After consumption, serrapeptidase 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 serrapeptidase induces fibrinolytic, anti-inflammatory and anti-edemic 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)
- 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.
- Miyata, K. Intestinal absorption of Serratia Peptidase. J Appl Biochem. 1980;2:111-16.
- 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.
- 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.
- 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.
Effect of the proteolytic enzyme serrapeptase in patients with chronic airway disease.
Authors: Nakamura S, Hashimoto Y, Mikami M, Yamanaka E, Soma T, Hino M, Azuma A, Kudoh S.
Source: Respirology. 2003 Sep;8(3):316-20.
The proteolytic enzyme serrapeptase is widely used in clinical practice in Japan. We investigated the effect of serrapeptase on sputum properties and symptoms in patients with chronic airway diseases. This study was an open-labeled trial with a non-treatment control group. Patients were randomly assigned to oral treatment and without serrapeptase 30 mg/day for 4 weeks. Patients collected sputum samples for about 4 hours in the morning on the day the trial began and 4 weeks later. Part of each sputum sample was weighed and then completely dried and reweighed. The percentage solid component, viscosity and elasticity of the sputum were measured. Mucociliary transportability index was measured using ciliated bovine trachea ex vivo. RESULTS: After 4 weeks of serrapeptase treatment, sputum weight in the morning, percentage solid component, viscosity and elasticity of sputum, sputum neutrophil count, frequency of coughing and frequency of expectoration significantly decreased. CONCLUSIONS: serrapeptase may exert a beneficial effect on mucus clearance by reducing neutrophil numbers and altering the viscoelasticity of sputum in patients with chronic airway diseases.
A preliminary trial of serratiopeptidase in patients with carpal tunnel syndrome.
Author: Panagariya A, Sharma AK
Source: J Assoc Physicians India. 1999 Dec;47(12):1170-2.
This study was planned to assess the response of serratiopeptidase ( serrapeptase ) in patients with carpal tunnel syndrome (CTS). Twenty patients with CTS were evaluated clinically. After baseline electrophysiological studies, these patients were given serrapeptase 10 mg twice daily with initial short course of nimesulide. Clinical and electrophysiological reassessment was done after 6 weeks. RESULTS: Sixty five percent of serrapeptase cases showed significant clinical improvement which was supported by improvement in electrophysiological parameters. Recurrence was reported in four cases. No significant side effect was observed. CONCLUSIONS: Serrapeptase therapy may proved to be a useful alternative mode of conservative treatment. Larger study may be further helpful to establish the role of serrapeptase in CTS.
Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo.
Authors: A Mazzone, M Catalan, M Costanzo, A Drusian, A Mandol, S Russo, E Guarini and G Vesperini
Source: J Int Med Res. 1990 Sep-Oct;18(5):379-88.
The efficacy and tolerability of serrapeptase were evaluated in a multicentre, double-blind, placebo-controlled study of 193 subjects suffering from acute or chronic ear, nose or throat disorders. Treatment lasted 7-8 days, with the drug or placebo being administered at a rate of two tablets three times a day. After 3-4 days' treatment, significant symptom regression was observed in serrapeptase treated patients. There was also a significant reduction in symptoms after 7-8 days for patients in both treatment groups but the response was more marked in those patients receiving the active drug. Statistical comparison between the two groups confirmed the greater efficacy and rapid action of the serrapeptase against all the symptoms examined at both stages. Tolerance was found to be very good and similar for both groups. It is concluded that serrapeptase has anti-inflammatory, anti-edemic and fibrinolytic activity and acts rapidly on localized inflammation.
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) on 70 patients complaining of breast engorgement. Serrapeptase was noted to be superior to placebo for improvement of breast pain, breast swelling and induration and while 85.7% of the patients receiving serrapeptase had "Moderate to Marked" improvement, only 60.0% of the patients receiving placebo had a similar degree of improvement. "Marked" improvement was found in 22.9% of the treatment group and 2.9% of the placebo group. These differences were statistically significant. No adverse reactions were reported with the use of serrapeptase. 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 -- a prospective study
Author: Esch PM, Gerngross H, Fabian A
Source: Fortschr Med. 1989 Feb 10;107(4):67-8, 71-2.
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 post-operative swelling and pain was carried out in 3 randomized groups of patients. In the group receiving serrapeptase, 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. 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 post-operative reduction of swelling, in comparison with the classical conservative measures, for example, the application of ice.
The effect of an orally administered proteolytic enzyme on the elasticity and viscosity of nasal mucus.
Author: Majima Y, Inagaki M, Hirata K. Takeuchi K, Morishita A, Sakakura Y.
Source: Arch Otorhinolaryngol. 1988;244(6):355-9.
We have evaluated the effect of serrapeptase, a proteolytic enzyme, on the elasticity and viscosity of the nasal mucus in adult patients with chronic sinusitis. Serrapeptase was administered in a dose of 30 mg/day orally for 4 weeks. Nasal mucus was collected from the nasal cavities of each patient before (week 0) and 4 weeks after the start of the medication (week 4). The storage modulus (G') and the dynamic viscosity (eta') of each specimen of nasal mucus were determined. The dynamic viscosity of the mucus at week 4 was significantly lower than that at week 0 (at frequencies of 5, 10 and 20 Hz). No significant differences were observed in the storage modulus (G') between the mucus at week 0 and week 4. Serrapeptase reduced the viscosity but not the elasticity of the nasal mucus.
