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Online Submission Print ISSN: 2249 4995 eISSN: 2277 8810 www.njmr.in NATIONAL JOURNAL OF MEDICAL RESEARCH Volume 6 │ Issue 1 │ Jan – March 2016 │ Page: 1 - 110 print ISSN: 2249 4995│eISSN: 2277 8810 NATIONAL JOURNAL OF MEDICAL RESEARCH Official Publication of National Association of Medical Research Print ISSN: 2249 4995 Online ISSN: 2277 8810 EDITORIAL BOARD Chief Editor Dr. Viren Patel MD (Pathology), USA Associate Editor Dr. Sunil Nayak MD (Community Medicine), Patan, Gujarat Executive Editor Dr. Harsh Shah, MD (Skin & VD) Associate Executive Editor Mr. Bhaumik M Members Dr. Chirag Mehta MS (ENT), Palanpur Dr. Mehul Gosai, MD (Pediatric), Bhavanagar Dr. Deepak Agrawal, MD (Pathology), Agra Dr. N K Gupta, MS, MCh (CTVS), PGDHHM, Lucknow Dr. Deepak Parchivani PhD (Biochem), Bhuj Dr. Praful J. Dudharecha MD (Medicine), Rajkot Dr. Deepak Shukla MD (Medicine), Surat Dr. Rajesh Solanki, MD (TB & Chest), Ahmedabad Dr. H. R. Jadhav, MS (Anatomy), Ahmedabad Dr. Gunvant Kadikar MD (Ob. & Gy.), Bhavnagar Dr. Hitendra Desai MS (Surgery), Ahmedabad Dr. Indira Parmar, MD (Pediatric), Vadodara Dr. Kaushik Kadia MS (Surgery), Patan Dr. Rudresh Jarecha, DMRE, DNB (Radio.), Hydrabad Dr. Uma Gupta, MD (Ob. & Gy.), Lucknow Dr. Suprakash Chaudhury, MD (Psychi.), PHD, Ranchi Dr. Shalini Srivastav MD (PSM), Greater Noida Dr. Vani Sharma, MD (Ob. & Gy.), Himachal Pradesh Dr. K. M. Maheriya MD (Pediatrics), Ahmedabad Dr. Gurudas Khilani, MD (Med & Pharmac), Patan All the views expressed in the articles are personal views of the authors and not the official views of the National Journal of Medical Research or the Association. The Journal retains the copyrights of all material published in the issue. However, reproduction of the published material in part or total in any form is permissible with due acknowledgement of the source as per ethical norms. Mr. Bhaumik M., Associate Executive Editor, NJMR Email: [email protected], Mob: 8140975850 PUBLISHER MedSci Publications National Journal of Medical Research (Reg. No. 24-022-21-48410) C-43, Umiya Bunglows, Bhadreshwar, Hansol, Ahmedabad – 382475. NATIONAL JOURNAL OF MEDICAL RESEARCH │ Volume 6│Issue 1│ Jan – March 2016 www.njmr.in CORRESPONDENCE [email protected] The journal is indexed in Scopemed, DOAJ, WHO HINARI, IndexScholar, IndMedica, NewJour, Index Copernicus International, eJManager, Medical Journal Links, Research Bible, Universal Impact Factor, etc. Open Access Journal NATIONAL JOURNAL OF MEDICAL RESEARCH NATIONAL JOURNAL OF MEDICAL RESEARCH Volume 6│Issue 1│Pages 1 – 110 │Jan - March 2016 Table of Content Original Article Study of Ocular Changes in Pregnancy O K Radhakrishnan, Debapriya Datta, Jyoti Yadav, Priti Kumari, Vasundhara Phillips, Nimrita Nagdev ... 1 - 4 Prevalence of raised inter-arm BP difference in young healthy adults –A cross sectional study Simmy Kurian, Manjula V D, Roshni Paul Joseph ................................................................................................. 5 - 8 Effect of Chronic Alcohol Intake on Auditory System with Changes in Auditory Brainstem Evoked Responses Harinder J.Singh, Sharanjit Kaur, Amandeep Kaur, Lily Walia, Anand Sharma ................................................ 9 - 12 Outcome of Chemotherapy in Lung Cancer: Our Experience At A Rural Tertiary Care Hospital in Central India Babaji Ghewade, Tarushi Sharma, Satyadeo Choubey, Swapnil Chaudhari ........................................................ 13 - 16 Clinical examination and foot pressure analysis of diabetic foot: Prospective analytical study in Indian diabetic patients Harshanand J Popalwar, Anil Kumar Gaur, Badrinath D Athani, Jayasree Ramesh ......................................... 17 - 22 Prevalence of Vitamin-A deficiency & refractive errors in primary school-going children Rupali D Maheshgauri, Radhika R Paaranjpe, Abha Gahlot, Ami Gohil, Sonali Pote, Deepaswi Bhavsar ... 23 - 27 Effects of Tadalafil on cardiopulmonary haemodynamics in patients of chronic pulmonary diseases with pulmonary hypertension- A pilot study Indrajeet Sharma, Purshottam K. Kaundal, Malay Sarkar, Tulika Jha, Prakash C. Negi, Ashok K. Sahai, Sanjeev Asotra .............................................................................................................................................................. 28 - 34 A Study on Awareness of Tobacco Use and Cancer Risk Among Medical Students (Col) Prakash G Chitalkar, Rakesh Taran, Deepak Singla, Prashant Kumbhaj .................................................. 35 - 37 A Study to Evaluate and Compare the Efficacy and Safety of Topical Cyclosporine A 0.5% with Topical Placebo (Artificial Tears) in Alleviating the Principal Signs Associated with Vernal Keratoconjunctivitis Abha Gahlot, Rupali Maheshgauri, Bhargav Kotadia, Kanisha Jethwa, Gira Raninga ...................................... 38 - 41 Prevalence and risk factors of non fatal road traffic accidents in a community setting of district Dehradun Shubham M. Sharma,Ruchi Juyal, Shaili Vyas, Jayanti Semwal ............................................................................. 42 - 44 Study on Clinico-epidemiological pattern of foreign bodies in Otorhinolaryngology and associated morbidities Richa Gupta, Manish Mittal ........................................................................................................................................ 45 - 47 A prospective study of comparison between Open Gastrojejunostomy and Laparoscopic Assisted Gastrojejunostomy in patients of post corrosive ingestion pyloric stenosis Samir M.Shah, Chirag K. Patel, Smit M. Mehta, Vikram B. Gohil ....................................................................... 48 - 50 Study of Change In Macular Volume With Uncontrolled HbA1c Levels in a Diabetic patient in absence of Diabetic Macular Oedema Parag Apte, Priti Kumari, Debapriya Datta, Nilesh Jagdale, Jatin Patel, Richa Naik......................................... 51 - 53 Evaluation of visual outcome of cataract surgery in rural eye-camps in the state of Maharashtra Rupali D Maheshgauri, Abha Gahlot, Sonal Kohli, Radhika R Paaranjpe, Bhagyashree Kadam, Gira Raninga .......................................................................................................................................................................... 54 - 57 Volume 6│Issue 1│ Jan – March 2016 print ISSN: 2249 4995│eISSN: 2277 8810 Open Access Journal NATIONAL JOURNAL OF MEDICAL RESEARCH Assessment of the profile of psychiatric manifestations in cannabis users: A cross sectional study Indrajeet Sharma, Tulika Jha, Purshottam K. Kaundal .......................................................................................... 58 - 61 Effects of intrathecal Bupivacaine with normal saline versus Bupivacaine with Fentanyl in patients undergoing surgery Jigna R Shah, Manish Bhatt ........................................................................................................................................ 62 - 68 Scientific Validation of Disease Diagnosis System, Using Human Energy Field (Aura) For GIT Cases Rajeev Pahwa, Uday Kumar Jejurikar, Menka Kuril, Barkha Kuril ...................................................................... 69 - 72 Evaluation of Stress urinary incontinence among non pregnant female patients in a tertiary care hospital Shraddha Agarwal, Ashwin Vacchani, Jigisha Chauhan, Sneha .C. Halpati......................................................... 73 - 76 Incidence and Treatment Abandonment in Teen And Young Adult Cancers (Col) Prakash.G Chitalkar, Rakesh Taran,. Prashant Kumbhaj, Deepak Singla ................................................. 77 - 79 A radiographic study of rib anomalies in patients of various chest diseases belonging to north Indian population at a tertiary care centre Darshan K Bajaj, Shailesh K Singh, Abhishek Dubey, Anand Srivastava, Surya Kant, Ajay K Verma, Ved Prakash, Mona Asnani ......................................................................................................................................... 80 - 83 Study of clinical profile and complications of Dengue fever in Tertiary care hospital of Puna City Pradnya Mukund Diggikar, Prasanna Kumar Satpathy, Gaurav Dinesh Bachhav, Kanishka Dinesh Jain, Anuja Mukesh Patil, Prafull Chajjed .......................................................................................................................... 84 - 86 A study of visual problems in children scoring low grades and those with lack of concentration at school in Pune city Radhika Ramchandra Paranjpe, Rupali Darpan Maheshgauri, Shraddha Ramadhar Yadav, Bhargav Jitendra Kotadia, Nimrita Gyanchand Nagdev, Kanisha Girish Jethwa .............................................................. 87 - 88 A Study on Comparison of Intravenous Butorphanol with Intravenous Fentanyl for Premedication in General Anesthesia Hemangini M Patel, Bansari N Kantharia ................................................................................................................ 89 - 91 Comparison of haemodynamic fluctuation of intravenous Ketamine with intravenous Propofol – Fentanyl combination in short surgical procedure Madhavi S Mavani, Sudevi Desai ............................................................................................................................... 92 - 94 Trends of Nosocomial Infections in A Private hospital of Surat, Gujarat Latika N Purohit, Prashant V Kariya......................................................................................................................... 95 - 97 Review Article Using the methodology of wavelet analysis for processing images of cytology preparations Vyacheslav V Lyashenko, Asaad Mohammed Ahmed abd allah Babker, Oleg A Kobylin............................... 98 - 102 Case Report Acute disseminated encephalomyelitis in chicken pox Arijit Sinha, Suvrendu Sankar Kar, Tirtha Pratim Purkait, Uttam Kumar Pandit .............................................. 103 - 104 Retrocaval /circumcaval ureter: rare congenital anomaly of ureter or inferior vena cava Samir M Shah, Chirag K Patel, Smit M. Mehta, Vikram B Gohil ......................................................................... 105 - 107 Mesenteric Panniculitis- A Case Report Amol Jagdale, Saurav Mittal, Krutik Patel, Azhar Shaikh....................................................................................... 108 - 110 Volume 6│Issue 1│ Jan – March 2016 print ISSN: 2249 4995│eISSN: 2277 8810 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE STUDY OF OCULAR CHANGES IN PREGNANCY O K Radhakrishnan1, Debapriya Datta2, Jyoti Yadav3, Priti Kumari2, Vasundhara Phillips2, Nimrita Nagdev2 Author’s Affiliations: 1Professor; 2PG Resident; 3Senior Resident, Department of Ophthalmology, Dr D. Y. Patil Medical College, Pimpri, Pune Correspondence: Dr Debapriya Datta Email: [email protected] ABSTRACT Introduction: In pregnancy, women undergo a tremendous number of systemic and ocular changes. Physiological changes occur in the cardiovascular, hormonal, metabolic, hematologic and immunologic systems. Hormonal changes are among the most prominent systemic changes in pregnant women with the placenta, maternal endocrine glands and the fetal adrenal glands combining their productivity to make a high-powered hormone factory. Aims: To evaluate the various ocular changes taking place in pregnancy in women with no other co-morbid ocular or systemic diseases and to compare ocular changes in three trimesters of pregnancy with controls of non pregnant women. Materials and Methods: The ocular changes occuring in varying stages of pregnancy in 225 pregnant women were studied and compared with 75 healthy non pregnant women. Results: Age was similar in the pregnant and non pregnant women studied. Headache was significantly more common among pregnant women when compared to non pregnant women. Diplopia was not significantly different between pregnant and non pregnant women. Intraocular pressure was significantly less among the pregnant women as compared to non pregnant women. Occurrence of conjunctival pigmentation was significantly more in pregnant women when compared to non pregnant women. There was no difference in corneal thickness when pregnant and non pregnant women were compared. Krukenberg’s spindles were seen more commonly among pregnant women when compared to non pregnant women. Conclusion: Various ocular changes occur during a normal pregnancy. Knowledge of these changes can help to differentiate the physiological changes occurring in a normal pregnancy from ocular manifestation of systemic diseases. Keywords: Pregnancy, Diplopia, Krukenberg’s spindle INTRODUCTION Pregnancy is a physiological situation which places abnormal stress and demands on a pregnant woman’s body.1 The physiological, hematological, hormonal, immunological and metabolic changes in the body of a pregnant woman merit special consideration, as also the eye. The maternal endocrine system and the placenta (the hormone factory) cause ocular abnormalities which are reversible and rarely permanent.2 The ocular effects of pregnancy may be physiological or pathological or may be modifications of preexisting conditions.3 Physiological changes include increased pigmentation of the lids, ptosis, changes in cornea and refractive status and decreased intraocular pressure. 4 These usually resolve post partum. Preexisting diseases such as Graves’ disease, Retinitis NJMR│Volume 6│Issue 1│Jan – Mar 2016 pigmentosa and Optic neuritis should be monitored due to their relapses in pregnancy. There may be worsening of Diabetic retinopathy and Central serous chorio-retinopathy with increased risk of retinal detachment. Conditions like glaucoma and non infectious uveal inflammatory disorders may even improve transiently. Pre-eclampsia and eclampsia could result in hypertensive retinopathy, exudative retinal detachment and cortical blindness. Neuroophthalmological disorders such as venous sinus thrombosis, benign intracranial hypertension, pituitary adenoma, meningioma and optic neuritis should be kept in mind as differential diagnosis in pregnant women presenting with visual acuity loss, visual field loss, persistent headaches or oculomotor sies.5 Use of ophthalmic drugs can affect foetal health during pregnancy. Page 1 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Knowledge of ocular changes in pregnancy can help to differentiate the physiological changes from ocular manifestation of systemic disease and diseases pertaining to the eye in a pregnant woman.4 AIMS: The aim of the study was to evaluate the various ocular changes taking place in pregnancy in women with no other co-morbid ocular or systemic diseases and to compare ocular changes in three trimesters of pregnancy with controls of non pregnant women. MATERIALS AND METHODS It was a cross sectional observational study carried out jointly in the Department of Ophthalmology and Department of Obstetrics and Gynaecology of a tertiary care centre in Western Maharashtra from July 2012 to September 2014. The study included 225 pregnant women and 75 non pregnant women. Ethics Committee Clearance was obtained before starting the study. Written and informed consent was obtained from all women participating in the study. Inclusion Criteria: Pregnant women between the age of 19-40 years in the 1st, 2nd and 3rd trimester of pregnancy and non pregnant women with no ocular or systemic co-morbidity were included in the study. Exclusion Criteria: Pregnant women with any preexisting co-morbidity like Diabetes and Hypertension; and Pregnant women with any pre-existing ocular morbidity like Cataract, Uveitis, Glaucoma, Retinal and Optic nerve disorders were excluded from the study.. The selected patients were divided into 4 groups: - Group A: 75 pregnant women in 1st trimester with no other ocular and systemic co-morbidity. - Group B: 75 pregnant women in 2nd trimester with no other ocular and systemic co-morbidity. - Group C: 75 pregnant women in 3rd trimester with no other ocular and systemic co-morbidity - Group D: 75 non pregnant women with no other ocular and systemic co- morbidity. Evaluation of the patient included the following in each case: Demographic factors like age, sex, occupation and address were recorded. Complete ophthalmic history and medical history was taken. The measurement of the uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) was done. Intraocular pressures were recorded using Goldmann applanation tonometer. Anterior segment of both eyes were examined under the slit lamp biomicroscope. Corneal thickness was measured using Pachymeter. Fundus evaluation of both eyes was done through dilated pupils using direct ophthalmocope , slit lamp biomicroscopy with a 90D lens and indirect ophthalmoscopy. Keratometry was done using Bausch and Lomb Keratometer. Perimetry was done using Humphrey’s visual field analyzer. RESULTS In all group 75 women included in each. Thus total 225 womenr participated. The mean age was analyzed quantitatively within groups as shown in table 1. The P value was >0.05, which was statistically not significant. Table 1: Comparison of Age in Study Groups Group Group A Group B Group C Group D Women 75 75 75 75 Mean Age (yrs) 24.75 25.03 24.96 24.64 p-Value >0.05 Group A: Pregnant in 1st rimester; Group B: Pregnant in 2nd Trimester; Group 3: Pregnant in 3rd Trimester; and Group 4: Non pregnent Table 2: Comparison of Ocular Problems in Study Groups and its Statistical Significance Ocular problems Headache Diplopia IOP Mean (mm Hg) Conjunctival pigmentation Corneal thickness Mean(microns) Krukenberg’s spindles Group A (%) 30 (40.0) 0 15.03 20 (26.67) 548.89 10 (13.33) Group B (%) 34 (45.33) 2 (2.67) 13.05 19 (25.33) 551.96 14 (18.67) Group C (%) 28 (37.33) 0 11.07 16 (21.33) 553.48 6 (8.0) Group D (%) 5 (6.67) 0 15.33 1 (1.33) 547.77 0 p-Value <0.0001 >0.05 <0.0001 <0.001 >0.05 <0.05 Group A: Pregnant in 1st rimester; Group B: Pregnant in 2nd Trimester; Group 3: Pregnant in 3rd Trimester; and Group 4: Non pregnant NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 2 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table 3: Comparison of ocular changes between pregnant and non pregnant women and its statistical significance Ocular Problem Headache Diplopia Conjunctival Pigmentation Krukenberg’s spindle Groups Pregnant Non Pregnant Pregnant Non Pregnant Pregnant Non Pregnant Pregnant Non Pregnant Present 92 5 2 0 55 1 30 0 DISCUSSION Pregnancy is a natural state of physiological stress for the body. Each organ system of the body in a pregnant women behaves differently from that of a body in a non-pregnant state. The present study was conducted to evaluate the various ocular changes taking place in pregnancy in women with no other comorbid ocular or systemic diseases. Headache was more commonly seen among pregnant women as compared to non pregnant women in the study. Within group comparison showed that all cases in 1st, 2nd and 3rd trimester had significantly more headache as compared to non pregnant women. Increase in headaches is caused by surge of hormones in pregnancy along with an increased volume of blood circulating throughout the body.6 Diplopia was not seen to be a significant problem among the pregnant women studied. In a study of 240 normal pregnant women, it was found that 12 pregnant women developed Idiopathic Intracranial Hypertension during their pregnancies. Ten were found to have headaches, five were found to have transient visual obscuration, four were found to have visual field loss, four were found to have reduced visual acuity and three had diplopia. Bilateral papilledema of varying severity was seen in all 12 women. 7,8 Intraocular pressure was found to be significantly less among pregnant women as compared to non pregnant women in this study. Within group comparison showed that intraocular pressure in 2nd and 3rd trimester pregnant women was significantly less as compared to non pregnant women. Similar finding was also observed in a study conducted by Ebeigbe JA, Ebeigbe PN and Ighoroje ADA (2012) who found that there was a fall in intraocular pressure across the trimesters and this was very significant (P<0.0001). 9,10 The prevalence of Conjunctival pigmentation was more commonly seen among the pregnant women as compared to non pregnant women in the study. Within group comparison also showed that in 1st 2nd and 3rd trimester of pregnancy, conjunctival pigmentation was more commonly seen as compared NJMR│Volume 6│Issue 1│Jan – Mar 2016 Absent 133 70 223 75 170 74 195 75 Odds Ratio (CI) 9.68 (3.76 - 24.92) P value <0.0001 1.69 (0.08 - 35.58) >0.05 23.94 (3.25 - 176.28) <0.001 23.56 (1.42 - 390.14) <0.05 to non pregnant women (P<0.0001). A study conducted by Gaikin AV and Vavilis D et al reported similar findings where conjunctival pigmentation was found to be more common in pregnant women. Authors felt that an increase in conjunctival pigmentation is due to elevated estrogen levels associated with normal pregnancy which resolves post partum. 11 Corneal thickness was not significantly different between pregnant and non pregnant women in our study. Weinreb RN, Lu A, Beeson C. (1988) measured central corneal thickness in 89 pregnant women.They found that there was no significant difference (P = .79) in corneal thickness between the nongravid and postpartum women. A study by Huna Baron R et al done in 2002 found that corneal thickness increased by 16 micron (P = .01) in the pregnant women when compared to the control eyes of 18 non gravid and 17 postpartum women. Authors mentioned that in pregnancy, there is a measurable increase in corneal thickness due to edema.12 Krukenberg’s spindles on the cornea was more common among the pregnant women as compared to non pregnant women in our study (P<0.0001). Study by Riss B, Riss P showed similar results of increase in Krukenberg’s spindles in pregnant women in comparison with non pregnant women. Newly developed Krukenberg’s spindles on the cornea have been observed early in pregnancy and they tend to decrease in size during the third trimester and during the postpartum period.13 The mechanism presumably is related to hormonal changes such as low progesterone levels. However, by the third trimester, an increase in progesterone and aqueous outflow often result in decreased or absence of Krukenberg’s spindles.14 CONCLUSIONS Pregnancy produces numerous changes in the organ systems of a pregnant women’s body. Headache was a common symptom reported by pregnant women. Decreased intra ocular pressure and conjunctival pigmentation were seen during pregnancy. Krukenberg’s spindles were more common among pregnant Page 3 NATIONAL JOURNAL OF MEDICAL RESEARCH women when compared to non pregnant women.The occurrence of diplopia and a change in corneal thickness was not different between pregnant and non-pregnant women. REFERENCES 1. Garg P et al. Ocular changes in pregnancy. Nepal J Ophthalmol.2012;4(7):150- 61. 2. Sunness J.S. The pregnant woman's eye. Surv Ophthalmol.1988;32:219–238. 3. Gary F, Kenneth J, Steven L, et al. Williams Obstetrics Twenty-third Ed 2010;8:195. 4. Sushil C, Tarun C, Jairam Y, et al. Ophthalmic considerations in pregnancy. Med J Armed Forces India. Jul 2013;69(3):278– 84. 5. Erkkila H, Raitta C, Iivanainen M, et al.Optic neuritis during lactation. Graefes Arch Clin Exp Ophthalmol 1985; 222:134. 6. Carlin A, Alfirevic Z. Physiological changes of pregnancy and monitoring. Best Pract Res Clin Obstet Gynaecol. 2008;22:801–23. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 7. Tang RA, Dorotheo EU, Schiffman JS, et al. Medical and surgical management of idiopathic intracranial hypertension in pregnancy. Curr Neurol Neurosci Rep 2004; 4:398. 8. Huna-Baron R, Kupersmith MJ.Idiopathic intracranial hypertension in pregnancy. J Neurol 2002;249:1078. 9. Ebeigbe JA, Ebeigbe PN and Ighoroje ADA. Intraocular Pressure in Pregnant and Non-Pregnant Nigerian Women. African Journal of Reproductive Health December 2011; 15(4):20. 10. Pitta Paramjyothi, Lakshmi A.N.R, Surekha D. Physiological Changes of Intraocular Pressure (IOP) in the Second and Third Trimesters of Normal Pregnancy. Journal of Clinical and Diagnostic Research. 2011 October ; 5(5):1043-45. 11. Gaikin AV.Condition of the microcirculatory bed of the bulbar conjunctiva in physiological and pathological pregnancies. Arkh Anat Gistol Embriol 1985;89:36. 12. Weinreb RN, Lu A, Beeson C. Maternal corneal thickness during pregnancy. Am J Ophthalmol 1988;105:258. 13. Riss B, Riss P. Corneal sensitivity in pregnancy. Ophthalmologica 1981;183:57-62. 14. Duncan TE: Krukenberg spindles in pregnancy. Arch Ophthalmol 1974; 91:355. Page 4 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE PREVALENCE OF RAISED INTER-ARM BP DIFFERENCE IN YOUNG HEALTHY ADULTS –A CROSS SECTIONAL STUDY Simmy Kurian1, Manjula V D2, Roshni Paul Joseph3 Author’s Affiliations: 1Assistant Professor; 3Tutor, Department of Physiology, Govt Medical college lam; 2Professor, Department of Community Medicine, Govt Medical College Idukki, Kerala. Correspondence: Dr Simmy Kurian Email: [email protected] ABSTRACT Background: Inter-arm difference (IAD) in blood pressure (BP) has been observed in various general populations and in individuals with increased risk of cardio vascular disease and peripheral vascular disease. The prevalence of raised IAD in BP in young healthy adults has not been well addressed in most prior studies. Objectives: To estimate the prevalence of raised IAD in BP in young healthy adults, to find the gender difference in mean IAD and mean arterial BP, to find the difference in mean arterial BP according to the presence of IAD in BP. Methods: A cross sectional study was carried out among 284 medical students. BP was measured twice in each arm, using an automatic device that was calibrated according to the manufacturer’s recommendations and the values were averaged. IAD in BP is defined as difference between average BP in right arm and average BP in left arm. Results: Prevalence of raised IAD in BP in the study group was 16.5% (47). None had IAD in BP ≥ 20 mm of Hg. Mean systolic IAD in BP was 5.915(±3.81) mm of Hg and mean diastolic IAD in BP was 3.18 (±2.44) mm of Hg. The mean values of systolic and diastolic IAD in BP were almost similar in males and females , but the mean values of mean arterial BP in both arms were significantly different (P<0.05) in males and females. Mean values of Mean arterial BP in both arms were higher in those with raised IAD in BP and this was statistically significant (P<0.05). Interpretation & conclusion: Significant IAD in blood pressure (≥ 10 mm of Hg) is common in young healthy adults. The clinical significance of raised IAD in BP in young healthy adults requires long term follow up. Key words: Inter-arm difference in blood pressure, mean arterial blood pressure, cardio vascular disease, peripheral vascular disease. INTRODUCTION Inter–arm BP difference (IAD) has received increasing attention recently since it has been found to be associated with peripheral vascular disease1 and is identified as a risk factor for cardiovascular morbidity2. A difference in BP readings between arms can be observed in various general populations, healthy women during antenatal period and in population with an increased risk of cardiovascular disease (CVD), such as people with hypertension, diabetes mellitus, chronic renal disease or peripheral vascular disease. The prevalence of IAD in young healthy adults is not well addressed in most of the studies although the prevalence in older adults and hypertensives are well documented. WHO has predicted that by 2030 almost 23.6 million people will die from CVD, mainly from heart disease and stroke3. Over NJMR│Volume 6│Issue 1│Jan – Mar 2016 80 % of CVD deaths occur in low and middle income countries. Most of the risk factors for cardiovascular diseases are high in young adults4 which supports the fact that nearly half of the deaths due to CVD are occurring in young and middle aged individuals . A recent study5 found that participants with higher inter-arm Systolic BP (SBP) difference were at much higher risk for future CVD than those with less than 10 mm difference between arms. The prevalence of raised IAD in BP in young adults is not well addressed since only few studies,,6,7 were performed in this population. . The prevalence of systolic IAD ≥ 10mm of Hg was 12.6% in a study done on young healthy adults.7 IAD differences ≥ 20 mm of Hg systolic and/ or 10 mm of Hg diastolic warrant specialist referral. Page 5 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Hence prevalence of raised IAD in BP in young adults should be identified. If IAD in BP is high, it should be investigated. Operational Definitions used Aims & Objectives: The primary objective was to estimate the prevalence of raised IAD in BP in young healthy adults. Second objective was to find the gender difference in mean IAD in BP as well as gender difference in right and left mean arterial BP .Third objective is to find the difference in mean arterial BP according to the presence of inter-arm difference in BP. Raised diastolic inter-arm BP difference- ≥ 10 mm of Hg difference between average diastolic BP in right arm and average diastolic BP in left arm MATERIALS AND METHODS A medical institution based cross- sectional study was conducted among MBBS students in a tertiary care centre in central Kerala during the period July 2015 to November 2015, after approval by the institutional ethics committee. The study population consisting of 300 MBBS students enrolled for the course during the academic years 2013, 2014 and 2015. Sample size was estimated using the formula n= 4 x p x q / d2. n=sample size, P = the prevalence, q = 100 – p, d=the relative precision . The calculated sample size was 265 , but annual intake of students of this institution is 100 and it was decided to cover three batches of medical students(300 students). Exclusion criteria: The exlcusion criteria for the study were students less than eighteen years of age, with any major illness, on any regular drugs and found to have hypertension on clinical examination were excluded. On clinical examination, 9 students were found to have hypertension and were hence excluded.7 students did not participate in the study. Total 284 students participated in the study and response rate was 94%. Height and weight were measured using standard equipments. BP measurement was done in a quiet room with subject in sitting position following at least five minutes of rest. The subject was refrained from taking food or drinks half hour before BP measurement. The apparatus was kept at the level of heart and hands were supported during BP measurement. BP was measured twice in each arm .BP was measured first in the arm first presented without prompting , using an automatic device (OMRON –Model-HEM-7130) that was calibrated according to the manufacturer’s recommendations and the values were averaged. Cuff was then swapped to the other arm and two readings were taken with five minutes interval. Inter-arm BP difference is defined as difference between average BP in right arm and average BP in left arm. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Raised systolic inter-arm BP difference - ≥ 10 mm of Hg difference between average systolic BP in right arm and average systolic BP in left arm Statistical Methods: The data was coded and entered in Microsoft excel and analysed using SPSS version 16.0. Prevalence of raised inter- arm BP difference would be expressed as percentage. Continuous variables were summarised as arithmetic mean and standard deviation. Difference in mean IAD and mean arterial BP in males and females were tested using student t test. For all statistical analysis the significance level was set at p < 0.05. RESULTS Systolic inter-arm difference in BP ≥ 10 mm of Hg was present in 15.4%(44) subjects. Diastolic interarm difference ≥ 10 mm of Hg was present in 1.7% (5) subjects.(Table 1) Prevalence of raised inter-arm difference in BP in the study group was 16.5%(47). None had inter-arm BP difference ≥ 20 mm of Hg. Descriptives of anthropometric parameters and BP are described in table 2. Table 1: Prevalence of Raised Inter-arm BP difference Gender Male Female Total Inter-arm Difference Present (%) Absent (%) 15 (17.6) 70 (82.4) 32 (16.1) 167 (83.9) 47 (16.5) 237 (83.5) Total 85 199 284 Table 2: Descriptives of anthropometric parameters and BP of study subjects Clinical/Anthropometric Mean (±SD) Measures (n=284) Height 162.97 ( ±10.386 ) Weight 54.43 ( ±11.752) BMI 20.249 ( ±3.094) LSBA 105.4 ( ±10.774) RSBA 109.121 (±11.85) LDBA 67.54 ( ±6.49) RDBA 69.02 (±6.88) SIAD 5.915 (±3.81) DIAD 3.18 (±2.44) BMI-Body Mass Index; LBSA-Left arm Systolic BP Average; RSBA-Right arm Systolic BP Average; LDBA-Left arm Diastolic BP Average; RDBA-Right arm Diastolic BP Average; SIAD-Systolic Inter-arm Difference in BP; DIAD-Diastolic Inter-arm Difference in BP. Page 6 NATIONAL JOURNAL OF MEDICAL RESEARCH All variables were normally distributed. Mean systolic inter-arm difference in BP was 5.915(±3.81) mm of Hg and mean diastolic inter-arm difference in BP is 3.18 (±2.44) mm of Hg. Mean BP recorded from 284 subjects were 109.12 (±11.85) / 69.09 (±6.88) mm of Hg in Right arm and 105.04 ( ±10.77) / 67.5 (±6.4) mm of Hg in left arm. The mean values of systolic and diastolic inter-arm BP differences were comparable in males and fe- print ISSN: 2249 4995│eISSN: 2277 8810 males and the slight difference observed was not statistically significant. But the mean values of mean arterial BP in both arms were higher in males than females and this difference was statistically significant (P=0.001 in both arms).) Similarly when subjects were grouped based on presence and absence of IAD, those with presence of IAD had higher mean values of mean arterial BP in both arms .This was also statistically significant.(Left arm-P=0.02 ,Right arm –P=0.01) (Table 3). Table 3: Comparison of means of IAD and mean arterial BP according to gender and presence of raised IAD Parameter SIAD Factors Mean±SD p-Value Males 5.62(±4.39) 0.40 Females 6.04(±3.53) DIAD Males 3.27(± 2.15) 0.67 Females 3.14(±2.56) LAM Males 83.76(±5.99) 0.001 Females 78.19(±7.36) RAM Males 86.12(±7.02) 0.001 Females 80.50(± 8.96) LAM Raised IAD present ( n=47) 82.01(±7.26) 0.02 Raised IAD absent (n=237) 79.43(±7.39) RAM Raised IAD present ( n=47) 88.2(±8.2) 0.01 Raised IAD absent (n=237) 80.98(±8.4) IAD-Inter- Arm Difference in BP; DIAD-Diastolic Inter-Arm Difference in BP; SIADSystolic Inter-Arm Difference In BP.LAM-Left Arm Mean arterial BP, RAM-Right Arm Mean arterial BP. DISCUSSION The present study done in young healthy adults showed the prevalence of raised IAD in BP as 16.5%. In a similar study done in young healthy adults7 , the prevalence was 12.5%.Both studies used sequential method for BP estimation which may have resulted in higher prevalence rates. Mean systolic inter-arm difference in BP is 5.915(±3.81) mm of Hg and mean diastolic inter-arm difference in BP is 3.18 (±2.44) mm of Hg in this study. This result was almost similar to values obtained in other studies,8,9 Many previous studies 10,11 have shown that mean IAD was unrelated to gender . Similarly, in the present study mean values of systolic and diastolic IAD does not vary much in males and females. In our study BP in right arm tended to be higher than BP in left arm which was similar to the observation in a study by Adam J Singer11.This may be due to the right handedness of majority of subjects. The larger muscle mass in right arm is less easily compressed by blood pressure cuff. This might not have occurred if direct intra arterial blood pressure monitoring was performed. In a study by Kimura etal 12 done in Japan, there is considerable difference in measured BP in left and right arm and systolic BP in right arm was slightly lower than the left arm .Large difference in absolute systolic BP was associNJMR│Volume 6│Issue 1│Jan – Mar 2016 ated with risk factors of atherosclerosis like hypertension, hypercholesterolemia and obesity in the above study. According to a study by Rajiv Agarwal13 , every 10mm difference in systolic BP between arms conferred mortality hazard of 1.24(95% CI:1.01 1.52) after adjusting for average BP. Also his observation was that BP difference between arms are reproducible and carry prognostic information. In our study systolic IAD was present in 15.4%(44) of subjects which may also have prognostic significance . They have to be followed up as coronary artery disease development later is observed5 in a community based cohort and documented in those with raised IAD in BP. Also greater than 10 mm Hg of IAD in BP was independently associated with future cardiovascular risks in a recent study.14 The mean values of mean arterial BP were significantly different in males and females in the present study. The mean values were higher in males than females. Mean values of mean arterial BP in both arms were high in those with raised IAD in BP . Mean arterial pressure is a major independent predictor of cerebrovascular events 15 .Raised IAD along with high values of mean arterial pressure in these subjects warrants their follow up for future cardio vascular events development. Page 7 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 LIMITATIONS The study used sequential method for estimation of raised IAD in BP which might have resulted in higher prevalence rate .Influence of mid arm circumference on IAD in BP was not considered in the study. CONCLUSION and cardiovascular disease in Framingham Heart Study. The American Journal of Medicine. 