PANCREATIC-ENZYME THERAPY IN CHILDHOOD CELIAC-DISEASE - A DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY

The validity of pancreatic enzyme substitution therapy in the two mont hs following diagnosis of celiac disease was investigated. Twenty pati ents (8 males, 12 females), mean age 14.2 months (group A) received an enzyme substitution preparation. The control group (group B) included 20 patients (9 males, 11 females), mean age 14.5 months, treated with placebo. Before starting treatment, we performed a stratification for age, weight-for-age at diagnosis, and degree of pancreatic insufficie ncy. The therapies were then administered randomly in double-blind fas hion. On diagnosis and 30 and 60 days after commencement of a gluten-f ree diet with identical calorie intake in both groups, a series of ant hropometric variables were determined. After 30 days weight increase i n group A patients was significantly higher (in grams) than in group B : 1131 +/- 461 vs 732 +/- 399 (P < 0.006). Weight-for-age increase als o was greater in group A than in group B: 9.2 +/- 5.1% vs 5.0 +/- 4.0% (P < 0.002). The increase in height Z score, weight-for-height, arm c ircumference, and subscapular and tricipital fold measurements were gr eater in group A patients than those in group B, but the difference wa s not significant. After 60 days of therapy none of the parameters con sidered were significantly different in the two groups. We concluded t hat pancreatic enzyme therapy is certainly useful in the first 30 days after diagnosis of celiac disease.