Evaluation of double-blind, placebo-controlled food challenge (DBPCFC) value in confirmation of tolerance to cow milk – preliminary trial

Introduction: The only diagnostic test is double-blind, placebo-controlled food challenge (DBPCFC). This test allowed us to diagnose food hypersensitivity independently of pathogenesis and for individual food.
Aim: To evaluate DBPCFC value in confirmation of tolerance to bovine milk after temporary use of a milk-free elimination diet in children, and to evaluate cashback costs of strong hydrolysates used in the treatment of children without verification of diagnosis.
Material and methods: Medical records of 30 children were included in the study. Each child had an elimination diet due to cow milk hypersensitivity symptoms. In every case after symptoms resolution DBPCFC was performed for diagnosis verification. Causes of milk-free diet use, duration of treatment and costs were analysed.
Results: Mean age of study group was 18.8 months of age. The most common cause of diet prescription was atopic dermatitis, which was observed in 70% of children. Symptoms from the gastrointestinal tract were observed in 30% of children. Mean duration of the elimination diet was 13.5 months. 50% used the diet for a period longer than 12 months (from 13 months to 33 months). The most commonly used preparation was whey hydrolysate (77%) and casein hydrolysate was used by 13% of children. Only two children used soy preparations for the elimination diet. It was found that 80% of children had or acquired cow milk tolerance. In 20% of children clinical symptoms of verum use were observed and half of them had a family history of allergy. Patients with positive provocation challenge had symptoms of atopic dermatitis. In patients without DBPCFC in the 12th month of the elimination diet (50%) the monthly cashback cost of strong hydrolysate varied between 38.68 zloty and 126.84 zloty.
Conclusions: The use of DBPCFC in confirmation of tolerance to bovine milk after temporary use of a milk-free elimination diet in children is an effective method with considerable clinical value. Use of a milk-free elimination diet needs temporary verification of its justification. The introduction of a requirement for allergy diagnosis verification for general practitioners after the initial period of an elimination diet could decrease social costs of food allergy in Poland.