No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
A multi-centre, double-blind study of serrapeptase versus placebo in post-antrotomy buccal swelling
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 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.
... [9] In maxillary sinus antrotomy, serratiopeptidase is said to significantly reduce buccal swelling. [10] Al-Sandook et al. [11] clinically evaluated the efficacy of orthalforte (prolytic enzymes, trypsin and chymotrypsin) on postoperative sequel following the removal of lower impacted third molar. ...
... The effectiveness of bromelain in reducing swelling and pain after surgical removal of third molars was assessed in Tachibana et al. [10] and it was concluded that 28 patients (70%) had reduced swelling and pain after consuming bromelain. Singh et al. [9] studied the ability of serrapeptase to decrease the postoperative swelling, trismus, and pain after third molar impaction surgery. ...
... Singh et al. [9] studied the ability of serrapeptase to decrease the postoperative swelling, trismus, and pain after third molar impaction surgery. But, our paper has compared two proteolytic enzymes [9,10] from different origin, and to prove which enzyme provides a faster healing. One of the proteolytic enzymes involves a combination with a flavonoid. ...
Objective:
The postoperative symptoms after third molar removal surgery were commonly uneventful. The aim of this study was to compare two proteolytic enzymes from different origin and to prove which enzyme provides a faster healing. One of the proteolytic enzymes involves a combination with a flavonoid. This involves trypsin, bromelain, along with a flavonoid rutin. Another proteolytic enzyme is serratiopeptidase that helps in degradation of insoluble proteins causing reduced swelling in the operated site.
Materials and methods:
In this study, voluntary subjects of clinically indicated bilateral lower third impaction were selected. The subjects were recommended to undergo extraction of impacted teeth in two sittings, one extraction per visit. In the first sitting, subjects were prescribed trypsin, bromelain, and rutin combination after removal of 48 teeth and in the second sitting subjects were prescribed serratiopeptidase after removal of 38 teeth. There was a time interval of 2-3 weeks in between the sittings. The post findings such as mouth opening, swelling, and pain scale were noted.
Results:
The results showed that the proteolytic enzyme combination of trypsin, bromelain, and rutin is better than serratiopeptidase.
Conclusion:
It is recommended that trypsin, bromelain, and rutin combination can be used effectively for postoperative purpose to facilitate wound healing.
... It is produced in the intestines of silkworms to break down cocoon walls 13 . This enzyme has been used as an alternative to analgesics and nonsteroidal anti-inflammatory agents [13][14][15] and also has been used to treat chronic sinusitis and postoperative inflammation [16][17][18][19] . The enzyme is believed to induce degradation of insoluble protein products like fibrin, biofilm, and inflammatory mediators. ...
... Nevertheless, the influence of the enzyme on other periarticular tissues and on long-term implant fixation would still need to be tested in experimental studies. Several studies that have investigated the systemic use of serratiopeptidase have demonstrated no adverse effects 14,[16][17][18]22,33 , but there have been two case reports in which serratiopeptidase induced complications 36,37 . In one of those reports, pruritic I on August 23, 2006 www.ejbjs.org ...
Infection around an implanted orthopaedic device is a devastating complication, and the treatment of infections involving slime-forming bacteria is especially difficult. The purpose of the present study was to evaluate the effectiveness of a proteolytic enzyme, serratiopeptidase, in the eradication of a periprosthetic infection in an in vivo animal model.
In sixty Sprague-Dawley rats, the medullary canal of the right femur was drilled through the intercondylar notch and was inoculated with a Staphylococcus epidermidis strain (ATCC 35984) with a high slime-producing capacity. The cavity was filled with polymethylmethacrylate cement, and a Kirschner wire that had contact with the knee joint was inserted. None of the animals received any treatment for two weeks. Twenty rats were killed at two weeks after the inoculation in order to determine if the infection had become established. The remaining forty rats were randomized into two groups. One group received serratiopeptidase enzyme injections into the knee joint in addition to antibiotic therapy for four weeks, and the other group received intra-articular saline solution injections together with the same antibiotic therapy. The animals from both groups were killed two weeks after the end of therapy (on Day 56). The knee specimens were evaluated bacteriologically and histologically to determine the prevalence of persistent infection and the effects of the enzyme on local tissue.
At two weeks, inoculated bacteria grew on culture of specimens from twelve (63.2%) of nineteen animals in the no-treatment group. Microbiological testing suggested that infection persisted in only one (5.6%) of eighteen animals in the serratiopeptidase-and-antibiotic group, whereas it was present in six (37.5%) of sixteen animals in the antibiotic-only group (p = 0.001). Histological evaluation showed similar results (kappa = 0.92).
Serratiopeptidase was effective for eradicating infection caused by biofilm-forming bacteria in this experimental animal model. The antibiofilm property of the enzyme may enhance antibiotic efficacy in the treatment of staphylococcal infections.
