Bioidentical hormones can be delivered in various ways including creams, patches, injections, sublingual and pellets. Data supports that hormone replacement therapy with pellet implants is an effective bio-identical method to deliver hormones in both men and women. Implants, placed under the skin, consistently release small, physiologic doses of hormones. Pellet insertion has been well researched since the 1930s as one of the leading Bioidentical Hormone Replacement Therapies. When using bioidentical hormones the benefits are exponential and even protective to our health.
Bio-Identical Hormone Pellet Therapy
Hormone pellets are placed under the skin, and consistently release small, physiologic doses of hormones.
What is BHRT?
- An individualized approach to hormone replacement therapy, using biologically identical hormones (BHRT), pinpoints a person’s exact hormone levels, and what hormones are needed to balance their hormone deficiency.
- The differences between synthetic and biologically identical hormones are in their chemical structures and functionality. Biologically identical hormones have the same chemical structure as the hormones created naturally in the human body.
What Are BHRT pellets?
- Fused pellet implants are compounded using biologically identical hormones (most often estradiol or testosterone).
- The hormones are pressed / fused into very small cylinders (inactive ingredient is stearic acid)
BHRT pellet implant history
- Hormone replacement using pellet implants has been used with great success in the U.S., Europe, and Australia since 1938.
- In fact, pellet implants were a very popular mode of hormone administration in the U.S. until the 1970s, when many oral and topical commercial products were developed. While the demand for pellets diminished in the U.S., pellet implants continued to be a very popular mode of hormone administration throughout Europe and Australia.
- In the last 10 years, due to advances made in processes and a better understanding of the benefits of fused pellet implants for hormone replacement, this mode of hormone administration has grown in popularity in the U.S.
Over 70 years of research shows:
- Pellet implants deliver consistent, physiologic levels of hormones.
- The consistent and physiologic dosing has been shown to maintain and improve bone density.
- One time procedure. No more worrying about creams, injections or supplements.
- Due to steady absorption there is less fluctuation of symptoms.
- Hormones are released into the blood stream in a way that mimics your own hormone rhythm.
- Consistent supply of hormones delivered through pellets reduces the chances of experiencing adverse side effects.
- Pellet implants bypass the liver and don’t negatively impact clotting factors, blood pressure, lipid levels, glucose, or liver function.
Pellets have been shown to improve:
- Cardiovascular health
- Sex drive and libido
- Headaches/migraines
- Insomnia
- Hot flashes and menopausal symptoms
- Mood and depression
- Joint aches and pains
- Diabetes
- Muscle mass
- Cellulite
- Motivation
- Mood enhancement
- Cardiovascular protection
- Fatigue
- Memory
- Mental clarity
Where are BHRT pellets inserted?
- Pellet insertion is a relatively simple in-office procedure done under local anesthesia.
- The pellets are inserted subcutaneously (under the fatty lining of skin), either in the lower abdomen or the upper buttocks through a very small incision. The incision is then closed with surgical glue or sterile-tape strips.
- If inserted correctly, patients cannot feel the implants under their skin. Implants placed under the skin consistently release small, physiologic doses of hormones, which have been shown to have many benefits.
How long do BHRT pellets last?
- Fused pellet implants typically last between 3-5 months, depending on how rapidly the hormones are metabolized.
- After insertion of the pellets, vigorous physical activity should be avoided for 2-3 days, or as suggested by the healthcare practitioner.
- Some patients begin to feel symptom relief within 48 hours, while others may take up to two weeks to notice a marked difference.
- The pellets do not need to be removed. They are completely dissolved by the body.
How do I know what hormones I need?
- Before starting any hormone replacement therapy, patients should work directly with a knowledgeable healthcare practitioner to have hormone testing done to evaluate their personal hormone profile.
- Based on existing hormone levels and health history, the practitioner will make a hormone replacement recommendation. Once pellets have been inserted, hormone levels will be reevaluated prior to the insertion of the next round of pellets.
- After the first year of therapy, the practitioner may suggest testing less frequently based upon patient feedback and prior hormone levels.
Estrogen pellets for women
- Estrogen is a woman’s most important hormone. Without hormone replacement therapy, the loss of estrogen puts her at increased risk for premature ovary failure, osteoporosis, heart disease, colon cancer, Alzheimer’s disease, tooth loss, impaired vision, Parkinson’s disease and diabetes.
- There are estrogen receptors in a variety of organs throughout the body and brain. That is why hormonal imbalance produces different symptoms such as loss of skin elasticity, bone shrinkage, moodiness and cognitive decline.
