HORMONE REPLACEMENT: WHAT YOU NEED TO KNOW

In 1939, hormone therapy by use of pelleting was developed for women who had undergone radical hysterectomies (removal of the uterus and cervix). In other parts of the world, this practice is still widely used.

Unfortunately, many studies and reports done on “hormone” therapy don’t consider some important factors that make all the difference in health vs. illness, and benefits vs. side effects. In the case of hormone therapy, often little to no distinction is made in many cases between synthetic vs. true hormone therapy, and the route of hormone administration—oral vs. topical (e.g., creams) vs. transdermal (e.g., patch form) vs. subcutaneous (e.g., pellets injected under the skin). As we will see below, these details make ALL the difference.

One big reason that many patients, and even most physicians, are reluctant to consider hormone therapy are the numerous stories of bad outcomes or potential side effects that are backed up by multiple independent medical studies. A common one you may hear regards medications such as PremPro (a combination of Provera, a synthetic progestin with the synthetic estrogen Premarin). These synthetic “hormones” are not true hormones, but molecules created to mimic the effects of natural hormones. This medication is well known to carry a markedly higher risk of causing cancer. If you look at the warning label for this drug, it reads “CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY.”  Yikes.

To better explain that statement, if you look at synthetic progestins (progesterone replacement medication), they have been additionally found to block the benefits bio-identical estrogen has on nerve cells and limit the positive effects said estrogen has on lower harmful lipids (fats). Put those together and you have a drug that increases cancer risk, dementia, and heart attack/stroke risk all in one. Who wouldn’t be a bit freaked out by trying hormone therapy after reading that?

WHY HORMONE PELLETS?

By all available evidence, how the body receives hormones also makes a difference. Injections of a form of testosterone called cypionate (brand name Depo-Testosterone) are quite common nowadays, especially among men. But these injections have significant drawbacks. The first problem is that the dosing is time dependent; once injected, the countdown starts as the testosterone is metabolized and degraded, leading to a roller coaster effect of ups and downs depending on dosing date.

Additionally, there have been allergic reactions reported with the cottonseed oil medium that is used in the formulary, more issues with elevated liver enzymes, ramped up production of blood platelets (called thrombocytosis), and an increased rate of the body converting excess testosterone into high levels of estrogen (called aromatization), all of which can be dangerous for men (excess platelets = higher risk of stroke or heart attack).

The biggest issue is that the injections haven’t been shown to provide a significant and consistent elevation in blood testosterone levels. This is important because lacking this, you lose the benefit of protection of many disease processes that subcutaneous pelleting with bio-identical hormones provides—protection from osteoporosis, cardiovascular events such as heart attack and stroke, dementia, even diabetes and prostate cancer (we’ll touch on these later).

Creams and patches can have compliance issues (remembering to apply twice a day), and can pose health concerns for those accidentally exposed to the substance (e.g., there have been cases of children exposed to testosterone cream showing early secondary sex characteristics such as underarm and genital hair well before puberty). Also, these methods of delivery are notorious for having a wide variety in absorption rates in individuals. More importantly, much like injections, creams and patches also don’t provide the same level of protection from the diseases listed above that pelleting does because of inadequate and/or sustained blood levels of these hormones.

For example, a study by the American Journal of Obstetrics and Gynecology found that testosterone replacement by pelleting gave four times the increase in bone mineral density (BMD) recovery compared to oral estrogen, and two and half times greater than patches. Pellets show an increase in BMD of 8% per year, while patches show an increase of 3.5% per year, and oral estrogen1–2% per year)

The reality is that bio-identical hormones, correctly dosed and given after careful medical screening, provide several important advantages that other means of delivery do not:

