CFDB - Cystic Fibrosis DataBase

primary studies published RCT

A comparison of two pancreatin microsphere preparations in cystic fibrosis.

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

double blind, crossover study

Participants

27 children with cystic fibrosis

Interventions

two pH sensitive microsphere preparations of pancreatin (Creon, Pancrease), given in equivalent lipase dosage

Outcome measures

coefficient of fat absorption (CFA), coefficient of nitrogen absorption (CNA), weight gain, mean adequate daily intake for energy, and subjective symptoms.

Main results

at similar lipase activity no significant difference was found in the following: coefficient of fat absorption (CFA), coefficient of nitrogen absorption (CNA), weight gain, mean adequate daily intake for energy, and subjective symptoms. Three children who had a CFA less than 70% while receiving Pancrease all improved on Creon. No children had a CFA less than 70% while receiving Creon. A significant reduction in the number of capsules required daily to achieve similar control was possible when changing from Pancrease (mean 25/day) to Creon (mean 15/day). Seventy percent of patients preferred Creon and this was likely to be related to a perceived reduction in abdominal pain and stool frequency, and need for less capsules per day.

Authors' conclusions

Creon and Pancrease are equally effective at doses providing equal lipase activity, however, the reduced number of capsules, fewer symptoms, and possible improvement of more severe steatorrhoea result in an increased patient preference for Creon.

Keywords: Adolescent; Caloric Intake; Child; Microspheres; pharmacological_intervention; Pancreatic Enzyme Replacement Therapy; Supplementation; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Creon; Gastrointestinal Agents;