Study design (if review, criteria of inclusion for studies)
4-week open-labelled, randomised, two-period, crossover study
Participants
18 children with cystic fibrosis
Interventions
equal doses of lipase were provided by either Creon Forte or Cotazym S Forte.
Outcome measures
Efficacy was determined by a 4-day faecal fat study at the end of each 2-week period. Patients were also asked to record daily the degree of abdominal symptoms including abdominal pain, abdominal bloating, diarrhoea, constipation, nausea, vomiting and anorexia.
Main results
No significant differences were found between the two enzyme preparations as assessed by fat absorption studies when equivalent doses of lipase were used. The mean fat absorption for Creon Forte was 89% and 91% for Cotazym S Forte (p > 0.05). This allowed a 2.5-fold reduction in the number of capsules taken per day with Creon Forte compared to Cotazym S Forte. Scoring of abdominal symptoms were not significantly different between the two medications. The 14 patients who completed the trial preferred Creon Forte.
Authors' conclusions
Creon Forte is as effective as Cotazym S Forte in improving fat absorption in children with cystic fibrosis when equivalent doses of lipase are used with a lower number of capsules.