Bioidentical Hormone Replacement for Men

Bioidentical Hormone Replacement for Men

A (not so) funny thing happens to men as we mature.  After the career is launched, the job and family fortune secured, the promise of youth gives way to “I’ve made it,” what next? settles in, or “I didn’t make it, so it goes,” we notice, our muscles shrink, our performance in the bedroom falls off, we tire easily, we gain weight, especially around the middle, we don’t sleep as well, we acquire dark spots on our skin, “hey, those weren’t there last week,” and we might even be overtly depressed.  What is going on?

The I Ching, China’s oldest text, presents us with the perfect explanation of this phenomena.  Qi, or “life force,” describes, for men, eight year cycles or patterns of evolution. (1)

  1. A man’s Kidney energy is prosperous, his hair develops and his teeth emerge at the age of eight (1x 8).
  2. His Kidney energy grows and is filled with vital energy, and he is able to let his sperm out at the age of 16 (2×8).
  3. His Kidney energy is developed, his extremities are strong, and all of his teeth are developed by the age of 24 (3×8).
  4. His body has developed to its best condition, and his extremities and muscles are very strong at the age of 32 (4×8).
  5. His Kidney energy begins to decline, his hair falls out and his teeth begin to whither at the age of 40 (5×8).
  6. His Kidney energy declines more, the yang energy of the entire body declines, his complexion becomes withered and his hair turns white at the age of 48 (6×8).
  7. His Liver energy declines as a result of Kidney deficiency; the tendons become rigid and fail to be nimble at the age of 56 (7×8).
  8. His essence and vital energy is weak, as are his bones and tendons. His teeth fall out and his body becomes decrepit at the age of 64 (8×8).

Chi Po, the Yellow Emperor’s scribe, who recorded the ancient wisdom, specifically highlighted cycle 4 when the body is best developed (age 32), and cycle 5, when the Kidney energy begins its’ decent.  Thinning hair and withering teeth are no one’s idea of a good time.

Beginning around age 35 or so, our brain, and the rest of our systems, begin to slow.  In the past, this was considered a natural, “shelf life” and was accepted as entirely “normal.”  As we extend life towards 100 years of age and beyond, those of us in the “middle” want and need to remain vibrant, healthy and productive.

Enter Bioidentical Hormone Replacement Therapy (BHRT).  Like a finely tuned, high end race car, our bodies need certain fluids and filters to operate at maximum capacity. Chevy’s and Maserati’s both need oil, brake and transmission fluid to function optimally.  Testosterone, DHEA, Vitamin D, adequate thyroid hormones, peak nutrients, and low levels of inflammation are middle age man’s fluids and filters necessary to function optimally.

Testosterone is the big dog in this hunt and rightly so.  It is the “juice,” that makes a guy a guy.  (Don’t fret ladies.  Women need testosterone too.  We will cover that in BHRT for Women.)

Testosterone is the main male sex hormone produced in the testicles and adrenal gland and secreted in the testes.

Passing between life Cycles 4 and 5, around age 35, men produce approximately 1-2% less testosterone per year.  An estimated 20% of men over the age of 50 have abnormally low testosterone levels. (2) Between ages 35 and 75 men experience a 30% decrease in total testosterone and a 50% decrease in unbound (usable) free testosterone. (3)

Signs and Symptoms of Testosterone Deficiency:

  1. Low libido and an inability to maintain an erection
  2. Anxiety, depression
  3. Weight gain, decreased fitness level and decreased effectiveness of workouts
  4. Low self esteem
  5. Thin drying hair, sagging cheeks, droopy eyelids, thinning lips
  6. Thin, pale, dry skin, with poor turgor
  7. Muscle wasting
  8. Memory loss, joint pain
  9. Loss of drive, competitive edge
  10. Increased brain aging
  11. Cardiovascular Aging; Increased Incidence of Heart Attacks and Strokes
  12. Hot flashes
  13. Persistent fatigue
  14. Irritable, nervous and hesitant
  15. Increased fat in hips, abdomen, and breasts
  16. Anemia

Benefits of Restoration of Adequate Testosterone Levels:(4)