  1. Convenience of implantation (typically 2–4 times/year) vs. taking a pill/applying cream or patch 1–2x/day.
  2. Providing a steady state of hormone release (i.e., no “ups and downs”) that’s regulated by cardiac output (i.e., activity) instead of time from application to break
  3. Proven efficacy with optimal bone mass improvement (as we saw above), which is crucial in the elderly, particularly post-menopausal women.
  4. No evidence of increased risk of stroke, blood clot formation, or heart
  5. No evidence of an increased risk of breast

TESTOSTERONE

The biggest challenge health care providers have when it comes to the subject of discussing testosterone replacement is combating the myths that have sprung up over the decades regarding its use, and separating fact vs. fiction. I’ll start off with a few; I’m sure these will sound very familiar to most of you:

#1: Testosterone is a “male” hormone. False. Both men and women need testosterone for optimal health and activity, although not in the same proportions. In fact, many of the issues women suffer from in later adulthood can be linked to testosterone deficiency (testosterone levels in women can drop as early as the mid-20s, and can lose 50% of their testosterone production by their 40s, whereas levels in men typically begin to decline a decade or so later). Keep in mind the AR gene (that makes instructions for the androgen, or “male,” hormone) is on the X, or “female,” chromosome.

#2: Testosterone supplements will “masculinize” women. False. If dosed correctly, side effects are typically minor, such as excess hair on the lip or chin (which happens anyway as women age—I have this on good authority from the women in my life, although normally they’d never admit it!). One myth is that even careful testosterone dosage will cause the clitoris to grow into what looks like a small penis.

The reality is that improved testosterone levels cause enlargement of the blood vessels to the organ, which cause it to more easily protrude from the labia. As for voice changes, this may be true for anabolic steroids, but not testosterone per se if used correctly. According to Dr. Donovitz, it would take 30 times the dosages that BRHT uses to have a masculinizing effect. When it comes to voice changes, recall that a good percentage of women’s voices change naturally due to several factors as they age (thickening of vocal cords at puberty, environmental factors, etc.).

#3: Testosterone will turn you into a rage monster (“roidasaurus” is the term I hear a lot now). Again, false. This is true only if the balance between testosterone and estrogen is disrupted (yes, men have estrogen in their system as well, just in lower amounts than women). Most instances of uncontrolled aggression that occur with individuals taking androgens involve the use of excessive amounts of aromatase inhibitors.

Aromatase is the enzyme that converts excess testosterone to estrogen. Like everything else hormonally related, it’s a balancing act—too little or too much can be harmful. Optimized levels of testosterone tend to make you calmer and more relaxed. If you won’t take my word for it as a BHRT patient, understand that many other BHRT recipients include members of the military and law enforcement community—not exactly the kind of professions where a treatment causing an uncontrolled violent streak would be a good idea!

On a personal note, as a martial arts instructor and practitioner of over 40 years, the absolute last thing on earth I’d ever subject myself to would be any treatment regimen that ran the risk of making me more impulsive and potentially violent, benefits be damned. And that goes double for the fact that I have a wife and two small children at home!

#4: Testosterone will give you a stroke, or cause blood clots or a heart attack. As always, the devil is in the details. Testosterone use began in 1942 to prevent peripheral vascular disease (i.e., the process that causes blood clots, heart attacks, and strokes)9, and 11 years later to treat chest pain (aka angina pectoris), with 91% of men and women showing a reduction of symptoms.

There is no evidence supporting the idea that testosterone given by hormone pellets will cause these conditions. Synthetic testosterone, such as that given with injections, has been found to increase the aggregation, or “clumping” of platelets in the blood and constrict blood vessels, both of which pose a risk for increased risk for stroke, MI, etc. But this effect is not seen with bio-identical testosterone pellets.

The reality is that testosterone in physiologically healthy doses is protective against cardiovascular events (stroke, MI), osteoporosis, dementia, and other neurodegenerative conditions such as Parkinson’s.