2014;127(3). 6. Martin D.Fotherby, Barnabas Panayiotou and John F Potter.Age related difference in simultaneous inter-arm BP measurements. Postgrad Med J 1993;69:194-196. 7. Alon Grossman, Alex Prokupetz , Barak Gordon, Nira MoragKoren, Ehud Grossman. Interarm BP difference in young healthy adults. The Journal of clinical Hypertension Aug 2013;.vol(15)/No 8. 8. Arnett D K, Tang W, Province M A,etal .Interarm difference in seated systolic and diastolic BP;The Hypertension Genetic Epidemiology Network study.J Hypertension 2005;23:11411147. Bilateral upper extremity blood pressure determined by automated indirect measurements has wide degree of inter-arm variation. So in a primary care setting 9. Verberk W J,Kessel A G,Thien T. BP measurement method blood pressure should be measured routinely in both and inter arm difference: A metaanalysis . Am J Hypertenarms to prevent under estimation of hypertension. sion 2011; 24(11) :1201-1208. Individuals with raised inter-arm difference in BP 10. Lane D, Beevers M, Barnes N, Bourne J etal .Inter-arm difrequire long term follow up. ference in blood pressure:When are they clinically significant?.J Hypertens.2002 Jun;20(6):1089-95. REFERENCES 1. 2. 3. 4. 5. Clark C E, Campbell J L, Powell R J, Thompson J F. The inter-arm BP difference and peripheral vascular disease:Cross sectional study-Fam Pract 2007;24:420-426. Clark C E ,Taylor R S, Shore A C,etal. Association of a difference in systolic blood pressure between arms with vascular disease and mortality;a systematic review and meta analysis.Lancet 2012;379;905-914. Global Atlas on Cardiovascular Disease Prevention and Control. Whorld Health Organisation Geneva 2011.Available at http://www.world-heart federation .org/fileadmin/user.../ Global – CVD-Atlas.PDF.Accessed on 15 th January 2015. Simmy Kurian, Manjula V.D, Annamma , Jaimol Zakariah.A study on cardiovascular risk factor profile of medical students in a tertiary care hospital in central Kerala.National Journal of Medical Research 2015 Jan-March;5(1):11-17. Ido Weinberg, Philimon Gons, Christophem J .O Donnel etal.The systolic Blood Pressure Difference Between Arms NJMR│Volume 6│Issue 1│Jan – Mar 2016 11. Adam.J.Singer, Judd . E. Hollander. Blood Pressure Assessment of Inter arm difference. Arch Intern Med. 1996;156(17) : 2005-2008. 12. Kimura A, Hashimoto J , Watabe D, Takahashi H, et al . Patient characteristics and factors associated with interarm difference of BP measurement in a general population in Ohasama , Japan.J Hypertens. 2004 Dec;22(12):2277-83. 13. Rajiv Agarwal, Zerihuu Bunaye, Dagis M . Bekele.Prognostic significance of between arm BP difference.Hypertension 2008;51:657-662. 14. Takanori Tokitsu , Eiichiro Yamamoto, Yoshihiro Hirata, Koichi Sugamura et al.Relationship between future cardiovascular events in coronary artery disease.J Hpertens 2015,33:1780-1790. 15. Verdecchia P. Schillaci G,Reboidi G, Franklin SS.Different prognostic impact of 24 hour mean BP and pulse pressure on stroke and coronary artery disease in essential hypertension.Circulation.2001;103:2579-2584 Page 8 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE EFFECT OF CHRONIC ALCOHOL INTAKE ON AUDITORY SYSTEM WITH CHANGES IN AUDITORY BRAINSTEM EVOKED RESPONSES Harinder J.Singh1, Sharanjit Kaur2, Amandeep Kaur3, Lily Walia4, Anand Sharma5 Author’s Affiliations: 1Associate Professor, 4Professor & Head; 5Professor, Dept. of Physiology; 2Associate Professor, Dept. of Pharmacology, MMMC&H, Solan; 3Medical Officer, NHM, Ludhiana Correspondence: Dr Harinder J.Singh E-mail: [email protected] ABSTRACT Objective: Alcohol affects the auditory threshold, processing of tones and frequency change at different levels of auditory processing system.1 ABR is the sensitive tool for identifying the various changes in auditory processing unit. Material and Methods: A total of 52 subjects were divided in group 1 with 26 non-alcoholics males and Group 2 (in lower case) with 26 alcoholic males. Chronic alcoholics who were taking alcohol for more than 8 years (300ml/day) without the history of any neurological and audiological problem and none of them were taking any medication that was oto-toxic were included in our study. Brainstem auditory evoked potential was performed on these subjects and results were analyzed statistically. Results: There was a significant increase in latency of wave V in alcoholics (5.678 ± 0.2271 ms) as compare to non-alcoholics (5.874 ± 0.2969 ms). (p = 0.0102) The mean value of inter peak latency for I-V in group -1 (non-alcoholics) was 3.88 ± 0.26 ms and in group 2 (alcoholics) was 4.19 ± 0.42 ms which showed a statistically significant increase in group 2. (p =0.0020). There was also a statistically significant increase in inter peak latency for III-V in group 2 (2.495 ± 0.389 ms) as compared to group 1 (2.228 ± 0.35 ms). (p= 0.0119) but there was no significant result noted for changes in other waveform pattern and inter peak latency I-III. Key words: Alcoholism, Brainstem auditory evoked potential, latency waves, inter peak latency. INTRODUCTION Chronic alcohol intake is one of the most popular abused substance to affect the hearing mechanism. It is known to cause increase in the hearing threshold by altering the central auditory processing particularly at level of summation of auditory signals. Initially this temporary threshold shift in hearing mechanism may become permanent if alcohol taken over a period of time.1, 2 The mechanism of alcohol toxicity is because of increase in fluidity of neuronal cell membrane and change in neurotransmitters.3 Chronic intake of alcohol affects auditory brainstem responses and causes delay in neurotransmission time, which reflects damage to central auditory pathways in the form hearing loss.4 Brainstem auditory evoked potentials (BAEPs) are a common non-invasive objective method to evaluate the integrity of central auditory pathways. It is one of the best measure used for the identification of cochlear and retrocochlear disorders and for threshold testing. Calibrated clicks are delivered to one ear, and NJMR│Volume 6│Issue 1│Jan – Mar 2016 electrical events are recorded in the form of seven waves (I-VII) that appear at certain latent period of time. Any delay or absence of the peaks can locate the brainstem lesions. So this is an sensitive objective tool to measure the function and abnormalities through the entire auditory pathway from cochlea to cortex.5, 6 There was a study conducted in patients with sensorineural deafness due to alcoholism and the results showed prolongation of wave I in 57% of cases and prolongation of inter peak latency I-V in 43% of cases.6 Certain studies showed significantly delay in appearance of wave V and inter peak latencies III-V and I-V.7 The current study was designed to evaluate the abnormalities in Auditory brainstem response (ABR) waves in chronic alcoholics to detect early changes in auditory processing unit. METHODOLOGY This study was conducted in Department of Physiology, M.M. Medical College and Hospital, KumarhatPage 9 NATIONAL JOURNAL OF MEDICAL RESEARCH ti, Solan. Himachal Pradesh. The study protocol was duly approved by institutional ethics committee. Our study was conducted to observe the effects of alcohol on brainstem auditory evoked potentials. 26 nonalcoholics males as controls (Group 1) and 26 chronic alcoholic male subjects (Group 2) as cases were included in our study. All the subjects were of the age group of 25 to 55 years with a mean age of 43.00 ± 10.131in group I and 46.370 ± 8.367 in group 2 (p > 0.05). The subjects were randomly selected from the general population of Solan, Himachal Pradesh and surrounding areas of Solan district. Inclusion criteria: Alcoholics who have been consuming more than 300 ml of alcohol daily for more than 8 years and absteince of alcohol for 10 days prior to this study were included in our study. These patients were recruited from college staff only giving this above history. All alcoholics were without the history of any neurological and audiological problem and none of them were taking any medication that was oto-toxic. The subjects were free from symptoms of Wernick’s encephalopathy like nytagmus and ataxia. Exclusion criteria: All the subjects having history of clinical auditory abnormality, subjective symptoms of hearing loss, diabetes mellitus or hypertension were excluded from our study. All the subjects were interviewed on a proforma which include clinical history for each subject. The subjects were explained about the study and informed consent was taken before their participation. The test performed on these subjects was short latency auditory evoked potential using Neuro- Perfect 2-channel EMG NCV EP PC based machine in Physiology Department. print ISSN: 2249 4995│eISSN: 2277 8810 BAEP Recording Procedure: The subjects were seated in front of machine. High quality EEG electrodes were used. Spots were marked on scalp of subjects and these spots were rubbed with acetone to remove oil. The electrodes were dipped in conductive jelly and pressed on each spot with adhesive tape. The ground electrode was placed on midline point on forehead. The active electrodes were placed on left mastoid and on right mastoid region. Reference electrode was placed on vertex of skull. The impedence of electrodes was kept below 5 ohm. Filter setting was kept at 10 Hz as low filter and at 3000Hz as high filter. 2000 clicks were given at the rate of 11.1 per second with intensity of 60 decibels above normal hearing threshold. A series of 5 waves were recorded during first 10 milliseconds of both right and left ears and its latencies and inter peak latencies were noted. Then we take the average of these 2000 sweeps using computer techniques. The mean wave latency I, II, III, IV, V and inter peak latencies I-III, I-V and III-V of auditory brainstem response (ABR) were measured.8,9 The data was analysed statistically between group 1 and group 2. RESULTS Our study compared the latencies and interpeak latencies between alcoholics and non-alcoholics. The mean latency V in group 1(non-alcoholics) was 5.678 ± 0.2271 ms and in group 2 (alcoholics) was 5.874 ± 0.2969 ms. There was a significant increase in latency of wave V in alcoholics as compare to non-alcoholics (Table 1) (p = 0.0102). Table 1: Comparative evaluation of latencies of ABR waves in group 1 (non-alcoholics) and group 2 (alcoholics) ABR latency waves (in milliseconds) Group 1 Group 2 p-value I (ms) Mean ±S.D. II(ms) Mean ±S.D. III(ms) Mean ±S.D. IV(ms) Mean ±S.D. V(ms) Mean ±S.D. 1.795 ± 0.2246 1.688 ± 0.2725 0.1263 * 2.730 ± 0.2032 2.698 ± 0.2084 0.5739 * 3.450 ± 0.2240 3.380 ± 0.2431 0.2854* 4.716 ± 0.2446 4.740 ± 0.2561 0.7328* 5.678 ± 0.2271 5.874 ± 0.2969 0.0102 ** * Non significant, ** significant, ABR= Auditory brainstem response, SD = Standard deviation Table 2: Comparative evaluation of inter-peak latencies of ABR waves in group 1 (non-alcoholics) and group 2 (alcoholics) ABR INTERPEAK LATENCY (in milliseconds) Group 1 Group 2 p- value I-III(ms) Mean ±S.D. 1.654 ± 0.3597 1.692 ± 0.3514 0.7011* I-V(ms) Mean ±S.D. 3.883 ± 0.2579 4.199 ± 0.4225 0.0020*** III-V(ms) Mean ±S.D. 2.228 ± 0.3485 2.495 ± 0.3892 0.0119** * Non significant, ** significant, *** highly significant, ABR= Auditory brainstem response, SD = Standard deviation. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 10 NATIONAL JOURNAL OF MEDICAL RESEARCH The inter peak latency I-III, I-V and III-V in group 1 (non-alcoholics) was 1.654 ± 0.3597 ms, 3.883 ± 0.2579 ms and 2.228 ± 0.3485 ms and in group 2 (alcoholics) was 1.692 ± 0.3514 ms, 4.199 ± 0.4225 ms and 2.495 ± 0.3892 ms respectively. The inter peak latency I-V showed statistically significant increase in group 2 as compared to group 1 (Table 2) (p =0.0020). Also the inter peak latency III-V showed significant increase in group 2 as compared to group 1 (Table 2) (p = 0.0119). Our results revealed that ABR latency V; inter peak latency I-V and III-V has statistical significant prolongation in group 2 when compared to group 1 (Table 2) (p < 0.05) showing that chronic alcoholism affects the central auditory pathway with prolongation of transmission of nerve impulse in chronic alcoholics. Data was analysed using student’s unpaired‘t’ test comparing the means and standard deviation between group 1 and group 2. The differences between the means was considered significant when p < 0.05. DISCUSSION Chronic alcohol intake was related to hearing loss due to neuronal degeneration as suggested by few researchers like Sandra Beatriz et al, Nordahl et al, Golabeck et al.10, 11, 12 but some contradicted this relation like studies done by Propelka et al and Itoh et al who found no association between alcohol consumption and hearing loss.13, 14 Previous studies also showed that chronic alcoholism was a known cause of hearing loss of the sensorineural type at high frequencies (4000 – 8000 Hz). 15 Auditory threshold (AT) measurement method is a standard behavioural procedure for measuring auditory sensitivity. Verma et al. in their study had shown to affect the auditory threshold in alcohol-dependent patients for higher frequencies.1 The studies done in past show the effects of alcohol on brain auditory evoked potentials with variable results. Our result mostly correlates with other studies which show delay in latencies of ABR waves II, III, IV and V in alcoholics.[7] In a study conducted in 2002, the authors have shown that 57% patients with hearing loss due to chronic alcoholism have latency prolongation of wave I and 43% patients with hearing loss due to chronic alcoholism shows latency prolongation of wave V, showing that auditory pathways were involved in sensorineural hearing loss.6 Our observations also showed the increase in latency V and increase in inter-peak latency I-V and III-V in alcoholic group. The wave V originates from inferior colliculus.13 The statistical comparison in our study showed the increasing trend of wave latency V in alcoholics as compared to non-alcoholics. The possible reason for NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 this increase in latency V is because of demyelination of auditory pathways. 16 Our study was also in agreement with a previous study showing the prolongation of III-V wave. The prolongation of III-V wave suggests alcoholic cerebellar degeneration.17 There were also prolonged I-V and I-III inter peak intervals in patients of Wernicks–korsakoff syndrome group in another study.18 Our study also shows the increase in inter peak latency I-V showing the disturbances in neurological functions in chronic alcoholics. The results observed in alcoholics could be explained due to degeneration in auditory pathway. It can also be due to peripheral hearing loss due to auditory nerve atrophy which can lead to increase in latencies and increase in inter peak latencies.19 Another reason for these changes is change in membrane transmission, neuronal loss, death of axons and demyelination of nerves which produces delay in absolute latencies in alcoholics.16 The chronic alcohol consumption leads to depletion of vitamin B12 stores in liver and greater vitamin B12 intake would be required to preserve cochlear functioning.20 In our study as a limitation of this study, we could not demonstrate the causal association between vitamin B12 and hearing loss. CONCLUSION Chronic alcohol consumption can lead to brainstem damage, resulting in hearing degradation depending upon the quantity of alcohol ingested and time duration for this intake. Deviations from normal wave pattern or delay in peak latencies and inter peak latencies can detect various pathologies in auditory processing unit. REFERENCES 1. Verma RK, Panda NK, Basu D, Raghunathan M. Audiovestibular dysfunction in alcohol dependence. Are we worried? Am J Otolaryngol 2006 Jul-Aug;27(4):225-8. 2. Kähkönen S, Marttinen Rossi E, Yamashita H. Alcohol impairs auditory processing of frequency changes and novel sounds: a combined MEG and EEG study. Psychopharmacology (Berl) 2005 Feb;177(4):366-72. 3. Melgaard B. The neurotoxicity of ethanol. Acta Neurologica Scandinavica 1983;67(3)131–142. 4. Smith, E.S. & Riechelmann, H. Cumulative life-long alcohol consumption alters auditory brainstem potentials.. Alcoholism: Clinical & Experimental Research 2004;28(3):508-515. 5. Weber BA. Patient specific normative values of Auditory brainstem response audiometry. AJA 1992 Nov; 24-26. 6. Zhelyazkova Z, Benchev R. Auditory evoked Brainstem response (ABR) of Patients with hearing loss, suffering from chronic alcoholism. Balkan Journal of Otology and Neuro-Otology 2002; 2(1):26-29. Page 11 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 7. Begleiter H, Porjesz B and Chou CL. Auditory brainstem potentials in chronic alcoholics. Science 1981;211:1064-6. 8. Rosenhamer H, Lindstrom B, Lundborg T. On the use of click-evoked electric brain stem responses in audiological diagnosis. III. Latencies in cochlear hearing loss. Scand Audiol 1981;10: 3-1 1. 9. Jewett D, Romano M, Williston J. Human auditory evoked potentials: possible brain stem components detected on the scalp. Science 1970;167:1517-8. 10. Ribeiro SBA, Jacob LCB, Alvarenga KDF, Marques JM, Campelo RM, Tschoeke SN. Auditory assessment of alcoholics in abstinence Rev. Bras. Otorrinolaryngol. 2007;73:1590/S003 – 72992007000400004 11. Legatt AD. Arezzo IC, Vaughan HG Jr. The anatomic and physiologic bases of brainstem auditory 1988:6:681-704. evoked potentials. Neurol Clin 12. Golabek W, Niedzielska G. Audiological investigation of chronic alcoholics. Clinl Otolaryngol 1984;9:257 -61. 13. Popelka MM, Cruickshanks KJ, Wiley TL, Tweed TS, Klein BE, Klein R, Nondahl DM. Moderate alcohol consumption and hearing loss: a protective effect. J Am Geriatr Soc 2000;48:1273 -78 NJMR│Volume 6│Issue 1│Jan – Mar 2016 14. Itoh A, Nakashima T, Arao H, Wakai K, Tamakoshi A, Kawamura T et al. Smoking and drinking habits as risk factors for hearing loss in the elderly; epidomological study of subjects undergoing routine health checks in Aichi, Japan. Public Health 2001;115(3):192 – 6. 15. Pearson P, Dawe LA, Timnay B. Frequency selective effects of alcohol on auditory detection and frequencydiscrimination thresholds. Alcohol and alcoholism.1999;34(5):741749. 16. F Diaz, F Cadaveirs and C Grau. Short and middle latency auditory evoked potentials in abstinent chronic alcoholics: preliminary findings. Electroencephalography and clinical Neurophysiology 1990;77:145-50. 17. Chu N, Squires K, Starr A. Auditory brainstem response in chronic alcoholics. Electroencephalogr Clin Neurophysiol 1982;54:418-25. 18. Chan YW, Mcleod JG, Tuck RR, and Feary PA. Brainstem auditory evoked response in chronic alcoholics. Journal of Neurology, neurosurgery and Psychiatry 1985; 48:1107-12. 19. Matas CG, Filha VA, Okada MM and Resque JR, Auditory evoked potentials in individuals over 50 years. Pro Fono R Atual Cient 2006 Sep-Dec;18(3). 20. Halsted CH, Villanueva JA, Devlin AM, Chandler CJ. Metabolic interactions of alcohol and folate. J Nutr 2002; 32:2367S–2372S. Page 12 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE OUTCOME OF CHEMOTHERAPY IN LUNG CANCER: OUR EXPERIENCE AT A RURAL TERTIARY CARE HOSPITAL IN CENTRAL INDIA Babaji Ghewade1, Tarushi Sharma2, Satyadeo Choubey3, Swapnil Chaudhari2 Author’s Affiliations: 1Professor; 2Junior Resident; 3Associate Professor, Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Wardha Correspondence: Dr Babaji Ghewade Email: [email protected] ABSTRACT Background: It is well known that lung cancer is one of the leading causes of mortality worldwide. In the treatment of lung cancer, chemotherapy has become a generally accepted and widely applied therapeutic modality. In present study we find out the outcome of chemotherapy, variations in outcome due to various factors, its effect on quality of life of patients, common complications due to it and various reasons of default among these patients. Materials & Methods: A total of 42 cases diagnosed histopathologically as lung cancer and treated with chemotherapy over the year were analyzed. Results: A total of 42 patients were included in the study. There were a total of 24 males (57.2%) and 18 females (42.8%) among them .7(16.6%) patients were below the age of 50 years and 35(83.4%) were more than 50 years in age. A total of 16(38%) patients diagnosed with lung carcinoma were smokers and the rest (62%) were nonsmokers. NSCLC was found to be more common than SCLC in non-smokers, while SCLC was more common among smokers. Only 30.95% of patients completed the full course of chemotherapy and thus were assessed for improvements in quality of life following chemotherapy treatment. It was found that SCLC patients showed more improvement in scores than NSCLC patients. 29 (69.05%) of the total patients left chemotherapy in between. The main reason for this was found to be financial problems followed by switching to alternate forms of medicine. Conclusions: Lack of funds to procure chemotherapy was the major factor responsible for default among patients. In patients completing the chemotherapy, significant improvements were seen in Quality of Life. Key words: Lung cancer, Chemotherapy, INTRODUCTION Worldwide, lung cancer is one of the most commonly diagnosed oncological diseases and the leading cause of cancer-related death in men. In women, lung cancer ranks number four with regard to incidence but number two in terms of mortality.1 There are two major types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Non-small cell lung cancer is much more common and accounts for 85% of all lung cancer cases (2). There are three main types of NSCLC, which are named for the type of cells in which the cancer develops: squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. Only 17.3% of the people who develop non-small cell lung cancer survive for 5 years.2 Small cell lung cancer also called “oat cell cancer,” accounts for 14% of all lung cancers.2 This type of lung cancer grows more quickly. Small cell lung cancer is mainly attributable to smoking. Only 6.2 % of the people who develop small cell lung cancer survive for 5 years.2 Only 20-30% of patients present NJMR│Volume 6│Issue 1│Jan – Mar 2016 with an operable disease, while most of the patients present in an advanced stage II and III. According to demographic data available from various Indian studies the ratio of small cell carcinoma to non small cell carcinoma was 2.7:1 in India (19862001).3 Most patients are diagnosed at an advanced stage without curative treatment options. In this situation, systemic palliative treatment has only limited effect on survival. Consequently, to maintain or improve patients’ quality of life (QOL) represents a main treatment goal.4 Chemotherapy for non-small cell lung cancer Depending on the stage of non-small cell lung cancer (NSCLC), chemo may be used in different situations: 1) Before surgery (sometimes along with radiation therapy) to try to shrink a tumor. This is known as neoadjuvant therapy. 2) After surgery (sometimes along with radiation therapy) to try to kill any cancer cells that may have been left behind. This is known as adjuvant therapy. Page 13 NATIONAL JOURNAL OF MEDICAL RESEARCH 3) As the main treatment (sometimes along with radiation therapy) for more advanced cancers or for patients who aren’t healthy enough for surgery. Chemotherapy cycles generally last about 3 to 4 weeks. It is often not recommended for patients in poor health, but advanced age by itself is not a barrier to getting chemotherapy.5 Most often, treatment for NSCLC uses a combination of two chemo drugs. If a combination is used, it often includes either cisplatin or carboplatin plus one other drug. Sometimes combinations that do not include these drugs, such as gemcitabine with vinorelbine or paclitaxel, may be used. For people with advanced lung cancers who meet certain criteria, a targeted therapy drug such as bevacizumab or cetuximab may be added to treatment. For advanced cancers, the initial chemo combination is often given for 4 to 6 cycles. If the initial chemo treatment for advanced lung cancer is no longer working, the doctor may recommend second-line treatment with a single drug such as docetaxel or pemetrexed. Again, advanced age is no barrier to receiving these drugs as long as the person is in good general health.5 Small cell lung cancer chemotherapy Chemotherapy is usually the main treatment for small cell lung cancer (SCLC). Doctors give chemo in cycles, with a period of treatment (usually 1 to 3 days) followed by a rest period to allow the body to recover. Each cycle generally lasts about 3 to 4 weeks, and initial treatment is typically 4 to 6 cycles. It is given as a combination of 2 drugs at first. If the cancer progresses (get worse) during treatment or returns after treatment is finished, other chemo drugs may be tried. The choice of drugs depends to some extent on how soon the cancer begins to grow again. If cancer returns more than 6 months after treatment, it might respond again to the same chemo drugs that were given the first time, so these can be tried again. Drugs/combinations used in treatment of lung cancer Drugs used in NSCLC Cisplatin Carboplatin Paclitaxel Albumin-bound paclitaxel Docetaxel Gemcitabine Vinorelbine Irinotecan Etoposide Vinblastine Pemetrexed Drugs used in SCLC Cisplatin and etoposide Carboplatin and etoposide Cisplatin and irinotecan Carboplatin and irinotecan NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 If the cancer comes back sooner, or if it keeps growing during treatment, further treatment with the same drugs isn’t likely to be helpful. If further chemo is given, most doctors prefer treatment with a single, different drug at this point to help limit side effects. Topotecan, which can either be given into a vein (IV) or taken as pills, is the drug most often used, although others might also be tried. Aims and objectives The objectives of this research were to study the outcome of chemotherapy in histopathologically diagnosed lung cancer patients; to assess and compare the variations among them in relation to age, sex, histological type, staging of carcinoma & no. of chemotherapy cycles; to study the outcome of chemotherapy in form of Survival & Quality of life; to study the pattern of complications among these patients; and to find out cause of default of chemotherapy. METHODOLOGY The study was conducted at Acharya Vinobha Bhave Rural Hospital, Sawangi (Meghe) in indoor patients of Lung Cancer. This was an interventional, prospective, longitudinal study. The data was collected from patients receiving chemotherapy at AVBRH from September 2013 to September 2014. Inclusion Criteria: All histopathologically diagnosed patients of lung cancers who had taken at least one cycle of chemotherapy and patient who has given consent to participate in the study were included in the study. Exclusion Criteria: Patient unwilling for chemotherapy and not fulfilling inclusion criterias were excluded from the study. The patients with lung cancer in inpatient department of AVBRH, SAWANGI who took at least one cycle of chemotherapy and the patients who were histologically diagnosed cases of lung cancer and had been advised chemotherapy by Institutional Tumor Board Committee (comprising of Oncophysician, Oncosurgeon, Oncoradiotherapist) were included in this study. Patients included in this study were evaluated after each chemotherapy cycle for improvements in general condition. Routine blood investigations & radiological investigations i.e Xray & CT scans were performed after each cycle to assess the progress after chemotherapy. FACT-L (4) questionnaire was used to measure Qol (Quality of life) in patients who completed the course of chemotherapy. Exclusion criteria consisted of cooperation problems and lack of consent. The sample size for this study included all patients subjected to chemotherapy during the period September 2013 to September 2014. Page 14 NATIONAL JOURNAL OF MEDICAL RESEARCH RESULTS Among 42 patients included in the study, 24 were males (57.2%) and 18 were females (42.8%). 7(16.6%) patients were below the age of 50 years and 35(83.4%) were more than 50 years in age. A total of 16(38%) patients diagnosed with lung carcinoma were smokers. 32(76.2%) were having non small cell carcinoma of lung while 10(23.8%) were having small cell carcinoma of lung. Out of 32 patients of NSCLC, 16(50%) were males and 16(50%) were females. 10 patients who were diagnosed with SCLC had 8(80%) of male patients and 2(20%) were female patients. In NSCLC 5(15.6%) of patients were below the age of 50 years. 27(84.4%) were above age of 50 years. Patients with SCLC had 2(20%) below the age of 50 years and 8 (80%0 patients above the age of 50 years NSCLC group had 9 patients (28.1%) who were smokers and the rest 23(71.9%) were non smokers. Patients with SCLC included 7(70%) patients who were smokers and 3(30%) who were non smokers. ECOG performance score: In patients with NSCLC, majority of patients i.e 26(81.2%) had an ECOG Performance score between 0-2, and 6(18.8%) patients scored between 3 to 5. 9(90%) patients of SCLC had an ECOG performance score between 0-2, only 1(10%) had performance score between 3-5. A total of 13(30.95%) patients completed full course of chemotherapy while rest of 29 (69.05.%) were defaulters and dropped out of chemotherapy before completion. Among those who completed chemotherapy, 8(61.53%) patients were of NSCLC, and 5(39.47%) were of SCLC. In NSCLC group 3(37.5%) were males and 5(62.5%) were females, while in SCLC group 3(60%) males and 2(40%) females completed the treatment. Reasons for default: Out of 29 patients who defaulted chemotherapy, 24(82.8%) were cases of NSCLC and 5(17.2%) were cases of SCLC. The main reasons for default in NSCLC patients were financial problems in 13(54.2%), switching to alternate medicine in 5(20.8%) & non tolerance of side effects in 6(25%). Among the SCLC patients, the reasons for default were switching to alternate medicine in 2(40%), intolerable side effects in 2(40%) and financial problem was seen in 1(20%) patient. Quality of life: As observed by changes in FACT-L score before and after chemotherapy, NSCLC patients showed an average improvement of 22.6%, with males showing 23% and females showing 22.2% improvement in QOL. Among SCLC patients showed an average improvement of 27.59%, with males showing 26.48% and females showing 28.71% improvement in QOL. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 Table 1: Demographic features of the study participants Demographic Feature Sex Age Smoking ECOG Male Female <50 >50 Smoker Non smoker ECOG0 ECOG 1 ECOG 2 ECOG 3 ECOG 4 ECOG 5 NSCLC (%) N=32 16(50.0) 16(50.0) 5(15.6) 27(84.4) 9(28.1) 23(71.9) 8(25.0) 7(21.9) 11(34.3) 6(18.8) 0(0) 0(0) SCLC (%) N=10 8(80.0) 2(20.0) 2(20.0) 8(80.0) 7(70.0) 3(30.0) 2(20.0) 4(40.0) 3(30.0) 1(10.0) 0(0) 0(0) Table 2: Distribution of patients completing chemotherapy Gender Male Female NSCLC (%) N=8 3(37.5) 5(62.5) SCLC (%) N=5 3(60.0) 2(40.0) Table 3: Distribution of patients according to reasons for default Reasons For Default NSCLC (n=24)(%) Financial Problem 13(54.2) Switching To Alternate Medicine 5(20.8) Non Tolerance Of Side Effects 6(25.0) SCLC (n=5)(%) 1(20.0) 2(40.0) 2(40.0) Table 4: Fact-L score, before & after chemotherapy Characteristics Mean Fact-L Score Before After Chemo Chemo NSCLC* Male 56 88 Female 59.28 89.36 SCLC* Male 57 93 Female 55 94 % Improvement In Qol 23.0 22.2 26.48 28.71 Only 13(30.95%) patients completed the course of chemotherapy. An increase in Qol score was seen in these patients. 29 patients (69.05%) dropped out of chemotherapy during the treatment. DISCUSSION In the treatment of lung cancer, chemotherapy has become a generally accepted and widely applied therapeutic modality. Since the majority of patients with this disease are not cured by surgery or radiotherapy and many cases present with advanced stages of disease, chemotherapy is regarded as the most promisPage 15 NATIONAL JOURNAL OF MEDICAL RESEARCH ing approach to the ultimate control of lung cancer. In small cell tumors, significant advances in therapy have produced striking results.6,7 The non-small cell tumors, however, have remained relatively refractory. treatment.8,9 In this study 42 cases diagnosed as lung cancer and treated with chemotherapy over the year were analyzed. Majority of patients belonged to age group above 50 years as was also reported in previous Indian studies.10 NSCLC was found to be more common than SCLC in nonsmokers, while SCLC was more common among smokers. 70% of patients with small cell carcinoma were smokers. This association has been proved in recent studies.11 Only 30.95% of patients completed the full course of chemotherapy and thus were assessed for improvements in quality of life following chemotherapy treatment. FACT-L questionnaire has been developed as a part of FACIT measurement system. On measuring the scores on FACT-L before and after the course of chemotherapy, it was found that SCLC patients showed more improvement in scores than NSCLC patients. NSCLC patients showed an average improvement of 22.6% while SCLC patients showed an average improvement of 28% showing that chemotherapy is more beneficial in small cell carcinoma patients 29 (69.05%) of the total patients, left chemotherapy in between. The main reason for this was found to be financial problems. Majority of patients in India who are diagnosed with lung carcinoma usually belong to lower socioeconomic group and are thus unable to afford chemotherapy. With a per capita income of Rs 50,000, many Indians cannot afford high prices of chemotherapeutic agents. Another reason for default was switching to alternate forms of medicine. This may be partially attributed to high cost of chemotherapy and the associated side effects. Partly this can be due to high rates of illiteracy and lack of awareness among patients. About 25% of patients left chemotherapy because of nontolerance of side effects. This can be avoided by educating the patient about the side effects that may occur and preparing the patient for treatment. print ISSN: 2249 4995│eISSN: 2277 8810 pivotal role in a patient’s outcome. To minimize or prevent toxicity, chemotherapy should only be administered if there is adequate baseline blood picture, renal and liver functions, no contraindication with regard to underlying medical conditions, and for certain chemotherapeutic agents, further chemotherapy is discontinued if cumulative doses have reached tolerance levels.12 CONCLUSION Lack of funds to procure chemotherapy was the major factor responsible for default among patients. In patients completing the chemotherapy, significant improvements were seen in QoL. In past few years, little progress has been made in treatment of lung cancer patients in form of increased survival. As a result, the effect of chemotherapy on QoL becomes important while discussing the benefits of treatment with patients. REFERENCES 1. Ferlay J, Shin H, Bray F, Forman D, Mathers C, Parkin D. Estimates of worldwide burden of cancer in 2008. Int J Cancer. 2010 Dec 15;127 (12):2893917. 2. Michael B Cook, Katherine A McGlynn, Susan S Devesa, Neal D Freedman, William F Anderson. Sex Disparities in Cancer Mortality and Survival. Cancer Epidemiol Biomarkers Prev. 2011 Aug; 20(8): 1629–1637. 3. Behera D, Balamugesh T. Lung cancer in India. Indian J Chest Dis Allied Sci. 2004 OctDec;46(4):26981. 4. Wintner L M, Giesinger J M, Zabernigg A, Sztankay M, Meraner V, Pall G , Hilbe W, Holzner B. Quality of life during chemotherapy in lung cancer patients: results across different treatment lines. Br J Cancer. 2013 Oct 29; 109(9): 2301– 2308. 5. Chemotherapy for non-small cell lung cancer. Available from http://www.cancer.org/acs/groups/cid/documents/webco ntent/003115-pdf.pdf 6. Hoffman PC, Golomb HM, Bitran JD, et al. Small cell carcinoma of the lung: A five year experience with combined modality therapy. Cancer 1980, 46. 2550-2556. 7. Greco FA, Einhorn LH, Richardson RL, Oldham RK. Small cell lung cancer: progress and perspectives. Semin Oncol. 1978 Sep;5(3):323–335. Side effects of chemotherapy range from mild, like 8. Selawry OS. The role of chemotherapy in the treatment of non‐specific tiredness to life‐threatening as in neulung cancer. Semin Oncol. 1974 Sep;1(3):259–272. tropenic fever. They can be classified into haemato- 9. Vogl SE, Mehta CR, Cohen MH. MACC chemotherapy for logical, gastrointestinal, dermatological, renal, puladenocarcinoma and epidermoid carcinoma of the lung: low response rate in a Cooperative Group Study. Eastern Coopmonary, cardiac, neurological, hepatic and gonadal erative Oncology Group. Cancer. 1979 Sep;44(3):864–868. toxicities. It is important that doctors and nurses are 10. Thippanna G, Venu K, Gopalkrishna V, Reddy PNS, Sai knowledgeable regarding the drugs’ adverse effects cheiran BG. A profile of lung cancer patients in hydrabad. J and expected time of occurrence, and know how to Indian Med Asso. 1999 (97): 357-359 prevent, minimize and manage them. Patients and families’ education is also important, as many side 11. Vineis P, Alavanja M, Buffler P, et al. Tobacco and cancer: recent epidemiological evidence. J Natl Cancer Inst, 2004 effects will occur when the patient is at home. In (96): 99-106. managing side effects, assessment for patient’s toler- 12. Carol Kwok.. Management of Side Effects from Chemotheance to the prior dose and early intervention play a rapy. Available from http://www.hkacs.org.hk/content/JTT NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 16 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE CLINICAL EXAMINATION AND FOOT PRESSURE ANALYSIS OF DIABETIC FOOT: PROSPECTIVE ANALYTICAL STUDY IN INDIAN DIABETIC PATIENTS Harshanand J Popalwar1, Anil Kumar Gaur2, Badrinath D Athani3, Jayasree Ramesh4 Author’s Affiliations: 1Senior Resident, Department of PMR, AIIMS Bhopal, Bhopal; 2Head of the Department; 4Assistant Professor, Department of PMR, AIIPMR, Mumbai; 3Special Director General Health Services, Ministry of Health and Family welfare, Government of India, Delhi Correspondence: Dr Harshanand J Popalwar Email: [email protected] ABSTRACT Aim: Clinical examination of diabetic foot to find out its pathological Complications and analysis of plantar foot pressure of diabetic foot patients in Indian population. Method: This was prospective analytical study in Indian diabetic patients. 