International Journal of Current Research and Review
ISSN: 2231-2196 (Print)ISSN: 0975-5241 (Online)
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IJCRR - Vol 03 Issue 01, January, 2011

Pages: 11-17

Date of Publication: 30-Nov--0001


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COMPARISON BETWEEN THE PAIN RELIEVING ACTION OF SERRATIOPEPTIDASE, NSAIDs AND
COMBINATION OF BOTH IN THE ROOT CANAL TREATMENT PATIENTS

Author: Prafulla Mane, Kavita Atre, Rahul Mayee

Category: Healthcare

Abstract:A three arm observational study was conducted by SRM Clinical Research Services Pvt. Ltd. to compare the efficacy of NSAIDs, serratiopeptidase enzyme and the combination of the two in relieving of pain of the root canal patient in the Aurangabad (MS) region. The study was conducted on 45 patients who were provided with a pain scale to keep a record of their rate of pain at the dosing time as well as at an hour from dosing. The rate of pain for each day was recorded in the patient's diary provided to the patients. The data was recorded from the time the root canal was opened till it was operated which is usually about 4-5 days. The data was then analyzed using statistical method and was finally represented as a histogram for easy comparison. The comparison was done for all the three arms i.e., patients prescribed with only NSAIDs, only serratiopeptidase and a combination of both the drugs. The histogram clearly indicated the change in level of pain in the patients. It was observed that the pain decreased in level when the patients consumed only NSAIDs or only serratiopeptidase enzyme but the pain was found to have aggravated in some patients of Aurangabad region when combination of both NSAIDs and serratiopeptidase was prescribed to them, hinting at an antagonistic action of the two.

Keywords: Serratiopeptidase, Pharmacovigilance, Root Canal Treatment.

Full Text:

INTRODUCTION

Pharmacovigilance The word ?pharmacovigilance' has been derived from a Greek word -pharmakon? which means medicinal substance and a Latin word ?vigilare? which means to keep watch. In 2002, World Health Organization (WHO) defined Pharmacovigilance as ?The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.?[1] The percentage of hospital admissions due to iatrogenic diseases (those caused by drugs) is as high as 3 to 5 % in USA alone. [2] Therefore, it is one of the most important pre-requisites for the progress of medicine that the new drug being introduced in the market should not cause many adverse drug reactions (ADRs). Studies directed at detecting and assessing safer use of medications, appear mandatory to prevent ADRs and achieve rational therapeutic practices. Such activity requires collective and coordinated efforts from all the healthcare professionals such as - doctors, nurses and pharmacists. In addition, distribution of ADR data among consumer groups and pharmaceutical firms also becomes necessary. [3] There is certainly a need to be ?vigilant' about Pharmacovigilance studies.

Serratiopeptidase

Pain is one of the most troubling aspects of inflammation. Acute pain produced by cellular chemical reactions is part of the body's natural inflammatory healing response. Chronic pain, though, can be detrimental to healing. Swelling caused by inflammation can cause tissue to press against sensitive nerves and cause pain. The conventional treatment for inflammation disorders has a dark side - serious side effects. The two most common treatments for inflammation are steroids such as Prednisone and non-steroidal anti-inflammatory drugs, called NSAIDs both of which are associated with serious side effects such as thinning of skin, slow wound healing, high blood pressure, lowered immune system, fluid retention, suppression of normal adrenal function ulcers, internal bleeding etc. [4] Fortunately, there is a natural alternative to steroids and NSAIDs that is effective without serious side effects - Serratiopeptidase or serrapeptase which is a protein (proteolytic) enzyme isolated from the non-pathogenic enterobacteria Serratia E15 found in silkworms. Serratiopeptidase's ability to reduce and drain fluid from the inflamed area can reduce swelling and pain. It also reduces pain through its ability to block the release of paininducing amines from inflamed tissues. [5] Unlike NSAID pain medications, serratiopeptidase does not cause dangerous internal bleeding, nor is it addictive like many pain medications. Hence, it is being widely used in treating various diseases such as, inflammation, sinusitis, bronchitis, infection, atherosclerosis, carpel tunnel syndrome and in reducing pain. [6-13]

