South Florida Woman’s Health Associates
Patient Informed Consent Form
HCG Weight Loss Program
Purpose:
This Informed Consent Form is intended to give fair notice of the requirements of patients seeking to participate in the HCG Weight Loss Program at SFWHA, to fully disclose any risks associated with participation in the
H CG Weight Loss Program, and to obtain written “Informed Consent” from the patient to u ndergo treatment. Historical Applications:
HCG was used in the treatment of obesity disorders by a British doctor and PhD. ATW Simeons of the renowned Salvator Mundi International Hospital in Rome, Italy over a 16 year period commencing in the mid 1950’s.  Dr. Simeons concluded that H CG (“Human Chorionic Gonadotrophic”) Hormone when used for weight reduction and concurrent with a regimented low calorie diet, not only resulted in significant weight loss from targeted areas where fat deposits were likely to collect, but also improved t
he lipolytic functions of the body when co-utilized with dietary protein sources.  Dr. Simeons hypothesized that HCG, which is produced in the female body in large quantities during pregnancy and in quantities ranging anywhere from 5000mlU/ml to 288,000mjU/ml, had a significant role in not only producing a healthy placenta for the fetus to survive, but also had a role in metabolizing fats depos its from the mother’s subcutaneous fat stores as an additional food source for the fetus.  Dr. Simeons theorized that by giving daily injections of small amounts of HCG concurrent with a controlled low calorie diet, that the HCG would mobilize the fat into the blood stream where protein and various enzymes could exercise their lipolytic functions (lipolytic means to break down fats usually for the consumption of energy:  Dr. Simeons’ clinic had a 97% success ratio.
A number of medical authorities have since supported the theories advanced by Simeons.  IN “Medicine and Science in Sports and Exercise” (19:5, sec 179-190, 1986), Dr. Layman, MD Affirmed that the intake of high dietary protein (1) aided in the metabolism of the free floating fat, (2) enhanced increased muscle mass, (3) preserved protein composition in organs, (4) stabilized the blood glucose levels, and (5) enhanced the production of human growth hormone from the pituitary gland.  Accord in J Am Coll Nutr 2004 Dec. 23
(6:Suppl) 631S-636S
Nevertheless in spite of these findings by specialized experts in the field of Preventative Health Care, the American FDA requires the following disclaimer:
“This weight reduction treatment includes the use
of HCG, a drug which has not been approved by the
Food and Drug Administration as safe and effective
in the treatment of obesity or weight control.  There
is no substantial evidence that hCG increases weight
loss beyond that resulting from calorie reduction, that
i t causes a more attractive or “normal” distribution of
fat, or that it decreases the hunger and discomfort
associated with calorie restricted diets.”
Risks and Discomforts
Below is a list of risks and discomforts that may be experienced by a small part of the population, in particular, those patients that are already predisposed to allergies, the latter conditions caused by a hyper stimulation of  the hormone heparin within the body.  The patient should inform their primary health provider if any of the following conditions occur:
Allergic Responses
If you experience allergic reaction to other substrates, you may have sensitivities to HCG.  It is required that you stop using HCG and report your allergic response to you provider immediately.  The following are signs of an allergic reaction:
∙Hives
∙Difficulty breathing
∙Swelling of your face, lips, tongue, or throat
Before receiving HCG tell your provider if you are allergic to any drugs or medications or if you have: ∙  A thyroid or adrenal gland disorder
∙An ovarian cyst
∙Cancer or a tumor of the breast, ovary, uterus, prostate, hypothalamus, or pituitary gland
∙Undiagnosed uterine bleeding
∙Heart disease
∙Kidney disease
∙Epilepsy
∙Migraines
∙Asthma
It is necessary for the provider to know these predisposed pathologies in order to rule out conditions that may not be related to the HCG.