102 patients were evaluated through clinical, vascular, neurological and plantar foot pressure assessment. Results: 35% patients developed diabetic neuropathy. ABI- 62% patients had vascular complication. On foot examination 51% patients had nail changes, 32% had foot lesion and 52% had foot deformity. 7.8% had Charcot joint arthropathy, 5.8% had interdigital infection, 38.2 % had restricted joint mobility of first MTP joint. 20% had past history of foot ulceration; out of which 71% had high peak pressure point areas at healed ulcer area. High pressure values were seen in healed ulcer group patients. Average value of peak foot pressure in dynamic mode is- left foot 156.41Kpa (min 105 Kpa- max 346 Kpa) and right foot is 153.05 Kpa (min 100Kpa-max 245Kpa). Maximum values of peak pressure were seen at abnormal pressure point areas such as 4-5th metatarsal heads, lateral aspect of foot and middle of arch. Conclusion: Meticulous clinical examination can easily identify diabetic neuropathy and related pathological complications of diabetic foot. This shall help for early diagnosis and prevention of diabetic foot complications. Foot pressure analysis can be useful tool to screen patients of diabetic foot for abnormal high pressure point areas and can predict future risk of ulceration due to high foot pressure. This study states findings in Indian diabetic patients. Key words: clinical examination of foot, diabetic neuropathy, foot pressure analysis. INTRODUCTION Diabetes Mellitus (DM) is one of the most common chronic diseases in nearly all countries and is fast becoming the epidemic of 21st century.1 People with DM in developing countries are of working age, between 40 and 60 years, and over 60 years in developed countries. This could have a long-lasting adverse effect on a nation’s health and economy, especially for developing countries.2 India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed as the “Diabetes capital of the world”. It is estimated that the total number of people with diabetes in 2010 to be around 50.8 million in India, rising to 87.0 million by 2030.3 The long-term sequel of the diabetic foot includes motor neuropathy that leads to the clawing of toes and prominent metatarsal heads. Motor neuropathy is perhaps the most important etiopathogenic factor in the production of high foot pressure. Motor neuropathy causes intrinsic muscle atrophy that promotes foot deformity and decreased joint mobiliNJMR│Volume 6│Issue 1│Jan – Mar 2016 ty. The final result of these changes is the development of high foot pressures under the metatarsal heads and loss of toe function, especially of the great toe.4-6 Furthermore, autonomic neuropathy accompanies the development of chronic sensorimotor neuropathy and at the foot level is responsible for denervation and subsequent anhydrosis of the foot. This leads to atrophic skin, fissures, and callous formation. Additionally, increased blood stagnation and swelling in the foot predisposes the foot to ulceration.7-9 Because of sensory neuropathy, high foot pressures may lead to tissue breakdown and the development of ulceration. The combination of peripheral vascular disease and neuropathy makes the diabetic patient particularly susceptible to foot ulceration and infection.10 Diabetic foot amputations are one of the most frequent of diabetic complications. Patients with foot complications spend higher percentage of their income (32.3%) for treatment when compared with those without foot infections.11 Page 17 NATIONAL JOURNAL OF MEDICAL RESEARCH Eighty five percent (85%) of diabetes related lower extremity amputations are preceded by ulceration. Increased dynamic foot pressures are among the identified risk factors in the formation of diabetic foot ulcer.12 Jeremy Rich 13 tried to find out correlation of Forefoot and Rear foot Plantar Pressures in Diabetic Patients to Foot Ulceration. He conclude that the peak foot pressures of the forefoot, but not the rear foot, correlate with neuropathy measurements and can also predict foot ulceration over a 36month period. Measurements of the forefoot peak pressures, rather than the whole foot, may therefore be more useful in identifying the at risk patient for developing foot ulceration. Limited literature is available to predict data on complications of diabetic foot and foot pressure analysis in Indian population. This study aims to find out prevalence of pathological complications of diabetic foot and analysis of plantar foot pressure in Indian population. Objective The objective of this study were to find out prevalence of pathological complications and risk factors of diabetic foot in a study population and correlate between different clinical parameters; and to find out peak high foot pressure areas for early identification and prevention of risk of future foot ulceration due to high foot pressure. METHODOLOGY After confirming suitability for the study, the patients and care takers were explained the nature and duration of examination involved in the study. A written informed consent was obtained from participating subjects prior to participation in the study. Institutional ethics committee approved the study. This was a prospective analytical study conducted in diabetic foot care clinic at All India Institute of Physical Medicine and Rehabilitation, Mumbai, India. All patients coimg to the clinic between May 2011 to Dec 2013 were included in the study after assessing for inclusion and exlusion criterias New as well as referred patients for diabetic foot care clinic were included in the study. Sample size (n): One hundred and two (102) diabetic patients. Inclusion Criteria: Patients with age between 35 to 85 years of both sexes; who are able to walk independently and having old healed foot ulcers were included in the study. Exclusion criteria: Patinet having non healing chronic ulcers; acute ulcers; amputation on one or both limb; systemic complications of diabetes mellitus; spine deformity; and abnormal gait were exNJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 cluded from the study.. After assessment of inclusion and exclusion criteria, patients were first assessed for clinical examination.The parameters assessed include: 1. Demographic parameters including age, sex, and total duration of diabetes mellitus from date of diagnosis. 2. Neuropathy diagnosis has been done by use of neuropathy symptoms score and neuropathy disability score. Young et al14 criteria for clinical diagnosis of DPN (NSS + NDS Score > 10) used as bed side tool. NSS (Neuropathy Symptoms Score) is burning, numbness or tingling, fatigue, cramping, aching, or nocturnal exacerbation. Score of 1 is given for each symptom and 2 are given for night exacerbation. Neuropathy Disability Score (NDS): This was used to quantify the severity of diabetic neuropathy obtained from physical examination and was based on the examination of tendon reflexes and sensory modalities as previously described. The patellar and Achilles tendon reflexes were examined. NSS and NDS score used as bedside tool for diagnosis of diabetic neuropathy.15 3. Vascular examination of lower limb has been done by ankle brachial index. Ankle brachial index has been done by measuring blood pressure at brachial and ankle region using hand held Doppler ultrasound machine. Ankle brachial index calculated by using formula ankle blood pressure/brachial blood pressure 4. Integumentary examination includes autonomic changes of peripheral neuropathy. This includes skin examination, loss of hair over dorsum of foot, tibia and nail changes, and interdigital infection. 5. Musculoskeletal examination for deformity of toes. Examination includes: hammer toe, clawing of toes, bunion, hallux rigidus, high arch, flat foot, amputation of toes, dislocation,hallux valgus,rocker bottom deformity, etc. Other findings include corn, callosity and fissure. Patient examined for past healed ulcer site. 6. The total range of motion at the first metatarsophalangeal joint (MTPJ) was measured by Goniometer. For the first MTPJ, the range of motion from the maximal passive plantar flexion to maximal passive dorsiflexion was measured. Normal passive range of motion of the first metatarsal joint is 70° of extension and 45° of flexion. 7. Radiological examination done to find out prevalence of Charcot joint neuro-arthroparthy in study population. Page 18 NATIONAL JOURNAL OF MEDICAL RESEARCH 8. Foot Pressure Mapping: Multiple foot pressure mapping systems are available for measurement of plantar foot pressure. In shoe and platform methods are used widely for measuring plantar foot pressure. In this study, the machine used is a mat platform with basic EDMD system. It captures 100 images per second. The mat was calibrated for each patient by using the patient’s weight and foot size before each testing session. The mat system was employed to measure the static and dynamic plantar foot pressures. Subjects were instructed to stand bare foot on the mat. Static analysis of the subject’s foot pressure was done and area of contact and peak pressure was recorded. Dynamic analysis was done by asking patient to walk without footwear over the mat. Value of maximum peak plantar pressures for the entire foot was obtained. Several practice runs were made to familiarize the patient with the system and to ensure the recording of natural gait. The environmental conditions of temperature were maintained. The mean reading of three mid-gait footsteps was entered for final data analysis. Machine software is calibrated with color codes. A peak pressure area with red color shows maximum pressure and blue color shows least pressure. Calibration: the pressure is force per unit area. P=F/A. The pressure color codes calibration is automatic through software and is standardized to patient’s value according to his foot contact area and body weight. (Red = maximum pressure area, Blue= minimum) print ISSN: 2249 4995│eISSN: 2277 8810 Figure 2: Foot Pressure analysis Report. (Dynamic phase) Red color showing maximum peak pressure point area Statistical analysis: Microsoft excel 2007 and IBM SPSS statistics 20. RESULTS Total number of patients included in study n= 102. Average age of all patients was 61.52 years. (Minimum age: 39, Maximum age: 83 years SD 10.05) Sex distribution- 88 were male and 34 were females. Average duration of diabetes mellitus was 11.49 years. (Minimum 1 to maximum 35 years SD 7.53) Table 1: Ankle Brachial Index Values Ankle brachial index Range Above 1.2 1.0 To 1.99 0.9 To 0.99 0.8 To 0.89 0.5 To 0.79 Less Than 0.5 Cases 0 2 37 34 29 0 Severity Of Ankle brachial index Normal Or Acceptable Mild Arterial Disease Moderate Arterial Disease Severe Arterial Disease Table 1 show that 62% have impaired ABI. Out of that, 33% have mild arterial disease and 29 % moderate arterial disease. Diabetic neuropathy: Total number of patients who developed diabetic neuropathy was 36. In diagnosed diabetic neuropathy patients, average duration of years to develop diabetic neuropathy was 12.9 years. In non neuropathy diabetic patients, average duration of diabetes is 10.6 years. Statistically no significant correlation has been found between duration of diabetes mellitus and diabetic neuropathy.(p=0.18) Figure 1: Foot Pressure analysis Report. (Static phase) Red color showing maximum peak pressure point area NJMR│Volume 6│Issue 1│Jan – Mar 2016 Statistical correlation applied between various clinical parameters. No association found between duration of diabetes mellitus versus diabetic neuropathy and its complications. Positive association has been seen between neuropathy and joint mobility, neuropathy and history of past ulcer group patients. Page 19 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table: 2 various complications of diabetic foot Diabetic foot complication Nail changes Normal Atrophy of Nail Of Great Toe Atrophy of Nail Of All Toes Onychodystrophy Lesions of foot Normal Callosity Fissure Corn Foot deformities Normal Hammer Toe Deformity Clawing Of Toes Hallux Valgus Plano Valgoid Foot Rocker Bottom Foot High Arched Foot Amputation Of Toes Dislocation Of Toe Other foot examination findings Charcot Joint Arthropathy Interdigital Infection Loss Of Hair Over Tibial Shin Skin Changes First MTP Joint Mobility Restriction No.(%) 50 (49.0) 19 (18.5) 24 (23.5) 5 (4.9) 70 (68.0) 17 (17.0) 12 (12.0) 3 (3.0) 60 (58.0) 10 (10.0) 4 (4.0) 3 (3.0) 8 (8.0) 2 (2.0) 9 (9,0) 5 (5.0) 1 (1.0) 8 (7.8) 6 (5.8) 51 (50.0) 49 (48.0) 39 (38.2) Pressure in Past healed ulcer patients: 21 patients had past history of foot ulceration with most common on base of great toe. Table 3: Showing peak Pressure Points areas in Patients with Old Healed Ulcer and Non Ulcer Patients Variable Base of great toe Other toe MT Head Mid foot Lateral aspect of foot Heel Total Past Healed ulcer 11 1 4 4 1 0 21 Dynamic peak pressure point 8 1 4 1 1 0 15 Table 4: showing average peak pressure value in left and right foot (Dynamic mode) in Patients with Old Healed Ulcer and Non Ulcer Patients Right Foot Left Foot Pressure in non ulcer patients 153.31Kpa 155.05 Kpa Pressure in Healed Ulcer patients 155.79 Kpa 161.64 Kpa Table 5: Pressure Values In Static and Dynamic Mode (Abberivations- kpa: Kilo Pascal) Pressure Dynamic- Left Pressure Dynamic- Right Pressure Static- Left Pressure Static –Right n 102 102 102 102 Minimum 105kpa 100kpa 44kpa 44kpa Maximum 346kpa 245kpa 118kpa 118kpa Mean 156.41kpa 153.07kpa 68.69kpa 67.72kpa Std. Deviation 34.731 30.801 14.872 13.282 Table 6: maximum peak pressure point areas of foot Pressure point no pressure point base of great toe first and second metatarsal third to fifth metatarsal lateral aspect of foot middle of arch heel Left foot (static) 44 1 13 4 1 3 0 Right foot (static) 45 1 9 10 0 3 0 Patients who had past ulcer history, 71% (15) had maximum peak pressure point areas at healed ulcer area. This signifies that 71% patient had risk of recurrent ulceration due to high pressure at same old healed ulcer site. Maximum pressure values were seen in dynamic mode as compared to static mode. Abnormal peak pressure point areas are - 3rd,4th and 5th metatarsal heads, middle of foot, and lateral aspect of foot. In dynamic mode abnormal peak pressure point areas are high. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Left foot (dynamic) 13 28 35 15 3 6 2 Right foot (dynamic) 19 27 32 13 4 5 2 Table 7: Maximum Pressure point areas in different parts of foot Overall Pressure Points (area wise): Dynamic mode fore foot mid foot hind foot No (%) 88 (86.0) 11 (10.0) 3 (3.0) Above table shows that forefoot has more peak pressure point areas than mid foot and hind foot. Page 20 NATIONAL JOURNAL OF MEDICAL RESEARCH DISCUSSION Very few Indian studies have been done on diabetic foot complication and foot pressure analysis. Vicente I et al,16 Studied prevalence and risk factors of Anklebrachial index in patients with diabetes mellitus. They found that Prevalence of a low ABI in subjects with or without diabetes was 11.3% and 4.3% and prevalence of a pathological ABI was 18.8% and 7%, respectively. Factor associated with a low or pathological ABI were gender, age, duration of diabetes, the type of anti-diabetic treatment and the presence of vascular disease in another vascular bed. After multivariate adjustment, only age and duration of diabetes continue being significant. In this study no significant correlation has been found between ABI and other variates. According to Ramachandran, C. et al,17 Indians are susceptible to the major complications related to diabetes like coronary artery disease, neuropathy, nephropathy and retinopathy. In this study overall prevalence of diabetic neuropathy was 35%. Average duration of years to develop neuropathy was 12.9 years. M J Young et al 17 done a cross-sectional multicentre study of randomly selected diabetic patients to establish the prevalence of peripheral neuropathy. The overall prevalence of neuropathy was 28.5%. The prevalence of diabetic peripheral neuropathy increased with age. Neuropathy was associated with duration of diabetes. They concluded that Diabetic neuropathy increases with both age and duration of diabetes, until it is present in more than 50% of Type 2 diabetic patients aged over 60 years. In this study 38.2% patients had restricted joint mobility of first MTP joint. Positive correlation has been seen between neuropathy and joint mobility. C. H. M. van Schie18 studied biomechanics of diabetic foot and shown the importance of range of motion of first MTP joint. The main motion of the first MTPJ and the lesser MTPJs is in the sagittal plane (dorsiflexion and plantar flexion). During propulsion the body weight is moving forward over the hallux creating relative dorsiflexion of the first MTPJ. Maximum loading of the first MTH and hallux is practically at the same time during stance in normal gait, highlighting the importance of the load bearing function of both the hallux and first MTH. Michael J Mueller et al 19 studied Plantar Stresses on the Neuropathic Foot during Barefoot Walking. In their study they proposed mechanism for occurrence of high metatarsal head peak pressure. They says that, the Soft tissue clearly plays an important role in stress distribution, and the thicker tissue under the rear foot compared with the forefoot may help to distribute stresses evenly to the underlying bony structures. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 People with diabetes mellitus and peripheral neuropathy have a high incidence of hammer-toe deformity (hyperextension of the metatarsophalangeal joint) that is associated with high plantar pressures and skin breakdown. Although the precise reason for the hammertoe deformity is not known, weakness and atrophy in the intrinsic muscles of the foot from peripheral neuropathy are thought to contribute for further discussion of the muscle and bone changes secondary to peripheral neuropathy. People with intrinsic muscle weakness develop hammer toe deformity. Early identification of restriction of First MTP joint mobility and hammer toe deformity can help to reduce skin break down subsequent ulcer formation. Tatiana Almeida Bacarin, et al20 studied Plantar pressure distribution patterns during gait in diabetic neuropathy patients with a history of foot ulcers. Results were-Neuropathic subjects from both the diabetic neuropathy and Diabetic without neuropathy groups showed higher plantar pressure than control subjects. At midfoot, the peak pressure was significantly different among all groups: control group (139.4±76.4 kPa), diabetic neuropathy (205.3±118.6 kPa) and DNU (290.7±151.5 kPa) (p=0.008). They concluded that A history of foot ulcers in the clinical history of diabetic neuropathy subjects influenced plantar pressure distribution, resulting in an increased load under the midfoot and rearfoot and an increase in the variability of plantar pressure during barefoot gait. The progression of diabetic neuropathy was not found to influence plantar pressure distribution. The findings of above study and pressure values coincide with this study. Andrew J M Boulton, et al 21 studied Dynamic Foot Pressure and Other Studies as Diagnostic and Management Aids in Diabetic Neuropathy. They used microprocessor-controlled optical system. Fifty-one percent of neuropathic feet had abnormally high pressures underneath the metatarsal heads compared with 17% of the diabetic controls and 7% of non diabetic subjects. All those feet with previous ulceration had abnormally high pressures at the ulcer sites. They conclude that simple bedside investigations, such as measurement of the VPT alone, may be useful in identifying those patients at risk of foot ulceration. Foot pressure studies may then be used in such patients as a predictive and management aid by determining specific areas under the foot that are prone to ulceration. Dynamic foot pressure is important for prediction of ulcer due to high foot pressure. In our study High pressure values with abnormal peak pressure point areas are seen at metatarsal heads and mid foot area. Richard M Stess et al22 in their study “The Role of Dynamic Plantar Pressures in Diabetic Foot Ulcers” studied dynamic pressure variables, such as normalized peak pressure of maximum pressure picture Page 21 NATIONAL JOURNAL OF MEDICAL RESEARCH (MPP), pressure-time integral (PTI), and force-time integral (FTI), were measured Using the EMED-SF plantar pressure analyzer, in each foot. They concluded that Neuropathic patients have an increase in dynamic plantar foot pressures placing them at risk for plantar ulceration. Instruments such as the EMED-SF system can be helpful in detecting possible sites of plantar ulcerations by locating the areas of maximum pressure. Dynamic plantar foot pressure assessment is important for Identification of high pressure areas of foot and can help to prevent future ulcer. CONCLUSION Meticulous clinical examination can easily identify diabetic neuropathy and related complications of diabetic foot. This will help for early diagnosis and prevention of diabetic foot complications. Foot pressure analysis can be useful tool to screen patients of diabetic foot for high pressure point areas and can predict future risk of ulceration due to high foot pressure. This study gives findings and data of complications of diabetic foot and foot pressure analysis in Indian diabetic patients as limited studies are available. REFERENCES 1. Shaw J, Sicree R, Zimmet Z. Global estimates of the prevalence of diabetes for 2010 and 2030. Journal of Diabetes Research and Clinical Practice. 2010; 87:4 –1 4. 2. Ramachandran A, Das AK, Joshi SR, Yajnik CS, Shah S, Prasanna KM. Current Status of Diabetes in India and Need for Novel Therapeutic Agents. Journal of Association of Physicians;2010; 58: 7-9. 3. Mohan V, Sandeep S, Deepa R, Shah B, Varghese C. Epidemiology of type 2 diabetes: Indian scenario. Indian J Med Res. 2007; 125(March):217-230.. 5. Stess RM, Jensoen SR, Mirmiran R. The role of dynamic plantar pressures in diabetic foot ulcers. Diabetes Care 1997;20:855 6. Young MJ, Veves A, Boulton AJM. The diabetic foot: Aetiopathogenesis and management. Diabetes Metab Rev 1993;2:10927. 7. Veves A, Fernando DJS, Walewski P, Boulton AJM. A study of plantar pressures in a diabetic clinic population. Foot 1991;1:8992. 8. VM, Veves A. Foot pressure measurement. Orthop Phys Ther Clin N Am 1997;6:1–16 9. Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care 1998;21:17149. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 10. Pham HT, Armstrong DG, Harvey C, Harkless LB, Giurini JM, Veves A. Screening techniques to identify persons at high risk for diabetic foot ulceration: A prospective multicenter trial. Diabetes Care 2000;23:60611 11. Young MJ, Breddy JL, Veves A, Boulton AJ. The prediction of neuropathic foot ulceration using vibration perception thresholds, a prospective study. Diabetes Care 1994;17:5576. 12. Reiber GE, Boyko EJ, Smith DG. Lower extremity foot ulcers and amputations in diabetes. In: Harris MI, Cowie C, Stern MP (eds.). Diabetes in America, Second Edition. NIH Publications No. 951468, 1995. 13. Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA: Lower extremity amputation in people with diabetes:epidemiology and prevention. Diabetes Care 12:2431, 1989 14. Jeremy Rich, DPM; Aristidis Veves, MD, DSc Forefoot and Rearfoot Plantar Pressures in Diabetic Patients: Correlation to Foot Ulceration Wounds. 2000;12(4) 15. Matthew j. young, john l. breddy, aristidis veves, andrew j. m. boulton, The Prediction of Diabetic Neuropathic Foot Ulceration Using Vibration Perception Thresholds: A prospective study, diabetes care, volume 17, number 6, June 1994 16. A Chawla, G Bhasin, R Chawla. Validation Of Neuropathy Symptoms Score (NSS) And Neuropathy Disability Score (NDS ) In The Clinical Diagnosis Of Peripheral Neuropathy In Middle Aged People With Diabetes . The Internet Journal of Family Practice. 2013 Volume 12 Number 1. 17. Vicente I, Lahoz C, Taboada M, Laguna F, García-Iglesias F, Mostaza Prieto JM Rev Clin Esp. Ankle-brachial index in patients with diabetes mellitus: prevalence and risk factors 2006 May;206(5):225-9. 18. Ramachandran A, Snehalatha C, Viswanathan V. Burden of type 2 diabetes and its complications – The Indian scenario. Current Science. 2002; 83:1471–1476 19. C. H. M. van Schie MSC, PhD, A. J. M. Boulton MD, FRCP Biomechanics of the Diabetic Foot, The Diabetic Foot Contemporary Diabetes 2006, pages 185-200. 20. Michael J Mueller, Dequan Zou, Kathryn L Bohnert, Lori J Tuttle and David R Sinacore; Plantar Stresses on the Neuropathic Foot During Barefoot Walking; PHYS THER. 2008; 88:1375-1384. 21. Tatiana Almeida Bacarin,I Isabel C. N. Sacco,I Ewald M. HennigII; Plantar pressure distribution patterns during gait in diabetic neuropathy patients with a history of foot ulcers; CLINICS 2009;64(2):113-20 22. Andrew J M Boulton, Colin A Hardisty, Roderic P Betts,Christopher I Franks, Richard C Worth, John D Ward and Thomas Duckworth; Dynamic Foot Pressure and Other Studies as Diagnostic and Management Aids in Diabetic Neuropathy; Diabetes care 6: 26-33, January -February 1983. 23. Richard M Stess, DPM, Shayne R Jensen, BS and Roya Mirmiran, BS;The Role of Dynamic Plantar Pressures in Diabetic Foot Ulcers; Diabetes care, volume 20, number 5, may 1997. Page 22 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE PREVALENCE OF VITAMIN-A DEFICIENCY & REFRACTIVE ERRORS IN PRIMARY SCHOOL-GOING CHILDREN Rupali D Maheshgauri1, Radhika R Paaranjpe2, Abha Gahlot3, Ami Gohil4, Sonali Pote5, Deepaswi Bhavsar5 Author’s Affiliations: 1Associate professor; 2Assistant Professor; 3Professor; 4UG student; 5PG student, Dept. of ophthalmology, Dr.D.Y.Patil Medical College, Pimpri, Pune Correspondence: Dr Rupali D Maheshgauri Email: [email protected] ABSTRACT Purpose: The objectives of the study were to assess refractive errors in primary school-going children; to critically analyze the need for supplementation of Vitamin A; and to children of low socioeconomic strata. Methods: Students were examined from 2 primary schools. Visual acuity was tested using Snellen’s chart, Pictogram & Landolt C chart. Detailed anterior and posterior segment examination was done using Binocular loop, Ophthalmoscope and Streak retinoscope. Results: Total no of 560 children of age 3 to 13yr were screened from 2 primary schools.Statistically significant difference was found in the age of the study subject & presence of refractive errors. Percentage of students having Refractive error: myopia (29.64%) is the major cause of refractive error, followed by astigmatism (4.28%) hypermetropia (3.25%) and amblyopia (1.25%). Conclusion: It was observed that many children had high refractive error and were undiagnosed. The possible reason could be ignorance on the part of teachers and parents, even when the children have vision related complains. Also the children in the younger agegroup lack the acumen to judge whether they can see clearly or not. Prevalence of Vitamin A deficiency appears reduced in urban areas. Key words: Vitamin A deficiency, refractive error, primary school going children, INTRODUCTION According to the World Health Organization (WHO) “Approximately 250,000-500,000 children in developing countries become blind each year owing to Vitamin A deficiency, with the highest prevalence in Southeast Asia and Africa.” 1 Vitamin A is needed by the retina in the form of a specific metabolite, the light-absorbing molecule, Retinal, that is absolutely necessary for both low-light (scotopic) and colour vision. “Vitamin A” covers both a pre-formed vitamin, retinol, and a pro-vitamin, beta carotene, some of which is converted to retinol in the intestinal mucosa.2 Vitamin A also functions in a very different role, as an irreversibly oxidized form of retinol known as Retinoic acid, which is an important hormone-like growth factor for epithelial and other cells. It is the role of vitamin A in the visual cycle that we are concerned with in this study. 3 Vitamin A deficiency can be of two categories: Primary and Secondary. Primary deficiency of the vitamin is due to its inadequate intake in the diet. In certain cases (especially in the developing countries) early weaning of a child can later lead to primary deficiency. Secondary vitamin A deficiency is the result of malabsorption disorders or a defect in NJMR│Volume 6│Issue 1│Jan – Mar 2016 its metabolism. Poor eyesight is one of the first manifestations of Vitamin A deficiency. A severe deficiency leads to night-blindness, Bitot’s spots, corneal xerosis and keratomalacia which is a major cause of blindness in India. There is a decline in clinical Vitamin A deficiency in under-five children in the country. This could perhaps be due to increase in access to health care, consequent reduction in severity and duration of common childhood morbidity due to infections. Data from NNMB surveys show that there has been substantial decline in prevalence of Bitot’s’s spots. The NNMB micronutrient survey indicates that currently prevalence of Bitot’s spots in preschool children is only 0.7% 4 prevalence of night blindness is less than 0.5 %. Data from NNMB and ICMR surveys indicate that prevalence of Bitot’s’s spots is less than 1%. Data from NNMB survey showed that prevalence of Bitot’s spots is higher in children of illiterate mothers; prevalence of Bitot’s spots is lowest in children from small families.5 There are large inter-state variations in the prevalence of VAD among children. In the 1950s, prevalence of night blindness and Bitot’s spots in pre-school children ranged between 5 per cent and 10 per cent in most states. The number of Page 23 NATIONAL JOURNAL OF MEDICAL RESEARCH children with vision problems has fallen below 10 per 1,000 children in states such as Gujarat and Punjab.6 Secondly, Refractive errors are the most commonly encountered ocular problems worldwide. In many a case, they go unnoticed, especially among children: owing to the fact that they are too young to even realise, let alone tell, that they are having difficulty in seeing clearly. What adds to the iceberg phenomenon of the disease was the fact that India is a developing nation, with a large population living below the poverty line. This results in a vast number of children who don’t even know how to read. It were these children that formed the core interest- in our study. The purpose of this study was to find out the efficacy vitamin A supplementation programme and to sensitize awareness of balanced diet in people of lower socioeconomic strata. And also to find out the refractive error in primary school going children and spread awareness of eye examination in them and parents to avoid childhood refractive amblyopia. METHODOLOGY Ethics: Study was conducted after a ethical clearance from ethical committee of our Institute (Dr. D.Y.Patil vidyapeeth)which follows Helsinki Declaration of 1975, as revised in 2000. Permission from school headmistress was obtained to conduct a study. In this prospective study, a total number of 652 students from two primary schools in suburban area, including both the sexes, between 1 to 13 age group students were examined in mid-June-August 2015. All students were examined for both, Vitamin A deficiency and Refractive errors. Vitamin A deficiency was assessed by looking for specific signs and symptoms along with extra-ocular manifestations, as per proforma. Visual acuity was tested with Snellen’s chart, Pictogram and Landolt C chart (for distant vision) Jaeger’s chart (for near vision), anterior segment examination done with help of corneal loop and torch. Procedure for corneal examination with the help of Binocular loop and torch: Indistinct or blurred edges of the corneal light reflex (reflection of light from the cornea when illuminated) suggest that the corneal surface is not intact or is roughened, as occurs with a corneal abrasion or corneal xerosis. Posterior segment examination was done with Beta Heinz Direct Ophthalmoscope. Ametopic children underwent cycloplegic refraction with streak retinoscope and were prescribed glasses after postmydriatic test. All data was documented and analysed with ‘Statistical Package for Social Science’ version 15(IBM). All data was analysed for quantitative measures. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 RESULTS A total of 560 children of age 3 years to 13 years were screened from two primary schools. Among 560 students, 215 students had refractive error and 345 students revealed emmetropia. Laterality of visual acuity is shown in Table 1 Table 1: Visual Acuity of Each Eye (n=560 Visual Acuity Right Eye No. (%) 372 (66.4) 84 (15.0) 51 (9.1) 27 (4.8) 14 (2.5) 7 (1.3) 5 (0.8) 6/6 6/9 6/12 6/18 6/24 6/36 6/60 Left Eye No. (%) 351 (62.6) 93 (17.0) 62 (11.0) 30 (5.4) 12 (2.1) 6 (1.0) 6 (1.0) Table 2: Association between Age of the Study Subject and Refractive Error Age in years 5 6 7 8 a 10 11 12 Refractive Error Yes (%) No (%) 27 (27.55) 71 (72.45) 32 (32.32) 57(64.04) 9 (17.31) 43 (82.69) 36 (52.94) 32 (47.06) 36 (46.15) 42 (53.85) 14 (40.00) 21 (60.00) 40 (40.82%) 58 (59.18%) 21 (50.00%) 21 (50.00%) Total (%) 98 (100) 89 (100) 52 (100) 68 (100) 78 (100) 35 (100) 98 (100%) 42 (100%) X 2 = 27.006; df=7; p value = 0.0001, Highly significant Statistically significant difference was found in the age of the study subject and presence of refractive error. Percentage of refractive error is increased with the increase in age group. (Table 2 ) Table 3: Association between Gender of the Study Subject and Refractive Error Gender Male Female Total Refractive Error Yes (%) No (%) 117 (33.33) 189 (33.75) 98 (32.56) 156 (28.00) 215 (32.97) 345 (61.60) X2 = 0.016; df=1; p value = 0.899 Total 306 (100) 254 (100) 560 (100) Table 4: Distribution of Refractive Error Refractive Error Myopia Hypermetropia Astigmatism Amblyopia No. (%) 166 (29.64) 18 (3.25) 24 (4.28) 7 (1.25) Page 24 NATIONAL JOURNAL OF MEDICAL RESEARCH No statistically significant difference was found in the gender of the study subject and presence of refractive error. As shown in Table 3 X 2 = 0.016 with 1 df: p value = 0.899 As per shown in table no 4 myopia was the most common refractive error followed by astigmatism and hypermetropia DISCUSSION A total of 560 children were screened for vitamin A deficiency and refractive errors in two primary schools. A complete ophthalmic examination of 560 children was then performed. Among them a significantly high percentage (33.42%) was suffering from refractive errors. The visual acuity testing was done with the help of Snellen’s chart, Landolt C chart (for distant vision) and Jaeger’s chart (for near vision). All the children diagnosed with any refractive error or ocular pathology was further referred for a detailed examination to the hospital. Those diagnosed with a refractive error were given a spectacle correction after cycloplegic refraction with appropriate correction. From Table 4 it was observed that a high percentage (215) out of 560 students, were diagnosed with refractive errors. Out of which 166 students were diagnosed with myopia. Factors that contributed to a high percentage of myopia within the study group includes- Poor socio-economic status, Undiagnosed case and Ignorance by parents/ teachers when the child complains of difficulty in seeing. A study on refractive errors among school children in Kolkata by Das A, Dutta H, Bhaduri G, De Sarkar A, Sarkar K, Bannerjee M. their study shows close resemblance with our study There is an increase of prevalence of refractive errors with increase of age, but it is not statistically significant (p > 0.05). which in our study we found it stastially significant (p<0.001)considering increase in axial length with increased age may be the reason for the myopic patients .7 with increasing age patient may have better perception of surrounding and reports well. There is also no significant difference of refractive errors between boys and girls. This is comparable to our study as per which of myopia (29.64%) is the major cause of refractive error, followed by astigmatism (4.28%) hypermetropia (3.25%) and amblyopia (1.25%). 7 By Kawuma M, Mayeku R. 8 They found that astigmatism is commonest followed by hyperopia and least common, Myopia, as refractive error. Our findings were the polar opposite of the above mentioned project- myopia being the most common condition. This reveals that there may be difference in types of refractive errors, but meticulous examination to find them has to be done in primary school-going children. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 In the study, B.M. El-Bayoumy, A. Saad and A.H. Choudhury; Landolt broken ring chart and pin-hole were employed as the primary tools. We too utilized the same instruments- Landolt broken ring chart and Snellen’s chart. The principal reason for this was that majority of children were too young to read. Others were poor in language skills and incapable of reading Hindi, Marathi and English Snellen’s charts. We too concluded that myopia is the most commonly occurring refractive error among children; the majority being cases of school myopia. 