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

Abstract

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.

• Authors: H Vyas, D J Matthew, P J Milla
• Journal: European journal of pediatrics (Eur J Pediatr) Vol. 149 Issue 4 Pg. 241-3 (Jan 1990) ISSN: 0340-6199 [Print] Germany
• PMID: 1689245 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Pancreatic Extracts
• Pancrex V
• Tablets, Enteric-Coated
• Pancreatin
• Lipase
• Amylases

Topics

• Adolescent
• Amylases (administration & dosage)
• Analysis of Variance
• Celiac Disease (prevention & control)
• Child
• Child, Preschool
• Cystic Fibrosis (drug therapy)
• Double-Blind Method
• Humans
• Lipase (administration & dosage)
• Microspheres
• Pancreatic Extracts (administration & dosage)
• Pancreatin (administration & dosage)
• Randomized Controlled Trials as Topic
• Tablets, Enteric-Coated