Oral Food Challenges in an Office Setting

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Oral Food Challenges in an Office Setting S. Allan Bock, MD National Jewish Health and Boulder Valley Asthma and Allergy Clinic, University of Colorado, Denver School of Medicine, Boulder, California

Faculty Disclosure for S. Allan Bock, MD For the 12 months preceding this CME activity, I disclose the following types of financial relationships: Honoraria received from: None Consulted for: None Held common stock in: None Research, clinical trial, or drug study funds received from: None I will not be discussing products that are investigational or not labeled for the use under discussion.

Disclosures Employer: Boulder Valley Asthma and Allergy Clinic Academic Affiliations: Consulting Staff in Pediatric Allergy, National Jewish Health, Denver Clinical Professor, Dept. of Pediatrics University of Colorado, Denver, School of Medicine. Member: Medical Advisory Board Food Allergy Research and Education (FARE) I have no current financial or industry conflicts or relationships to disclose

No doubt a drop of truth may rarely be tossed up from the depths of a sea of folly, but a dependable means is needed to pick out a drop of sense in a spray on nonsense. For this purpose, the success of the scientific method places it will above empiricism. Charles D. May, M.D. 1975 [Allergy: Principles and Practice (First edition)]

CHALLENGE GOALS To determine if symptoms can actually be produced. To reproduce the symptoms as described in the history. To determine the dose causing symptoms.

Office Food Challenge Materials 1. A scale (triple beam balance works well) 2. Mortar and pestle; Coffee grinder, food processor

Office Food Challenge Materials 3. Foods (nuts, seeds, spices, dry milk, dried egg white, others) 4. Score sheets 5. Have families bring most of the challenge material and vehicle

Office Food Challenge Supervision Have a dedicated nurse perform the challenges including: Weighing and measuring. Handing out each challenge portion. Asking about symptoms before each portion is given to subject. Recording score before each portion. Notify physician of any symptoms occur.

VEHICLES {Must be specific allergen free!} CAPSULES (rarely) INFANT FORMULA APPLESAUCE NEOCATE MILK SHAKES CHOCOLATE PUDDING TAPIOCA FRUIT MIXTURE HAMBURGER TUNA FISH ICE CREAM (grape) POPSICLES LENTIL SOUP MASHED POTATO CEREAL GRAPE JUICE ELECARE BAKED RECIPES

HISTORY TO BE OBTAINED FROM A SUBJECT REPORTING AN ADVERSE REACTION TO A FOOD Description of symptoms and signs Timing from ingestion to onset of symptoms Frequency with which reactions have occurred Time of most recent occurrence Quantity of food required to evoke a reaction Associated factors (activity, meds)

HISTORY TO BE OBTAINED FROM A SUBJECT REPORTING AN ADVERSE REACTION TO A FOOD Be sure to maintain details for each food. Often patients/parents want to gloss over details saying that each reaction is the same. When the history is very complex it may be necessary to have the patient/parents work on the details at home. (Pt with multiple problems).

PHYSICAL EXAMINATION Look for stigmata of allergic disease: SKIN: atopic dermatitis, urticaria, angioedema RESIRATORY SYSTEM: nose, chest, [eyes] GASTROINTESTINAL SYSTEM

PLACEBOS {Must be specific allergen free!} Dextrose Wheat Flour Rice Flour Nut Flours Canned Tuna Oat Flour Corn Starch Formulas Safe Fish Safe Meat

PERFORMING CHALLENGES 1. Identify the likely foods. 2. Determine the smallest amount likely to cause symptoms. 3. Use one quarter or less of the suspected amount for the initial dose. [We usually start at.5 gm]

PERFORMING CHALLENGES (CON T) 4. Allow an adequate interval between challenges (usually 20-30 min for a total of 5 portions) 5. Use an adequate placebo (or not now most docs use open challenge protocols). 6. Observe the subject very closely at frequent intervals. 7. Have baseline measurements of vital signs, wt, and spirometry.

PERFORMING CHALLENGES (CON T) 8. An indwelling intravenous line is rarely necessary. 9. Determine whether exercise / other additional stimulus is a cofactor (alcohol, anti GER meds) 10. Challenge with entire meal (plus stimulus?).

PERFORMING CHALLENGES (CON T) 11. If single doses over several days are required, give the dose under observation each morning and have the patient return when symptoms occur. 12. If multiple doses over several days are required, give the amount necessary as described by the patient, 2 or 3 times per day.

OFFICE CHALLENGES Scoring systems for immediate and delayed symptoms will be different, behavior rating scores may be used.

CHALLENGE INTERPRETATION Positive: unequivocal symptoms Negative: food back in the diet Equivocal: subjective reaction or complaints; reaction too likely to reintroduce food to diet immediately (DBPCFC required)

When the challenge is complete Review the results. Encourage pt to be with parents or another adult. Suggest they go home after challenge. If going to school be sure that teacher knows that there was a challenge. Epi available (should be brought to challenge visit) No further challenge food that day, then into the diet starting the next day.

