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Oral Proteolytic Enzymes

Orally administered pancreatic enzyme preparations have been used for the treatment of inflammation, injuries and shingles soubreaks for over 30 years. Inflammation is part of the body's normal healing response to injury and infections. However, severe injury or infection can trigger an inflammatory cascade that can cause complications, excessive pain and hinder the healing process. Numerous studies have shown that proteolytic enzymes taken orally reduce pain and inflammation from injuries and surgery. (10)(17)(18)(19) Proteolytic enzyme supplementation reduces inflammation by neutralizing bradykinins and pro-inflammatory eicosanoids to levels where the synthesis, repair and regeneration of injured tissues can begin.

Absorption of Oral Proteolytic Enzymes

Enzymes are proteins and proteins are broken down by the digestive process into discrete amino acids. The question has been raised as to how orally administered enzymes could possibly get into the blood and produce a therapeutic effect. Early sudies demonstrated therapeutic effects from proteolytic enzymes administered by injection. Later studies done in the 1950's and 1960's demonstrated that enterically coated proteolytic enzymes administered orally are absorbed into the blood and produce physiological effects. Studies were performed on papain, bromelain, chymotrypsin and trypsin that was enterically coated. (3)(4)(5)(6)(7)(8)(9)

Enteric coating is a substance used to protect the enzymes from stomach acid but dissolve in the intestines and allow the enzymes to be absorbed intact through the intestinal wall.

Shingles - Herpes Zoster (Chicken Pox)

Proteolytic enzymes may be helpful for the initial attack of shingles. Shingles is caused by the herpes zoster virus, the same virus that causes chicken pox. A double-blind study of 190 people with shingles compared proteolytic enzymes to the antiviral drug acyclovir. Participants were treated for 14 days and their pain was assessed at intervals. Both groups had similar pain relief, but the enzyme-treated group experienced fewer side effects. Another double-blind study in which 90 people were given either an injection of acyclovir or proteolytic enzymes followed by a course of oral medication for 7 days showed similar beneficial results. (20)(21)(57)(58)(59)

Additional studies have investigated the use of proteolytic enzymes as a treatment for other viral agents including HIV (60), Hepatitis C (61)(64) and Hepatitis B (62)(63). The results reported were generally positive but more research is needed.

Proteolytic enzymes and Sports Injuries

A double-blind, placebo-controlled study of 44 people with sports-related ankle injuries found that treatment with proteolytic enzymes improved healing time by about 50%. (22) Three additional small double-blind studies, involving a total of about 80 athletes, found that treatment with proteolytic enzymes significantly improved the healing of bruises and other mild athletic injuries as compared to placebo.(23)(24)(25) Another study involving 71 individuals with finger fractures found that treatment with proteolytic enzymes improved recovery times. (26) In another double-blind trial, 100 people were treated for experimentally induced hematomas (bruises) with proteolytic enzymes. The researchers found that enzyme treatment significantly speeded recovery. (27)

Proteolytic Enzymes and Surgery

Numerous studies using several different proteolytic enzyme protocols with surgery patients have produced mixed results. The mixed results may represent the use of different enzyme protocols in the different studies. The use of mixed proteolytic enzymes was found to be beneficial in knee surgery, oral surgery, dental surgery, episotomy surgery, nasal surgery, foot surgery and cataract removal. (28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)

Chronic Musculoskeletal Pain

A double-blind, placebo-controlled trial of 30 people with chronic neck pain found that use of a proteolytic enzyme mixture (Wobenzm) modestly reduced pain symptoms as compared to a placebo.(43)

Proteolytic Enzymes and Osteoarthritis

A clinical trial demonstrated significant improvement for individuals with degenerative arthritis of the lower spine and sciatica-type leg pain. (49)(50) A study involving more than 300 people compared proteolytic enzymes to the standard anti-inflammatory medications for the treatment of osteoarthritis of the shoulder, back, or knee. The results showed equivalent benefits with the supplement and the medication. (44)(45)

Proteolytic enzymes in Cancer Ttherapy

The use of proteolytic enzymes for cancer treatment began with Scotish Embryologist John Beard. Beard noted the similarity between placenta cells and cancer cells and the regulation of the growth of both types of cells fetal pancreatic proteolytic enzymes. (Placenta cells are now called stem cells) He published his work in his book The Enzyme Treatment of Cancer and its Scientific Basis. Following Beard, proteolytic enzymes have been promoted by numerous alternative cancer practitioners. More recently Nicholas Gonzalez, M.D. is evaluating the benefit of proteolytic enzymes in patients with advanced pancreatic cancer in a large-scale study, funded by the National Institute of Health's National Center for Complementary and Alternative Medicine, with collaboration from the National Cancer Institute. This larger trial is a follow-up to a smaller study that showed dramatic positive results.