Brainwave

Pharmacovigilance (PV) has now been established as an important part of research activities owing to the statistical observations of ADRs recorded in various countries. But, like every research activity, PV also needs generation of some idea or as it may be rightly called a ?brainwave' for the commencement of the study. Such a brainwave was generated by few dentists in Aurangabad (MS) region which are a part of the SRM Clinical Research Services Pvt. Ltd. database. It was regarding the above mentioned miracle enzyme - Serratiopeptidase. Given its anti-inflammatory capability, Serratiopeptidase is widely used by dentist during the root canal treatment (RCT). It is prescribed during the preRCT period from the time RC is opened till the time it is operated. It is either prescribed individually or in combination with NSAIDs. These conventional NSAIDs are used widely during the root canal treatment for dental patients. The NSAIDs are used as covering agents for pain before and after the root canal procedure. Now-adays, Serratiopeptidase and the combination of NSAIDs and Serratiopeptidase are also used for the same purpose. It was observed by few dentists that though Serratiopeptidase is an established anti-inflammatory agent, it was found to be aggravating the pain in the RCT patients when administered in combination with other NSAIDs. It was this observation that led us to propose the study to compare the efficacy of NSAIDs, Serratiopeptidase and combination of both in the pain relieving capacity.

MATERIALS AND METHODS

Protocol was generated for comparing the efficacy of NSAIDS, Serratiopeptidase and a combination of both in the pain relieving capacity in the root canal patients of the Aurangabad (MS) region. The protocol was submitted to the Institutional Review Board (IRB) of SRM Clinical Research Services Pvt. Ltd. Feasibility assessment was conducted for 20 dental sites after the protocol was approved by the IRB of SRM Clinical Research Services Pvt. Ltd. Only 14 sites were selected for the study as they provided us with patients undergoing RCT. Each of the sites was assigned a specific site number. Recruitment of the patients was done after their informed consent. Totally 45 patients were enrolled for the study, out of which 12 patients were prescribed NSAIDs, 10 patients were prescribed serratiopeptidase and 13 patients were prescribed combination. This being a pharmacovigilance observational study, the prescription of the drug was left to the sole decision of the dentist. A three arm study was conducted which comprised of patients being treated with only NSAIDs, only Serratiopeptidase and the combination of both. The case report form was duly filled which included patient's medical history and the drugs prescribed for RCT. The patients were provided with a patient diary which contained a pain rating scale ranging from 0 - 10 (Figure 1). Data was recorded at both dosing time as well as after one hour from dosing, from the time root canal was opened till it was operated which is usually about 4-5 days. Average of the rate of pain of both the timings was calculated for each patient. A gross average was calculated for both the timings for each of the patient of all the three arms. The final average value was calculated by taking the average of the gross values. These final average values were then used to plot the histogram to compare the efficacy of the three arms in the treatment of the RCT patients.

RESULT AND DISCUSSION

The average rate of pain for NSAIDs was found to have decreased from 5.72 at dosing time to 2.98 after one hour from dosing. A similar decrease in pain was also seen in patients administered with serratiopeptidase enzyme where the rate of pain at dosing time was 3.15 but after one hour from dosing it was reduced to 1.02. But, a similar pattern was not observed in case of combination drugs. Contrary to decrease in pain in case of NSAIDs and serratiopeptidase, the pain was found to have aggravated in the patients of Aurangabad (MS) region which were administered with a combination of the two drugs. The rate of pain increased from 5.63 at the dosing time to 8.22 after one hour from dosing.

