testosterone really needs to be above 600 mg/dl for normal healthy function, which means that many men unfairly wind up not being able to receive treatment for their fatigue, depression, loss of libido, etc.. If they elect to treat their low levels, it must come from out of their own pockets and this can be very expensive for brand name products (compounded formulations are much less expensive and work just as well, in my personal experience).

How to administer HRT? Many of us believe that the safest route is through the skin. There are no testosterone pills because they would screw up the liver. For women, there was a concern that perhaps oral conjugated estrogens could affect the liver, making the blood hypercoaguable and more likely to clot. Bypassing the “first pass” through the liver through topical administration theoretically makes HRT safer, hence many hormone preparations are prescribed for topical use, either as a patch, cream or suppository. The bioidentical HRT that many of us prescribe (for both men and women) is a cream that is easily applied every morning, which beats the heck of having to receive injections deep into the buttock on a regular basis (for men). (It also results in more stable daily levels than the highs and lows associated with the injections.)

As noted, brand name products for HRT can be very expensive, on the order of $400-$500 per month for a leading manufacturer of testosterone. Insurance co-pays might cut that down to $15-$45/month. Compounded products, on the other hand, are much more affordable, particularly if insurance won’t cover them – testosterone can range from $60-$80 per month, depending upon dosage strength. For women, compounded HRT cream runs in the vicinity of $50-$60 per month (and that includes 3 hormones: estradiol, progesterone, and testosterone all in one).

In summary, unless an individual has an absolute contraindication to HRT, it should be considered by both men and women to keep our bodies in good repair and functioning for as long as we remain on the planet. (end of part 2 of article series)

[Copyright, Jeffrey Pearson, D.O., F.A.O.A.S.M.]

Dr. Pearson is a Board-certified Family Physician and a past recipient of the national “Patient Care Award for Excellence in Patient Education,’ sponsored by the Academy of Family Practice and the Society of Teachers of Family Medicine. He is the medical director of Medicine in Motion, in Carlsbad, CA.