Bioidentical Hormone Replacement Therapy

Pellets have been used as a hormone replacement therapy (HRT) since 1939, when it was mainly used for women who had radical hysterectomies. Bioidentical HRT was popular until 1942, when Wyeth/Ayerst (a pharmaceutical company) developed Premarin. This dominated the industry. Bioidentical hormones cannot be patented because they are natural, so it doesn’t benefit pharmaceutical companies to market them.

Unlike synthetic hormones, which have to be altered before the body can process them, bioidentical hormones go directly into the body and are quickly absorbed.

• Pellets help the body regulate hormones back to their natural state before the therapy was needed.
• Within the first 24 hours of pellets entering the body, capillaries are formed around them.
• The blood constantly flows past the pellets and absorbs the hormones. This means that there is no inbetween time and no “roller‐coaster effect.”
• For patients who have trouble remembering or keeping up with the therapy, BioTE® can be extremely helpful.

BioTE® pellets are made from the steroid ring of yam or soy plants. These are used to create estradiol and/or testosterone molecules. These don’t cause cross allergies in patients that are allergic to soy because it is not the same molecule that cause reactions. The binding agent is stearic acid, which very rarely causes an allergic reaction. If you have taken aspirin, you have had stearic acid.

The BioTE® pellets are about the size of a large grain of rice. These usually aren’t felt through the skin, but it isn’t cause for concern if you do feel them. Often times, the area of insertion is just swollen. It is important to limit gluteal exercises after insertion for 72 hours for women and 7 days in men.

The pellets themselves are not FDA approved, but the estradiol and testosterone hormones in them are. BioTE® pellets are subject to strict regulation by the FDA because they are made in a 503B facility.

BioTE® pellets are different from other HRT pellets in that they are tested for ultimate quality and must pass 8 quality measures. They are E Beam sterilized, which means they are given the highest-quality sterilization possible, with a 3% variance in T and a 5% variance in E.

Depending on age, activity levels, and stress levels, women typically receive treatments every 3 to 6 months. Most women experience relief from symptoms between 3 to 4 months. Men usually need treatment every 4 to 6 months. The more active you are, the easier you will absorb the hormones in the pellets, but this will also speed up the process.

• Because pellets are bioidentical, they are more easily absorbed by the body.
• They are metabolized through the kidneys rather than the liver, which means the production of byproducts is minimal.
• This method of absorption also bypasses the stomach, allowing more of the hormones to be used.
• Blood flows past the pellets, so you will get their full effect over time.
• Cardiac exercise is vital for proper absorption of the pellets, so they can help motivate you to live a healthier lifestyle.

For women, lab work will consist of testing for the following: Total Testosterone, Estradiol, TSH, FSH, Free T3, Total T4, CMP (comprehensive metabolic profile), Vitamin D, TPO and B12 (lipids are optional)

For men, lab work will consist of testing: Total Testosterone, Estradiol, Free Testosterone, TSH, PSA (for men 50‐69), Free T3, Total T4, TPO, CMP (comprehensive metabolic profile), Vitamin D, CBC, Vitamin B12 (lipids are optional).

• Patients do not need to stop taking their medications prior to bloodwork. If you are using a different method of HRT, like patches, oral medicines, or cremes, do not use them right before getting blood work.
• For those who take injectable hormones, it is recommended that the bloodwork be taken the same day the shot is supposed to be given (before they receive their shot).
• Once pelleted, women should remain on the regular estrogen for HRT for 3 days and stop taking this on day 4. For those using testosterone cream, they should stop using this method after 7 days.
• Men should stop using their existing HRT methods 7 days after getting BioTE® pellets.
• If any patient is using thyroid medications, BioTE® suggests they take this medicine 4 to 5 hours before blood work is taken.

Premenopausal women should remain on birth control to prevent pregnancy. If you are pregnant or are trying to become pregnant, pellets are not recommended.

Salivary testing measures the hormones that are in the saliva, not in the rest of the body. This means it gives an inaccurate idea of what hormones are coursing through your entire system. One important hormone that is vital in determining menopausal status, FSH, cannot be found in saliva.

It can take 24 to 72 hours for the pellets to get into your bloodstream. Patients can start seeing relief from symptoms after 24 hours but this can take up to 3 weeks. If you do not feel relief in this time frame, talk to your doctor about altering your dosage. Some patients start at low doses, so they will not see benefits until the second treatment.

Women

• Fluid retention can happen, especially during the warmer months. Some doctors may prescribe a low dosage medication to help if needed.
• Post-Menopausal Bleeding: Some women may experience irregular bleeding after starting on hormone therapy. Most of the time this is due to patient compliance with progesterone, however, it is important to remember that NO bleeding in menopausal women should ever be considered normal. Please remember that Progesterone should be taken at the same time every night with food.
• Acne is common in patients who are prone to this condition, so some doctors may prescribe Spironolactone or minocycline.
• Hair growth may be faster for those who have HRT. If this concerns you, spironolactone (a DHT blocker) may help, as well as dosage changes.
• About 1% of women experience hair thinning, which could be a result of a thyroid imbalance or testosterone conversion to DHT (dihydrotestosterone).

Men

• Mild fluid retention, increased hair growth, and acne can also happen in men. Testicular shrinkage can also occur.

A healthy diet and exercise regimen are important for regulating hormones. Even with this healthy lifestyle, changes may take some time to occur. Typically, changes in the body are noticed 4 to 6 months after starting therapy, during the second or third insertions.

BioTE® pellets are released based on cardiac output and blood flow, so the more active you are, the more hormones you will receive.

Shots can give you a “roller coaster” effect because of the surge of hormones and drop in amount when the injection is given. Natural pellets release hormones over a steady, constant period, so the body can absorb and use them more easily.

Patients report an initial stick from the needle and a burning sensation from the lidocaine/bicarbonate injection. Pressure can also be felt during the procedure. For women, the procedure lasts about 3 to 5 minutes, while for men, this can be longer. You should never feel pain when getting the pellets.