CONCLUSION

This three arm study was conducted to compare the efficacy of NSAIDs, serratiopeptidase enzyme and combination of the two in the pain relieving capacity for root canal treatment. It was observed from the study that NSAIDs and serratiopeptidase were capable of reducing the pain whereas a combination of the two drugs exhibited aggravation of pain in the root canal patients. Hence, it can be concluded that there might be an antagonistic relationship between the two drugs. This was a pilot study conducted by SRM Clinical Research Services Pvt. Ltd. in the Aurangabad (MS) region. Thus, it clearly suggests that a similar pharmacovigilance study on a large population should be conducted for the benefits of the consumer groups and Pharmaceutical firms.

References:

1. WHO - The importance of Pharmacovigilance, Safety Monitoring of medicinal Products, Geneva; 2002.

2. Das BP, Rauniar GP, Bhattacharya SK. Medical errors challenges for the health professionals: need of Pharmacovigilance to prevent. JNMA. 2006 Apr-Jun; 45(162): 273-8.

3. Kuruvilla A. Pharmacovigilance - Review Topic Rational Drugs. 2006 Oct - Dec; Issue 26. 4. Miyata K. Intestinal absorption of Serratia Peptidase. J Appl. Biochem. 1980; 2:111-16.

5. Mazzone A, et al. Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathogoly: a multicentre, double-blind, randomized trial versus placebo. J Int Med Res. 1990; 18(5):379-88.

6. Kakinuma A, Moriya N, Kawahara K, Sugino H. Repression of fibrinolysis in scalded rats by administration of Serratia protease. Biochem Pharmacol 1982; 31(18):2861-6.

7. 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.

8. Esch PM, Gemgross H, Fabian A. Reduction of postoperative swelling. Objective measurement of swelling of the upper ankle joint in treatment with serrapeptase-a prospective study (German) 2FortscherMed. 1989; 107(4):67-8, 71-2.

9. Kee WH, Tan SL, Lee V, Salmon YM. The treatment of breast engorgement with Serrapeptase (Danzen); a randomized doubleblind controlled trial. Singapore Med J. 1989; 30 (1):48-54.

10. Klein G, Kullich W. Short-term treatment of painful osteoarthritis of the knee with oral enzymes. A randomized, double-blind study versus diclofenac. Clin Drug Invest. 2000; 19 (1):15-23.

11. 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.

12. Selan L et al. Proteolytic enzymes: a new treatment strategy for prosthetic infections? Antimicrob Agents Chemother. 1993; 37(12):2618-21.

13. Panagariya A, Sharma AK. A preliminary trial of serratiopeptidase in patients with carpal tunnel syndrome. J Assoc Physicians India; 1999; 47 (12); 1170-1172.

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Dr. Pramod Kumar Manjhi joined Editor-in-Chief since July 2021 onwards

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Awards, Research and Publication incentive Schemes by IJCRR

Best Article Award: 

One article from every issue is selected for the ‘Best Article Award’. Authors of selected ‘Best Article’ are rewarded with a certificate. IJCRR Editorial Board members select one ‘Best Article’ from the published issue based on originality, novelty, social usefulness of the work. The corresponding author of selected ‘Best Article Award’ is communicated and information of award is displayed on IJCRR’s website. Drop a mail to editor@ijcrr.com for more details.

Women Researcher Award:

This award is instituted to encourage women researchers to publish her work in IJCRR. Women researcher, who intends to publish her research work in IJCRR as the first author is eligible to apply for this award. Editorial Board members decide on the selection of women researchers based on the originality, novelty, and social contribution of the research work. The corresponding author of the selected manuscript is communicated and information is displayed on IJCRR’s website. Under this award selected women, the author is eligible for publication incentives. Drop a mail to editor@ijcrr.com for more details.

Emerging Researcher Award:

‘Emerging Researcher Award’ is instituted to encourage student researchers to publish their work in IJCRR. Student researchers, who intend to publish their research or review work in IJCRR as the first author are eligible to apply for this award. Editorial Board members decide on the selection of student researchers for the said award based on originality, novelty, and social applicability of the research work. Under this award selected student researcher is eligible for publication incentives. Drop a mail to editor@ijcrr.com for more details.


