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SCLERODERMA
PILOT STUDY BY
JOHN
W STEARNS MD OUTLINE Research Question:
..Page
3 Mission Statement:
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3 Study Methods:
.Page
3-4 Study
Formulary--------------------------------Page 5 Scleroderma Disease
Review:
..Page 6-11 Molecular Biology of
Human Disease:
Page 12-24 Information
Materials:
..Page 25 Expectations of
Participants:
Page25-26 Informed Consent:
Page
27-31 Research Question:
Can a proprietary blend of glyconutrients have a profound effect on the
disease process of scleroderma in a year long case history study. Mission Statement: To investigate the
potential impact of micronutrients on the symptoms of the scleroderma
disease in a cross section of scleroderma patients participating in a 12
month study. Study Methods: All clinical subjects will receive their standard medical care
through their current medical advisors. Every third patient will be a
control the first patient will be on the original glyconutrient
formulation and the second patient will be on the advanced glyconutrient
formulation. Each person will be assigned a group as they enroll. If the
severity scores are improving significantly in the micronutrient group
the control only subjects will be crossed over to the best performance
leg and supplied with micronutrients for a full 12 months. The study will build
to a maximum of 50 patients during the first three months of the twelve
month study. The patients will all come once a month to a central
location to receive their micronutrient products. They will fill out the
John Hopkins Self-reported Questionnaire and the Skin Scale. This is 34
questions or six pages and will be done monthly. We will add one or two
questions regarding compliance with the micronutrient program. We are
requesting that each patient give us a chronological statement of their
scleroderma disease treatment prior to the study. The patients will have
a monthly evaluation called Computerized Electro Dermal Stress Analysis
or CEDSA. This test will be collected as an objective marker for health
improvement in scleroderma patients. The patients will be
managed by their physicians and we will have a summary of the patients
progress at six months and a year. The Fisher Institute may decide to
publish these case histories and serial assessments. We are hoping to
interest a research center to do a broader and more intensive study on
scleroderma patients following the conclusion of this study. All of the
data will be shared with Manna Relief and the patients will complete an
information release and an informed consent paper prior to beginning the
study. Education of the
patients will be done by giving them Dr Reg McDaniels paper on the
benefits of micronutrients. Dr Stearns will be available to answer
questions regarding the micronutrients. Vickie Goswick, Marian Hughes,
and Kay Goldstein will assist with the information gathering and study
management. Dr John Stearns will be responsible for the entire study and
appropriate delegation of responsibility. The patients
physicians will be given a packet of information regarding the
scientific rational for the study and the study design. Dr Stearns will
be available to answer questions as needed. Micronutrient
Product for the study: The micronutrient
product will be provided to a central location on a bimonthly basis and
the products will be distributed from there. Dr John Stearns will
oversee the project STUDY FORMULARY ARM I Ambrotose-----------------3 teaspoons twice a day. Ambrotose A/O:-----------------2 pills twice a day. Plus:---------------------------------3 pills twice a day. GI-Pro-------------------------------1 pill twice a day. GI-Zyme:---------------------------1 pill twice a day. Catalyst:---------------------------1 pill twice a day. The above formulation will be taken daily for a year. We are expecting
patients to continue the above program during hospitalizations. STUDY FORMULARY ARM
II Ambrotose Advanced: -------3 teaspoons twice a day: The rest of Arm II will be the same as Arm I the only difference is the
Ambrotose in Arm I and Advanced Ambrotose in Arm II. Scleroderma Disease Review. The MayoClinic.com web site provides a modern review of the current state of medical understanding of the scleroderma condition. We are providing this review as a non commercial informational presentation regarding the current medical understanding of scleroderma at the time of this study Scleroderma Overview Scleroderma (sklere-o-DER-muh) is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues- the fibers that provide the frame work and support for your body. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin, In fact, scleroderma literally means "hard skin." In some cases, scleroderma also affects the blood vessels and internal organs. Scleroderma is one of a group of arthritic conditions called connective tissue disorders. In these disorders, a person's antibodies are directed against his or her own tissues. Researchers haven't established a definitive cause for scleroderma. About 150,000 Americans have the disease. It's more common in women than in men and more common in adults than in children. Scleroderma can run in families, but in most cases it occurs without any known family tendency for the disease. It's not considered contagious or cancerous, but this chronic condition can greatly affect self-esteem and the ability to accomplish everyday tasks. Signs