9 Gupta et al showed that overall prevalence of ocular morbidity in government and private schools did not show any statistical significant difference.10 In our study we too examined children from two schools- a private institution and a municipal school. Our observations were similar to the one stated formerly- there was no significant difference between the findings in the two kinds of educational set-ups. More importantly, in consistence with the study in Kolkata by Das et al 7my observations and calculations revealed that gender does not play a causal role in the development of refractive errors. As per study of Murthhy et al. 11 there was an agerelated shift in refractive error from hyperopia in young children (15.6% in 5-year-olds) toward myopia in older children (10.8% in 15-year-olds) as compared with our study. Through careful statistical analysis of the data collected, we deduced that the risk of developing myopia increases with age. Myopia existed in the same proportion as the aforementioned studies. Therefore, it would not be erroneous to say that a similar trend persists through the rest of the country Nazia Uzma et al 12 stated that the prevalence of refractive error was higher in the urban than the rural group. Increased literacy rate, duration of study hours and older age of the child were found to have contributed more to prevalence of myopia in the urban group. In the study 54% presented with refractive errors in the urban group and 3.2% students showed night-blindness as a sign of vitamin A deficiency. Comparison with our study showed findings that were consistent to those of the aforementioned study. The percentage of children suffering from refractive errors was comparable. But there was no case of vitamin A deficiency in our study. The study was also conducted in suburban area as like our area. The area has been well covered by health-care centres and other medical facilities. Also due to urbanization and mass-coverage of the Vitamin A prophylaxis programme, there seems to be a significant decrease in vitamin A deficiency. We concluded that viatamin A deficiency varies from place to place. Study by Chaturvedi S, Aggarwal OP. 13 . Trachoma (18%) was the most common ocular morbidity followed by vitamin A deficiency (10.6%), it revealed Page 25 NATIONAL JOURNAL OF MEDICAL RESEARCH that there are certain parts of India that are still tackling preventable diseases like Trachoma and Vitamin A deficiency. Vitamin A deficiency is one of the major deficiencies among the lower economic strata of India. In the fifties and sixties many of the states reported that blindness due to Vitamin A deficiency was one of the major causes of blindness in children below five years. A five-year long field trial conducted by NIN showed that if massive dose Vitamin A (200,000 units) was administered once in six months to children between one and three years of age, the incidence of corneal xerophthalmia is reduced by about 80 per cent 14 In view of the serious nature of the problem of blindness due to Vitamin A deficiency, it was felt that urgent remedial measures in the form of massive dose Vitamin A supplementation covering the entire population of susceptible children should be undertaken. In 1970, the National Prophylaxis Programme against Nutritional Blindness was initiated as a centrally sponsored scheme. Under this scheme, all children between ages of one and three years were to be administered 200,000 IU of Vitamin A orally once in six months. 15 This programme had been implemented in all the states and union territories during the last thirty-five years. The major bottleneck during the 1970s was lack of infrastructure at the peripheral level to ensure timely administration of the dose.16 In the 1980s there was considerable improvement in the infrastructure. The lack of adequate supply of Vitamin A, which came in the way of improved coverage, was also corrected. In an attempt to improve the coverage, especially of the first two doses, it was decided to link Vitamin A administration with the on-going immunization programme during the Eighth Plan period. Under the revised regimen a dose of 100,000 IU of Vitamin A was administered to all infants at nine months along with measles vaccine and a second dose of 200,000 IU was administered at 18 months of age along with booster dose of DPT and OPV. Subsequently, the children were to receive three 281 doses of 200,000 IU of Vitamin A every six months until 36 months of age. 17 The reported coverage figures under the modified regimen indicate that there was some improvement in coverage with the first dose (50 –75 per cent). However, the coverage for subsequent doses was low. In an attempt to further widen the coverage, some states like Odisha linked administration of Vitamin A with the pulse polio immunization campaign. It is reported that the state took precautions to prevent overdosing by stopping Vitamin A administration in the preceding six months. The state reported improved coverage 18. Following this report several states embarked on a similar exercise. Planning Commission, the Department of Family Welfare and the Indian Academy of Pediatrics stated that this strategy is inappropriate. 19 NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 During the campaign mode administration of Vitamin A, along with pulse polio, in Assam 20 (21) (22) in November 2001, deaths among children who were administered massive dose Vitamin A was reported. Some of these deaths could be coincidental where Vitamin A had been administered to ill children, but the possibility that some of the deaths could have been due to Vitamin A toxicity (either due to administration of higher dose or a massive dose Vitamin A administration earlier) cannot be ruled out. 23 The Tenth Five Year plan recommended that the second and subsequent doses of massive dose vitamin A may be administered biannually in the pre summer (April-May) and pre winter (Sept-Oct) period. This strategy was successfully put into operation in states like U.P with UNICEF 24 assistance and resulted in improved coverage for all the doses. In 2006-07, a policy decision has been taken to cover all children in the 9 month to 6 yr age group under the massive dose vitamin A programme. Clinical Vitamin A deficiency often coexists with other micronutrient deficiencies and hence, there is a need for broad-based dietary diversification programmes aimed at improving the overall micronutrient nutritional status of children. 25 WHO’s goal 26 is the worldwide elimination of vitamin A deficiency and its tragic consequences, including blindness, disease and premature death. To successfully combat VAD, short-term interventions and proper infant feeding must be backed up by longterm sustainable solutions. The arsenal of nutritional “well-being weapons” includes a combination of breastfeeding and vitamin A tion 27coupled with enduring solutions, such as promotion of vitamin A-rich diets and food fortification .28 The basis for lifelong health begins in childhood. Vitamin A is a crucial component. Since breast milk is a natural source of vitamin A, promoting breastfeeding is the best way to protect babies from VAD.29 CONCLUSION The study was conducted in a municipal school and a private school. Myopia contributed to 29.64% refractive error being the commonest of the refractive errors. We observed that many children had high refractive error and were undiagnosed. The possible reason could be ignorance on the part of teachers and parents when the child complained about difficulty in seeing clearly. Also a child in the younger age-group lacks the acumen to judge whether he/she can see properly or not. Lack of proper nutrients and undernourishment culminate in refractive errors. All the children with the aforesaid complaints were sent for detailed ophthalmic examination, and correct power spectacles were prescribed. During screening of the children there were new cases of refractive erPage 26 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 urban population in New Delhi.” Invest Ophthalmol Vis Sci. rors of which few had a very high refractive error 2002 Mar; 43(3):623-31. Source - Dr. Rajendra Prasad Centre and needed immediate correction and a few who had for Ophthalmic Sciences, All India Institute for Medical Scijust developed myopia-school/simple myopia. The ences, New Delhi, India. children with amblyopia were also detected and beNazia Uzma PhD et al- “A comparative clinical survey of the fore it could progress into other ocular conditions it 12. prevalence of refractive errors and eye diseases in urban and was corrected. rural children.” If we speculate the present scenario of our country, 13. Chaturvedi S, Aggarwal OP. - “Pattern and distribution of ocular morbidity in primary school children of rural Delhi.” we will come to see that India has taken a giant leap Asia Pac J Public Health. 1999; 11(1):30-3.Sourceforward in an attempt to improve the general health Department of PSM, University College of Medical Sciences, and well-being of the population. Through the decDelhi, India. ades, more and more emphasis has been laid on reducing the prevalence and incidence of the slow, si- 14. NNMB National Nutrition Monitoring Bureau. 2002. NNMB Micronutrient Survey. National Institute of Nutrilent killers- the deficiency disorders. The National tion, Hyderabad. Programme for Prevention of Nutritional BlindnessNational Nutrition Monitoring Bureau (NNMB). 1979-2006. launched in 1970- bears testimony to the progress 15. NNMB Reports. National Institute of Nutrition, Hyderabad. made by the health-care sector of India. 16. WHO (1973). WHO Chr. 27 (1) 28 REFERENCES 1. K. Park.: Park’s textbook of Preventive and Social Medicine. 567-569. (21st edition) Published February 2011 by Banarsidas Bhanot Publishers ISBN 8190607995 (ISBN13: 9788190607995 2. Lancet 2: 325 Editorial (1984) 3. Carolyn Berdanier : Advanced Nutrition Micronutrients. Pg 22-39.1997 4. Report of District Nutrition Project. Indian Council of Medical Research. 1999.< R> 5. India’s Undernourished Children: A Call For Reform and Action, World Bank Report:http://siteresources.worldbank.org/HEALTHNUTRIT IONANDPOPULATION/Resources/28162710956981401 67/IndiaUndernourishedChildrenFinal.pdf; last accessed on 24/09/07 6. Chakravarty, I., Ghosh, K. Micronutrient Malnutrition - Present Status and Future Remedies. J. Ind. Med. Assoc.; 98: 539.2000 7. Das A, Dutta H, Bhaduri G, De Sarkar A, Sarkar K, Bannerjee M.- “A study on refractive errors among school children in Kolkata. J Indian Med Assoc. 2007 Apr; 105(4):169-72. Source - Regional Institute of Ophthalmology, Medical College, Kolkata 700073.WHO (1982). Techn. Rep. Ser., No. 672 8. 9. Kawuma M, Mayeku R. – “A survey of the prevalence of refractive errors among children in lower primary schools in Kampala district.” Afr Health Sci. 2002 Aug; 2(2):69-72. Source-Department of Ophthalmology, Makerere University, Kampala, Uganda. B.M. El-Bayoumy, A. Saad and A.H. Choudhury- “Prevalence of refractive error and low vision among schoolchildren in Cairo” 10. Gupta M, Gupta BP, Chauhan A, Bhardwaj A – “Ocular morbidity prevalence among school children in Shimla, Himachal, North India.” 17. Report of the Workshop to Review Programs for Control of Vitamin A Deficiency in India, 1997. 18. IAP Policy on linking vitamin A to pulse polio programme. Indian Pediatr 2000; 37:727. 19. National Family Health Survey (NFHS-2) 1998 20. India Times News. 13 November, 2001. 21. Sommer A. Vitamin A Deficiency and its consequences: A field guide to detection and control. World Health Organisation, Geneva 1996. 22. Bauernfeind JC. 1980. The safe use of vitamin A. A report of the International vitamin A Consultative Group. Washington, DC. 23. Kapil U. Administration of massive dose of vitamin A and related deaths in India. BMJ 2001; 323:1206. 24. Vitamin A Global Initiative; a strategy for acceleration of progress in combating vitamin A deficiency. 1998. UNICEF/MI/WHO/CIDA/USAID. 25. Gopalan C. Prevention of micronutrient malnutrition. NFI Bulletin. October 2001; vol 22, No.4. 26. WHO/CHD Immunisation-linked vitamin A supplementation study Group. Randomised trial to assess benefits and safety of vitamin A supplementation linked to immunisation in early infancy. Lancet 1998; 352:1257-63. 27. Beaton GH, Martorell R, Aronson KJ et al. “Effectiveness of vitamin A supplementation in the control of young child morbidity and mortality in developing countries.” ACC/SCN State of the Art Series. Nutrition policy discussion paper No.13. 1993. WHO, Geneva. 28. Viajayaraghavan K, Nayak U, Bamji MS, Ramana GNV, Reddy V. Home gardening for combating vitamin A deficiency in rural India. Food and Nutrition Bulletin.1997; 18:33729. A Report on National Consultation on Benefits and Safety of Vitamin A Administration to Pre-school Children and Pregnant and Lactating Women. 2000. Conclusions and Recommendations. Ministry of Health & Family Welfare, New 11. Murthy GV, Gupta SK, Ellwein LB, Muñoz SR, Pokharel GP, Sanga L, Bachani D. – “Refractive error in children in an NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 27 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE EFFECTS OF TADALAFIL ON CARDIOPULMONARY HAEMODYNAMICS IN PATIENTS OF CHRONIC PULMONARY DISEASES WITH PULMONARY HYPERTENSION: A PILOT STUDY Indrajeet Sharma1, Purshottam K. Kaundal2, Malay Sarkar3, Tulika Jha4, Prakash C. Negi5, Ashok K. Sahai6, Sanjeev Asotra7 Author’s Affiliations: 1Assistant Professor; 2Professor; 4PG Student; 6Professor & Head, Dept. of ogy; 3Professor & Head, Dept. of Pulmonary Medicine; 5Professor & Head; 7Associate Professor, Dept. of Cardiology, IGMC, Shimla Correspondence: Dr Indrajeet Sharma E-mail: [email protected] ABSTRACT Background and Objectives: Effect of tadalafil on cardiopulmonary haemodynamics in patients of chronic pulmonary diseases residing at an altitude has not been studied adequately. The present study reports the effect of tadalafil on cardiopulmonary haemodynamics in patients of chronic pulmonary diseases with PH residing at an altitude ranging between 1000 meters to 2500 meters above mean sea level. Methods: Seventy six patients of chronic pulmonary diseases with PH diagnosed by echocardiography were randomized to receive tadalafil 40 mg once a day or to the control group. The effect of tadalafil on cardiopulmonary haemodynamics was assessed after 3 months of tadalafil exposure. The echo Doppler derived indices of cardiopulmonary haemodymics recorded were; TR gradient, pulmonary flow acceleration time, pulmonary vascular resistance, myocardial performance index, RV eccentricity index, tricuspid annular plane systolic excursion and cardiac output. The arterial oxygen saturation was measured by Pulse oxymeter. Results and Interpretation: Tadalafil significantly improved the indices of RV performance; pulmonary flow velocity time integral (14.54 ± 3.17cm versus 12.25 ± 2.25cm, p <0.0002), tricuspid annular plane systolic excursion (18.53±4.0mm versus 17.11±3.94mm, p<0.002), RVFS 30.6% vs. 24.8% p<0.003. There was no significant change in the TR gradient although PFAT increased significantly with tadalafil; (89.8±11.7 vs. 76.2±8.2 msec. p<0.001). There was a trend of lower PVR with tadalafil buts not statistically significant 3.6±0.9 vs. 3.1±1.0. Tadalafil also improved the arterial oxygen saturation, SPO 2 (90.91±1.76% versus 88.40±1.79%, p<0.0001) significantly. Conclusions: Tadalafil improved RV function significantly but its effect on PVR was modest. Key words: Cardiopulmonary haemodynamics, Phosphodiesterase-5 inhibitors, Pulmonary hypertension, Tadalafil. Trial registration: CTRI/2015/01/005413. INTRODUCTION Pulmonary hypertension (PH), a condition of elevated pressure in the pulmonary vasculature, is a common co-morbidity observed in the setting of parenchymal lung disease and in patients who experience chronic hypoxemia.1 Amongst chronic lung diseases, PH occurs frequently in patients with chronic obstructive lung disease (COPD) as well as in patients with interstitial lung disease (ILD).2 COPD is a leading cause of morbidity and mortality with WHO’s Global Burden of Disease and Risk Factors project[3] showing that in 2001, COPD was the fifth leading cause of death in high-income countries, accounting for 3.8% of total deaths, and it NJMR│Volume 6│Issue 1│Jan – Mar 2016 was the sixth leading cause of death in nations of low and middle income, accounting for 4.9% of total deaths.3 Interstitial lung diseases (ILDs), also known as diffuse parenchymal lung diseases (DPLDs) refers to a group of lung diseases affecting the interstitium (the tissue and space around the air sacs of the lungs). It concerns alveolar epithelium, pulmonary capillary endothelium, basement membrane, perivascular and perilymphatic tissues. As the inflammation causes thickening and scarring of the interstitium, gas exchange at the alveolo-capillary membrane gets impaired and patient gradually becomes dyspneic even at rest.4 Page 28 NATIONAL JOURNAL OF MEDICAL RESEARCH Echocardiography is a non-invasive method for estimation of the presence and severity of PH. TR velocity derived gradient is the most reliable noninvasive method for estimation of the presence and severity of PH. A TR gradient of more than 46 mm Hg5 and/or Pulmonary flow acceleration time <90 msec6-7 has been taken as an evidence of the presence of PAH. The sensitivity and specificity for the detection of PAH depends on the cut-off value of pulmonary flow acceleration time. Tadalafil, a selective inhibitor of cGMP-specific PDE-5, increases the levels of cGMP and thereby enhances nitric oxide-mediated vasodilatation.8 Alveolar oxygen tension is an important stimulus for the generation of cGMP by smooth muscles of the pulmonary vascular resistance vessels. Tadalafil augments the vasodilatory effect of cGMP by inhibiting its degradation. The longer elimination half-life of tadalafil makes it suitable for the treatment of PH as it can be used as once daily dose.9 The response of PDE-5 inhibitors in the setting of low atmospheric tension among natives of medium altitude has not been reported. The present study reports the effect of tadalafil on the cardiopulmonary haemodynamics in patients of chronic pulmonary diseases with PH residing at an altitude of 1000 meters to 2500 meters above mean sea level. METHODOLOGY Study population and selection process: The patient population screened for recruitment to the study were all consecutive patients of chronic pulmonary diseases; chronic obstructive pulmonary diseases, interstitial lung diseases and post-tubercular pulmonary fibrosis attending the outpatient service of pulmonary medicine. Diagnosis of PH was based on the following criteria; TR gradient of ≥46 mmHg and/or pulmonary flow acceleration time of ≤90 msec.[5-7] Patients of stable chronic pulmonary disease with PH, aged between 20 to 80 years and willing to participate in the study after informed consent were enrolled. Patients were excluded if they had a history or clinical evidence of chronic pulmonary diseases with acute exacerbation and or without PH, coronary artery disease, chronic kidney disease, liver disease, left ventricular failure, myopathy/muscular dystrophy, peripheral vascular disease/osteoarthritis of knees, pregnancy, drug history of anorexigens intake, HIV, and those already on tadalafil therapy. Study design: It was a tertiary care centre hospital based Randomized controlled trial. Patients were recruited from July 2013 to July 2014 and follow up ended by Oct. 2014. The study protocol was approved by IGMC ethical committee. Baseline data collection: Data pertaining to sociodemographic characteristics, exposure to self reNJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 ported tobacco smoking and biomass fuel smoke was recorded using structured questionnaires. The status of effort tolerance using NYHA functional class was recorded. The medications prescribed for chronic lung disease by treating physician was also recorded. Examination included recording of blood pressure, heart rate, and arterial oxygen saturation with pulse oxymeter model: DR-50D. Severity of pulmonary function compromise was assessed by measuring the lung volumes and flow rates using spirometer model Vitalgraph-Compact-Buckingham, England. Echocardiography examination was done in all patients using an echocardiography machine, Model 1E-33 of Philips Medical System using a broad band phased array adult probe in supine left lateral decubitus position with real time ECG signals to record following indices of cardiopulmonary hemodynamic parameters: • Indices of RV systolic Function; Myocardial performance index (MPI): The MPI is defined as the ratio of isovolumic time divided by ET; [(IVRT + IVCT)/ET]. IVRT (Isovolumic relaxation time), IVCT (Isovolumic contraction time) is the time from tricuspid valve closure to tricuspid valve opening. Right ventricular ET (Ejection time) time interval from beginning of pulse Doppler derived spectral envelop across RVOT to end of the spectral envelop. • Pulmonary flow acceleration time (PFAT); Time interval from beginning of the pulse Doppler signal to the peak of spectral envelop at RVOT. • Tricuspid Regurgitation (TR) Gradient; Patients with TR in colour flow imaging TR velocity was recorded to Quantify the RV-RA instantaneous peak systolic gradient to estimate PH. TR gradient of ≥46 mmHg was taken as the evidence of raised PAP. • PVR was estimated by recording velocity time integral (VTI) of pulse Doppler spectral recorded in RVOT and maximum TR velocity (TRV max)measured by using colour flow mapping guided Continuous wave TR Doppler signal and using the formula (TR Vmax/RVOT VTI)×10 + 0.16. • TAPSE as an index of axial shortening of RV was recorded with M Mode tracing recorded at lateral TV annulus in modified four chamber view. • RVFS % was measured by measuring RV dimensions at end diastole and at end systole recorded at the tip of TV leaflet in modified four chamber view using formula RVED-RVES/RVED*100. • RV. It is calculated from the parasternal short axis projections as the ratio of the minor axis of the LV parallel to the septum at the level of the chorPage 29 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 dae, divided to minor-axis perpendicular to and bisecting the septum at the same section. After baseline evaluation patients were randomized to tadalafil or control group using stratified randomization method. Patients were stratified based on gender and age groups of 10 years age interval. Randomization procedure: The envelope was opened after patient’s eligibility was confirmed and informed consent was obtained. Under each strata, envelope containing equal number of opaque sealed envelopes bearing treatment codes were numbered sequentially so that order of treatment allocation codes was random. The treatment allocation was concealed and investigator assigning was not participating in patient evaluation and outcome measurement. Treatment group was assigned by picking up first number in the sequentially numbered sealed opaque envelop from the respective strata the patient belonged to. Intervention; Patients randomized to tadalafil group received tadalafil 40 mg once a day apart from usual care prescribed by the treating physician. In the control group patients received usual therapy as per patient’s underlying chronic lung disease. Follow up Period: All the patients were examined on scheduled monthly follow up visits for three months. The dose of usual care medication was adjusted as per discretion of the treating physician. The medications prescribed by the treating physician were recorded. Outcomes measured: At the end of three months all patients underwent repeat echo Doppler evaluation for recording of indices of cardiopulmonary haemodynamics as at baseline. Investigator measuring the outcome was blinded to the treatment assigned. Statistical analysis: The data was reported as percentages and mean±SD for categorical and continuous variables respectively. The differences in the distribution of categorical variables between study groups were compared by χ2 test and unpaired students t-test for continuous variable. 2 tailed significance at value <0.05 was taken as statistically significant. Data was analysed using Epi Info version 3.4.3. Trial registration: Central trial registry of India: CTRI/2015/01/005413. 224 patients screened -COPD-118 -ILDS- 69 [SLE-17, IPF-24, PSS-25 & MCTD-3] -OSA-7 -Post-TB Fibrosis-30 148 Patients did not meet inclusion criteria’s:128 patients had either PFAT>90msec and or TR gradient <46mmHg 9 patients had poor echogenic window 7 patients had H/O CAD and, 4 patients had H/O PTE 76 patients recruited Control group 36 patients 3 patients lost to follow-up due to death Intervention group 40 patients 5 patients lost to follow-up 4 patients died and 1 patient discontinued due to drug intolerance during follow-up 33 patients included in the analysis 35 patients included in the analysis Fig 1: Flow chart of patients screened, enrolled, randomized and followed up. RESULTS Baseline clinical characteristics of the study groups: Table 1 describes the distribution of clinical characteristics of the study population under intervention and control arm; in brief. Both the study groups were well matched for socio demographical and geographical characteristics, exposure to tobacco smoke and biomass fuel smoke, NYHA functional class, resting SPO 2 , and SPO 2 at peak of 6-MWT. The baseline distribution of indicators of pulmonary NJMR│Volume 6│Issue 1│Jan – Mar 2016 hemodynamic status; TR gradient, PFAT, RVOT VTI, PVR, and indices of RV functions; MPI, TAPSE, RVFS% and RV eccentricity index was also well matched. The indices of pulmonary functions were also similar between the groups. The mean Hb levels and renal functions were also well matched. The medications used and use of domiciliary oxygen therapy was also similarly distributed in both the groups. Page 30 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table 1: Clinical characteristics of the study groups Characteristics Age (Mean ± SD) (years) Gender (Male) % Education status (literate) % Occupation Employed Self Employed Farming House Keeper Retired Residence Urban Rural Smoking Status Never smoked (yes) Ex-smoker (yes) Current smoker (yes) Smoking Index (Mean ± SD) Smoke Biomass fuel smoke exposure (yes) Frequency of exposure Occasionally Frequently Daily Duration of Biomass fuel smoke exposure (years) Group-A (%) (n=35) 62.2 ± 10.9 20 (57.1) 23 (65.7) Group-B (%) (n=33) 61.7 ± 10.1 17 (51.5) 16 (48.5) P values 0.86 0.65 0.16 10 (28.6) 5 (14.3) 11 (31.4) 8 (22.9) 1 (2.9) 10 (30.3) 4 (12.1) 2 (6.1) 13 (39.4) 4 (12.1) 0.05 6 (17.1) 29 (82.9) 10 (30.3) 23 (69.7) 0.21 9 (25.7) 23 (65.7) 3 (8.6) 422.45 ± 578.21 26 (74.3) 33 (94.3) 10 (30.3) 17 (51.5) 6 (18.2) 394.88 ± 481.27 23 (69.7) 33 (100) 0.40 13 (37.1) 18 (51.4) 4 (11.4) 35 (44.89 ± 16.65) 14 (42.4) 15 (45.5) 4 (12.1) 33 (49.70 ± 9.76) 0.89 0.83 0.68 0.17 0.15 Table 2: Baseline cardiopulmonary haemodynamic parameters, pulmonary function test variables, biochemical investigations and medications Characteristics NYHA Class (Mean ± SD) SPO 2 at rest SPO 2 after 6MWT TR grad. (mmHg) PFAT (msec) PFVTI (cm) PVR (woods unit) MPI TAPSE (mm) RVFS (%) RV Eccentricity Index (Systole) RV Eccentricity Index (Diastole) SVC(%predicted) FVC(%predicted) FEV 1 (%predicted) FEF 25-75% (%predicted) FEV 1 /FVC(%predicted) Hb (gm/dl) BUN (mg/dl) Creatinine (mg/dl) Medications: Methylxanthines group OD LABA+ Corticosteroids OD Anticholinergics OD Anticholinergics+ LABA OD Domiciliary O 2 therapy NJMR│Volume 6│Issue 1│Jan – Mar 2016 Group-A (%) (n=35) 2.33 ± 0.48 88.76 ± 1.7 80.64 ± 2.8 11 (53.05 ± 10.55) 77.75 ± 5.25 11.92 ± 2.41 11(3.76 ±1.49) 0.32 ± 0.19 15.76 ± 2.15 24.21 ± 7.09 1.06 ± 0.02 1.06 ± 0.01 52.27 ± 10.31 45.12 ± 12.07 42.05 ± 15.17 18.78 ± 14.48 73.07 ± 13.11 14.89 ± 1.41 40.17 ± 12.25 1.09 ± 0.15 Group-B (%) (n=33) 2.43 ± 0.61 88.37 ± 1.8 79.14 ± 5.0 14 (60.24 ± 19.17) 73.71 ± 9.29 12.78 ± 2.91 11(3.78 ± 1.66) 0.35 ± 0.22 17.11 ± 3.94 30.17 ± 8.32 1.06 ± 0.01 1.06 ± 0.01 52.73 ± 13.05 46.79 ± 14.27 42.63 ± 16.73 17.78 ± 7.30 71.81 ± 10.85 14.93 ± 1.81 38.82 ± 12.19 1.08 ± 0.17 P values 0.48 0.37 0.14 0.28 0.11 0.19 0.98 0.54 0.09 0.003 0.77 0.37 0.87 0.60 0.88 0.72 0.67 0.92 0.65 0.67 16(48.5) 22(66.7) 24(72.7) 5(15.2) 6(18.2) 25(71.4) 27(77.1) 28(80.0) 7(20.0) 12(34.3) 0.05 0.34 0.48 0.60 0.13 Page 31 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table 3: Effects of tadalafil on the cardiopulmonary haemodynamic status Characteristics NYHA Class SPO 2 at rest SPO 2 after 6MWT TR grad. (mmHg) PFAT (msec) PFVTI (cm) PVR (woods unit) MPI TAPSE (mm) RVFS (%) RV Eccentricity Index (Systole) RV Eccentricity Index (Diastole) SVC(%predicted) FVC(%predicted) FEV 1 (%predicted) FEF 25-75% (%predicted) FEV 1 /FVC(%predicted) Hb(gm/dl) BUN(mg/dl) Creatinine(mg/dl) Medications: Methylxanthines group OD LABA+ Corticosteroids OD Anticholinergics OD Anticholinergics+ Corticosteroids OD Domiciliary O2 therapy Group-A (n=35) 2.31 ± 0.58 90.94 ± 1.75 83.89 ± 4.56 14 (56.70 ± 13.27) 89.87 ± 11.70 14.54 ± 3.17 14 (3.16 ± 1.08) 0.33 ± 0.20 18.53 ± 4.0 30.60 ± 8.21 1.05 ± 0.01 1.05 ± 0.01 63.49 ± 12.05 58.06 ± 14.39 56.47 ± 15.47 24.31 ± 8.98 77.45 ± 9.38 14.98 ± 1.76 33.33 ± 6.98 1.02 ± 0.11 Group-B (n=33) 2.45 ± 0.51 87.91 ± 2.17 78.55 ± 4.92 11 (55.22 ± 10.14) 76.29 ± 8.21 12.25 ± 2.25 11 (3.64 ± 0.93) 0.33 ± 0.18 15.96 ± 2.90 24.82 ± 7.48 1.06 ± 0.01 1.06 ± 0.01 53.84 ± 9.78 45.13 ± 10.56 41.21 ± 12.70 18.55 ± 13.85 73.65 ± 14.02 14.87 ± 1.36 44.02 ± 15.57 1.12 ± 0.16 Mean difference(95% CI) 0.14(-0.12 to 0.40) -3.03(-3.99 to -2.08) -5.34(-7.63 to -3.05) -1.48(-11.17 to 8.21) -13.58(-18.50 to -8.65) -2.29 (-3.62 to -0.95) 0.49(-0.35 to 1.32) -0.01(-0.10 to 0.09) -2.57(-4.27 to -0.87) -5.78(-9.59 to -1.97) 0.01(0.00 to 0.01) 0.01(0.00 to 0.02) -9.66(-14.99 to -4.32) -12.94(-19.08 to -6.80) -15.26(-22.14 to -8.38) -5.76(-11.38 to -0.14) -3.80(-9.63 to 2.04) -0.12(-0.87 to 0.64) 10.69(4.91 to 16.74) 0.10(0.04 to 0.17) P value 0.29 0.0000 0.0000 0.76 0.0000 0.0002 0.24 0.89 0.002 0.003 0.007 0.001 0.0003 0.0001 0.0001 0.0001 0.19 0.76 0.0006 0.001 23(65.7%) 28(80.0%) 27(77.1%) 6(17.1%) 14(40%) 18(54.5%) 26(78.8%) 25(75.8%) 6(18.2%) 8(24.2%) -0.11(-0.35 to 0.12) -0.01(-0.21 to 0.18) -0.01(-0.22 to 0.19) -0.17(-0.21 to 0.19) -0.15(-0.38 to 0.06) 0.35 0.90 0.89 0.91 0.17 Effect of Tadalafil on Cardiopulmonary Hemodynamics: Indices of RV Function; Tadalafil improved indices of RV systolic Function significantly; increased pulmonary flow velocity time integral (PFVTI) (14.54 ± 3.17 cm versus 12.25 ± 2.25 cm, p <0.0002), increased tricuspid annular plane systolic excursion (TAPSE)(18.53±4.0 mm versus 17.11±3.94 mm, p<0.002), Improved RVFS 30.6±8.2% vs. 24.8±7.4% p<0.002 ,improved right ventricular eccentricity index in systole (1.05±0.01 versus 1.06±0.01, p<0.007) and in diastole (1.05±0.01 versus 1.06±0.01, p<0.001), significantly. Pulmonary Hemodynamics; Tadalafil did not result in significant change in TR gradient (56.7±3.2 vs. 55.2±10.1) However Pulmonary flow acceleration time (PFAT increased significantly (89.8±11.7 vs. 76.2±8.2 p<0.001. There was a trend of decrease in PVR but was statistically not significant (3.1±1.0 vs. 3.6±0.9) Pulmonary Functions; (Table 2) It was intriguing that the all the indices of pulmonary functions; FVC, FEV 1 and ratio of FEV 1 /FVC were significantly improved in the tadalafil group. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Effort Tolerance; NYHA Class; There was no significant change in the functional class with tadalafil (2.3±.5 vs. 2.4±0.5). Resting SPO2; Tadalafil increased resting SPO2 and post 6-Minute walk test significantly. Renal functions; Blood urea and serum Creatinine levels were significantly reduced by tadalafil. DISCUSSION The effect of tadalafil on cardiopulmonary haemodynamics was assessed in patients of chronic pulmonary disease with PH residing at altitude of 1000 to 2500 meter from sea level. Tadalafil improved the RV systolic function significantly as demonstrated by significant increase in TAPSE, RVFS%, RVOT VTI, and improvement in renal function. This improvement in RV systolic function is possibly mediated by decrease in PVR. Although tadalafil decreased the PVR (mean difference of 0.48 woods with 95% C.I. of -0.35 to 1.32) woods unit but was statistically not significant. Wide confidence interval of the mean change in PVR indicates the limited power of the study to detect the true change in PVR with tadalafil due to small sample size. There was no significant decrease in TR gradient as the indicator of change in Page 32 NATIONAL JOURNAL OF MEDICAL RESEARCH PA systolic pressure (PASP). The failure to decrease in PASP with tadalafil may be related to proportionate increase in RV output. The usual treatment prescribed to the intervention and control group was as per the discretion of the treating physicians. There were no significant differences in the medications prescribed between the groups. Tadalafil may produce relaxation of the airway smooth muscle also leading to airway dilatation and improving the ventilator function. The significant increase in SPO 2 by tadalafil observed may be due to improvement in pulmonary function and RV output.9-11 The improvement of glomerular filtration with tadalafil apart from improved cardiopulmonary haemodynamic effects could also be due to the vasodilatory effect of tadalafil on the renal vascular bed. Tadalafil, as other PDE5 inhibitors, prevents the breakdown of NO derived cGMP, primarily in vascular smooth muscle cells, thus inducing vasodilator effects. It was observed in a study done on rats that at the renal level, PDE5 is localized to the vasculature, glomeruli, mesangial cells, cortical tubules, and inner medullary collecting duct cells of rat kidney, where its inhibition positively affects renal haemodynamic and excretory function.12 The vasodilatory action of tadalafil is of a special importance in light of the intrarenal activation of vasoconstrictory systems that contribute to reduction in GFR, together with vascular congestion in the outer medulla and activation of tubule-glomerular feedback.13 The improvement in arterial saturation may also be mediated by an improvement in the ventilation-perfusion matching caused by tadalafil through vasodilatation of pulmonary arterioles perfusing better ventilated alveoli.14 Tadalafil has been reported to have vascular smooth muscle relaxation effect on bronchial smooth muscles isoenzyme-selective PDE inhibitors that have been known to cause bronchodilation are usually related to PDE type-3 and PDE type-4 types, but recently PDE type-5 inhibitions also has been implicated in reversing bronchoconstriction. Therefore, it is possible that oral tadalafil therapy may improve airway functions by causing airway smooth muscle relaxation. Tadalafil is a selective inhibitorof cyclicGMP specific PDE-5, which is the predominant enzyme that metabolizes cyclic-GMP. Thus by inhibiting its metabolism, cyclic-GMP levels are raised.1521 Another mechanism of improvement in indices of pulmonary function test is decrease in airway hyperreactivity and decrease in airway inflammation and mucus production. It is possible that oral tadalafil therapy may improve airway functions by causing airway smooth muscle relaxation. These results were supported by some studies.21-22 However, The significant improvements in pulmonary function tests cannot be due to the tadalafil alone as patients were also advised to take inhaled bronchodilators also NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 both long term and short term on regular basis depending on patients condition. Thus the improvement in cardiopulmonary haemodynamic status with tadalafil in patients of chronic pulmonary disease can be attributed to diverse mechanisms. LIMITATIONS It was a Pilot study. Study subjects were not truly inhabitants of high altitudes thus the efficacy of tadalafil in patients of chronic pulmonary disease residing at high altitude with hypobaric hypoxia cannot be ascertained from the present study. It was not a placebo controlled double blind study thus the element of measurement bias and placebo effect cannot be ruled out. CONCLUSION In the present study, tadalafil 40mg once daily showed significant improvement in the cardiopulmonary hemodynamic status in patients with chronic pulmonary diseases with PH. REFERENCES 1. Simonneau G, Robbins IM, Beghetti M, Channick RN, Delcroix M, Denton CP, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2009 Jun 30;54(1Suppl):S43-S54. 2. Todd MK, Paul MH. Right ventricular dysfunction in chronic lung diseases. Cardiolclin. 2012;30:243-56. 3. Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJL. Global burden of disease and risk factors. Washington: The World Bank. 2006. 4. Interstitial Lung Disease and Asbestos. http://www.interstitial lung disease.com/html. (Cited on March 21st, 2013). 5. Negi PC, Marwaha R, Asotra S, Kandoria A, Ganju N, Sharma R, et al. Prevalence of High Altitude Pulmonary Hypertension Among the Natives of Spiti Valley—A High Altitude Region in Himachal Pradesh, India. High Alt Med Biol. 2014 Dec;15(4):504-10. 6. Kumar U, Ramteke R, Yadav R, Ramam M, Handa R, Kumar A. Prevalence and Predictors of Pulmonary Artery Hypertension in Systemic Sclerosis. JAPI. 2008 June; 56:41317. 