SLOW-RELEASE 5-AMINOSALICYLIC ACID THERAPY IN CHILDREN WITH SMALL-INTESTINAL CROHNS-DISEASE

Pharmacologic agents effective in the treatment of Crohn's disease con fined to the small intestine are limited. The therapeutic efficacy of oral mesalazine in small bowel inflammation, although theoretically pr omising, remains unproven. In an open-labeled initial trial, timed-rel ease 5-aminosalicylic acid (5-ASA), administered at a daily dosage of 30.6 +/- 9.0 mg/kg (mean +/- SEM) to children with active Crohn's dise ase involving the small intestine, was associated with improvement on the Harvey index in six of 12 patients treated for 8.1 +/- 3.9 weeks. In a subsequent prospective, double-blind study 14 children, ages 9.3 to 16.1 years, with active Crohn's disease limited radiologically in t he small intestine were randomized to receive either timed-release 5-A SA [50 mg/kg/day (maximum 3 g/day)] or placebo for 8 weeks. Following a 4-week washout period, patients crossed over to receive the other st udy drug for a further 8 weeks. Six children completed the entire 20-w eek trial. The van Hees index improved among patients receiving 5-ASA for 8 weeks (DELTA = -18 +/- 6.4) but deteriorated among patients give n placebo (DELTA = +14 +/- 4. 1) (p < 0.05). Mean Crohn's Disease Acti vity Index (CDAI) decreased marginally after 8 weeks of 5-ASA treatmen t (DELTA = -48 +/- 38.2) but not with placebo (DELTA = -3.0 +/- 7.9) ( p = 0.31). Of the eight noncompleters, more patients dropped out of th e study because of lack of therapeutic response to placebo (n = 5) tha n to 5-ASA (n = 2). No serious adverse clinical effects were observed during either trial, but one adolescent girl reported mild hair loss t hat was promptly reversed after the drug was discontinued. These resul ts indicate that timed-release 5-ASA may be beneficial in the medical therapy of children with active small bowel Crohn's disease.