Partially hydrolyzed cow's milk formula has a therapeutic effect on the infants with mild to moderate atopic dermatitis: a randomized, double-blind study.

OBJECTIVE: The allergy-preventing effect of partially hydrolyzed cow's milk formula (phCMF) in infants at high risk of atopic dermatitis (AD) has been demonstrated in many studies. However, the therapeutic potential of phCMF in treating the infants with AD has not been reported. We sought to assess such therapeutic efficacy of phCMF in infants with mild to moderate AD.

METHODS: From 2006 to 2008, 113 infants <6 months of age with AD were randomized to receive either partially hydrolyzed cow's milk formula (phCMF) or conventional cow's milk formula (CMF) in a double-blind clinical trial. Assessments were made at enrollment and at weeks 4, 8, and 12. The severity of AD was assessed using two scoring systems: Standard guideline for management (diagnosis, severity scoring, and therapy) of AD by the Japanese Dermatological Association Scoring System (JDASS) and the SCORing Atopic Dermatitis (SCORAD). Growth status of the infants was evaluated. Allergy profile was assessed by measuring total blood eosinophils (EOS), total/specific IgE, Th1/Th2 cytokine profiles, and the percentage of regulatory T cells.

RESULTS: After follow-up for 12 wk, 27 infants (23.89%) dropped off study. Analysis was performed on 86 infants by the end of 12-wk observation. The AD severity scores were significantly reduced in the phCMF group (n = 56) compared with CMF group (n = 30) after 12 wk (p < 0.05). The severity scores of phCMF group were significantly reduced at weeks 4, 8, and 12 compared to enrollment (p < 0.05). In contrast, no significant improvement was observed for CMF group at any of those time points (p > 0.05). The number of AD flare-ups was significantly decreased in the phCMF group (p = 0.002). Th1/Th2 ratio in phCMF was significantly increased compared with CMF group (p = 0.041). The growth rates did not differ significantly between these feeding groups at any assessed time point (p > 0.05) and were in the normal range.

CONCLUSION: This study suggests a novel therapeutic effect of phCMF in treating infants with mild to moderate AD during the first 6 months of their life without affecting their nutritional status.