Best Article Award

A Study by Amr Y. Zakaria et al. entitled "Single Nucleotide Polymorphisms of ATP-Binding Cassette Gene(ABCC3 rs4793665) affect High Dose Methotrexate-Induced Nephrotoxicity in Children with Osteosarcoma" is awarded Best Article for Vol 13 issue 19
A Study by Kholis Ernawati et al. entitled "The Utilization of Mobile-Based Information Technology in the Management of Dengue Fever in the Community Year 2019-2020: Systematic Review" is awarded Best Article for Vol 13 issue 18
A Study by Bhat Asifa et al. entitled "Efficacy of Modified Carbapenem Inactivation Method for Carbapenemase Detection and Comparative Evaluation with Polymerase Chain Reaction for the Identification of Carbapenemase Producing Klebsiella pneumonia Isolates" is awarded Best Article for Vol 13 issue 17
A Study by Gupta R. et al. entitled "A Clinical Study of Paediatric Tracheostomy: Our Experience in a Tertiary Care Hospital in North India" is awarded Best Article for Vol 13 issue 16
A Study by Chandran Anand et al. entitled "A Prospective Study on Assessment of Quality of Life of Patients Receiving Sorafenib for Hepatocellular Carcinoma" is awarded Best article for Vol 13 issue 15
A Study by Rosa PS et al. entitled "Emotional State Due to the Covid – 19 Pandemic in People Residing in a Vulnerable Area in North Lima" is awarded Best Article for Vol 13 issue 14
A Study by Suvarna Sunder J et al. entitled "Endodontic Revascularization of Necrotic Permanent Anterior Tooth with Platelet Rich Fibrin, Platelet Rich Plasma, and Blood Clot - A Comparative Study" is awarded Best Article for Vol 13 issue 13
A Study by Mona Isam Eldin Osman et al. entitled "Psychological Impact and Risk Factors of Sexual Abuse on Sudanese Children in Khartoum State" is awarded Best Article for Vol 13 issue 12
A Study by Khaw Ming Sheng & Sathiapriya Ramiah entitled "Web Based Suicide Prevention Application for Patients Suffering from Depression" is awarded Best Article for Vol 13 issue 11
A Study by Purushottam S. G. et al. entitled "Development of Fenofibrate Solid Dispersions for the Plausible Aqueous Solubility Augmentation of this BCS Class-II Drug" is awarded Best article for Vol 13 issue 10
A Study by Kumar S. et al. entitled "A Study on Clinical Spectrum, Laboratory Profile, Complications and Outcome of Pediatric Scrub Typhus Patients Admitted to an Intensive Care Unit from a Tertiary Care Hospital from Eastern India" is awarded Best Article for Vol 13 issue 09
A Study by Mardhiah Kamaruddin et al. entitled "The Pattern of Creatinine Clearance in Gestational and Chronic Hypertension Women from the Third Trimester to 12 Weeks Postpartum" is awarded Best Article for Vol 13 issue 08
A Study by Sarmila G. B. et al. entitled "Study to Compare the Efficacy of Orally Administered Melatonin and Clonidine for Attenuation of Hemodynamic Response During Laryngoscopy and Endotracheal Intubation in Gastrointestinal Surgeries" is awarded Best Article for Vol 13 issue 07
A Study by M. Muthu Uma Maheswari et al. entitled "A Study on C-reactive Protein and Liver Function Tests in Laboratory RT-PCR Positive Covid-19 Patients in a Tertiary Care Centre – A Retrospective Study" is awarded Best Article of Vol 13 issue 06 Special issue Modern approaches for diagnosis of COVID-19 and current status of awareness
A Study by Gainneos PD et al. entitled "A Comparative Evaluation of the Levels of Salivary IgA in HIV Affected Children and the Children of the General Population within the Age Group of 9 – 12 Years – A Cross-Sectional Study" is awarded Best Article of Vol 13 issue 05 Special issue on Recent Advances in Dentistry for better Oral Health
