Eighty five children (median age 2.3 years, range 0.3 to 13.3 years) with refractory atopic dermatitis affecting more than 12% of the body surface area, were randomly allocated to receive a few foods diet (eliminating all but five to eight foods) supplemented with either a whey hydrolysate (n = 27) or a casein hydrolysate formula (n = 32), or to remain on their usual diet and act as controls (n = 26), for a six week period. Thirty five patients who received the diet and four controls had to be withdrawn because of non-compliance with the diet or intercurrent illness. The change in dermatitis severity was evaluated by a blinded observer who estimated the extent and severity of the dermatitis, using a skin severity score. After six weeks, there was a significant reduction in all three groups in the percentage of surface area involved (controls, median reduction (MR) = 4.9% (95% confidence interval 1.5%, 11.9%); whey hydrolysate group, MR = 17.8% (8.3%, 23.0%); casein hydrolysate group, MR = 5% (1.6%, 21.2%), and skin severity score (controls, MR = 15.9 (5.0, 22.5); whey hydrolysate group, MR = 21.8 (12.8, 30.2); casein hydrolysate group, MR = 13.5 (3.4, 38.0). Sixteen (73%) of the 22 controls and 15 (58%) of the 24 who received the diet showed a greater than 20% improvement in the skin severity score. This study failed to show benefit from a few foods diet.
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