... It also reduces the viscosity of exudates, facilitates drainage and alleviates pain by inhibiting the release of bradykinin, a pain-inducing amine 12 . Serrapeptase was shown to significantly reduce the amount of buccal swelling after maxillary sinus antrotomy 23 , and ESCH et al. 5 demonstrated that serrapeptase is an effective preparation for the reduction of postoperative swelling of the ankle joint. Serrapeptase has also been used for the treatment of a number of inflammatory conditions 3,10,18,19 . ...
... Several studies investigating the systemic use of serrapeptase have demonstrated no adverse effects 3,5,10,12,13,15,16,18,19,21,23 . In this study the drug was very well tolerated by all patients, and none of them reported any untoward reaction. ...
The aim of this study was to investigate the ability of serrapeptase to reduce postoperative swelling, pain and trismus after third molar surgery. Twenty-four healthy individuals with symmetrically impacted mandibular third molars underwent surgical removal in a prospective, intra-individual, randomized, double-blind, cross-over study. Teeth were removed in 2 sessions by the same surgeon. At each session, one third molar was removed under local anaesthesia via a buccal osteotomy. All patients received a combination of either serrapeptase 5mg or placebo tablets and 1000 mg paracetamol tablets at either the 1st or 2nd operation in accordance with the randomization plan. Cheek thickness, pain and interincisal distance were measured preoperatively, and on the 1st, 2nd, 3rd and 7th postoperative days. Cheek thickness and maximum interincisal distance were measured using calipers. Pain intensity was assessed clinically using a numeric scale. There was a significant reduction in the extent of cheek swelling and pain intensity in the serrapeptase group at the 2nd, 3rd and 7th postoperative days (P<0.05), but no significant difference in mean maximal interincisal distance was found between the 2 groups (P>0.05).
... Serrapeptase (SPT) is a metalloprotease discovered in the Gram-negative bacterium Serratia marcescens (Miyata et al. 1970). Multiple beneficial properties have been attributed to SPT, namely anti-inflammatory, analgesic (Tachibana et al. 1984;Nakamura et al. 2003;Al-Khateeb and Nusair 2008), anti-amyloid (Fadl et al. 2013;Metkar et al. 2017Metkar et al. , 2020 and anti-biofilm properties (Longhi et al. 2008;Artini et al. 2011;Papa et al. 2013;Selan et al. 2015Selan et al. , 2017Zapotoczna et al. 2015;Tsitsa et al. 2016). SPT is a promising agent for pharmaceutical applications, as it is non-toxic for animal cells (Chopra et al. 2009;Papa et al. 2013;Selan et al. 2017). ...
Pseudomonas aeruginosa is an emerging threat for hospitalized and cystic fibrosis patients. Biofilm, a microbial community embedded in extracellular polymeric substance, fortifies bacteria against the immune system. In biofilms, the expression of functional amyloids is linked with highly aggregative, multi-resistant strains, and chronic infections. Serrapeptase (SPT), a protease possessing similar or superior anti-microbial properties with many antibiotics, presents anti-amyloid potential. However, studies on the employment of SPT against Pseudomonas biofilms and Fap amyloid, or the possible mechanisms of action are scarce. Here, SPT inhibited biofilm formation of P. aeruginosa ATCC 27853 on both plastic and glass surfaces, with an IC50 of 11.26 µg/mL and 0.27 µg/mL, respectively. The inhibitory effect of SPT on biofilm was also verified with optical microscopy of crystal violet-stained biofilms and with confocal microscopy. Additionally, SPT caused a dose-dependent decrease of bacterial viability (IC50 of 3.07 µg/mL) as demonstrated by MTT assay. Reduction of bacterial functional amyloids was also demonstrated, employing both fluorescence microscopy with thioflavin T and photometrical determination of Congo-red-positive compounds. Both viability and functional amyloids correlated significantly with biofilm inhibition. Finally, in silico molecular docking studies provided a mechanistic insight into the interaction of SPT with FapC or FapD, proving that both peptides are possible targets of SPT. These results offer new insights into the biofilm formation of P. aeruginosa and potentiate the involvement of SPT in the prevention and eradication of Pseudomonas biofilms.
Graphical abstract
Key points
• Serrapeptase inhibits biofilm formation of P. aeruginosa on plastic and glass.
• Biofilm inhibition correlated with reduced viability and functional amyloid levels.
• In silico studies indicated that serrapeptase may target FapC and FapD peptides.
... Serrapeptase (SPT), commonly also known as serratiopeptidase, is a metalloprotease first isolated from the Gram-positive bacterium Serratia marcescens (Miyata et al. 1970;Jadhav et al. 2020). Since its discovery, SPT is widely studied for its anti-inflammatory, analgesic (Tachibana et al. 1984;Nakamura et al. 2003;Al-Khateeb and Nusair 2008), anti-amyloid (Fadl et al. 2013;Metkar et al. 2017Metkar et al. , 2020, and anti-biofilm (Longhi et al. 2008;Artini et al. 2011;Papa et al. 2013;Selan et al. 2015;Zapotoczna et al. 2015;Tsitsa et al. 2016;Selan et al. 2017) properties. SPT is tolerable and non-toxic for animal cells (Chopra et al. 2009;Papa et al. 2013;Selan et al. 2017), and several formulations (nanoparticles, liposomes, gels, etc.) have been designed to improve its delivery, bioavailability, and activity (KV et al. 2008;Shinde and Kanojiya 2014;Devlin et al. 2021). ...
