Serrapeptase: A Natural Anti-Inflammatory

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Serrapeptase: 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)

http://smart-drugs.net/serrapeptase-research.htm

 

serrapeptase testimonials

 

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

 

1. Raskin JB. Gastrointestinal effects of nonsteroidal anti-

inflammatory therapy. Am J Med. 1999; 106 (5B):3S-12S.

 

2. No author listed. Regular Use of Pain Relievers Can Have

Dangerous Results. Kaleidoscope Interactive News, American Medical

Association media briefing. July 24, 1997.

 

3. Fung HB, Kirschenbaum, HL. Selective cyclooxygenase-2 inhibitors

for the treatment of arthritis. Clin Ther. 1999; 21(7):1131-57.

 

4. Geis GS. Update on clinical developments with celecoxib, a new

specific COX-2 inhibitor: what can we expect? Scand J Rheumatol

Suppl. 1999; 109:31-7.

 

5. Cheatum DE, Arvanitakis C, Gumpel M, Stead H, Geis GS. An

endoscopic study of gastroduodenal lesions induced by nonsteroidal

anti-inflammatory drugs. Clin Ther. 1999; 21(6):992-1003.

 

6. Tibble JA, Sigthorsson G, Foster R, Scott D, Fagerhol MK, Roseth

A, Bjarnason I. High prevalence of NSAID enteropathy as shown by a

simple faecal test. Gut. 1999; 45(3):362-6.

 

7. Dingle JT. The effects of NSAID on the matrix of human articular

cartilages. Z Rheumatol. 1999; 58(3):125-9.

 

8. Murphy PJ, Badia P, Myers BL, Boecker MR, Wright KP Jr.

Nonsteroidal anti-inflammatory drugs affect normal sleep patterns in

humans. Physiol Behav. 1994; 55(6):1063-6.

 

9. Metz SA, Robertson RP, Fujimoto WY. Inhibition of prostaglandin E

synthesis augments glucose-induced insulin secretion in cultured

pancreas. Diabetes. 1981; 30(7):551-7.

 

10. Raskin JB. Gastrointestinal effects of nonsteroidal anti-

inflammatory therapy. Am J Med. 1999; 106 (5B):3S-12S.

 

11. Tokumine F, Sunagawa T, Shiohira Y, Nakamoto T, Miyazato F, Muto

Y. Drug-associated cholelithiasis: a case of sulindac stone

formation and the incorporation of sulindac metabolites into the

gallstones. Am J Gastroenterol. 1999;94(8):2285-8.

 

12. Jiang HK, Chang DM. Non-steroidal anti-inflammatory drugs with

adverse psychiatric reactions: five case reports. Clin Rheumatol.

1999;18(4):339-45.

 

13. Fung HB, Kirschenbaum, HL. Selective cyclooxygenase-2 inhibitors

for the treatment of arthritis. Clin Ther. 1999; 21(7):1131-57.

 

14. FDA MedWatch: The FDA Medical Products Reporting Program. May

12, 1999. FDA Talk Paper.

 

15. 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.

 

16. Miyata, K. Intestinal absorption of Serratia Peptidase. J Appl

Biochem. 1980;2:111-16.

 

17. 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.

 

18. 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.

 

19. 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.

 

20. Esch PM, Gerngross H, Fabian A. Reduction of postoperative

swelling. Objective measurement of swelling of the upper ankle joint

in treatment with serrapeptase-a prospective study (German).

Fortschr Med. 1989;107(4):67-8, 71-2.

 

21. Kee WH, Tan SL, Lee V, Salmon YM. The treatment of breast

engorgement with Serrapeptase (Danzen): a randomized double-blind

controlled trial. Singapore Med J. 1989;30(1):48-54.

 

22. 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.

 

23. 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.

 

24. 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.

 

25. Tomoda K, and Miyatam K. Some information on the composition of

trachael secretions before and after the administration of Danzen.

Exper Ther. 1972; 477:9-16.

 

26. Kase Y, et al. A new method for evaluating mucolytic expectorant

activity and its application to two proteolytic enzymes,

serratiopeptidase and seaprose. Arznelrnitteltorachung. 1982; 32:374-

378.

 

27. Marriott C. Modification in the rheological properties of mucus

by drugs. Adv Exp Med Biol. 1982; 144:75-84.

 

28. 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):2618-21.

 

29. Perna L. Osservazionl Clniche sui traitamento in osppio cleco

con Serratio peptidasl nella neifre perenna naila ninite cronica

nacutizzata con sinusopattia, nella bronchia cronica nacutizzata.

Rlv Pat Clin Tuberc Penumol. 1985; 56:509-516.

 

30. 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.

 

31. Brewer Science Library website. 1999.

 

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A preliminary trial of serrapeptase

in patients with carpal tunnel syndrome.

 

Panagariya A, Sharma AK

 

Dept. of Neurology, SMS Medical College and Hospital, Jaipur.

