Informed Consent for Personalized Bio-Identical Hormone Replacement Therapy (BHRT)
Background
Recent research continues to shape our understanding of hormone therapy’s safety and effectiveness. It is essential that you are fully informed about the potential risks and benefits before beginning any hormone treatment.
What Are Bio-Identical Hormones?
Bio-identical hormones share the exact chemical structure as the hormones produced by your body. Because your BHRT prescription is tailored by a compounding pharmacy to meet your unique needs—and is not a fixed-dose combination—it is classified as an unlicensed medication.
BHRT is commonly prescribed for women during perimenopause (from the onset of menopausal symptoms up to several years after the last period) and menopause (one year after the last period) to help alleviate:
- Hot flushes
- Vaginal dryness
- Low libido
- Mood disturbances (e.g., depression, irritability, or PMS-like symptoms)
- Bone loss or osteoporosis, or to aid in prevention
- Cardiovascular concerns
BHRT may also be recommended for other conditions such as PMS, PCOS, endometriosis, or hormonal acne. Often, it is combined with nutritional guidance or psychological support for a comprehensive approach.
Hormone Replacement Therapy (HRT)
The U.S. Food and Drug Administration (FDA) specifically approves HRT for managing hot flushes and preventing osteoporosis. Any use beyond these indications is considered “off label,” and healthcare providers rely on scientific evidence to support such uses.
Potential Benefits
By restoring hormone levels to a normal range, BHRT may offer numerous health benefits:
- Reduced risk of osteoporosis and fractures
- Alleviation of hot flushes (estrogen therapy is the most effective treatment)
- Improved sleep, mood, and memory
Bio-identical treatments may include one or a combination of the following hormones: estrogens (estradiol and estriol), progesterone, testosterone, dehydroepiandrosterone (DHEA), and in some cases thyroid hormones (thyroxine and triiodothyronine).
Risks
- Estrogen Alone: Research suggests that estrogen-only therapy may increase the risk of endometrial cancer while decreasing the risk of breast cancer compared to no hormone use.
- Estrogen + Synthetic Progestins: Adding synthetic progesterone (progestins) helps protect the uterine lining but may raise the overall breast cancer risk compared to estrogen alone.
- Lifestyle and Genetics: Factors such as obesity, alcohol use, smoking, and genetic predispositions also influence breast cancer risk and should be discussed with your doctor.
- Bio-Identical vs. Synthetic Progestins: There is limited data on how bio-identical progesterone compares to synthetic progestins in terms of risk; however, preliminary cohort studies suggest there may be a lower risk with bio-identical formulations.
At our clinic, we routinely monitor patients on BHRT with recommended pelvic ultrasounds, mammograms, or breast ultrasounds based on individual risk factors. Your doctor will guide you on the frequency of these tests.
Declaration
Understanding of Benefits and Limitations
I acknowledge that while BHRT can provide potential benefits, results cannot be guaranteed.
Discussion of Reasons and Risks
I have discussed the reasons for using hormone therapy with my doctor. I understand the potential risks, including but not limited to increased risk of breast or endometrial cancer, blood clots, stroke, or heart attack.
Opportunity for Questions
I have received an explanation of the risks and possible side effects associated with BHRT and have had the opportunity to ask questions.
Personalized Prescription
I understand that my prescription is individualized. Unless otherwise requested, the doctor will send it directly to the Specialist Pharmacy to be compounded according to required standards.
Medication Responsibility
I acknowledge that I am responsible for contacting the relevant provider to order and pay for my medication.