Staphylococcus aureus biofilms are implicated in hospital infections due to elevated antibiotic and host immune system resistance. Molecular components of cell wall including amyloid proteins, peptidoglycans (PGs), and lipoteichoic acid (LTA) are crucial for biofilm formation and tolerance of methicillin-resistant S. aureus (MRSA). Significance of alkaline phosphatases (ALPs) for biofilm formation has been recorded. Serrapeptase (SPT), a protease of Serratia marcescens , possesses antimicrobial properties similar or superior to those of many antibiotics. In the present study, SPT anti-biofilm activity was demonstrated against S. aureus (ATCC 25923, methicillin-susceptible strain, methicillin-susceptible S. aureus (MSSA)) and MRSA (ST80), with IC 50 values of 0.67 μg/mL and 7.70 μg/mL, respectively. SPT affected bacterial viability, causing a maximum inhibition of − 46% and − 27%, respectively. Decreased PGs content at [SPT] ≥ 0.5 μg/mL and ≥ 8 μg/mL was verified for MSSA and MRSA, respectively. In MSSA, LTA levels decreased significantly (up to − 40%) at lower SPT doses but increased at the highest dose of 2 μg/mL, a counter to spectacularly increased cellular and secreted LTA levels in MRSA. SPT also reduced amyloids of both strains. Additionally, intracellular ALP activity decreased in both MSSA and MRSA (up to − 85% and − 89%, respectively), while extracellular activity increased up to + 482% in MSSA and + 267% in MRSA. Altered levels of DING proteins, which are involved in phosphate metabolism, in SPT-treated bacteria, were also demonstrated here, implying impaired phosphorus homeostasis. The differential alterations in the studied molecular aspects underline the differences between MSSA and MRSA and offer new insights in the treatment of resistant bacterial biofilms.
Key points
• SPT inhibits biofilm formation in methicillin-resistant and methicillin-susceptible S. aureus.
• SPT treatment decreases bacterial viability, ALP activity, and cell wall composition.
• SPT-treated bacteria present altered levels of phosphate-related DING proteins.
Graphical Abstract
... Serratiopeptidase enzyme reduces the inflammatory responses and their subsequent arrest of producing inflammatory mediators by absorbing the disintegrated bi-products and major products in blood and lymphatics. The Serratiopeptidase enzyme acts as a prosthetic group with any metals such as manganese and zinc, for the efficient treatment to acute, sub-acute/sub-chronic, and chronic inflammatory disorders [3]. Also, the Serratiopeptidase enzyme is more efficient when it acts as a prosthetic group and their subsequent addition of metal ions [2,4]. ...
Serratiopeptidase is a proteolytic enzyme which finds implications as an inflammation reducing factor. The present study shows that the enzyme does not bind with LOX and not able to block lipoxygenase (LOX)-catalyzed SPMs (specialized pro-resolving mediators) biosynthesis, thereby offering no impediment in the natural resolution of inflammation, instead aiding in it. Prior to start the procedural input, the medium was selected and optimized using Plackett–Burman Design with 5 variables and 3 dummies for 12 runs. Based on Plackett-Bruman results, one variable at a time (OVAT) method was carried out for soy bean flour (defatted) and peptone which were studied to be the major components affecting the yield. Serratiopeptidase was produced at 5.0–6.0 g/L by shake flask level compared with 2.0–3.0 g/L with basal medium. In case of fermentation, adding specific feeding solutions helped in achieving maximum yield of more than 17 g/L. Study of feeding pattern of soy bean oil and ammonia solutions in order to keep a track of the growth phases, pH effects, and consequently the yield of Serratiopeptidase has well corroborated the consideration of optimized product yield, considering the conditions for the settling down of mass, filtration rate and temperature profile for drying of Serratiopeptidase.
Graphical abstract
... A prospective study on serratiopeptidase for reduction of postoperative swelling after upper ankle joint surgery was conducted, and it was concluded that significant reduction in swelling was achieved with the use of serratiopeptidase. [19] Another trial was conducted to investigate the clinical efficacy of the anti-inflammatory enzyme preparation, serratiopeptidase in patients who underwent Caldwell-Luc-antrostomy for chronic empyema and concluded that swelling was smaller in size in the serratiopeptidase treated group than in the placebo-treated group. [20] Serratiopeptidase was the other drug, which was compared with dexamethasone for its efficacy to control postoperative edema. ...
... Methylcobalamin, Acetyl-L-Carnitine, N-Acetyl Cysteine, Vitamin D, and Curcumin improve nerve regeneration in a number of conditions including nerve injuries (crush), nerve repair after transection and neuropathic conditions such as diabetes . Curcumin, Bromelain, and Serratopeptidase decrease the inflammatory response and have demonstrated improved recovery after surgery with less pain and earlier return to activity [61][62][63][64][65][66][67][68][69][70][71][72][73]. ...