A multi-centre, double-blind study of 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. Changes 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 0.01 to p 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.
Proteolytic enzymes: a new treatment strategy for prosthetic infections?
Author: Selan L, Berlutti F, Passariello C, Comodi-Ballanti MR, Thaller MC
Source: Antimicrob Agents Chemother 1993 Dec;37(12):2618-21
Among the different mechanisms of bacterial resistance to antimicrobial agents that have been studied, biofilm formation is one of the most widespread. This mechanism is frequently the cause of failure in the treatment of prosthetic device infections, and several attempts have been made to develop molecules and protocols that are able to inhibit biofilm-embedded bacteria. We present data suggesting the possibility that proteolytic enzymes could significantly enhance the activities of antibiotics against biofilms. Antibiotic susceptibility tests on both planktonic and sessile cultures, studies on the dynamics of colonization of 10 biofilm-forming isolates, and then bioluminescence and scanning electron microscopy under seven different experimental conditions showed that serratiopeptidase greatly enhances the activity of ofloxacin on sessile cultures and can inhibit biofilm formation.
A new method for evaluating mucolytic expectorant activity and its application to two proteolytic enzymes, serrapeptase and seaprose
Author: Y Kase, H Seo, Y Oyama, M Sakata, K Tomoda, K Takahama, T Hitoshi, Y Okano, T Miyata
Source: Forsch. Drug Res. 32 (1), Nr. 4 (1982)
Using our new method described in a preceding paper, in vivo effects of two proteolytic enzymes such as serrapeptase (SER) and seaprose (SAP) on sputa collected from bronchitis rabbits were examined. SER (20 mg/kg) and SAP (30 mg/kg) significantly reduced the viscosity of sputum (P < 0.05) at the 1-3-h periods and the 4-6-h periods, respectively, after intraduodenal administration. 50 mg/kg of SER also significantly decreased not only viscosity (P < 0.001) but also amount of freeze-dried substance (P < 0.05) of sputum at the 1-3-h periods, but SAP did not affect the amount of dried substance. Both enzymes significantly increased the volume of sputum, probably as the result of liquefaction. Thus, mucolytic expectorant activity of both enzymes can be demonstrated first by the reduction in viscosity and next by the increase in volume of sputa. However, the decrease in amount of freeze-dried substance is not always in accord with the reduction in viscosity.
Intestinal absorption of serrapeptase in rats.
Author: Moriya N, Nakata M, Nakamuma M, Takaoka M, lwasa S; Kato K; Kakinuma
Source: Biotechnol Appl Biochem. 1994 Aug;20 ( Pt 1):101-8.
A sensitive sandwich enzyme immunoassay for serrapeptase, an orally available anti-inflammatory proteinase, was established using affinity-purified anti-serrapeptase rabbit IgG and its Fab' fragment conjugated with horseradish peroxidase as the first and the second antibodies respectively. Serrapeptase in the plasma was determined after its oral administration (100 mg/kg) to rats. The peak concentration was observed between 30 min and 2 h after administration. These results indicate that orally administered serrapeptase was absorbed from the intestinal tract and transferred into the circulation in an enzymically active form.
- 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.
- Mizukoshi, D. et al. A double-blind clinical study of serrapeptase in the treatment of chronic sinusitis. Igaku Ayrni 109:50-62.1979.
- 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.
- 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.
- 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.
- Conticello, S. et al. La serrapeptase in ORL Nuova Clin. ORL 31:15-20,1979.
- Pallotti, S. et al. Valutazu-one della'attivita fibrinolytica della serrapeptase. Farmaci 3:163-173,1982.
- Kakinumu, A. et al. Regression of fibrinolysis in scalded rats by administration of serrapeptase. Biochem. Pharmacol. 31:2861-2866,1982.
- Marly, M. Enzymotherapie anti-inflammatoire a l'aide de la serrapeptase: resultats cliniques en traumatologie et en ORL. C RTherapeut. 3:9-19,1985.
- Odagiri, J. et al. Clinical applications of serrapeptase in sinusitis. Med. Consult. New Remedy 6:201-209, 1979.
- Yamazaki, J. et al. Anti-inflammatory activity of TSP, a protease produced by a strain of Serratia. Folia Pharmacol. Japon. 6:302-314,1967.
- Elies, W. et al. Akute und subakute Entzundungen der Nassenbenholen. Z. Allmeinmed. 4:92-95, 1987.
- Harada, Y. Clinical efficacy of serrapeptase on buccal swelling after radical operation for chronic sinusitis. Igaku Ayumi 123:768-778.1982.
- Matsudo, A. et at. Effect of serrapeptase (Danzen) on inflammatory edema following operation for thyropid disease. Med. Consult. New Remedy 18:171-175, 1981.
- 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.
- 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.
- 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.
- 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.
- 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.
- Marriott, C. Modification of the rheoloaical properties of mucus by drugs. Adv. Exp. Med. Biol. 144:75-84, 1982.
- Majima. Y. et al. Effects of orally administered drugs on dynamic viscoelasticity of human nasal mucus. Am. Rev. Respir. Dis. 141:79-83.1990.
- Miyata, K. Intestinal absorption of serrapeptase. J ApplBiochem. 1980:2:111-16.
- 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.
- 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.
- 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.
- 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.
- 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.