Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis.
BACKGROUND
Pancreatic enzyme supplementation is standard treatment for malabsorption caused by chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications 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.


OBJECTIVE
To review systematically 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), diarrhoea 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 four manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared with 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 steatorrhoea.
Waljee
A K
AK
Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.
Dimagno
M J
MJ
Wu
B U
BU
Schoenfeld
P S
PS
Conwell
D L
DL
D000681:Amylases / Q000627:therapeutic use; D001682:Biological Availability; D003550:Cystic Fibrosis / Q000150:complications / Q000188:drug therapy* / Q000201:enzymology; D057487:Enzyme Therapy; D005243:Feces / Q000201:enzymology*; D005260:Female; D006801:Humans; D008049:Lipase / Q000627:therapeutic use; D008286:Malabsorption Syndromes / Q000188:drug therapy* / Q000201:enzymology / Q000209:etiology; D008297:Male; D050500:Pancreatitis, Chronic / Q000150:complications / Q000188:drug therapy* / Q000201:enzymology; D010447:Peptide Hydrolases / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
D008049:Lipase; D000681:Amylases; D010447:Peptide Hydrolases