Bioidentical Hormone Pellet Therapy: An Option for Hormone Replacement

1/10/2023|Updated: 1/10/2023

Jill, a 54-year-old woman, began having symptoms of menopause at 49. At first, it was just a hot flash here and there, but things quickly changed with the passage of time.

“Once I hit 50, I had full-on hot flashes, moodiness,” explained Jill. “As time progressed, I had really bad night sweats, I wasn’t sleeping, I was irritable, had no sex drive, and had vaginal dryness.”

Jill said initially she tried to “suffer through” her symptoms, but soon changed her mind and scheduled an appointment with an obstetrician-gynecologist who recommended bioidentical hormone pellet treatment. After a full blood panel, which also included hormone levels, Jill received her first pellet insertion a few weeks later and never looked back. Jill’s symptoms improved soon after her first pellet treatment.

“The hot flashes were gone almost immediately,” said Jill. Over time, as her doctor continued to check her hormone levels and adjust the dosage of hormones in the pellet treatments, Jill continued to see improvement in menopause symptoms.

As a fitness enthusiast, Jill also noticed improved energy during workouts and decreased muscle pain postworkout. “It’s definitely given me my energy back. I was tired during workouts and had muscle aches before.”

Nearly three years later, Jill is still receiving bioidentical hormone pellet treatment, without any significant side effects except for feeling “revved up” in the first week following pellet insertion and anxiety just before the next insertion, as the hormones wind down.

What Are Bioidentical Hormones?

Hormone therapy has been prescribed to perimenopausal and postmenopausal women for many years. However, in recent years, the FDA has approved new hormone replacement therapies containing bioidentical hormones.

What are bioidentical hormones? The term does not have a universally accepted definition. It’s usually defined as hormones that are plant-derived and are chemically and molecularly identical to those produced by the human body.

When the term “bioidentical hormone therapy” first came out, it was a marketing term for custom-compounded bioidentical hormones, meaning the bioidentical hormones are custom-mixed and therefore not FDA-approved. However, the term bioidentical hormone therapy is also used to describe FDA-approved therapies.

Compounded bioidentical hormone pellet treatment is one method of administering bioidentical hormone therapy.

In an email to The Epoch Times, Dr. Leigh Ann Scott, a gynecologist qualified in bioidentical hormone replacement therapy, explained that her practice offers only bioidentical hormones because “they are the same chemical structure as the hormones produced by the body.”

Synthetic hormones, on the other hand, have a different chemical structure than those in our bodies.

“What’s most important is that the molecules are identical to the hormone molecule found naturally in the body,” Scott said.

Benefits and Safety Concerns of Hormone Therapy

All hormone therapy treatments have risks and benefits.

According to the North American Menopause Society (NAMS), the health benefits of hormone therapy include improvements in hot flashes, mood swings, sexual function, vaginal dryness, dry skin, sleep disturbances, and urinary tract symptoms, such as irritable bladder.

Additionally, hormone therapy has the potential to improve glucose control and decrease the possibility of developing type 2 diabetes.

Hormone therapy also helps prevent bone loss and may help maintain or increase muscle mass, according to limited studies. Interestingly, it may also lower the risk of tooth loss and improve joint pain.

Studies reviewed by the NAMS have shown that hormone therapy could also reduce the incidence of colon cancer.

Hormone treatment has been widely accepted; however, the results of a 2002 study conducted by the Women’s Health Initiative (WHI) showed an increased risk of breast cancer, stroke, cardiovascular disease, and blood clots in women who were taking estrogen (conjugated equine estrogen) and progesterone (medroxyprogesterone acetate).

Nonetheless, today both types of hormone treatments are considered safer than the WHI suggests. The NAMS' position on hormone therapy states: “For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio is favorable.”

Also, according to NAMS, other studies have suggested that initiating hormone therapy in symptomatic women within 10 years of menopause may have a benefit in the reduction of atherosclerosis progression.

Compounded Bioidentical Hormone Therapy: a Safer Option?

Findings from the WHI study lead some women to discontinue hormone therapy or seek a safer method of hormone treatment for menopausal symptoms. The study also prompted many women to ask their physicians for bioidentical hormone therapy—also known as natural hormone therapy, including compounded bioidentical hormone therapy.

The term “compounding” is defined by the FDA as a practice in which a licensed pharmacist or a licensed physician, “combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.”

The main components of the therapy are usually estrogen and progesterone. Depending on the results of a patient’s lab work/hormone deficiencies and body mass index (BMI), components may also include dehydroepiandrosterone (DHEA), pregnenolone, testosterone, estrone, estradiol, and estriol.

“We run a full hormone panel before the initial pellet insertion and then again before every replacement pellet,” explained Scott.

Scott said that some practices do not check hormone levels prior to each pellet insertion appointment but that it is necessary to ensure patients are in “an optimal and healthy therapeutic range.” In Scott’s practice, symptoms are also considered to adjust dosing.

Compounded bioidentical hormones can be administered via subdermal implants, pellets, or troches, which are essentially like throat lozenges.