The clinical research that currently exists on proteolytic enzymes suggests significant benefits in the treatment of many forms of cancer. These studies have shown improvements in the general condition of patients with cancers of the breast lung, stomach, head and neck, ovaries, cervix, and colon along with lymphomas and multiple myeloma. These studies involved the use of proteolytic enzymes in conjunction with conventional therapy (surgery, chemotherapy and/or radiation). The results showed modest to significant improvements in quality of life and life expectancy. (65)(66)

Safety Issues

In some infrequent cases, proteolytic enzymes have been associated with digestive upset or allergic reactions. (47) In addition, pancreatin may interfere with folate absorption. (46) Papain and bromelain may have anti-coagulant properties and could complicate bleeding disorders or interfere with anti-coagulant medications. Bromelain may increase the blood concentration of certain anti-biotics and may interact with certain sedatives.(47) Individuals with malabsorption syndromes are often deficient in fat digesting lilpases and, therefore, should use enzyme mixtures that are high in lipase and low in proteolytic enzymes because the proteolytic enzymes may destroy lipase. (48) Colon damage has been reported in children with cystic fibrosis who receive enzyme therapy. The exact mechanism and parameters are not clearly understood. Children with cystic fibrosis should avoid proteolytic enzymes until this issue is better understood. (51)(52)(53)(54)(55)(56)

For the majority of individuals , oral proteolytic enzymes are considered quite safe.

Oral Proteolytic Enzyme References

1. Brendel R, Beiler JM, Martin GJ. American Journal of Pharmacology 1956;128:172.

2. Martin GJ, Brendal R, Beiler JM. Uptake of labelled chymotrypsin across the GI. American Journal of Pharmacology 1957;129:194-197.

3. Ambrus JC, Lassman HB, Marchijj DE. Absorption of exogenous and endogenous proteolytic enzymes. Clinical Pharmacology and Therapeutics 1967;8(3):362-367.

4. Vakians A. Further studies on the absorption of chymotrypsin. Clinical Pharmacology and Therapeutics 1964:5(6):712-715.

5. Miller J, Opher A. Increased proteolytic activity of human blood serum after oral administration of bromelain. Exp Med Surg 1964;22:277.

6. Innerfield I, Wernick T. Plasma anti-thrombin alterations following oral papain. Proc Soc Ext Biol Med July 1961;107:505-506.

7. Miller J. Absorption of proteolytic enzymes from the gastrointestinal tract. Clinical Medicine October 1968;75:35-40.

8. Ito C. Anti-inflammatory actions of proteases, bromelain, trypsin and their mixed preparations. Folia Pharmacol JPN 1979;75:227.

9. Kabacoff B, Wohlman A, et al. Absorption of chymotrypsin from the intestinal tract. Nature 1963;199:815.

10. Taussig SJ, Batkin S. Bromelain, the enzyme complex of pineapple (Ananas comosus) and its clinical application. An update. J Ethnopharmacol . 1988;22:191-203

11. Deitrick RE. Oral Proteolytic Enzymes in the treatment of athletic injuries: a double-blind study. Pa Med.

1965;68:35-37

12. Blonstein JL. Control of swelling in boxing injuries. Practitioner. 1969;203:206.

13. Baumuller M. The application of hydrolytic enzymes in blunt wounds to the soft tissue and distortion of the ankle joint: a double-blind clinical trial [translated from German]. Allgemeinmedizin. 1990;19:178-182.

14. Zuschlag JM. Double-blind clinical study using certain pproteolytic enzyme mixtures in karate fighters. Working paper. Mucos Pharma GmbH (Germany). 1988;1-5.

15. Rathgeber WF. The use of proteolytic enzymes (Chymoral) in sporting injuries. S Afr Med J. 1971;45:181-183.

16. Deitrick RE. Oral Proteolytic Enzymes in the treatment of athletic injuries: a double-blind study. Pa Med. 1965;68:35-37

17. Smyth RD, Brennan R, Martin GJ. Studies establishing the absorption of bromelains (Proteolytic enzymes) from the gastrointestinal tract. Exp Med Surg. 1964;22: 46-59.

18. Miller JM, Ginseberg M, McElfatrick GC, et al. The administration of bromelain orally in the treatment of inflammation and edema. Exp Med Surg. 1964;22:293-299.

19. Castell JV, Friedrich G, Kuhn CS, et al. Intestinal absorption of undegraded proteins in men: presence of bromelain in plasma after oral intake. Am J Physiol. 1997;273:G139-G146.