As for the idea that testosterone causes or increases the risk for prostate cancer in men without the disease, Morgentaler noted in 2006, after an in-depth review of medical history, that, “The historical perspective reveals that there is not now—nor has there even been—a scientific basis for the belief that T[testosterone] causes pCA [prostate cancer] to grow. Discarding this modern myth will allow exploration of alternative hypotheses regarding the relationship of T and pCA that may be clinically and scientifically rewarding.”12 It should be noted, however, that a man with a history of past or active prostate cancer will need to be screened and may have to hold off on testosterone therapy. Ask your BHRT provider about this if this is an issue.

The bottom line is that testosterone is responsible for the maintenance and optimization of hundreds of bodily functions, and more than just making you feel good, gets you well. If you just want to feel good, there’s no shortage of candy or soft drink machines, drug stores, or shady hucksters on a street corner that can provide you something to give you energy or a mood boost—for a while, and typically at a cost to your body. The goal of testosterone therapy is to make you both feel better (improved sleep, energy, bone and muscle mass, libido, et. al.) and be better.

ESTROGEN

Like testosterone, estrogen could be considered a “super hormone”; it’s produced by the ovaries and is responsible for over 400 different functions in women. Estrogen helps keep the skin looking youthful, burns excess body fat, provides cardiovascular protection, and prevents vaginal dryness and issues such as urinary incontinence.13 Also, like testosterone, estrogen replacement has been linked to several adverse events that were the result of poor data collection and/or not defining exactly what kind of estrogen was being studied.

We mentioned earlier the use of estrogen pellets in the 1930’s for women who had undergone hysterectomies and the advantages it provided. We also know that drop off in estrogen levels is a huge risk factor for increased mortality and morbidity (i.e., adverse health effects) in women, which has been corroborated by many studies. To name one, a group of women aged 50–59 who had undergone hysterectomies and no estrogen replacement were followed for 10 years. It was calculated that between 18,000 to as many as 91,000 died prematurely, primarily from AMI (acute myocardial infarction, aka “heart attack”) or breast cancer.

On a personal note, I recall talking to my father (the cardiologist, as you’ve already read) about heart attack victims. He said that in over 50 years of treating patients, while it was true that men tended to have heart attacks more than women, when an older woman (near or after menopause) had one, the end result was usually much worse. Why? Simple: the protection that adequate levels of hormones offered in both prevention and recovery of the death of heart tissue that occurs when an artery that feeds the heart muscle is physiologically “walled off ” was simply not there.

Like testosterone, estrogen deficit in women is associated with mood swings, depression, osteoporosis, the heart/circulation adverse effects mentioned above, as well as dementia, breast cancer, and Parkinson’s disease—all of which lead, directly or indirectly, to fatal outcomes. Decades ago, however, the pharmaceutical industry decided that synthetic estrogen was more profitable than bio-identical hormone pellets (since you can’t put a patent on a bio-identical substance) and came up with the synthetic hormone Premarin, which we discussed earlier. When the synthetic estrogen began to cause breast tenderness and excess vaginal bleeding in patients, at first it was treated by bio-identical progesterone (which helps regulate or moderate the effects of estrogen in women). But the drug companies found it more profitable to patent the synthetic progestin MPA (Provera), which lead to the rash of unfortunate outcomes we’ve been seeing for years, and still see today, despite knowing better.

As we’ll talk about in the next section, doing research into how to safely find an HRT formulary that works for you is difficult, because many of the studies that people hold up as gospel have been found to have holes in them, which has led to a lot of bad long-term outcomes for an untold number of patients.

STUDIES ON HORMONE REPLACEMENT: WHY SPECIFICS AND STUDY DESIGN MATTER

If you look anywhere on TV or in magazines, you’ll find a study that’s either validating or tearing down some drug, medical treatment, or wellness plan. As a rule, most people tend to believe their doctors when they’re told that “the medical literature shows” that this is good or bad for you. As physicians are, by nature, men and women of science, and the goal of science is to get to the truth, we have to ask: how reliable are those studies? How reliable was the data gathering and the interpretation of the results? What do they consider “normal” vs. “abnormal”? Without putting those crucial modifiers on research, all sorts of shenanigans can occur that can be misleading to the public.