J Assoc Physicians India 1999 Dec;47(12):1170-2

 

 

OBJECTIVES: This study was planned to assess the response of

serrapeptase in patients with carpal tunnel syndrome (CTS).

 

METHODS: Twenty patients with CTS were evaluated clinically. After

baseline electrophysiological studies, these patients were given

serrapetase10 mg twice daily with initial short course of

nimesulide. Clinical and electrophysiological reassessment was done

after 6 weeks.

 

RESULTS: Mean age was 43.9 years with male to female ratio of

1:2.33. Sixty five percent cases showed significant clinical

improvement which was supported by significant 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.

 

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Proteolytic enzymes: a new treatment strategy for prosthetic

infections?

 

by Selan L, Berlutti F, Passariello C, Comodi-Ballanti MR, Thaller MC

 

Istituto di Microbiologia, Facolta di Farmacia, Universita La

Sapienza, Rome, Italy.

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 serrapetase greatly enhances the activity of ofloxacin

on sessile cultures and can inhibit biofilm formation.

 

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A New Method for Evaluating Mucolytic Expectorant Activity and its

Application

 

II. Application to two proteolytic enzymes, serrapeptase and

seaprose*

 

By Y. Kase, H. Seo, Y. Oyama, M. Sakata, K. Tomoda, K. Takahama, T.

Hitoshi, Y. Okano, and T. Miyata

 

Arzneim.-Forsch. / Drug Res. 32 (1), Nr. 4 (1982)

 

From the Department of Chemico-Pharmacology. Faculty of

Pharmaceutical Sciences, Kumamoto University, Kumamoto (Japan)

 

Summary: Using our new method described in a preceding paper, in

vivo effects of two proteolytic enzymes such as serrapeptase and

seaprose (SAP) on sputa collected from bronchitis rabbits were

examined. Serrapeptase (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 serrapeptase 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.

 

Key words: Bromhexine • Bronchitis • Mucolytic expectorants •

Proteolytic enzymes • Seaprose • serrapeptase

 

1. Introduction

 

In this previous paper [1], we reported a new method which seems to

be applicable to examine the in vivo effect of mucolytic

expectorants. By the use of this method, the expectorant effect of a

drug can be evaluated from the changes in both quantity and quality

of sputa, which were quantitatively collected from the rabbits

suffering from subacute bronchitis caused by long-term exposure to

SO2 gas. The purpose of the present study is to ascertain whether

this method is well applicable to the evaluation of mucolytic

expectorant effect of the reference drugs as was expected, whose

clinical efficacy was already well established. Two proteolytic

enzymes, serrapeptase and seaprose, were chosen for such a purpose.

Though their chemical properties differ, both enzymes have so far

been used as the effective mucolytics in the treatment of various

disorders related to viscous sputum or pus, and their efficacies

have been war-ranted to be more potent and reliable than those of a-

chymotrypsin and others. Therefore, they have widely been used not

only in Japan but also in. some other countries. Nevertheless, the

pharmacological evidence which sub-stantiates their clinical

efficacies, in particular, mucolytic expectorant effect, is

insufficient, though they exhibit potent mucolytic activity in in

vitro experiments [2, 3]. Bromhexine, a representative of the

expectorants, was used as a control drug, because its mechanism of

action is quite different from that of proteolytic enzyme, that is,

it does not exhibit in vitro mucolytic activity and its main effect

is known only by the increase in the volume of respiratory tract

fluid (RTF) when it was examined by Perry and Boyd's method [4-7]

using normal healthy rabbits. Further pharmacological study, for

instance, the acting mechanism of mucolytic expectorant effect of

intraduodenally administered enzymes will be described in the

subsequent paper.

 

2. Materials and methods

 

2.1. Animals and drugs

 

Male rabbits of New Zealand White-strain, weighing 1.8 to 2.5 kg,

were used. Serrapeptase (Danzen*, hereafter abbreviated as SER), a

proteolytic enzyme (endopeptidase) prepared from the culture broth

of. genus Serratia sp. E-15 (one of enteric bacilli in silkworm)

which comes as grayish powder, was provided

 

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Evaluation of Serratia Peptidase in Acute or Chronic Inflammation of

Otorhinolaryngology Pathology: a Multicentre, Double-blind,

Randomized Trial versus Placebo

 

A. Mazzone1, M. Catalan2, M. Costanzo3, A. Drusian4, A. Mandol5, S.

Russo6, E. Guarini7 and G. Vesperini8

 

 

1Institute of Clinical Otorhinolaryngology, University of Naples,

Naples, Italy;

2Ear, Nose and Throat Department, 'Gradenigo' Hospital, Turin,

Italy;

3Ear, Nose and Throat Department, 'Villa Sofia' Hospital, Palermo,

Italy;

4Ear Nose and Throat Department, Treviso Regional Hospital, Treviso,

Italy;

5Ear, Nose and Throat Department, 'E. Fornaroli' Hospital, Magenta,

Italy;

6Ear, Nose and Throat Department, Lucca Hospital, Lucca, Italy;

7Ear, Nose and Throat Department, Civil Hospital, Lecce, Italy;

8Ear, Nose and Throat Department, 'Madonna del Soccorso' Hospital,

San Benedetto del Tronto, Italy

 

 

The efficacy and tolerability of Serratia peptidase were evaluated

in a multi-centre, 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

peptidase-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 peptidase against all

the symptoms examined at both stages. Tolerance was found to be very

good and similar for both groups. It is concluded that Serratia

peptidase has anti-inflapimatory, anti-edemic and fibrinolytic

activity and acts rapidly on localized inflammation.

