CELIAC PILOT STUDY
Jack Wise, NMD and J. E. Block, M.D. F.A.C.P.
INTRODUCTION: Celiac disease is vastly under diagnosed. It takes an average 11 years between the first appearances of bowel symptoms until it is diagnosed. Adding insult to injury, it often remains silent in the intestine while extra intestinal problems are occurring. Gluten, a protein found in wheat, is the most common significant “allergen” known to civilized man. Approximately 10% of the human race is sensitive to it. Although not all doctors agree, it is found in beans (dark), oats and peanuts. Non-Gluten cereals include, but are not limited to rice, millet, tapioca, buckwheat, flaxseed, millet, teff and quinoa (KEEN-WA). Gluten is not found in vegetables or meat. It is used in 90% of all protein-fortified products.
When this foreign protein is ingested, it not only attacks the intestine, causing inflammation and poor absorption of nutrients, but the gluten antibodies also destroy some of our other tissue. Gluten intolerance causes malabsorption in the intestine and the partially digested protein absorbed across the mucosa causing havoc in the rest of the body.
Onset of Celiac Disease may occur between infancy and senility. As children, neurological symptoms, stunted growth and anemia can be seen. In adulthood these issues are compounded with osteoporosis, infertility, irritable bowel syndrome (IBS), dermatitis, GERD, arthritis, vitiligo and other autoimmune diseases such as low thyroid (Hashimoto’s Disease). Lymphoma and other cancers are also more common in individuals who have this sensitivity and continue to consume gluten.
Gluten intolerance is frequently the result of some preceding damage to the lining of the intestine due to toxic exposure, infections and overuse of medications, particularly antibiotics. Gluten intolerance, like true Celiac Disease, is treated by total abstention from gluten. I advise my patients of an easy way to remember what to stay away from with the acronym “BROWS” where B stands for barley and beans (dark), R for rye, O for oats, W for wheat, and S for spelt. There are three criteria for true Celiac Disease; a genetic predisposition, the consumption of gluten and a triggering event of a physical or emotional nature. With the loss of the integrity of the intestinal lining, the small intestine fails to absorb micronutrients, which then affects bodily function. Rarely are the typical symptoms related to just the gastrointestinal tract with abdominal pain and distention, diarrhea and weight loss.We have evolved almost 500,000 years without the consumption of gluten. The first wheat was accidently discovered and occasionally gathered around 8,000 BC. Dated archeological remains of einkorn wheat in settlement sites near Karacadag Mountain Range in Turkey confirms the first known cultivation around 7,000 BC. So we as a species have gone from great hunters to canaries in only 10,000 years. Geneticists know that a much longer period of time is required to change our genes to evolve sufficiently to form adequate enzymes to change the gluten protein from being an “enemy” of our body to what our body recognizes as a “non- intruder”. There was no wheat in the Garden of Eden and Adam and Eve with their myriad of descendants weren’t supposed to eat this "food".
At least a third of Gluten Intolerant individuals are also lactose intolerant. For example, during consumption of pizza, an extremely potent reactant within the dough, along with the cheese, can cause acute symptoms within 20 minutes. A visible trait of Celiacs was discovered in Poland in 1953, and presented to the Western World by renowned expert on food allergies, James Braly, MD. The majority of Celiacs have a foreshortened 5th finger designated as Braly’s Sign. This is to say that the end of the pinky is shorter than the last joint of the ring finger.
To document the diagnosis, many doctors conduct a few blood studies that are only positive if the patient has terrible bowel disease when the blood is drawn and he/she continues to consume gluten. A stool sample study for anti-gliadin antibody can be obtained from for $100.00. Your doctor can also order this special test from Intestinal Health Institute, P.O. Box 570744, Dallas TX, 75357. It is only positive if the individual continues to consume gluten. A stool genetic study can be added for another $50 and can be obtained even if the patient is gluten free. In the near future a finger-stick test for gluten will be available for less than $10.00. Individuals who have Celiac Disease also have HLA-DQ2 or HLA-DQ8 haplotype in which markers show a genetic R predisposition to the disease. A more complete stool test is the Celiac Plus conducted by Prometheus (888-423-0896) which includes all antibodies withthe genetic haplotype test. At a cost of around $700, this test might be the best money spent to pin down this disease and many insurance companies now pay for this test.
Most doctors feel there is no cure for Gluten Intolerance and often say the best way to treat the disease is to abstain from eating food high in gluten content. Much research is to be done on potential vaccine and drugs for the disease with a cure still decades away. We conducted a preliminary study of over 200 individuals who were clinically and, in most cases, laboratory positive for Celiac Disease. In almost 90% of the patients there was marked improvement, and in
some cases they were able to resume eating gluten again without adverse symptoms. Subsequently, the investigators performed the following double blind pilot study.
PATIENTS AND METHODS: The study was conducted from November 3, 2009 until August 16, 2010 from the outpatient clinic of Integration Medicine of Tulsa. Since only “natural and homeopathic” products were used, no IRB was required. Each individual signed an informed consent form prior to the study. Included were both males and females and ranging in age from 32 to 66. All had the positive Braly’s sign, gastro-intestinal symptoms, and an abnormal anti-gliadin stool study. These were performed by Enterolab of Dallas, a certified laboratory with experience in performing over 10,000 such tests. In addition to the history and brief physical examination, one of us, Jack Wise NMD, conducted an Autonomic Nervous System test through applied kinesiology (Muscle Testing).