20. Billigmann VP. Enzyme therapy-an alternative in treatment of herpes zoster. A controlled study of 192 patients [translated from German]. Fortschr Med. 1995;113:43-48.

21. Kleine MW, Stauder GM, Beese EW. The intestinal absorption of orally administered hydrolytic enzymes and their effects in the treatment of acute herpes zoster as compared with those of oral acyclovir therapy. Phytomedicine. 1995;2:7-15.

22. Baumuller M. The application of hydrolytic enzymes in blunt wounds to the soft tissue and distortion of the ankle joint: a double-blind clinical trial [translated from German]. Allgemeinmedizin. 1990;19:178-182.

23. Zuschlag JM. Double-blind clinical study using certain proteolytic enzyme mixtures in karate fighters. Working paper. Mucos Pharma GmbH (Germany). 1988;1-5.

24. Rathgeber WF. The use of proteolytic enzymes (Chymoral) in sporting injuries. S Afr Med J. 1971;45:181-183.

25. Deitrick RE. Oral Proteolytic Enzymes in the treatment of athletic injuries: a double-blind study. Pa Med.1965;68:35-37.

26. Shaw PC. The use of a trypsin-chymotrypsin formulation in fractures of the hand. Br J Clin Pract. 1969;23:25-26.

27. Kleine MW, Pabst H. The effect of an oral enzyme therapy on experimentally produced hematomas [translated from German]. Forum des Prakt und Allgemeinarztes. 1988;27:42, 45-46, 48.

28. Rahn HD. Efficacy of hydrolytic enzymes in surgery. Paper presented at: 24th FIMS World Congress of Sports Medicine; May 27-June 1, 1990; Amsterdam.

29. Vinzenz K. Treatment of edema with hydrolytic enzymes in oral surgical procedures [translated from German]. Quintessenz. 1991;42:1053-1064.

30. Seltzer AP. Minimizing post-operative edema and ecchymoses by the use of an oral enzyme preparation (bromelain): a controlled study of 53 rhinoplasty cases. Eye Ear Nose Throat Mon. 1962;41:813-817.

31. Blonstein JL. Control of swelling in boxing injuries. Practitioner. 1969;203:206. 26. Zatuchni GI, Colombi DJ. Bromelains therapy for the prevention of episiotomy pain. Obstet Gynecol. 1967;29:275-278.

32. Zatuchni GI, Colombi DJ. Bromelains therapy for the prevention of episiotomy pain. Obstet Gynecol. 1967;29:275-278.

33. Spaeth GL. The effect of bromelains on the inflammatory response caused by cataract extraction: a double-blind study. Eye Ear Nose Throat Mon. 1968;47:634-639.

34. Tassman GC, Zafran JN, Zayon GM. Evaluation of a plant proteolytic enzyme for the control of imflammation and pain. J Dent Med. 1964;19:73-77.

35. Howat RC, Lewis GD. The effect of bromelain therapy on episiotomy wounds-a double-blind controlled clinical trial. J Obstet Gynaecol Br Commonw. 1972;79:951-953.

36. Gylling U, Rintala A, Taipale S, et al. The effect of a proteolytic enzyme combinate (bromelain) on the postoperative oedema by oral application. A clinical and experimental study. Acta Chir Scand.1966;131:193-196.

37. Cameron IW. An investigation into some of the factors concerned in the surgical removal of the impacted lower wisdom tooth, including a double blind trial of chymoral. Br J Oral Surg. 1980;18:112-124.

38. Soule SD, Wasserman HC, Burstein R. Oral Proteolytic enzyme therapy (Chymoral) in episiotomy patients. Am J Obstet Gynecol. 1966;95:820-823.

40. Howat RC, Lewis GD. The effect of bromelain therapy on episiotomy wounds-a double blind controlled clinical trial. J Obstet Gynaecol Br Commow. 1972;79:951-953.

41. Frank SC. Use of chymoral as an anti-inflammatory agent following surgical trauma. J Am Podiatr Assoc.1965;55:706-709.

42. Gylling U, Rintala A, Taipale S, et al. The effect of a proteolytic enzyme combinate (bromelain) on the postoperative oedema by oral application. A clinical and experimental study. Acta Chir Scand.1966;131:193-196.

43. Tilscher H, Keusch R, Neumann K. Results of a double-blind, randomized comparative study of WobenzymW-placebo in patients with cervical syndrome [translated from German]. Wien Med Wochenschr .1996;146:91-95.

44. Singer F, Oberleitner H. Drug therapy of activated arthrosis. On the effectiveness of an enzyme mixture versus DiclofenacW [translated from German]. Wien Med Wochenschr . 1996;146:55-58.