A Study by Alkhansa Mahmoud et al. entitled "mRNA Expression of Somatostatin Receptors (1-5) in MCF7 and MDA-MB231 Breast Cancer Cells" is awarded Best Article of Vol 13 issue 06
A Study by Chen YY and Ghazali SRB entitled "Lifetime Trauma, posttraumatic stress disorder Symptoms and Early Adolescence Risk Factors for Poor Physical Health Outcome Among Malaysian Adolescents" is awarded Best Article of Vol 13 issue 04 Special issue on Current Updates in Plant Biology to Medicine to Healthcare Awareness in Malaysia
A Study by Kumari PM et al. entitled "Study to Evaluate the Adverse Drug Reactions in a Tertiary Care Teaching Hospital in Tamilnadu - A Cross-Sectional Study" is awarded Best Article for Vol 13 issue 05
A Study by Anu et al. entitled "Effectiveness of Cytological Scoring Systems for Evaluation of Breast Lesion Cytology with its Histopathological Correlation" is awarded Best Article of Vol 13 issue 04
A Study by Sharipov R. Kh. et al. entitled "Interaction of Correction of Lipid Peroxidation Disorders with Oxibral" is awarded Best Article of Vol 13 issue 03
A Study by Tarek Elwakil et al. entitled "Led Light Photobiomodulation Effect on Wound Healing Combined with Phenytoin in Mice Model" is awarded Best Article of Vol 13 issue 02
A Study by Mohita Ray et al. entitled "Accuracy of Intra-Operative Frozen Section Consultation of Gastrointestinal Biopsy Samples in Correlation with the Final Histopathological Diagnosis" is awarded Best Article for Vol 13 issue 01
A Study by Badritdinova MN et al. entitled "Peculiarities of a Pain in Patients with Ischemic Heart Disease in the Presence of Individual Combines of the Metabolic Syndrome" is awarded Best Article for Vol 12 issue 24
A Study by Sindhu Priya E S et al. entitled "Neuroprotective activity of Pyrazolone Derivatives Against Paraquat-induced Oxidative Stress and Locomotor Impairment in Drosophila melanogaster" is awarded Best Article for Vol 12 issue 23
A Study by Habiba Suhail et al. entitled "Effect of Majoon Murmakki in Dysmenorrhoea (Usre Tams): A Standard Controlled Clinical Study" is awarded Best Article for Vol 12 issue 22
A Study by Ghaffar UB et al. entitled "Correlation between Height and Foot Length in Saudi Population in Majmaah, Saudi Arabia" is awarded Best Article for Vol 12 issue 21
A Study by situs slot and Siti Sarah Binti Maidin entitled "Sleep Well: Mobile Application to Address Sleeping Problems" is awarded Best Article for Vol 12 issue 20
A Study by Avijit Singh et al. situs slot "Comparison of Post Operative Clinical Outcomes Between “Made in India” TTK Chitra Mechanical Heart Valve Versus St Jude Mechanical Heart Valve in Valve Replacement Surgery" is awarded Best Article for Vol 12 issue 19
A Study by Sonali Banerjee and Mary Mathews N. entitled "Exploring Quality of Life and Perceived Experiences Among Couples Undergoing Fertility Treatment in Western India: A Mixed Methodology" is awarded Best Article for Vol 12 issue 18
A Study by Jabbar Desai et al. entitled "Prevalence of Obstructive Airway Disease in Patients with Ischemic Heart Disease and Hypertension" is awarded Best Article for Vol 12 issue 17
A Study by Juna Byun et al. entitled "Study on Difference in Coronavirus-19 Related Anxiety between Face-to-face and Non-face-to-face Classes among University Students in South Korea" is awarded Best Article for Vol 12 issue 16
A Study by Sudha Ramachandra & Vinay Chavan entitled "Enhanced-Hybrid-Age Layered Population Structure (E-Hybrid-ALPS): A Genetic Algorithm with Adaptive Crossover for Molecular Docking Studies of Drug Discovery Process" is awarded Best article for Vol 12 issue 15