and symptoms In addition to thickening and hardening of your skin, scleroderma can cause your skin to lose its elasticity and become shiny as it stretches across underlying bone. Other signs and symptoms may include:. Numbness, pain or color changes in your fingers, toes, cheeks, nose and ears, often brought on by cold or emotional distress (Raynaud's phenomenon). Stiffness or pain in your joints and curling of your fingers . Digestive problems ranging from poor absorption of nutrients to delayed movement of food due to impaired muscular activity in your intestine. Sores can develop over joints, such as your elbows and knuckles, puffy hands and feet, particularly in the morning. Causes Collagen is a fibrous type of protein that makes up your body's connective tissues, including your skin. Scleroderma results from an overproduction and accumulation of collagen in body tissues. Although doctors aren't sure what prompts this abnormal collagen production, the body's immune system appears to play a role. For unknown reasons, the immune system turns against the body, producing inflammation and the overproduction of collagen. In addition to its effects on your skin, some types of scleroderma affect tiny blood vessels and can affect almost every organ. Doctors classify scleroderma into different subsets: Localized
scleroderma This type of scleroderma is limited to your skin and the deep tissues below your skin. It includes' the following sub classifications: Morphea: In this form, oval-shaped thick patches appear on your skin - white in the middle, with a purple border. These patches are most likely to occur on your torso, but they can also appear on your arms, legs or forehead. Linear scleroderma: This form results in bands or streaks of hardened skin on one or both of your arms or legs, or on your forehead. Systemic
scleroderma This type of scleroderma affects not only your skin, but also your blood vessels and major organs. It's also called systemic sclerosis and includes the following sub classifications: Diffuse cutaneous systemic sclerosis. This type affects the skin of your fingers, hands, arms, legs, face, neck and trunk. It can also affect internal organs, such as your lungs, heart, kidneys and gastrointestinal tract including your esophagus .It can hinder the functions of your digestive system, create respiratory problems and cause kidney failure. When left untreated, systemic scleroderma may be fatal within several years of onset. Limited cutaneous systemic sclerosis: This type involves the skin of your fingers, lower arms and legs, face, and neck. A variation is called CREST syndrome. CREST stands for these conditions: .
Calcinosis : Calcification in the
skin: .
Raynaud's phenomenon:
Numbness and coolness in the
fingers, toes or nose in . Esophageal dysfunction: such as reflux or difficulty in swallowing. . Sclerodactyly: hardening of the skin of the fingers or toes . Telangiectasia - dilatation of tiny blood vessels, particularly of the skin Sine scleroderma: Some doctors may describe one variation of systemic scleroderma as sine scleroderma, which can be similar to either limited or diffuse scleroderma, the difference being that this form doesn't affect your skin. Sine is the Latin word for "without." Overlap
syndrome This is diffuse or limited systemic sclerosis with features of one or more of the other connective tissue diseases. For example, mixed connective tissue disease (MCTD) is an overlap syndrome with features of scleroderma, lupus, polymyositis and rheumatoid arthritis, and with the presence of an antibody produced by your immune system that is directed against cellular proteins in your body. Undifferentiated
connective tissue disease This has features of systemic sclerosis, but there are no clinical or specific laboratory findings to make a definite diagnosis. When
to seek medical advice: If
youre experiencing the early signs and symptoms of scleroderma-
numbness, pain or color
changes in the skin of your extremities, gradual hardening and
tightening of your skin, and stiffness or
pain in your joints see
your doctor. It's important to establish a diagnosis. Early before the disease progresses and to determine if the condition has affected your internal organs. Screening
and diagnosis Scleroderma can be difficult to diagnose. It's rare and, early on, it can affect the skin as well as the joints, making it look like other diseases such as rheumatoid arthritis or lupus another connective tissue disease that can cause rashes and inflammation of the joints and kidneys. To make a diagnosis, your doctor will review your medical history and conduct a physical examination. As part of the examination, your doctor will look at your skin, checking for thickened and hardened areas. Your doctor may also examine and touch some of your joints and tendons to check for possible changes in connective tissue beneath your skin. Because Raynaud's phenomenon is commonly a sign of scleroderma, your doctor will look for color changes in your skin that may indicate Raynaud's. Your
doctor may also conduct the following tests:
Blood tests. People with scleroderma have elevated blood levels
of certain antibodies produced by the
immune system. .Tissue sample: Your doctor may remove a small tissue sample (biopsy) of your affected skin to be examined in the laboratory for abnormalities. Your doctor may recommend a number of additional diagnostic tests to identify any lung, heart or gastrointestinal complications accompanying scleroderma. Complications Having systemic scleroderma may result in a number of other health conditions: . Gastrointestinal complication:. In scleroderma, wasting occurs in the muscular walls of your intestine. This can reduce absorption of nutrients and movement within the intestine, resulting in weight loss and malnutrition. When scleroderma affects the muscular lining of your esophagus, heartburn can occur. Lung complications: Scarring of lung tissue (pulmonary fibrosis) can result in reduced lung function, reduced ability to breathe and reduced tolerance for exercise. You may also develop high blood pressure in the arteries to your lungs (pulmonary