Among them, pellet therapy is administered through rice-grain-sized hormone “pellets” inserted under the skin, usually in the hip area, providing a constant supply of hormones for about three or four months. The incision is closed with a stitch, Steri-Strips, or both.

Postprocedure, patients must follow certain guidelines and will have some physical limitations.

“After the pellet procedure, patients should avoid submersing in water for five days,” explained Scott. Scott also said patients should avoid heavy lifting and vigorous physical exercise for at least 48 hours following pellet insertion.

“It usually takes a couple of weeks before a patient will start to notice the effects of the hormones, with levels peaking around six to eight weeks,” Scott said. “After that, patients return every three months to have a new pellet inserted.”

There has been controversy regarding compounded bioidentical hormone pellet therapy, but many health care providers offer this service to women who are suffering from menopausal symptoms. Like Jill, many women report a significant improvement in menopausal symptoms and an overall increase in quality of life.

The convenience of a once-every-three-to-four-months treatment versus daily oral, vaginal, or topical treatments is a huge benefit to many women. Also, many physicians believe that bioidentical hormone pellet therapy administered through pellets allows hormones to be constantly released, increasing the effectiveness of the treatment.

“One of the biggest reasons patients choose pellets for their bioidentical hormones is their convenience,” explained Scott.

Not having to take a pill or apply a patch or cream is also a plus for some women.

“Pellets can help simplify bioidentical hormone replacement therapy,” said Scott. “In some cases, pellets can help with compliance since there is no element of forgetting to take or apply your medication.”

Additionally, pellet therapy may be a good choice for highly active or athletic patients who sweat a lot and might have concerns about a patch coming off during exercise.

While some patients and physicians believe bioidentical hormone pellet therapy is safer and more natural than other recognized hormone treatments, so far there is no agreement on the issue.

“In general, bioidentical hormones have similar risks regardless of delivery method,” Scott said.

The American College of Obstetricians and Gynecologists (ACOG) states that there is “no scientific evidence that compounded hormones are safer or more effective than standard hormone therapy.” ACOG also warns that compounded drugs are not regulated by the FDA and may vary in purity and strength. This means that a patient could take too much or too little of a hormone.

Concerns regarding compounding facility practices and conditions also exist. The FDA has witnessed unsanitary work areas during inspections of compounding facilities. Contaminated drugs have the potential to cause harm to patients and even death.

Erin Coletti, a functional medicine specialist, has provided compounded bioidentical hormone therapy to patients for over 10 years. She used to administer hormone therapy through pellets but stopped doing so years ago.

“On pellets, it all sounds so great, but I am so against it,” she explained in an email to The Epoch Times.

This has to do with the side effects she has witnessed in her own patients. Coletti said that she’s seen women go from having “zero hormones” to suddenly having “a lot of hormones,” often at levels that are higher than they should be.

Coletti said that although providers can measure hormones in the blood, they can’t measure levels in tissues.

“Hormones lie in the tissue, not in the bloodstream. Hormones will show lower values in the bloodstream and a patient will get overdosed via bloodwork only.”

She has also seen patients in their mid-30s receiving bioidentical hormone pellet therapy and without a history of blood clots suddenly have a heart attack.

“All they did was get a pellet,” explained Coletti.

Additionally, Coletti has had pellet patients experience adrenal fatigue—a condition where the adrenal glands are unable to meet the body’s demand for the hormone cortisol—in women receiving pellet therapy.

Although Coletti is against using pellets, she is a proponent of regular bioidentical hormone therapy and believes it is a better option than synthetic hormones. She also has confidence in the compounding pharmacies that provide the hormones for her patients.

“Compounding is completely safe,” she declared.

Coletti said it is important to know the compounding pharmacy’s owner, accreditation, and whether lab results indicate drugs are being properly compounded.

“You have to look at the whole picture,” she said. “There are good and bad pharmacies out there.”

Scott also echoed Coletti’s sentiments regarding the importance of using an accredited compounding pharmacy.

“We strive to only work with compounding pharmacies with the highest accreditation levels.”

Scott said that her office only uses 503B pharmacies, “which have the highest level of certification a compounding pharmacy can obtain and are regulated by the FDA.”

Of course, almost all medical treatments come with side effects and risks; bioidentical hormone pellet therapy is no exception.

Scott says patients may experience bleeding, minor bruising, and discomfort at the pellet placement site immediately after the insertion procedure.

“Any time you break the skin, infection is a possibility,” explained Scott.

Although rare, Scott said some women experience a pellet extrusion—meaning the pellet backs out through the skin. In addition, Scott noted that patients may develop scarring over time from multiple implantations. Other common side effects of bioidentical hormones pellet treatment include:

Weight gain
Blurred vision
Tiredness
Acne
Increased facial and body hair
Headaches
Breast tenderness
Spotting
Cramping
Bloating
Mood swings
Breakthrough bleeding
Oily hair/skin

The decision to begin or continue hormone therapy is a personal one, and should not be taken lightly. With more hormone therapy options now available, women can determine what is best for them with the help of their physician.