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THE OFFICIAL PATIENT S SOURCEBOOK on JAMES N. PARKER, M.D. AND PHILIP M. PARKER, PH.D., EDITORS

iv Dedication To the healthcare professionals dedicating their time and efforts to the study of celiac disease. Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this sourcebook which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which directly or indirectly are dedicated to celiac disease. All of the Official Patient s Sourcebooks draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this sourcebook. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany LaRochelle for her excellent editorial support.

Contents ix Table of Contents INTRODUCTION... 1 Overview... 1 Organization... 3 Scope... 3 Moving Forward... 4 PART I: THE ESSENTIALS... 7 CHAPTER 1. THE ESSENTIALS ON CELIAC DISEASE: GUIDELINES... 9 Overview... 9 What Is Celiac Disease?... 11 What Are the Symptoms?... 11 How Is Celiac Disease Diagnosed?... 13 What Is the Treatment?... 14 The Gluten-Free Diet... 15 Example Foods... 16 What Are the Complications of Celiac Disease?... 20 How Common Is Celiac Disease?... 20 Diseases Linked to Celiac Disease... 21 Dermatitis Herpetiformis... 21 Additional Resources... 22 Points to Remember... 23 More Guideline Sources... 23 Vocabulary Builder... 32 CHAPTER 2. SEEKING GUIDANCE... 37 Overview... 37 Associations and Celiac Disease... 37 Finding More Associations... 42 Finding Doctors... 44 Selecting Your Doctor... 45 Working with Your Doctor... 46 Broader Health-Related Resources... 47 Vocabulary Builder... 47 CHAPTER 3. CLINICAL TRIALS AND CELIAC DISEASE... 49 Overview... 49 Recent Trials on Celiac Disease... 52 Benefits and Risks... 54 Keeping Current on Clinical Trials... 57 General References... 58 Vocabulary Builder... 59 PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL... 61 CHAPTER 4. STUDIES ON CELIAC DISEASE... 63 Overview... 63 The Combined Health Information Database... 63 Federally-Funded Research on Celiac Disease... 73 E-Journals: PubMed Central... 86 The National Library of Medicine: PubMed... 87 Vocabulary Builder... 88

x Contents CHAPTER 5. PATENTS ON CELIAC DISEASE... 95 Overview... 95 Patents on Celiac Disease... 96 Patent Applications on Celiac Disease... 97 Keeping Current... 97 Vocabulary Builder... 97 CHAPTER 6. BOOKS ON CELIAC DISEASE... 99 Overview... 99 Book Summaries: Federal Agencies... 99 Book Summaries: Online Booksellers... 104 The National Library of Medicine Book Index... 106 Chapters on Celiac Disease... 110 Directories... 118 General Home References... 119 Vocabulary Builder... 120 CHAPTER 7. MULTIMEDIA ON CELIAC DISEASE... 125 Overview... 125 Video Recordings... 125 Bibliography: Multimedia on Celiac Disease... 126 Vocabulary Builder... 129 CHAPTER 8. PERIODICALS AND NEWS ON CELIAC DISEASE... 131 Overview... 131 News Services & Press Releases... 131 Newsletters on Celiac Disease... 140 Newsletter Articles... 141 Academic Periodicals covering Celiac Disease... 147 Vocabulary Builder... 148 CHAPTER 9. PHYSICIAN GUIDELINES AND DATABASES... 151 Overview... 151 NIH Guidelines... 151 NIH Databases... 152 Other Commercial Databases... 158 The Genome Project and Celiac Disease... 159 Specialized References... 163 CHAPTER 10. DISSERTATIONS ON CELIAC DISEASE... 165 Overview... 165 Dissertations on Celiac Disease... 165 Keeping Current... 166 Vocabulary Builder... 166 PART III. APPENDICES... 167 APPENDIX A. RESEARCHING YOUR MEDICATIONS... 169 Overview... 169 Your Medications: The Basics... 170 Learning More about Your Medications... 171 Commercial Databases... 172 Contraindications and Interactions (Hidden Dangers)... 174 A Final Warning... 175 General References... 175 Vocabulary Builder... 176

