A person taking a pill out of a pink pill holder.
Research shows that bioidentical hormone replacement therapy may be safer than regular hormone replacement therapy.

Bioidentical Hormone Replacement Therapy

As people transition through menopause, their levels of estrogen and progesterone decrease. This can lead to a variety of symptoms, including hot flashes, mood changes, sleep problems, low libido and more. It also increases the risk of several chronic diseases, including osteoporosis, heart disease and diabetes.

One way to counteract this hormonal loss is by taking hormone replacement therapy, commonly known as HRT. But in the past, HRT has received some negative press and many people and their doctors became concerned about the potential dangers.

Bioidentical hormone replacement therapy (BHRT) is promoted as a safer and more natural alternative to traditional HRT. But is that really the case? This article explains the benefits and risks, and explores whether BHRT is actually an effective solution.

What is Bioidentical Hormone Replacement Therapy?

The term bioidentical hormone replacement therapy can be interpreted in several ways. In general, it means a therapy utilizes hormones that are structurally identical to those that the body produces. However, people often use the term interchangeably with something known as compounded bioidentical hormone replacement therapy.

Compounded BHRT is a combination of different hormones — usually two to three different forms of estrogen and a progesterone. Some preparations also contain other hormones, such as testosterone, dehydroepiandrosterone (DHEA) and pregnenolone. It is marketed and an individualized therapy because the hormones are combined in different concentrations depending on the results of a blood or saliva test.

The hormones in compounded BHRT originate from natural sources — plants like soybeans and yams — but they undergo significant processing to make the plant hormones identical to those made by the body. The products are formulated in specialist compounding pharmacies according to a doctor’s prescription.

Compounded BHRT is not FDA-approved, but some FDA-approved hormone therapies are classed as bioidentical. These products are sometimes referred to as regulated bioidentical hormone therapy (RBHRT) or body-identical hormone replacement therapy. Examples of regulated BHRT include 17β-estradiol and micronized progesterone.

Both compounded and regulated BHRT are used to relieve menopause symptoms by replacing the hormones that are naturally lost as a person ages. They are available in several different forms, including oral tablets, transdermal patches, creams, gels and vaginal preparations.

How Does Bioidentical Hormone Replacement Therapy Differ From Other Forms of HRT?

In the past, many HRT products were not bioidentical. For example, the most common form of estrogen therapy was conjugated equine estrogen. This hormone is derived from pregnant mare urine and has a different structure from estrogen in the human body. Furthermore, many forms of progesterone were synthetic, such as medroxyprogesterone.

These were the hormones that were used in the infamous Women’s Health Initiative study. This research linked HRT use with an increased risk of breast cancer, cardiovascular disease, blood clots and strokes. The reporting of the study’s results has since been called into question. However, since its publication, HRT prescribing has fallen dramatically, and many people are searching for more natural alternatives.

BHRT has been marketed as a safer and more effective way to manage menopausal symptoms. However, this is not necessarily the case, especially when it comes to compounded BHRT. Let’s take a look at why.

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The Benefits and Risks of Bioidentical Hormone Replacement Therapy

Benefits

There are some clear benefits to BHRT in comparison to traditional HRT. For example, synthetic progesterone has been associated with an increased risk of breast cancer and other side effects, including acne, weight gain and mood changes. Micronized progesterone, which is bioidentical, appears to be safer with a lower risk of side effects.

Taking progesterone alongside estrogen is essential for people who have not had a hysterectomy. It reduces the risk of endometrial cancer that can occur when using estrogen alone. It also reduces the risk of estrogen-related blood clots.

Estrogen has many benefits too, including protecting the cardiovascular system and reducing the risk of heart disease. Some synthetic progesterone products block these beneficial effects, but bioidentical micronized progesterone does not.

FDA-approved BHRT, such as micronized progesterone and 17β-estradiol, are considered safe or safer compared to synthetic options. However, the same cannot be said for compounded BHRT.

Risks

Because it is not regulated, compounded BHRT is not subject to the rigorous testing that FDA-approved products are. Therefore, its safety and efficacy are largely unknown.

There have not been many clinical trials into its use and there is a lack of evidence to support combining hormones in varying concentrations. Moreover, products could be more or less potent than they claim or be contaminated due to poor manufacturing processes.

The idea that it is possible to tailor these products to an individual’s needs using a blood or saliva test is also questionable. Hormone levels fluctuate rapidly throughout the day and these tests only provide a snapshot of a given moment in time, not an overall picture.

Another issue is that the products are often labelled with a total milligram dosage rather than how much of each hormone they contain. Therefore, it can be difficult to know the exact breakdown of estrogen and progesterone in a product. This is problematic if there is not enough progesterone included to protect against endometrial cancer and blood clots.

Other risks associated with BHRT are similar to those of traditional HRT. They include an increased risk of blood clots, stroke, cardiovascular disease and gallbladder disease. Other possible side effects include:

  • Acne.
  • Bloating.
  • Weight gain.
  • Mood changes.
  • Menstrual changes.
  • Breast tenderness.
  • Headaches.
  • Fatigue.

Does Bioidentical Hormone Replacement Therapy Really Work?

Bioidentical hormone replacement therapy can work as well as traditional HRT. However, it is essential to choose FDA-approved medicine rather than unproven compounded products. There is not enough evidence to support this individualized therapy and it may even be dangerous due to a lack of oversight.

In any case, anyone considering using any form of HRT should consult a physician to discuss the possible benefits and side effects. It is also currently recommended to take the lowest effective dose for the shortest duration possible to minimize the risks.