The world is full of medical studies where the data was cherry-picked, exaggerated to prove/disprove a point, or was flat out wrong. As we’ll see below, HRT has fallen victim to errors and lack of attention to important details. What’s worse, bad or incomplete studies have scared many individuals off of HRT, and, as we have seen above, led to premature death or bad health outcomes.

In the United States, a nationwide study was begun in 1993 called the Women’s Health Initiative (WHI) with 16,000+ participants to study the effects of the synthetic estrogen and progestin combination therapy we discussed above on elderly and middle-aged women. The WHI concluded that the risks outweighed the benefits of this treatment.

If you recall what we discussed earlier it the chapter, however, the combination of Premarin, a synthetic estrogen (made from the urine of pregnant horses) and MPA (a synthetic progesterone, called progestin) have been well established to cause an increase risk in cardiovascular events and breast cancer. Unfortunately, the public, and even people in the medical field who should know better, threw out the baby with the bathwater, and concluded that all hormone replacement for peri- and post-menopausal women is dangerous and should be either avoided or used for a short duration (e.g., to combat the effects of hot flashes).

The key point in the paragraph above was that you need to have your I’s dotted at T’s crossed when you make a strong statement such as “HRT in women causes breast cancer.” While there is an established link with oral, synthetic estrogen and progestin to adverse outcomes such as stroke, heart attack, Alzheimer’s, or breast cancer (recall that MPA has been banned in Europe for decades for just this reason), no such link has been established with bio-identical hormone pellets. This isn’t just my opinion, it’s what I’ve learned by listening to other authorities (such as Dr. Donovitz) who have done exhaustive reviews of the medical literature spanning decades of research, and been able to figure out for myself.

THYROID HORMONES AND THE ATHLETIC POPULATION

Most people are familiar with the thyroid gland. It’s that roughly butterfly or H-shaped organ in the anterior neck that releases hormones necessary for human vitality. Its main function is controlling our metabolism— burning fat into energy, temperature, pulse rate, etc. Much like the hormones we’ve already discussed, it’s an important protector of disease processes, such as heart and circulation disorders, obesity, memory issues, excess fatigue, and blood sugar regulation. I’m quite sure anyone reading this book knows of someone who is on thyroid medication for the near ubiquitous lack of energy, weight gain, and “brain fog” so many people get as they age, because the thyroid tends to release lower amounts of triiodothyronine (aka T3) and tetraiodothyronine (aka thyroxine, or T4). Also, the enzyme that converts excess amounts of T4 (which the brain preferentially uses) to T3 (the one the body uses) also tends to drop off around age 40 or so. A bad double whammy for your health.

The problem, in my experience and that of many physicians, is that modern medicine is inexplicably focused on regulating the levels of thyroid stimulating hormone (TSH) via the use of levothyroxine (trade name Synthroid), which is not a thyroid hormone at all, but comes from the pituitary gland, an endocrine (i.e., hormone producing) organ in the brain. TSH, like the name suggests, stimulates the activity of the thyroid gland. But time and experience have shown that maintaining a “normal” TSH level is not predictive of thyroid-related symptoms. Personally, and professionally, I know several people who take levothyroxine and tell me their TSH is “in the normal range,” but still feel tired, cranky, sleep deprived, and even lousy.

Every person is different, and each will find his or her “happy place” with thyroid hormone replacement. In the case of free T3, the goal is usually to aim for the far-right end of the bell curve (around 4.0–4.4). But, again, treat the patient, not the number.