Contents xi APPENDIX B. RESEARCHING ALTERNATIVE MEDICINE... 177 Overview... 177 What Is CAM?... 177 What Are the Domains of Alternative Medicine?... 178 Can Alternatives Affect My Treatment?... 181 Finding CAM References on Celiac Disease... 182 Additional Web Resources... 188 General References... 194 Vocabulary Builder... 195 APPENDIX C. RESEARCHING NUTRITION... 197 Overview... 197 Food and Nutrition: General Principles... 198 Finding Studies on Celiac Disease... 202 Federal Resources on Nutrition... 205 Additional Web Resources... 206 Vocabulary Builder... 212 APPENDIX D. FINDING MEDICAL LIBRARIES... 215 Overview... 215 Preparation... 215 Finding a Local Medical Library... 216 Medical Libraries Open to the Public... 216 APPENDIX E. YOUR RIGHTS AND INSURANCE... 223 Overview... 223 Your Rights as a Patient... 223 Patient Responsibilities... 227 Choosing an Insurance Plan... 228 Medicare and Medicaid... 230 NORD s Medication Assistance Programs... 233 Additional Resources... 234 Vocabulary Builder... 235 ONLINE GLOSSARIES... 237 Online Dictionary Directories... 245 CELIAC DISEASE GLOSSARY... 247 General Dictionaries and Glossaries... 264 INDEX... 266

Guidelines 11 grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. The following patient guideline was recently published by the NIDDK on celiac disease. What Is Celiac Disease? 7 Celiac disease is a digestive disease that damages the small intestine and interferes with absorption of nutrients from food. People who have celiac disease cannot tolerate a protein called gluten, which is found in wheat, rye, barley, and possibly oats. When people with celiac disease eat foods containing gluten, their immune system responds by damaging the small intestine. Specifically, tiny fingerlike protrusions, called villi, on the lining of the small intestine are lost. Nutrients from food are absorbed into the bloodstream through these villi. Without villi, a person becomes malnourished--regardless of the quantity of food eaten. Because the body s own immune system causes the damage, celiac disease is considered an autoimmune disorder. However, it is also classified as a disease of malabsorption because nutrients are not absorbed. Celiac disease is also known as celiac sprue, nontropical sprue, and gluten-sensitive enteropathy. Celiac disease is a genetic disease, meaning that it runs in families. Sometimes the disease is triggered--or becomes active for the first time--after surgery, pregnancy, childbirth, viral infection, or severe emotional stress. What Are the Symptoms? Celiac disease affects people differently. Some people develop symptoms as children, others as adults. One factor thought to play a role in when and how celiac appears is whether and how long a person was breastfed--the longer one was breastfed, the later symptoms of celiac disease appear, and the more atypical the symptoms. Other factors include the age at which one began eating foods containing gluten and how much gluten is eaten.

12 Celiac Disease Villi on the lining of the small intestine help absorb nutrients. Symptoms may or may not occur in the digestive system. For example, one person might have diarrhea and abdominal pain, while another person has irritability or depression. In fact, irritability is one of the most common symptoms in children. Symptoms of celiac disease may include one or more of the following: Recurring abdominal bloating and pain Chronic diarrhea Weight loss Pale, foul-smelling stool Unexplained anemia (low count of red blood cells) Gas Bone pain Behavior changes Muscle cramps Fatigue Delayed growth Failure to thrive in infants Pain in the joints Seizures Tingling numbness in the legs (from nerve damage) Pale sores inside the mouth, called aphthus ulcers Painful skin rash, called dermatitis herpetiformis Tooth discoloration or loss of enamel

