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Serrapeptase Research

In nature, serrapeptase is produced by a bacteria that lives in the intestinal tract of the silk worm. There is absolutely no way to extract enough serrapeptase from nature to support the world's consumption of serrapeptase. What is actually used to meet the global demand for serrapeptase is serratia peptidase. Serratia peptidase, is a proteolytic enzyme isolated from the non-pathogenic enterobacteria Serratia E15. This bacteria is cultured to produce, through batch fermentation, the necessary amount of serratia peptidase to meet global demand. At this point, however, the actual silk worm has nothing to do with the enzymes that make it into our (or anyone else's) products. And thus, silk worms are not harmed.

Additionally, after consumption, serratia peptidase is found in negligible amounts in the urine, suggesting that it is transported directly from the intestine into the bloodstream.(1, 2) Clinical studies show that serratia peptidase induces fibrinolytic, anti-inflammatory and anti-edemic (prevents swelling and fluid retention) activity in a number of tissues, and that its anti-inflammatory effects are superior to other proteolytic enzymes.(3)

Besides reducing inflammation, one of Serratia Peptidase's most profound benefits is reduction of pain, due to its ability to block the release of pain-inducing amines from inflamed tissues.(4) Physicians throughout Europe and Asia have recognized the anti-inflammatory and pain-blocking benefits of this naturally occurring substance and are using it in treatment as an alternative to salicylates, ibuprofen, and other NSAIDs.(5)

References:

  1. Moriya N, Nakata M, Nakamura M, Takaoka M, Iwasa S, Kato K, Kakinuma A. Intestinal absorption of serrapeptase (TSP) in rats. Biotechnol Appl Biochem. 1994; 20 (Pt1): 101-8.
  2. Miyata, K. Intestinal absorption of Serratia Peptidase. J Appl Biochem. 1980; 2:111-16.
  3. Mazzone A, Catalani M, Costanzo M, Drusian A, Mandoli A, Russo S, Guarini E, Vesperini G. Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo. J Int Med Res. 1990; 18(5):379-88.
  4. Mazzone A, et al. Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo. J Int Med Res. 1990; 18(5):379-88.
  5. Aso T et al. Breast engorgement and its treatment: Clinical effects of Danzen an anti-inflammatory enzyme preparation. The world of Obstetrics and Gynecology (Japanese). 1981; 33:371-9.

Anti-Stroke Therapy with Serrapeptidase Enzyme

This organic material (insect enzyme protein) is not a human food, not a drug, not a medicine by itself. It is a harmless protein needed in the silkworm life cycle to open an escape port for the mature pupa to take up life as an adult silkworm. It breaks apart only dead tissue. Taking as little as 10 mg. half an hour before a meal three times a day can assist the immune system. If you are not sick, it can be used as a preventative measure against the ill effects of a diet rich in partially hydrogenated fats.

To determine whether you are the victim of hydrogenated fats, read the labels of everything you eat that has a label. If the words 'partially hydrogenated' appear anywhere on the label, you are ingesting the single most effective means of coating your entire cardiovascular system of arteries and capillaries with patching plaster (cholesterol) and calcium (artery hardening). The degeneration of your blood delivery system is everywhere in your body- from the scalp to the soles of your feet, especially including the hair thin capillaries in your brain.

Probably the easiest way to get a stroke, or series of strokes (that may go unnoticed), is to eat candy bars all day, and slather margarine on everything instead of bovine milk butter. Hydrogenated fats are also called 'trans-fatty acids.' Biochemistry literature is soaked in research proving beyond argument that trans-fatty acids are anti-nutrition toxins that cannot be digested normally and directly cause hardening of the arteries throughout the body.

Hydrogenation is the chemical process of super-heating a vegetable oil in the presence of hydrogen with nickel as a catalyst. An extra hydrogen atom is injected into each molecule of vegetable fat. This stiffens the otherwise liquid vegetable fat. Between the super heat and the extra atom, a never before seen non-food ingestible is created.

If you take serrapeptase as suggested here, add in a 1/4 teaspoon (1 gram) of calcium ascorbate (which is the real vitamin C) crystals dissolved in distilled water along with at least 500 milligrams (1/8 teaspoon) of any bioflavonoid (such as quercetin) at the same time you ingest the serrapeptase. This will trigger growth of healthy new tissue as the old crud is dissolved out. Moreover, it will detoxify a variety of toxins that will be freed from the plaque to float around looking for a new home inside your pipes.