... Similar observations have been made on serratiopeptidase by Aso et al [19] in 1981 on 70 patients of fibrocystic breast disease and concluded serratiopeptidase to be superior to placebo for breast pain, swelling and induration. Another trial by Tachibana M et al [20] in 1984 also concludes the efficacy of serratiopeptidase as anti-inflammatory enzyme. Esch et al [21]conducted a double blind study to determine the effect of serratiopeptidase on postoperative swelling and pain in 66 patients who were treated for rupture of knee ligament. ...
The aim of this study was to evaluate and compare the efficacy and safety of serratiopeptidase and aceclofenac in reducing swelling and pain following soft tissue injury. This study included 100 patients with soft tissue injury to upper limb, lower limb or both. They were randomly divided into two groups of 50 each to receive serratiopeptidase and aceclofenac. Evaluation of efficacy was made using tape measurement (for swelling), and visual analogue scale (for pain) on day 0, week 1and week 2. Serratiopeptidase showed significant anti-inflammatory effect and mild analgesic effect. None of the patient was required to be put on another analgesic or any alteration in treatment. Aceclofenac showed superior analgesic effect as compared to serratiopeptidase. Mild to moderate adverse effects were reported. The most common adverse effect reported was dyspepsia. All were mild and did not require any alteration or discontinuation of treatment.
... Serratiopeptidase is a natural molecule that is being used for decades, hence commonly considered as safe. The safety of this enzyme in different areas of therapeutics is supported by several studies [15,19,22,48,54,72] in which no side effects or adverse events were reported. However, some studies have reported adverse effects of this molecule, but at a rare frequency. ...
Therapeutic applications of enzymes have been widely accepted in clinical practices for decades. Proteolytic enzymes in particular, have been used for the treatment of diseases and disorders. Serratiopeptidase is a proteolytic enzyme having immense applications in therapeutic areas which have been validated by several in vitro, in vivo, and clinical studies as well as through anecdotal evidences. These applications are attributable to its versatile properties including anti-inflammatory, anti-biofilm, analgesic, anti-edemic, and fibrinolytic effects. The significant impact of serratiopeptidase reported needs to be backed by more scientific data. This review encompasses the details of therapeutic applications of serratiopeptidase based on available in vitro, in vivo, and clinical studies. We found some strong evidences regarding the efficacy of serratiopeptidase. However data on safety, tolerability, and its mechanism of action need detailing. This review aims to further explore the available literature on serratiopeptidase as well as provide scientific details for existing applications.
... A prospective study on serratiopeptidase for reduction of postoperative swelling after upper ankle joint surgery was conducted, and it was concluded that significant reduction in swelling was achieved with the use of serratiopeptidase. [19] Another trial was conducted to investigate the clinical efficacy of the anti-inflammatory enzyme preparation, serratiopeptidase in patients who underwent Caldwell-Luc-antrostomy for chronic empyema and concluded that swelling was smaller in size in the serratiopeptidase treated group than in the placebo-treated group. [20] Serratiopeptidase was the other drug, which was compared with dexamethasone for its efficacy to control postoperative edema. ...
Comparision and Evaluation two class of drugs, Dexamethasone, a Steroid and Serratiopeptidase, an Enzyme in reduction of postoperative swelling after Oral Surgical Procedure
... A prospective study on serratiopeptidase for reduction of postoperative swelling after upper ankle joint surgery was conducted, and it was concluded that significant reduction in swelling was achieved with the use of serratiopeptidase. [19] Another trial was conducted to investigate the clinical efficacy of the anti-inflammatory enzyme preparation, serratiopeptidase in patients who underwent Caldwell-Luc-antrostomy for chronic empyema and concluded that swelling was smaller in size in the serratiopeptidase treated group than in the placebo-treated group. [20] Serratiopeptidase was the other drug, which was compared with dexamethasone for its efficacy to control postoperative edema. ...
Aim:
The present study is designed to evaluate and compare the ability of serratiopeptidase and dexamethasone to control edema following the surgical removal of mandibular third molar.
Materials and methods:
Two drugs, dexamethasone and serratiopeptidase, were compared for its efficacy in reducing the postoperative swelling. A total of 100 patients requiring the surgical removal of impacted mandibular third molar were randomly divided into two groups, consisting of 50 patients each. One group was administered 1 mg dexamethasone, one-half h preoperatively and every 8th hourly for 3 days postoperatively. The other group was given 10 mg serratiopeptidase every 8th hourly for 3 days postoperatively. The swelling was measured on 1st, 2nd, 5th, and 7th postoperative days. The results of this study showed that serratiopeptidase was effective in reducing swelling from 2nd to 5th postoperative day, and dexamethasone was effective in reducing swelling from 1st to 2nd postoperative day, further, it also reduced the swelling from 2nd to 5th postoperative day.
Results:
There was highly significant difference in the facial measurement between serratiopeptidase and dexamethasone group on postoperative day 2 (the mean difference was 62.5 with P < 0.001) and statistically significant difference on postoperative day 1, day 5, and day 7 (P < 0.01).
Conclusion:
It can be concluded that serratiopeptidase, a proteolytic enzyme and dexamethasone, a long-acting corticosteroid was effective in reducing the swelling, but dexamethasone was more effective than serratiopeptidase in reducing the swelling.
