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Choose Your Passions, Loose Your Addictions - Part 1

In Loving Memory, Dr. Roy Kupsinel

Active Antisepsis as a Safe and Effective Therapy For a Diabetic Foot Ulcer: A Case Report

Diet, Energy and Hormone Regulation, Part 1 and 2

The Coming Diabetic Epidemic

ANMA 26th Annual Convention & Educational Semiar, A Great Weekend For All Who Attended!

ANMA Photo I.D. Membership Cards

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INSIDE THIS ISSUE:

The President's Corner
Successful Convention!

By: Mary Dunlap, N.D. for Dr. Charles Curtis

In 2008 there will be a flood of legislation across the country that will attempt to deprive you of your practice. ANMA will be fighting hard to keep legislation fair for you. Additionally, ANMA will be supporting legislation that will recognize practice rights of all individuals. ANMA will keep you informed as legislation is introduced in different states.

We highly recommend you maintain an active interest in your future. Non-involvement and non-interest in tracking legislation in your state can be disastrous to your practice. If you have any questions please contact us.

With a successful convention behind us and plans for a new one, I encourage you to continue your support for this hard working organization. ANMA will hold its next convention at the Riviera Hotel in Las Vegas, Nevada on July 25, 26, & 27, 2008. A credible, rewarding program is being planned for you and elections will be held. Mark your calendars now, and plan to attend.

I want to give special recognition to the staff at ANMA for doing such a superb job, having worked tirelessly to insure the success of each annual convention. Their dedication has ensured the smooth operation for the continued growth of ANMA. I want also, to thank all the state presidents of our constituent organizations for working so hard for the good of the association. There is still much to do to continue the momentum. We ask that you continue your dedicated support and encourage your colleagues to join ANMA. Finally, I wish to thank those graduates of National and Bastyr College for joining with the ANMA. It is only through unity, cohesiveness, hard work, dedication, and a non-discriminating policy that the naturopathic profession can progress to its rightful place in the health care of the American people. The time is now. The place is right here with ANMA.

On a sad note, ANMA and the naturopathic profession lost a dear friend recently. On September 10, 2007, Dr. Roy Kupsinel passed away. Since the very beginning Roy has been a major supporter of ANMA and recently became the Science Editor of the JANMA. In addition, Roy blessed all of us with his beautiful photos which graced the covers of the JANMA. He will be deeply missed.

INSIDE THIS ISSUE:

Foil Embossed Membership Certificate 

To commemorate over 27 years of success ANMA has created a special membership certificate that looks as beautiful as a work of art. Our already attractive membership certificate is now even more mesmerizing. This special membership certificate is foil embossed with five vibrant and metallic colors. The price is only $75.00 and shipping is included. I guarantee the new ANMA Certificate will be the best looking certificate on your wall. If you are not a 100% satisfied and as crazy as I am about this membership certificate, ANMA will gladly refund your money after the certificate has been returned. To order please call Julie Morgan at 702-897-7053 or e-mail us at webmaster@anma.com. 

INSIDE THIS ISSUE:

Choose Your Passions
Loose Your Addictions
Part 1: The Law of Attraction and The Lure of Addiction

By: Asad Shahsavari, NMD, PhD, MD (MA)

A litany of books, films and documentaries have emerged over the past few decades which have brushed aside the cobwebs of religious, scientific and philosophical premise vaulting us into a proverbial paradigm shift. Among them: The Book of Urantia, The Celestine Prophecy, A Course In Miracles, Silva Mind Control, What The Bleep Do We know?, The Elegant Universe, The Da Vinci Code and most recently, The Secret, which has been on the best-seller list since it made its debut in 2006. All of these tempt us to leave the comforts of our complacency and wander into a world of realities that evokes powers from within the deepest and highest layers of human consciousness.

The so-called secret is allegedly thousands of years old, but it is not new to the inner workings of universal law. Its thought process, however, has been strictly guarded and has become more the private property of elitist groups than the rightful inheritance of humankind. So what is this secret anyway? According to well-lettered members of both the physics and metaphysics communities, it is a simple and profound concept of the universal Law of Attraction. Simply put: Like energy attracts like energy. Similar thoughts attract similar actions. Those of you familiar with homeopathy will recognize "like cures like" or the Law of Similars. We are imaged as magnets of energetic ions in the universe that attract all manner of actions and reactions to us by the energy of our thoughts.

A favorite Einsteinian quote is: "All matter is thought vibrating at a certain frequency." The chairs we sit in, the clothes we wear, the cars we drive, the houses we live in, the cell phones in our coat pockets, the computers on our desks, all were once thoughts in someone’s mind that manifested into matter by design and decision. Could we really be that powerful? Isn’t there something else out there controlling our fates? Whatever happened to destiny? Is it possible that we have been pressing the buttons of our own realities all along by what we simply think? If so, then how do we think ourselves into abuse and addictions? What is the secret to living a liberated addiction-free life?

Perhaps, instead of exposing the secret, we should be exploring the truth. After all, a mystery is only something that someone doesn’t know (yet) and a secret is something someone does know and doesn’t want anyone else to know. Either way, there are only mysteries and secrets in the universe due to ignorance or arrogance. Eliminate ignorance and arrogance and you gain access to the truth masked by all mysteries and secrets. And that truth may be related more to why than what.

There is a definitive relationship between the law of attraction and addictive behavior. The premise of addiction often begins with replacing a feeling of need with a missing sense of fulfillment with drugs, alcohol, tobacco, sexual gratification, gambling, shopping, eating; etc…. All of which are related to the relentless reception of reward and the repetition of stimulation through external objects. The reward is received as an acquisition rather than an accomplishment. It is a yearning rather than an earning. Therefore, the satisfaction of having done something worthwhile for which we are recompensed is missing in the process of simply buying a high.

We can pretty much make any pleasure into an addiction if we choose to abuse. And that brings us to the concept of choice. In a truly addictive situation, the deeper danger is loss of choice and the eventual development of enslavement as the brain and body become entrenched in an altered metabolism of chemical dependence. The user becomes used. Use becomes abuse. The catch-22 is that once we relinquish choice, we become a puppet in the hands of a substance or activity, which then becomes the manipulator.

Interestingly, in an age where we are now becoming increasingly more dependent on mechanics and robotics to manage our lives, we are also feverishly seeking to become free of confinements, restrictions and controls that could transform us into very machines and robots ourselves. In an attempt to be liberated from the daily drudgery of survival and put ourselves at ease, we find ourselves more prone to the seductions of addictive behaviors and the tragedies of dis-ease.

From time immemorial, humans have sought to satisfy pleasure at inexplicable costs. Bypassing that creature comfort desire often requires great strength of character and a genuine passion for developing a life of purpose. Somewhere along the way, that passion may become defined by processes of denial of pleasure, often perpetrated by religious practices and beliefs and which lead the way to inevitable abuse of pleasure seeking due to repression. Once again, balance is the key and anything that promotes extremism on either side mocks true equilibrium. Passions can also inspire us to better ourselves and extend our circle of identity beyond our local selves. Addictions, however, cut us off from the rest of life and we become self-consumed and auto-intoxicated. Passion forms the basis for compassion, whereas addiction becomes its own entropic world, a black hole, so to speak, devoid of cognizance, integrity and pride of ownership.