 

Received for publication 2 January 1990; accepted 16 January 1990.

 

Address for correspondence: A. Mazzone, MD, Institute of Clinical

Otorhinolaryngology, University of Naples, Via Pansini 5, 80131

Naples, Italy.

 

 

INTRODUCTION

The use of enzymes with fibrinolytic, I proteolytic and anti-edemic

activities has gained increasing support in recent years for the

treatment of inflammatory ear, nose and throat (ENT) conditions1.

Included among these enzymes is the Serratia peptidase (Danzen® ), a

protease obtained from non-pathogenic enterobacteria of the genus

Serratia. This proteolytic enzyme, which is available in tablet form

to enable it to be absorbed from the intestinal lumen, has been

shown lo induce intense fibrinolytic. anti-inflammatory, and anti-

edemic activity in a number of tissues and results suggest that its

anti-inflammatory activity may be of particular use for the

treatment of localized or 'closed' forms of inflammation, such as

those frequently found in ENT pathologies.' ^ Another important

feature of Serratia peptidase is its effect on pain, the enzyme

acting by inhibiting the release of pain-inducing amines, such as

bradykinin, from inflammed tissue.1.7

 

This peptidase induces fragmentation offibrinose aggregates and

reduces the viscosity of exudates, " ^ thus facilitating the drainage

of these products of the inflammatory response and thereby promoting

the tissue repair process, and clinical trials have confirmed that

the use of Serratia peptidase resulted in fast resolution of the

inflammatory process. " ~ '° The aim of the present placebo-

controlled multicentre study was to evaluate the efficacy and

tolerability of the Serratia peptidase in the treatment of ENT

inflammatory conditions.

 

PATIENTS AND METHODS

 

Patients

 

Patients, who were recruited from ENT clinics throughout Italy, were

all suffering from inherent acute or chronic inflammatory

conditions. Any patients with serious concomitant conditions, such

as severe renal and/or hepatic impairments, or who required

additional drugs were excluded from the tnal, as this could

interfere with evaluation of the parameters under examination, and

the use of steroids, non-steroidal anti-inflammatory drugs and/or

anti-inflammatory/analgesic agents was prohibited. Antibiotics were

permitted when deemed necessary.

 

Treatment

 

Indistinguishable tablets containing 5 mg Serratia peptidase or a

placebo were provided in blister packs and patients were randomly

assigned to receive two tablets of either drug, which they were

instructed to take three times daily after meals for 7 -8 days.

 

Evaluation of treatment

Clinical signs and symptoms were assessed on days 0, 3-4 and 7-8 of

treatment on a scale of O-3 (0, absence of the symptoms: 3, maximum

severity). Clinical parameters recorded were as follows: pain;

quantity of secretion; difficulty in swallowing; nasal obstruction;

anosmia; and body temperature. The appearance of the secretion was

also recorded on a scale ofO-3 (0, normal; I, mucoid; 2,

mucopurulent: 3, purulent). All evaluations were performed by an ENT

specialist unaware of the treatment given.

 

Evaluation of tolerability

Tolerability of Serralia peptidase was evaluated on the basis of the

presence, absence or severity of side-effects, recorded on the

patients' data-collecting forms.

 

Statistical analysis

All data were analysed by the most appropriate statistical tests (^-

test and Student's f-test).

 

RESULTS

 

A total of 193 subjects (96 males, 97 females), aged between 12 and

77 years (mean ± SD 38 ± 15.7 years), with acute or chronic ENT

pathologies were recruited to the trial. Of these 193 cases, 97 (43

males, 54 females; mean ± SD 37.3 ± 15.2 years) were placed in group

A and 96 (53

 

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The treatment of breast engorgement with Serrapeptase (Danzen): a

randomised double-blind controlled trial.

 

Kee WH, Tan SL, Lee V, Salmon YM.

 

Singapore Med J 1989 Feb;30(1):48-54

 

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 (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 Danzen

(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 (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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A multi-centre, double-blind study of serrapeptase versus placebo in

post-antrotomy buccal swelling.

 

Tachibana M, Mizukoshi O, Harada Y, Kawamoto K, Nakai Y.

 

Pharmatherapeutica 1984;3(8):526-30

 

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.