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Studies and
Technical Information
Serrapeptase –
Scientific Background of the Most Potent Proteolytic Enzyme?
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Inflammatory Response
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Drugs
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NSAIDs
- The Side Effects
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The Enzyme Alternative
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Serrapeptase the Enzyme
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Wide Range of Applications
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Chronic Inflammation
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Powerful Anti-Inflammatory
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Standard Treatment In Europe
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Cystic Breast Disease
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ENT Success
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Carpal Tunnel RSI
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Enteric Coating for Intestinal Absorption
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Superior Effects
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More Studies
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Serrapeptase References
Inflammatory Response
The
Inflammatory Response is normally an important mechanism for protecting the
body from attack by invading organisms, faulty cells and trauma. When the
immune system becomes dysfunctional, it loses its ability to differentiate
between innocuous and potentially dangerous substances. This dysfunction
results in a wide array of autoimmune diseases such as rheumatoid arthritis,
ulcerative colitis, allergies, psoriasis, uveitis, multiple sclerosis and some
forms of cancer.
In spite of the huge range of successful enzyme studies
showing safety and effectiveness, the standard therapy for
inflammatory-mediated diseases and trauma include drugs such as steroids and
non-steroidal anti-inflammatory agents (NSAIDs). These classes of drugs do in
most cases offer temporary, symptomatic relief from swelling, inflammation and
accompanying pain, but without treating the underlying condition.
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Drugs
The drugs used to control the inflammatory response may be
immunosuppressive and cause dangerous side effects. The benefits and long-term
risks associated with the use of NSAIDs, especially in cases of rheumatoid
arthritis, need to be weighed very carefully. If not successfully treated, the
inflammatory process itself can lead to limitation of joint function and
destruction of bone, cartilage and articular structures.
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NSAIDs
NSAIDs are one of the most widely prescribed drugs for
rheumatoid arthritis and other inflammatory joint conditions. They inhibit the
biosynthesis of prostaglandins by irreversibly blocking cyclooxygenase, the
enzyme which catalyses the reactions of arachidonic acid to endoperoxide
compounds.
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The Side Effects
The neurological and gastrointestinal side effects of these
agents have been reviewed in considerable detail. All of the NSAIDs, with the
exception of Cytotec, inhibit prostaglandin El, a local hormone responsible
for gastric mucosal cytoprotection. A common side effect from these
medications is gastric ulcers. More serious adverse reactions such as blood
dyscrasias, kidney damage and cardiovascular effects have been noted. Most
physicians rotate among the ten most widely prescribed NSAIDs, as soon as one
causes side effects or stops working.
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The Enzyme Alternative
The search for a superior enzyme that offers safe but
powerful anti-inflammatory properties, thus averting the terrible side
effects, ended when Serratia peptidase (Serrapeptase) enzyme was discovered in
the early 70’s. Serrapeptase is now in wide clinical use throughout Europe and
Asia as a viable alternative to salicylates, ibuprofen (sold as an OTC in the
U.S.) and the more potent NSAIDs. Serrapeptase is an anti-inflammatory,
proteolytic enzyme isolated from the microorganism, Serratia E15 and has no
inhibitory effects on prostaglandins, is devoid of gastrointestinal side
effects and offers a sensible alternative.
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Serrapeptase the Enzyme
Serrapeptase is processed commercially in the laboratory
through fermentation. It was originally found in the silkworm where it is
naturally present in its intestine. This immunologically active enzyme is
completely bound to the alpha 2 macroglobulin in biological fluids. Histologic
studies reveal powerful anti-inflammatory effects of this naturally occurring
enzyme. The silkworm has a special relationship with the Serratia E15
microorganisms in its intestines. The enzymes secreted by the bacteria in
silkworm intestines have the ability to dissolve avital tissue, but have no
detrimental effect on the host’s living cells. Thus by dissolving the
silkworm’s protective cocoon (avital tissue), the winged creature is able to
emerge and fly away.
Wide Range of Applications
The discovery of this unique biological phenomenon led
researchers to study clinical applications of the Serrapeptase enzyme in man.
In addition to its widespread use in:
• Arthritis
• Fibrocystic breast disease
• Carpal tunnel syndrome
• Atherosclerosis.
Researchers in Germany have used Serrapeptase for
atherosclerosis to digest atherosclerotic plaque without harming the healthy
cells lining the arterial wall.
