A comparison of enteric coated microspheres with enteric coated tablet pancreatic enzyme preparations in cystic fibrosis. A controlled study.

A comparative study of the efficacy of pH sensitive enteric coated microspheres (ECM) with an enteric coated tablet (ECT) pancreatic enzyme preparation was carried out in 20 children with cystic fibrosis in a double-blind double-placebo crossover manner. Steatorrhoea was assessed by 3 day faecal fat analysis and dosage of medication, stool frequency and consistency; abdominal pain and appetite were documented by a patient-kept diary card. ECM controlled steatorrhoea (11.8 +/- 9.2 g vs 23.2 +/- 18.9 g, P less than 0.02), stool frequency (1.7 +/- 0.6 vs 2.1 +/- 0.9, P less than 0.01) and abdominal pain (8.8 +/- 13.8 vs 23.4 +/- 24.1, P less than 0.05) significantly better than ECT. Out of 20 patients 17 preferred ECM to ECT (P less than 0.00036). ECM preparations should allow more satisfactory dietary management of patients with cystic fibrosis with longterm beneficial effect.

RCT Entities:   Population Interventions Outcomes