Study design (if review, criteria of inclusion for studies)
open-label crossover clinical trial
Participants
21 stable hospitalized cystic fibrosis patients with malabsorption syndrome
Interventions
Standard dosing consisted of 500 U lipase/kg body weight/meal, 250 U lipase/kg body weight/snack; high dosing consisted of 1,500 U lipase/kg body weight/meal, 750 U lipase/kg body weight/snack. Doses were determined by units of lipase/kg body weight to provide dosing consistency among patients of varying size. Each patient was on a regular diet of approximately 100 g of fat per day. Subjects were then stratified into two groups, based on the grams of fecal fat eliminated (GFFE) as follows: Group 1 with < or = 7 GFFE/24 h on both dosages (n = 7) and Group 2 with > 7 GFFE/24 h on either dose (n = 14).
Outcome measures
Two separate, 72-h stool collections were performed between markers. Fat absorption was measured. constipation, elevated serum uric acid levels
Main results
A significant difference in mean percentage fat absorbed between the standard dose and the high dose was found (86% versus 91%, p < 0.05). Subjects were then stratified into two groups, based on the grams of fecal fat eliminated (GFFE) as follows: Group 1 with < or = 7 GFFE/24 h on both dosages (n = 7) and Group 2 with > 7 GFFE/24 h on either dose (n = 14). A significant difference (p < 0.05) between Group 1 (96%) and Group 2 (88%) was noted in the percentage fat absorbed while on the high dose. Fat absorption improved from 81% to 88%, (p < 0.05) in Group 2. During the study period, the adverse reactions of constipation or elevated serum uric acid levels were not observed.
Authors' conclusions
The increased doses of pancreatic enzymes resulted in improved correction of steatorrhea.