Serrio Peptidase (Serrapeptase) is the protein enzyme silk worms use to dissolve their cocoons so they can emerge as moths.

Serrapeptase is an anti-inflammatory proteolytic enzyme. It has the anti-inflammatory effects of the non-steroidal anti-inflammatories such as aspirin, Motrin, and Naprosyn, but without their side effects e.g., stomach ulceration, and kidney failure. Serriopeptidase is used, by European physicians, for a wide variety of conditions, including: sinusitis, fibrocystic breast disease, post-trauma swelling, arthritis, idiopathic edema, cystitis, epididymitis, post-surgical trauma. See the Medline research citations below.

Replaces By-pass Surgery

Serrapeptase slices and dices only dead tissue. 'Dead tissue' has no living cells in it. The late alternative medicine renowned internist physician, Dr. Hans Nieper, M.D., (1928-1998) of Germany, pioneered the use of this enzyme in clearing arteries and capillaries of accumulated cholesterol-loaded plaque. In this extraordinary application of an inexpensive and entirely safe food grade natural protein, Dr. Nieper fed the protein to a small group of men scheduled for artery by-pass surgery by him. He delighted in presenting a pair of 70 year old former gymnasts doing handsprings who previously could barely walk to the door unaided, and suffered extreme chest pains.

Hans Nieper's Cardiovascular Therapy Protocol:

The astounding results of this no-side-effects therapy are documented in a paper by Dr. Nieper published by the Brewer Science Library, Wisconsin. In curing nearly completely blocked arteries without surgery or balloons, Dr. Nieper included Magnesium oratate, bromelain, L-carnitine, Thiamine chloride (Vitamin B1) and selenium. If you are attempting to avoid heart by-pass surgery, an entirely experimental non-approved surgical procedure with a 5% or higher mortality rate, with this enzyme, there is lots more to the Nieper protocol than merely popping a couple of tiny white pills several times a day. Brewer will sell a true copy of Nieper's Therapy for a few dollars. www.mwt.net/~drbrewer/brew_art.htm.

If your circulation around your heart is so bad that your life is at risk moment to moment, you need to have an informed medical physician close by along with a syringe filled with magnesium sulfate ready for injection to keep you alive during a heart attack. You will have to go outside the mainstream American Medical Association allopathic roster. A good place to start is the American College for Advancement of Medicine (www.acam.org). This is the largest group of nutritionally based physicians.

You may be promoted into a 30 treatment course of EDTA intravenous chelation therapy to clear your pipes. Nieper's enzyme protocol discussed here appears to be at least as effective, far cheaper, non-invasive, and totally without adverse side effects. You should keep searching ACAM's roster to find one that knows of Nieper's Therapy. Perhaps a combination of the two therapies will be your salvation. If you are already a heart disease case, you need informed assistance. Both types of therapy will open up your pipes everywhere in your body, especially including your brain where nothing else can help.

(Bombyx), insect and source of commercial silk and an important member of the family Bombycidae (order Lepidoptera). Because of its centuries-old role in sericulture (silk production), the native Chinese silkworm has been introduced throughout the world and approaches complete domestication. The adult attains a wingspan of 40 to 50 millimeters (about 2 inches) and has a thick, hairy body. In its brief adulthood of two or three days, it does not eat and seldom flies. The female lays between about 300 and 500 eggs.

Besides its natural food of mulberry leaves, the silkworm may sometimes eat the foliage of the Osage orange or lettuce. The pale naked larva has a characteristic caudal (posterior) horn. It attains a maximum length of 75 mm (about 3 in.) during a 45-day growing period. Pupation occurs within a cocoon that is made of one continuous white or yellow silken thread, averaging about 915 meters (1,000 yards).