Chronic Inflammation
Today, researchers consider atherosclerosis an inflammatory
condition (similar to many other degenerative diseases whose cause is
identified as chronic inflammation). Some immunologists are even categorizing
atherosclerosis as a benign tumour. Hardening and narrowing of the arterial
wall is a cumulative result of microscopic trauma; inflammation occurs in the
presence of oxidized lipids. Serrapeptase doesn’t interfere with the synthesis
of cholesterol in the body, but acts as an anti-inflammatory and helps clear
avital tissue from the arterial wall. It is important to note that cholesterol
in its pure state is an antioxidant and a necessary component of the major
organ and hormonal systems in the body. The use of medications, which block
cholesterol biosynthesis, may eventually damage the liver and compromise
anti-oxidant status of the eyes, lungs and other soft tissues.
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Powerful Anti-Inflammatory
A wealth of information exists regarding its
anti-inflammatory properties. Serrapeptase has been used as an
anti-inflammatory agent in the treatment of:
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Chronic sinusitis
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To improve the elimination of bronchopulmonary secretions
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Traumatic injury (e.g. sprains and torn ligaments)
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Post-operative inflammation
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To facilitate the therapeutic effect of antibiotics in
the treatment of infections
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Cystitis and epididymitis.
Standard Treatment In Europe
Serrapeptase has been admitted as a standard treatment in
Germany and other European countries for the treatment of inflammatory and
traumatic swellings. In one double-blind study of Serrapeptase conducted by
Esch et al at the German State Hospital in UIm, 66 patients with fresh rupture
of the lateral ligament treated surgically were divided in three randomised
groups. In 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 or without the application of ice), no
reduction in swelling had occurred at that time. The difference was of major
statistical significance. Decreasing pain correlated for the most part with
the reduction in swelling. The patients receiving Serrapeptase became
pain-free more rapidly than the control groups. By the 10th day, all patients
were free of pain in the Serrapeptase-treated group. The therapeutic daily
dose was 1-2 tablets (5 mg) 3 times daily.
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Cystic Breast Disease
In another double-blind study, the anti-inflammatory
enzyme, Serrapeptase, was evaluated in a group of 70 patients with evidence of
cystic breast disease. These patients were randomly divided into a treatment
group and a placebo group. Serrapeptase was noted to be superior to placebo
for improvement of breast pain, breast swelling and induration, with 85.7% of
the patients receiving Serrapeptase reporting moderate to marked improvement.
No adverse reactions were reported with the use of Serrapeptase. The use of
enzymes with fibrinolytic, proteolytic and anti-edemic activities for the
treatment of inflammatory conditions of the ear, nose and throat has gained
increasing support in recent years.
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ENT Success
In a third double-blind study, 193 subjects suffering from
acute or chronic ear, nose or throat disorders were evaluated. Treatment with
Serrapeptase lasted 7-8 days taking 5mg tablets. After 3-4 days treatment,
significant symptom regression was observed in the Serrapeptase-treated group,
while this was not noted in the control group. Patients suffering from
laryngitis, catarrhal rhinopharyngitis and sinusitis noted markedly rapid
improvement. The physicians’ assessments of efficacy of treatment were
excellent or good for 97.3% of patients treated with Serrapeptase compared
with only 21.9% of those treated with placebo. In a similar study of chronic
bronchitis, conducted by a team of otolaryngologists, the Serrapeptase-treated
group showed excellent results compared with the placebo group in the
improvement of loosening sputum, frequency of cough and expectoration. Other
improvements included the posterior nasal hydro rhea and rhinostenosis. The
administration of Serrapeptase reduces the viscosity of the nasal mucus to a
level at which maximal transport can be achieved. It has also been
demonstrated that the simultaneous use of the peptidase and an antibiotic
results in increased concentrations of the antibiotic at the site of the
infection.
The mechanisms of action of Serrapeptase, at the sites of
various inflammatory processes consist fundamentally of a reduction of the
exudative phenomena and an inhibition of the release of the inflammatory
mediators. This peptidase induces fragmentation of fibrinose aggregates and
reduces the viscosity of exudates, thus facilitating drainage of these
products of the inflammatory response and thereby promoting the tissue repair
process. Studies suggest that Serrapeptase has a modulatory effect on specific
acute phase proteins that are involved in the inflammatory process. This is
substantiated by a report of significant reductions in C3 and C4 complement,
increases in opsonizing protein and reductions in concentrations of
haptoglobulin, which is a scavenger protein that inhibits lysosomal protease.
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Carpal Tunnel RSI
Carpal tunnel syndrome is a form of musculo-ligamentous
strain caused by repetitive motion injury. Individuals who work at keyboard
terminals are particularly susceptible to this condition. While surgery has
been considered the first line treatment for carpal tunnel syndrome, recent
studies reveal that the use of anti-inflammatory enzymes (e.g. Serrapeptase
and bromelain), in conjunction with vitamins B2 and B6, is also effective. The
use of non-invasive, nutritional approaches to the treatment of this common
condition will become more important as a generation of keyboard operators
approach retirement.
