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

  • Year: 1990
  • Date: 1990
  • Author: Vyas H
Source

Eur J Pediatr. 1990 Jan;149(4):241-3.

Study design (if review, criteria of inclusion for studies)

double-blind double-placebo crossover study

Participants

20 children with cystic fibrosis

Interventions

enteric coated microspheres (ECM) with an enteric coated tablet (ECT) pancreatic enzyme preparation

Outcome measures

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.

Main results

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).

Authors' conclusions

ECM preparations should allow more satisfactory dietary management of patients with cystic fibrosis with longterm beneficial effect.

Keywords: Adolescent; Child; Enteric-Coated; Microspheres; pharmacological_intervention; Pancreatic Enzyme Replacement Therapy; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Tablets; Gastrointestinal Agents;