Throughout the course of the study, the participants were encouraged to consume gluten. During the study, of the 27 patients involved, 15 were either lost to follow up or did not finish the requirements of the protocol and subsequently could not be used for statistical purposes. Neither the patient, nor the two principles knew which of the numbered bottles contained the active or the inactive product until all of the stool samples and patient histories were complete.
PRODUCT: Identical capsules were produced for us by the ENERGIQUE HERBAL Company:
1. Lycopodium clavatum 12x
2. Pulsatilla 12x
1. Aronia Berry 2. L-Carnosine 3. Capsule (Gelatin) 4. DNA (Deoxyribonucleic acid)
5. RNA (Ribonucleic acid) 6. Rice Flour 7. Vitamin D3 (From Cholecalciferol) 8. Folic acid
Before and After Treatment Anti- Gliadin Study Results
Participants Active Product
Participants Receiving Placebo
*+ indicates worsening of anti-gliadin test *- indicates improvement of the anti-gliadin test #+ Gastro-intestinal symptoms worsening #- Gasto-intestinal symptoms improving
RESULTS: (See Table).
All participants took the product for only 30 days. Of those 7 that had the Placebo, only 2 had a drop of their anti-gliadin titer and they were less than 30 %. Of the 5 patients on the “active product” all had a decrease of their titers and most had more than a 50% reduction in symptoms. Symptoms improved in 3 out of 7 on the placebo and in all of those on the active product. There were no adverse effects of either product in any participant.
The P-value of the PLACEBO group was only 0.5%, a 50% possibility, (50 out of 100) that these results were by chance alone. In the other group of ACTIVE product, the P-value was < 0.001 in that it was less than 1 in 1000 these results were by chance.
On final examination of the patients who received the active product and didn’t get a reduction to normal titers it was found after testing that they were low on digestive enzymes, magnesium and omega 3. These individuals were prone to having irritable bowel syndrome (IBS) when they ate genetically altered (GMO) wheat. They did not have IBS symptoms when they ate organic wheat. They were however, able to consume altered (GMO) wheat without displaying IBS symptoms, when provided with adequate amounts of omega 3’s, magnesium and digestive enzymes.
We chose the following ingredients for the ACTIVE product because we felt that when given this combination we would achieve a “cure” for Celiac Disease.
Lycopodium clavatum 12X –A homeopathic remedy widely used as a remedy for digestive issues including: dyspepsia due to farinaceous and fermentable food (i.e. cabbage, beans); excessive hunger; desire for sweets; weak digestion; bulimia, with bloating. Immediately after a light meal abdomen is full and bloated. It has been shown to help in Diarrhea.
Pulsatilla 12X – Another homeopathic remedy also widely used digestive aid. Used for heartburn, painful distended stomach and gas.
Aronia Berry - Aronia berries are considered one of the "super fruits" and contain what may be the world’s highest concentration of the antioxidant anthocyanin. High concentrations of anthocyanins are well documented in many fruits (most famously the dark grapes that color red wine) to offer almost supernatural benefits. They work by boosting and assisting your body's immune system.
L-Carnosine - a double amino acid which can extend lifespan; protection from oxidation (free radical damage); a strong antioxidant, anti-aging nutrient and wound healer.
Gelatin Capsule – pharmaceutical capsules used to make the product easier to swallow.
DNA - Deoxyribonucleic Acid is a double stranded helical nucleic acid containing the genetic instructions used in the development and functioning of all known living organisms. Contains information coding RNA molecules for their role in protein synthesis.
RNA - Like DNA it is composed of smaller nucleotide units but is a single stranded nucleic acid central to protein synthesis.
RNA-DNA Nucleotides - are involved in storing genetic information and in a number of other biochemical reactions in the body. They are especially necessary for cellular division. During times of stress, including injury or illness, the need for nucleotides increases because the body needs to manufacture new cells to replace damaged ones. Nucleotides have been shown to improve gut health, enhance immune function and aid tissue healing.
Rice Flour - used as a binder or anti-clumping agent in the product.
Vitamin D3 (from Cholecalciferol) – The essential function is to increase the absorption of calcium and phosphorus in the intestine. It ensures the optimal mineralization of mineralized fabrics, in particular bone, cartilage and teeth; contributing to the maintenance of the plasmatic concentrations of calcium and phosphorus. Vitamin D also closes the “Zonulin Gate” which decreases the permeability of the Gut to partially digested protein.
Folic Acid - promotes healthy new rapidly dividing cells in the intestine. It facilitates cell maintenance and repair, synthesis of DNA, and amino acid.
Although, there are rational decisions based on research, many cures are serendipitous. Almost by intuition, some practitioners derive a treatment that works. Dr. Wise is one such clinician and felt that it was his calling to try this combination in order to help those needing a cure for Celiac Disease. Much to the surprise of his colleagues, this combination has proven not only to increase the overall health of the bowel, but end this malady which has been so poorly diagnosed. It has also shown to be an alternative to the total and complete removal of gluten from the diet.
Although much more work needs to be done to prove the efficacy of this remedy, this pilot study indicates that some, if not all, of the ingredients in this preparation may be useful in helping the estimated the 20 million people in the United States who have Gluten Intolerance. At $140 for the treatment, is certainly very economical for all people.
Note from The Wise Alternative:
We're glad you're taking the time to inform yourself of gluten issues, lifestyle needs and healthy living. When you choose to take our patented Gluten Sensitivity Formula, you have the peace of mind of our Money Back Guarantee. If you take 3 bottles of our product and do not see clinical, laboratory results you get your Gluten Sensitivity Formula money back!! No other company in the world has a product like ours and no other company would dare to make this offer. Period.