CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Enteric-coated pancreatic enzyme with bicarbonate is equal to standard enteric-coated enzyme in treating malabsorption in cystic fibrosis.

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

Randomized double-blind crossover study

Participants

Twenty-one patients with cystic fibrosis and pancreatic insufficiency (14 female, mean age 20.6 +/- 11.5 years, range 8.8-41.9) completed the study.

Interventions

subjects were randomly assigned to two consecutive, 2-week phases using an EC buffered PE product and conventional EC-PE product.

Outcome measures

Seventy-two hour stool collections from each phase were analyzed for energy, fat, and nitrogen content and expressed as percent of estimated intake

Main results

There was no significant difference in percent malabsorption of energy (19.4% vs. 19.0%), fat (20.7% vs. 20.2%), or nitrogen (10.4% vs. 10.7%) between the EC buffered PE product and the conventional EC-PE product. However, patients taking the EC buffered PE product received less enzyme based on actual enzyme activity measured in vitro (3,468 +/- 1,434 U lipase/g fat vs. 3,978 +/- 1,474 U lipase/g fat, P < 0.02).

Authors' conclusions

In the doses used, nutrient absorption of patients taking EC buffered PE preparation offers no advantage over a conventional EC-PE preparation.

Keywords: Adolescent; Adult; Antacids; Bicarbonates; Child; Enteric-Coated; Gastrointestinal Agents; Gastrointestinal Diseases; Malabsorption; pharmacological_intervention; Nutrition Disorders; Pancreas insufficiency; Pancreatic Diseases; Pancreatic Enzyme Replacement Therapy; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Respiratory System Agents;