7. Lanzarini L, Fontana A, Campana C, Klersy C. Two simple echo-Doppler measurements can accurately identify pulmonary hypertension in the large majority of patients with chronic heart failure. J Heart Lung Transplant. 2005; 24:745– 54. 8. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of COPD. 2014. Global Initiative for Chronic Obstructive Lung Disease. http://www.goldcopd.org/ Guidelines/guidelines-resources.html. (cited on 9 June 2014). 9. Thabut G, Dauriat G, Stern JB, Logeart D, Lévy A, MarrashChahla R, et al. Pulmonary haemodynamics in advanced Page 33 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 COPD candidates for lung volume reduction surgery or lung transplantation. Chest. 2005;127(5):1531-36. of lung fibrosis and pulmonary hypertension: a randomised controlled trial. Lancet. 2002;360:895-00. 10. Bharani A, Patel A, Saraf J, Jain A, Mehrotra S, Lunia B. Efficacy and safety of PDE-5 inhibitor tadalafil in pulmonary arterial hypertension. Indian Heart J.2007;59: 323–328. 17. Tessler RB, Zadinello M, Fiori H, Colvero M, Belik J Fiori RM. Tadalafil improves oxygenation in a model of newborn pulmonary hypertension. PediatrCrit Care Med. 2008;9:33032. 11. Galiè N, Brundage B, Ghofrani H, Oudiz R, Simonneau G, Safdar Z, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009;119: 2894–2903. 12. Bishara B, Abu-Saleh N, Awad H, Ghrayeb N, GoltsmanI, Aronson D, et al. Phosphodiesterase-5 inhibition protects against increased intra-abdominal pressure-induced renal dysfunction in experimental congestive heart failure. Eur J of Heart Failure. 2012;14:1104-11. 13. Guzeloglu M, Yalcinkaya F, Atmaca S, Bagriyanik A, Oktar S, Yuksel O, et al. Beneficial effects of tadalafil on renal ischemia-reperfusion injury in rats. Urol Int. 2011;86:197-03. 14. Kucuk A, Yucel M, Erkasap N, Tosum M, Koken T Ozkurt M, et al. The effects of PDE-5 inhibitory drugs on renal ischemia/reperfusion injury in rats. MolBiol Rep. 2012; 39:9775-82. 15. Santos RC, De Faria AP, Barbaro NR, Modolo R, FerreiraMelo SE, Matos-Souza JR, et al. Tadalafil-induced improvement in left ventricular diastolic function in resistant hypertension. Eur J Clin Pharmacol. 2014; 70:147-54. 16. Ghofrani HA, Wiedemann R, Rose F, Schermuly RT, Olschewski H, Weissmann N, et al. Sildenafil for treatment NJMR│Volume 6│Issue 1│Jan – Mar 2016 18. Charan NB. Does sildenafil also improve breathing? CHEST. Jul 2001;120(1):305-06 19. Zahmatkesh MM, Faramarzi S, Shahmiri SS, Sharif MR, Taghiyan M, Naemy V, et al. Evaluation of the Sildenafil Effects on Forced Expiratory Volume in One Second (FEV 1 ) in Patients with Chronic Obstructive Pulmonary Disease (COPD). Indian J of applied research. Nov 2013;3(11).36466. 20. Stanopoulos I, Manolakoglou N, Pitsiou G,Boutou AK, Argyropoulou. Sildenafil may facilitate weaning in mechanically ventilated COPD patients: a report of three cases. Anaesth Intensive Care. Aug 2007;35(4):610-3. 21. Toward TJ and Broadley KJ. Airway reactivity, inflammatory cell influx and nitric oxide in guinea-pig airways after lipopolysaccharide inhalation. Br J of Pharmacol. 2000;131:271-81. 22. Wang T, Liu Y, Chen L, Wang X, Hu XR, Feng YL, et al. Effect of sildenafil on acrolein-induced airway inflammation and mucus production in rats. EurRespir J. 2009; 33:1122-32. Page 34 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE A STUDY ON AWARENESS OF TOBACCO USE AND CANCER RISK AMONG MEDICAL STUDENTS (Col) Prakash G Chitalkar1, Rakesh Taran2, Deepak Singla3, Prashant Kumbhaj3 Author’s Affiliations: 1Professor; 2Associate Professor; 3Senior Resident, Department of Medical Oncology, Sri Aurobindo Institute of Medical Sciences,Indore, Madhya Pradesh Correspondence: Dr Prashant Kumbhaj Email: [email protected] ABSTRACT Introduction: Tobacco use is a major health and social problem worldwide.Among the Ill effects of tobacco use, the proportion of cancer in Male and female is 56.4% and 44.9%.Youth in general and adolescents in particular fall prey to this deadly habit with severe physical, psychological, and economic implications.Among the youth, students are particularly involved due to increasing academic pressures and life related stress Objective: The objective of the study was to Estimate the Awareness on Use of Tobacco and cancer risk among medical students. Material and methods: it was a Cross sectional study and was done in Sri Aurobindo Medical College. Prior permission was obtained from college authorities.Ethical Approval is obtained from the ethical committee of Sri Aurobindo institute of medical sciences.The study period was of 3 months duration i.e. from may 2015 July 2015. 300 Under graduate medical students were selected for the study. Results: Awareness about ill effect of tobacco was high.About 90% students were aware of role of smoking in causing oral and lung cancer, whereas only 60 % were aware of other cancers caused by smoking other than lung and oral.80% students were aware of role of passive smoking in causing cancer.Reason for starting smoking was Influence of friends, parents and movies were 22%, 20%, 27% respectively. Surprisingly 31% students gave reason for exam and life related stress for their smoking. 97% tobacco users were male and 3 % were female.In females all were using smoking tobacco. Conclusion: The awareness among medical students regarding harmful effects of tobacco use and its cancer risk was very high. Key words: Tobacco use, smoking, medical students INTRODUCTION Tobacco use is a major health and social problem worldwide. Tobacco use kills nearly 6 million people each year and causes loss of hundreds of billions of dollars worldwide. Most of these deaths occur in low- and middle-income countries1.In India, around 10.9% use tobacco in one or the other form 2.Among the Ill effects of tobacco use, the proportion of cancer in Male and female is 56.4% and 44.9% respectively.3 Youth in general and adolescents in particular fall prey to this deadly habit with severe physical, psychological, and economic implications.4 Among the youth, students are particularly involved due to increasing academic pressures and life related stress.5 Easy availability of tobacco in different forms, Encouragement from peer group and the lure of popularity make a teenager an easy prey.5 NJMR│Volume 6│Issue 1│Jan – Mar 2016 Objective: The objective of the study was to Estimate the Awareness on Use of Tobacco and cancer risk among medical students. METHODOLOGY It was a Cross sectional study and was done in Sri Aurobindo Medical College. Prior permission was obtained from college authorities. Ethical Approval is obtained from the ethical committee of Sri Aurobindo institute of medical sciences. The study period was of 3 months duration i.e. from may 2015 - July 2015. 300 Under graduate medical students were selected for the study. Students who were present on the day of interview were included in the study. The purpose of the study was explained to the students, confidentiality was ensured. The data were collected regarding age, sex, socioeconomic class, influencing factor for tobacco use, form of product used, their Page 35 NATIONAL JOURNAL OF MEDICAL RESEARCH knowledge about passive smoking and association of tobacco use and cancer. Tobacco users were defined as having used tobacco at any stage in their life. On user was Those who had not used tobacco products in any form even once in their lifetime. The data collected were compiled and analyzed. RESULTS In Table 1, age, sex and socioeconomic status wise distribution of the study population was shown: Majority (35%) of the study population was in the age group 19-20 years followed by 18-19 years (26%). In the study population, 53% were males and 47 % were females. Socio economic status: Based on Kuppuswamy’s Classification, majority of the study population belonged to Middle class (60%). Table 1: Demographic details of the study population Variables Age in Years Sex Socio economic status Factor 17-18 18-19 19-20 >20 Male Female Upper Middle Lower Numbers (%) 60(20.0 ) 78(26.0) 105(35.0) 57 (19.0) 159(53.0) 141(47.0) 60(20.0) 180(60.0) 60(20.0) Table 2: Percentage of knowledge, Use and Reason for tobacco use Variables Numbers (%) Knowledge on Ill effects of tobacco use Oral cancer 270 (90.0) Lung cancer 255(85.0) Other cancers 180(60.0) Passive smoking 240(80.0) Use of tobacco in any form 60(20.0) Smoking 51(85.0) Chewing Tobacco 9(15.0) Combined use 3(5.0) Reason for tobacco use Friends 13(22.0) Parents’ smoking 12(20.0) Movies 16(27.0) Academic Stress 19(31.0) Table 2 shows percentage wise distribution about knowledge, ill effects and influence of smoking. In the study population 20% students were using tobacco,85% were using as smoking tobacco,15% using as chewing tobacco and 5% populations using both smokeless and smoking tobacco. Awareness about ill effect of tobacco was high. About 90% students NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 were aware of role of smoking in causing oral and lung cancer, whereas only 60 % were aware of other cancers caused by smoking other than lung and oral.80% students were aware of role of passive smoking in causing cancer. Reason for starting smoking was Influence of friends, parents and movies were 22%, 20%, 27% respectively. Surprisingly 31% students gave reason for exam and life related stress for their smoking. 97% tobacco users were male and 3 % were female. In females all were using smoking tobacco. DISCUSSION The prevalence of tobacco use in this study was 20%.The studies conducted among undergraduate medical students in different parts of India reported the prevalence of tobacco consumption ranging from 8.7% to 50.7%.6-17The cultural & geographical factors may be the reason for such a wide variation. The cigarette smoking was most common form of tobacco use in the present study, this is also shown by study done by Selokar et al.17 In this study, cause for initiating tobacco use was mainly academic stress (31%),followed by movies (27%)which is also shown by Sargent JD et al19 in their study, while in studies done by Ganesh et al 8,Aggarwal et al 10, Kumari et al 11,Basu et al 12,Sharma et al 13 and Selokar et al 17 the peer pressure was observed to be the main cause for initiation. Among tobacco users about 20 % medical student’s tobacco consumption habit was affacted by parental tobacco use. Studies done by Ramakrishna et al 7,Ganesh et al 8,Kumari et al 11 and Basu et al 12 shows the similar findings.The tobacco consumption among female students was lower to that of male in our study.This was statistically significant and the similar findings have been shown by Ramakrishna et al 6, Chatterjee et al 7,Basu et al 12and Thankappan et al 16. In the present study high level of awareness (90% ) about the adverse effect of tobacco consumption is comparable to the studies done by Khan et al 9 in Bareilly (89.53%)and Sharma et al 13 in Dehradun (91.8%). The study of Sreeramareddy et al 18 among the medical students of five Asian countries including India,reported that prevalence of smoking among males was higher than females in all countries which were statistically significant. About 80 percent of individuals who start smoking during adolescence will continue to smoke in adulthood, and one third of these individuals will die prematurely due to smoking related disease20. So we should make a stretagy to limit youth access to tobacco products by making Smoke free air laws and state,by enforcing age restrictions for sales,increasing Taxes and cost of tobacco products,Restrictions on flavored tobacco products. Page 36 NATIONAL JOURNAL OF MEDICAL RESEARCH LIMITATIONS print ISSN: 2249 4995│eISSN: 2277 8810 9. Khan S, Mahmood S E, Sharma A K, Khan F. Tobacco Use Among Medical Students: Are They Role Models Of The Society? Journal of Clinical and Diagnostic Research. 2012; 6: 605-7. There might be possibility that some tobacco users did not disclose about tobacco use despite of being ensuring about their confidentiality,so the prevalence 10. Aggarwal S, Sharma V, Randhawa H, Singh H.Knowledge, attitude and prevalence of use of tobacco among male mediof tobacco users observed in our study may not give cal students in India: A single centre cross-sectional study. the correct picture. Ann Trop Med Public Health. 2012;5:327-9. CONCLUSION 11. Kumari R, Nath B. Study on the use of tobacco among male medical students in lucknow, India*. Indian J Community Med. 2008 Apr; 33 (2): 100-3. The awareness among medical students regarding 12. Basu M, Das P, Mitra S, Ghosh S, Pal R, Bagchi S. Role of harmful effects of tobacco use was very high. Most family and peers in the initiation and continuation of smokcommon reason behind tobacco use among medical ing behavior of future physicians. J Pharm Bioallied Sci. 2011 Jul;3(3):407-11. students is academic pressure followed by influence of movies. 13. Sharma M, Aggarwal P, Kandpal S D. Awareness about Tobacco Use Among Medical Students Of Uttarakhand. Indian J Community Health. 2011; 22:23-5. REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 14. Mehrotra R, Chaudhary AK, Pandya S, Mehrotra KA, Singh M. Tobacco use by Indian medical students and the need for WHO Report On The Global Tobacco Epidemic, 2011. comprehensive intervention strategies. Asian Pac J Cancer Warning about the Dangers of Tobacco [Accessed On 2012, Prev. 2010;11(2):349-52. PubMed PMID: 20843114. December 18] Available from http:/ www.who.int/tobacco/global_report/2011/en. 15. Mony PK, John P, Jayakumar S. Tobacco use habits and beliefs among undergraduate medical and nursing students of Ministry of Health and Family Welfare. [cited 2013 Mar 08]. two cities in southern India. Natl Med J India. 2010 NovAvailable from http://www.mohfw.nic.in/NRHM.htm Dec;23(6):340-3. PubMed PMID: 21561044. World Health Organization. Media Centre- Tobacco [cited 16. Thankappan KR, Yamini TR, Mini GK, Arthur C, Sairu P, 2013 Mar 08]. Available from ;http://www.who.int/ mediaLeelamoni K, Sani M, Unnikrishnan B, Basha SR, Nichter M. centre/factsheets/fs339/en/index.html Assessing the readiness to integrate tobacco control in medical curriculum: experiences from five medical colleges in Luk J, Rau M. Are tobacco subsidies a misuse of public Southern India. Natl Med J India. 2013 Jan-Feb;26(1):18-23. funds? BMJ. 1996;312:832–5. PubMed PMID: 24066988 Juyal R, Bansal R, Kishore S, Negi KS, Chandra R, Semwal J. Substance use among intercollege students in district of De- 17. Selokar DS, Nimbarte S, Kukde MM, Wagh VV. Tobacco use amongst the male medical students, Wardha, Central Inhradun. Indian J Community Med. 2006;31:252–4 dia. Int J Biol Med Res. 2011;2(1):378-81. Ramakrishna GS, Sankara Sarma P, Thankappan KR. Tobacco use among medical students in Orissa. Natl Med J India. 18. Sreeramareddy C T, Suri S, Menezes R G, Kumar H H N, Rahman M, Islam M R et al. Self-reported tobacco smoking 2005 Nov-Dec;18(6):285-9. PubMed PMID: 16483025. practices among medical students and their perceptions toChatterjee T, Haldar D, Mallik S, Sarkar GN, Das S, Lahiri wards training about tobacco smoking in medical curricula: A SK. A study on habits of tobacco use among medical and cross-sectional, questionnaire survey in Malaysia, India, Panon-medical students of Kolkata. Lung India. 2011 kistan, Nepal, and Bangladesh. Substance Abuse Treatment, Jan;28(1):5-10. doi: 10.4103/0970-2113.76293. PubMed Prevention, and Policy. 2010; 5:29. PMID: 21654978; PubMed Central PMCID: PMC3099511. 19. Sargent JD, Tickle JJ, Beach ML, et al. Brand appearances in Ganesh Kumar S, Subba SH, Unnikrishna B, Jain A, Badiger contemporary cinema films and contribution to global marS. Prevalence and factor associated with current smoking keting of cigarettes. Lancet 2001; 357:29 2012 US Surgeon among medical students in coastal South India. Kathmandu General's Report: Preventing Tobacco Use Among Youth Univ Med J (KUMJ). 2011 Oct-Dec;9(36):233-7. PubMed and Young Adults. Available at: http://www.sur geongenerPMID: 22710529. al.gov/library/reports/preventingyouthtobacco use/(Accessed on August 22,2012) NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 37 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE A STUDY TO EVALUATE AND COMPARE THE EFFICACY AND SAFETY OF TOPICAL CYCLOSPORINE-A 0.5% WITH TOPICAL PLACEBO (ARTIFICIAL TEARS) IN ALLEVIATING THE CLINICAL FEATURES ASSOCIATED WITH VERNAL KERATOCONJUNCTIVITIS Abha Gahlot1, Rupali Maheshgauri2, Bhargav Kotadia3, Kanisha Jethwa3, Gira Raninga3 Author’s Affiliations: 1Professor; 2Associate Professor; 3Junior Resident, Dr. D. Y Patil Medical College, Pune Correspondence: Dr Abha Gahlot E-mail: [email protected] ABSTRACT Introduction: Vernal keratoconjunctivitis is a severe, typically seasonal recurrent ocular inflammatory disorder. Topical cyclosporine-A is inhibitory to many T-cell dependent inflammatory mechanisms which are likely to play role in treatment of vernal keratoconjunctivitis. Methodology: The study was conducted on 100 patients of vernal keratoconjunctivits selected from Ophthalmology out patients Department of Dr. D.Y Patil Hospital, Pune. Patients were divided in two groups of 50 each, group I and group II. It was double masked comparison study to assess and compare the efficacy of 0.5% topical Cyclosporine-A and topical placebo in the treatment of vernal keratoconjunctivits. Results: Comparing therapeutic response of symptoms in two groups at day 28 of the study shows topical cyclosporine was better and favored over placebo. Patients showed improvement in following symptoms accordingly. Itching: 49 in group I, 33 in group II. Discharge: 33 in group I, 4 in group II. Photophobia: 32 in group I, 1 in group II. Foreign body sensation: 35 group I, 11 in group II. Patients showed improvement in following signs accordingly: Conjunctival inflammation: 40 in group I, 11 in group II. Papillary hypertrophy: 15 in group I, none in group II. Limbal changes: 7 in group I, none in group II. Conclusion: The use of topical cyclosporine for treatment of vernal keratoconjunctivitis should be encouraged to prevent complications associated with the natural course of the disease and prolonged topical use of corticosteroids. Keywords: Vernal keratoconjunctivitis, Cyclosporine-A, Papillary hypertrophy, Limbal changes, Itching INTRODUCTION Vernal keratoconjunctivitis(VKC) is defined as “recurrent, bilateral, interstitial, inflammation of the conjunctiva of periodic seasonal incidence, self limiting in character and (as yet) of unknown aetiology, characterized by flat topped papillae usually on the tarsal conjunctiva resembling cobblestones in appearance, a gelatinous hypertrophy of the limbal conjunctiva, either discrete or confluent and a distinctive type of keratitis associated with itching, redness of the eyes, lacrimation and a mucinous or lardaceous discharge usually containing eosinophils.VKC has a seasonal predilection for spring time, with peak incidence between April and August, for some individuals, the disease can manifest itself year round.1 Pathologically, there is hypertrophy of adenoid layer of conjunctiva with infiltration of eosinophils. There is marked eosinophilia of inflammatory exudates as well as raised tear and serum IgE. IgE mediated reactions involve mast cell degranulation and release of NJMR│Volume 6│Issue 1│Jan – Mar 2016 prostaglandins, chemical mediators as histamine, slow reacting substances of anaphylaxis and serotonin. These vasoactive amines cause increased capillary permeability, cellular infiltration, increased serum neutrophil chemotactic activity and exudation.2 Recent studies have shown prevalence of local helper T-cell type 2 response in vernal keratoconjunctivitis, with the presence of helper T-cell type 2 like cells in tears and conjunctival biopsy specimens. Interleukin (IL) – 3, IL-5, IL-6 and granulocyte – macrophage colony-stimulating factor are particularly expressed in conjunctival eosinophils of vernal keratoconjunctivitis patients. High levels of tear IL-5 and eosinophil cationic protein (ECP) have also been found in patients with vernal keratoconjunctivitis.So, T-cell mediated inflammation appears to play central role in pathogenesis of vernal keratoconjunctivitis.3 Topical cyclosporine-A is inhibitory to many T-cell dependent inflammatory mechanisms. It has unique ability to selectively suppress the synthesis and proPage 38 NATIONAL JOURNAL OF MEDICAL RESEARCH duction of interleukins. Cyclosporine-A also has direct and indirect inhibitory effects on mast cell activation and mediator release, which are likely to play role in treatment of allergic inflammation. It is antiapoptotic, immunomodulatory and antiinflammatory.4 Topical cyclosporine-A has been successfully used in vernal keratoconjunctivitis, with an improvement in symptoms and clinical signs. The aim of our study is to compare efficacy of topical cyclosporine A drops with placebo in steroid resistant cases of vernal keratoconjunctivitis.5,6 METHODOLOGY Selection of Cases: - Hundred patients having bilateral signs and symptoms of vernal keratoconjunctivitis were selected of any age, sex and habitat attending out patients department of Ophthalmology, Dr. D.Y Patil Hospital, Pune. Patients were studied to evaluate and compare the efficacy of topical cyclosporine A 0.5% with topical placebo (artificial tears CMC 0.5%) in treating vernal keratoconjunctivitis. All these patients were in contact with clinician prior to the study, so that they were using topical steroids for atleast 2 weeks and remained refractory, with persistent or progressive inflammation. - Patients with other active ocular disease or infection, a history of ocular surgery, serious medical illness and concurrenttreatment for other allergic conditions like rhinitis were excluded from the study. Ethical committee permission was taken prior to the study and written informed consent was taken from each patient. Diagnosis of Vernal Keratoconjunctivitis: This was done on the basis of history and examination. Prior to initiation of therapy, relevant history and clinical details were recorded according to proforma. A detailed history was recorded with special reference to history of swollen eye, burning/stinging sensation, discharge/tearing, foreign body sensation, photophobia, itching and any past ocular history. History of allergic symptoms elsewhere in body and family history of allergy was taken. Detailed examination of both the eyes under diffuse illumination and slit lamp examination was done to confirm the conjunctival, limbal and corneal signs such as lid edema, conjunctival chemosis, conjunctival inflammation, conjunctival discharge, papillary hypertrophy, limbal changes and also to rule out any other ocular pathology. Visual acuity of the patients was also recorded. Grading of Patients: Allergic ocular symptoms i.e. itching, swollen eyes, burning/ stinging, discharge/tearing, foreign body sensation, photophobia NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 and allergic signs i.e. lid edema, conjunctival chemosis, conjunctival inflammation/injection, papillary hypertrophy and limbal changes were rated using a scale from 0-3 i.e. allergic symptoms were rated as 0 for none, I for mild, II for moderate and III for marked, while signs were rated as 0 for none, I for mild, II for moderate and III for severe. Grouping of Patients: Hundred patients of vernal keratoconjunctivitis were included in the study. They were randomly divided into two groups of fifty each, 50 receiving cyclosporine A and other 50 receiving placebo drops. Treatment Regime: In this masked paired study, patients were randomly assigned either to have topical cyclosporine A 0.5% or topical placebo (artificial tears CMC 0.5%) 2 times daily for 4 weeks. Both the eye drops were dispensed to the patients in identical sterile vials coded I for cyclosporine-A & II for placebo,by masked health personnel unassociated with the study. Thus, the nature of the drug in each vial was masked. Follow up: After the initial baseline assessment, treatment was started and every patient was subsequently examined after 7 days, 14 days, 21 days and 28 days of initiation of therapy. At each visit, the signs and symptoms were graded as already explained. Response to therapywas measured for each sign and symptom in relation to vernal keratoconjunctivitis and rated +2 for much improved, +1 for improved, 0 for no change, 1 for worse and –2 for much worse. RESULT Itching Gradewise distribution of group I and group II treated eyes for itching at day 0: In group I, 45 (90%) patients and in group II, 47(94%) patients presented with severe, grade 3 itching. 5(10%) patients and 3 (6%) patients in group I & II respectively had mean baseline score of 2 on day 0. Therapeutic response at day 28 of group I and II for itching: At the end of study, 49 patients in group I had much improved symptoms while in group II, 30 patients reported with much improved symptoms and 17 had +1 (improved) response. Ocular itching improved almost 100% in group I patients as compared to group II patients. Discharge Gradewise distribution of group I and group II treated eyes for discharge/tearing at day 0: 28 patients (56%) in group I had severe discharge/tearing while 11 had moderate and 1 had Page 39 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 mild discharge. In group II, 26 patients presented with severe discharge, 13 with moderate and 1 with mild discharge/watering. Therapeutic response at day 28 of group I and II for discharge/tearing: Evaluation for therapeutic response at the end of study showed that 33 patients in group I were much improved, with 7 patients having improved symptoms. In group II, only 4 patients had improvement of ocular discharge while 46 had no change in discharge or tearing. Photophobia Gradewise distribution of group I and II treated eyes for photophobia at day 0: Most of the patients 32( 64%) in group I and 28(56%) in group II presented with moderate photophobia. 3(6%) patients in group I and 5(10%) in group II had marked photophobia at baseline evaluation. Mild photophobia was seen in 5(10%) patients in group I and 6 (12%) in group II. Therapeutic response at day 28 of group I and II for photophobia: At the end of study, 32 patients had much improved photophobia with 8 patients improved and 10 patients had no change in group I. In comparison, 47 patients in group II had no change . Foreign body sensation Gradewise distribution of group I and II treated eyes for foreign body sensation: At the day 0 in group I,27 patients(54%) and 26 patients( 52%) in group II had marked foreign body sensation. 8 (16%) in group I and 9(18%) in group II presented with moderate foreign body sensation. Mild foreign body sensation was reported in 6 (12%) in group I and 7(14%) in group II vernal keratoconjunctivits patients. Therapeutic response at day 28 of group I and II for foreign body sensation: At the end of the study in group I, 35 patients had much improved symptoms with 6 improved and 9 had no change while in group II, 27 patients reported improvement in foreign body sensation, 11 cases had much improved and no improvement in 12 cases. Conjunctival Inflammation Gradewise distribution of group I and II treated eyes for conjunctival inflammation at day 0: In group I, 12(24%) patients & in group II, 11 (22%) patients had severe conjunctival inflammation at day 0, while 19(38%) in group I and 22(44%) in group II patients presented with moderate conjunctival inflammation. Mild conjunctival inflammation was seen in 19(38%) patients in group I and 17(34%) in group II. Therapeutic response at day 28 of group I and II for conjuntival inflammation: Evaluation for therapeutic response at the end of study showed that 40 patients had much improved cojunctival inflammation and 9 improved in cyclosporine treated eyes. 11 patients had improvement in their condition while 39 patients had no change in placebo treated eyes. Table 1: Comparision of symptoms and it’s severity in group 1 and Group 2. Symptoms Itching Discharge Photophobia Foreign body sensation Conjunctival inflammation Papillary hypertrophy Limbal changes Mild 1 5 6 12 2 18 Group 1 Moderate 5 11 3 8 19 18 8 Papillary Hypertrophy Gradewise distribution of group I and II treated eyes for Papillary hypertrophy at day 0: Baseline evaluation showed that 9(18%) patients in group I and 10(20%) patients in group II presented with grade 3 papillae. Moderate papillary hypertrophy was present in 18(36%) patients in group I and 19(38%) patients in group II. Mild papillary reaction was present in 2 patients (4%) in group I and 1patient (2%) in group II, while no papillae were present in 21(42%) in group I and 20 (40%) in group II patients. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Severe 45 28 32 27 19 9 3 Mild 1 6 7 11 1 17 Group 2 Moderate 3 13 5 9 22 19 9 Severe 47 26 28 26 17 10 2 Therapeutic response at day 28 of group I and II for papillary hypertrophy: At the end of study, papillary hypertrophy was much improved in 15 patients and improved in 14 , while 21 patients had no change in papillary reaction group I. In placebo treated eyesiegroupII, 16 patients had improved papillae while 34 patients had no change in papillary reaction. Limbal Change Gradewise distribution of group I and II treated eyes for Limbal changes at day 0: 62% of patients in both groups presented with limbal Page 40 NATIONAL JOURNAL OF MEDICAL RESEARCH changes on baseline evaluation, 5% patients in both cyclosporine treated and placebo treated eyes had severe limbal changes (grade 3), while 8(16%) in group I and 9(18%) in group II presented with (grade 2) moderate limbal changes 18(36%) in group I and 17 (34%) in group II had mild limbal changes. No limbal changes were seen in 19 (38%) patients of both groups. Therapeutic response at day 28 of group I and II of limbal changes: 7 patients showed much improvement and 21 patients had improvement in limbal changes with topical cyclosporine treated while 22 presented with no improvement at the end ofstudy. 13 patients showed improvement and 37 patients had no improvement in placebo treated eyes. DISCUSSION The present study was conducted on hundred patients to compare the effects of topical cyclosporine and topical placebo (artificial tears CMC 0.5%) in vernal keratoconjunctivitis in the department of Ophthalmology, Dr.D.YPatil Medical College, Pune. Topical cyclosporine 0.5% and topical placebo (CMC 0.5%) were used, one drop 2 times a day for 4 weeks. Most of the patients in the study were males i.e. 39 males in group I and 37 in group II with 11 (22%) females in group I and 13 (26%) in group II 66% in group I and 78% in group II were from rural areas. The maximum number of patients, 18 in group I and 25 (50%) in group II were of 10-12 years age group. The disease was seen to have a chronic, recurrent form with a majority of patients 28 (56%) in group I and 20 (40%) in group II having history of 1 to 3 years. Most of these patients had exacerbation in summer. The mixed form of disease was most common, found in 50% in group I and 46% in group II patients. In the present study, topical cyclosporine 0.5% have been found to be safe and effective in alleviating prominent ocular symptoms of itching, discharge, photophobia and foreign body sensation on day 7, 14 21 and 28 of the study. Among the signs, conjunctival inflammation was reduced significantly with topical cyclosporine in comparison to topical placebo but papillary hypertrophy and limbal changes remained largely unaffected probably due to shorter duration of time. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 Comparing therapeutic response of symptoms in two groups at day 28 of the study shows topical cyclosporine was better and favoured over placebo. Total 49 patients showed improvement in itching in group I and 33 in group II. 33 patients showed improvement in discharge in group I and only 4 in group II. 32 patient showed improvement in photophobia in group I and 1 in group II. 35 patient showed improvement in foreign body sensation in group I and 11 in group II. Greater numbers of patients, at the end of study, were improved for signs of vernal keratoconjunctivitis with topical cyclosporine than topical placebo. 40 patients showed improvement in conjunctival inflammation in group I and 11 in group II. 15 patients showed improvement in papillary hypertrophy in group I and none in group II. 7 patients showed improvement in limbal changes in group I and none in group II. CONCLUSION The study suggests that topical cyclosporine -A is safe and effective in treatment of severe vernal keratoconjunctivitis. Most of its effects on signs and symptoms were achieved after 2 weeks of treatment. The only side effect was mild burning sensation and tearing soon after the instillation of the eye drops. REFERENCES 1. Barradah. Bull OphthalmolSoc Egypt, 1956;49:115. Quoted from duke Elder's system of Ophthalmology. 1965;VIII (part I) 491. Henry Kimpton London. 2. BenEzra D, Matanoros N, Cohan E. Treatment of severe vernal keratoconjunctivitis with-cyclosporine a eye drops. Transplant Proc 1988;20(2 suppl 2):644-9. 3. Leonardi A. Vernal keratoconjunctivitis, pathogenesis and treatment. Progress in Retina and Eye Research 2002;21:319-39. 4. BenEzra D, Pe’er J, Brodsky M, Cohen E. Cyclosporine eye-drops for the treatment of severe vernal keratoconjunctiviitis. Am J Ophthalmol 1986;101:278-82. 5. El-Asrar AM, Tabbara KF, Geboes K et al. An immunohistochemical study of topical cyclosporine in vernal keratoconjunctivitis. Am J Ophthalmol 1996;121:15661. 