Nationwide Medical Foods | Medical Foods in the Physician's Practice

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Background
Science of Medical Foods
Medical Foods in my Practice
Medical Supervision and Regulations
In-Office Dispensing Program
Getting Started
Dose Guidelines
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Medical Foods in Your Practice

What are Medical Foods?

A Medical Food is a formula used for the dietary management of disease. Medical Foods are used to correct a nutritional shortage in the body that is related to a known disease, i.e. Medical Foods are used to manage specific diseases and conditions.
They are made with ingredients found in the normal food chain. i.e.: these products contain amino acids (found in protein) and certain cofactors including very small amounts of herbs and some spices that act as antioxidants (found in fruits and vegetables) to enhance the movement of the neurotransmitter into the cell.
Medical Foods are intended to be given while a patient is under continuous medical supervision.

What do Medical Foods do?

Medical Foods allow certain amino acids to target and enter nerve, brain and muscle cells. Cells and cell receptors are specific for the substance they use and the activity they exhibit. For example, the hippocampus in the brain is responsible for memory and cognition. The cells in this part of the brain use glutamate for storing new information in the brain.
Once these amino acids enter the cell, the selected neurotransmitter can be made and released, i.e. a cascade of physiological events takes place in the cell. Electrolytes, such as Na+, Cl- and Ca++ are important for cell stimulation and function. Certain medical conditions can be managed by using specific nutrients.

What are neurotransmitters?

Neurotransmitters are the messengers that travel between one cell and another.
These messengers are made from amino acids, stored in the terminal end of the cell and released when needed and/or the cell is stimulated.
Neurotransmitters are found in both the Central Nervous System (CNS) and the Peripheral Nervous System (PNS).They are chemical signals that neurons use to talk to each other, which is what makes the brain and nervous system work. Without proper communication, the brain will give the body wrong signals. For example, the brain will tell you to eat when the body does not need food or to stay awake when the body needs to sleep.

Why are neurotransmitters necessary for bodily functions?

Neurotransmitters help determine how the body functions and how you feel, think and act. For instance, poor sleep is caused by the improper balance of neurotransmitters in the brain.
Many diseases and conditions are caused by a decrease of certain neurotransmitters.
Medical Foods contain the neurotransmitters that are needed to help restore our bodies to a healthy state. A recent double blind placebo study indicates an improvement in sleep quality in patients with sleep disorders such as insomnia, snoring and sleep apnea.

What causes neurotransmitter depletion?

The body uses amino acids to make neurotransmitters. Amino acids are found in protein.
These amino acids come from the foods we eat; therefore, the wrong diet can cause a lack of neurotransmitters.
Stress (physical, emotional or mental), disease (caused by a virus, bacteria or parasite), environment (toxins can be found in pesticides, air, old buildings etc.), and genetics (a person can be born with a deficiency or have a predisposition for one which can be manifested if triggered). Prescription drugs or illegal drugs can also cause a reduction of neurotransmitters by breaking down their natural and functional pathways.

Diseases and Conditions That Can Be Managed Using Medical Foods

Some of the conditions that are caused by lack of neurotransmitters are:

Depression
Appetite control
Fibromyalgia
Pain
Ability to focus
Sleep problems
Anxiety/panic
High blood pressure
Lung related disease (COPD, chronic cough, asthma)
Sexual Dysfunction

Medical Foods can manage these conditions by supplying the body with the proper neurotransmitters in the right proportions to restore healthy cell function.

Medical Foods vs. Dietary Supplements

Medical Foods ingredients are found on the FDA’s GRAS (generally regarded as safe) list

Medical Foods are made from neurotransmitter precursors and contain an uptake stimulator, a neuron activator, adenosine brake inhibitor and an attenuation inhibitor.
Medical Foods must make a disease claim (i.e. they have an ICD-9 #).
Continuous medical supervision is necessary for the distribution and patient consumption of Medical Foods. Medical Foods can be given by a variety of licensed healthcare professionals according to individual state law.
A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. No medical claims can be made for dietary supplements. They are used to support normal structure and function of the body.
A dietary supplement cannot make a disease claim and the FDA would consider the product as “misbranded” if it does. In the past 18 months, the FDA has become strict about the correct branding of a dietary supplement. NO physician can make a disease claim for a dietary supplement.

Neurotransmitter Science / Neurophysiology

Medical Foods act through a pathway different from any prescription drug. This pathway includes cellular uptake, neuronal activation, adenosine brake inhibition and attenuation inhibition.
A patient may or may not “feel” the results immediately because the mechanism of action is different from a prescription drug, i.e. it does elicit its effect directly on the postsynaptic receptors.
The amount of time that a patient may feel the effects of the product will vary, depending on the amount of neurotransmitter depletion. Usually a person will notice changes within two weeks; however, it may take up to a month or more in severe cases for the full effect to be noticed.
Medical Foods are non toxic and non addictive. Any product that is not stored in the vesicle of the cell is broken down into molecules that are naturally found in the body. In addition, because the pre synaptic cell will uptake and store the neurotransmitter, the product does not “sit” on the postsynaptic receptors and will therefore not produce a tolerance as with prescription drugs.
Patient education is important with product distribution. Because of the unique mechanism of this product (compared to prescription drugs) it is imperative that people understand how and why Medical Foods can help them. Long-term use will improve their condition and can repair cellular damage. Refer to Diagrams below:

Products
There are several products that are available for patient distribution and consumption.

