Pancreatin consists of enzymes from cow or pig pancreas, namely amylase, protease, and lipase, which digest starch, protein, and lipids, respectively. Historically, pancreatic enzyme preparations were available over-the-counter (OTC); however, due to problems associated with their use, the U.S. Food and Drug Administration (FDA) now requires manufacturers to obtain FDA approval before they can market and sell their pancreatin product.
Pancreatin and pancrelipase share similar functions and indications; however, pancrelipase contains a more concentrated extract than pancreatin. Pancrelipase is found in FDA-approved pancreatic enzyme replacement therapy (Creon®, ZenpepTM, Pancreaze®, etc.). Pancrelipase contains 12 times the lipase activity, four times the amylase activity, and four times the protease activity of conventional pancreatin.
In the United States, most pancreatic enzyme preparations are prescribed for patients with pancreatic digestive enzyme insufficiency from cystic fibrosis or chronic pancreatitis (inflammation of the pancreas). The efficacy of pancreatic enzyme supplements is widely accepted for these conditions.
Pancreatic enzymes are used in modern medicine mainly for treating exocrine pancreatic insufficiency, a condition in which food is not properly digested because the pancreas does not make an adequate amount of digestive enzymes. Other potential uses, which have less supportive evidence, include immune stimulation, tissue repair, blood clot treatment, and as a general digestive aid.
Aczym, amylase, Berizym®, bovine pancreatin, Cotazyme-S®, Cotazyme-S-Forte®, Cotazyn®, Creon®, Digepepsin®, Dizymes®, Donazyme®, Elzyme®, Entolase-HP®, Entozyme®, Hi-Vegi-Lip®, Hyperzym®, Kreon®, Lypase®, Maxamase HL-16®, Nortase®, Panar®, pancrease, Pancrease®, Pancrease MT4®, Pancrease MT10®, Pancrease MT16®, pancreatic acid, Pancreatin enseals®, Pancreatin® Merck, pancreatinum, pancreatis pulvis, pancrelipase, Pancrex®, Pancrex-Duo®, Pancrex V®, Pancrex V® Forte, Pankreoflat®, Pankreon®, Panteric®, Panzytrat®, PEP, procine pancreatin, protease, Ultrase MT12®, Ultrase MT20®, Ultrase MT24®, Viokase®, Zymase®.
Select combination products: FZ 560 (fentonium bromide 10mg, dehydrocholic acid 25mg, pancreatin 3FU 50mg, and lactulose 200mg).
These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.
Digestive enzyme/pancreatic insufficiency
Enzyme replacement therapy is commonly used for patients with digestive enzyme insufficiency associated with cystic fibrosis or chronic pancreatitis (pancreatic inflammation). The safety of pancreatin, especially high-dose use in children, is not well-documented. Further research is needed to completely evaluate the safety and efficacy of pancreatin.
Hernia (hiatal hernia complex)
Hiatal hernia complex is a condition characterized by symptoms including enlarged stomach, gas, and expulsion of gas. Limited study suggests that pancreatin may be effective in reducing these symptoms; however, additional studies are needed to confirm these preliminary findings.
Recovery from surgery (pancreatic, gastrectomy)
Results of preliminary human study show that pancreatin may improve symptoms of maldigestion after partial or total surgical removal of the pancreas (pancreatectomy) or stomach (gastrectomy). Additional research is needed.
There is fair negative evidence that argues against pancreatin use in diabetic patients. Some study showed a lack of effect of pancreatin on blood glucose levels. In another study, switching from pancreatin treatment to mock treatment and vice-versa resulted in impaired regulation of blood glucose levels, including low blood sugar.
Pain (chronic pancreatitis)
Pancreatic enzyme supplements have been used for pain relief from chronic pancreatitis (inflammation of the pancreas). The available evidence indicates a lack of benefit from pancreatin; however, additional study is required to confirm these initial findings.