The thread is preserved intact for commercial use by killing the pupa with hot air or steam. The giant silkworm moth, or saturniid moth, species belong to the family Saturniidae. www.britannica.com

Serrapeptase references:

Serrapeptidase is an enzyme derived from silk worms. It is marketed in Asia under the trade name Danzen and in Europe as Anaflazyme. It has many clinical uses including:

  • as an anti-inflammatory agent (particularly for post traumatic swelling)
  • for Fibrocystic breast disease
  • for Bronchitis (Serrapeptase loosens and expels mucous)

Serrapeptase digests dead tissue, blood clots, cysts, and arterial plaque. The late German physician Dr. Hans Nieper, used serrapeptase to treat arterial blockage in his coronary patients. A doctor who requested anonymity calls serrapeptase "miraculous". Dr X claims serrapeptase protects against stroke and is more effective and quicker than EDTA chelation treatments in removing arterial plaque. He also reports that serrapeptase dissolves blood clots and causes varicose veins to shrink or diminish. Dr X excitedly told of a woman scheduled for hand amputation and a man scheduled for bypass surgery who both recovered quickly without surgery after treatment with serrapeptase.

  1. Kee WH. Tan SL, Lee V. Salmon YM. The treatment of breast engorgement with Serrapeptase (Danzen): a random ized double-blind controlled trial. Singapore Med J. 1989:30(l):48-54.
  2. Mizukoshi, D. et al. A double-blind clinical study of serrapeptase in the treatment of chronic sinusitis. Igaku Ayrni 109:50-62.1979.
  3. Carratu, L. et al. Physio-chemical and rheological research on mucolytic activity of serrapeptase in chronic broncho-pneumopathies. Curr.Ther. Res. 28(6):937-951. 1980.
  4. Braga, P.C. et al. Effects of serrapeptase on muco-ciliary clearance in patients with chronic bronchitis. Curr. Ther. Res. 29(5):738-744,1981.
  5. Mazzonie, A. et al. Evaluation of serrapeptase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind randomized trial versus placebo. J. int. Med. Res. 18(5):379-388,1990.
  6. Conticello, S. et al. La serrapeptase in ORL Nuova Clin. ORL 31:15-20,1979.
  7. Pallotti, S. et al. Valutazu-one della'attivita fibrinolytica della serrapeptase. Farmaci 3:163-173,1982.
  8. Kakinumu, A. et al. Regression of fibrinolysis in scalded rats by administration of serrapeptase. Biochem. Pharmacol. 31:2861-2866,1982.
  9. Marly, M. Enzymotherapie anti-inflammatoire a l'aide de la serrapeptase: resultats cliniques en traumatologie et en ORL. C RTherapeut. 3:9-19,1985.
  10. Odagiri, J. et al. Clinical applications of serrapeptase in sinusitis. Med. Consult. New Remedy 6:201-209, 1979.
  11. Yamazaki, J. et al. Anti-inflammatory activity of TSP, a protease produced by a strain of Serratia. Folia Pharmacol. Japon. 6^302-314,1967.
  12. Elies, W. et al. Akute und subakute Entzundungen der Nassenbenholen. Z. Allmeinmed. 4:92-95, 1987.
  13. Harada, Y. Clinical efficacy of serrapeptase on buccal swelling after radical operation for chronic sinusitis. Igaku Ayumi 123:768-778.1982.
  14. Matsudo, A. et at. Effect of serrapeptase (Danzen) on inflammatory edema following operation for thyropid disease. Med. Consult. New Remedy 18:171-175, 1981.
  15. Perna, L. Osservazioni cliniche sul trattamento in doppio cieco con Serratio peptidasi, nella rinite perenne nella rinitie cronica riacutizzata con sinusopatia. nella bronchite cronica riacutizzata. Riv. Pat. Clin.Tuberc. Penumol. 56:509-516,1985.
  16. Fujitani, T. et al. Effect of anti-inflammatory agent on transfer of antibiotics to the maxillary sinus mucosa in chronic sinusitis. Otorhinolaryngol. Clin. North Am. 66:557-565. 1976.
  17. Tago. T. and Mitsui, S. Effects of serrapeptase in dissolution of sputum, especially in patients with bronchial asthma. Jap. Clin. Exp. Med. 49:222-228, 1972.
  18. Tomoda, K. and Miyatam K. Some information on the composition of tracheal secretions before and after the administration of serrapeptase. Exper. Ther. 477:9-16, 1972.
  19. Kase, Y. et al. A new method for evaluating mucolytic expectorant activity and its application. II. Application to two proteolytic enzymes, serrapeptase and seaprose. Arzneimittelforschung 32:374-378,1982.
  20. Marriott, C. Modification of the rheoloaical properties of mucus by drugs. Adv. Exp. Med. Biol. 144^75-84, 1982.
  21. Majima. Y. et al. Effects of orally administered drugs on dynamic viscoelasticity of human nasal mucus. Am. Rev. Respir. Dis. 141:79-83.1990.
  22. Miyata, K. Intestinal absorption of serrapeptase. J ApplBiochem. 1980:2:111-16.
  23. Aso T. et al. Breast engorgement and its treatment: Clinical effects of Danzen (serrapeptase) an anti-inflammatory enzyme preparation. The world of Obstetrics and Gynecology (Japanese). 1981:33:371-9.
  24. Esch PM, Gemgross H. Fabian A. Reduction of postoperative swelling. Objective measurement of swelling of the upper ankle joint in treatment with serrapeptase-a prospective study (German). FortschrMed. 1989; 107(4):67-8, 71-2.
  25. Majima Y, Inagaki M, Hirata K. Takeuchi K, Morishita A, Sakakura Y. The effect of an orally administered proteolytic enzyme on the elasticity and viscosity of nasal mucus. Arch Otorhinolaryngol. 1988;244(6):355-9.
  26. Selan L, Berlutti F, Passariello C. Comodi-Ballanti MR, Thaller MC. Proteolytic enzymes: a new treatment strategy for prosthetic infections - Antimicrob Agents Chemother. 1993; 37(12):26l8-21.
  27. Koyama A, Mori J, Tokuda H, Waku M, Anno H, Katayama T, Murakami K, Komatsu H, Hirata M, Arai T, et al. Augmentation by serrapeptase of tissue permeation by cefotiam (Japanese). Jpn J Antibiot. 1986; 39(3):761-71.

