Pancreatic enzyme supplementation as acid-resistant microspheres versus enteric-coated granules in cystic fibrosis. A double placebo-controlled cross-over study.
In order to compare the efficacy of pancreatic enzyme supplementation as pH-sensitive enteric-coated microspheres Pancrease to that of conventional supplementation with enteric-coated Pancreatin in cystic fibrosis, a double blind cross-over study was conducted. Eleven patients under 12 years of age received each of the enzyme preparations for four weeks. Treatment efficacy was evaluated by means of a symptom score card recording stool frequency, consistency, colour, odour, abdominal cramps and appetite as well as a 3 days fat absorption test. Weight increments were recorded 3 months before the study when patients were on Pancreatin, and 3 months after the study when patients were on Pancrease. In eight of the patients fat absorption was improved on Pancrease, but the difference did not reach statistical significance. However, the patients experienced significantly less dyspeptic symptoms, decreased stool frequency, better appetite and increments in weight were significantly higher on Pancrease compared to Pancreatin.
D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003550:Cystic Fibrosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008863:Microspheres; D010194:Pancreatin / Q000008:administration & dosage*; D011897:Random Allocation; D013608:Tablets, Enteric-Coated
D013608:Tablets, Enteric-Coated; D010194:Pancreatin