... 10 Dex is being used commonly in various specialties like surgery, anesthesiology, critical care medicine, neurosurgery, and dentistry for its anti-inflammatory and sedative effects. [11][12][13][14] Intravenous injection is the standard method of Dex administration. 10,15 However, studies have shown that intranasal inhalation of Dex can also produce good sedative effects, and the drug is widely used for general anesthesia induction in children. ...
Objective
The focus of this meta-analysis was to assess the sedative effect and safety of intranasal dexmedetomidine (Dex) in mandibular third molar surgery.
Methods
The PubMed/Medline, Web of Science, Cochrane Library, and China National Knowledge Infrastructure databases were searched for studies published until May 1, 2018. Eligible studies were restricted to randomized controlled trials (RCTs) and controlled clinical trials. The evaluation indicators mainly included the bispectral index, observer assessment of alertness/sedation scale, systolic blood pressure, and heart rate. Data for each period in the Dex and control groups were pooled to evaluate its sedative effect and safety.
Results
Five RCTs met the inclusion criteria. This study included 363 patients: 158 patients received intranasal inhalation of Dex before surgery, and 158 patients were negative controls. The pooled results showed a good sedative effect during tooth extraction when intranasal inhalation of Dex was performed 30 minutes before third molar extraction (assessment of alertness/sedation, Dex vs control SMD −1.20, 95% CI −1.73 to −0.67, I²=0, P=0.95; bispectral index, Dex vs control SMD −11.68, 95% CI −19.49 to −3.87, I²=89%; P=0.0001), and parameters returned to normal within 90 minutes after inhalation. During the operation, blood pressure and heart rate decreased to some extent, but the decreases did not exceed 20% of the baseline, and all patients returned to normal conditions within 90 minutes after inhalation.
Conclusion
Intranasal inhalation of Dex 30 minutes before third molar extraction can provide a good sedative effect, and large-sample multicenter RCTs are needed to evaluate the analgesic effect of Dex.
... Garg et al. [53] evaluated and compared the efficacy and safety of serratiopeptidase and aceclofenac in reducing swelling and pain following traumatic soft tissue injury. Serratiopeptidase showed significant anti-inflammatory effect with mild analgesic action, whereas aceclofenac exhibited superior analgesic effect as compared to serratiopeptidase. ...
Serratiopeptidase, a proteolytic enzyme derived from Serratia E-15 species enterobacteria, is widely used in medical field for its anti-inflammatory, anti-edemic properties, and analgesic properties. It is being used commonly in various specialties such as orthopedics, otolaryngology, gynecology, surgery, pulmonology, ophthalmology, and dentistry. Research has shown that serratiopeptidase is the most effective anti-inflammatory agent compared to other enzyme preparations. This article reviews the efficacy, safety, and applications of serratiopeptidase in oral surgery. This article also discusses the mechanism of action of serratiopeptidase, its contraindications and complications. From the recently published literature, it is clear that the role of serratiopeptidase as a therapeutic agent in oral and maxillofacial surgery is expanding and they hold a promising future as a broad-spectrum anti-inflammatory drug with minimal side effects and complications. Further, research will broaden their applications in the field of medicine and dentistry.
... First, published trials evaluating the efficacy of serratiopeptidase were few and generally of poor methodological quality with mostly placebo-controlled trials. [23,[27][28][29][30] Similar findings have been reported in an earlier review which reported that in several studies, there was no mention of the dose and duration of treatment, and in few even the outcome of the study was not clearly defined. [6,28,31,32] Second, the availability of serratiopeptidase preparations in the strengths of 2.5 and 50 mg is not understandable when the recommended daily dose is 30 mg. ...
Background and Objectives: Serratiopeptidase is available as an oral preparation. The effectiveness of this enzymatic preparation is questionable. Despite this fact, serratiopeptidase is prescribed for a variety of inflammatory conditions. The study was conducted to determine the availability, cost and rationality of serratiopeptidase preparations available in Indian market. Materials and Methods: Serratiopeptidase preparations were assessed for total number, composition, strength and cost. Data were collected from ‘The Drug Today’ of the years 2009 (October–December) and 2015 (April–June). The rationality of preparations was assessed on validated 6-point scoring criteria. An extensive literature search was made using evidence-based print and electronic databases for the studies on efficacy and safety of serratiopeptidase. Results: A total of 642 serratiopeptidase preparations were available in the year 2009, which increased to 647 in 2015. Eighty percent preparations were fixed-dose combinations (FDCs) with either non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, muscle relaxants or miscellaneous drugs. Of all FDCs, 96% preparations were combinations with one or more NSAIDs. Single drug preparations showed a decline from 19.9 to 12.3%. Serratiopeptidase was available in strengths from 2.5 to 50 mg. The cost of 10 mg dose of serratiopeptidase preparations ranged between Rs. 1.35 and Rs. 8.16. The cost of FDCs was more than that of single non-serratiopeptidase agent. FDCs scored poorly on rationality assessment scale in both years, and an increase in irrational preparations was observed. Conclusion: Too many serratiopeptidase preparations are available. Evidence on their efficacy and safety is lacking. The rationality of available FDCs of serratiopeptidase is poor. The availability of expensive FDCs of unknown efficacy and safety is an important contributory factor for the irrational use of drugs.
