Informed consent for Bio-Identical Hormone Replacement Therapy

I have been diagnosed with or have an increased risk of having a hormone deficiency, and Doctor has recommended treatment with bio-identical hormone replacement therapy (BHRT). Some of the bio-identical hormone preparations that may be prescribed for you are regulated by pharmacy compounding laws, which follow the Pharmacy Compounding Accreditation Board (PCAB) guidelines. The use of this therapy as it relates to your diagnosis, while common in alternative practices, may be debated in the traditional medical community.

You have the right, as a patient, to be informed about your condition and the recommended conventional, integrative, complementary, alternative, non-conventional, or non-standard procedures to be used so that you make an informed decision whether or not to undergo the procedures after knowing the risks and hazards involved. This disclosure is not meant to scare or alarm you, but to simply inform you. Hence, you have the information needed to give or withhold your consent to the procedure or treatment.

NOTICE: Refusal to consent to the innovative, integrative, complementary, or non-standard procedure shall not affect your right to future care or treatment.

Therapeutic Basis:

Many individuals have inadequate hormone levels despite technically regular blood tests. Some individuals suffering symptoms related to menopause or andropause or inability to lose weight may also benefit from these therapies. Bio-identical HRT can be used to augment hormone levels in several conditions where diminished hormone levels are evident.

  1. a) Estrogen therapy can maintain vaginal and urethral function and slow the progression of osteoporosis. It may also improve sleep, decrease hot flashes and night sweats, decrease pain and perhaps cognitive function, and improve libido and overall well-being. This therapy may contain combinations of the following medications: estriol, estradiol, and/or estrone.
  2. b) Progesterone hormone replacement therapy can offer protection from endometrial cancers, irregular menstruation treatment, and other low progesterone conditions. It also can improve sleep quality and decrease anxiety. For males, low dose progesterone therapy, in conjunction with testosterone therapy, can maximize the hormone ratios, reducing side effects.
  3. c) Testosterone replacement therapy is used to treat symptoms or lab tests, suggesting suboptimal hormone levels as determined by your provider. Low testosterone is associated with elevated cholesterols, high blood pressure, diabetes, and prostate problems. Other low testosterone symptoms include excessive fatigue, abdominal weight gain, irritability, and decreased sexual drive and function.

Objectives:

Bio-identical HRT is implemented to optimize hormone levels in the blood, helping to reduce symptoms associated with low levels of these hormones.

Potential Risks:

The safety of any of these hormones during pregnancy cannot be guaranteed. Notify Lev Paukman, MD, if you are pregnant, suspect that you are pregnant, or are planning to become pregnant during this therapy.

  1. a) Estrogen Therapy: Bio-identical estrogens are available in various forms, including oral capsules, troches, patches, pellets, and topical creams. Adverse reactions may include bloating, breakthrough bleeding, breast swelling and tenderness, fluid retention, and weight gain. Nonetheless, the whole area of estrogen replacement is undergoing further evaluation. Do not take estrogen if you have breast cancer.
  2. b) Progesterone Therapy: Bio-identical progesterone is available in various forms, including oral capsules, troches, vaginal or rectal suppositories, and topical creams. Progesterone therapy may be sedating, so it is recommended to coordinate dosing with the sleep cycle. Adverse reactions may include bloating, breakthrough bleeding, missed menstrual periods, breast swelling and tenderness, fluid retention, weight gain, sedation, and depression.
  3. c) Testosterone Therapy: Bio-identical testosterone therapy is available in various forms, including sublingual drops, troches, topical creams, pellets, and injection. Side effects include acne, chronic priapism (persistent, abnormal erection of the penis), change in libido, angina or heart attacks, hirsutism (facial hair growth), and scalp hair loss, or water retention. Because it may improve insulin resistance in males, diabetics who use insulin should closely monitor glucose levels, as less insulin may be needed.

Although the use of bio-identical hormone replacement therapy has been shown in many studies to be safer than synthetic hormone replacement therapy, the risk of cancer-related side effects is still possible.

Statement of Patient:

I understand that along with the benefits of any medical treatment or therapies, there are both risks and potential complications to treatment, as well as not being treated. Those risks and possible complications have been explained to me. I have not been promised or guaranteed any specific benefit from the administration of these therapies. No warranty or guarantee has been made regarding the treatment results. I agree to proceed with treatment and to comply with recommended dosages.

I understand that along with the benefits of any medical treatment or therapies, there are both risks and potential complications to treatment, as well as to not being treated. Those risks and possible complications have been explained to me. I agree that I have received information regarding those risks, potential complications and benefits, and the nature of Bio-identical and other hormone treatments. I have had all my questions answered. Furthermore, I have not been promised or guaranteed any specific benefit from the administration of bio-identical hormone therapy.

I certify this form has been fully explained to me that I have read it or have had it read to me and that I understand its contents. I agree not to undergo any treatment unless I fully understand the treatment and discuss possible risks and benefits.