Objective: To test a protocol for a double-blind placebo-controlled cow's milk provocation for the diagnosis of acute allergic reactions to milk in an outpatient setting.
Design: Prospective, descriptive.
Method: During the period from June 1, 1999 to February 28, 2001 the protocol was tested on all infants and children who were referred to the Paediatric outpatient clinic of the University Medical Centre on Utrecht with symptoms indicative of cow's milk allergy. The protocol comprised of a phased administration of two test meals, one with a true feed and one with placebo, during the course of one day. In case of allergic symptoms the test was discontinued and the code was broken. A diagnosis of 'cow's milk allergy' was made if the symptoms appeared during the provocation with true feeding.
Results: The test group (n = 154) consisted of 85 boys and 69 girls with ages ranging from 0.25 to 14 years (median 1.5). Acute type reactions to cow's milk occurred in 21 of the children who underwent the provocation. These reactions mainly consisted of cutaneous symptoms (erythema and urticaria). In none of these cases the symptoms were severe enough to require a prolonged stay in the hospital. There were no reactions on placebo meals nor acute reactions during the reintroduction of milk at home.
Conclusion: It is possible to perform double-blind placebo-controlled provocations routinely in the diagnostic work-up of children with a suspicion of cow's milk allergy.