The treatment of breast engorgement with Serrapeptase (Danzen): a double-blind controlled trial.

Author: Kee WH, Tan SL; Lee V, Salmon YM Source: Singapore Med J, 30(I):48-5s4 1989 Feb

We evaluated an anti-inflammatory enzyme drug Danzen (Serrapeptase) Takeda Chemical Industries, Ltd.) on 70 patients complaining of breast engorgement These patients were randomly divided into 2 groups, a treatment group and a placebo group. A single observer, unaware of the group the patients were in, assessed the severity of each of the symptoms and signs of breast engorgement before treatment was commenced, and daily for 3 days, during which therapy was administered. Danzen was noted to be superior to placebo for improvement of breast pain, breast swelling and duration and while 85.7% of the patients receiving Danzen had "Moderate to Marked improvement, only 60.0% of the patients receiving placebo had a Similar degree of improvement. "Marked improvement was found in 229% of the treatment group and 2.9% of the placebo group. These differences were statistically significant (P less than 0.05), No adverse reactions were reported with the use of Danzen (Serrapeptase). Danzen (Serrapeptase) is a safe and effective method for the treatment of breast engorgement.

Reduction of postoperative swelling objective measurement of swelling of the upper ankle joint in treatment with serrapeptase.

Author: Esch PM, Gerngross H, Fabian A Source: Fortachr Med,107(4):67.8, 71-2 1989 Feb 10

Using a quantitative standardized procedure, the swelling of the ankle produced by supination trauma was measured. In the 66 patients with fresh rupture of the lateral ligament treated surgically at our Department between December 1986 and April 1987, a prospective study of the effect of serrapeptase (Aniflazym) on postoperative swelling and pain was carried out in 3 randomized groups of patients. To the group receiving the test substance, the swelling had decreased by 50% on the third post-operative day, while in the other two control groups (elevation of the leg, bed rest, with and without the application of ice) no reduction in swelling had occurred at that time. The difference is statistically significant (p = 0.013). Decreasing pain correlated for the most part with the reduction in swelling Thus, the patients receiving the test substance more) rapidly became pain-free than did the control groups. On the basis of these results, serrapeptase would appear to be an effective preparation for the port-operative reduction of swelling, in comparison with the classical conservative measures for example, the application of ice.