Once again, the search for the secret continues. Is it found in an external object or an internal awareness? For those of you who may consider yourselves computer savvy, consider this: is it an external or an internal drive? Perhaps the proverbial secret lies hidden in the very aspects of clarity, concentration and creativity found in practices that are thoughtful, respectful, wholesome and inspired. The processes of learning and earning are accepted components of spiritual advancement techniques throughout the world.

Holistic health derives from the concept of holism, hologramatic and holy. The laws of nature abide within the laws of attraction. A seed attracts minerals and ground water to develop its roots. Roots develop into a plant. A plant attracts sunlight and develops fruit. Fruit develops seeds…and the cycle goes on.

Nutrition is based on life-giving biochemicals that furnish the tools for the body to regenerate and repair individual cells and entire cellular systems. Again, the question remains: why would we choose something that is not considered a nourishing substance, but, in fact, erases the ability of the body to regenerate and repair itself, thereby degrading and denaturing the health of the entire being? This, in fact, flies in the face of instinctual habits of preservation as well as intelligent and logical understandings of well-being. Again, the whats are affected by the whys and we must face the fact that the thought, indeed, precedes the action. Perhaps, the lure of a momentary high erases millions of years of instinct and intelligence in favor of unchallenged indulgence.

Processes that involve trickery, escapism, fraud and theft are criminal actions and are at the fulcrum of addictive behaviors such as drug and alcohol abuse, gambling and sexual perversion. They are acquired without concern for consequence and consequently develop thoughtless lives. Those who engage continually in these practices are training for a lifestyle that robs them of their higher states of being and subjugates them to becoming servants to substances and intense urges of indulgence. Interestingly, healthier bodies exhibit an attractiveness that is well defined. Glowing skin, bright eyes, silken hair, well-structured muscles, etc…Anyone who has witnessed the sullen and sallow complexions of crystal meth users readily understands that these drugs rob one of youth, vitality, and energy, as they are attracted to what is missing from within themselves. Consider this: Those who fear, attract those who wish to frighten, just as those who shine, attract those who seek the light.

The secret and the answer lie in balancing assumed wants with vital needs and investing oneself in the fuller experiences of life that involve giving and receiving rather than getting and taking. Oddly enough, even the wordage is applicable. We speak of getting and taking drugs but of giving and receiving gifts; of getting a room or building a home, of grabbing a fast bite or of preparing a meal, of having sex or making love and of getting a date or of finding a soul mate. We say we gather the wheat or slaughter the cattle. Our choices are clearly defined by the presence or absence of compassion, caring, depth and integrity of character from which they evolve. As an apple seed fosters an apple tree, germinating thoughts of loss, abandonment, uncaring and indulgence give rise to a slew of substances and practices that thieve, abandon and abuse. Rather than living a life of substance abuse, one may choose to embrace a life of substance, worthy of true self and higher being.

We often define our successes and ourselves in terms of what we can acquire, such as wealth or power, rather than what we can achieve, such as peace of mind or self-respect.

When we lose our sense of self and become enslaved to a product or a process, use turns into abuse and abuse turns into addiction. This loss of choice becomes a choice in itself. More importantly is why we are seeking life’s ultimate pleasures from lifeless objects and activities.

It is believed among many physicists that the same atomic components exist in all life forms: planets, minerals, animals, plants, humans, etc…If this hold true, then what is the make-up of thoughts, beliefs, desires, emotions, etc…? Are they made of frequencies or vibrations that are elements of energy? If so, then channeling such energy is not only the secret, but may well be the answer to life’s so-called mysteries. Then, again, could consciousness, which embodies the totality of mind processes, be ordered by a different system of logistics, unbound by dimensional law and the confines of energy, to be the very essence of life force, itself?

How do we learn to use this consciousness so that we may experience being causes rather than effects? When we are addicted to something or someone or someway, we expect that we will be fulfilled from an outside source. We rely on the utility company to provide the energy to light our houses, bring us warmth and turn on our stoves. But, how do we become masters of energy from within so that we do not need to always depend on exterior sources? First, there is the wealth of knowledge. Ignorance is its own worst enemy. Know the truth of how the body works. Know the truth of thought generation and distribution. Know the truth of action and reaction. Be conscious of the truth and embrace a truthful consciousness, devoid of the dangers of denial.

Just as your body understands survival in terms of the vital gas exchange in the lungs while you breathe and the moment to moment rhythmic beating of the chambers of the heart, we need to become conscious partners, rather than silent observers, in our existence. It is through consciousness that we truly become alive and aware of the vast array of choices that will determine fulfillment of our life’s deepest passions rather than mere momentary pleasures. We are given the choice and the chance to find ecstasy from within, rather than the street version we have to sell ourselves to obtain. The addictive process is a downward spiral of an indentured life, loyal only to gratification and oblivious to the absolute joys of liberation and enlightenment. That is a high you can’t buy but belongs to a lifestyle that is not for sale and it truly priceless.

The brain is an organ and the chemistry of the brain is intimately affected by thought. The mind, however, is more elusive and more energetic in its constituents. It is delicately influenced and may operate independently of exclusive brain function. It is not bound only by what is logical or chemical or material, but is the residence of memories, emotions and beliefs. Much to the chagrin of science, there is still a ways to go before empirical premise catches up with the essential ingredients of thought. Imagine a thought and it is translated by the brain into chemical conductors of metabolic action. But even when the brain is in "lock-down mode", as in a coma, those who have regained consciousness have remarked on the experiences of "feeling the presence of those who believed they would survive and those who didn’t." Here, again, we are catapulted into the realm of emotions and beliefs-the territory of the chemistry and the alchemy of thoughts.

Just as all elements in the universe are comprised of energy, the energy of thought manifests all matter. Interestingly, it is our current infatuation with materialism and acquisition that are at the very root of substance abuses, whether they be drugs, alcohol, tobacco, etc…They all must be acquired. The further we remove ourselves from original energy and foundational elements of life force, we become disempowered and look elsewhere for validation. Thomas Moore alludes in his book Care of The Soul, that the root word of violence is a down line of vis, referring to force. Violent actions, therefore, may be possible results of a quest for life force. If one does not discover it from within, they may seek it through external fabrications and adulterations of force and resort to taking it from others, as in murder, rape, extortion, theft, etc…

Addictions to sexual gratification, beauty and power often result from insecurities regarding a self-perspective. We are encouraged to view our self worth according to acceptance by others, whether evidenced by illusion or by coercion. Again, there is the attachment to life force and the principles behind survival and empowerment. If we are accepted and respected, then we may be loved and become significant. At the core of human existence is the egoistic need for validation. Love is, perhaps, the most powerful validation and acquisition of all. When a person feels loved, they sense value and significance. Without love, they feel disconnected and abandoned. Pleasure seeking replaces the missing joy of security in knowing that one is accepted and respected and has a place in a well-defined circle of loving support.

