Serrapeptase studies                       

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 

Abstract

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.

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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
 
Abstract

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.

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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

Abstract

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 emphysema. 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.

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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

Abstract

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.

References

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. Japan. 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 JAntibiot. 1986; 39(3):761-71.

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