Guidelines 13 Missed menstrual periods (often because of excessive weight loss) Anemia, delayed growth, and weight loss are signs of malnutrition--not getting enough nutrients. Malnutrition is a serious problem for anyone, but particularly for children because they need adequate nutrition to develop properly. Some people with celiac disease may not have symptoms. The undamaged part of their small intestine is able to absorb enough nutrients to prevent symptoms. However, people without symptoms are still at risk for the complications of celiac disease. How Is Celiac Disease Diagnosed? Diagnosing celiac disease can be difficult because some of its symptoms are similar to those of other diseases, including irritable bowel syndrome, Crohn s disease, ulcerative colitis, diverticulosis, intestinal infections, chronic fatigue syndrome, and depression. Recently, researchers discovered that people with celiac disease have higher than normal levels of certain antibodies in their blood. Antibodies are produced by the immune system in response to substances that the body perceives to be threatening. To diagnose celiac disease, physicians test blood to measure levels of antibodies to gluten. These antibodies are antigliadin, anti-endomysium, and antireticulin. If the tests and symptoms suggest celiac disease, the physician may remove a tiny piece of tissue from the small intestine to check for damage to the villi. This is done in a procedure called a biopsy: the physician eases a long, thin tube called an endoscope through the mouth and stomach into the small intestine, and then takes a sample of tissue using instruments passed through the endoscope. Biopsy of the small intestine is the best way to diagnose celiac disease. Screening Screening for celiac disease involves testing asymptomatic people for the antibodies to gluten. Americans are not routinely screened for celiac disease. However, because celiac disease is hereditary, family members--particularly first-degree relatives--of people who have been diagnosed may need to be tested for the disease. About 10 percent of an affected person s first-degree

14 Celiac Disease relatives (parents, siblings, or children) will also have the disease. The longer a person goes undiagnosed and untreated, the greater the chance of developing malnutrition and other complications. In Italy, where celiac disease is common, all children are screened by age 6 so that even asymptomatic disease is caught early. In addition, Italians of any age are tested for the disease as soon as they show symptoms. As a result of this vigilance, the time between when symptoms begin and the disease is diagnosed is usually only 2 to 3 weeks. In the United States, the time between the first symptoms and diagnosis averages about 10 years. What Is the Treatment? The only treatment for celiac disease is to follow a gluten-free diet--that is, to avoid all foods that contain gluten. For most people, following this diet will stop symptoms, heal existing intestinal damage, and prevent further damage. Improvements begin within days of starting the diet, and the small intestine is usually completely healed--meaning the villi are intact and working--in 3 to 6 months. (It may take up to 2 years for older adults.) The gluten-free diet is a lifetime requirement. Eating any gluten, no matter how small an amount, can damage the intestine. This is true for anyone with the disease, including people who do not have noticeable symptoms. Depending on a person s age at diagnosis, some problems, such as delayed growth and tooth discoloration, may not improve. A small percentage of people with celiac disease do not improve on the gluten-free diet. These people often have severely damaged intestines that cannot heal even after they eliminate gluten from their diets. Because their intestines are not absorbing enough nutrients, they may need to receive intravenous nutrition supplements. Drug treatments are being evaluated for unresponsive celiac disease. These patients may need to be evaluated for complications of the disease. If a person responds to the gluten-free diet, the physician will know for certain that the diagnosis of celiac disease is correct.

Guidelines 15 The Gluten-Free Diet A gluten-free diet means avoiding all foods that contain wheat (including spelt, triticale, and kamut), rye, barley, and possibly oats--in other words, most grain, pasta, cereal, and many processed foods. Despite these restrictions, people with celiac disease can eat a well-balanced diet with a variety of foods, including bread and pasta. For example, instead of wheat flour, people can use potato, rice, soy, or bean flour. Or, they can buy glutenfree bread, pasta, and other products from special food companies. Whether people with celiac disease should avoid oats is controversial because some people have been able to eat oats without having a reaction. Scientists are doing studies to find out whether people with celiac disease can tolerate oats. Until the studies are complete, people with celiac disease should follow their physician or dietitian s advice about eating oats. Plain meat, fish, rice, fruits, and vegetables do not contain gluten, so people with celiac disease can eat as much of these foods as they like. Examples of foods that are safe to eat and those that are not are provided below. The gluten-free diet is complicated. It requires a completely new approach to eating that affects a person s entire life. People with celiac disease have to be extremely careful about what they buy for lunch at school or work, eat at cocktail parties, or grab from the refrigerator for a midnight snack. Eating out can be a challenge as the person with celiac disease learns to scrutinize the menu for foods with gluten and question the waiter or chef about possible hidden sources of gluten. Hidden sources of gluten include additives, preservatives, and stabilizers found in processed food, medicines, and mouthwash. If ingredients are not itemized, you may want to check with the manufacturer of the product. With practice, screening for gluten becomes second nature. A dietitian, a health care professional who specializes in food and nutrition, can help people learn about their new diet. Also, support groups are particularly helpful for newly diagnosed people and their families as they learn to adjust to a new way of life.

