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Serrapeptase ~ Insect-Derived Enzyme Fights Inflammation 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 Serrapeptase 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 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)
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.
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) 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)
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 ,19)
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.(25,10) 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.(24) 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.(22)
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.(24)
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.
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. Marriott C. Modification in the rheological properties of mucus by drugs. Adv Exp Med Biol. 1982; 144:75-84. 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. 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. 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. 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. 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. Brewer Science Library website. 1999. 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. 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.
A preliminary trial of serrapeptase in patients with carpal tunnel syndrome. 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. Proteolytic enzymes: a new treatment strategy for prosthetic infections? 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. A New Method for Evaluating Mucolytic Expectorant Activity and its Application II. Application to two proteolytic enzymes, serrapeptase and seaprose* 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 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 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, 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 The treatment of breast engorgement with Serrapeptase (Danzen): a randomised double-blind controlled trial. A multi-centre, double-blind study of serrapeptase versus placebo in post-antrotomy buccal swelling.
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