Addictive behaviors, like gangs, then become surrogate circles of support. Albeit, they are high maintenance companions, but they do offer risky avenues of escape through sensory stimulation. Freedom from addiction begins with an internal awareness of trusting and loving oneself and developing the ability to share that trust and lovingness with others. The validation comes from within and eliminates the need for escapism. In the addictive mentality, life becomes a mathematical equation that begins and ends with how much or how large, or how often or how fast. This equation, however, is not balanced, for it omits quality and concentrates only on quantity. Without quality, life becomes a mathematical enigma and we seek to escape from it or rather from ourselves who have created it. We then become drunk or drugged, shop till we drop, gamble our earnings away and then we still have to face the fact that we are the answer we seek and, as the old saying goes, wherever we go, there we are.

Our thoughts are at the core of our actions and our actions are the designers of our addictions. Rather than mind over matter, consider mind is matter or what’s the matter with the mind? Change the mind and you change the matter. The secret of the law of attraction lies in the knowledge of the energy of thought and the reality of consciousness. We must choose between becoming victims or being victors.

But how do we reclaim a body and brain that have become addicted? Remember, the causative factors leading to addiction begin as thought processes before they become translated into biochemical processes. Once the brain chemistry, however, has been altered by the addictive process, thoughts become marionettes in the hands of an abusive puppeteer. To be free of these addictions, we must redefine the parameters of our lifestyles to be less self-conscious and more of a conscious self. We must rid the cellular system of toxic emotions and their inherent toxic chemistry and replace panic, anxiety and despair with renewed senses of encouragement and determination.

Desire. Decision. Direction. There must be a deep desire to engineer a lifestyle free of addiction. To be responsible to that desire, we must make a decision to make specific choices, rather than take random chances. To gamble on life, rather than gamble with it. To become what we seek. If we wish to be interesting, than we must become interested. If we wish to be cared about, then we must become caring. If we wish to be respected, then we must become respectful. If we wish to be powerful, then we must become empowered. If we wish to be known, then we must become knowledgeable. If we wish to be loved, then we must become loving. Moving in the direction of these actions immediately frees us of a path of subservience and bondage from acquisition and high-maintenance to a lifestyle of renewal, regeneration and reconnection.

To encapsulate the journey from addictive behavior and substance abuse to a life of enlightened consciousness and determined accomplishment, there is a stepladder of success to consider which combines the laws of attraction and integrity:

1.) Poisons attract poisons. All drugs have a distinct level of toxicity. Eliminate poisoning the body and brain with substances that are not life-generating by replacing them with nutrient-rich foods and beverages.

2.) Emotional imbalances can be regulated by identifying the issues, keeping them in perspective to the totality of one’s life and filtering out emotions that are high maintenance and take more than their fair share of time and resources, such as anger, pride, jealousy, pity, resentment and hatred.

3.) Develop skills of patience and peacefulness through mindful meditation and clearance of thought clutter. A mind that is constipated with old conditionings and brain washings, including addictions, has little room for clear thinking and fresh ideas. Clean out the closet of bitter memories, self-consumption and depression by expanding into the social environment with offerings of resources, time and consideration to others. This ability to project oneself beyond a concentrated inner circle of issues provides an outlet that is earthed in positive action.

4.) Establish a mission directive that will challenge each day to be memorable. Escapism is expensive and addictive in itself. After the momentary high is over, we are still faced with the reality of the lives we are designing by our thoughts and eventual manifestations through actions.

We discover a gravitational force within these practices that grounds us but does not bury us. We develop and intelligence liberated from conditioned beliefs and responses into enlightened consciousness. We stand strong without crutches and are independent but not alone. We join forces with a universal energy that is creative in nature and manifests its own destiny. In so doing, we realize the wealth that can never be bought nor sold nor stolen is of a wealth of character and of knowledge. And the magic potion we seek is no magic, no mystery, no secret at all. It is a simple law of physics: for every action, there is an equal and opposite reaction. If you have known what its like to be a slave to a life of substance abuse…you are only a thought away from becoming master of a life of substance. Choose your passions…lose your addictions…and never again put yourself at risk for someone else’s pleasure or profit.

Look for Part II: Substance Abuse Prevention & Withdrawal: The Dynamics of Detox and Metabolic Rejuvenation in the upcoming JANMA

INSIDE THIS ISSUE:

In Loving Memory
Roy Kupsinel, MD, NMD

Dr. Roy Kupsinel, 78, passed away September 10, 2007. Roy was a good friend to ANMA. He was a supporter and contributor to the success of the natural health movement. He will be missed by the entire profession. Roy was sick for the past two years, and on July 20^th a CT scan confirmed a diagnosis of Metastatic pancreatic cancer with masses in his liver, lymph, and lungs. At Roy’s request, no funeral services were held. He asks that you celebrate his life in a way that is significant to you.

INSIDE THIS ISSUE:

Active Anisepsis as a Safe and Effective Therapy For a Diabetic Foot Ulcer: A Case Report

By: Breeana K. Saffel, Steven R. Frank, Gary B. Clark, MD

Background: Foot ulcers are common in diabetics and are not only expensive to treat, but can lead to amputation of limbs. Due to the risk of amputation in infected ulcers and the incidence of antibiotic resistance, additional therapies should be evaluated (1). Silver has demonstrated healing and antimicrobial abilities and may be a beneficial therapy for diabetic foot ulcers.

Objective: To evaluate the effectiveness of the combination of an iontophoretic application of silver ions and a topical herbal lotion as a therapy for facilitating the healing of diabetic foot ulcers.

Methods: The Active Antisepsis (AA) therapy was applied a total of four times to an open diabetic foot ulcer. In addition, the subject applied a silver hydrogel twice daily for the first part of the study and then applied a topical herbal lotion three times daily for the remainder of the study. Both the investigator and subject rated the severity of symptoms and signs. Photographs were taken sequentially.

Results: The open ulcer quickly closed up, scabbed, and completely healed. The data collected by the investigator and subject portrayed similar trends and mirrored the improvement that was recorded in the photographs.

Conclusion: The AA therapy appears to be an effective therapy for increasing the rate and quality of healing in diabetic foot ulcers. The natural healing process was further complimented by the addition of the herbal lotion.