16 Celiac Disease Example Foods 8 Following are examples of foods that are allowed and those that should be avoided when eating gluten-free. Please note that this is not a complete list. People are encouraged to discuss gluten-free food choices with a physician or dietitian who specializes in celiac disease. Also, it is important to read all food ingredient lists carefully to make sure that the food does not contain gluten. Serving size: Breads, Cereals, Rice, and Pasta 9 1 slice bread, 1 cup ready-to-eat cereal, ½ cup cooked cereal, rice, or pasta; ½ bun, bagel, or English muffin Recommended foods: Breads or bread products made from corn, rice, soy, arrowroot corn or potato starch, pea, potato or whole-bean flour, tapioca, sago, rice bran, cornmeal, buckwheat, millet, flax, teff, sorghum, amaranth, and quinoa Hot cereals made from soy, hominy, hominy grits, brown and white rice, buckwheat groats, millet, cornmeal, and quinoa flakes Puffed corn, rice or millet, and other rice and corn made with allowed ingredients Rice, rice noodles, and pastas made from allowed ingredients Some rice crackers and cakes, popped corn cakes made from allowed ingredients Foods to omit: Breads and baked products containing wheat, rye, triticale, barley, oats, wheat germ or bran, graham, gluten or durum flour, wheat starch, oat bran, bulgur, farina, wheat-based semolina, spelt, kamut Cereals made from wheat, rye, triticale, barley, and oats; cereals with added malt extract and malt flavorings Pastas made from ingredients above 8 9

Guidelines 17 Most crackers Tips: Use corn, rice, soy, arrowroot, tapioca, and potato flours or a mixture instead of wheat flours in recipes. Experiment with gluten-free products. Some may be purchased from your supermarket, health food store, or direct from the manufacturer. Vegetables 10 Serving size: 1 cup raw leafy, ½ cup cooked or chopped, ¾ cup juice Recommended foods: All plain, fresh, frozen, or canned vegetables made with allowed ingredients Foods to omit: Any creamed or breaded vegetables (unless allowed ingredients are used), canned baked beans Some french fries Tips: Buy plain, frozen, or canned vegetables and season with herbs, spices, or sauces made with allowed ingredients. Fruits 11 Serving size: 1 medium size, ½ cup canned, ¾ cup juice, ¼ cup dried 10 3-5 servings each day 11 2-4 servings each day

18 Celiac Disease Recommended foods: All fruits and fruit juices Foods to omit: Some commercial fruit pie fillings and dried fruit Milk, Yogurt, and Cheese 12 Serving size: 1 cup milk or yogurt, 1½ oz natural cheese, 2 oz processed cheese Recommended foods: All milk and milk products except those made with gluten additives Aged cheese Foods to omit: Malted milk Some milk drinks, flavored or frozen yogurt Tips: Contact the food manufacturer for product information if the ingredient is not listed on the label. Serving size: Meats, Poultry, Fish, Dry Beans and Peas, Eggs, and Nuts 13 2-3 oz cooked; count 1 egg, ½ cup cooked beans, 2 tbsp peanut butter, or 1 /3 cup nuts as 1 oz of meat Recommended foods: All meat, poultry, fish, and shellfish; eggs 12 2-3 servings each day 13 2-3 servings or total of 6 oz daily.