AppTrim ~ for obesity management
GABAdone ~ for the management of sleep disorders associated with anxiety
Pulmona ~ for pulmonary function management
Sentra AM ~ for the management of cognitive disorders
Sentra PM ~ for the management of sleep disorders associated with depression
Theramine ~ for the management of pain syndromes
Hypertensa ~ for vascular function management
Virilex ~ for the management of erectile dysfunction

The above products treat medical conditions by restoring the body’s depleted neurotransmitter supply.

Dose Regulating

The typical dose for an individual is 2 capsules twice a day, regardless of age. However, the dosage can be adjusted according to a patient’s needs.
All products should be taken with water on an empty stomach at least 30 minutes before or after eating.
Taking more of the product will not hurt a patient if more is needed Medical Foods are non toxic and non addictive.
If patient experiences loose stools or diarrhea with the increase have the patient return to their previous dose for a week, then increase again. This side effect is caused by the increase of serotonin in the intestinal tract.
However, it is a good idea to wait two weeks before the initial increase since often times it will take this long before the patient feels any noticeable improvements.
We are all conditioned to expect immediate results, but in some cases, patients are severely depleted of neurotransmitters and it will take a little time to replete their supply. In the case of fibromyalgia patients, many of them are very depleted and it will take them more time to notice the results. Neurotransmitters are working within their bodies well before they "feel" the effect.
Two (2) capsules of Theramine can be taken every 4 hours or as needed. If a patient can tolerate and increased dose, they can take as much as they need since the product is non toxic and non addictive.
Theramine can be taken with prescription medications under medical supervision.
One (1) to two (2) capsules of Sentra PM or GABAdone should be taken at bedtime to initiate sleep. Occasionally, a person only needs to take one (1) capsule at bedtime because two (2) capsules are too much and will cause night time waking.
Take one (1) or two (2) capsules during the night if awakened and cannot fall back to sleep.
Sentra PM and GABAdone can be used to taper off prescription sleep medications.
Two (2) capsules of Sentra AM should be taken daily in the morning.
Two (2) capsules of AppTrim twice a day can be taken in mid morning and mid afternoon, depending on the schedule of the patient. An additional two capsules can be taken in the evening using AppTrim-D, decaffeinated, if needed.
Pulmona and Hypertensa can be in dosages of two (2) to three (3) capsules twice a day depending on their clinical response.
If a patient is taking more than one Medical Food product, it is best to space out the doses by I hour to avoid the intestinal issues as mentioned above.

Multi Dosing

If a patient has a need for several products, it is best not to prescribe all of them at once.

Sentra AM and Sentra PM can be started on the same day.
Theramine can be started 2 to 5 days after the Sentra AM and Sentra PM and can be taken as needed and as tolerated.
Wait two weeks to begin the AppTrim management regimen. Delay any increase in AppTrim after the initial amount for 2 weeks since it may take this long to obtain optimal appetite suppression.

Programs

Physicians Therapeutics currently offers a weight loss program. This program consists of one bottle of AppTrim, a calorie counting book, a pedometer and a weight management program: complete with sample recipes, portion control, food and drink guidelines, exercise regimens and more.
We also recommend using our calorie prescription computer program in conjunction with the weight loss program.
We will soon offer co-packaging of pharmaceuticals and Medical Foods. The purpose of this program is to wean a patient off their prescription drugs or to lower the active dose to avoid harmful side effects and addiction from long-term usage.

Side Effects

The side effects from Medical Foods are comparable to food intolerance found in the general population.
Side effects are rare, but there have been occasional complaints of mild stomach upset, mild headaches or mouth dryness.
These side effects are minor and temporary. The best way to deal with these issues is to decrease the dose for 5 to 7 days then increase gradually to the desired amount of product.
Additionally, a patient taking more than one Medical Food should not take two products at the same time. Spacing the dosages by 1 hour will help prevent stomach upset.

Contradictions

Medical Foods work through a different pathway than prescription drugs and therefore, rarely interfere with other medications.
Medical Foods should not be taken with MAO inhibitors.
Patients who have been diagnosed with malignant melanoma should not take Medical Foods products.

Cost and Insurance Coverage

Medical Foods are regulated by the FDA in a special category of treatment agents.
An MD or a DO can bill an insurance company for reimbursement of a Medical Food product. Chiropractors and other health care professionals can distribute Medical Foods to patients as long as a patient is “under the ongoing care of a health care professional who can assess their health status.”
Insurance companies recognize Medical Foods as falling under the prescription drug category. Medical Foods have a NDC (national drug code) number and an AWP (average wholesale price).
Workers Comp currently covers the cost of Medical Foods.
It is anticipated that Medicare will begin to cover the cost of Medical Foods in January of 2006.

We are currently working with private insurance companies and anticipate more participation in coverage of Medical Foods. Patients can purchase these products directly from their doctor or other qualified health care professionals.

Languages Availability

Each Medical Food Product contains a patient information pamphlet in English and Spanish.