... It can also modify the cell adhesion molecules that are involved in guiding inflammatory cells to the site of infection (Klein and Kullich, 2000). It is orally effective in treating inflammation caused by laryngitis, catarrhal rhino-pharyngitis, sinusitis, breast engorgement, carpal tunnel syndrome, inflammation in prostate gland, acute and chronic ear-nose-throat disease, and chronic emphysema (Tachibana et al., 1984;Vicari et al., 2005;UmaMaheswari et al., 2016). ...
Background
Serrapeptase is a proteolytic enzyme with many favorable biological properties like anti-inflammatory, analgesic, anti-bacterial, fibrinolytic properties and hence, is widely used in clinical practice for the treatment of many diseases. Although Serrapeptase is widely used, there are very few published papers and the information available about the enzyme is very meagre. Hence this review article compiles all the information about this important enzyme Serrapeptase. MethodsA literature search against various databases and search engines like PubMed, SpringerLink, Scopus etc. was performed. ResultsWe gathered and highlight all the published information regarding the molecular aspects, properties, sources, production, purification, detection, optimizing yield, immobilization, clinical studies, pharmacology, interaction studies, formulation, dosage and safety of the enzyme Serrapeptase. Conclusion
Serrapeptase is used in many clinical studies against various diseases for its anti-inflammatory, fibrinolytic and analgesic effects. There is insufficient data regarding the safety of the enzyme as a health supplement. Data about the antiatherosclerotic activity, safety, tolerability, efficacy and mechanism of action of the Serrapeptase are still required.
... New research on this novel enzyme demonstrates its efficacy for treating several disease states. Studies on serrapeptase have focused on its use for treating chronic lung disease; ear, nose, and throat disorders; carpal tunnel syndrome; and edema following injury and surgery (Tachibana et al. 1984;Esch et al. 1989;Mazzone et al. 1990;Nakamura et al. 2003). ...
... S. marcescens strain SRM (MTCC 8708) used in this study was isolated from the flowers of summer squash plants, showing no apparent symptoms of yellow vine disease. Application of Spep as pharmaceutical and insecticidal agent was well studied (8,9,10) . Therefore, the large scale production of Spep is significant for the commercial purpose. ...
Keywords: Serratia marcescens, Pichia pastoris, Serratiopeptidase, cloning, purification, Mass spectroscopy. Serrapeptidase (Spep) produced from Serratia marcescens is a secretary protein devoid of signal peptide. Spep was over expressed in E.Coli as inclusion bodies however the purified fusion protein was enzymatically inactive. To achieve the production of active Spep, in this study, the gene corresponding to Spep (Accession No. KP869847) from the genomic DNA of Serratia marcescens MTCC 8707 was cloned into Pichia pastoris using a modified transfer vector. The expression was induced with methanol and the secreted protein was affinity purified. The yield of the recombinant protein was 0.06 mg/ml with a maximum activity of 30 U/ml. An optimum activity of recombinant Spep was observed at 30oC and pH 8.0. The molecular weight of the purified mature active recombinant protein was 52 kDa. The secreted protein was characterized by mass spectrometric analyses using LC/MS-MS. To the best of our knowledge this is the first report on the production of active form of Spep from S.marcescens of plant origin. This protein may be exploited for the pharmaceutical and insecticidal application.
... Further, enzyme promotes wound healing and repair and restores the skin temperature of the inflamed area, burn or trauma to normal. The activity of serratiopeptidase remains stable and offer more efficiency in combination with the addition of metal ions like zinc and manganese [51]. Serratiopeptidase has been shown to be absorbed from the digestive tract. ...
Inflammation remains key event during most of the diseases and physiological imbalance. Acute inflammation defines protective measure by immune system to remove cause and failure of resolution lead to chronic inflammation. Over a period of time, numbers of drugs mostly chemical have been deployed to combat acute and chronic inflammation. In the recent time enzyme based anti-inflammatory, drugs became popular over conventional chemical based. Serratiopeptidase a proteolytic enzyme from trypsin family possess tremendous scope in combating inflammation. Serine protease possesses a higher affinity for cyclooxygenase (COX-I and COX-II) a key enzyme associated with production of different inflammatory mediators including interleukins (IL), prostaglandins (PGs) and thromboxane (TXs) etc. Currently, arthritis, sinusitis, bronchitis, fibrocystic breast disease, and carpal tunnel syndrome, etc. are the leading inflammatory disorders affected entire the globe. In order to conquer inflammation, both acute and chronic world, physician mostly relies on conventional drugs. The most common drugs to combat acute inflammation are Nonsteroidal anti-inflammatory drugs (NSAIDs) alone and or in combination. However, during chronic inflammation, NSAIDs are often used with steroidal drugs such as autoimmune disorders (RA. These drugs possess several limitations such as side effect and ADR etc. In order to overcome these limitations and complications enzyme based drugs (anti-inflammatory) emerged and aiming a new high since last one decade. Serine protease, the largest proteolytic family has been reported for several therapeutic applications, including anti-inflammatory. Serratiopeptidase is a leading enzyme has a very long history in medical as an effective anti-inflammatory drug. Current study emphasizes present scenario and future prospect of serratiopeptidase as an anti-inflammatory drug. The study also illustrates a comparative analysis of conventional drugs and enzyme based therapeutic to combat inflammation.