Guidelines 19 Dry peas and beans, nuts, peanut butter, soybean Cold cuts, frankfurters, or sausage without fillers Foods to omit: Any prepared with wheat, rye, oats, barley, gluten stabilizers, or fillers including some frankfurters, cold cuts, sandwich spreads, sausages, and canned meats Self-basting turkey Some egg substitutes Tips: When dining out, select meat, poultry, or fish made without breading, gravies, or sauces. Fats, Snacks, Sweets, Condiments, and Beverages Recommended foods: Butter, margarine, salad dressings, sauces, soups, and desserts made with allowed ingredients Sugar, honey, jelly, jam, hard candy, plain chocolate, coconut, molasses, marshmallows, meringues Pure instant or ground coffee, tea, carbonated drinks, wine (made in U.S.), rum Most seasonings and flavorings Foods to omit: Commercial salad dressings, prepared soups, condiments, sauces and seasonings prepared with ingredients listed above Hot cocoa mixes, nondairy cream substitutes, flavored instant coffee, herbal tea, alcohol distilled from cereals such as gin, vodka, whiskey, and beer Beer, ale, cereal, and malted beverages Licorice

20 Celiac Disease Tips: Store all gluten-free products in your refrigerator or freezer because they do not contain preservatives. Remember to avoid sauces, gravies, canned fish and other products with HVP/HPP made from wheat protein. What Are the Complications of Celiac Disease? Damage to the small intestine and the resulting problems with nutrient absorption put a person with celiac disease at risk for several diseases and health problems: Lymphoma and adenocarcinoma are types of cancer that can develop in the intestine. Osteoporosis is a condition in which the bones become weak, brittle, and prone to breaking. Poor calcium absorption is a contributing factor to osteoporosis. Miscarriage and congenital malformation of the baby, such as neural tube defects, are risks for untreated pregnant women with celiac disease because of malabsorption of nutrients. Short stature results when childhood celiac disease prevents nutrient absorption during the years when nutrition is critical to a child s normal growth and development. Children who are diagnosed and treated before their growth stops may have a catch-up period. Seizures, or convulsions, result from inadequate absorption of folic acid. Lack of folic acid causes calcium deposits, called calcifications, to form in the brain, which in turn cause seizures. How Common Is Celiac Disease? Celiac disease is the most common genetic disease in Europe. In Italy about 1 in 250 people and in Ireland about 1 in 300 people have celiac disease. It is rarely diagnosed in African, Chinese, and Japanese people. An estimated 1 in 4,700 Americans have been diagnosed with celiac disease. Some researchers question how celiac disease could be so uncommon in the United States since it is hereditary and many Americans descend from European ethnic groups in whom the disease is common. A recent study in

Guidelines 21 which random blood samples from the Red Cross were tested for celiac disease suggests that as many as 1 in every 250 Americans may have it. Celiac disease could be underdiagnosed in the United States for a number of reasons: Celiac symptoms can be attributed to other problems. Many doctors are not knowledgeable about the disease. Only a handful of U.S. laboratories are experienced and skilled in testing for celiac disease. More research is needed to find out the true prevalence of celiac disease among Americans. Diseases Linked to Celiac Disease People with celiac disease tend to have other autoimmune diseases as well, including: Dermatitis herpetiformis Thyroid disease Systemic lupus erythematosus Type 1 diabetes Liver disease Collagen vascular disease Rheumatoid arthritis SJÖGREN S syndrome The connection between celiac and these diseases may be genetic. Dermatitis Herpetiformis Dermatitis herpetiformis (DH) is a severe itchy, blistering skin disease caused by gluten intolerance. DH is related to celiac disease since both are autoimmune disorders caused by gluten intolerance, but they are separate diseases. The rash usually occurs on the elbows, knees, and buttocks.