A multi-centre, double-blind study serrapeptase versus placebo in post-antrotomy buccal swelling

Author: Tachibana M, Mizukosi 0, Harada Y, Kawamoto K, Nakai Y Source: Pharmatherapeutica, 3(8):526-30 1984

A multi-centre, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of the anti-inflammatory enzyme serrapeptase in a total of 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight patients received 10 mg serrapeptase 3 times on the day before operation, once on the night of the operation and 3 times daily for 5 days after operation, the other 86 received placebo Chanes in buccal swelling after operation were observed as a parameter of the response to treatment. The degree of swelling in the serrapeptase-treated patients was significantly less than that in the placebo-treated patients at every point of observation after operation up to the 5th day (p less than 001 top less than 0.05). Maximal swelling throughout all the post-operative points of observation was also significantly smaller in size in the serrapeptase-treated group than in the placebo-treated group. No side effects were reported.

Intestinal absorption of serrapeptase in rats.

Author: Moriya N, Nakata M, Nakamuma M, Takaoka M, lwasa S; Kato K; Kakinuma Address: Biotechnology Research Laboratories, Takeda Chemical Industries Ltd., Osaka, Japan

A sensitive sandwich enzyme immunoassay (e.i.a) for serrapeptase (TSP), an orally available anti-inflammatory proteinase, was established using affinity-purified anti-TSP rabbit IgG and its Fab fragment conjugated with horseradish peroxidase as the first and the second antibodies respectively TSP in the plasma was determined by the e.i.a. after its oral administration (100 m/kg) to rats. The peak concentration was observed between 30mm and 2 h after administration. TSP in the plasma samples was trapped in a microtitre plate coated with the affinity-purified anti-TSP rabbit IgG. and the hydrolysis of a synthetic fluorogenic substrate, butoxycarbonyl-Glu(benzyloxy)-Ala-Arg-4- methylcoumaryl- 7-amide, by the trapped TSP was fluorometrically measured (proteinase assay. The values obtained by the e.i.a. and those obtained by the proteinase assay correlated well for various plasma samples. These results indicate that orally administered TSP was absorbed from the intestinal tract and transferred into the circulation in an enzymically active form.

Glossary Terms:

enterobacterium: any of a family (Enterobacteriaceae) of gram-negative straight rod bacteria (as a salmonella or a shigella) that ferment glucose and include saprophytes as well as some serious plant and animal pathogens.

pathogen: a specific causative agent (as a bacterium or virus) of disease

pathogenic: causing or capable of causing disease

Serrapeptase is an anti-inflammatory proteolytic (protein-dissolving) enzyme originally isolated from silkworms. Serrapeptase has been used in Europe to treat arterial blockages due to its ability to alleviate arterial inflammation and dissolve blood clots and arterial plaque. It has been used to treat arthritis, fibrocystic breast disease, carpal tunnel syndrome, and other inflammatory conditions. The ingredients in the Serrapeptase capsules are enterically coated for proper absorption.

Serrapeptase: Insect-Derived Enzyme Fights Inflammation

December 1999, by Kimberly Pryor

Our bodies have a love-hate relationship with inflammation. On the one hand, inflammation is a natural response, necessary to protect the body from invading organisms. On the other hand, inflammation can limit joint function, and destroy bone, cartilage and other articular structures.

An elusive goal of scientists and physicians has been to find a side-effect-free substance to reduce the pain and inflammation associated with fibrocystic breast disease, rheumatoid arthritis, idiopathic edema, carpal tunnel syndrome and post-operative swelling. It appears that the search may be nearing an end, thanks to an enzyme produced by the larval form of the silk moth.

Serrapeptase is an enzyme that is produced in the intestines of silk worms to break down cocoon walls. This enzyme is proving to be a superior alternative to the non-steroidal anti-inflammatory agents (NSAIDs) traditionally used to treat rheumatoid arthritis and osteoarthritis. Its uses have also been extended to the treatment of chronic sinusitis and postoperative inflammation, and some researchers believe the substance can play an important role in arterial plaque prevention and removal.

Harmful Effects of NSAIDs

NSAIDs, which include aspirin, ibuprofen, salicylates, and naproxen, are among the most commonly prescribed medications for inflammation resulting from rheumatoid arthritis, joint conditions, osteoarthritis, gouty arthritis, joint and muscle discomfort associated with systemic lupus erythematosus, and other musculoskeletal disorders.(1) In some cases, this overeliance on NSAIDs has proved deadly. Annually, 76,000 people are hospitalized from NSAID-induced gastrointestinal complications. The American Medical Association estimates that from 50-80 percent of those hospitalized for gastrointestinal bleeding are taking some form of NSAIDs. At this stage in the medication-induced bleeding, there is a ten percent chance of fatality.(2)

NSAIDs lethal effects result from the inhibition of the biosynthesis of prostaglandins. NSAIDs block cyclo-oxygenase, the enzyme responsible for catalyzing the reactions of arachidonic acid to endoperoxide compounds. This process results in the inhibition of gastric prostaglandin E, a hormone which protects the lining of the stomach from acid. After prolonged and frequent ingestion of NSAIDs, the stomach remains defenseless and at increased susceptibility to ulcers.(3-4) If an ulcer erodes into a blood vessel, bleeding results. An ulcer can destroy part of the stomach and duodenal walls, leaving a gap that requires immediate surgery.