6. Gupta V, Sahu PK. Topical cyclosporine A in the management of vernal keratoconjunctivitis. Eye 2001;15:39-41. Page 41 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE PREVALENCE AND RISK FACTORS OF NON FATAL ROAD TRAFFIC ACCIDENTS IN A COMMUNITY SETTING OF DISTRICT DEHRADUN Shubham M. Sharma1,Ruchi Juyal2, Shaili Vyas3, Jayanti Semwal4 Author’s Affiliations: 1Demonstrator; 2Professor; 3Assistant Professor; 4Professor and Head, Department of Community Medicine, Himalayan Institute of Medical Sciences, Dehradun Correspondence: Dr Ruchi Juyal Email: [email protected] ABSTRACT Objectives: To study the prevalence and various environmental risk factors related to Road Traffic Accidental injuries in district Dehradun. Material and Methods: A cross-sectional descriptive study was conducted in rural and urban areas of district Dehradun. Multistage stratified random sampling method was used to reach the desired sample size. Overall 4000 individuals were interviewed using a structured pretested questionnaire. The data was entered in computer and analyzed by using SPSS software version 20. Results and conclusion: Maximum numbers of Road Traffic Accident (RTA) victims were in the age group of 20 – 29 years (33.6%). Males (79.5%) were involved significantly more as compared to females (20.5%). Most of the RTAs (61.9%) occurred during evening hours (4 – 10pm) and on crowded municipality roads (43.9%). Rural area had significantly more accidents (69.6%) as compared to urban area (30.8%). Maximum RTAs (78.7%) happened to occur on good roads. Key words: Prevalence, Community, Environmental Risk Factors, Road Traffic Accident. INTRODUCTION Accidental injuries are a neglected epidemic in developing countries, causing more than five million deaths every year. Unfortunately, accidents occur due to carelessness, recklessness and over confidence and not often due to ignorance. These injuries account for high economic and social costs for communities around the globe. The costs involved are greater in low- and middle-income countries, where many public health systems have yet to prioritize injuries as a major health concern, despite the cost-effective methods available to prevent them.1 Indirect estimates by the World Health Organization (WHO) suggest that unintentional injuries account for 3.9 million deaths worldwide, of which about 90% occur in low and middle income countries. The majorities of these deaths are attributable to Road Traffic injuries, falls, drowning, poisoning and burns. In 2004, WHO estimated about 0.8 million deaths in India were due to unintentional injuries.2 Road Traffic Accidents (RTAs) can be studied in terms of agent (Vehicle), host (human) and environmental factors, which play an important role before, during and after a trauma event. In India, not many systematic and scientific studies are available to highlight specific human, vehicle and environmental factors responsible for several types of injuries. Hence, NJMR│Volume 6│Issue 1│Jan – Mar 2016 the present epidemiological study was planned to address this research gap by focusing mainly on the prevalence and role of various risk factors including environmental factors in Road Traffic Accidents in a community setting. These findings are a part of a larger study carried out to know about the magnitude and pattern of injury in our area. METHODOLOGY This community based cross sectional study was conducted in the rural and urban areas of district Dehradun. Ethical clearance from the ethical committee of the institute was taken prior to conduction of survey. A sample of 3992 was worked out taking a prevalence of 30.6% 3 as a reference. It was rounded off to 4000 and for comparison point of view, equal number of subjects (2000) were covered in both groups (urban and rural). All individuals who have sustained an accidental injury in the last one year that needed medical attention or stay in bed at least for one day; or required to stop regular work or activity for at least one day after injury were included in the study. Individuals with mental illness, physical or developmental disabilities were excluded from the study. Page 42 NATIONAL JOURNAL OF MEDICAL RESEARCH A pre-designed, semi structured (modified version of WHO questionnaire) was used to carry out the survey.4 This included socio demographic details of the family, details pertaining to the Road Traffic Accident and other injuries and factors related to RTA. Data was collected by house to house survey in the chosen areas. Multistage stratified random sampling was used to select the household. After taking written consent from the head of the family, interview of the eligible subject was taken. For children, proxy interview of the mother/ guardian/ caretaker was undertaken. Collected Data was compiled and analyzed by using SPSS software version 20. Percentages and proportion were calculated for all the variables, while Chi square test was applied for association between two variables. RESULTS The study population comprised of all individuals who had sustained a traffic accidental injury in the last twelve months preceding the survey that needed medical attention or stay in bed for at least one day; or to stop regular work or activity for at least one day after the injury. print ISSN: 2249 4995│eISSN: 2277 8810 Table 2: Sex wise distribution of RTA victims Variable Male Female P value Urban (%) (n=74) 68 (91.8) 6 (8.2) < 0.001 Rural (%) (n=170) 126 (74.3) 44 (25.7) < 0.001 Total (%) (n=244) 194 (79.5) 50 (20.5) < 0.001 Table 3: Environmental factors in RTAs Variable Urban (%) (n=74) Light conditions Good 45 (60.8) Dim light 13 (17.6) Dark 16 (21.6) P value < 0.001 Weather conditions Clean/Clear 60 (81.0) Rainy 11 (14.9) Foggy 3 (4.1) P value < 0.001 Rural (%) (n=170) Total (%) (n=244) 93 (54.7) 46 (27.1) 31 (18.2) < 0.001 138 (56.5) 59 (24.2) 47 (19.3) < 0.001 161 (94.7) 9 (5.3) 0 (0.0) < 0.001 221 (90.6) 20 (8.2) 3 (1.2) < 0.001 Out of all injuries occurring in the surveyed population in last twelve months, fall accounted for 49.1%, RTA for 29.3%, assault 6.5% and others 15.1% of the cases. Maximum number of RTA victims (Table - 1) were in the age group of 20 – 29 years (33.6%) followed by 30 – 39 years age group (23.8%). Similar trends were seen in both the areas. It was observed that overall males (79.5%) were involved significantly more in RTAs as compared to females (20.5%) (Table– 2). Trends were similar in both urban and rural areas. Most of the RTAs (61.9%) occurred during evening hours (4 – 10pm) followed by day time i.e 10am – 4pm (21.7%). Similar trends were seen in both the areas (Figure – 1). Most of the RTA cases occurred when day light was adequate (56.5%) and weather was Good (90.6%) (Table-3). Table 1: Age wise distribution of RTA victims Variable < 10 yrs. 10 – 19 yrs. 20 – 29 yrs. 30 – 39 yrs. 40 – 49 yrs. 50 – 59 yrs. ≥ 60 yrs. P value Urban (%) (n=74) 4 (5.5) 9 (12.3) 29 (39.7) 22 (30.1) 4 (5.5) 4 (4.1) 2 (2.7) < 0.0001 Rural (%) (n=170) 29 (17.0) 21 (12.3) 53 (31.0) 36 (21.1) 17 (9.9) 10 (6.4) 4 (2.3) < 0.0001 For chi square age groups are ≤ 19, 20 years Total (%) (n=244) 33 (13.5) 30 (12.3) 82 (33.6) 58 (23.8) 21 (8.6) 14 (5.7) 6 (2.5) < 0.0001 -39, 40-59 and ≥ 60 NJMR│Volume 6│Issue 1│Jan – Mar 2016 Figure 1: Time distribution of Road Traffic Accidents Table 4: Road related factors in RTAs Variable Type of road Highway Rural/Brick road Municipality road P value Road conditions Good Bad Average P value Urban (%) Rural (%) Total (%) (n=74) (n=170) (n=244) 26 (35.1) 6 (8.1) 42 (56.8) > 0.05 58 (34.1) 47 (27.7) 65 (38.2) < 0.001 84 (34.4) 42 (21.7) 107 (43.9) > 0.05 62 (83.8) 3 (4.0) 9 (12.2) <0.001 130 (76.5) 6 (3.5) 34 (20.0) <0.001 192 (78.7) 9 (3.7) 43 (17.6) <0.001 It was also observed (Table – 4) that maximum RTAs occurred on municipality roads (43.9%), followed by highways (34.4%). In urban area, RTA on the municipality roads was significantly higher (56.8%) as compared to rural area (38.2%). Maximum RTAs (78.7%) happened to occur on good roads, while only 3.7% occurred on bad roads. SimiPage 43 NATIONAL JOURNAL OF MEDICAL RESEARCH lar findings were observed in RTAs in both rural and urban areas. DISCUSSION In our study, maximum number of RTA victims were in the age group of 20 – 29 years (33.6%) followed by 30 – 39 years age group (23.8%). Similar results were also observed by Mahajan N and Jha N5,6.In contrast, Dixit et al from Srinagar Garhwal, Uttarakhand reported that 50% of drivers involved in RTAs were less than 40 years of age and 15.8% of drivers were less than 20 years of age.7 There was male preponderance in our study as males (79.5%) were significantly more involved in RTAs as compared to females (20.5%). Similar results were also observed by Patil S and Jha N.6,8 RTAs maximally (61.9%) occurred during evening hours (4 – 10pm) followed by 10am – 4pm (21.7%). Similar results were also observed by Dixit S and Verma P.7,9 In contrast, Kandpal et al in their study from Dehradun Uttarakhand, observed that majority of accidents (76.8%) occurred during day time i.e. from morning to evening with a peak (31.1%) in afternoon.10Day light was reported to be adequate in most of the RTA cases (56.5%) and weather was good (90.6%). It might be due to the fact that this part of Uttarakhand, fog usually occurs in winter evenings and clears by late morning and people avoid travelling during night and early morning hours. The days in winters are usually sunny unlike plain areas. In rural area no RTA was reported under foggy conditions, while in urban area 4.1% of cases were seen. Similar results were also observed by Joshi et al.11 Maximum RTAs (78.7%) were reported to occur on good roads, while only 3.7% occurred on bad roads. This shows that despite of good road conditions, RTAs are bound to happen because of human factors such as not following the traffic rules properly, rash driving, overloading and other such conditions. Similar results were also observed by Dixit S.7 CONCLUSIONS & RECOMMENDATIONS From the above study it can be concluded that the prevalence of RTA injuries are fairly high in rural as well as urban areas of district Dehradun. Its increasing prevalence in rural community and in the younger age group is a pointer to the fact that the burden of RTAs is going to rise in near future. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 Greater attention should be paid towards the prevention of RTA in India. Computerized Trauma Registry, health insurance coverage of population for efficient and timely management of injured persons, devising better road and traffic management networks as well as educating the public in general for road safety measures including use of personal safety gears as well as following traffic rules etc. are some of the few recommendations advised for prevention and better management of RTA injuries. REFERENCES 1. Injuries: the neglected burden in developing countries. Richard A Gosselin, David A Spiegel, Richard Coughlin & Lewis G Zirkle. Bulletin of the World Health Organization, 2009; 87:246-246. doi:10.2471/BLT.08.052290. 2. World Health Organization: The Global Burden of Disease: 2004 update. Geneva: World Health Organization; 2008. 3. Kalaiselvana G, Dongre AR, Mahalakshmy T. Epidemiology of injury in rural Pondicherry, India. Journal of injury and violence research. 2011;3(2):62. 4. Shankar G, Naik VA, Powar R. Epidemiolgical Study of Burn Injuries Admitted in Two Hospitals of North Karnataka. Indian Journal of Community Medicine : Official Publication of Indian Association of Preventive & Social Medicine. 2010; 35(4):509-512. doi:10.4103/0970-0218.74363. 5. Mahajan, N., Aggarwal, M., Raina, S., Verma, L. R., Mazta, S. R., & Gupta, B. P. (2013). Pattern of non-fatal injuries in road traffic crashes in a hilly area: A study from Shimla, North India. International journal of critical illness and injury science, 3(3), 190. 6. Jha, N., Srinivasa, D. K., Roy, G., &Jagdish, S. (2003). Injury pattern among road traffic accident cases: A study from South India. Indian J Community Med, 28(2), 84-90. 7. Dixit, S., Tyagi, P. K., Singh, A. K., Gupta, S. K., & Malik, N. Clinico – epidemiological profile of Road Traffic incidents admitted at a Tertiary care Hospital in Garhwal - Uttarakhand. 8. Patil, S. S., Kakade, R. V., Durgawale, P. M., &Kakade, S. V. (2008). Pattern of road traffic injuries: A study from western Maharashtra. Indian journal of community medicine: official publication of Indian Association of Preventive & Social Medicine, 33(1), 56. 9. Verma, P. K., &Tiwari, K. N. (2004). Epidemiology of Road Traffic injuries in Delhi: Result of a survey. In Regional Health Forum (Vol. 8, No. 1, pp. 6-14). 10. Kandpal SD, Vyas S, Deepshikha, Semwal J. Epidemiological profile of Road Traffic Accidents reporting at a Tertiary Care Hospital in Garhwal Region of Uttarakhand. Indian J Comm Health.2015; 27, 2: 235-240. 11. Joshi, A. K., Joshi, C., Singh, M., & Singh, V. (2014). Road traffic accidents in hilly regions of northern India: What has to be done? World journal of emergency medicine, 5(2), 112. Page 44 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE STUDY ON CLINICOEPIDEMIOLOGICAL PATTERN OF FOREIGN BODIES IN OTORHINOLARYNGOLOGY AND ASSOCIATED MORBIDITIES Richa Gupta1, Manish Mittal 2 Author’s Affiliations: 1Assistant Professor. Dept. of ENT, S.S. Medical College, Rewa (MP), 2 Assistant Professor, Dept. of PSM, Pacific Medical College, Udaipur (Rajasthan) Correspondence: Dr Manish Mittal E-mail: [email protected] ABSTRACT Background: Foreign bodies in ENT are common occurrence. The present research was conducted to study clinicoepidemiological pattern of 117 cases of foreign bodies in ear, nose & throat presented to the S.S. Medical college & G.M. Hospital, Rewa. Materials & methods: The present study was a case series of 117 patients of foreign bodies in ear, nose & throat who presented to the S.S. Medical college & G.M. Hospital, Rewa from January 2014 to August 2014. Results: Among 117 patients 58.12 % were males with age ranging from 14 months to 75 years. Most patients 82 (70.09 %) belong to <10 year age group. Commonest site of lodgement of foreign body was ear (58.97 %) followed by nose (18.80 %). Commonest type of foreign body was insect (24.79 %). Conclusion: Foreign bodies in ENT are commonly encountered. They should be diagnosed timely and managed with utmost care to prevent complications. Keywords: Ear, Foreign body, Insect, Nose INTRODUCTION Otorhinolaryngeal foreign bodies are continuing medical problem and their referral to the otorhinolaryngologist for removal is a common occurrence. 1-3 The incidence of foreign body is seen throughout the year with a surge in cases during rainy season when flying insects are more common. The FB removal success depends on the patient’s cooperation, the doctor’s ability, the type of FB, the previous manipulation, the visibility and depth of the FB and the available equipment.4 Foreign body in ear nose & throat can pose a complication if not treated timely by skilled otorhinolaryngologist. The negligence of patient and their attendants can lead to delayed diagnosis and difficulty in managing the case. The cooperation by patient in eliciting history and while local examination of foreign body by otorhinolaryngologist plays a vital role. Foreign body in ear can be managed with the help of removal by instruments like jobson horn probe, alligator forceps, packing forceps or syringing depending on the type of foreign body and duration between time of insertion and presentation. FB can be removed either under local or general anaesthesia depending upon age of patient. NJMR│Volume 6│Issue 1│Jan – Mar 2016 METHODOLOGY The present study was a case series of 117 patients of foreign bodies in ear, nose & throat who presented to the S.S. Medical College & G.M. Hospital, Rewa from January 2014 to August 2014. The relevant data were collected with regard to age and sex distribution, site of lodgement, type of foreign body, laterality, associated complaints, duration between incident & presentation, clinical presentation, complication & management as per the predetermined questionnaire. All the patients were examined thoroughly with appropriate investigations like X-ray neck, chest and abdomen as per requirement. Various instruments played a vital role in management such as Jobson Horne probe, crocodile forcep, endoscope, laryngoscope and oesophagoscope with forceps. RESULTS The male predominance i.e. 58.12 % was observed in present study. Most patients (70.09 %) belonged to < 10year age group followed by 11.11 % in 11-20 year age group (Table no. 1). Page 45 NATIONAL JOURNAL OF MEDICAL RESEARCH Table 1: Age-wise distribution of cases (N=117) Age <10 11-20 21-30 31-40 41-50 >50 Cases (%) 82 (70.09) 13 (11.11) 11 (9.40) 6 (5.13) 3 (2.56) 2 (1.71) Table 2: Distribution of cases according to site of lodgement of foreign body (N=117) Site Ear Nose Oesophagus Hypopharynx Nasopharynx Oropharynx Larynx Bronchus Cases (%) 69 (58.97) 22 (18.80) 19 (16.24) 3 (2.56) 1 (0.85) 1 (0.85) 1 (0.85) 1 (0.85) Table 3: Type of foreign body as per its location (N=117) Location Ear Nose Oesophagus Hypopharynx Nasopharynx Oropharynx Larynx Bronchus Type Insect Wheat Pencil tip Cotton ball Star sequence Others Beans Groundnut Tamarind seed Insect Button Coin Denture Fishbone Glass Groundnut Fishbone Fishbone Nosepin Cases (%) 29 (24.79) 20 (17.09) 4 (3.42) 3 (2.56) 1 (0.85) 12 (10.26) 10 (8.58) 7 (5.98) 3 (2.56) 1 (0.85) 1 (0.85) 17 (14.53) 2 (1.71) 2 (1.71) 1 (0.85) 1 (0.85) 1 (0.85) 1 (0.85) 1 (0.85) The youngest patient was 14 months while oldest patient was 75 years old. The most common site of lodgement of foreign body is ear (58.97 %) followed by nose (18.8 %) cases. Least common site of lodgement was nasopharynx , larynx , bronchus and oropharynx with 0.85 % cases each (Table no. 2). The time of incidence and presentation varied from within an hour to 1 month. About 52.13 % patients presented within an hour of foreign body insertion while 25.64 % percentage patients presented within 24 hours. Rest of the cases presented i.e. 8.54 % arrived between 1-10 days and 13.67 % cases came between 11 days to 1 month. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 The most common type of foreign body in ear was insect (24.79 %) followed by wheat in 17.09 % cases. Beans were the commonest foreign body in nose (8.58 %) cases. Coin was the most common foreign body in oesophagus followed by denture. Fishbone came out to be the commonest foreign body in hypopharynx, oropharynx and larynx (Table no. 3). About 44.92 % cases among foreign body ear presented without symptoms. While the common symptoms noted were blockadge sensation in 29.98 %, hypoacusis in 14.49 %, otalgia in 11.59 %. Among foreign body nose the symptoms were blockadge sensation (45.45 %) & unilateral rhinnohrea (31.81 %). No symptoms were seen in 22.7 % cases. Odynophagia was seen in 31.57 % cases and vomiting in 15.78 % of foreign body oesophagus. No symptoms were observed in 52.63 % foreign body oesophagus cases. In foreign body oropharynx & larynx foreign body sensation was the symptom. The foreign body nasopharynx and bronchus presented with no symptom and respiratory distress respectively. The complications such as laceration of external ear i.e. 14.49 % and tympanic membrane perforation i.e. 1.45 % were seen in cases handled previously before arrival in hospital. Among foreign body nose patients 4.54 % patient had perforation of nasal symptom. Foreign body in 29.06 % cases were removed under general anaesthesia or sedation. The foreign body ear was removed with the help of jobson horn probe, syringing (in cases of intact tympanic membrane), nasal packing forceps or hook. In oesophageal foreign bodies, oesophagoscopy and forceps were used for removal. For bronchial foreign bodies bronchoscope was used. DISCUSSION Foreign bodies in ear nose & throat account for majority of emergencies in otorhinolaryngology. Foreign body refers to any object that is placed in nose or mouth that is not meant to be there and could cause harm without any medical attention.5 To reach a final diagnosis thorough history should be elicited along with detailed examination and appropriate investigations. In majority of the cases children reported the history of foreign body insertion to their parents or caregivers. This helped the ENT surgeon in adequate and timely removal of foreign body. In most of the cases, by how easy it is to identify such foreign bodies and for the patient to report the issue to his/her caregiver.6 In our study we found male predominance which was in accordance with studies of other authors. 4 Ear, nose, and throat (ENT) foreign bodies are more common among children, although adult age groups are involved.7 In present study we found that most of the patients belong to less than 10 year age group Page 46 NATIONAL JOURNAL OF MEDICAL RESEARCH with incidence of foreign bodies decreasing as age advances. This might be because of inquisitive and exploratory behavior of children. In our study we found ear to be the commonest site of lodgement of foreign body followed by nose, oesophagus and pharynx. This is in accordance with previous studies7 with ear being the most common site and nose second most common. Our study differs in oesophagus being third common site which might be due to small size of ingested foreign bodies which passed pharynx. Mostly foreign body cases presented within 24 hours with a vast majority of patient arriving within an hour of foreign body insertion. This is in accordance with previous studies.4 The time of presentation of patients immediately after insertion indicates their awareness towards their health and knowledge of various ailments. A few patients arrived after a delay of 24 hours. This might be due to the lack of ENT surgeon in their locality or their inaccess to medical facilities. A few patients were already handled by general practitioners and presented with complication such as laceration of external ear canal and tympanic membrane perforation. In foreign body ear cases the most common foreign body was insect followed by wheat. Wheat is a common foreign body in this region might be because children play with wheat during harvesting season and insert it while playing. Multiple foreign bodies in both ears were found in such cases. Hence otorhinolaryngologist must always be careful while dealing with these foreign bodies to ensure complete removal. In the foreign body ear patients the symptoms may start with hypoacusis,otalgia, otorrhoea or tinnitus. In the oropharynx, the main symptom is odynophagia.4,8 In our study blockadge sensation, hypoacusis or otalgia were the main symptoms. In foreign body nose cases blockadge sensation and unilateral rhinnohrea was the common symptom. In oeophageal foreign bodies odynophagia and vomiting were the most common symptoms. Foreign bodies are of grave concern to the surgeon as their removal not only demands a great skill but there is unpredictability in the degree of difficulty of the procedure.9 FB removal is often carried out in an operating room, with the patient under sedation or general anesthesia.4,10 In present study 29.06 % required general anaesthesia or sedation. In majority of cases requiring anaesthesia patient was either uncooperative especially children or foreign body was in oesophagus or bronchus. In a previous study the relationship between the need for general anesthesia for removal of FB ranged from 8.6 to 30% .11 NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 CONCLUSION Foreign body cases should be handled with utmost priority especially the cases with prior manipulations and complications. The masses should be educated about consulting otorhinolaryngologist in case of foreign body insertion. The caregivers should encourage their child to inform their parents without hesitation. A vast majority of cases can be handled easily but otorhinolaryngologist must be vigilant enough to categorize the cases as per cooperation, previous manipulation, dimensions and location of foreign body in order to ensure best possible procedure and need for anaesthesia. REFERENCES 1. Ijaduola GT, Okeowo PA. Foreign body in the ear and its importance: The Nigerian experience. J TropPediatr 1986;32:4-6. 2. Endican S, Garap JP, Dubey SP. Ear, nose and throat foreign bodies in Melanesian children: An analysis of 1037 cases. Int J PediatrOtorhinolaryngol 2006;70:1539-45. 3. Aracy P, Tanit G, Ossamu B, Marcia A, Fernando V, Claudio M, et al. Ear and nose foreign body removal in children. Int J Pediatrotorhinolaryngol 1998;46:37-42. 4. Tiago MPC, Salgado DC, Correa JP, Pio MRB, Lambert EE. Corpoestranho de orelha, nariz e orofaringe: experiência de um hospital terciário. Rev Bras Otorrinolaringol. 2006, 72:177-81. 5. Chadha S., Sardana P, Bais AS. Migrating foreign bodies in bronchus. IJO & HNS Aug 1999. Special no. FB:143-45. 6. Figueiredo RR, Azevedo AA, Kós AO, Tomita S. Complications of ENT foreign bodies: a retrospective study. Braz J Otorhinolaryngol. 2008;74(1):7-15. PMID: 18392495 7. Chiun KC, Tang IP, Tan TY, Jong DE. Review of ear, nose and throatforeign bodies in Sarawak General Hospital. A five year experience. Med J Malaysia 2012;67:17-20. 8. Marques MPC, Sayuri MC, Nogueira MD, Nogueirol RB,Maestri VC. Tratamento dos corposestranhosotorrinolaringológicos: um estudoprospectivo. Rev Bras Otorrinolaringol. 1998, 64:42-7. 9. Jane Y Yang. Bronchoesophagology. Ballenger S. Otorhinolaryngology head and neck surgery 16th edition1553. 10. Mukherjee A, Haldar D, Dutta S, Dutta M, Saha J, Sinha R. Ear, nose and throat foreign bodies in children: a search for socio-demographic correlates. Int J PediatrOtorhinolaryngol. 2011;75(4):510-2. 11. Thompson SK, Wein RO, Dutcher PO. External auditory canal foreign body removal: management practices and outcomes. Laryngoscope. 2003, 113:1912-5. Page 47 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE A PROSPECTIVE STUDY OF COMPARISON BETWEEN OPEN GASTROJEJUNOSTOMY AND LAPAROSCOPIC ASSISTED GASTROJEJUNOSTOMY IN PATIENTS OF POST CORROSIVE INGESTION PYLORIC STENOSIS Samir M.Shah1, Chirag K. Patel2, Smit M. Mehta2, Vikram B. Gohil3 Author’s Affiliations: 1Professor & Head; 2Resident Doctor; 3Associate Professor, Department of General Surgery, Govt. Medical College, Bhavnagar, Gujarat Correspondence: Dr Chirag K. Patel Email: [email protected] ABSTRACT Background: It is important to understand and study the trends in the incidence of various factors responsible for gastric outlet obstruction in the present scenario and outline the rationale behind treatment of gastric outlet obstruction by open and laparoscopic method. Method: This is a prospective study of 70 patients diagnosed as GOO .We observed all case of GOO, but to minimize the bias in comparison of Open Gastrojejunostomy and Lap Assisted Gastrojejunostomy due to disease condition, we included those 30 patients of post corrosive ingestion pyloric stenosis for comparison between two operations. We also observed the nature of corrosive injury to stomach. Intra operative findings and postoperative complications were noted. Results: We observed that benign etiology was more common for GOO (58%) compared to malignant cause (42%) and post corrosive ingestion pyloric stenosis was most common benign cause(42%) of GOO, Pancreatic cancer was most common malignant cause(18.5%) of GOO. Corrosive ingestion was more common in younger age group (66% in 15 -30yr age) and female gender(63.34%) and mostly as a suicidal attempt(86.66%) and most common corrosive agent was sanitary cleansing agent(hydrochloric acid) (70%).Post prandial nonbillious vomiting and weight loss were consistent symptom and appeared after 6-8 week of corrosive ingestion and 50% of patient of post corrosive ingestion pyloric stenosis had concomitant esophageal stricture. In present study those patient operated with Lap Assisted Gastrojejunostomy had smaller size of incision, reduce intra operative need of blood transfusion, less post-operative pain and less chance of wound infection, early drain and suture removal and early discharged from hospital with minimal post-operative morbidity and without significant increase in total duration and cost of operation. Conclusion: As compared to Open Gastrojejunostomy, Lap Assisted Gastrojejunostomy is better alternative operative method for pyloric stenosis. INTRODUCTION Gastric outlet obstruction (GOO, also known as pyloric obstruction) is not a single entity; it is the clinical and pathophysiological consequence of any disease process that produces a mechanical impediment to gastric emptying. Clinical entities that can result in GOO generally are categorized into 2 well-defined groups of causes—benign and malignant. It is important to understand and study the trends in the incidence of various factors responsible for gastric outlet obstruction in the present scenario and outline the rationale behind treatment of each patient with different etiology for gastric outlet obstruction by open and laparoscopic method. Corrosive injuries of the stomach are not uncommon in developing countries. The spectrum of gastric injury due to corrosives can vary from acute partial or total gastric mucosal or NJMR│Volume 6│Issue 1│Jan – Mar 2016 transmural necrosis to chronic gastric injuries of different types. We report our experience in different etiology of GOO, and post corrosive ingestion pyloric stenosis, and comparison between open and laparoscopic assisted Gastrojejunostomy. METHODOLOGY This is a prospective study of patient admitted with clinical feature suggestive of pyloric obstruction in surgery department of Sir T. Hospital Bhavnagar from April 2013 to April 2015. Data of all the patients with pyloric obstruction were collected. All the patients underwent upper gastrointestinal tract contrast studies and esophagogastroduodenoscopy to assess the site and extent of pyloric stenosis, also CT scan and USG and other hematological investigaPage 48 NATIONAL JOURNAL OF MEDICAL RESEARCH tions for diagnosis of other etiological factor of GOO. We observed all 70 patients of pyloric obstruction, but to minimize the bias in comparison of Open Gastrojejunostomy and Lap Assisted Gastrojejunostomy due to disease condition, we included only those patients of post corrosive ingestion pyloric stenosis for comparison. For randomization odd numbers of patients were operated with Lap Assisted Gastrojejunostomy and even numbers of patients were operated with Open Gastrojejunostomy. Information collected with attention to age, gender, presenting complaints, cause of pyloric stenosis , interval between time of corrosive ingestion and presentation as pyloric stenosis in hospital, nature of corrosive agent, mode of ingestion, definitive procedure performed is Gastrojejunostomy ,intraoperative data ( length of incision, need of intraoperative blood transfusion, duration of operation) and post operative data(post operative pain, wound infection, suture removal, drain removal, total hospitalized days, weight gain). Patients were followed up at 2 week and 3 month.. Definitive surgery (Gastrojejunostomy) was performed in 30 patients of post corrosive ingestion pyloric stenosis. Feeding jejunostomy were kept in those patients had concomitant esophageal stricture and significant weight loss. Operations were performed in presence of senior surgeons. Permission to carrying out study was taken from ethical committee of institute and funding was taken from institute. Inclusion criteria: Patients admitted to the surgery wards with a clinical diagnosis of GOO, Endoscopic and radiological evidence of gastric outlet obstruction, age 18 -80 year, willing for operative intervention. Procedure: Open Gastrojejunostomy performed as a conventional anterior loop side by side Gastrojejunostomy. In Lap Assisted Gastrojejunostomy initially stomach and jejunal loop mobilised by laparoscopy, then small upper midline vertical incision kept over epigastrium. Part of stomach and jejunal loop taken outside of peritoneal cavity under laparoscopic guidance and side to side gastrojejunal anastomosis performed by hand sewn method. RESULTS AND DISCUSSION As mentioned in table :1 ,We observed that ,out of 70 patients of gastric outlet obstruction, 41(58%) having benign etiology (most common post corrosive ingestion pyloric stenosis,42%) and 29 patient(42%) having malignant cause(most common pancreatic cancer,18.5%). As compared to Vivek sukumar et al study 1 reported, 38.60% having benign etiology and 61.40% having malignant etiology. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 As mentioned in table 2, out of 30 patients, Corrosive ingestion was more common in younger age group (66% in 15 -30yr age) and Similar findings were observed in Sharma et al2 in which mean age group of post corrosive ingestion was 31 year with male predominant but in our study we observed that female gender (63.34%) were more predominant and mostly as suicidal attempt (86.66%) most probably due to familial and marital conflicts and more suicidal tendency in female gender3. Table 1: Etiology of Gastric Outlet Obstruction Etiology Benign etiology Peptic ulcer disease Corrosive ingestion Hypertrophic pyloric stenosis Prepyloric web Malignant etiology Gastric cancer Gastric polyp Pancreatic cancer Cholangiocarcinoma Cases (n=70)(%) 41(58.0) 5(7.0) 30(42.0) 5(7.0) 1(1.0) 29(42) 10(14.28) 1(1.42) 13(18.5) 5(7.14) Table 2: Natural History of Disease and Clinical Feature Factor Age Gender Mode of corrosive ingestion Corrosive agent of ingestion Duration of a presentation of patients as a pyloric stenosis Presenting clinical feature Nonbillious Vomiting Weight loss Dysphasia Concomitant esophageal stricture # year,* Hydrochloric acid Most common Groups (%) 15-30 yr#(66) Female (63.34) Suicidal (86.66) Sanitary cleansing agent, HCl* (70.0) 6-8 weeks (63.34) 100 73.34 46.67 14 (46.66) Other similar findings were observed like most common corrosive agent was sanitary cleansing agent (70%) , because of easy availability at home and working place, post prandial nonbillious vomiting and weight loss were consistent symptom and appear after 6-8 week of corrosive ingestion because gradual narrowing of pyloric part of stomach .But we observed that those patients had concomitant esophageal stricture had initial complain of dysphasia and pyloric stenosis become evident after esophageal dilatation and oral feeding. In present study 50% of patients of post corrosive ingestion pyloric stenosis had concomitant esophageal stricture as study conducted by N.ananthkrishnan was reported two third of patients had concomitant esophageal stricture along with gastric corrosive injury.4 Page 49 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table 3: Camparision of Open Gastrojejunostomy and Laproscopic Assisted Gastrojejunostomy Factors Length of incision(mean) Need of intraoperative blood transfusion Total duration of operation (mean) Post op abdominal pain (no of patients) Mild Moderat Severe Post op drain removal (mean) Wound infection Post op suture removal (mean) Duration of hospitalization after operation (mean) Outcome Cured Morbidity in form of wound infection Anastomotic leak Reflux gastritis Dumping syndrome Weight gain after operation within 3 month(mean) *POD: post operative day Out of 30 patients, 6 patients required feeding jejunostomy up to definitive surgery for nutritional support. We observed that even after placement of feeding jejunostomy there was no significant increase in weight gain, so we planned for early definitive procedure (Gastrojejunostomy) within 6-8 weeks of post corrosive ingestion. As mentioned in table: 3,We observed that Gastrojejunostomy is definitive operative procedure for pyloric stenosis to relieve obstructive symptom of pyloric stenosis but as mention in table 3, those 15 patients of post corrosive ingestion pyloric stenosis operated by Lap Assisted Gastrojejunostomy had smaller size of incision because mobilization of stomach and jejunum done by laparoscopic method, it reduced post-operative pain and chance of wound infection, it lead to early suture removal. In Laparoscopic Assisted Gastrojejunostomy, there was minimal intra operative dissection so reduced intra operative need of blood transfusion and early drain and suture removal and early discharge from hospital with minimal post-operative morbidity and without significant increase in total duration in Lap Assisted Gastrojejunostomy in which time was utilized for laparoscopic asses. In Lap Assisted Gastrojejunostomy, we were done hand sewn anastomosis between stomach and jejunum which reduced the cost of operation compared to total Laparoscopic Gastrojejunostomy in which staper is used for anastomosis between stomach and jejunum. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Laparoscopic Assisted Gastrojejunostomy (n=15) 4-5 cm 2 patients 133.33 min Open Gastrojejunostomy (n=15) 9-10 cm 8 patients 127 min 3 0 0 4.3 day 0 (0 %) 7th POD 4.5 day 4 4 1 5.96 day 4(26.66%) 10.06th POD* 7.65 day 100% 0% 0% 0% 0% 10.3 kg 100% 26.66% 0% 0% 0% 11.2kg CONCLUSION Compared to Open Gastrojejunostomy, Lap Assisted Gastrojejunostomy operation is better alternative for pyloric stenosis with advantage of smaller size of incision, reduce intra operative need of blood transfusion, less post-operative pain and less chance of wound infection, early drain and suture removal and decrease duration of hospitalization and decrease morbidity without significant increase in total duration and cost of operation. REFERENCES 1. N Am J Med Sci. 2015 Sep; 7(9): 403–406,Demographic and Etiological Patterns of Gastric Outlet Obstruction in Kerala, South India by Vivek Sukumar, Chirukandath Ravindran, and Ramachandra Venkateshwara Prasad. 2. CIB tech journal of surgery ISSN, 2015 vol.4, January – April, p, 1-4/Sharma et al.-Surgical management of gastric corrosive stricture. 3. The Scientific World Journal, Volume 2013 (2013), Article ID 485851, 9 pages. Review Article, Life Cycle and Suicidal Behavior among women by Pablo Mendez-Bustos, Jorge Lopez-Castroman, Enrique Baca- García , and Antonio Ceverino. 4. International scholarly research network, ISRN gastroenterology, volume 2011, acute corrosive injuries of the stomach by. N.anantnkrishnan 2010. Page 50 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE STUDY OF CHANGE IN MACULAR VOLUME WITH UNCONTROLLED HBA1C LEVELS IN A DIABETIC PATIENT IN ABSENCE OF DIABETIC MACULAR OEDEMA Parag Apte1, Priti Kumari2, Debapriya Datta2, Nilesh Jagdale2, Jatin Patel2, Richa Naik2 Author’s Affiliations: 1Assistant Professor; 2PG Resident, Department of Ophthalmology, Dr D. Y Patil Medical College, Pimpri, Pune Correspondence: Dr Debapriya Datta E-mail: [email protected] ABSTRACT Background: This study is aimed to find out the correlation between change in macular volume on optical coherence tomography (OCT) in patients with uncontrolled HbA1c levels . Methods: It is a observational study. Patients with diabetes mellitus for over 5 years were included in the study. Only one eye of each patient was selected for analysis. Eyes with proliferative diabetic retinopathy were not included in the study. Chronic HBA1c level was defined as mean HbA1c value in last one year duration. Central Subfield Volume (CSV) , Central Subfield Thickness (CST) and Total Macular Volume (TMV) were all measured by OCT. Results: 50 eyes from 50 patients (22 women and 28 men ; mean age 63.5 years ). Mean duration of Diabetes Mellitus (DM) being 10.5 years. 