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Enteric Coating for Intestinal Absorption
Several research groups have reported the intestinal
absorption of Serrapeptase. Serrapeptase is well absorbed orally when
formulated with an enteric coating. It is known that proteases and peptidases
are only absorbed in the intestinal area.
These enzymes are mobilized directly to the blood and are
not easily detectible in urine. Other enzymes with structural similarities
have been reported to be absorbed through the intestinal tract. Chymotrypsin
is transported into the blood from the intestinal lumen. Horseradish
peroxidase can cross the mucosal barrier of the intestine in a biologically
and immunologically active form. Several studies have appeared so far which
refer to the systemic effects of orally given proteases and peptidases (e.g.
Serrapeptase), such as repression of oedema and repression of blood vessel
permeability induced by histamine or bradykinin. These enzymes also affect the
kallikrein-kinin system and the complement system, thus modifying the
inflammatory response.
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Superior Effects
In vitro and in vivo studies reveal that Serrapeptase has a
specific, anti-inflammatory effect, superior to that of other proteolytic
enzymes. A review of the scientific literature, including a series of
controlled, clinical trials with large patient groups, suggests that
Serrapeptase is useful for a broad range of inflammatory conditions. If one
considers the fact that anti-inflammatory agents are among the most widely
prescribed drugs, the use of a safe, proteolytic enzyme such as Serrapeptase
would be a welcome addition to the physician’s armamentarium of physiologic
agents.
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Click here for more studies
Serrapeptase references:
1) Kee WH. Tan SL, Lee V. Salmon YM. The treatment of
breast engorgement with Serrapeptase: a randomised double blind controlled
trial. Singapore Med J. 1989:30(1): 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 randomised trial versus placebo. J. Int. Med. Res.
18(5): 379-388,1990.
6) Kakinumu, A. et al. Regression of fibrinolysis in
scalded rats by administration of Serrapeptase. Biochem. Pharmacol.
31:2861-2866,1982.
7) Marly, M. Enzymotherapie anti-inflammatoire a l’aide de
la Serrapeptase: resultats cliniques en traumatologie et en ORL. C
RTherapeut. 3:9-19,1985.
8) Odagiri, J. et al. Clinical applications of
Serrapeptase in sinusitis. Med. Consult. New Remedy 6:201-209, 1979.
9) Yamazaki, J. et al. Anti-inflammatory activity of
Serrapeptase, a protease produced by a strain of Serratia. Folia Pharmacol.
Japon. 6^302-314,1967.
10) Harad, Y. Clinical efficacy of Serrapeptase on
buccal swelling after radical operation for chronic sinusitis. Igaku Ayumi
123:768-778.1982.
11) Matsudo, A. et at. Effect of Serrapeptase on
inflammatory oedema following operation for thyropid disease. Med.
Consult. New Remedy 18:171-175, 1981.
12) 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.
13) 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.
14) Mazzonie, A. et al. Evaluation of Serrapeptase in
acute or chronic inflammation of otorhinolaryngology pathology: a multicentre,
double blind randomised trial versus placebo. J. int. Med. Res. 18(5):
379-388,1990.
15) 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.
16) Marriott, C. Modification of the rheoloaical
properties of mucus by drugs. Adv. Exp. Med. Biol. 144^75-84, 1982.
17) Majima. Y. et al. Effects of orally administered
drugs on dynamic viscoelasticity of human nasal mucus. Am. Rev. Respit.
Dis. 141:79-83.1990.
18) Miyata, K. Intestinal absorption of Serrapeptase.
J ApplBiochem. 1980:2:111-16.
19) Aso T. et al. Breast engorgement and its treatment:
Clinical effects of (Serrapeptase) an anti-inflammatory enzyme
preparation. The world of Obstetrics and Gynaecology (Japanese).
1981:33:371-9.
20) Esch PM, Gemgross H. Fabian A. Reduction of
postoperative swelling. Objective measurement of swelling of the upper
ankle joints in treatment with Serrapeptase a prospective study (German).
FortschrMed. 1989; 107(4): 67-8, 71-2.
21) Majima Y, lnagaki M, Hirata K. Takeuchi K, M orishita
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.
22) Selan L, Berlutti F, Passariello C. Comodi-Ballanti MR,
Thaller MC. Proteolytic enzymes: a new treatment strategy for prosthetic
infections? Antimicrob Agents Cheroother. 1993; 37(12): 2618-21.
23) 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 JAntibiot.
1986; 39(3): 761-71.
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