Diet in infancy and later signs of beta-cell autoimmunity.

摘要

The analysis by Knip et al (Nov. 11 issue), which suggests that dietary intervention through infant weaning to hydrolyzed formula has a long-lasting effect on markers of beta-cell autoimmunity, is flawed in that it has overestimated the evidence of benefit because of failure to adequately use the intention-to-treat principle. First, children from whom follow-up samples were not obtained were excluded from the primary analysis of seroconversion to auto-antibody positivity. Of the children who were excluded, diabetes (and presumably autoantibody positivity before clinical disease) developed in three in the treatment group versus none in the control group. Correct inclusion of these 3 children in an intention-to-treat protocol would minimize evidence of treatment effect, with the development of beta-cell autoimmunity in 11 of 113 infants randomly assigned to hydrolyzed formula (9.7%) and in 17 of 109 infants assigned to standard formula (15.6%).