In one study, 1,826 osteoarthritis or rheumatoid arthritis patients who had been taking NSAIDs for six months or more and who had been unable to tolerate continuous NSAID use because of adverse gastrointestinal symptoms were examined endoscopically for gastroduodenal lesions and ulcers. Clinically significant gastroduodenal lesions were found in 37.1 percent of the patients. Of those, 24 percent had ulcers. The prevalence of gastroduodenal ulcers increased with age, duration of osteoarthritis, and duration of current NSAID use. The authors of the study wrote: "These results provide further endoscopic confirmation of the association between NSAID use and gastroduodenal lesions and ulcers and support the contention that safer treatment alternatives to conventional NSAIDs are required."(5)

That advice is particularly wise in light of the other effects NSAIDs have on the gastrointestinal tract. In one group of 312 NSAID takers, 20 percent had levels of inflammation comparable to that previously reported in patients with inflammatory bowel disease.(6) Besides damaging the gastrointestinal tract, NSAIDs also interfere with and suppress bone repair and remodeling. One paper presented data obtained over a 12-year period, and outlined the effects of NSAIDs on the matrix synthesis and turnover in 650 arthritic and 180 non-arthritic human cartilages. The study showed that one category of NSAIDs that includes Naproxen, ibuprofen, indomethacin, and nimezulide significantly inhibited matrix synthesis and had toxic effects on cartilage metabolism.(7) Thus, it appears that the drugs many patients take to relieve their arthritic pains actually contributes to further destruction of their joints!

Additionally, NSAIDs have been shown to interfere with patients' sleep patterns. One study of 37 male and female subjects at the sleep laboratory at Bowling Green State University in Ohio demonstrated that aspirin and ibuprofen, in comparison to a placebo, increased the number of awakenings and the percentage of time spent awake. The drugs also decreased sleep efficiency, and delayed the onset of the deeper stages of sleep.(8)

Even insulin secretion is affected by NSAIDs. Neonatal rat pancreatic cells were examined partly to determine the effects of insulin secretion caused by prostaglandin E (PGE) and drugs that inhibit its synthesis - i.e. NSAIDs. Two NSAIDs, sodium salicylate (aspirin) and ibuprofen, at drug concentrations similar to those achieved therapeutically in humans, inhibited PGE synthesis up to 70-80 percent. Augmented insulin secretion accompanied the PGE inhibition. Both drugs shifted the glucose-insulin response curves to the left at low glucose concentrations and augmented maximal insulin release at high glucose concentrations.(9)

Other NSAID-induced side effects include kidney damage, blood dyscrasias and cardiovascular effects, complication of antihypertensive therapies involving diuretics or beta-adrenoceptor blockade, and adverse effects in patients with heart failure and cirrhosis.(10) In one instance, a woman treated for rheumatoid arthritis with the NSAID sulindac developed gallstones composed of sulindac metabolites.(11)

Interestingly, NSAIDs have also induced adverse psychiatric reactions. Five psychiatric outpatients?two with major depressive disorders, one with a bipolar disorder, one with a schizophrenic disorder and one with an anxiety disorder?were treated with NSAIDs due to rheumatoid arthritis, osteoarthritis, or other painful neuromuscular conditions. All five patients developed moderate to severe depression. Three patients became paranoid, and four either attempted or considered suicide. These psychiatric symptoms disappeared once the patients stopped taking NSAIDs. When the patients re-started the drugs, the symptoms returned.(12)

NSAIDs Roulette

Due to the detrimental effects of NSAIDs on the body, most physicians resort to a game of "NSAID musical-chairs," taking a patient off one NSAID as soon as side effects become evident or the drug stops working, then treating the patient with another of the 10 most widely prescribed propionic acid-derived NSAIDs.