6 patients had Type 1 DM and 44 patients had Type 2 DM. Of these , 19 eyes (38 % ) had no diabetic retinopathy (DR) and 31 eyes (62 % ) had non proliferative diabetic retinopathy. In statistical analysis , CST ( mean 188.82 ± 27.62 µm , p = 0.03 ) , CSV ( mean 0.148 ± 0.022 mm3 , p = 0.03 ) and TMV ( mean 6.495 ± 0.717 mm3 , p = 0.003 ), all positively correlated with chronic HBA1c level (8.95 ± 1.40 % ). Conclusion: There is a positive correlation between chronic HbA1c and macular volume in patients with DM > 5 years duration without Macular oedema. Our studies suggest that there are changes in values of subclinical macular volume or thickness before onset of diabetic macular oedema (DMO) becomes clinically significant. Strict glycaemic control ( HbA1c levels below 6 ) is needed in case of diabetic patients to prevent development and further deterioration of macular function prior to development of DMO . Key words: Macular thickness, macular volume, HbA1c, non proliferative diabetic retinopathy, diabetic macular oedema – optical coherence tomography INTRODUCTION Diabetic Macular oedema is defined as retinal thickening within 2 disc diameters of the centre of the macula , causing leakage of plasma constituents into the surrounding retina due to microvascular changes in the blood retinal barrier and ultimately leading to retinal oedema.1 It is one of the commonest cause of visual loss in DM. Diabetic macular edema is classified in focal and diffuse types and this is important because the treatments of the two types are different. Focal edema is caused by leakage from micro aneurysms and is associated with hard exudates rings. Diffuse edema is caused by leakage from retinal capillaries and arterioles. Two types of laser treatment for DMO are focal and grid. Focal laser treatment is used to treat focal diabetic macular edema; the purpose is to close the leaking micro aneurysms. Grid NJMR│Volume 6│Issue 1│Jan – Mar 2016 laser is used to treat diffuse macular edema and is applied in areas of retinal thickening with diffuse leakage.1 The Early Treatment Diabetic Retinopathy Study (ETDRS) Research group (1985) demonstrated the focal laser photocoagulation reduces moderate vision loss by 50 % or more in DMO. The Wisconsin Epidemiology Study of Diabetic Retinopathy (WESDR) in 1995 showed that there is an increase in diabetic macular edema in patients with increase HbA1c.2 Two other randomized trials conducted revealed that good control and reduction in HbA1c levels lead to a decrease in rates and development and progression of Diabetic macular edema as well as diabetic retinopathy.3,4,5 The drawback of these earlier studies were that they were unable to detect mild changes in macular edema. A newer modality, OCT enables us to study the structures of Page 51 NATIONAL JOURNAL OF MEDICAL RESEARCH the macula properly and detect even minimal changes in thickness. Some recent studies have shown that there is retinal thickness before development of macular edema.6 Another recent study states that as the probability of macular thickening increases on OCT examination there is probability of increase in severity of diabetic retinopathy. The purpose of this study is to find out the correlation between change in macular volume on optical coherence tomography (OCT) in patients with uncontrolled HbA1c levels. METHODOLOGY It is a observational study conducted in 50 patients attending the ophthalmology OPD between Jan15July 15. Written informed consent was taken from all patients. Ethics Committee Clearance was obtained before starting the study. Inclusion criteria: Patient who had diabetes since >5 years without macular edema with or without NPDR were include in the study. Exclusion criteria: Patient having eyes with proliferative diabetic retinopathy (PDR); Eyes with cystoids serous maculae edema (CSME); and Other modalities like epiretinal membrane (ERM), age-related macular edema (ARMD), prior laser IV Bevacizumab, Triamcinolone were excluded from the study. One eye of each patient was selected. If both eyes had increase macular thickness the eye with thinner macula was selected. A complete ocular examination print ISSN: 2249 4995│eISSN: 2277 8810 was done which included VA using Snellens, intraocular pressure (IOP) measurement with non contact tonometer; dilated fundus examination with direct ophthalmoscopy and indirect ophthalmoscopy, OCT was used to evaluate macular thickness and volume. RT (Retinal thickness), CST (Central Subfield Thickness), CSV (Central Subfield Volume), TMV (Total Macular Volume) were recorded for each patient. CST and CSV are the mean thickness and volume in a region <0.05 mm from the fovea respectively. TMV is the total volume within a radius of 3mm from the fovea. Single sample of HbA1c was taken to check glycaemic control over last 3 months. Statistical analysis- Pearson’s correlation coefficient was used to find out the relationships between age, duration of diabetes, HbA1c level, CST, CSV and TMV. P value <0.05 was considered statistically significant. All patients were divided into 2 groups with no diabetic retinopathy and those with NPDR. RESULTS 50 eyes from 50 patients (22 women and 28 men; mean age 63.5 years) were selected. Mean duration of DM being 10.5 years. 6 patients had type 1 DM and 44 patients had type 2 DM. Of these, 19 eyes (38%) had no DR and 31 eyes (62%) had NPDR. In statistical analysis, CST (mean 188.82 +/-27.62um, p=0.03) CSV (mean 0.148 +/- 0.022 mm3,p=0.03) and TMV (mean 6.495 +/- 0.717mm3, p=0.003) , all positively correlated with chronic HbA1c level (9.95 +/- 1.40%). Table 1: Comparisons between patients with and without diabetic retinopathy Variable Age(years) Diabetic duration(years) HbA1c value CST CSV TMV No DR 61.5+/-14.7 12.3+/-5.9 9.1 180.4+/-26.2 0.146+/-0.166 6.356+/-0.612 Table 1 shows that patients who had more uncontrolled HbA1c levels showed more macular thickening. However there was no significant difference in age and DM in 2 groups. P value is calculated by independent sample t-test. DISCUSSION OCT is the new and precise method to look for macular thickening which was used in our study.7 The increase in macular thickening in DM can be explained by 2 mechanisms. Firstly microvascular damage can cause changes in hemodynamic of macula causing thickening of macula due to breakdown of NJMR│Volume 6│Issue 1│Jan – Mar 2016 NPDR 61.75+/-12.5 13.7+/-4.2 10.6 192.6+/-26.2 0.156+/-0.100 6.616+/-0.761 P value 0.753 0.335 0.002 0.012 0.030 0.046 inner blood retinal barrier. Studies have shown that long standing hyperglycemia can cause hydration of macula due to osmosis and also increase in foveal thickening. Endometrial cell dysfunction due to microvascular damage causes changes in structure of retinal cells and the microvascular damage is more with uncontrolled HbA1c and our results are similar to that.8,1 In our study TMV has stronger correlation to uncontrolled HbA1c as compared to CST and CSV. This finding is different from an earlier study which shows that CST is preferred for OCT measurement of central macula. This difference could be due to Page 52 NATIONAL JOURNAL OF MEDICAL RESEARCH DMO which was excluded from the study unlike previous study which has included it. The hemodynamic changes in pre-macular edema stages are diffused disturbances rather than focal changes in fovea. So in our study there is change in TMV instead of CMV.9 print ISSN: 2249 4995│eISSN: 2277 8810 3. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329:977–986. 4. UK Prospective Diabetes Study (UKPDS) Group. UK prospective diabetes study VIII. study design, progress and performance. Diabetologia. 1991;34:877–890. 5. No treatment was given to the patients who participated in our study because patient did not have CSME. Higgins GT, Khan J & Pearce IA (2007): Glycaemic control and control of risk factors in diabetes patients in an ophthalmology clinic: what lessons have we learned from the UKPDS and DCCT studies? Acta Ophthalmol Scand 85: 772–776. 6. Browning DJ, Fraser CM & Clark S (2008a): The relationship of macular thickness to clinically graded diabetic retinopathy severity in eyes without clinically detected diabetic macular oedema. Ophthalmology 115: 533–539. CONCLUSION 7. Schaudig UH, Glaefke C, Scholz F & Richard G (2000): Optical coherence tomography for retinal thickness measurement in diabetic patients without clinically significant macular oedema. Ophthalmic Surg Lasers 31: 182–186. 8. Ferris FL III & Patz A (1984): Macular oedema. A complication of diabetic retinopathy. Surv Ophthalmol 28: 452–461. 9. Kayykcyolu O, Ozmen B, Seymenoglu G, Tunali D, Kafesciler SO, Guclu F & Hekimsoy Z (2007): Macular oedema in unregulated type 2 diabetic patients following glycaemic control. Arch Med Res 38: 398–402. In our study, there is more significant increase in TMV, CST, CSV in subgroup with NPDR than sub group with no DR. this finding is similar to an earlier study done by Browning.10,11 In our study we concluded that there is a positive correlation between macular volume and thickness in patients with uncontrolled HbA1c levels. Hence these patients require regular follow up since they are more prone to develop macular edema and hence regular OCT was advised to these patients for early detection and treatment of macular oedema. REFERENCES 1. Antcliff RJ & Marshall J (1999): The pathogenesis of oedema in diabetic maculopathy. Semin Ophthalmol 14: 223–232. 2. Klein R, Moss SE, Klein BE, et al. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XI. The incidence of macular edema. Ophthalmology. 1989;96:1501–10. NJMR│Volume 6│Issue 1│Jan – Mar 2016 10. Browning DJ, Fraser CM & Clark S (2008a): The relationship of macular thickness to clinically graded diabetic retinopathy severity in eyes without clinically detected diabetic macular oedema. Ophthalmology 115: 533–539. 11. Browning DJ, Glassman AR, Aiello LP et al. & the Diabetic Retinopathy Clinical Research Network (2008b): Optical coherence tomography measurements and analysis methods in optical coherence tomography studies of diabetic macular oedema.Ophthalmology 115:1366–1371. Page 53 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE EVALUATION OF VISUAL OUTCOME OF CATARACT SURGERY IN RURAL EYE-CAMPS IN THE STATE OF MAHARASHTRA Rupali D Maheshgauri1, Abha Gahlot2, Sonal Kohli3, Radhika R Paaranjpe4, Bhagyashree Kadam5, Gira Raninga5 Author’s Affiliations: 1Associate professor; 2Professor; 3UG student; 4Assistant professor; 5PG student, Dept. of ophthalmology, Dr.D.Y.Patil Medical College, Pimpri, Pune Correspondence: Dr Rupali D Maheshgauri Email: [email protected] ABSTRACT Aim: The present study was conducted to evaluate patients’ satisfaction and success of cataract surgery. Methods: This population based retrospective study included 1000 patients .Out of which 500 were operated in surgical camp and remaining 500 were operated in “Pdm. Dr. D. Y. Patil Medical College Hospital and Research Centre, Pimpri, Pune in institution setup from July to December 2013.The study was conducted at a number of camps held in peripheral north Maharashtra .Evaluation of visual acuity and patients satisfaction with scheduled porforma was done. Statistical analysis was performed with the help of cataract monitoring outcome software developed by International Centre for Eye Health, London School of Hygiene and Tropical Medicinefor evaluation of genderdifference, visual acuity, complications and patients satisfaction. Result: In camp, 71.60% female and 28.40% male patients operated. And in base hospital, 58.40% male and 41.60% female were operated..Post operative.Visual acuity of 6/6 in base hospital was 90.4% and in camp was 69.2%. Number of visits in base hospital was 81.6% and in camp was 43% due to lack of post operative follow-ups cause of absence of transportation coupled with socio-economic background..Thepost operativecomplication rate and patients satisfaction in base hospital was 9.6% and 83% respectively and .In camp was 30% and58.6 % respectively. Conclusion: Camp services should be at same location of base hospital with good transportation that helps to make doctor- patient bonding and improve visual outcome. Involvement of the local community leaders may provide an improved alternative. Key words: Cataract, Visual acuity ,patient satisfaction INTRODUCTION WHO defines cataract as “clouding of the crystalline lens of the eye which prevents clear vision”. Cataract is the leading cause of unavoidable blindness worldwide .1 Epidemiologic models estimated that more than 20 million people in the world are blind from cataract and with increased life expectancy; it is projected that this will increase to 50 million by 2020.2 Eye camps in rural areas provide inexpensive surgery to poor patients. The results of surgery in eye camps are often not evaluated and the role of IOL implantation under camp has been questioned. Rural eye camps are able to provide a cost- effective .Several patients did not visit and not taken post operative care which leads to complications after surgery. The two models of this study were discussed in the rural Maharashtra especially the backward regions NJMR│Volume 6│Issue 1│Jan – Mar 2016 such as Vidarbha.9 These models were complimentary and proposed to work in conjunction. Repetitive eye-camps with the same set of professionals also provide an emotional integration of the patients with their doctors, thereby giving better result with cataract related complications of the rural poor. The patients already suffering with systemic diseases and having a very low pre-operative visual acuity are proposed to be separated and provided differential treatment at the base hospital. It will reduce percentage of post-operative complications and would lead to better acceptability of the camp operated model. The “Vision 2020: Right to Sight” initiative, calls upon us to take initiative to achieve the goals of right to sight for all. With this background in mind, the present study was undertaken with a hypothesis that a viable solution for cataract afflicted rural populace can be provided by improvising and improving the models of camps being organised for cataract surgerPage 54 NATIONAL JOURNAL OF MEDICAL RESEARCH ies. Aims & Objective: To evaluate patients satisfaction and visual outcome after cataract surgery in rural surgical camp and institutional level. Objective of this study is a right to sight and to eliminate avoidable blindness by 2020. The burden of blindness has an enormous personal, social and economic impact, limiting the educational potential and quality of life of otherwise healthy people, and producing a severe drain on family, community, social and health services. Blindness is also associated with lower life expectancy .13 METHODOLOGY Study Site and Context: The population-based retrospective study was conducted at camps held in peripheral north area of Maharashtra. The field study was also extended to the OPD of the base hospital at Pdm. Dr. D. Y. Patil Medical College Hospital and Research Centre, Pimpri, Pune. The study included 1000 patients (500 camp-operated and 500 base hospital operated) and were examined in period of July to December 2013. Patients above 40 years suffering from age-related cataract who have undergone cataract surgery in past 3 years were included. The success of cataract surgery is assessed by visual acuity 68 weeks post-operatively. The world health organisation recommends that at least 90% of patients have a good outcome ( i.e., corrected distance visual acuity [CDVA] > 6/18) after cataract surgery and that a poor outcome (CDVA < 6/60) be limited to 5% of cases.14 Inclusion criteria- Patients suffering from age-related cataract who have undergone cataract surgery in past 3 years Patients from rural areas, who have been selected by government/NGOs through camps for free surgery.Walk-in patients’ suffering from cataract attending the tertiary care centre in a private medical college and eventually operated. Exclusion criteria: Patients having pre-existing corneal opacity, pseudoexfoliation, uveitis etc. Ethical committee approval was taken. Data collection procedures: manually, with the help of a Performa. Procedure for examination of visual acuity: Visual acuity in each eye was tested with Snellen’s chart and Landolt C chart (distant vision), Jaeger’s chart (for near vision).15 Procedure for corneal examination with the help of Binocular loop and torch examination was done to exclude a corneal abrasion or corneal xerosis. 15 Fundus examinations done under pupillary dilatation with use of Beta Heinz direct ophthalmoscope when light is shown in one eye, both the pupils constrict. Constriction of the pupil to which light is shown, is called direct light reflex; and that of the other pupil, is called conNJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 sensual or indirect light reflex.16 Collected data has been evaluated with the help of cataract monitoring outcome software developed by International Centre for Eye Health, London School of Hygiene and Tropical Medicine.17 RESULTS In camp, 71.60% female and 28.40% male patients operated. And in base hospital, 58.40% male and 41.60% female were operated as shown in table 1. Table1: Male-Female percentage Camp operated and Base operated patients Gender Male Female Total Camp operated (%) 142(28.40) 358(71.60) 500 (100) Base operated (%) 292(58.40) 208 (41.60) 500 (100) Table 2: Visual Acuity in postoperative patients Visual Acuity PLPL+ 1/60 3/60 3/60-6/60 6/60 6/36 6/24 6/24-6/18 6/18 6/12 6/9 6/6 Base Hospital 0 0 0 0 3 0 0 0 11 34 0 0 452 Camp Operated 13 0 0 0 22 0 14 0 47 58 0 0 346 Table 3: Post-operative follow-up Visits 1 2 3 4 Base Hospital (%) 457(91.4) 431(86.2) 411(82.2) 408(81.6) Camp operated (%) 426(85.2) 402(80.4) 351((70.2) 215 (43.0) Table 4: Post-Operative Cataract Complications Post-operative catAract complications Corneal Haze Wound Leak Vitreous Loss Endophthalmitis TASS Base- Hospital (%) 34 (6.8) 0 (0.0) 3 (0.6) 0 (0.0) 11 (2.2) Camp- operated (%) 58 (11.6) 14 (2.8) 22 (4.4) 13 (2.6) 47 (9.4) Table 5: Satisfaction to Surgery Satisfaction to Surgery Satisfied Average Satisfaction Not Satisfied Base Hospital (%) 415 (83.00) 57 (11.40) 28 (5.60) Camp Operated (%) 293 (58.60) 75 (15.00) 132 (26.40) Page 55 NATIONAL JOURNAL OF MEDICAL RESEARCH Total 500 (100) 500 (100) Table 2 shows Post operative Visual acuity of 6/6 in base hospital was 90.4% and in camp was 69.2%. As shown in Table 3 Number of visits in base hospital was 81.6% and in camp was 43% it due to lack of post operative follow-ups cause of absence of transportation coupled with socio-economic background. Definitely no of visits of patients are more in base operated patients. Table no 4 describes the patient satisfaction after surgery. Analysis of the satisfaction level of camp- operated and base-operated patients after a period of 4-6 weeks shows a higher level of satisfaction for the latter. The patients having systemic diseases diagnosed out of routine screening are transferred to the base hospital for improved management for avoiding incidence of intra & post-operative complication. Table no 5 describes postoperative complication incidence of endophthalmitis is high in camp operated patients. DISCUSSION Cataract is the leading cause of blindness in India. The male patients are taken care of and transported to improved health care centres such as the base hospital in our case, whereas the female patients belonging to the same group have to depend largely on the free health camps organised nearer to their dwellings. In our study, 71.60% female and 28.40% male were operated in camp while , 41.60% female and 58.40% male were operated in base hospital. Similar results were seen in a study conducted by as of our study undertaken by Gogate Pet al al at a base hospital and outreach camps in the rural areas in Maharashtra.10 As per this study, 59.1% female patients were operated at camp and 48% were operated at hospital. The study undertaken by Kapoor H et al similar with our study as efficacy of eye camps can be improved by repeat camp at the same venue, was evaluation of visual outcome of cataract surgery in an Indian eyecamp.3 In another study of Nowak R et al on outcome of an outreach microsurgical project in Nepal ,compare with our study with application of appropriate surgical techniques and standard protocols at camp level.4 Another similarity with our study was conducted by Murthy G V et al the better visual acuity levels achieved in base hospitals as compared to camp operated cataract patients.5 Our proposed model acquires significance as it will lead to improved visual acuity, satisfaction and surgical care to the rural population especially the females near their community living. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 One study done by Finger RP at al highlightened the importance of providers building trust by organizing regular outreach in the same location.6 A study was done by Pai SG at alin which patient were screened in camp and transported to base hospital for low rate of intraoperative complications.7 A study done by Jagat Ram at al ,found that follow up in camp operated children declined gradually.8 A other study was done by Reddy A et al found that outcome for the eyecamp operated patients was almost similar with patients operated in hospital.9 One study was done by Gogate P et al l found that postoperative follow up at base hospital was very poor.10 A study undertaken by R Anand,et al in Chandigarh on visual outcome following cataract surgery in rural Punjab had similar outcome to our study.11 One study done by Rushoo A et al found that large scale operations were held in rural area due to intensive volunteer cataract programs.12 In above mentioned studies result were similar with our study. The results thrown up by us findings show a wide gap between the qualitative results achieved between the two sets (camp and base hospital) of medical services. As similar set of professionals performed these services, the results were expected to be similar. This throws up another challenge to find out ways and means to improve the qualitative results of the camp operated cataract patients. Perhaps, the two models proposed by us may provide a lasting solution. Model 1: “On site repetitive eye-camps at the same location, with the same set of medical professionals (especially the surgeon) using standardised techniques and acceptable level of sterilisation.” The advantage of such a model is to provide a qualitative and consistent post-operative care by the same set of medical professionals who operated the patients in the camp. While comparing the results of the camp operated patients with those of well-equipped hospitals, a major difference which was observed was that in a hospital condition normally the post operative care is carried out by the same medical professionals, whereas follow-up in a camp may or may not be done by the same professionals. This was also found to be one of the major reasons for the patients not coming forward for post operative care in camp conditions and also better results with consistency in operations carried out at hospitals. Repetitive eyecamps with the same set of professionals also provide an emotional integration of the patients with their doctors, thereby giving better results. Model 2: “Patients identified after screening at camps, suffering from systemic diseases, are proposed to be referred to base hospitals for surgery and follow-up. Transportation from the camp to the base hospital and back to their respective places postsurgery, with provision of regular transportation for follow-up minimises post-operative complications.” Page 56 NATIONAL JOURNAL OF MEDICAL RESEARCH The two models are complimentary and proposed to work in conjunction, to provide aholistic solution to the problems associated with cataract related complications of the rural poor. The patients already suffering with systemic diseases and having a very low preoperative visual acuity are proposed to be separated and provided differential treatment at the base hospital. It will reduce percentage of post-operative complications and would lead to better acceptability of the camp operated model. Another interesting aspect , though not related directly to our study is the level of ignorance and superstition that afflicts the rural populace, especially the poor, the aged and the female, resulting in acceptance of cataract related diseases as a fate and not making enough attempts to attend the especially organised rural camps for getting proper medical treatment at the appropriate time. This also results in post operative complications. CONCLUSION During our study we come to the conclusion considering the socio-economic and gender specific importance of the camp operated cataract services. In most of the studies it has been established beyond doubt that the management of incidence of cataract in the Indian subcontinent in general and rural Maharashtra in particular cannot be carried out without the camps being organised especially for this purpose. However, as discussed earlier, the results thrown up by our findings show a wide gap between the qualitative results achieved between the two sets (camp and base hospital) of medical services. As similar set of professionals performed these services, the results were expected to be similar. This throws up another challenge to find out ways and means to improve the qualitative results of the camp operated cataract patients. To improve the techniques at the camp and providing repeat services at the same location and involvement of the local community leaders may provide an improved alternative. REFERENCES 1. ThyleforsB Negrel A-D, Pararajasegaram R, Dadzie KY. Global data on blindness. Bull World Health Organization. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 1995;73:115121 2. Thylefors B. ‘A global initiative for the elimination of avoidable blindness’ Amer. Journal of Ophthalmol. 1998;125:9093 also available at Community Eye Health11(25):1-3 3. Kapoor H., Chatterjee A., Daniel R., Foster R. Evaluation of visual outcome ofcataract surgery in an Indian eye camp. (Br J Ophthalmol1999;83:343-346) 4. Nowak R, Grzybowski A. Outcome of an outreach microsurgical project in rural Nepal. (Saudi Journal of Ophthalmology 2013; 27(1):3–9 5. Murthy GV, Gupta SK, Talwar D. ‘Assessment of cataract surgery in rural India.Visualacuity outcome’. (ActaOphthalmologicaScandinavicaVolume 74, Issue 1,pages 60–63, February 1996) 6. Robert P. Finger, David G. Kupitz, Frank G. Holz, Seetha Chandrasekhar, BharathBalasubramaniam, Ramanathan V. Ramani and Clare E. Gilbert. ‘Regular provision ofoutreach increases acceptance of cataract surgery in South India’. (Tropical Medicine andInternational Health volume 16 no 10 pp 1268–1275 october 2011) 7. SGPai, SJ Kamath, V Kedia, K Shruthi, A Pai. ‘Cataract Surgery in Camp patients: astudy on visual outcomes’. (Napalese Journal of Ophthalmology; Vol 3, No 2, 2011,Pai) 8. Jagat Ram, JaspreetSukhija and Virendra K Arya. ‘Comparison of Hospital Versus Rural Eye Camp based Pediatric Cataract Surgery’ (Middle East Afr J Ophthalmol. 2012 JanMar;19(1): 141-146) 9. Reidy A, Mehra V, Minassian D, Mahashabde S. ‘Outcome of cataract surgery in centralIndia: a longitudinal follow-up study’ (Br J Ophthalmol 1991 Feb;75(2):102-5. 10. ParikshitGogate, MS(Ophth) MSc FRSc (Ed) and Anil N Kulkarni, Ms (Ophth). ‘Comparison of Cataract Surgery in a Base Hospital and in Peripheral Eye Camps.’ (Community Eye Health. 2002;15(42):26-27). 11. R Anand, A Gupta, J Ram, U Singh, R Kumar. ‘Visual outcome following cataractsurgery in rural Punjab. Indian Journal of Ophthalmology’ 2000:48(2):153-8 12. Adel A. Rushood‘Outcomes of Cataract Surgeries Over 16 Years in Camps Held by AlBasar International Foundation in 38 Underdeveloped Countries’.(Middle East Afr JOphthalmol.2011 Apr-Jun; 18(2): 129-135). 13. RamanjitSihota, RadhikaTandon, ‘Parsons Diseases of the Eye’(Chapter 34, The causes and prevention of blindnessVision 2020, Page 544). 14. Kathryn Colby ‘Merck manuals: Last full review/revision’ 1(April2009) 15. Limburg H, Foster A, Gilbert C, Johnson GJ, Kyndt M. ‘Routine monitoring of visualoutcome of cataract surgery. Part 1: development of an instrument.’ Br J Ophthalmol.2005;89:45-49. Page 57 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE ASSESSMENT OF THE PROFILE OF PSYCHIATRIC MANIFESTATIONS IN CANNABIS USERS: A CROSS SECTIONAL STUDY Indrajeet Sharma1, Tulika Jha2, Purshottam K. Kaundal3 Author’s Affiliations: 1Assistant Professor, Department of Pharmacology, AIMS, Rajsamnd; 2Post-Graduate student; 3Professor; Department of Pharmacology, Indira Gandhi Medical College, Shimla-1, Himachal Pradesh, India Correspondence: Dr Indrajeet Sharma E-mail: [email protected] ABSTRACT Background: Cannabis is the world’s most commonly used illicit drug, with approximately 200 to 300 million regular users. It occupies fourth place in worldwide popularity among psychoactive drugs, after caffeine, nicotine and alcohol. Nowadays, cannabis is widely used by young people and, the prevalence of lifetime use of cannabis by young adults has increased in many developed countries over the past several decades. Methods: It was a one year cross-sectional observational study. The study included 60 patients, who had been taking cannabis for at least previous six months with a frequency of minimum 20 days/month. The eligible patients fulfilling inclusion and exclusion criteria and giving written informed consent were enrolled in the study. Results: Most common co-morbid psychiatric disorders were bipolar affective disorders, current manic episode with or without psychotic features (25.0%). Second most common co-morbid disorder was cannabis induced psychosis which was present in thirteen patients (21.7%). Seven patients (11.7%) had acute and transient psychosis; six patients (10.0%) were diagnosed as schizophrenia, whereas three patients (5.0%) had Psychosis Not Otherwise Specified (NOS). Anxiety disorder and depressive disorder accounted for 10% and 3.4% of comorbidity, respectively. Two patients (3.3%) were having cannabis dependence syndrome with withdrawal state and three patients (5.0%) were having cannabis dependence syndrome only without any associated psychiatric comorbidity. Conclusion: Among the various psychiatric disorders, bipolar affective disorder, current episode mania with or without psychotic features was the most prevalent disorder.Most of cannabis users seeking treatment suffer from various psychiatric comorbid disorders particularly psychotic disorders (38.4%). Key words: Cannabis, Bipolar affective disorder, Psychiatric comorbidity. INTRODUCTION Cannabis is associated with a significant psychiatric comorbidity.1 The effects of cannabis use on the aetiology and course of psychiatric disorders such as psychotic or mood disorders have been examined by the researchers. Cannabis users experience euphoria and changes in thought processes with thoughts being experienced as fragmented or more accurate. In addition, changes occur in visual and auditory perception and in the perception of time as well as changes in short term memory and attention. The use of high doses of cannabis may even result in psychotic symptoms like delusions and hallucinations; the latter phenomena are sometimes described as cannabis psychosis.2-6 However, the incidence and prevalence of such cannabis psychosis is not wellknown because the concept of cannabis psychosis is NJMR│Volume 6│Issue 1│Jan – Mar 2016 poorly defined and the specificity and existence of such a nosological entity remains controversial.7-8 Both DSM-IV-TR9 and ICD-1010 have given various categories of disorders associated with the use of cannabis, with ICD-10 having a wider approach. The most important thing which is apparent from the classification is that cannabis is implicated as the causative agent for all the categories, but on the contrary, research has shown that it may not act as a causative agent, but may worsen the pre-existing mental illness or may unmask the mental illness in predisposed subjects.9 The association between cannabis use and psychotic symptoms and/or disorders has also been explained by the hypothesis that patients use cannabis as a form of self-medication. Within the framework of the self-medication hypothesis, several sub hypotheses can be considered.11-13 Page 58 NATIONAL JOURNAL OF MEDICAL RESEARCH Considering the fact that India remains a traditional cannabis use country, the importance of research from our country cannot be overestimated. Furthermore, in view of the paucity of literature from our state, the present study was planned to assess the profile of psychiatric manifestations in cannabis users. METHODOLOGY Set up and study design: The study was conducted at Indira Gandhi Medical College, Shimla, which is a tertiary care centre of Himachal Pradesh from July2014 to June-2015, located in North India and caters to the majority of population of the state. It was a Cross-sectional observational study. The study protocol was approved by IGMC ethical committee. Study population and selection process: Patients attending out-patient department (OPD) and inpatient department (IPD) services of psychiatry department were the patient population screened for enrolment in the study. The study included 60 patients, who had been taking cannabis for at least previous 6-months with a frequency of minimum 20 days/month. The eligible patients fulfilling following inclusion and exclusion criteria and giving informed consent were enrolled in the study. Inclusion criteria includedpatients within the age group of 18-65 years, consuming cannabis for the last >6 months with a frequency of 20 days/month or more, and having willingness to participate in the study.An exclusion criterion includedpatients fulfilling the criteria for abuse/dependence for other substances except nicotine and evidence of an organic mental disorder. Baseline data collection: Demographic and clinical data was obtained from the patients or relatives and recorded using structured formats. Psychiatric symptoms were assessed using Mini-International Neuropsychiatric Interview 6.0 (M.I.N.I.6.0)14. Diagnosis of psychiatric disorders was made according to ICD1010. If the patient was found to have some psychiatric syndrome, the severity of the same was assessed using appropriate scales such as: Young Mania Rating Scale, Brief Psychiatric Rating Scale, Hamilton Depression Rating Scale or Hamilton Anxiety Rating Scale as per the psychiatric diagnosis. Assessments were done when the patients were in sober state. Statistical analysis: In the study various sociodemographic and drug related variables were compared by using appropriate statistical methods. The categorical and continuous variables were reported as percentages and mean ± standard deviation respectively.2 tailed value of <0.05 was taken as statistically significant. Data was analysed using statistical software Epi Info version 3.4.3. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 RESULTS Baseline clinical characteristics of the study groups: Table 1 describes the distribution of clinical characteristics of the study population under observation Table 1: Socio-Demographic characteristics of the patients Characteristics Age (yrs)(Mean ± SD) Sex Rural/Urban: Rural Urban Marital status: Single Married Divorced/Widowed Type of family: Nuclear Joint Socioeconomic status*: Upper Upper middle Lower middle Upper lower Lower *Modified Kuppuswamy’s scale Patients (%) 31.63 ±10.86 100% (male) 43 (71.7) 17 (28.3) 30 (50.0) 27 (45.0) 3 (5.0) 44 (73.3) 16 (26.7) 0 11 (18.3) 20 (33.3) 17 (28.3) 12 (20.0) Age of initiating cannabis use: Most of the patients (38.3%) initiated cannabis consumption before the age of 20 years. Only four patients (6.7%) had initiated cannabis consumption after the age of >40 years. The mean age of initiating cannabis use was 23.98 ± 8.30. Duration of cannabis use: Majority of the patients (58.3%) were consuming cannabis for 6-10 years. Only one patient (1.7%) had history of cannabis consumption for more than 20 years. Mean duration of cannabis use was 8.08 ± 3.83. Patients with History of past abstinence attempts: Out of sixty patients, 28 patients (46.6%) had made abstinence attempts in the past. 20 patients had one abstinence attempt and 8 patients had made two abstinence attempts. Among the patients who made one or two abstinence attempts in the past, the duration of abstinence attempt was less than three months in majority of cases (20 out of 28 patients). None of the patients had made >2 abstinence attempts and in none of the cases, the duration of abstinence was more than 9 months. Total Psychiatric co-morbidities: Vast majority of the patients (91.7%) had psychiatric co-morbidities. Page 59 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table-2: Psychiatric co-morbid disorder in cannabis dependent patients Psychiatric co-morbid disorder Cannabis dependence syndrome with psychiatric co-morbidities Schizophrenia Acute and transient psychosis Psychosis NOS Cannabis induced psychosis Manic episode without psychotic features Manic episode with psychotic features Bipolar affective disorder, current episode mania without psychotic features Bipolar affective disorder, current episode mania with psychotic features Severe depressive disorder without psychotic features Recurrent depressive disorder Generalized anxiety disorder Mixed anxiety and depression Panic disorder Cannabis dependence syndrome with withdrawal state Cannabis dependence syndrome Types of Psychiatric co-morbidities: Most common co-morbid psychiatric disorder was bipolar affective disorders, current manic episode with or without psychotic features (25.0%). Additional three patients (5.0%) were diagnosed having first episode mania with or without psychotic features. Second most common co-morbid disorder was cannabis induced psychosis which was present in thirteen patients (21.7%). Seven patients (11.7%) had acute and transient psychosis; six patients (10.0%) were diagnosed as schizophrenia, whereas three patients (5.0%) had Psychosis Not Otherwise Specified (NOS). Anxiety disorder and depressive disorder accounted for 10% and 3.4% of comorbidity, respectively. Out of sixty patients observed, two patients (3.3%) were having cannabis dependence syndrome with withdrawal state and three patients (5.0%) were having cannabis dependence syndrome only without any associated psychiatric comorbidity. DISCUSSION In the present study, mean age of the patients was 31.63 ± 10.86 years and 78.3% of the patients were more than 20 years old. There was no female patient. This probably reflects that consumption of cannabis by females is less prevalent in this region and it may be culturally unacceptable also.15,16,1738.3% of the patients initiating cannabis consumption were within the age range of 18-25 years which is comparable to the study by Arias et al.16 where 42% of the patients started consuming cannabis between 16-25 years. Mean age of initiating cannabis consumption was 23.98 ± 8.30 years. In most of the Western studies, the age of cannabis initiation was lower in comparison to that of the Indian studies suggesting that the cannabis use begins at younger age in Western population.18,19The mean duration of cannabis use in our study was 8.08 ± 3.83 years and 50.0% patients were consuming cannabis for 6-9 years. Only 1.7% paNJMR│Volume 6│Issue 1│Jan – Mar 2016 Cases (%) 6 (10.0) 7 (11.7) 3 (5.0) 13 (21.7) 1 (1.7) 2 (3.3) 7 (11.7) 8 (13.3) 1 (1.7) 1 (1.7) 3 (5.0) 2 (3.3) 1 (1.7) 2 (3.3) 3 (5.0) tients had history of cannabis consumption for more than 20 years. In the present study, 46.6% patients had history of abstinence attempts in the past. Sarkar et al.20 has found almost similar percentage of patients (45.3%) had attempted abstinence in the past. A vast majority of our patients had comorbid psychiatric disorders.21 In our study, 25.0% (15) patients were suffering from bipolar affective disorder, out of which 13.3% (8) had current manic episode with psychotic features and 11.7% (7) had current manic episode without psychotic features. Our findings were in coherence with some studieswhere 15.4% (10) patients had current manic episode with psychotic features and 13.4% (9) patients had current manic episode without psychotic features.16,21 In the present study, second most common psychiatric comorbid illness found was cannabis induced psychosis which was present in 21.7% patients. The prevalence of cannabis induced psychosis was more or less similar to that of the previous studies where it ranged from 11.5% to 34.5%.16,19,20,21Clinical research has shown that high proportions of persons with schizophrenia report regular cannabis use and meet criteria for cannabis use disorders.22,23 In the present study, 11.7% of patients had acute and transient psychosis and 10.0% of patients qualified for a diagnosis of schizophrenia. 