45. Klein G, Kullich W. Reducing pain by oral enzyme therapy in rheumatic diseases [translated from German]. Wien Med Wochenschr . 1999;149:577-580.

46. Russell RM, Dutta SK, Oaks EV, et al. Impairment of folic acid absorption by oral pancreatic extracts. DigDis Sci. 1980;25:369-373.

47. Shaw D, Leon C, Kolev S, et al. Traditional remedies and food supplements. A 5-year toxicological study (1991-1995). Drug Saf. 1997;17:342-356.

48. Layer P, Groger G. Fate of pancreatic enzymes in the human intestinal lumen in health and pancreatic insufficiency. Digestion 1993;54(suppl 2):10-4.

49. Hingorani K. Oral enzyme therapy in severe back pain. Br J Clin Pract 1968;22:209-10.

50. Gaspardy G, Balint G, Mitsuova M, et al. Treatment of sciatica due to intervertebral disc herniation with Chymoral tablets. Rheum Phys Med 1971;11:14-9.

51. Stevens JC, Maguiness KM, Hollingsworth J, et al. Pancreatic enzyme supplementation in cystic fibrosis patients before and after fibrosing colonopathy. J Pediatr Gastroenterol Nutr 1998;26:80-4.

52. Oades PJ, Bush A, Ong PS, Brereton RJ. High-strength pancreatic enzyme supplements and large-bowel stricture in cystic fibrosis. Lancet 1994;343:109 [letter].

53. Campbell CA, Forrest J, Muscgrove C. High-strength pancreatic enzyme supplements and large-bowel stricture in cystic fibrosis. Lancet 1994;343:109-10 [letter].

54. Milla CE, Wielinski CL, Warwick WJ. High-strength pancreatic enzymes. Lancet 1994;343:599 [letter].

55. Jones R, Franklin K, Spicer R, Berry J. Colonic strictures in children with cystic fibrosis on low-strength pancreatic enzymes. Lancet 1995;346:499-500 [letter].

56. Powell CJ. Pancreatic enzymes and fibrosing colonopathy. Lancet 1999;354:251 [letter].

57. Clinical Experience with Systemic Enzyme Therapy in the Treatment of Herpes zoster, Pospíšilová A., Haklová L. II. dermato-venerology clinic, Faculty Hospital Brno-Bohunice Cesko-slovenská dermatologie, 1999, 74 (1), 17-20.

58. Possibility to Treat Herpes zoster Using Enzymes I. Mikazans Department of Dermatology, Medical Academy of Latvia, Riga, Latvia Australasian Journal of Dermatology 38 (2), 1997. Abstracts of the 19th World Congress of Dermatology, 15-20 June, 1997, Sydney, Australia

59. Introduction to Oral Enzyme Therapy and Its Use in Varicella zoster Treatment Kleine M.-W., Ertl D. Allergist, Egenhofenstrasse 18, 82152 Planegg/Munich, Germany Int J Tiss Reac XIX (1/2), 1997 - abstracts of 7th Interscience World Conference on Inflammation, Antirheumatics, Analgesics, Immunomodulators, May 19-21, Geneva, Switzerland

60. Hydrolytic Enzymes in the Treatment of HIV Infections H. Jäger. Allgemeinmedizin (1990) 19: 160-164 Kuratorium für Immunschwäche, München.

61. Oral Enzyme Therapy in Hepatitis C patients Stauder G.,1 Kabil S.2. Int. J. Immunotherapy XIII(3/4) 153-158 (1997).

62. Clinical use of Belosorb and Wobenzym in the Treatment of Viral Hepatitis B Nikolaev V.G., Matiasch V.I., Kononenko V.V. Kiev, Ukraine. Presented at the conference "Current approaches in infectology, epidemiology, and microbiology", Kiev, 1998.

63. A Study of Serum Glycolytic Enzymes and Serum B Hepatitis in Relation to LIV.52 Therapy Patney NL, Pachori S. The Medicine and Surgery 1986;4:9

64. Stauder G, Kabil S. Oral enzyme therapy in hepatitis C patients. Int J Immunother 1997;3:153-158 Kabil S, Stauder G. Oral enzyme therapy in hepatitis C patients. Int J Tiss Reac 1997;1-2

65. Gonzalez NJ, Isaacs LL: Evaluation of pancreatic proteolytic enzyme treatment of adenocarcinoma of the pancreas, with nutrition and detoxification support. Nutr Cancer 1999;33:117-24.

66. Leipner J, Saller R: Systemic enzyme therapy in oncology: effect and mode of action. Drugs. 2000;59:769-80.


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