To provide a more consistent form of treatment, researchers have long searched for a side-effect free anti-inflammatory agent. Researchers have recently focused on selective cyclo-oxygenase (COX-2) inhibitors, more precise versions of NSAIDs. Whereas previous NSAIDs reduced inflammation by inhibiting all cyclo-oxygenase activity, these new selective COX-2 inhibitors differentiate between the two forms of COX: COX-1 appears to regulate many normal physiologic functions and COX-2 mediates the inflammatory response. These selective inhibitors are believed to reduce inflammation without influencing normal physiologic functions by inhibiting only COX-2. By leaving COX-1 alone, the selective inhibitors result in fewer gastrointestinal side effects.

At first glance, these COX-2 inhibitors look like the solution to NSAID complications. Upon further inspection, however, celecoxib, a highly selective COX-2 inhibitor, can cause headaches, change in bowel habits, abdominal discomfort and dizziness in osteoarthritis patients. Fewer adverse effects are reported in rheumatoid arthritis patients, but because the drug is metabolized in the liver by cytochrome P-450 isozyme CYP2C9, serious drug interactions are possible. Fung and colleagues pointed out that more clinical studies are needed before the selective COX-2 inhibitors are put into widespread use.(13)

Another new drug, Enbrel, initially showed promise of treating the pain associated with rheumatoid arthritis. Currently, however, the FDA is advising physicians about safety concerns of the new drug. Thirty of the 25,000 patients treated with Enbrel since the drug's approval have developed serious infections, including sepsis. Several of those patients died as a result of the infections. Those at greatest risk when taking Enbrel appear to be patients with a history of chronic or recurrent infections, pre-existing infections, diabetes, or other conditions making them more susceptible to infection.(14)

The potentially lethal side effects associated with NSAIDs and other drugs indicate that a superior anti-inflammatory substance is needed.

A Natural Anti-Inflammatory

Serrapeptase, also known as Serratia peptidase, is a proteolytic enzyme isolated from the non-pathogenic enterobacteria Serratia E15. When consumed in unprotected tablets or capsules, the enzyme is destroyed by acid in the stomach. However, enterically-coated tablets enable the enzyme to pass through the stomach unchanged, and be absorbed in the intestine. Serrapeptase is found in negligible amounts in the urine, suggesting that it is transported directly from the intestine into the bloodstream.(15,16)

Clinical studies show that serrapeptase induces fibrinolytic, anti-inflammatory and anti-edemic (prevents swelling and fluid retention) activity in a number of tissues, and that its anti-inflammatory effects are superior to other proteolytic enzymes.(17)

Besides reducing inflammation, one of serrapeptase's most profound benefits is reduction of pain, due to its ability to block the release of pain-inducing amines from inflamed tissues.(18) Physicians throughout Europe and Asia have recognized the anti-inflammatory and pain-blocking benefits of this naturally occurring substance and are using it in treatment as an alternative to salicylates, ibuprofen and other NSAIDs.(19)

In Germany and other European countries, serrapeptase is a common treatment for inflammatory and traumatic swellings, and much of the research that exists on this substance is of European origin. One double-blind study was conducted by German researchers to determine the effect of serrapeptase on post-operative swelling and pain. This study involved sixty-six patients who were treated surgically for fresh rupture of the lateral collateral ligament of the knee. On the third post-operative day, the group receiving serrapeptase exhibited a 50 percent reduction of swelling, compared to the controls. The patients receiving serrapeptase also became more rapidly pain-free than the controls, and by the tenth day, the pain had disappeared completely.(20)

Cystic Breast Disease

Serrapeptase has also been used in the successful treatment of fibrocystic breast disease. In a double-blind study, 70 patients complaining of breast engorgement randomly were divided into a treatment group and a placebo group. Serrapeptase was superior to the placebo for improvement of breast pain, breast swelling and induration (firmness). 85.7 percent of the patients receiving serrapeptase reported moderate to marked improvement. No adverse reactions to serrapeptase were reported and the researchers concluded that "serrapeptase is a safe and effective method for the treatment of breast engorgement."(21,22)