Also in allergic responses, the body overproduces fibrin which induces blood clotting, a potentially lethal situation.  Call your healthcare provider immediately if you have any of these signs of a blood clot: ∙Pain
∙Warmth
∙Redness
∙Numbness
∙Tingling in your arm or leg
∙Confusion
∙Extreme dizziness
∙Severe headache
∙Nausea and/or vomiting
∙Urinating less than normal
Less Serious Side Effects May Include
Less Serious side effects may occur from the change in dietary patterns, until the blood sugar levels stabilize. These less serious side effects include
∙Headaches (diet related)
∙Feeling restless or irritable
∙Mild swelling or water weight gain
∙Depression
∙Breast tenderness or swelling
∙Pain, swelling, irritation, or minor bruising at the injection site
Other drugs may affect HCG
There may be other drugs that can interact with HCG.  Therefore it may be necessary to discontinue the use of certain medications and supplements.  Tell your provider about all prescriptions and over-the-counter medications, and nutritional supplements you use.  This includes vitamins, minerals, and herbal products, including medications prescribed by other providers.  If it is deemed necessary to discontinue or reduce the frequency of use of a medication it is your responsibility to communicate and receive clearance from the prescribing provider.  Do not start using a new medication without telling your providers.
Birth Control, Pregnancy and Breast Feeding
If your provider recommends discontinuing oral birth control pills during the hCG Weight Loss Program, it is imperative that alternative birth control methods be used responsibly.  If you have any reason to believe you may be pregnant or become pregnant during your weight loss program contact your healthcare provider immediately.
It is not known whether HCG passes into breast milk, therefore breast feeding should be discontinued for the duration of the HCG Weight Loss program.
Mandatory Adherence to hCG Weight Loss Protocol
To experience success on the HCG Weight Loss Program, it is preferable that you follow the protocol explicitly.  For obvious reasons, we do not warrant the results of its weight loss program due largely to off-site administration and patient imposed application of the program.
Consent Form for HCG /Weight Loss Program
I, the undersigned patient of SFWHA agree to undergo weight loss treatment that includes the use of Human Chorionic Gonadotropin (HCG) along with diet and other recommendations.  I have disclosed
my full medical history and have been physically examined by a healthcare provider.  I am aware of the significant risks, benefits, side effects and adverse reactions of HCG, and I have had full opportunity to ask any questions.  I understand the HCG has not been approved by the United States Food and Drug Administration (FDA) for adjunctive therapy in the treatment of obesity and the FDA states that there is no substantial evidence the HCG increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.  Nevertheless, considering all the above, I hereby give my informed consent to this treatment.
Patient’s Name ____________________________________  Chart # __________________ Address __________________________________________
__________________________________________
Phone # __________________________________________
Signature _______________________________________ Date______________________ Witness___________________________________________
Dr. Simeon’s Original H CG Diet Menu
Gain Before Loss
You must eat to capacity for two days after starting the treatment regardless of how much weight you may gain in the process.  You cannot begin a 500 calorie diet comfortably unless your normal fat reserves are reasonably well stocked.  It is a fundamental mistake to start a 500 calorie diet as soon as the treatment starts, as it seems to take about three treatments before abnormally deposited fat begins to circulate and this becomes available.
Breakfast:
Tea or coffee in any quantity without sugar: stevia may be used.
Lunch:
1.Protein – 100 grams of organic veal, beef, chicken breast, fresh white fish, lobster, crab or shrimp.  All
visible fat must be carefully removed before cooking and the meat must be weighed raw.  It must be
boiled or grilled without additional fat.  Salmon, eel, tuna, herring, dried or pickled fish are not
allowed.  The chicken breast must be removed from the bird.
2.Vegetable – Must be selected from the following:  spinach, chard, chicory, beet-greens, green lettuce,
tomatoes, celery, fennel, onions, red radishes, cucumbers, asparagus, and cabbage (vegetables should not be mixed)
3.Starch – One breadstick (grissini only) or one 20 calorie Melba toast
4.Fruit – An apple, orange, a handful of strawberries or on half grapefruit.
Dinner:
The same four choices as lunch, however you should not eat the same combination of protein and vegetables for both meals.
parsleyDrinks & Seasonings:
Black Coffee, plain tea and water may be consumed without restriction; no sweeteners except Stevia are acceptable.
The juice from one lemon daily is allowed for all purposes.
Salt, pepper, vinegar, mustard powder, garlic, sweet basil, parsley, thyme, marjoram, etc. may be used for seasoning but no oil, butter, or dressings or balsamic vinegar.  Make sure that any spices or seasonings used do contain sugar.
The fruit or the starch may be eaten between meals instead of with lunch or dinner, but no more than four items listed for lunch and dinner may be eaten at one meal.

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