What is the initial dosing for bioidentical hormone replacement therapy (BHRT) in postmenopausal women?

From the Guidelines

Bioidentical hormone therapy in postmenopausal women should be initiated with caution and under close monitoring, as there is limited evidence on its safety and effectiveness, and the FDA has not approved any type or class of bioidentical hormone therapy for the prevention of chronic diseases in postmenopausal women 1.

Initial Dosing Considerations

When considering bioidentical hormone therapy, it's essential to start with low doses and gradually increase based on symptom response. For estrogen, a common starting dose is 0.5-1 mg of oral estradiol daily, 0.025-0.0375 mg/day of transdermal estradiol patch (changed twice weekly), or 0.5 mg of estradiol gel applied daily.

Key Points to Consider

• For women with an intact uterus, progesterone must be added to prevent endometrial hyperplasia, usually starting with oral micronized progesterone 100-200 mg daily for 12-14 days per month in a cyclic regimen, or 100 mg daily in a continuous regimen.
• Vaginal estrogen for local symptoms can begin with estradiol vaginal tablets 10 mcg inserted vaginally twice weekly or estradiol vaginal cream 0.5-1 g inserted 1-3 times weekly.
• Treatment should be individualized based on symptom severity, patient preferences, and risk factors.
• Starting with the lowest effective dose minimizes side effects while providing symptom relief.
• Hormone levels should be monitored after 3-6 months of therapy, with dosage adjustments made accordingly.

Important Considerations

• Common side effects include breast tenderness, bloating, and mood changes, which often improve after the first few months of treatment.
• The American Heart Association and the American Congress of Obstetricians and Gynecologists recommend against the use of menopausal hormone therapy for the primary or secondary prevention of cardiovascular disease 1.
• The Canadian Task Force on Preventive Health Care and the American Academy of Family Physicians recommend against the use of hormone therapy in postmenopausal women for the prevention of chronic conditions 1.

From the FDA Drug Label

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. Patients should be started at the lowest dose for the indication The usual initial dosage range is 1 to 2 mg daily of estradiol adjusted as necessary to control presenting symptoms.

The initial dosing for bioidentical hormone therapy with estradiol for postmenopausal women is 1 to 2 mg daily, and should be adjusted as necessary to control presenting symptoms. The lowest effective dose should be used, and medication should be discontinued as promptly as possible. Administration should be cyclic (e.g., 3 weeks on and 1 week off) 2.

• The dose may need to be titrated to determine the minimal effective dose for maintenance therapy.
• Patients should be reevaluated periodically (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary.

From the Research

Initial Dosing of Bioidentical Hormone Therapy

• The initial dosing of bioidentical hormone therapy for postmenopausal women is not explicitly stated in the provided studies, but it is mentioned that low doses should be used and increased gradually until effective control of symptoms is achieved 3.
• A study on compounded bioidentical transdermal hormone therapy used a daily dose of BiEst (80% Estriol/20% Estradiol) and/or Progesterone to meet established physiologic reference ranges for the luteal phase in premenopausal women 4.
• Another study found that bioidentical hormone replacement therapy relieved symptoms of menopause and was well tolerated, with the most commonly reported side effects being weight gain, breast tenderness, and bloating 5.

Factors Affecting Initial Dosing

• The decision to use bioidentical hormone replacement therapy is influenced by factors such as symptoms unalleviated by synthetic hormone replacement therapy, side effects from synthetic hormone replacement therapy, and personal preference 6.
• Women obtain information and support from various sources, including family and friends, publications, and specialists in menopausal health 6.

Safety and Efficacy

• Bioidentical hormones that are approved by the FDA may be preferred over standard hormone replacement therapy due to their physiologic benefits and safety profile 7.
• A study found that compounded bioidentical transdermal hormone therapy significantly relieved menopausal symptoms and favorably impacted cardiovascular biomarkers, inflammatory factors, and health outcomes 4.
• However, it is essential to note that the safety and efficacy of bioidentical hormone replacement therapy can vary depending on the specific formulation and dosage used, as well as individual patient factors 3, 4, 7, 6, 5.