A Study by Varsha M. Shindhe et al. entitled "A Study on Effect of Smokeless Tobacco on Pulmonary Function Tests in Class IV Workers of USM-KLE (Universiti Sains Malaysia-Karnataka Lingayat Education Society) International Medical Programme, Belagavi" is awarded Best article of Vol 12 issue 14, July 2020
A study by Amruta Choudhary et al. entitled "Family Planning Knowledge, Attitude and Practice Among Women of Reproductive Age from Rural Area of Central India" is awarded Best Article for special issue "Modern Therapeutics Applications"
A study by Raunak Das entitled "Study of Cardiovascular Dysfunctions in Interstitial Lung Diseas epatients by Correlating the Levels of Serum NT PRO BNP and Microalbuminuria (Biomarkers of Cardiovascular Dysfunction) with Echocardiographic, Bronchoscopic and HighResolution Computed Tomography Findings of These ILD Patients" is awarded Best Article of Vol 12 issue 13 
A Study by Kannamani Ramasamy et al. entitled "COVID-19 Situation at Chennai City – Forecasting for the Better Pandemic Management" is awarded best article for  Vol 12 issue 12
A Study by Muhammet Lutfi SELCUK and Fatma situs slot entitled "Distinction of Gray and White Matter for Some Histological Staining Methods in New Zealand Rabbit's Brain" is awarded best article for  Vol 12 issue 11
A Study by Anamul Haq et al. entitled "Etiology of Abnormal Uterine Bleeding in Adolescents – Emphasis Upon Polycystic Ovarian Syndrome" is awarded best article for  Vol 12 issue 10
A Study by situs slot et al entitled "Estimation of Reference Interval of Serum Progesterone During Three Trimesters of Normal Pregnancy in a Tertiary Care Hospital of Kolkata" is awarded best article for  Vol 12 issue 09
A Study by Ilona Gracie De Souza & Pavan Kumar G. entitled "Effect of Releasing Myofascial Chain in Patients with Patellofemoral Pain Syndrome - A Randomized Clinical Trial" is awarded best article for  Vol 12 issue 08
A Study by Virendra Atam et. al. entitled "Clinical Profile and Short - Term Mortality Predictors in Acute Stroke with Emphasis on Stress Hyperglycemia and THRIVE Score : An Observational Study" is awarded best article for  Vol 12 issue 07
A Study by K. Krupashree et. al. entitled "Protective Effects of Picrorhizakurroa Against Fumonisin B1 Induced Hepatotoxicity in Mice" is awarded best article for issue Vol 10 issue 20
A study by Mithun K.P. et al "Larvicidal Activity of Crude Solanum Nigrum Leaf and Berries Extract Against Dengue Vector-Aedesaegypti" is awarded Best Article for Vol 10 issue 14 of IJCRR
A study by Asha Menon "Women in Child Care and Early Education: Truly Nontraditional Work" is awarded Best Article for Vol 10 issue 13
A study by Deep J. M. "Prevalence of Molar-Incisor Hypomineralization in 7-13 Years Old Children of Biratnagar, Nepal: A Cross Sectional Study" is awarded Best Article for Vol 10 issue 11 of IJCRR
A review by Chitra et al to analyse relation between Obesity and Type 2 diabetes is awarded 'Best Article' for Vol 10 issue 10 by IJCRR. 
A study by Karanpreet et al "Pregnancy Induced Hypertension: A Study on Its Multisystem Involvement" is given Best Paper Award for Vol 10 issue 09
Late to bed everyday? You may die early, get depression situs slot
Egg a day tied to lower risk of heart disease situs slot
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List of Awardees

A Study by Ese Anibor et al. "Evaluation of Temporomandibular Joint Disorders Among Delta State University Students in Abraka, Nigeria" from Vol 13 issue 16 received Emerging Researcher Award


A Study by Alkhansa Mahmoud et al. entitled "mRNA Expression of Somatostatin Receptors (1-5) in MCF7 and MDA-MB231 Breast Cancer Cells" from Vol 13 issue 06 received Emerging Researcher Award


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