60 DAYS
10 MONTHS
HEALED

Approximately 5% to 10% of the United States population is affected by diabetes mellitus (1). Chronic hyperglycemia resulting from Type I and Type II diabetes can lead to various complications such as accelerated peripheral atherosclerosis, complicated coronary artery disease, and peripheral neurologic degeneration (1). Commonly, these complications can cause the generation of lower-extremity ulcerations. Repetitive pressure from daily movements such as walking and standing can lead to connective tissue damage between the bone and the skin (1). In advanced stages of neuropathy, the distortion of the appendage leads to conditions for miss-use which put unnaturally high pressures on regions of tissue leading to accelerated damage. Generally, the peripheral neuropathy makes it difficult for an individual to sense the developing tissue damage until the necrotic tissue forms an ulceration of the skin (1, 2). Additionally, the poor state of the capillary bed in the appendage reduces support from the immune system and diminishes the ability of systemic antibiotics from reaching effective concentrations in the region. An estimated 5% to 15% of individuals with diabetes will develop a foot ulcer at some point of their lives and 50% of older patients with type II diabetes (2, 3). Often, foot ulcers become infected with opportunistic pathogens and are unresponsive to antibiotic treatment, which can lead to amputation (3). In the United States, over 600,000 amputations are performed annually in patients with diabetes (4). Generally, half of these patients will go on to have additional amputations of the contralateral limbs due to ulcers within 3-5 years following the initial amputation (4). The mortality rate of these patients is 20%-50% following the first amputation (4). The cost of medical treatment for diabetics amounted to $77.7 billion in 1997 (4). Treatment costs range from $7,000 to $8,000 for a single ulcer, amount to over $17,000 for infected ulcers, and up to $45,000 for amputations (4).

The standard steps that are taken to treat a diabetic foot ulcer begin with cleansing of the wound and attempting to achieve adequate tissue perfusion (1). Once a wound has been debrided, if there is an indication of wound colonization by any type of pathogen based on appearance or swab cultures, some evidence supports the use of broad-spectrum topical antimicrobial agents such as silver sulfadiazine (1). Commonly, silver dressings are used to fill or cover wounds in order to attempt to attenuate bacterial colonization. If it is determined that a wound is infected, systemic antibiotics are appropriate, but the identification of the pathogens from wound swabs is important in choosing which agents to prescribe (1). If an individual has a neuroischemic foot, systemic antibiotics are critical to prevent the need for amputation whether or not the wound is positive for infection (3). The typical pathogens that invade the damaged tissue of a diabetic foot ulcer include various strains of Staphylococcus, Streptococcus, Citrobacter, Serratia, Actinobacter, and Pseudomonas (3). These ubiquitous opportunistic pathogens are notorious for developing antibiotic resistance, so it is important to be constantly monitoring the appearance and the swab cultures of the wound (3).

Due to the high rate of antibiotic resistance that develops in the pathogens commonly associated with diabetic foot ulcers, there is a great need for additional options of treatment. Silver treatments such as topical silver sulphadiazine and silver dressings are commonly used as antimicrobials in treating diabetic foot ulcers. In general, these dressings deliver silver ions to tissue at a steady rate for a short period of time and are designed to prevent bacterial colonization in infection-prone areas. Studies have shown that these wound dressings have been somewhat effective in suppressing surface bacteria and supporting more rapid healing in burn patients (5) and early studies show that some of these therapies may directly inhibit bacterial proteases in chronic wound patients (6). Past studies have demonstrated the ability of silver to reduce the presence of various common skin pathogens such as Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus group D, and Escherichia coli utilizing electric current (7).

To be efficacious, the silver treatment must achieve consistent and sustained clinically effective local silver ion concentrations (8). In passive coated and topical treatments and dressings, the rate of antimicrobial elution and the depth of penetration cannot be controlled. In addition, the dose rate and antimicrobial concentration can be diluted by the exudate from the surface and not be sustained at levels that can effectively fight infection. As the elution rate of the topical treatments drops significantly below that level of effectiveness (5 to 10 ug/ml of ionic silver is optimal for effective antisepsis in tissue) (9), bacteria begin to re-grow and inhibit the healing process.

The Active Antisepsis (AA) Technology therapy uses actively controlled silver iontophoresis with broad-spectrum antibacterial silver ions that can be delivered into the tissue at a controlled rate and dosage. This provides sustained infection control and treatment of the wound through all levels of exudate and for extended periods of time. The antimicrobial cannot be washed or rubbed off, so it remains effective. Since the delivery rate and the penetration and dispersion parameters are controlled electrically, treatment protocols can be tailored to the changing conditions of the wound and treatment can be extended almost indefinitely. Bacterin, Inc., an independent laboratory specializing in evaluating antibacterial coatings, tested the AA Technology against biofilms of staphylococcus aureus, one of the most antibiotic-resistant forms of bacterial infection, and they considered it to be "superior to all commercially available anti-infective coatings technologies (10)."

It is documented that silver ion densities of 5 to 10 ug/ml are required for effective antisepsis in tissue (9). The currently available silver bandages are unable to perfuse to an effective depth of infected tissue, and therefore, cannot maintain this antiseptic tissue density over time. Furthermore, currently available silver ion dressings do not provide control over the elution rate or ion density at the wound site so the anti-infective treatment cannot be adjusted for optimal delivery during changing conditions of the tissue surface and the surrounding environment. In contrast, the AA Technology therapy uses controllable silver iontophoresis to deliver broad-spectrum antimicrobial silver ions directly to the infected tissue at a rate and penetration depth that can be effective for the treatment of complex infected wound surfaces.

Due to the fact that the AA Technology therapy delivers antimicrobial silver ions into the tissue where the bacteria are colonizing and does not depend on the peripheral vasculature to deliver the agent, this makes it superior to oral systemic antibiotics. This is especially true in cases of poor vascularization in the area or peripheral artery disease, which are commonly found in patients with diabetes. Additionally, since ionic silver is not an immunomodulator, it attenuates the population of bacteria without the support of the patient’s immune system. Also, since it applied locally, there is no systemic dilution of the silver.

In addition to the antimicrobial properties of silver, the continuous elution of silver into a region has been shown to produce silver collagen complex. This complex has been shown in laboratory tests to induce cell multiplication that can facilitate wound healing by accelerating re-epithelialization and may have potential for accelerating the healing process of diabetic foot ulcers (11). The addition of an herbal lotion containing multiple herbs with tissue-regenerative properties following the AA therapy will contribute to the healing process.

A detailed medical history was documented and the subject completed an informed consent. Initial photographs and measurements were taken of the ulcer. The subject completed a Symptoms Survey to rate the following on a scale of 1-9: the amount of sleep interference, the severity of pain, the severity of overall discomfort, the amount of crusting, the severity of redness, the severity of bleeding, and the severity of the overall appearance of the ulcer. In addition, the investigator completed a Clinician Global Assessment to rate the following on a scale of 1-9 based on observation: the severity of redness, the severity of fluid discharge, the amount of wound contraction, the amount of crusting, the amount of bleeding, the amount of granulation tissue, and the severity of the overall appearance of the ulcer. Photographs, a Symptoms Survey, and a Clinician Global Assessment was completed at all 10 clinic visits. All Clinician Global Assessments completed after the second visit are based on the observations made in the second visit.

