AIMS: To study the efficacy of oral immunotherapy (OIT) in schoolchildren with cow's milk (CM) allergy (CMA). METHODS:Twenty-eight children aged 6-14 years with CMA documented by oral challenge were enrolled into a randomized, double-blind, placebo-controlled OIT study. In the active treatment, CM protein amount was increased during 23 weeks from 0.06 mg to a maximum of 6400 mg (200 mL of milk). RESULTS: Twenty-four (86%) patients completed the protocol: 16/18 in active and 8/10 in placebo groups. All children in the active and 2/3 in the placebo group suffered from symptoms considered by the parents as induced by milk. The children were contacted by phone 12 months later, and 13 (81%) used daily CM or milk products corresponding 6400 mg of CM protein. After double-blind OIT, all 10 children in the placebo group completed successfully an open-label OIT by an identical protocol, and all used daily CM or milk products 6 months later. Three to 3.5 years later, one child more had discontinued daily milk use. Thus, the long-term success rate was 22/28 (79%). CONCLUSIONS: This placebo-controlled, double-blind study confirmed that OIT was effective in desensitizing schoolchildren with CMA. With occasional exceptions, the reached desensitization sustained for more than 3 years.
RCT Entities:
AIMS: To study the efficacy of oral immunotherapy (OIT) in schoolchildren with cow's milk (CM) allergy (CMA). METHODS: Twenty-eight children aged 6-14 years with CMA documented by oral challenge were enrolled into a randomized, double-blind, placebo-controlled OIT study. In the active treatment, CM protein amount was increased during 23 weeks from 0.06 mg to a maximum of 6400 mg (200 mL of milk). RESULTS: Twenty-four (86%) patients completed the protocol: 16/18 in active and 8/10 in placebo groups. All children in the active and 2/3 in the placebo group suffered from symptoms considered by the parents as induced by milk. The children were contacted by phone 12 months later, and 13 (81%) used daily CM or milk products corresponding 6400 mg of CM protein. After double-blind OIT, all 10 children in the placebo group completed successfully an open-label OIT by an identical protocol, and all used daily CM or milk products 6 months later. Three to 3.5 years later, one child more had discontinued daily milk use. Thus, the long-term success rate was 22/28 (79%). CONCLUSIONS: This placebo-controlled, double-blind study confirmed that OIT was effective in desensitizing schoolchildren with CMA. With occasional exceptions, the reached desensitization sustained for more than 3 years.
Authors: Stacie M Jones; A Wesley Burks; Corinne Keet; Brian P Vickery; Amy M Scurlock; Robert A Wood; Andrew H Liu; Scott H Sicherer; Alice K Henning; Robert W Lindblad; Peter Dawson; Cecilia Berin; David M Fleischer; Donald Y M Leung; Marshall Plaut; Hugh A Sampson Journal: J Allergy Clin Immunol Date: 2016-03-09 Impact factor: 10.793