Study design (if review, criteria of inclusion for studies)
The first study was an open randomized crossover trial. The second study consisted in a comparison of the response to Pancrease for at least 3 months (3-67 months) with the response to conventional pancreatin given to the same patients from 10 months to 8 years earlier.
Participants
children with cystic fibrosis (CF).
Interventions
1st study: enteric-coated microsphere preparation (Pancrease) versus conventional pancreatin given alone or with cimetidine. 2nd study: Pancrease for at least 3 months (3-67 months) with conventional pancreatin
Outcome measures
The parameters evaluated included the following: fecal fat excretion, coefficient of fat absorption, daily caloric intake, percent of diet as fats, proteins and carbohydrates, increase in height and weight, frequency and consistency of stools, palatability of the preparation, and patient compliance.
Main results
With Pancrease compared to conventional pancreatin, a significant improvement was observed in all the digestive parameters in addition to better patient compliance. In comparison to conventional pancreatin, Pancrease provided better digestive efficacy and greater increases in the growth rate of teenage patients. With Pancrease, the number of daily dosage units is decreased even when fat intake is increased. No adverse reactions were seen with either of the enzyme preparations used in these studies.