Foods & Vehicles for Challenges Food Challenge material Vehicle Egg Dried Egg white, Chopped hard boiled egg Mashed potato, oatmeal, applesauce yogurt, pudding

Foods & Vehicles for Challenges Food Challenge material Vehicle Cow s milk Non-fat dried milk, Skin milk Rice, soy milks Infant formula Applesauce Milk-free pudding

Foods & Vehicles for Challenges Food Challenge material Vehicle Wheat Whole wheat flour, crushed up saltine crackers Applesauce, oatmeal, rice cereal, mashed potato, chocolate pudding

Foods & Vehicles for Challenges Food Challenge material vehicle Soy Soy flour, Soy formula Rice milk, safe formula, elemental formula, cow milk, pudding

Foods & Vehicles for Challenges Food Challenge material vehicle Peanut Peanut flour (ground or crushed) Oatmeal, chocolate pudding, Hamburger

Foods & Vehicles for Challenges Food Challenge material vehicle Tree nuts Crushed suspected nut (preferably from the shell) [not always available] Peanut butter Chocolate pudding, Hamburger

Foods & Vehicles for Challenges Food Challenge material vehicle Fish/Shell fish Suspected fish or shellfish Safe fish patties Canned tuna Grape flavored Ice cream

Challenging Challenges Food Challenge material Vehicle Dyes Aspartame Preservatives Food coloring: single/multiple Aspartame Equal Na Benzoate, BHA, BHT Capsules Grape juice Capsules Capsules

Challenging Challenges Food Challenge material Vehicle MSG ETOH (occasional adult subject) MSG powder Wine, Beer, straight grain alcohol Capsules Mixed spices Elemental liquid diet

HISTORY = FOOD ASSOCIATED SYMPTOM - NO FOOD SUSPECTED ELIMINATION DIET Symptoms Resolve Symptoms Persist Regular Diet Symptoms Recur Diet Not the Problem No Symptoms Recur Elimination Diet Repeated Problems Resolved Symptoms Resolve Add Foods Openly by Food Group Long List of Foods Tolerated Short List of Food Associated With Symptoms DBPCFC for Each Food (May Use Skin Test First)

Food challenges in an office over time From June 1999 through Nov 2013 we performed food 1254 challenges almost all in children. These have been done in an office setting and almost all have been open challenges.

Results of 100 office challenges Patients 3 to 18 years of age (60% M) Positive challenges = 17 Sensitized patients positive = 15 (88%) Non-sensitized pts positive = 2 Of 83 negative challenges: 52 (63%) sensitized to the food 31 (37%) not sensitized (challenges in off due to risk)

Results of 100 office challenges (con t) Symptoms: GI, skin, respiratory Severe symptoms: epinephrine required 2 pts 1 marked upper respiratory tract symptoms and urticaria during a baked milk challenge. 1 vomiting, urticaria, cough, wheeze, pharyngeal pruritus. Foods challenged: peanut, tree nuts (not Brazil nut) egg, baked egg, milk, baked milk, shrimp, scallops, lobster, soy, sesame, wheat.

Results of baked egg/baked milk challenges 26 baked egg challenges 8 positive (31%) Skin test range for positive challenges 3 mm to 15 mm sige to egg range for positive challenges 0.42 ku/l to 23 ku/l 34 baked milk challenges, 14 positive (41%) Skin test range for positive challenges 3mm to 15 mm sige to milk range for positive challenges.35 ku/l to 24 ku/l. All pos challenges had pos skin test, all but one positive challenge had detectable sige.

Suggested Procedure for home introduction of foods (deemed safe by both parents and doctor) Both parents much be present (or 2 adults) Injectable epinephrine on the table (if prescribed) Begin with one small bite. Increase by a bite (or 2) every 20 to 30 minutes until a reasonable total portion has been consumed (or a reaction has occurred).

Suggested Procedure for home introduction of foods (con t) If no reaction during the introduction phase watch closely for 24 hours and if no problem then begin introduction of the food into the diet regularly and in any acceptable form. If a reaction occurs treat appropriately (no Benadryl, if antihistamine is needed use Zyrtec [Cetirizine] in the recommended dose). If epinephrine used 911 must be called.

Suggested Procedure for home introduction of foods (con t) If there is doubt that a possible reaction is occurring, and it is felt that a trip to ED or urgent care is necessary then both parents (or 2 adults) must go! If the ED is not within a few minutes they should call 911. (If 911 is called from a cell phone, the location must be reported to the EMS.)

Never underestimate the power of the human mind of aggravate or alleviate the ills we suffer.

A few selected references 1. Nowak-Wegrzyn A, Assa ad AH, Bahna SL, Bock SA, Sicherer SH, Teuber SS, Work group report: oral food challenge testing. J Allergy Clin Immunol 2009;123:S365-83. 2. Sampson HA, Gerth VW, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW et al. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol 2012; 130:1260-74. 3. Fleischer D, Bock SA, Spears GC, Wilson DG, Miyazawa, NK, Gleason MC, Gyorkos EA, Murphy JR, Atkins D, Leung DYM. Oral food challenges in children with a diagnosis of food allergy. J Pediatr 2011;158:578-83.