For an athlete, an underactive thyroid can manifest itself in subtle ways at first, then those effects become more pronounced. Back in my Sports Medicine fellowship, I recall a gentleman in his late 40s who had been physically fit and athletic his entire life, who came to us because he noticed that he was, as he put it, “a step or two off ” from where he was. He didn’t feel it was just being older; he slept enough and ate a healthy diet. But he noticed his energy was down, and his reflexes and reaction time were dulled (he was a fantastic racquetball player, a sport where fast decisions and reflexes are essential). He stated he felt like he was being blown off by other doctors and hoped that a group of Sports Medicine specialists could help. His labs all looked good, except that his TSH, free T3, and free T4 were all low, and, if I recall correctly, he went to his primary care physician to discuss treatment of these. If I’d known then what I know now about doing a hormone panel on him, I would have discussed the importance of treating his T3/4 instead of focusing on “normalizing” his TSH (which is what I fear his PCP did) as well as discussing BHRT.

As with testosterone and estrogen above, optimizing thyroid hormones is important for keeping that “edge” that most athletes need as they get older, especially in sports or activities where a second or two can be the difference between victory and defeat, or a personal best vs. the same- old, same-old result. Weight loss, while not a direct goal but nonetheless a benefit of thyroid hormone optimization, is important in the fact that losing that extra abdominal, or visceral fat (the dreaded “spare tire” or “middle age spread”) will remove the fat cells that are inflammatory in nature and increase a risk of cardiovascular issues. You can do a medical literature search on the link between abdominal fat and increased risk of stroke, MI. etc., and easily come up with dozens upon dozens of credible articles.

So, by optimizing metabolism, combined with exercise and good food choices, the secondary effect of healthy weight loss occurs, which leads to not just looking better (I’ve never heard anyone complain about being able to cinch their belts four or five extra notches or dropping down two pant sizes), but being healthier by losing those inflammatory fat cells. I would call that a win-win.

SOME EXAMPLES OF BIO-IDENTICAL HORMONE REPLACEMENT THERAPY OUTCOMES

CASE #1 – BIO-IDENTICAL HORMONE THERAPY REPLACEMENT FOR LOW ENERGY

Dave is a 39-year-old gentleman who…well, was good enough to explain his symptoms and experiences with hormone replacement therapy in his own words:

“My name is Dave and I’m a former Division One athlete in college. I have always lived an active lifestyle, but in my late 30s I really started to feel fatigued all the time. I couldn’t understand why, but I would literally hit the wall in the early afternoon, and this NEVER happened before. I was used to taking on more work than my peers and still being a very helpful spouse at home. Suddenly, I found myself too tired to keep the pace up. I knew something was wrong.

Things finally reached the breaking point for me when I could tell that my wife started viewing me as lazy for the first time in our lives together. I had learned years ago that I couldn’t keep up with her, but I know that I have never been referred to as lazy. Once again, I knew something was wrong.

I was 39 years old at the time and after talking to a co-worker who had a few years on me, he told me about pellet therapy and how it has literally changed his life. At that point, I started my research. After reading all the symptoms of having low T, I knew this was me!

I finally found Dr. John Stavrakos and after getting my blood work done, not only did I learn about other aspects of my body and health, I learned that I had very low levels of testosterone for my age. At first, I was a little embarrassed that an athletic guy like myself was in this position, but then I decided it was because I had literally used it all up in my younger years!

My first hormone insertion was a little scary, but after about a week, I start feeling like my old self and it was amazing. Not only did I have energy, but I could tell my body was handling everything better. My workouts in the gym were better and having better results. I was able to get rid of some of the annoying belly fat that was creeping onto my frame…After my first insertion, I didn’t get the second in a timely manner and my whole life fell apart as those low levels set in. One trip back to the Doc and my life is back on its normal path. Don’t be miserable… “Life is not a dress rehearsal.”

