Consent to Treatment

I.)   The Nature of the Treatment

I hereby give my consent to evaluation and treatment of andropause, thyroid disorders, adrenal fatigue/stress, menopause and other hormone imbalances by the administration of Hormone Replacement Therapy (“HRT”) and/or nutritional supplements, including vitamins, minerals and anti-oxidants and/or drugs designed to alter hormone levels. The nature of the procedure is to raise levels of hormones in my body to levels which will improve quality of life, as well as functional ability, the goal of which being to decrease the incidence of sickness and disease.

II.)  Alternative Treatment Approach

The reasonable alternatives to these therapies have been EXPLAINED to me and they include, but are not limited to:

• MAINTAINING HEALTHY BODY MASS INDEX “BMA” AND WEIGHT
• MAINTAINING CURRENT HORMONE LEVELS
• TREATING CHRONIC (PERSISTENT) DISEASES AS THEY OCCUR
• TREATING SYMPTOMS WITH NON BIP-IDENTICAL MEDICATION(S)

III.) The General Nature and Extent of Treatment-Related Risks

Most hormone deficiencies are indicated by symptoms and may implicate the potential for illness when certain hormone levels are too high or low. Along with my doctor, I believe that it is when hormones are within a safe range to reduce my unwanted symptoms, that we will obtain the optimum goal in my health.

In andropause, men gradually lose their ability to produce testosterone and some men develop elevated levels of estrogen. As men undergo an ever-increasing loss of testosterone, they are faced with anxiety, irritability, erectile dysfunction, bone loss, muscle loss, loss of strength, and loss of energy and memory impairment.

Possible side effects of male testosterone replacement include, but are not limited to: unwanted hair growth, enlargement of the prostate, loss of sperm production (sterility), enlargement of breast tissue, testicular atrophy ( shrinking), acne, oily skin and hair, and in some studies, an increased risk of prostate cancer growth.

In hypothyroidism, studies have shown that physicians may under-treat this condition. I understand that my physician will be working with me to suppress my symptoms and improve my quality of life by considering my symptoms as well as my thyroid hormone levels to monitor the treatment of my disease. I understand that the potential side effects in using thyroid medication include osteoporosis palpitations, dizziness, psychiatric problems ( mania), and elevated or irregular heart rate.

With respect to age and incidence of Adult Growth Hormone Deficiency Syndrome, I appreciate that there are certain risks associated with the use of Sermorelin, Ipamorelin growth hormone releasing hormone and/or growth hormone releasing peptides. While Sermorelin, Ipamorelin, growth hormone releasing hormone and/or growth hormone releasing peptides have been shown to help stimulate endogenous growth hormone production, and increased endogenous production of growth hormone, thus, may stimulate lean muscle mass, lower fat mass and improve bone density, the clinical guidelines for the use of such medications in the treatment of adult growth hormone deficiency have yet to be clearly established. Therefore, my physician at Optima Health and Wellness and I have discussed the benefits of human growth hormone therapy using such medications, as well as the associated risks. These risks may include but are limited to: water retention, which may result in leg swelling and elevated blood pressure, mild increase in fasting blood sugar and occasional bruises at the injection site. I may also develop infection at the injection site if I use improper technique. Most all of these side effects are reversible by dosage adjustment or discontinuing therapy.

I understand that there are reasons to avoid the use of Sermorelin, Ipamorelin growth hormone releasing hormone and/or growth hormone releasing peptides if I am prescribed such medication(s). Some of these reasons are as follows: preexisting cancer or tumor(s), uncontrolled diabetes, unusual lung diseases such as pulmonary fibrosis, pneumoconiosis, proliferative disease, bronchiolitis, obliterans, systematic sclerosis or pregnancy. I do not currently have nor have I been diagnosed with any of these medical problems. I understand that if I am diagnosed with any of these medical problems, I should stop the entire treatment protocol immediately and notify my physician, so that my treatment plan can be re-evaluated. I understand that taking Sermorelin, Ipamorelin, growth hormone releasing hormone and/or growth hormone releasing peptides raises IGF-1 levels in the blood. In addition to the risks discussed above, I am aware that there are reports that indicate there may be an increased risk of prostate cancer associated with higher IGF-1 levels.

In menopause, women lose the majority of their hormones within a few years, causing in many cases, severe distress, both mental and physical. Through the use of the hormone replacement therapy, one can counter this decline and help alleviate the symptoms due to menopause. Additionally, studies now indicate that hormone therapy is effective in the treatment of osteoporosis, as well as other disease processes associated with hormone decline as we age.