Guidelines 23 Points to Remember People with celiac disease cannot tolerate gluten, a protein in wheat, rye, barley, and possibly oats. Celiac disease damages the small intestine and interferes with nutrient absorption. Treatment is important because people with celiac disease could develop complications like cancer, osteoporosis, anemia, and seizures. A person with celiac disease may or may not have symptoms. Diagnosis involves blood tests and biopsy. Because celiac disease is hereditary, family members of a person with celiac disease may need to be tested. Celiac disease is treated by eliminating all gluten from the diet. The gluten-free diet is a lifetime requirement. More Guideline Sources The guideline above on celiac disease is only one example of the kind of material that you can find online and free of charge. The remainder of this chapter will direct you to other sources which either publish or can help you find additional guidelines on topics related to celiac disease. Many of the guidelines listed below address topics that may be of particular relevance to your specific situation or of special interest to only some patients with celiac disease. Due to space limitations these sources are listed in a concise manner. Do not hesitate to consult the following sources by either using the Internet hyperlink provided, or, in cases where the contact information is provided, contacting the publisher or author directly. This is the end of the SAMPLE Sourcebook on Celiac Disease. Please return to page 1 to purchase complete version.

Development and Validation of the Celiac Disease Questionnaire (CDQ), a Disease-specific Health-related Quality of Life Measure for Adult Patients With Celiac Disease. Background and Goals: To develop and validate a disease-specific instrument for measuring health-related quality of life (HRQOL) in patients with adult celiac disease (CD). Study: Based on a Medline search of the literature, responses from 10 CD patients and 4 medical experts items potentially affecting HRQOL in CD were identified. This pool was reduced and pretested by 10 other patients and 4 medical experts constructing a preliminary version of the Celiac Disease Questionnaire (CDQ). In a national survey involving 522 respondents of 1000 CD patients (median age 45 y; 78% female) posted by the German Celiac Society completed a medical and sociodemographic questionnaire, the CDQ, the Short Form Health Survey (SF-36), the Hospital Anxiety and Depression Scale German Version HADS-D and the Gießener Symptom List (GBB 24). Subscales were constructed by a principal factor analysis following predefined criteria and validated with other HRQOL measures. Forty-seven out of one hundred patients answered the CDQ a second time 4 weeks after the first posting for the assessment of test-retest reliability. Results: The factor analysis suggested 4 domains with 7 items each: emotional and social problems, diseaserelated worries, and gastrointestinal symptoms. The Cronbach α for the subscales ranged from 0.80 to 0.91. Test-retest reliability correlations ranged from 0.45 to 0.89. The correlation coefficients with comparable subscales of other instruments ranged between 0.26 and 0.79. The CDQ discriminated in all subscales patients with CD-associated diseases from patients without CD-associated diseases (P<0.001). Conclusions: The CDQ is an instrument suited for future use in clinical and research settings.

Celiac Disease Questionnaire (CDQ) Scoring Instructions - Scoring: If you have checked one or more line in either Section I or II and have any of the Illness in Section III (especially males or women under forty-five with osteopenia and/or osteoporosis). You should consider testing for celiac disease. If you have checks in all three sections, you and your doctor(s) should definitely explore a diagnosis of celiac disease. All of the symptoms in Section I, all of the diagnoses in Section II, and all of the associated illnesses in Section III are intimately related to celiac disease. Reference: Green, Peter H. R., M.D., Jones, Rory, Celiac Disease, A Hidden Epidemic, HarperCollins Publishers, New York, NY This is the end of the SAMPLE CDQ scoring instructions. Please return to page 1 to purchase complete version.

CELIAC DISEASE QUESTIONNAIRE Page 1 Celiac disease is an autoimmune disorder that affects nearly one in every hundred people. Unfortunately, 97 percent remain undiagnosed and untreated. To find out if you may have this very common disease, complete the following health questionnaire: Section1: Symptoms Check each of the symptoms that you have experienced at least once a week during the past three months: Bloating Gas and/or stomach cramping Diarrhea or runny stools Constipation Joint pain Numbness or tingling in your extremities This is the end of the SAMPLE CDQ questionnaire. Please return to page 1 to purchase complete version.