  1. Increased sexual interested and sexual performance
  2. Increased sense of well-being
  3. Increased muscle mass, strength, endurance, and exercise tolerance
  4. Adequate memory
  5. Improved skin turgor
  6. Decreased body fat
  7. Maintained bone strength, protection against osteoporosis
  8. Elevated brain norepinephrine enhancing memory and cognition.
  9. Cardio-protection
  10. Decreases in inflammatory markers interleukin 6, c-Reactive Protein, TNF-alpha.)
  11. Increases anti-inflammatory markers IL-4, IL-10
  12. Reduced clotting factors (PAI)-1 and Fibrinogen.
  13. Reduced LDL (bad) cholesterol and improved insulin sensitivity
  14. Protection against high blood pressure, arthritis and excess body fat
  15. Protection against diabetes, insulin resistance and multiple sclerosis
  16. Prevention and treatment of depression.
  17. Prevention of Alzheimer’s disease and dementia
  18. Relief from Dry Eye Syndrome
  19. Adjunct therapy for chronic lumbar pain and chronic pain associated with fibromyalgia.

 

The combination of a progressive decline of testosterone along with the excess production of a binding protein, sex hormone binding globulin, rendering the remaining testosterone even more ineffective, results in “male menopause,” or “andropause.”

Andropause is implicated in the development of many chronic diseases of aging including diabetes/metabolic syndrome, dementia, Alzheimer’s Disease, coronary artery disease and myocardial infarctions, Frailty Syndrome, osteoporosis, and chronic inflammation.

The Question of the Day is:

Do I Have Low T?

The answer, of course, is maybe.  Clearfield Medical Group employs a variety of diagnostic tests including blood, urine and saliva to test not only testosterone, but estrogen, human growth hormone, insulin, DHEA, thyroid function, cholesterol, blood sugar and blood count.

Subjectively, we can infer a possible or probable deficiency by reviewing the symptoms listed above or by taking this short quiz.

Testosterone Quiz (5)

                                                                                      Never (0)                             Always (1)

  1. My face has gotten slack and more wrinkled.
  2. I’ve lost muscle tone.
  3. My belly tends to get fat.
  4. I’m constantly tired.
  5. I feel like making love less often than I used to.
  6. My breasts are getting fatty.
  7. I feel less self-confidant and more hesitant.
  8. My sexual performance is poorer than it used to be.
  9. I have hot flashes and sweats.
  10. I tire easily with physical activity.

Add up your Overall Score ____________: 3 or less: Satisfactory level: Between 4 and 7: Possible Testosterone Deficiency: 8 or more: Probable Testosterone deficiency.

What Can Go Wrong?

Side Effects of Testosterone Therapy:

  1. Increased RBC’s (Polycythemia)
  2. Gynecomastia
    1. Always have your estrogen levels measured before treatment, and regularly thereafter, every 3-6 months in the first year of testosterone therapy.  If your practitioner does not do this, or says it isn’t necessary, run; run as fast as you can and call us.  We always, always, always monitor and measure estrogen levels in men contemplating or those on testosterone. The remedies are plentiful, safe, and inexpensive.  The consequences for ignoring high estrogen levels run the gammet from chest wall disfigurement, i.e. “man boobs” to advanced cardiovascular disease.
  3. Fluid retention
  4. Decreased Testicle Size
  5. Decreased Sperm Count
  6. Elevated PSA

Are there remedies for these side effects?   I joke that after twenty years of treating hormone deficiencies, I’ve made every mistake in the book.  Fortunately attention was paid and I’ve learned to appropriate corrections when necessary.  Any adverse effects from bioidentical testosterone can be managed if identified early.  Don’t be a stranger.  If you are having issues with testosterone or any hormonal therapies, do not hesitate to call.

Increases in hemoglobin, or red blood cell counts are one reason men experience increased strength and energy. Increased numbers of red blood cells increases oxygen carrying capacity.

The fear of blood clots and strokes due to increased red blood cell mass is, when using bioidentical testosterone, unjustified.  Increases in red blood cell mass due to testosterone do not result in changes in clotting factors.  Hence, athletes who “T  Juice” do not experience vascular catastrophes even when their hemoglobin’s reach even 23 and 24 grams per deciliter (normal is 13-17 gm/dl).

Easy remedies include phlebotomy and decreasing the testosterone dosage.

Gynecomastia, breast enlargement, i.e. “man boobs,” results from the break down of testosterone to estradiol.  We always, always, always measure Estradiol, and if elevated, treat with a prescription or natural Aromatase inhibitor.

Fluid retention is usually dose dependent.  If reducing testosterone dosage fails to correct the excess edema, a testosterone alternative (see below) is appropriate.

Decreased testicle and sperm count due to decreased testicular fluid, can be remedied by using a Luteinizing Hormone Stimulator, either exclusively or simultaneously with testosterone.  Young men who desire to continue their family lineage should be treated with testosterone alternatives.  Sperm count may not recover after stopping testosterone therapy.