Visit 1

The subject reported minimal sensation in the area around the ulcer, but appeared to have adequate perfusion. Due to the amount of crusting, it was determined that an application of the Active Antisepsis (AA) therapy would not be beneficial until the wound was debrided. The subject was scheduled to have the ulcer debrided only a few days later, so it was decided that the subject would begin the therapy following the debridement.

Visit 2

The subject returned to the clinic 3 days following the first visit, one day after the debridement. The clinician also completed the same previous ratings on the Clinician Global Assessment, in addition to ratings of change in all of those signs based on the first visit’s observations. After all baseline assessments were completed, the therapy was initiated. The AA therapy is applied by coating the ulcer with a silver hydrogel, then covering the area with a silver nylon cloth, and taping it in place. The positive electrode clips onto the edge of the silver nylon cloth, while the ground electrode is taped to an area of skin on the leg away from the ulcer. A current of 500 milli-amps (ma) is applied through the silver nylon cloth over the ulcer for a period of 30 minutes. This equates to approximately 1 ma per square inch. Following the therapy, the subject was sent home with silver hydrogel and bandages and was instructed to change the bandage and reapply the silver hydrogel twice daily.

Visit 3

The subject returned to the clinic 3 days following the first therapy application. A Clinician Global Assessment was completed based on the comparison to the second visit’s observations. The second 30-minute AA therapy at 500 amps was applied and the subject was sent home with the same instructions for use of the silver hydrogel.

The fourth clinical visit was 2 days following the second therapy application, 5 days following the first application. Another 30 minutes AA therapy at 500 milli-amps was applied and the subject was sent home with the same instructions for use of the silver hydrogel.

Visit 5

The subject returned to the clinic 2 days following the third therapy application, 7 days following the first application. The fourth and final 30-minute AA therapy was applied and the subject was sent home with same instructions for use of the silver hydrogel, but was told that a bandage was likely not necessary.

Visit 6 and Visit 7

The sixth clinic visit was 6 days following the final therapy application, 13 days following the initial therapy application. The subject was sent home with an herbal lotion and instructed to apply the lotion to the ulcer region three times daily. The subject returned 14 days later, 27 days following the initial AA therapy application. The subject was instructed to continue applying the herbal lotion to his foot.

Visit 8 and Visit 9

The subject received another debridement of the ulcer 8 days following the last clinic visit. The subject returned to the clinic for the eighth visit 10 days following the second debridement, 45 days following the initial AA therapy application. It was apparent that, due to the healing of the wound, the attending physician had only trimmed the superficial crusted tissue and left a small scab over the wound area. The subject was instructed to continue using the herbal lotion and to return to the clinic when the scab falls off. The subject returned to the clinic 60 days following the initial AA therapy application. There was little change observed since the previous visit on day 45.

Visit 10

The subject’s tenth clinic visit was 208 days following the initial AA therapy application. The wound area had completely healed with normal tissue and it was difficult to see any sign of the ulcer that had been there only 7 months earlier.

A 40-year-old male presented to the clinic with a diabetic foot ulcer on the inferior-lateral aspect of his right heel. The subject was diagnosed with Type II Diabetes mellitus 2 years earlier, requiring noninsulin therapy to regulate his blood sugar. The subject attributed the ulcer to his occupation that involved extensive periods of driving, thus applying constant pressure to that area of the heel. Although the subject no longer spends long periods of time driving, he still spends the majority of his days on his feet. Surgical intervention was required 6 days following the initial formation of the ulcer, which was approximately one year prior to enrolling into the current case study. Following the initial surgery, the ulcer bled constantly for 10 months and was never able to fully heal. The subject had undergone a number of light therapy treatments in the past, but not within 2 months prior to enrolling in the current case study. Additionally, the subject had been instructed to apply a silver sulfadiazine cream to the ulcer. However, when the subject began the study, he was not using any additional treatments other than debridement. The subject has the ulcer examined and debrided on a monthly basis in order to cut away the constantly forming dead tissue.

The first observation of the ulcer located on the lateral aspect of the bottom right foot, showed a crusted wound with some scabbing over the central region (Fig. 1). When the subject was observed following debridement, the wound was no longer crusted over and the open wound was an indentation with a diameter of 10mm at the deepest part of the wound. The tissue in the wound and immediately surrounding it was red and slightly inflamed, but did not appear to be infected (Fig. 2). Following the initial AA therapy application, no change in the appearance of the wound was observed. Three days following the first application of the therapy, the wound had contracted significantly and granulation tissue was forming around the edge of the open wound, which now had a diameter of 6.25mm (Fig 3). Five days following the first therapy application, the wound had again demonstrated significant contraction to a diameter of 2.5mm and the tissue surrounding the wound was crusting. The redness was almost completely gone and a slight brownish discoloration of the crusting tissue was noted (Fig. 4). Upon observation 7 days following the initial therapy, the wound was more closed to a diameter of 1.25mm and more tissue was crusted. The brownish discoloration was again noted (Fig. 5).

Thirteen days following the first therapy, and 6 days following the fourth and last therapy, the wound was completely contracted and crusted over. The crusted area over the wound was still discolored (Fig. 6). Upon observation of the ulcer 27 days following the initial therapy, the crusted area was more solid and still discolored, but had not changed in size (Fig. 7). Forty-nine days following the initial therapy and 10 following a second debridement, the large crusted area over the wound was gone and only a small scab remained over the center of the wound area. The tissue surrounding the scab was healthy, normal tissue (Fig. 8). The wound area was unchanged on day 64 (Fig. 9). The wound area was completely healed on day 212, 7 months following the initiation of therapy (Fig. 10).

Figure 1: Photograph taken Day 1, prior to debridement and AA therapy.	Figure 2: Photograph taken Day 4, 1 day following debridement.
Figure 3: Photograph taken Day 7, 3 days following the first therapy.	Figure 4: Photograph taken Day 9, 5 days following the first therapy.
Figure 5: Photograph taken Day 11, 7 days following the first therapy.	Figure 6: Photograph taken Day 17, 13 days following the first therapy.
Figure 7: Photograph taken Day 31, 27 days following the first therapy.	Figure 8: Photograph taken Day 49, 45 days following the first therapy.
Figure 9: Photograph taken Day 64, 60 days following the first therapy.	Figure 10: Photo taken Day 212, 208 days following the first therapy.

All of the data that was collected from the subject and the clinician demonstrated similar changes to those recorded in the photographs. The most notable data are the signs that represent healing, such as wound contraction, granulation tissue, and crusting. The data portrays the fact that these values were high in the first observation, prior to the first debridement, but were very low following the debridement. These signs gradually increase as the therapies are applied and continue afterward (Graph 1). Additionally, the assessments made by the subject and the clinician showed that the overall appearance of the ulcer was worse following the debridement than the first day observed, but that the improvement seen over the course of the treatment and afterwards eventually exceeded the original observed appearance (Graph 2). As seen in the two graphs and as is true with all of the data, the assessments made by the subject and the clinician were very similar and followed the same trends (Graphs 1 & 2). Due to the subject’s low levels of sensation in the ulcerated region due to neuropathy, there was very little change seen in symptoms of pain and discomfort. Although there were additional symptomatic and sign assessments recorded, the data is not reported in this case report due to the similarities to the data reported.