hypertension). . Kidney complication:. When scleroderma affects your kidneys, you can develop an elevated blood pressure and an increased level of protein in your urine. More serious effects of kidney complications may include renal crisis, which involves a sudden increase in blood pressure and rapid kidney failure. Heart complications: Scarring of heart tissue increases your risk of heart arrhythmias and congestive heart failure and can inflame the membranous sac surrounding your heart (pericarditis). Treatment: Scleroderma has no known cure- there is no treatment to stop the overproduction of collagen. Your doctor may recommend a number of medications to make it easier for you to live with scleroderma by treating its symptoms. Your doctor may also suggest medications to prevent complications of scleroderma that may affect various organs. Here are some of the many treatments prescribed for the symptoms and complications of this condition. Skin changes: If you have localized scleroderma, your doctor may recommend a topical treatment, such as a moisturizer or corticosteroid medication that you apply to your skin. Corticosteroid medications impede your body's ability to make substances that can cause inflammation .If your condition involves more body area or an arm or leg, your doctor may recommend additional treatments. Doctors sometimes prescribe minocycline (Minocin, Dynacin) to control the skin-related (cutaneous) symptoms of scleroderma, although no studies have addressed its long-term effectiveness. In preliminary studies, light therapy (phototherapy) has also proved effective in treating the lesions that are associated with scleroderma, but more research is needed. Cosmetic treatments are another consideration. Some people with scleroderma are discouraged or embarrassed by lesions and marks on the skin, including telangiectasia- the tiny dilated blood vessels that often appear on the face. Specialized brands of foundation makeup and pulsed dye laser surgery can help camouflage or eliminate these lesions. Consult your dermatologist about treatments for skin changes. Circulation problems Your doctor also may prescribe medications to dilate blood vessels and promote circulation. These medications can prevent high blood pressure and kidney problems and help treat Raynaud's phenomenon: Medications that help with blood circulation include: Calcium channel blockers. These medications help relax blood vessel muscles, and some slow your heart rate. One example is nifedipine (Procardia). . Alpha blockers. These medications prevent muscle contractions in smaller arteries and reduce the effects of naturally occurring body chemicals that narrow blood vessels. Alpha blockers include doxazosin (Cardura). Angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors help relax your blood vessels by blocking the formation of a natural chemical (angiotensin) inside your body that narrows blood vessels. These medications include captopril (Capoten). . Angiotensin II receptor blockers. These medications act in a manner similar to that of ACE inhibitors, but they block the action of the chemical instead of the formation of the chemical itself. They include losartan (Cozaar). . Low-dose enteric coated aspirin. Aspirin reduces your blood's clotting action and helps keep your blood vessels open. The coating on the aspirin prevents the release and absorption of the aspirin until the pill reaches your intestines. Creams containing nitroglycerin also may help promote circulation. Joint
stiffness, pain and inflammation Your doctor may prescribe anti-inflammatory medications such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose corticosteroids to relieve joint pain and stiffness. Often, along with NSAIDs, doctors prescribe certain medications called disease-modifying anti rheumatic drugs (DMARDs). These medications seem to do their job by having an effect on immune systems that have gone out of control, but doctors don't understand exactly how DMARDs work. Common DMARDs include:. Hydroxychloroquine (plaquenil). Originally developed as a treatment for malaria, this drug has relatively few side effects, and it's also effective for the arthritis that can be associated 'with scleroderma. Apart from hydroxychloroquine's apparent ability to affect the way immune cells work, scientists don't completely understand how it helps tame the disease process. . Penicillamine (Cuprimine). Similar to other DMARDs, penicillamine can reduce inflammation, but you must be patient. Its full effect may require many months to develop, but its beneficial effects may be longer lasting. However, because of a relatively high incidence of adverse reactions to this drug and studies casting doubt on its effectiveness, its use has declined in recent years. . Methotrexate (Rheumatrex). This drug does its job by affecting cells that are responsible for some of the pain, inflammation and joint swelling that accompany scleroderma. Trials have shown conflicting results regarding the effectiveness of methotrexate in treating scleroderma. Immune suppressants are another class of medications that can tame out-of-control immune systems. Cyclophosphamide (Cytoxan) is one example. This extremely potent medication works by damaging cells' genetic information. In particular, it kills white blood cells called lymphocytes that are part of autoimmune disease. Cyclophosphamide may be used to treat lung inflammation. Lung
damage If you have scleroderma that affects your lungs, you may need additional medications. Cyclophosphamide (Cytoxan) is an immunosuppressant agent that is used to treat pulmonary fibrosis. Bosentan (Tracleer) is an oral medication that has been approved for pulmonary hypertension in people with scleroderma. Digestive