Elevated Prostate Stimulating Antigen (PSA) is dependent on the timing of the lab study.  PSA should be done on day 5-7 post testosterone injection or 12 hours after application of testosterone cream or gel.

Doesn’t Testosterone Cause Prostate Cancer?   This myth grew up around hormone therapy without any basis in realty.  Multiple studies repeatedly failed to demonstrate the exacerbation of voiding symptoms attributable to benign prostatic hypertrophy during testosterone supplementation. (6)

Testosterone replacement therapy appears to have little effect on prostate tissue androgen (PSA) levels and cellular function and causes no significant adverse effects on the prostate.  At the present time, there is no conclusive evidence that testosterone therapy increases the risk of prostate cancer or benign prostatic hyperplasia (BPH)(7)

In 1941 Huggins and Hodges reported that reductions in testosterone via castration or estrogen treatment caused metastatic prostate CA to regress.

Administration of exogenous testosterone caused a prostate cancer to grow in one patient. Multiple reports debunked this “theory,” revealing instead, no prostatic progression with testosterone administration and no increased risk of prostate cancer in clinical trials of testosterone supplementation based on longitudinal or population‐based studies of high‐risk population of hypo-gonadal men receiving testosterone treatment. (8)

“No compelling evidence at present suggests that men with higher testosterone levels are at greater risk of prostate cancer or that treating men who have hypogonadism with exogenous androgens increases this risk.  In fact, it should be recognized that prostate cancer becomes more prevalent exactly at the time in a man’s life when testosterone levels decline.” (9)

Close to Thanksgiving, 2013, a startling report, contradicting everything we thought we knew about testosterone made national headlines.  Testosterone Causes Heart Attacks!

“Don’t Ask Your Doctor About Low T,” read The New York Times.  New study links Testosterone Supplements to Heart Attacks, read Scott Pelley on the CBS Evening News.  “FDA Evaluating Safety of Testosterone Products,” was Forbes Magazine’s take.

So what of this?  Virgin et al (10) published a study in JAMA claiming the risk of non-fatal MI greater in the 3 months after testosterone therapy.  It was a bombshell.  My attorney friends called gleefully anticipating another huge windfall “saving” innocent victims of another example of “bad drugs” being foisted on mankind to line one’s pockets.

How could this be?  After thirty years and hundreds of studies documenting improved cardiac function, improved vascular blood flow, lower blood pressure, lower cholesterol levels and lower by 50% overall mortality in those treated with testosterone versus those not treated. (11)

It didn’t take long to spot the multiple flaws in the study rendering it worse than useless.  No patients were actually seen by the “investigators.”  They relied on after the fact medical records.  No information was ascertained on the preparation, dose or interval of usage of testosterone.  No info on fatal MI or cardiovascular mortality or all-cause mortality was established and incredibly, no information on testosterone serum levels before or after therapy were determined. (12)

In fact, the adverse events reported by the investigator, Virgin belie his conclusions:(12)

Cardiac Events

No Testosterone Patients: 21% had Cardiac Events

Testosterone Treated Patients: 10% had Cardiac Events.

Deaths

Without Testosterone = 9% deaths

Testosterone Treated Patients = 5% deaths

Professor Andre Guay, Prof. Of Endocrinology, Tufts University summed this whole fiasco up neatly:

“People find it hard to believe that JAMA would publish a study in which the percentages of men who suffered an adverse event was lower by half in men who received testosterone than untreated men, yet results were reported as if the opposite were true. There is nothing believable in this study.”(13)

The most egregious errors committed by the authors included improperly excluding 1132 men from analysis, leading to an 89% error rate in sampling.  100 women were included in the study group, meaning that one out of eleven “men” in the study were actually women.

Eventually more than 160 leading testosterone researchers and 29 medical societies from around the world called for retraction of the study following revelation of the data errors, asserting that the magnitude and quality of the errors rendered the study “no longer credible.” (14)

“Nuff said.

Testing:

a.  Serum (Blood)

CBC, Total/Free Testosterone, PSA, DHEA-S, DHT, SHBG, Estradiol, LH/FSH, Lipids, Glucose, Insulin, HBA1C, Prolactin, IGF-1  or

b.  24 hour urine, Saliva, Blood Spot

Repeat Total/free T, CBC, PSA, Estradiol, every 3 months in year one of therapy or sooner if S/S deficiency or excess occurs. (15)

(Caution: No sexual activity, exercise for 72 hours prior to exam)

Treatment Considerations

We recommend an anti-inflammatory, ketogenic, low glycemic index diet.  Confused?  We developed an online program that can deliver specific dietary recommendations to boost your testosterone delivered to your email inbox on a daily basis.