Testosterone pellets for women
- Testosterone hormone therapy gives a woman mental clarity, libido and muscle tone and mass. When this hormone is at low levels, women often complain of mental confusion, weight gain and poor muscle tone, even with regular exercise.
- The effect of hormone deficiency on the brain, muscle, bone, heart and metabolism can be significant without hormone replacement therapy for women, and it can be dangerous to long-term health. The brain needs normal amounts of testosterone in balance with estrogen to produce serotonin, which supports emotional balance.
- The musculoskeletal system is also adversely affected by the loss of testosterone. By not having bio-identical hormone therapy, the deficiency or imbalance of testosterone can lead to muscle atrophy, osteopenia, osteoporosis, and pain in the muscles and joints.
- Testosterone implants have been used in women. Doses used in studies are as low as 25mg and up to 225 mg. In the United States, common doses are 50, 75, 100, 110 mg, 125 and 150 mg. There are minimal side effects at these doses (slight increase in facial hair 20% and mild acne 5%), which may be reduced by lowering the dose, if the patient chooses.
Testosterone pellets for men
- The routine doses of testosterone delivered by pellet implantation in recent studies are between 500 and 1200 mg in men. The pharmacokinetics and pharmacodynamics are well established showing that these doses deliver reproducible physiologic levels of testosterone for 4-6 months.
- Testosterone implants have a near linear release rate. Peak serum testosterone levels with the implants are usually seen at month one. Therapeutic testosterone levels at month one, are expected at the upper limits of normal for healthy young males (800-1100 ng/dL). By month 4 to 5 testosterone levels drop to below 500-600 mg/dL at which time symptoms return and the pellets are reinserted. Each individual has their own reproducible levels where symptoms return.
How are hormones monitored during therapy?
- Hormone levels will be measured and evaluated before therapy is started.
- Women’s labs may include a FSH, estradiol, testosterone and free testosterone.
- Men’s labs may include a PSA, sensitive estradiol, testosterone, liver profile and blood count prior to starting therapy.
- Thyroid hormone levels may also be evaluated.
- Levels will be reevaluated during hormone therapy every 4-5 months, usually prior to insertion of the next set of pellets,
- After the first year of therapy, hormones levels may be followed less frequently.
- Men must notify their primary care physician and obtain a digital rectal exam each year.
- Women are advised to continue their monthly self-breast exam and obtain a mammogram and/or pap smear as advised by their gynecologist or primary care practitioner.
Are there any side effects?
- Generally, there are minimal side-effects associated with the pellet implant procedure.
- Complications include: minor bleeding, bruising, infection, and pellet extrusion.
- Other than slight bruising, the other complications are very rare. Hormone side-effects vary and should be discussed with your healthcare practitioner
Can a patient be allergic to the implants?
- Very rarely, a patient will develop local zone of redness (3-8 cm) and itching at the site of the testosterone implant.
- There is minimal or no tenderness and no other sign of infection. Many pellet formulations include stearic acid and PVP (povidone). Patients may react to the PVP.
- Many patients who develop a local reaction to the implant have low cortisol levels and upon further questioning, have symptoms of adrenal insufficiency. Cortisol testing may be recommended. If needed, 25-50mg of Benadryl works well for the itching.
Safety
- Pellets do not have the same risk of breast cancer as the synthetic progestins or synthetic Methytestosterone.
- In fact, studies show a reduction in the incidence of breast cancer with the implantation of testosterone pellets, with or without estradiol pellets (Dimitrakakis 04, Tutera 09).
- Even after over 20 years of therapy with hormone implants, the risk of breast cancer is not increased (Gambrel 06). In breast cancer survivors, hormone replacement therapy with pellet implantation does not increase the risk of cancer recurrence or death (Natrajan 02) as does estrogen in combination with the synthetic progestins (Habits Trial 04).
- Hormone replacement therapy with pellet implantation has an extremely low incidence of side effects (Cardoza 84, Barlow 86, Ganger 89, Pirwany 02) and high compliance rate (Gambrell 06). It has been shown to be extremely effective in the treatment of migraine headaches (Magos 83).
- Testosterone replacement therapy in men with subcutaneous implants (pellets) has been shown to be extremely effective, convenient and safe. (Handelsman 90, 92, 97, Kelleher 01, 04, Conway 88, Jockenhoval 96, Zacharin 03, Schubert 03, Dunning 04).
- A patented form of testosterone pellet with brand name Testopel has been FDA approved since before 1982.
Sources:
- Cited with permission – College Pharmacy
- Cited with permission – Wells Pharmacy Network