Pancreatic enzymes

Related Terms

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).

Background

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.

Evidence Table

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. GRADE *
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. GRADE *


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.

 C


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.

 C


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.

 C


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.

 C


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.

 C


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.

 C


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.

D


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.

D


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.

 D


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.

 D
* Key to grades

A: Strong scientific evidence for this use
B: Good scientific evidence for this use
C: Unclear scientific evidence for this use
D: Fair scientific evidence for this use (it may not work)
F: Strong scientific evidence against this use (it likley does not work)
* Key to grades

A: Strong scientific evidence for this use
B: Good scientific evidence for this use
C: Unclear scientific evidence for this use
D: Fair scientific evidence for this use (it may not work)
F: Strong scientific evidence against this use (it likley does not work)

Tradition / Theory

The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below.

Dosing

Adults (18 years and older)
Dosing of pancreatic enzymes is patient-specific. Pancreatic enzymes should be taken by mouth at the beginning of meals. A typical starting dose of pancreatin is 8,000-24,000 USP units of lipase taken by mouth.
For pancreatic insufficiency, Creon?, ZenpepT, and Pancreaze? are FDA-approved pancreatic enzyme replacement products.
For digestion of a regular meal, 25,000-40,000 units of lipase activity are required in the intestine to prevent lipid malabsorption; due to the rapid inactivation of lipase, up to 10 times that amount must be taken by mouth.

Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Interactions

Interactions with Drugs
Pancreatin may lower blood sugar levels. Caution is advised when using medications that may also lower blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.
Pancreatin may also interact with antacids, anticancer drugs, dehydrocholic acid, dimethylpolysiloxane, fentonium chloride, folic acid, H2 blockers, iron salts, lactulose, misoprostol, painkillers, and proton pump inhibitors (PPIs).

Attribution

This information is based on a systematic review of scientific literature edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

Bibliography

Brady MS, Rickard, K, Yu PL, et al. Effectiveness and safety of small vs. large doses of enteric coated pancreatic enzymes in reducing steatorrhea in children with cystic fibrosis: a prospective randomized study. Pediatr Pulmonol 1991;10(2):79-85.
Bruno MJ, Haverkort EB, Tijssen GP, et al. Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region. Gut 1998;42(1):92-96.
Chazalette JP. A Double-Blind Placebo-Controlled Trial of a Pancreatic Enzyme Formulation (Panzytrat 25 000) in the Treatment of Impaired Lipid Digestion in Patients with Cystic Fibrosis. Drug Investigation 1993;5(5):274.
Ewald N, Bretzel RG, Fantus IG, et al. Pancreatin therapy in patients with insulin-treated diabetes mellitus and exocrine pancreatic insufficiency according to low fecal elastase 1 concentrations. Results of a prospective multi-centre trial. Diabetes Metab Res Rev 2007;23(5):386-391.
Halm U, Loser C, Lohr M, et al. A double-blind, randomized, multicentre, crossover study to prove equivalence of pancreatin minimicrospheres versus microspheres in exocrine pancreatic insufficiency. Aliment Pharmacol Ther 1999;13(7):951-957.
Lancellotti L, Cabrini G, Zanolla L, et al. High- versus low-lipase acid-resistant enzyme preparations in cystic fibrosis: a crossover randomized clinical trial. J Pediatr Gastroenterol Nutr 1996;22(1):73-78.
Lauque S, Nourhashemi F, Baudouin M, et al. Assessment of the effectiveness of drug therapies on nutritional status in the elderly: "concerning a randomised, double-blind clinical study of the activity of pancreatic extracts and a placebo during the renutrition of elderly subjects suffering from protein caloric undernutrition". J Nutr Health Aging 1998;2(1):18-20.
Layer P and Keller J. Lipase supplementation therapy: standards, alternatives, and perspectives. Pancreas 2003;26(1):1-7.
Malesci A, Gaia E, Fioretta A, et al. No effect of long-term treatment with pancreatic extract on recurrent abdominal pain in patients with chronic pancreatitis. Scand J Gastroenterol 1995;30(4):392-398.
Mossner J, Secknus R, Meyer J, et al. Treatment of pain with pancreatic extracts in chronic pancreatitis: results of a prospective placebo-controlled multicenter trial. Digestion 1992;53(1-2):54-66.
Neoptolemos JP, Ghaneh P, Andren-Sandberg A, et al. Treatment of pancreatic exocrine insufficiency after pancreatic resection. Results of a randomized, double-blind, placebo-controlled, crossover study of high vs standard dose pancreatin. Int J Pancreatol 1999;25(3):171-180.
Patchell CJ, Desai M, Weller PH, et al. Creon 10,000 Minimicrospheres vs. Creon 8,000 microspheres--an open randomised crossover preference study. J Cyst Fibros 2002;1(4):287-291.
Petersen W, Heilmann C, and Garne S. Pancreatic enzyme supplementation as acid-resistant microspheres versus enteric-coated granules in cystic fibrosis. A double placebo-controlled cross-over study. Acta Paediatr Scand 1987;76(1):66-69.
Sarner M. Treatment of pancreatic exocrine deficiency. World J Surg 2003;27(11):1192-1195.
Shin SY, Hur GY, Ye YM, et al. A case of occupational rhinitis caused by porcine pancreatic extract developing into occupational asthma. J Korean Med Sci 2008;23(2):347-349.