You are not just testosterone. Balance of all hormones including estrogen, progesterone, DHEA,  insulin, cortisol, thyroid, Vitamin D, and testosterone is key.

Get adequate sleep, reduce stress, toxin exposure and inflammation.  Get adequate strength and cardiovascular training.

Testosterone Replacement(16)

(Goal:  Total 700-1100 ng/dl, “Free” 170-200 pg/dl, Quest, 30-40 Lab Corp.) (11)

  1. Oral-Methyltestosterone-Hepatotoxic.  Contra-indicated.
  2. Sublingual
  3. Transdermal
    1. Commercial Products (Synthetic-Not Recommended)
    2. Compounded-Preferred
  4. Injectable-Esters in Oil
    1. Testosterone Cypionate
    2. Testosterone Ethanate
  5. Pellets
    1. Bio-identical Testosterone implanted in buttocks via small incision.
    2. Lasts 4-7 months
    3. Delivers a time released steady level of hormone
  6. Human Chorionic Gonadotropin (HCG)
    1. Produced in Human Placenta
    2. Is an LH analog
    3. Stimulates testes to produce testosterone
    4. Does not affect sperm count or testicular volume
    5. Preferred if patient is under 40 or seeks fertility
  7. Clomephene (17)

Contraindications for Testosterone Therapy (18)

  1. Active Prostate Cancer
  2. Prostate nodules or indurations
  3. Breast Cancer
  4. Unexplained PSA elevation
  5. Hematocrit > 50
  6. Unstable Congestive Heart Failure
  7. Sleep apnea
  8. If fertility is an issue use HCG

How to Take Your Hormones (23)

Transdermal

  1. Use the recommended site. Rotate locations to prevent skin irritation.
  2. Application should be to clean, dry skin. Never apply hormones to broken inflamed areas.
  3. Avoid skin lotion at the application site.
  4. Place drug at site that is not subject to being rubbed off by clothing or movement.
  5. Wash hands thoroughly before and after applying the drug. Do not touch mouth or eyes after applying drug.
  6. Report any skin irritation.
  7. Keep gels it tightly closed.
  8. Only apply a thin film of the preparation.
  9. Do not wash the area for a few hours to allow the drug to have sufficient time to have an effect.
  10. Testosterone Cream – often best to apply this on the upper inner thigh or inner arm. Apply in the morning.  Testosterone cream can transfer to wives, chldren, lovers pets and goldfish.  Apply after a shower and when you will not be touched for 3 to 4 hours.  Change the site daily as hair growth will occur if placed on the same site. (Unfortunately this does not apply to the scalp.)

Oral Preparations

  1. Thyroid –take with sip of water on an empty stomach on waking. Nothing to eat or drink for 1/2 to 1 hr. after taking
  2. DHEA – take in the morning with breakfast.
  3. Pregnenolone – take in the morning with breakfast.
  4. Vitamin D3 (Prohormone) – take at bedtime.
  5. Melatonin – take at bedtime.
  6. Cortisol (Cortef)– best taken 10 am and 2 pm.
  7. HGH with IGF 1, IGF 2 (GH Secretagogue Spray) – 2-5 puffs under tongue at bedtime.

Injections

  1. Growth Hormone – inject S.C.at bed time.
  2. HCG – inject in the morning (S.C. or I.M.)
  3. Testosterone – inject in the morning (I.M or S.C.)

