Systematic Review: Pancreatic Enzyme Treatment of Malabsorption Associated with Chronic Pancreatitis.Waljee AK, Dimagno MJ, Wu BU, Schoenfeld PS, Conwell DL. Aliment Pharmacol Ther. 2008 Nov 8. [Epub ahead of print] Background: Pancreatic enzyme supplementation is standard treatment for malabsorption due to chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications (NDAs) to continue to market these agents because published data demonstrated variation in formulation, bioavailability, and shelf-life while providing limited data about efficacy and safety. Aim: To systematically review the design and results of randomized, parallel-design trials of pancreatic enzyme supplements in chronic pancreatitis patients with steatorrhea. Methods: A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Two authors performed duplicate data extraction on study design, improvement in coefficient of fat absorption (CFA), diarrhea, and adverse events using pre-specified forms. Agreement between investigators for data extraction was greater than 95%. Results: Of 619 articles found through literature searching, 20 potentially relevant articles were identified and 4 manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared to placebo, but fat malabsorption remained abnormal. Important differences in patient population, study endpoint, study design, pancreatic enzyme dosage, and measurement of CFA were present across trials which precluded comparison of different agents. Conclusions: Enzyme supplementation improves CFA compared to placebo but may not abolish steatorrhea.