Serrapeptase and Sinusitis

Due to its inflammatory properties, serrapeptase has been shown in clinical studies to benefit chronic sinusitis sufferers. In this condition, the mucus in patients' nasal cavities is thickened and hypersecreted. This thickening causes mucus to be expelled less frequently. Japanese researchers evaluated the effects of serratiopeptidase (30 mg/day orally for four weeks) on the elasticity and viscosity of the nasal mucus in adult patients with chronic sinusitis. Serratiopeptidase reduced the viscosity of the mucus, improving the elimination of bronchopulmonary secretions.(23)

Other clinical trials support serrapeptase's ability to relieve the problems associated with chronic sinusitis. In one study, 140 patients with acute or chronic ear, nose and throat pathologies were evaluated with either a placebo or the active serratia peptidase. Patients taking the serrapeptase experienced a significant reduction in severity of pain, amount of secretion, purulence of secretions, difficulty in swallowing, nasal dysphonia, nasal obstruction, anosmia, and body temperature after three to four days and at the end of treatment. Patients suffering from laryngitis, catarrhal rhinopharyngitis and sinusitis who were treated with serrapeptase experienced a significant and rapid improvement of symptoms after 3-4 days. Physicians assessed efficacy of treatment as excellent or good for 97.3 percent of patients treated with serrapeptase compared with only 21.9 percent of those treated with a placebo.(24)

Respiratory diseases are characterized by increased production of a more dense mucus modified in viscosity and elasticity. Traditionally, in respiratory diseases, muco-active drugs are prescribed to reestablish the physicochemical characteristics of the mucus in order to restore respiratory function. Some of these drugs, however, cause a functional depletion of mucus, whereas Serrapeptase alters the elasticity of mucus without depleting it.(25,27)

A powerful agent by itself, serrapeptase teamed with antibiotics delivers increased concentrations of the antimicrobial agent to the site of the infection. Bacteria often endure a process called biofilm formation, which results in resistance to antimicrobial agents. In an attempt to prevent this bacterial immunity, researchers have experimented with various means of inhibiting biofilm-embedded bacteria. Their search may have ended with serrapeptase. One study conducted by Italian researchers suggests that proteolytic enzymes could significantly enhance the activities of antibiotics against biofilms. Antibiotic susceptibility tests showed that serratiopeptidase greatly enhances the activity of the antibiotic, ofloxacin, and that it can inhibit biofilm formation.(28)

Another double-blind randomized study evaluated the effects of administering the antibiotic cephalexin in conjunction with serrapeptase or a placebo to 93 patients suffering from either perennial rhinitis, chronic rhinitis with sinusitis or chronic relapsing bronchitis. The serratia peptidase treated group experienced significant improvement in rhinorrhea, nasal stuffiness, coryza and improvement of the para-nasal sinus shadows.(29)

Researchers witnessed equally impressive results in the treatment of infections in lung cancer patients undergoing thoracotomy. Serrapeptase and cefotiam, an antibiotic with a broad spectrum of activity against both Gram-positive and Gram-negative microorganisms, were administered to 35 thoracotomy patients with lung cancer. The patients were divided into two groups. A single dose of cefotiam was administered to the 17 subjects in Group I. The 18 subjects in Group II received a combination of Cefotiam and serrapeptase. The level of the antibiotic in the tissues versus the blood was significantly higher in the serrapeptase group than the single dose group.(30)

Cardiovascular Implications

Hans A. Nieper, M.D., an internist from Hannover, Germany, studied the effects of serrapeptase on plaque accumulations in the arteries. The formation of plaque involves deposits of fatty substances, cholesterol, cellular waste products, calcium and fibrin (a clotting material in the blood) on the inner lining of the arteries. Excessive plaque results in partial or complete blockage of the blood's flow through an artery, resulting in arteriosclerosis, or hardening of the arteries, and an ensuing stroke or heart attack. The evidence to support serrapeptase's role in preventing plaque build-up is anecdotal. Still, further studies are called for in this area as Nieper's research indicated that the protein-dissolving action of serrapeptase will gradually break down atherosclerotic plaques.(31)

Conclusion

Regardless of whether serrapeptase is used for inflammatory diseases or to prevent plaque build up on the arteries, it is well-tolerated. Due to its lack of side effects and anti-inflammatory capabilities, serrapeptase is a logical choice to replace harmful NSAIDs. Thanks to the tiny larvae of the silk moth, researchers have taken a large step toward finding relief for inflammatory disease sufferers.

References

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