CASE #2 – BIO-IDENTICAL HORMONE REPLACEMENT THERAPY FOR POOR SLEEP

Janice was a 60-year-old woman who had ongoing issues of lack of restful sleep, energy loss, and dyspareunia (pain with sexual intercourse) for a few months prior to seeing me. She was not on any form of hormone therapy, but found that her day to day busy professional and personal life was suffering from these issues. After doing a careful medical screening and assessing her lab work (as always), Janice was found to be a good candidate for this procedure and received BioTE hormone pellet therapy. After doing her follow-up labs a few weeks after her procedure, we advised her to call us with any questions or concerns.

When she came in for her second round of pelleting three months later, Janice noted that she had received “amazing” results from the hormone replacement. The mood swings she had discussed with me were much better, her sleep was better, her libido had increased, and her pain with sex was all but gone. Janice has been coming in regularly since then for re-pelleting and has been very pleased with the positive change BHRT has made in her life.

CASE #3 – BIO-IDENTICAL HORMONE REPLACEMENT THERAPY FOR FATIGUE

Once again, it’s time for my story with BHRT. If you’re read this far you’ve picked up snippets of my story—going from active and fairly fit to fatigued with small aches and pains in multiple areas of my body—just past my mid-forties. While some of this was situational (more job responsibilities, the birth of our second child), it was plain to me that I didn’t feel “right.”

I recall hitting my shin on a guard rail I decided to vault over one day (pretending I was that younger me who did that all that time), and remarking at how long it took the pain and discoloration to go away— weeks as opposed to days like it used to. When I was able to get away to go exercise, I’d get 40–45 minutes into my routine and run out of motivation. For a guy used to using up all 90 minutes/2 hours of his workout time doing intense activities of jumps, kicks, punches, rolls, and falls, this was a huge departure from the norm.

Like most of us, I chalked it up to getting older, and tried “pushing through” the issues with longer sleep, making myself exercise harder, and eating better with limited results. I didn’t know of any safe, reliable alternative (that Peyton Manning commercial was playing like a broken record in my head almost daily). When I learned of bio-identical hormone replacement and had my labs drawn, I was surprised at the results, and not in a good way. Suddenly it all made sense.

A week after my first pelleting, I noticed how much deeper and more refreshing sleep was for me. Soon after, my energy level improved dramatically. I would sometimes work a 12-hour day and come home to play with my kids for a while, put my eldest son to bed (he likes some playtime, book reading and me holding him while I sing to him), and then come downstairs to talk to my wife while I ate a late dinner. When she said to me, “You must be exhausted,” I recall thinking for a moment and telling her, “It’s funny, I’m tired, but not dead tired like I should be.”

I have been a BHRT patient for nearly two years now. My lean muscle mass is up, energy is up, weight is down by at least 13 lbs., and I’m sorry to break it to Peyton, but I can see my abs again and I didn’t need to buy bigger shirts!

What my training had taught me was that the problem wasn’t just with the tendon in the forearm, like most modern medicine focuses on. It was in the ligaments underneath as well, because it’s a sure bet that the ligament instability (static stabilizers) put more strain on the tendon of the extensor muscles of the forearm (dynamic stabilizers).

Now, I don’t recommend self-injections like I did unless you have a little training under your belt. But I hope it will bring home the point for you, as it did for me, that even long-standing injuries like my bad elbow can be resolved.

A FINAL WORD ABOUT BIO-IDENTICAL HORMONE REPLACEMENT THERAPY

To improve or optimize athletic performance, it’s essential to do the same with your hormones. As the years progress, even the healthiest and fittest of people will see a decline in muscle mass, healing time, speed, strength, and reaction times. Most of us are all too familiar with the unhealthy ways to combat the effects of aging (anabolic steroids and other ergogenic, or performance-enhancing aides such as blood doping, etc.) which may provide a boost in ability, but at a terrible personal cost to one’s health.

The advantage of BHRT, when done correctly and under careful medical supervision, is that you can potentially get the best of both worlds— feeling better and being able to do more, while also truly being better, and protecting your body from the health issues that affect us over time.