Over the course of applying the AA therapy to a long-term and persistent open diabetic foot ulcer, the signs of healing gradually increased until the wound was completely healed. The initial signs of healing primarily included increased amounts of wound contraction, granulation tissue, and crusting. Although the subject began the study with a contracted wound and crusting prior to the debridement that opened the wound in order to allow it to re-heal, the healing that occurred following the AA therapy led to normal tissue with no indication of a prior ulcer. The ulcer had not shown any signs of normal healing in the 10 months following the initial operation, prior to this study. In addition to the photographs, the data also portrays that complete healing of the ulcer occurred. The brownish discoloration observed in the crusted tissue around the wound is believed to be traces of silver in the treated tissue and was removed along with the large crusted scab.

Based on the photographs and the data, it is apparent that the AA therapy seems to be a beneficial therapy for diabetic foot ulcers. The observations show that the wound quickly contracted and eventually healed completely with no harmful side effects or infection. Previously, this area simply covered over with eschar that died and required debridement. The potential of the AA via silver iontophoresis as a therapy for diabetic foot ulcers is worthy of further evaluation. Additionally, the herbal lotion that was applied after the wound healed appears to have maintained healthy and supple skin.

INSIDE THIS ISSUE:

Diet, Energy and Hormone Regulation
 

By: Jeannette Santino, PhD
Statistical Analysis By: Kim Kelly, ND

This study was concerned with the combined effect that a well-rounded, healthy, nutrient-dense food program while eliminating the use of selected substances known to alter hormones, such as alcohol, caffeine, soy, hormone-laced meat, common allergy foods, would have on the adrenal glands and specific hormones.

Accepted into the study were six individuals that had never been on hormone replacement therapy and were on a less than optimal diet. One post-menopausal woman, four menstruating women, and one male volunteered to be test subjects. A salivary assay baseline was taken of the hormones: cortisol, dehydroepiandrosterone sulfate (DHEA-S), testosterone, progesterone, and estradiol before they began the eight-week dietary change. Participants were given a list of approved foods and a list of foods forbidden during the eight-week program. They kept a detailed list of foods they consumed on a daily basis during the eight-week program as well as the week prior to the study when they consumed their usual foods. They reported in a detailed journal any changes in their energy, sex drive, bowel habits, and mood changes. At the end of eight weeks, the same salivary assay was taken of the five hormones and the pre and post lab reports were evaluated.

There was an increase in testosterone for five of the subjects and a slight decrease in the one test subject that was not 100% compliant. The male test subject was the only one that noted a substantial increase in sex drive in his journal. Even though four of the women test participants also had a rise in testosterone levels, they did not note an increase in their libido. Fifty percent showed a healthy increase in 8:00 a.m. cortisol. Four test participants began with erratic circadian cortisol rhythms. Of those four, three showed a return to normal circadian rhythms on the post-test. With respect to weight and body mass index (BMI), 100% lost weight and had a drop in BMI. There was no significant shift in DHEA-S, progesterone and estradiol in all six of the test participants.

Although the study period was short and there were only six participants, there was indication of an improvement in adrenal function, an increase in testosterone, and a positive shift in weight and body mass index. A healthy well-rounded nutrient-dense food program can have a positive effect on the adrenal glands and the hormones they produce. Further investigation needs to be done in this area to see the effects a nutrient-dense diet would have on adrenal function and hormone production over a longer period of time and with a larger participant base.

Currently synthetic hormone replacement therapy and natural hormone replacement therapy are the two most used means of balancing hormones in the traditional medical model. Any hormone, natural or synthetic, has the potential for abuse and can cause unwanted side effects, especially if a trained practitioner does not monitor the person regularly. However, correcting any hormone imbalance is, in most cases, not just simply a matter of supplying the body with hormones.

This study on diet, hormones and energy regulation sought to determine if the body’s natural ability to produce the necessary amounts of hormones for good physical and emotional health could be restored or aided by the use of nutrient-dense foods under reduced stressed conditions. An important aspect of this study is also to stop feeding the body substances that will deplete the body’s reserves of these hormones. Therefore, this study is not about how the body responds when given an isolated nutrient or hormone; neither is it about a drug given to suppress a symptom, but rather preventing a problem or possibly reversing the imbalance with essential nutrients alone.

For many years the hormone supplement of choice in traditional medicine for women with hormonal issues was Premarin. The Journal of the American Medical Association, in July 2002, published the results of the first large randomized, placebo-controlled trial of conjugated equine estrogen plus medroxyprogesterone acetate in healthy women. This study, known as The Women’s Health Initiative (WHI) trial identified an increased risk of heart attacks, strokes and deep venous thrombosis, prompting premature closure of the study^1,2. As with most pharmaceutical drugs, while there may be some benefit, there are often risky side effects.

With recent research findings, women are seeking alternatives that do not carry the risks associated with synthetic HRT. Some, to help with menopausal symptoms, use exercise, relaxation techniques, and dietary changes that incorporate whole foods and soy. Many women have used botanicals such as black cohosh and red clover to decrease the severity and frequency of hot flashes.

The general purpose of this study was to determine from salivary tests if the hormones cortisol, DHEA-S, testosterone, progesterone, and estradiol can be brought back into balance by giving the body what it needs on a foundational level without using hormones or supplements of any kind, natural or synthetic. Specifically, the investigator was interested in:

(a) Whether basic natural elements such as amino acids, enzymes, minerals, vitamins, and essential fatty acids from nutrient-dense foods, can aid the body to restore hormones naturally without HRT

(b) Can the adrenals return to a normal circadian rhythm and normal function by strict adherence to a healthy diet and lifestyle

Nutrients, or the lack thereof, have an effect either directly or indirectly on human hormones. In designing this study, the investigator needed to consider several factors with respect to food intake amounts and food choices. This was not a weight loss plan; therefore, the amount of nutrient-dense food was not restricted and the subjects were encouraged to eat healthy foods to satisfaction. Substances such as alcohol, cigarettes, gluten foods (due to possible sensitivities), hormone-laced meat, soy, caffeine, refined carbohydrates, and refined sugar were prohibited during the eight-week study because of the possible influence they may have on hormones^{17, 18, 19, 20, 21, 22, 23, 24} and stress they may place on the digestive tract and ultimately the adrenal glands.

It is important to differentiate between synthetic hormones, natural hormones, and bioidentical hormones. Synthetic hormones are formulated in a laboratory. Natural hormones come from another animal species, such as Premarin, from pregnant mares’ urine. Natural hormones are processed with very few chemical changes and are not chemically identical with those found in humans. Bioidentical hormones are synthesized from plant sources, which are modified chemically to form products that are chemically identical with human hormones. Bioidentical hormones are preferable when hormone replacement is necessary because they are identical to hormones produced by humans.