... Methylcobalamin, Acetyl-L-Carnitine, N-Acetyl Cysteine, Vitamin D, and Curcumin improve nerve regeneration in a number of conditions including nerve injuries (crush), nerve repair after transection and neuropathic conditions such as diabetes. Curcumin, Bromelain, and Serratopeptidase decrease the inflammatory response and have demonstrated improved recovery after surgery with less pain and earlier return to activity[55][56][57][58][59][60][61][62][63][64][65][66][67]. ...
... Similar observations have been made on Serratiopeptidase by 30-31 on patients of fibrocystic breast disease and concluded that Serratiopeptidase to be superior to placebo for improvement of breast pain, swelling and induration. Another trial by 32 also who concluded the efficacy of Serratiopeptidase as an anti-inflammatory enzyme. 33 conducted a double blind study to determine the effect of Serratiopeptidase on postoperative swelling and pain in patients who were treated for rupture of knee ligament. ...
The aim of this study was to evaluate the effect of using graded levels of enzyme Serratiopeptidase, treatment on growth
performance, immune response and some blood parameters of broiler chickens. One hundred twenty 1-day-old broiler chicks were
randomly assigned to 4 treatment groups; each group included 3 replicates of 10 birds. Birds were treated as the following group (1)
birds were non infected and non treated used as control group. Group (2) birds were only infected with E. coli and Mycoplasma
gallisepticum (MG) at 14th day of age. While birds of group (3) were infected with E. coli and Mycoplasma gallisepticum (MG) at 14th
day of age and treated with Serrapeptase in drinking water at a dose of 2 g/liter for the first 3 days of each week. Group (4) birds
were infected with E. coli and Mycoplasma gallisepticum (MG) at 14th day of age and were treated with Serrapeptase in drinking
water at a dose of 1 g / liter for the first 3 days of each week. The results showed significant improvement in final body weight, body
gain and feed conversion of birds which was treated with Serrapeptase at 2g /liter drinking water. Similar trend was noted for the
effect of Serratiopeptidase on total serum proteins of infected chickens, Serratiopeptidase significantly corrected the total protein
from (6.86±0.11) in the infected non treated group to (7.88±0.17 and 7.81±0.15) in groups 3 and 4 respectively. Serratiopeptidase
significantly decreased the total cholesterol, serum LDH and the inflammatory markers tested (CRP and ESR). Serratiopeptidase
treatment improved the immunological response to NDV vaccination, and decreased the re-isolation and shedding of MG and E. coli
BACKGROUND: Serratiopeptidase is a proteolytic enzyme prescribed in various specialities like surgery, orthopaedics, otorhinolaryngology, gynaecology and dentistry for its anti-inflammatory, anti-edemic and analgesic effects. Some anecdotal reports suggest it to possess anti-atherosclerotic effects also, due to its fibrinolytic and caseinolytic properties. Despite being widely used there are few published studies regarding its efficacy. Thus, evidence regarding its clinical utility is needed. OBJECTIVE: To evaluate the existing evidence regarding efficacy and safety of Serratiopeptidase in clinical practice. EVIDENCE ACQUISITION: A systematic review of all the published articles of Serratiopeptidase using Cochrane Library, PubMed, MEDLINE, Clinical Trials.gov, Google, Dogpile and a manual search of bibliographies was conducted from 1st May 2011 till 15th July 2012. Further emails were sent to all the leading pharmaceuticals who are manufacturing this enzyme preparation for any additional information. All studies related to Serratiopeptidase which included Randomised controlled trials (RCTs), meta-analysis of RCTs, placebo-controlled, single-blind, double-blind, open label, prospective trials as well as preclinical studies were screened and analysed. The scientific credibility of the studies was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) grading checklist. A total of 24 studies on clinical efficacy of Serratiopeptidase met the inclusion criteria. EVIDENCE SYNTHESIS: Serratiopeptidase search on Cochrane library revealed 16 results among which 9 were Cochrane Central Register of Controlled Trials 2011, issue 4 studies and 7 were Cochrane Central Register of Controlled trials 2012, issue 3 studies. Of these 16 results, 11 were RCTs on efficacy of Serratiopeptidase. PubMed search also revealed 74 results which showed 16 Clinical trials, out of which 9 were RCTs related to Serratiopeptidase. Bandolier online edition (retrieved on 1/5/2011) showed a review 'Serratiopeptidase-finding the evidence' which included 9 RCTs. The evidence supporting the use of Serratiopeptidase as anti-inflammatory and analgesic agent is based on clinical studies which are of poor methodology. Only few RCTs, which are usually placebo control, with a small sample size are there. The dose and duration of treatment was not specified in some studies, and the outcome of the study was not clearly defined in a few. Data on the safety and tolerability of Serratiopeptidase is lacking in these studies. LIMITATIONS: A thorough search of literature was done to include all the relevant studies but we may have unknowingly missed a few of those studies which have not been published or registered with any of these search engines. The clinical evidence obtained have been graded according to the "Scottish Intercollegiate Grading Network" checklist by two separate reviewers and then coordinated together to give the final grading. Any disagreement between the two reviewers was resolved by discussion with the third reviewer. This was done to minimise bias but still the risk of bias cannot be completely ruled out. CONCLUSION: Serratiopeptidase is being used in many clinical specialities for its anti-inflammatory, antiedemic and analgesic effects. It is even being promoted as a health supplement to prevent cardiovascular morbidity. The existing scientific evidence for Serratiopeptidase is insufficient to support its use as an analgesic and health supplement. The data on long term safety of this enzyme is lacking. Evidence based recommendations on the analgesic, anti-atherosclerotic efficacy, safety and tolerability of Serratiopeptidase are needed.
