title: The effect of oral pancreatic enzyme supplementation on the course and outcome of acute pancreatitis: a randomized, double-blind parallel-group study.
abstract: BACKGROUND
  Pancreatic exocrine insufficiency is a significant problem after acute pancreatitis.
  
  
  OBJECTIVE
  To evaluate whether oral pancreatic enzyme supplementation improves the recovery of pancreatic exocrine function and to explore the efficacy, safety and tolerability of pancreatic enzyme supplementation in patients during the refeeding period after acute pancreatitis.
  
  
  METHODS
  Prospective double-blind, placebo controlled, randomized study.
  
  
  METHODS
  The sudy included 56 patients with acute pancreatitis.
  
  
  METHODS
  Primary efficacy variable was recovery from pancreatic exocrine insufficiency. Secondary objectives were body weight, abdominal pain, course of APACHE II score, patient's symptoms and quality of life.
  
  
  RESULTS
  Twenty of the 56 patients showed low fecal elastase values indicating pancreatic exocrine insufficiency after acute pancreatitis. Median time to recovery from exocrine pancreatic insufficiency was 14 days in the enzyme supplementation group and 23 days in the placebo group but overall differences for primary and all but one secondary endpoint did not reach statistical significance. However, a positive tendency in favour of enzyme supplementation was found for quality of life parameters (FACT-Pa) in all subscores. There were no relevant differences between placebo and oral pancreatic enzyme supplementation detected with respect to safety and tolerability.
  
  
  CONCLUSIONS
  Enzyme supplementation positively effects the course of acute pancreatitis if administered during the early refeeding phase after acute pancreatitis. There is evidence that oral pancreatic enzyme supplementation has a positive impact on the course of the disease and the global health status (less weight loss, less flatulence, improved quality of life). Oral pancreatic enzyme supplementation was safely administered and can be added to the treatment regimen of patients in a refeeding status after severe acute pancreatitis.
authors.affiliation: Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University. Magdeburg, Germany. s.kahl@drk-kliniken-berlin.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Kahl
authors.forename: Kerstin
authors.initials: K
authors.lastname: Schütte
authors.forename: Bernhard
authors.initials: B
authors.lastname: Glasbrenner
authors.forename: Julia
authors.initials: J
authors.lastname: Mayerle
authors.forename: Peter
authors.initials: P
authors.lastname: Simon
authors.forename: Friederike
authors.initials: F
authors.lastname: Henniges
authors.forename: Suntje
authors.initials: S
authors.lastname: Sander-Struckmeier
authors.forename: Marcus M
authors.initials: MM
authors.lastname: Lerch
authors.forename: Peter
authors.initials: P
authors.lastname: Malfertheiner
mesh_terms: D018806:APACHE; D015746:Abdominal Pain / Q000517:prevention & control; D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use*; D001835:Body Weight; D004311:Double-Blind Method; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000209:etiology* / Q000378:metabolism; D005243:Feces; D005260:Female; D006801:Humans; D008049:Lipase / Q000008:administration & dosage / Q000378:metabolism / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010179:Pancreas / Q000201:enzymology*; D010196:Pancreatic Elastase / Q000378:metabolism; D010195:Pancreatitis / Q000150:complications* / Q000188:drug therapy* / Q000378:metabolism; D020799:Pancrelipase / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D020799:Pancrelipase; D008049:Lipase; D000681:Amylases; D010196:Pancreatic Elastase