Integrative health care providers recommend bioidentical hormone replacement when other lifestyle, nutritional, or herbal supplementations are not effective in controlling hot flashes. According to one systematic literature review, black cohosh, exercise, and soy protein have been shown to be safe and effective in short-term use³. However, sometimes the hormone levels are so low, and the adrenal glands are so exhausted that they can no longer produce the hormones required for optimal health. It must be noted that to date, there have not been any long-term trials studying the use of bioidentical hormones for hormone replacement, as there has with the drugs Premarin and Progestin.

Both menopause in women and andropause in men and the vast amount of symptoms they generate are due to a shift in adrenal and sex steroid hormones. A drop in hormones is normal as we age. It is the extreme drop and the resulting side effects that will cause many women, as well as some men to seek medical intervention. Lives may be healthier if hormones are maintained at healthy levels throughout our lifetime, even with advancing age. Since prescription drugs carry their own level of risk, it is beneficial to investigate the natural alternatives.

It has been determined in many studies, a few of which are referenced here, that low dietary intakes will have an effect on various hormones. These various studies give indication that fasting or food deprivation will raise cortisol levels, that a low calorie or low energy diet will disrupt the menstrual cycle and decrease steroid sex hormones, and estrogens are reduced with high fiber diets^{4, 5, 6, 7, 8}. These studies are mentioned here simply to express that what we ingest can have a positive or negative effect on our hormone production.

Intestinal micro floras are involved in a variety of processes within the human body and are important for maintaining health; therefore it is this investigators opinion that individual differences in the ability to harbor certain intestinal bacteria might be associated with individual differences in health and/or disease susceptibility as well as hormone stability. Compared with the usual micro flora of a typical Western diet, the gut of macrobiotic or vegetarian subjects may be richer in lactobacilli and bifidobacteria. It has been noted that dietary supplementation with isolated phytoestrogen-rich products may be less effective than a comprehensive healthy dietary change⁹, which may in the process modify bowel function and micro flora to the good.

There has been considerable interest in phytoestrogen intakes in relation to human health. Diadzein, an isoflavone phytoestrogen found in soy, is metabolized to equol and O-desmethylangolensin (O-DMA) by intestinal bacteria. Approximately 30%-50% of the human population produces equol and approximately 80% produce O-desmethylangoiensin¹⁰. There are substantial differences individually in the metabolizing of daidzein following the ingestion of soy due to the presence of gut flora. An individual’s ability to produce equol and O-DMA may be associated with reduced risk of certain disease including breast and prostate cancers. The primary roles of the intestinal micro flora include metabolic processes such as fermentation of non-digestible dietary components and metabolism of endogenous mucus and dietary compounds, control of epithelial cell proliferation, and a protective roll such as acting as a barrier to protect against pathogens¹⁰. However, relatively few studies in this area have been conducted to date.

Isoflavones are structurally similar to the human estrogens and for this reason interest has focused on their effects on hormone production. However the effects of the isoflavones have not always been consistent. Individual differences in isoflavone metabolism based on gut flora could be a contributing factor. Intestinal bacteria play an essential role in diadzein metabolism. Young infants with underdeveloped gut micro flora do not produce either equol or O-DMA¹⁰. In vitro work with human intestinal bacteria has shown that estrogen metabolism is carried out differently by various species of bacteria, and in vivo manipulations or disturbance in colon micro flora can alter estrogen metabolism¹⁰. It is possible that the daidzein-metabolizing bacteria could be involved in hormone metabolism, although currently there is no substantial data to support this.

Studies, primarily comparing Asian and Western populations, have been interpreted to indicate that consumption of a diet rich in phytoestrogens in soy improves estrogen deficiency symptoms in postmenopausal women. This fueled a movement towards increased consumption of foods rich in phytoestrogens, and oral supplements of concentrated isoflavone extracts are still being heavily promoted. However, more recent studies, question the validity of the proposed benefits of phytoestrogen supplementation.

Controversy exists about the benefit of soy for reduction of hot flashes and protection from heart disease or osteoporosis¹¹. There are three classes of phytoestrogen or estrogen-like substances found in certain plants: isoflavones, found primarily in soy products; lignans, found in most fiber-rich foods such as flax; and coumestans, found in many plants.

Two studies of an over-the-counter tablet preparation of isoflavones extracted from red clover versus a placebo in postmenopausal women showed that doses of both 40 milligrams per day and 160 milligrams per day had no greater benefit than placebos for vasomotor or other menopausal symptoms^{12, 13}. Another study reported a positive impact of the use of soy protein on bone health in post-menopausal women who were not on hormone replacement therapy but not on those that were¹⁴.

Davis (2001)¹⁵ concluded that phytoestrogens have not been shown to improve symptoms that characterize the menopausal transition, such as anxiety, mood changes, joint pain, muscle pain, and headaches. Women experiencing mild menopausal symptoms may gain relief by dietary modification and lifestyle changes, such as reducing smoking and consumption of caffeine and alcohol, managing stress, and increasing exercise. However, there seems to be no evidence to support the belief that even a very high intake of soy products will alleviate hot flushes, night sweats, and other symptoms such as dryness, mood changes, and musculoskeletal symptoms. Another study¹¹ concluded that the phytoestrogens available as soy foods, soy extracts, and red clover extracts do not improve hot flushes or other menopausal symptoms. The researchers’ objective was to assess the efficacy and tolerability of phytoestrogens for treatment of menopausal symptoms. The study found that the adverse effects of consuming soy were primarily gastrointestinal and taste intolerance. This may be due to the level of healthy gut micro flora in the subjects studied or a possible allergy to soy.

A more recent study¹⁶ showed that there are still gaps in the understanding of soy phytoestrogens and their impact on human health and safety. The researchers concluded that it appeared that phytoestrogens might exert both estrogenic and anti-estrogenic effects, depending on circulating levels of endogenous sex hormones. Additional research is required to be clear on the effect of dietary isoflavones. Further, some adults lack the intestinal bacteria required to metabolize daidzein in soy products, which may be why soy does not have a positive impact on some women for the treatment or prevention of hormone dependent conditions.

The results of the various studies of the effects of isoflavones on hormones in women are varied and conflicted. It is this investigators opinion that the differences may be due to differences in study design, the level of healthy gut micro flora in the test participants, any unknown food allergies of the individual test participants involved, their stress levels, and perhaps other factors yet to be identified. Therefore use of soy isoflavones and their effectiveness needs to be determined on a case-by-case basis.

The investigator established initial baseline values from pre-tests on individuals that had not had hormone replacement therapy. Saliva levels of cortisol, DHEA, progesterone, testosterone, and estradiol as well as the minerals sodium, potassium, chloride, phosphorus, calcium and magnesium were measured as the outcome variables. Other dependent variables such as height, weight, sex-drive, energy levels, moods, and stress levels were also measured.