Integrated practical and theoretical trends ▶ Describes fibrinolytic microbial enzymes for clinical applications ▶ Provides an outlook to future research Stress, high blood pressure, smoking, pollution, fast foods, overweight, excessive travelling, surgery, less movement are common features in our modern life. These features are risky for blood clotting disorders. According to WHO, over 29% of the total mortalities worldwide are due to thrombosis. By the year, 2020 cardiovascular diseases (CVDs) may cause an estimated 25 million deaths per year, thus antithrombotic therapy is of great interest. The available thrombolytic agents such as urokinase are highly expensive, antigenic, quite unspecific, pyretogenic and hemorrhagenic. Therefore, the production of fibrinolysing enzymes, which rapidly dissolute thrombi within the vascular tree, without the detriments by microorganisms, as described in this book, is the desirable aim of today's research. Order online at springer.com ▶ or for the Americas call (toll free) 1-800-SPRINGER ▶ or email us at: orders-ny@springer.com. ▶ For outside the Americas call +49 (0) 6221-345-4301 ▶ or email us at: orders-hd-individuals@springer.com. The first € price and the £ and $ price are net prices, subject to local VAT. Prices indicated with * include VAT for books; the €(D) includes 7% for Germany, the €(A) includes 10% for Austria. Prices indicated with ** include VAT for electronic products; 19% for Germany, 20% for Austria. All prices exclusive of carriage charges. Prices and other details are subject to change without notice. All errors and omissions excepted.
Die Enzymtherapie mit proteolytischen Enzymen spielt auch heute noch eine untergeordnete Rolle. Sie wurde lange kritisiert, da es als unmglich galt, dass Makromolekle resorbiert werden. Der Nachweis der Resorption aus dem Darm und der Anstieg der proteolytischen Aktivitt im Serum bilden die Basis fr den heutigen klinischen Einsatz. Eine Reihe von placebokontrollierten randomisierten Doppelblindstudien weist einen positiven Effekt der Enzymtherapie nach. Die besten Ergebnisse sind in den Bereichen Traumatologie, plastische Chirurgie und Zahnheilkunde mit den Hauptwirkungen der Reduktion des Wunddems und der schnelleren Hmatomrckbildung dokumentiert. Als positive Wirkung resultieren geringere Schmerzen und eine bessere Beweglichkeit. Ein weiterer positiver Effekt ist die hhere Gewebekonzentration von Antibiotika. Weitere Studien zu dieser interessanten Substanzklasse sind aufgrund der vielfltigen Mglichkeiten und des gnstigen Kosten-Nutzen-Verhltnisses sinnvoll und indiziert.
Protein translocation to the extracellular space is essential for the invasion, colonization, and survival of pathogenic gram-negative bacteria within a host organism. In addition to the N-terminal signal sequence-dependent secretion system, which is specific for protein transport to the periplasmic space, there are five major systems (type I, II, III, IV, and V) that are known to be involved in protein secretion into the extracellular space. Of the systems, the type I pathway, which is composed of three membrane components including an ATP-binding cassette (ABC) protein, translocates proteins into the extracellular space from the cytosol by directly using the energy generated from ATP hydrolysis, and therefore, the system is a member of the ABC transporter family and is also known as the ABC exporter. To date, ABC exporters have been discovered to be involved in the secretion of a wide variety of exoproteins including RTX (repeats-in-toxin) toxins, cell surface layer proteins, proteases, lipases, bacteriocins, heme-acquisition proteins, and nodulation-related proteins such as the exoglucanases of gram-negative bacteria. A secretory protein and its associated specific ABC exporter are encoded in the same gene cluster in most cases, and ABC exporters show substrate specificity for secretion. Consequently, ABC exporters are present based primarily on the number of secretory protein genes. A secretion signal is situated in the C-terminal region of secretory proteins, however, the characteristics of the secretion signal are not fully understood. Secretory substrates and their linked ABC exporters are reviewed in the following paper.
ResearchGate has not been able to resolve any references for this publication.