The potential adverse effects for women using estrogen, progesterone and/or testosterone include, but are not limited to: breast swelling and/or discomfort, fluid retention, dizziness, palpitations, break through bleeding, requiring an endometrial biopsy, acne, unwanted hair growth, oily skin and hair, and headache.

I also understand that if I am female and become pregnant, I should discontinue the entire treatment protocol immediately and notify

Optima Health and Wellness. I understand that this hormone therapy is not for the purpose of preventing pregnancy. If I should become pregnant during the course of therapy, there are potential risks to the fetus (unborn child).

IV.) Safety of Hormone Replacement

Although in my physician’s opinion, the majority of data points toward safety, no one has yet proven or disproven a causal relationship between the use of hormone therapy and cancer. I understand that careful surveillance and close monitoring are requirements of all patients to minimize any possible risk.

I understand that there are other studies that point to a higher incidence of cancer in patients who take Hormone Replacement Therapy. However, these studies, which show an association (two variables present simultaneously), do not demonstrate cause and effect. I realize that it may be a number we know if there is any true cause and effect between hormones and increased risk for cancer in women or men.

I understand that although each hormone has been approved by the Food and Drug Administration (*FDA) for use in the treatment of certain diseases, the FDA only approves or disapproves of products made by manufacturers which are produced in an established dosage and form. Therefore, by definition, the FDA does not “approve” or “disapprove” of hormones which are given in an individual dose and in an appropriate form for each patient as determined by my doctor at Optima Health and Wellness. I also understand that my doctor may choose to discuss with me and provide to me medications that are off-label in order to offer to me the widest range of therapies possible, (*Offlabel” use means the use of FDA approved drugs for purposes other than those for which the FDA has approved them.) *Off-label” prescribing is a legal and common practice by physician in the United States. A recent study found that more than 20% of overall prescription drugs in the U.S. and close to 50% of drugs in some specialties are used in off-label manner.

V.) Administering the hormones; Remedies; Termination of Treatment

Any questions I have regarding this treatment have been answered to my satisfaction. I understand that I will be responsible for administering the hormones prescribed to me. I will conform and comply with the recommended dose and methods of administration. I also agree to conform to the request for initial and subsequent blood tests, as required to monitor my hormone levels. I understand that failure on my part to follow my physician’s recommendation in dosage and use of my hormones and medication may result in unwanted and potentially harmful side effects /results. I understand that failure to have appropriate laboratory testing completed at the interval established by my physician and failure to follow up with my physician at the recommended appointments may lead also to adverse (unwanted) side effects.

I also understand there are possible benefits associated with these procedures. I understand that no guarantee has been made to me regarding outcomes neither of this treatment nor on resolution of my symptoms. I understand that not all patients receive the same degree of response. I also understand that the benefits derived from therapy will cease and those derived from hormone therapy and drugs that alter hormone levels may not reverse if the therapy is discontinued.

I authorize Optima Health and Wellness to perform this treatment. I understand they may be assisted by other health professionals, as necessary, and I agree to their participation in my care as it relates to nutritional supplementation and hormone modulation therapy. I certify that I am under the regular care of another physician for all other medical conditions. I understand that this is a specialized practice and does not hospitalize patients. I also understand that I will continue under the care of my other physician(s) for any ongoing medical conditions as well as any medical consultation that I may need.

I ASSUME FULL LIABILITY FOR ANY ADVERSE EFFECTS THAT MAY RESULT FROM THE NON-NEGLIGENT

ADMINISTRATION OF THE PROPOSED TREATMENT. I WAIVE ANY CLAIM IN LAW OR EQUITY FOR REDRESS OF ANY GRIEVANCE THAT I MAY HAVE CONCERNING OR RESULTING FROM THIS PROCEDURE, EXCEPT AS THAT CLAIM PERTAINS TO NEGLIGENT ADMINISTRATION OF THE PROCEDURE.

I hereby confirm that the nature and purpose of portions of the aforementioned treatment are considered by some to be medically unnecessary and/or experimental, as there are no long-term studies documenting the results. The risks involved and the possibilities of complication have been explained to me. I fully understand that some aspects of the treatment to be provided may be considered experimental and unproven by scientific testing and peerreviewed publication. I understand that I may suspend or terminate treatment at any time and hereby agree to immediately notify Optima Health and Wellness physician of any such suspension or termination.

The undersigned certifies that HE/SHE has read and understands all the above, and as the Patient, agrees to and accepts the terms. I acknowledge I have been encouraged to ask any questions regarding this therapy. To attest to

MY FULL, COMPETENT, AND INFORMED CONSENT to this treatment, I hereby affix my signature to this Consent to Treatment.