Excluded from the program was anyone who had been on any form of hormone replacement therapy, natural or prescription within two years. Also excluded were ones that had been on adrenal glandular supplements within two months of testing. The research participants were put on a program that included exercise, a diet of pure water, nutrient-dense raw foods, hormone-free poultry, fish, essential fatty acids, homemade kefir rich in beneficial flora, and fresh vegetable and fruit juices for sixty days. All non-prescription vitamins and herbal supplements were discontinued one week prior to and during this time. At the end of sixty days the research participants saliva was again tested on the same hormones and the change in values were evaluated. Measuring the change from pre-test to post-test may give an indication of what the human body is able to do with natural support only.

This is a present-day study looking at what affect a healthy diet will have on hormone function. The method of choice in this case was to use a clinical trial to acquire data. Test participants were taken that had previously been on poor diets and evaluated in seventeen areas using a combination of objective data and even some subjective data as well as eleven different laboratory tests. They were then put on a carefully designed protocol to accomplish the following:

a) The removal of stress from the digestive track, liver, and adrenal glands

b) To incorporate nutrient-dense foods

c) The elimination any foods known to alter hormone levels

The Test participants were then monitored for eight weeks. At the end of the eight weeks the same saliva tests were run, data was collected, evaluated and compared to the original saliva tests to determine what shift, in any, had taken place in the afore mentioned hormones and what could be done in future trials to make the program more effective.

The investigator established individual baselines by taking saliva samples at four-hour intervals in a twenty-four hour period. The saliva samples were taken at 8:00 a.m., noon, 4:00 p.m., 8:00 p.m., midnight and 4:00 a.m. Volunteers consisted of one male age 48, one post-menopausal female age 58, and four cycling women between the ages of 44 and 48. The test participants went through a program of exercise, a diet of pure water, nutrient-dense raw foods and juices for 60 days. They were given dietary instructions for healthy eating and instructed to abstain from specific foods and to include other specific foods for 60 days. Participants kept daily, detailed journals on food intake, exercise, energy changes, fluctuations in sex drive, bowel habits, changes in physical symptoms, and emotions. Personal interviews were held on a weekly basis, where weight and body mass index were measured.

Six test participants were accepted, both men and women were encouraged to apply, and no race was excluded. The only health issues that would have caused an exclusion from this study would have been diabetes and cancer. Diabetics were excluded from the program because of the need to be on a regulated diet, they might have been on medications, and because diabetes is a disease of the endocrine system. Participants with cancer were also excluded because the disease may prevent the body from showing an improvement in adrenal function and hormone levels in such a short time period. Also excluded was anyone that had been taking any form of hormone replacement therapy, or adrenal glandulars supplements, as these would skew the lab tests and not give an accurate indication of what the body itself is producing.

Sabre Sciences, Inc., a saliva-testing laboratory specializing in research, evaluated the pre- and post-saliva samples. The tests included the minerals: sodium (Na), potassium (K), chloride (Cl), calcium (Ca), phosphorus (P), and magnesium (Mg), taken at 8:00 a.m.; six periods of cortisol: 8:00 a.m., noon, 4:00 p.m., 8:00 p.m., midnight and 4:00 a.m.; three time periods of DHEA-S: 8:00 a.m., 8:00 p.m. and midnight. Samples for the steroid hormones progesterone, estradiol and testosterone were taken at 8:00 a.m. only.

The laboratory evaluated the saliva from the test participants against the median ranges of the general populace in the United States. This evaluation was done at the beginning of the program, prior to the test participants changing to a nutrient-dense food program, and again at the end of eight weeks of being on the nutrient-dense dietary program exclusively.

Test participants weighed in at the beginning of the program and during this initial week, they were instructed to take the 24-hr. saliva test. Saliva samples were sent to the lab for processing. At the end of the eighth week, saliva samples were taken exactly as at the beginning of the program, and samples were sent to the laboratory for evaluation.

Prior to beginning the nutrient-dense food program, the test participants were to keep a detailed food journal of daily foods eaten that was part of their typical dietary habits for a period of one week. They also recorded their energy levels and sex-drive at various times throughout the day, as well as any specific emotional and physical observation, and bowel habits. During every week, the test participants met with the Principal Investigator for weight and BMI checks. Week two they began the nutrient-dense phase of the program, keeping detailed journals exactly as they did in the week prior.

The protocol was designed to remove as many substances known to be harmful to the body and replacing them with as many nutrient-dense foods as possible while giving the test participants a variety of good foods to choose from. Juicing was encouraged for its ease of digestibility and because it could provide a denseness of minerals and vitamins. Journals were designed to keep the test participants focused, to document bodily changes, and record subjective data such as libido, energy, and emotions.

The time frame of eight weeks for the food program was chosen to keep the test participants compliant while still hoping for a measurable shift in adrenal function even though a relative short period of time was used. Ideally, it would be best to design the study for a longer period of time with more test participants. A test period of four to six months with at least 30 to 50 test participants would be closer to the ideal.

Results and Findings

After examining the baseline pre-tests and comparing them with the post-tests of the test participants, the investigator determined that there was over-all improvement in adrenal gland function and some of the hormones they produce, but in some areas, the shift was too small to be considered significant. There were aspects of the study that indicate that a nutrient-dense food program can have a positive impact on the adrenal glands and the hormones they influence. Five of the test participants were compliant with the entire program, and one of the female test participants did not comply with the protocol entirely. Rather than discount her results, the investigator included her in the final analysis because there were some significant aspects of her recorded results.

Analysis of Data Collected

Descriptive analysis was done on a pilot group of six people (five women and one man) over a nine-week period (Table 1). The variables included in the study are listed in Table 1.

Table 1 – Demographic Characteristics of Study Participants

Initial Period

The information gathered in the analysis was broken down into five different categories: Demographics, Electrolytes, Adrenal Hormones, Sex Hormones, and Well-being (Table 2). A 2-tailed paired T-test was run to look at differences in mean between baseline and end of study of the variables of interest listed below, using STATA version 7.0. The accepted level of significance for all tests was P<0.05.

Table 2 – Areas Evaluated

Findings

The investigator monitored the test participants throughout the entire study and the test participants kept daily journals as an additional aid in monitoring their progress. It was questionable if subject 19966-20741 was truly compliant in following the regulated diet 100%. However, she was still included in the analysis because she was compliant enough to show improvement in some areas and to help increase statistical power.

There was a statistically significant difference in BMI, K, Cl, and Ca when comparing week eight of regulated diet to baseline data when patients were on an unrestricted diet (Table 3). There was a 2.12 decrease (p<0.0001) in BMI during the 8-week study period. The changes in the electrolytes, K, Cl, and Ca were in a favorable direction as it was more in the optimal range at the end of the study period. K and Cl showed a decrease (p<01), and Ca showed an increase (p<0.01) during the 8-week study period. There were slight changes in actual levels of adrenal and sex hormones but they did not differ significantly (Table 4). The changes in libido, energy, and emotions were not statistically significant but were clinically significant (Table 5).

Table 3 - BMI, K, Cl, Ca Evaluations