Treatment of pancreatic exocrine insufficiency after pancreatic resection - Results of a randomized, double-blind, placebo-controlled, crossover study of high vs standard dose pancreatin

Background: Steatorrhea following major;pancreatic resection can be difficu lt to control, requiring high doses of pancreatic enzyme supplements. The a im of this study was to demonstrate equivalent efficacy of high-dose and st andard-dose pancreatin in treating steatorrhea after pancreatectomy. Methods: A randomized, double-blind, crossover study was conducted with a 2 -wk run-in period for stabilization on a suitable dose of standard-dose pan creatin and two 14-d treatment periods using either high-dose or standard-d ose pancreatin at this dosage. Parameters used to demonstrate efficacy of t reatment were stool fat excretion, stool volume, and clinical symptoms. Results: Thirty-nine patients who had undergone total or partial pancreatec tomy were randomised; 37 completed all parts of the study. During stabiliza tion, the mean daily capsule intake was 19.4 (range 9-54); even so, 22 (56% ) patients had stool fat excretion > 7 g/d. There were significant correlat ions between stool fat excretion and stool volume (p < 0.0001) and stool fr equency (p < 0.01), but not with indices of abdominal pain and global sympt oms. Both high-dose: and standard-dose pancreatin demonstrated statisticall y similar efficacy in the treatment period. Conclusion: The use of high-dose pancreatin for the treatment of pancreatic insufficiency in patients following pancreatectomy should significantly re duce capsule intake with increased convenience and greater compliance rate. Our results, however, indicate that further progress is needed to resolve steatorrhea following pancreatic resection.