Male symptom list

Androgen DeficiencyAndrogen ExcessEstrogen DeficiencyEstrogen Excess
___Low libido___Acne___Hot flashes__Nocturia
___Decreased Erections___Oily Skin___Night Sweats__Decreased Urine
___Prostate Problems___Aggression___Apathy__Increased  Urine
___Decreased Urine Flow___Irritable___Brain Fog__Frequency
___Increased Urinary Urgency___Anxious___Bone Loss__Poor Libido
___Memory Loss/Brain Fog___Red in Face___Depression__”Man Boobs”
___Decreased Mental Acuity___Edema__Palpitations
___Arthritis__Irritbility
___Joint Pain__Headaches
___Bone Loss__Elevated
___Decreased Muscle Mass __Triglycerides
___Fatigue/Decreased Stamina
___Sleep Disturbance
___Depression/”Burned Out”
___Heart Palpitations
___Thinning Skin/Hair Loss
___Irritablity
___Face is Slack and Wrinkled
___Less Self Confidence/Hesitant
Progesterone DeficiencyProgesterone ExcessCortisol DeficiencyCortisol Excess
___Bone Loss__Sleepiness__Fatigue__Sleep Disturbance
___Prostate Issues__Mild Depression__Sugar Craving__Bone Loss
___Decreased Urine Flow__Allergies__Fatigue
___Increased Urinary Urge__Asthma__Weight Gain
___Decreased Libido__Sinusitis__Muscle Loss
___Sleep Disturbances__Chemical Sensitivity__Thinning Skin
__Stress__Anxiety
__Aches/Pains__Stress
__Neck/Back Pain__Sugar Cravings
__Muscle Stiffness__Memory Lapses
__Hives/Itching
__Fibromyalgia
__Low Blood Pressure

References

  1. Twicken, D. “I Ching and Cycles of Jing,” Acupuncture Today, February, 2004, Vol. 5, Issue 2. http://www.acupuncturetoday.com/mpacms/at/article.php?id=28397
  2. Hormones; A Primer, Physicians Guide to Anti-Aging and Regenerative Medicine, 2009, 132
  3. Korenmann SG, Morley JE, Mooradian AD et al. Secondary Hypogonadism in older men: its relationship to impotence. J Clin Endocrinol Metab. 1990 71:963969
  4. Hormones; A Primer, Physicians Guide to Anti-Aging and Regenerative Medicine, 2009, 132
  5. Hertoguhe, T;Hormone Deficiency Quiz; Lecture Notes BHRT Lecture Series, February 25-28, 2015, p. 6
  6. Rhodeet al. “Medical Progress: Risks of Testosterone Replacement Therapy and Recommendations for Monitoring.” N Engl J Med 2004; Jan 29; 350:482‐492n E
  7. Bassil et al, “The benefits and risks of testosterone replacement therapy: a review,” Therapeutics and Clinical Risk Management 2009: 5 427‐448
  8. Morgentaler A Testosterone therapy and prostate risks: where’s the beef? Can J Urol. 2006 Feb;13 Suppl 1:40‐43
  9. Roden, E et al,” A Medical Progress: Risk of Testosterone replacement therapy and recommendations for monitoring,” NEJM 2004; 350:482-492
  10. Vigen R et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013 Nov 6;310(17):1829-36
  11. Morgantaler, A et al. Testosterone Therapy and Cardiovascular Risk:Advances and Controversies. Mayo Clin Proc. February 2015;90(2):224-251 18
  12. Vigen R et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013 Nov 6;310(17):1829-36
  13. http://www.prnewswire.com/news-releases/twenty-five-medical-societies-join-androgen-study-group-to-petition-jama-to-retract-misleading-testosterone-study-254707661.html
  14. Morgentaler A, Lunenfeld B. Testosterone and cardiovascular risk: world’s experts take unprecedented action to correct misinformation. Aging Male. 2014;17:63-65.
  15. Bassil et al, “The benefits and risks of testosterone replacement therapy: a review,” Therapeutics and Clinical Risk Management 2009: 5 427‐448
  16. Bassil, et al, “The benefits of testosterone replacement therapy, a review,” Therapeutics and Clinical Risk Management 2009: 5, 427-448.
  17. Katz, D., “Outcome of clomiphene citrate treatment in young hypogonadal men,” Brit Jour Urol Int 2012; 10(4):573-78. ◦ Shabsigh, A., et al., “Clomiphene citrate effects on testosterone/estrogen ratio in male hypogonadism,” Jour Sex Med 2005; 2(5):716-21.
  18. Morgentaler A Testosterone therapy and prostate risks: where’sthe beef? Can J Urol. 2006 Feb;13 Suppl 1:40‐43
  19. Roden, E et al,”A Medical Progress: Risk of Testosterone replacement therapy and recommendations for monitoring,” NEJM 2004; 350:482-492
  20. Hertoghe; The Hormone Handbook, 2006, International Medical Publications, UK, p. 221.
  21. Bassil, et al, “The benefits of testosterone replacement therapy, a review,” Therpeutics and Clinical Risk Management 2009: 5 427-448.
  22. Tsujimura, A, et. al. “Treatment with human chorionic gonadotropin for PADAM.” Aging Male, 2005 Sept-Dec.; 8(3-4):175-179
  23. Simpson, G,”How To Take Hormones.” 2010

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