CFDB - Cystic Fibrosis DataBase

primary studies published RCT

A double blind lipase for lipase comparison of a high lipase and standard pancreatic enzyme preparation in cystic fibrosis.

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

randomised double blind crossover study

Participants

18 children with cystic fibrosis completed the study.

Interventions

Each patient received his/her usual number of capsules and the same dose of lipase during each period of the study.

Outcome measures

gastrointestinal symptoms, fat absorption, faecal fat output and faecal energy loss

Main results

There were fewer gastrointestinal symptoms when pancreatic enzyme was supplied as the high lipase preparation. There was also a significant improvement in fat absorption (17%, 95% confidence interval (CI) 6 to 27), reduction in faecal fat output (15.8 g/day, 95% CI 6.4 to 22.5), and faecal energy loss (789 kJ/day, 95% CI 211 to 1384).

Authors' conclusions

half filled capsules of the new high lipase preparation are more effective than the standard preparation and it is likely that filled capsules would allow patients to use fewer than half the number of pancreatic enzyme capsules.

Keywords: Adolescent; Capsules; Child; Combined Modality Therapy; pharmacological_intervention; Pancreatic Enzyme Replacement Therapy; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Gastrointestinal Agents;