difficulties If scleroderma has affected your esophagus and you're experiencing heartburn, your doctor may suggest prescription medications that decrease stomach acid production. These medications may include proton pump inhibitors. Your doctor may also suggest antibiotics, special diets and medications that improve your gut's ability tocontract. Self-care You can take a number of steps to help manage your symptoms of scleroderma: . Stay active. Exercise keeps your body flexible, improves circulation and relieves stiffness. Range-of-motion exercises can help keep your skin and joints flexible. . Don't smoke. Nicotine causes the blood vessels to contract, making Raynaud's phenomenon worse. Smoking can also cause permanent narrowing of your blood vessels. Quitting
smoking can be difficult- ask
your doctor for help. Manage heartburn. Avoid foods that give you heartburn or gas. Also avoid late-night meals. Elevate the head of your bed to keep stomach acid from refluxing into your esophagus as you sleep. Try over-the-counter antacids for relief of symptoms. . Protect yourself from the cold. Wear warm mittens for protection when your hands will be subjected to cold temperatures - such as when you reach into a freezer. When you're outside in the cold, be sure to cover your face and head and wear layers of warm clothing. Coping
skills Depending on how greatly you're affected by scleroderma, you may benefit from physical therapy and occupational therapy. Therapists can help you manage pain, improve your strength and mobility, and work on performing essential daily tasks to maintain your independence. Ask your doctor to recommend a physical therapist or an occupational therapist. As is true with other chronic diseases, living with scleroderma can place you on a roller coaster of emotions. Here are some suggestions to help you even out the ups and downs: . Maintain normal daily activities as best you can. .Pace your self and be sure to get the rest that you need.. Stay connected with friends and family. Continue to pursue hobbies that you enjoy and are able to do. If scleroderma makes it difficult for you to do things you enjoy, ask your doctor about ways to get around the obstacles. Keep in mind that your physical health can have a direct impact on your mental health. Denial, anger and frustration are common with chronic illnesses .At times, you may need additional tools to deal with your emotions. Professionals, such as therapists or behavior psychologists, may be able to help you put things in perspective. They can also help you develop coping skills, including relaxation techniques. Joining a support group, where you can share experiences and feelings with other people, is often a good approach. Ask your doctor what support groups are available in your area. community. In addition, many chronic illnesses place you at an increased risk of depression. This -isn't a failure to cope but may indicate a disruption in your body's neurochemistry that can be helped with appropriate medical treatment. Talk with your family, friends and doctor if you're feeling depressed. By Mayo Clinic staff DSO0362 October 19,2004 «) 1998-2005Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.com," "Mayo Clinic Health Information," "Reliable
information for a healthier life" and the triple-shield Mayo logo
are trademarks of Mayo Foundation for Medical Education and Research. How Dietary
Supplements Support Optimal Human
Health H.
Reginald McDaniel, M.D. Educational
information for each participant: The healing response
Dr Reg McDaniel The introduction to
glyconutrients by Bill McAnalley: The three doctors CD
background on glyconutrients and why they might work. Information package
for private care physicians: Will be requested by
the patient or the physician. The healing response
..Reg
McDaniel The molecular
biology of micronutrients
.. Reg McDaniel The open letter to
Physicians Dr Goen The three doctor CD
background on glyconutrients and why they might work. Expectations of the
participants during the study: 1.
They will take the micronutrients as directed. 2.
They will make the appointments, fill out questionnaires and do
the CEDSA testing. 3.
The initial
evaluation and signed consent and baseline
CEDSA and self evaluation forms. 4.
Two weeks following the start of the glyconutrients an evaluation
to adjust amounts of the glyconutrients. 5.
Monthly visits for the first 6 months. 6.
Every other month visits for the last six months making a grand
total of 11 visits over the twelve months. 7.
The participants will also provide a narrative history of their
disease and the treatments they have taken. 8.
The participants will have a monthly sedimentation rate. Their
blood type will be noted. Saliva will be ph tested monthly to look for
trends. The patients will continue to have their regular blood tests
done by their physicians and the results will be made available to the
researchers. Expectations
regarding the private physicians: 1.
They will review the information package and will continue the
usual medical care of their patients. The Fisher Institutes
involvement: 1.
The Fisher Institute will provide the glyconutrient
products to a central location for distribution. 2.
The Fisher Institute will have access to the study data. The investigators
responsibilities: 1.
The investigators will make arrangements to distribute the
products and do the paper work and to also provide for the CEDSA
testing. 2.
The investigators will also answer questions and concerns of the
patients, physicians, and families during the study. 3.
The investigators will monitor compliance to the program by
asking a self evaluation question with each visit. The patients who have
no or slow response will be interviewed and evaluated regarding
compliance. 4.
Adjustments in the program will be done by consultation with Dr
John Stearns and the participant. |