5.0% patients had Psychosis Not Otherwise Specified (NOS). Chen et al.19 noted that 13.7% of patients had acute and transient psychosis and 8.0% of patients had schizophrenia. Arseneault L et al.24 however have observed a lesser number of patients (23.4%) with features of schizophrenia.In our study, 5.0% patients were diagnosed as having first episode mania, out of which, 3.3% patients were labelled as manic episode with psychotic features while another 1.7% as manic episode without psychotic features. Previous studies have reported variable frequency of manic episode in cannabis users. 23,25 Like our observations, Arias et al.16 have also Page 60 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 found almost similar frequency of first manic episode in their sample. 10. World Health Organisation. ICD-10 Classification of Mental and Behavioural Disorders: Clinical Description and Diagnostic Guidelines, Geneva: World Health Organisation. 1992. CONCLUSION 11. Dixon L, Haas HG, Weiden PJ, Sweeney J, Frances AJ. Drug abuse in schizophrenic patients: Clinical correlates and reasons for use. American J of Psychiatry. 1991; 148:224–30. Many patients were suffering from various comorbid and cannabis induced psychiatric disorders and such patients were associated with high cannabis use. Among the psychiatric disorders, bipolar affective disorder, current episode mania with or without psychotic features was the most prevalent disorder. It was seen in around 25% of patients. So, in the present study we may conclude that most of cannabis users seeking treatment suffer from various psychiatric comorbid disorders particularly psychotic disorders (38.4%). LIMITATIONS It was a hospital based cross sectional study and sample size was relatively small. History of cannabis use was based as reported by patient/family member. No body fluid test for cannabinoids was done. REFERENCES 1. Grover S, Basu D. Cannabis and Psychopathology: Update 2004. Indian J of Psychiatry. 2004; 46:299-09. 2. Basu D, Malhotra A, Bhagat A, Varma VK. Cannabis psychosis and acute schizophrenia: a case-control study from India. European Addiction Research. 1999; 5:71-73. 3. Chaudry HR, Moss HB, Bashir A, Suliman T. Cannabis psychosis following bhang ingestion. British J of Addiction. 1991; 86:1075-81. 4. Imade AGT, Ebie JC. A retrospective study of symptom patterns of cannabis-induced psychosis. ActaPsychiatricaScandinavica. 1991; 8:134-36. 5. Núñez LA, Gurpegui M. Cannabis -induced psychosis: A cross-sectional comparison with acute schizophrenia. ActaPsychiatr Scand. 2002; 105:173–78. 6. Onyango RS. Cannabis psychosis in young psychiatric inpatients. British J of Addiction. 1986; 81:419–23. 7. Cantwell R, Harrison G. Substance misuse in the severely mentally ill. Advances in Psychiatric Treatment. 1996; 2:11724. 8. Poole R, Brabbins C. Drug induced psychosis. British J of Psyciatry. 1996; 168:135-38. 12. Frances RJ. The wrath of grapes versus the self-medication hypothesis. Harvard Review of Psychiatry. 1997; 4:287–89. 13. Khantzian EJ. The self-medication hypothesis of substance use disorders: reconsideration and recent applications. Harvard Review of Psychiatry. 1997; 4:231–44. 14. Sheehan D, Janavas J, Harnett-Sheehan K, Sheehan M, Gray C. Mini International Neuropsychiatric Interview, English version 6.0.0. January 1, 2010. 15. International Institute for Population Sciences (IIPS) and Macro International. 2007. National Family Health Survey (NFHS-3), 2005–06: India: Volume II. 16. Arias F, Szerman N, Vega P, Mesias B, Basurte I, Morant C, Ochoa E, Poyo F, et al. Abuse or dependence on cannabis and other psychiatric disorders. Madrid study on dual pathology prevalence. ActasEspPsiquiatr. 2013;41(2):122-9. 17. Basu D, Malhotra A, Varma VK. Cannabis related psychiatric syndromes: A selective review. Indian J of Psychiatry. 1994; 36:121-28. 18. Brook JS, Cohen P, Brook DW. Longitudinal study of Cooccurring Psychiatric disorders and substance use. J of the American Academy of Child and Adolescent Psychiatry. 1998; 37:322-30. 19. Chen CY, Wagner F, Anthony J. Marijuana use and the risk of major depression episode: epidemiological evidence from the United States National Comorbidity Survey. Social Psychiatry and Psychiatric Epidemiology. 2002; 37:199-06. 20. Sarkar J, Murthy P, Singh SP. Psychiatric morbidity of cannabis abuse. Indian J of Psychiatry. 2003; 45:182-88. 21. Macfadden W, Woody GE. Cannabis related disorders. In. Comprehensive textbook of Psychiatry by Kaplan &Sadock (7th edition). 2000; 990-98. 22. Thomas H. Psychiatric symptoms in cannabis users. British J of Psychiatry. 1993; 163:141-49. 23. McGee R, Williams S, Poulton R, Moffitt T. A longitudinal study of cannabis use and mental health from adolescence to early adulthood. Addiction. 2000; 95:491–03. 24. Arseneault L, Cannon M, Poulton R, Murray R, Caspi A, Moffitt TE. Cannabis use in adolescence and risk for adult psychosis: longitudinal prospective study. British Medical J. 2002; 325: 1212-13. 25. Arseneault L, Cannon M, Witton J, Murray RM. Causal association between cannabis and psychosis: examination of the evidence. British J of Psychiatry. 2004; 184: 110- 17. 9. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Text Revised (DSM-IV TR). American Psychiatric Association, Washington, DC. 2000. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 61 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE EFFECTS OF INTRATHECAL BUPIVACAINE WITH NORMAL SALINE VERSUS BUPIVACAINE WITH FENTANYL IN PATIENTS UNDERGOING SURGERY Jigna R Shah1, Manish Bhatt2 Author’s Affiliations: 1Assistant Professor; 2DNB student, Department of Anesthesia, GMERS Medical College, Sola, Ahmedabad Correspondence: Dr Jigna R Shah E-mail: [email protected] ABSTRACT Objective:To know the effects of intrathecal 0.5% Bupivacaine 2.5 cc with 0.5 cc normal saline and 0.5% Bupivacaine 2.5 cc witth 25 μg fentanyl for various lower abdominal surgeries. Methods: A comparative study were conducted in 60 (ASA grade I / II) patients. The onset and duration of both sensory and motor blockade was compared using relevant scales i.e. Sensory scale and Bromage Scale. Intra-operative and post-operative hemodynamic monitoring was done. The complications which occurred were noted and studied. - The duration of analgesia after sensory wear off was compared between the 2 groups using Visual Analogue Scale. - Quality of post-operative analgesia was studied between the groups. Results: The duration of sensory and motor block as well as duration of effective analgesia was significantly longer in the bupivacaine–fantanyl group as compared with both bupivacaine–normal saline groups. Conclusion: Addition of intrathecalfantanyl to bupivacaine was more advantageous than bupivacaine with normal saline with special regard to its analgesic properties among surgical patients. Keyword:-bupivacaine, fentanyl, intrathecal INTRODUCTION PAIN is defined as an "unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage". Postoperative analgesia is now getting prime importance since few years in elective; emergency as well as day care surgeries. It is becoming popular all over world due to number of advantages to patient, hospital and community such as -1) Minimal psychological stress. 2) Decreased post-operative complication. 3) Greater flexibility about timing of surgery with rapid return to routine activities. 4) It improves respiration, hemodynamic stability and relieves sympathetic overactivity. 1,2,3 Over the past few years, post-operative analgesia has evolved from intravenous injections of pain killers to complex and skillful techniques requiring advanced knowledge, equipment and drugs. The aim is to have the technique which is minimally invasive, takes less time and causes minimal alteration in routine activities. The technique should give prolonged analgesia, be economically acceptable and have the least number of complications.4-8 NJMR│Volume 6│Issue 1│Jan – Mar 2016 Regional anaesthesia is preferred to general anaesthesia because of less risk of aspiration and other complications associated with tracheal intubation. There is enhanced ability to communicate with the patient and greater potential 2 for post-operative analgesia. There is reduced incidence of post-operative residual paralysis, nausea, vomiting, lethargy and central respiratory depression. Among regional anaesthesia, spinal anaesthesia is a simple, reliable technique which is quick in onset. Short acting local anaesthetic like lignocaine is now being questioned for various reports of transient to permanent neurological damage. In contrast, use of Bupivacaine in spinal anaesthesia is rarely followed by neurological symptoms. For the same reason, we accepted it as our basic drug for anaesthesia and decided to study the effectiveness of injection fentanyl with injection. Bupivacaine intrathecally for post-operative analgesia.9-15 The present study was designed to compare effect of intrathecal 2.5 cc Bupivacaine 0.5% heavy with 0.5 cc normal saline and 2.5 cc Bupivacaine 0.5% heavy with fentanyl 25 μg in various urological, gynaecological and general surgeries. Page 62 NATIONAL JOURNAL OF MEDICAL RESEARCH METHODOLOGY The present study was conducted in 60 patients. Patients accepted for the study were all ASA I or II physical status in the age group of 16-60 years posted for various lower abdominal surgeries, under spinal anaesthesia. The patients were divided into 2 groups, group A and group B with each having 30 patients. Pre-operative evaluation: Detailed pre-anaesthetic check-up was done when patients were referred in pre-anaesthetic clinic. Patients having contraindications to spinal anaesthesia like spinal deformity, local infection, bleeding diathesis, mental retardation or neurological deficit were excluded from study group. Routine laboratory tests like Hb%, renal function tests, serum electrolytes, urine examination, blood sugar and chest x-ray were done in all cases. Patients were explained about the procedure in detail and written consent was obtained. All patients were instructed to fast for minimum 8 hours prior to scheduled time of surgery. No patients received any sedative and narcotic premedication before arrival in operation theatre. On arrival in the operation theatre, usual monitoring like ECG, pulse- oximetry, blood pressure cuff were applied and baseline pulse, BP, Respiratory rate were noted. I.V. line was secured with 18G intravenous cannula and preloading with 500 ml of Ringer lactate was done in all patients. After giving lateral position, lumbar puncture was done in L3 - L4 space with no.25G Quincke's spinal needle by median route. After confirming free flow of CSF, drug was injected over 10 seconds. Study participants and procedure: They were divided into 2 groups and received following drugs in spinal anaesthesia. Group A: 2.5cc of 0.5 Bupivacaine heavy + 0.5 cc Normal saline Group B: 2.5 cc of 0.5% Bupivacaine heavy + 25 μg fentanyl (0.5cc). Immediately after completion of the block patients were returned to normal position and following observations were recorded. All the times were recorded from the point of injection of drug in CSF. The onset and duration of sensory blockade were assessed by using pinprick test, bilaterally in midclavicular line every 2 minutes for first 20 minutes and then every 5 minutes till level is stabilised. Highest level of sensory block and time to reach highest level were recorded. Motor blockade was assessed by using Bromage scale and its onset time is recorded. This is defined as the time to reach grade of 3 in Bromage scale. 31,43Grade 0: Full flexion of knees and feet, Grade 1 Just able to flex the knees, full flexion of feet, Grade 2 Unable to flex the knees, some flexion of feet, Grade 3 Unable to move legs or feet. Duration of grade 3 of Bromage scale was noted and time to recover to grade 0 of Bromage scale was noted. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 After the establishment of adequate level of analgesia, surgery was started and time of begining of surgery was noted. I.V. fluids were continued intraoperatively at the rate of 2 ml/kg/hour. Intraoperatively pulse, BP and SPO2 were monitored every 5 min. for first 30 min. and thereafter every 15 min till the end of surgery. Bradycardia was defined as pulse rate < 60 / min and was treated with inj. Atropine 0.6 mg I.V. Hypotension was fall in BP more than 30% of baseline value and was treated with I.V. fluids and injection. Mephentermine sulphate 6 mg if required. Any other complication like nausea, vomiting, inadequate block were noted and any supplementation in form of sedatives analgesics or anaesthetic agent was recorded. At the end of surgery, surgical time was recorded and patients were observed in PACU till the patient complained of pain as per Visual Analogue Scale. Rest, foot end elevation and hydration were advised. The time taken for 2 segment regression (T1) and total duration of motor blockade was noted. Patients were allowed to ambulate when (a) sensory block is regressed to S2 level and time noted (T2. and (b) complete recovery of motor blockade. All the patients were kept in PACU under observation with continuous ECG monitoring, SPO2, pulse, BP and respiratory rate. Duration in minutes after surgery was noted in those patients who had unbearable pain and this was considered as 25 as per VAS. This time was labelled as T4 min and data was used in discussion. The VAS score of ≤ 25 mm is considered analgesic success. Duration of analgesia was observed from time to S2 segment wear off (T2) i.e. sensory reversal to time of request of analgesic dose. Monitoring of complications: Patients were observed carefully for any complications. Retention of urine was defined as time to urination (from induction) > 6 hours or feeling distress or pain whatever is less. Accepted measures to get relief are reassurance, hot water bag and catheterisation. All urosurgical patients had catheterisation post-operatively before shifting the patient to PACU, so retention of urine was not observed post-operatively. At the time of transferring the patient to their respective ward, patients were prescribed oral analgesics or inj. Diclofenac sodium 1 amp. i.m. as and when required. They were instructed to drink plenty of fluids and rest for the remainder of day. They were also asked to report complications like headache, backache, dysaesthesia in buttocks, thigh and lower limb upto 1 week. Statistical analysis:Data were analysed using Unpaired 't' test and Fischer exact test with P < 0.05 considered statistically significant. Data were presented as mean values, Mean ± SD and numbers (percent). Hemodynamic parameters were represented graphically as well as in tables. Page 63 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 RESULTS Table 1: Demographic characteristics Highest level of sensory blockade was T6 in both groups. There was no significant difference in onset time and the time to reach highest sensory level in both groups. The time intervals for sensory level to regress 2 segments (T1) and Sensory regression to S2 dermatome (T2) were prolonged in group B patients compared to group A (12% and 14% respectively) (P < 0.001). The judgement of sensory blockade by sensory scale is almost same in both patients. The onset of motor blockade was similar in both group of patients. The assessment of motor blockade done by Bromage scale showed that duration of motor blockade was not prolonged by addition of fentanyl. The onset of spinal block is almost same in both groups. Variable Age (Years) Gender Male Female Height (cms) ASA Grade - I Grade - II Surgeries Gynecological Urological General Group A (n=30) 36.8 ± 5.8 Group B (n=30) 37.2 ± 3.4 13 17 158.2 ± 3.84 12 18 154 ± 4.36 24 6 24 6 13 07 10 11 07 12 Group A(n=30) Group B (n=30) 7 ± 2.4 T6 11 ± 3.4 150 ± 7.4 180 ± 12.4 7.2 ± 3 T6 12 ± 2.2 162 ± 8.2 206 ± 6.4 8.6 ± 4.1 110 ± 30 160 ± 40 8.4 ± 3.2 124 ± 18 168 ± 35 Group A: bupivacaine + normal saline, Group B: bupivacaine + fentalnyl Table 2: Characteristics of block Variable Characteristics of sensory block Mean Time of Onset (Mean ± SD) min. Highest Sensory level Mean Time from injection to Highest sensory level Mean Time for 2 segment regression from highest sensory level - T1 Mean Time for sensory regression to S2 from highest sensory level. T2 Characteristics of motor block Mean Onset to grade III motor block Mean Duration of Grade III motor block Mean Time to reach grade 0 from grade III -(Recovery time) Group A: bupivacaine + normal saline, Group B: bupivacaine + fentalnyl Table 3: Patient's judgment of block as per sensory scale A B C D Group A(n=30) 23 7 0 0 Group B (n=30) 25 5 0 0 Group A: bupivacaine + normal saline, Group B: bupivacaine + fentalnyl Table -3 shows comparison of Patient's judgment of block as per sensory scale in bothe the groups. Table 4: Pre-operative hemodynamic parameters (mean) Parameter Pulse (beats / min) SBP/DBP) mmHg SPO2% RR (per min) Group A(n=30) 79.4 126.6 / 81 98.4 14.2 Group B (n=30) 77.03 127.53 / 84.33 98.5 13.8 Gr A: bupivacaine + normal saline, Gr B: bupivacaine+fentalnyl Table -4 shows comparison of mean values of perioperative hemodynamic parameters in bothe the groups. Table5: Early intra operative hemodynamic parameters (mean) Time (min) Group A(n=30) Group – B (n=30) Pulse* SBP/DBP@ SPO2 % RR# Pulse* SBP/DBP@ SPO2 % RR# 5 80.73 131.8/84.3 99 13 97.06 123.4/76.13 99 13 10 77.33 114./46 / 79 98.5 13.5 81.76 115.33/74.36 98.5 13.5 15 75.13 108.9/73.67 99 13.5 77.8 113/88.26 99 13 20 77.13 110/73.4 99 13 76.76 111.46/74 98.5 13.5 25 76.67 111.73/76.67 98.5 13.5 80.26 117.53/78 99 13.5 30 80.67 114.6/74.8 99 13.5 78.93 120.73/77 99 13 45 89.53 123.8/77.34 99 13.5 78 118.13/76 98.5 13 60 87.33 120.86/84 98.5 13 77.5 117.4/76.8 99 13.5 Group A: bupivacaine + normal saline, Group B: bupivacaine + fentalnyl; *rate per minute;@Systolib BP / Diastolic BP in mmHg; #Respiratory rete per minute NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 64 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table 6 Early post-operative hemodynamic parameters (mean) Time (min) Group A (n=30) Group B (n=30) Pulse* SBP/DBP@ SPO2 % RR# Pulse* SBP/DBP@ SPO2 % RR# Imme diate in PACU 82.26 121.66 / 79.26 99 13.5 80.06 115.73 / 75.8 99 13 30 77.53 122 / 80.3 98.5 13 78.8 118.26/74.67 99 13.5 60 79.3 146.8/80.6 99 13.5 75.26 115.66/75 98.5 13 90 78.06 124.06 / 81.46 99 13 76.73 119.67/76.67 99 13.5 120 82.46 127.2/80.46 98.5 13.5 78.8 121.86/77.46 99 13 Group A: bupivacaine + normal saline, Group B: bupivacaine + fentalnyl; *rate per minute;@Systolib BP / Diastolic BP in mmHg; #Respiratory rete per minute Table 7 Comparison of analgesia, complications and response in both groups Variable Recovery and analgesia Mean Time to feel first pain (T3) Mena Time to feel unbearable pain or time of analgesic requirement (T4) - VAS > 25 mm Duration of analgesia T3 - T2 T4 - T2 Intraoperative complications Hypotension (H) Bradycardia (B) Nausea and Vomiting (V) Post-operative complications Hypotension (H) Vomiting (V) Pruritis (Pr) Urinary retention (RU) Patient response (subjective) Good Fair Poor The table shows that there is no significant difference in hemodynamic parameters in early intra-operative period in both groups. Oxygen saturation and respiratory rate are unaffected in both groups. This suggests that even addition of 25 mcg fentanyl intrathecally does not cause respiratory depression and does not alter hemodynamic parameters. The time to feel first pain and time of analgesic requirement is prolonged significantly compared to Group A in group B. (P < 0.001) Only 3 patients were having urinary retention post-operatively. 2 were relieved with hot water and one patient was catheterised. The patients were shifted to the ward immediately as soon as unbearable pain is felt after giving oral / parenteral analgesic. The patients’ response to intrathecal fentanyl 25 µg along with 0.5% Bupivacaine was superior to plain 0.5% Bupivacaine with 0.5 cc normal saline. (table -6) DISCUSSION Majority of studies for intrathecal fentanyl were done for 10, 20 and 25 µg. In this study we selected 25 µg fentanyl intrathecally20,28,30,18. Intrathecal route is better because drug is readily available in CSF to saturate opioid receptors in central nervous system, no NJMR│Volume 6│Issue 1│Jan – Mar 2016 Gr A(n=30) Gr B (n=30) 202 ± 9.8 234 ± 14.2 299 ± 17.3 364 ± 15.4 11.4 45.6 93 158.4 4 4 1 5 3 2 1 (3.33%) 1 (3.33%) 0 1 (3.33%) 5 (16.6%) 0 3 (10%) 2 (6.66%) 0 6 24 26 4 0 separate injection has to be given as the drug is injected with Bupivacaine 0.5% at the time of lumbar puncture and low dose is needed. In our study there was marginal difference between onset of sensory [ 7 ± 2.4 min (A) vs 7.2 ± 3 min (B) ] and motor [8.6 ± 4.1 min (A) vs 8.4 ± 3.2 min (B) ] blockade between group A and B. This suggests that onset of sensory and motor blockade is not affected by addition of fentanyl. H. Singh et al31,30 found that the onset of bupivacaine induced spinal block was not enhanced in fentanyl treated patients. In our study the volume of drug was kept constant in both groups and median block height was T 6 in both groups27,30 (median range T 6-10 ). As the drug and dose of Bupivacaine 0.5% heavy was similar for both groups, block intensity as indicated by degree of motor blockade and time to reach highest sensory level was unaltered in both groups. This suggested that addition of fentanyl intrathecally with Bupivacaine 0.5% does not alter intensity of motor and sensory blockade in SA. The judgement of sensory block as per sensory scale3 is same in both groups (Table-5). In our study the duration of sensory spinal blockade as measured by 2 segment regression and S 2 segment of wear off time in group A are considered standard and compared with group B. The 2 segment sensory Page 65 NATIONAL JOURNAL OF MEDICAL RESEARCH wear off time was higher in group B compared to group A. (P < 0.001) [150 ± 7.4 / 162 ± 8.2 and 180±12.4 / 206 ± 6.4], 12 and 14% respectively (Table-4). Thus initiation of sensory reversal begins at an average 158 min. with 2.5 cc of 0.5% Bupivacaine heavy35. Roussel JR31 studied addition of fentanyl to Bupivacaine 0.5% for spinal blockade and concluded that fentanyl does not enhance onset of sensory and motor block produced by 12.5 mg of intrathecal Bupivacaine 0.5%. Our study goes parallel with his conclusion. This suggests that addition of fentanyl with Bupivacaine 0.5% intrathecally does not alter onset of spinal blockade. The duration and recovery time of motor blockade were almost equal in both groups3 (Table-6). H. Singh et al31 found that addition of fentanyl 25 µg does not enhance onset of sensory and motor block. The time required for 2 segment regression and sensory regression to L 1 dermatome was 74 ± 18 min and 110 ± 33 min vs 93 ± 22 and 141 ± 37 min in group A with Bupivacaine 0.75% - 13.5 mg and group B with 0.75% - 13.5 mg Bupivacaine + 25 µg fentanyl respectively (P < 0.05) showing increased duration of sensory block in fentanyl treated patients. Bruce Ben - David et al3 found that in patients receiving 0.5% 1 cc Bupivacaine and 0.5% 1 cc Bupivacaine with 10 µg Fentanyl intrathecally in knee arthroscopic surgeries, the mean times to two segment regression was 53 vs 67 min (P < 0.01) and 120 vs 146 min. (P < 0.05) respectively. Our study also found significant difference (P < 0.001) in 2 segment regression and S2 segment regression time. Hypotension and bradycardia are normal physiological responses during spinal anaesthesia. In our study we found that addition of fentanyl in group B does not altered the hemodynamic parameters. We found the higher incidence of hypotension in group B (5) compared to group A (4). Incidence of bradycardia was found more in group A (4) than group B (3). This suggests that addition of fentanyl intrathecally causes marginal hypotension as associated with SA. The early intra-operative hemodynamic parameters are depicted in graph and Table 8 and 9. (P > 0.05) Shanon MT32 et al studied hypotension after intrathecal fentanyl with Bupivacaine 0.5% heavy and observed that SBP and MAP decreased 10% and 14% respectively following intrathecal fentanyl. No patient from either group needed any treatment for hypotension. He concluded that intrathecal fentanyl produces minimal hemodynamic changes with / without prior fluid administration. The graph-I show that pulse rate and BP are stable in both groups. Respiratory rate and oxygen saturation are unaffected in both groups implying that intrathecal fentanyl 25 µg is safe. Belzarena et al7 found that fentanyl > 0.5 NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 µg/kg intrathecally is associated with decreased respiratory rate and increased incidence of pruritis. The early post-operative hemodynamic parameters are depicted in graphII and table 10 show that these parameters were stable in both groups. Assessment of pain has always been troublesome for clinical investigators for years. Till today there is no reliable method to evaluate pain. Wolfe stated, 'it is not easy to measure something if one is not sure that one is measuring'. This applies to whole field of pain management. As discussed earlier pain is notoriously variable in different individuals and same surgical incision can elicit a several fold variation among different individuals. The easiest to use and most studied tool is the Visual Analgesic Scale45 (VAS). It is a simple tool, which measures the subjective pain of the patient at a given time. The scale consists of a ruler with markings from 0-10 or 0-100. The patient is asked to state their present perception of pain, assuming 0 to be no pain at all and 100 to be worst possible they could imagine. The pain score before and after treatment are useful to know the efficacy of treatment modality as well as a research tool. VAS was used for the assessment for depth of analgesia. Post operative pain started at around 200 min in group A which was considered as standard. After this, all the patients were scrutinised every 15 min. Main tool for assessment of analgesia were patients facial expression, Hemodynamic data, respiratory rate and SPO 2 , movement of limbs in bed, sedation if present. Pain started at around 300 min group B. The intensity of pain was highest for 93 minutes after sensory wear off in group B compared to group A which was at 11.4 min. Patients in group B were comfortable by look, vitals were stable, patients were awake and able to move limbs in bed. An absolute VAS score ≤25 mm was defined as an analgesic success. (Table-12)45. The mean value of SPO 2 was comparable in both groups at different time intervals. None of the patients in any group showed hypoxia (SPO 2 < 94% for > 12 min/hr) at any time during study. Our study correlates with Grant P Raymer et al Wooper DW et al39. Who found that intrathecal fentanyl upto 25 µg does not cause respirattory depression. The reasons may be interpreted as- 1) Analgesia was excellent to adequate in group B. 2) Study included minimal dose of fentanyl. 3) Patients were awake and comfortable in group B which added safety factor in relation to respiratory depression. 4) The operations involving lower abdominal organs, which excluded ribs, diaphragm or upper abdominal muscles, respiratory pattern and rate were not altered at all. A study of Herman NL16 et al, on analgesia, pruritis and ventilation after intrathecal fentanyl concluded in a dose response relationship of analgesia with the drug, concluding higher the dose, more the complications. In this regard, S2 segment wear off time (T2) Page 66 NATIONAL JOURNAL OF MEDICAL RESEARCH and time to feel first pain (T3) were suggesting requirement for analgesia as sensory blockade has been reversed. But in group B, as addition of fentanyl provided pain relief for some period after S2 segment wear off, time difference between T2 and T3 found more than that of group A. These values showed pattern of A T3-T2 < B T3-T2 (Table-12), T 3 - T 2 for group A and group B were 11.6 min. and 93 min. respectively. (Table-12). As personal interpretation, expression and explanation of pain varied a lot, total duration of post-operative analgesia is considered from S2 segment wear off time (T 2 ) to requirement of analgesic supplementation (T 4 ). This showed group A T4-T2 < group B T4-T2 (Table-12) (P<0.01). Hence post-operative analgesia due intrathecal drugs administration i.e. T 4 - T 2 was found to be more in group B than in group A. Ashok Kumar B, Newman LM2 conducted a study for intrathecal administration of fentanyl for post-operative analgesia and observed the analgesia time of 94.5 min with 25 mcg Fentanyl in 2.5 cc 0.5% Bupivacaine. Our study goes parallel with their observations. Thus addition of Fentanyl caused almost 4 times increase in total duration of analgesia. (P < 0.01) The efficacy of drug is justified by side effects and complications associated with it. The patients were observed in PACU for most common side effects of spinal anaesthesia and opioids. The most common side effect of fentanyl observed were hypotension, vomiting, urinary retention, respiratory depression, pruritis and sedation. (Table-13). It was considered as fall in BP more than 30% of baseline which found in 3.33%(1) and 16.6% (5) patients post-operatively in group A and B respectively. It is a known complication of SA, so whether fall in BP occurred due to Bupivacaine 0.5% or fentanyl is matter of debate. No patient required any specific treatment. (P > 0.05) PONV after lower abdominal surgery and SA are common complications which occurred in 3.33%(1) in group A but none in group B. In contrast to I.V. fentanyl which is usually expected to cause CTZ stimulation and vomiting, intrathecal fentanyl has opposite effect. None of the patient in group B required antiemetic treatment for PONV23. It is a known complication of spinal anaesthesia. In our study among group A and B, 3.33% (1) and 6.66% (2) were having retention of urine, respectively, 14 of our patients, had undergone urosurgical surgery and they were catheterised intraoperatively, whether retention was due to SA or intrathecalfenttanyl is not concluded and yet to be followed up for more conclusion. 10%(3) of patients in group B developed compared to group A in which none complained the same. Patients were reassured and I.V. injection chlorpheniramine maleate 22 mg was given. It might have occurred as a part of pharmacological effect of fentanyl. In the study by Vaghadiaet al41, pruritis was also found to be of mild to moderate intensity. Bruce Ben David et al3,7 studied intratthecal fentanyl with Bupivacaine and found NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 12% incidence of pruritis in patients. Out study parallels his study. None of our patients had even mild degree of hypoxia during spinal anaesthesia. This suggested thatt even 25 mcg fentanyl intrathecally does not cause any degree of respiratory depression in patients. The reasons may be-All surgeries were elective, All patients were ASA grade I and II, Patients were fully awake, not sedated.,Fentanyl given intrathecally acts on µ 2 opioid receptors (spinal cord) and not on µ 1 receptor (Brain). So respiratory depression does not occur, the dose of fentanyl was 25 µg which is far less to cause significant depression of respiration. None of the patients in our study complained of post-dural puncture head ache or transient neurological symptoms. Varassiet al42 demonstrated that the subarachnoid administration of 25µg fentanyl during spinal anaestthesia in non premedicated men did not alter respiratory rate, end tidal CO 2 , minute ventilation, respiratory drive and SPO 2 . Our study correlates with this study. CONCLUSION It was concluded that - - There is no difference in onset of sensory and motor blockade in both groups. - The duration of motor blockade is unaffected by the addition of fentanyl.The time to reach the highest sensory level is same in both groups. The time of sensory wear off was prolonged by fentanyl. Addition of fentanyl provides analgesia after reversal of sensory blockade. Intra-operative hemodynamics were unaltered even with addition of 25 μg fentanyl in group B compared to group A, suggesting that fentanyl provides hemodynamic stability without altering maximum block height.The incidence of PONV is decreased in group B suggesting antiemetic effect of intrathecal fentanyl. Acceptability amongst patients in group B was very good as they were awake, comfortable and satisfied compared to group A suggesting good quality analgesia. REFERENCES 1. AymanRofaeel, Suzanne Lilker - Intrathecal plain Vs hyper- baric bupivacaine for labour analgesia - Efficacy and side effects : Can. J. Anaesth. 2006 - Jan.:54(1) : 15-20. 2. Ashok Kumar B, Newman LM. McCarthy RJ; Intrathecal Bupivacaine reduces pruritis and prolongs durration of fentanyl analgesia during labour; Anaesth. Analg. 1998 Dec; 87(b) - 1309 - 15. 3. Bendavid B, Solomon E :Intrathecal fentanyl with small dose Bupivacaine, better anaesthesia without prolonging recovery. Anaesthesia Analgesia, 1997, 85(3) : 560-5. 4. Bentley J.B; Boral J.D.; Ninad R.E.; age and fentanyl phar- macokinetics. Anae. Analgesia 1982: 61: 968-71. 5. Bridenbaugh PO, Green NM et al, Spinal subarachnoid heavy blockade in clinical anaesthesia and management of pain. LippinCott 1980: 52; 589595. Page 67 NATIONAL JOURNAL OF MEDICAL RESEARCH 6. Benhamou D, Thorin D, BrichantJF :Intrathecalclonidinine and Fentanyl with hyperbaric bupivacaine improves analgesia during caesarean section - Anaesthesia and analgesia 1998, 87 - 609-613. 7. BelzorenaS : Clinical effects of intrathecally administered fentanyl in patients undergoing caesarean section. Anaesth. Analg. 1992. (74) - 653-7. 8. Critchley, LAH, Short TG, Gin T : Hypotension during su- barachnoid anaesthesia; Hemodynamic analysis of 3 treatments. Br. J. Anaesth. 1994; (72) - 151-6. 9. Choi DH, Ahn HJ, Kim MH : Bupivacaine sparing effect of fentanyl in spinal anaesthesia for Caesarean delivery - Regional Anaesthesia pain medicine 2000, 25: 240-45. 10. Dejong R.H. et al : Last round for a heavy weight ? Anaes- thesia and Analgesia; 1994: 78: 3-4. 11. Frank AJM, Moil JMH :Hort JF; a comparison of 3 ways of measuring pain. Can. J.A. 1982: 21: 211-7. 12. Gaiser RR; Check TG; Gutsche BB; Comparison of 3 differ- ent doses of intrathecal fentanyl for labour analgesia. J. Clin. Anaesth. 1998, Sep; 10(6) - 488 - 93. 13. Greene NM et al : The physiology of spinal anaesthesia 3rd edition - Williams and Wilkins 1981. print ISSN: 2249 4995│eISSN: 2277 8810 25. R.C. Bhola, KK Arora et al : Clinical evaluation of the in- trathecal bupivacaine a dose response study : Indian Journal of Anaesthesia 1988:61 - 75-79. 26. R.S.T. Kinson, GB - Rushmann, J.H. Davier. Lee's Lynopsis of Anaesthesia. Eleventh edition 691-748. 27. R.P. Alston et al : Spinal anaesthesia with Bupivacaine; Ef- fects of concentration and volume when administered in sitting position. Br. J. Anaesthesia 1988; 61: 75-79. 28. Roussel Jr. Heindel L; Effects of intrathecal fentanyl on du- ration of bupivacaine spinal blockade for out patient knee arthroscopy - AANA J 1999. August; 67(4) - 337-343. 29. Shanon MT, Ramanathan S; An IV bolus is not necessary before intrathecal Fentanyl; J. Clin. Anaesth. 1998. Sep; 10(6) - 452-6. 30. Singh H. Yang J :Intrathecal fentanyl prolongs sensory Bupivacaine block - Can. J. Anaesth. 1995, 42(11) - 987-91. 31. Singh H :Intrathecal fentanyl with small dose Bupivacaine, better anaesthesia without prolonging recovery. Anaesth. Analg. 1998, 86(4): 917-8. 32. Spencer S, Liu MD et al : Dose response characteristic of spinal Bupivacaine in volunteers; Clinical application for ambulatory anaesthesia. Anaesthesiology 1996; 85: 729-735. 14. Gustaffson LL. Adverse effects of extradural and intrathecal 33. Varassi G; Celleno D, Capogna G; et al :Ventilatory effects 15. Hample K.F., Schneider MC et al : Transient neurological 34. Van Zandrat AA, DeWolf AM et al : Extent of anaesthesia opioids: Results of nationwide study in Sweden. Br. J. Anaesth. 1982, 54, 471-480. symptoms after spinal anaesthesia. Anaesthesia and analgesia 1995; 81: 1148-53. 16. Herman NI, Choi KC, GaliCott R; Analgesia, Pruritis and ventilation exhibit a dose response relationship in patients receiving intrathecal fentanyl :Anaesth. Analg. 1999 Aug; 89 (z) : 378-83. 17. Hodgson PS et al : New developments in anaesthesia. Anaes- thesiology. Clin. North America 2000; 18(2) : 235-49. 18. Kashyap L. SeewalR : Effect of addition of various doses of fentanyl intrathecally to 0.5% hyperbaric bupivacaine on peri-operative analgesia and sub arachnoid block characteristics in lower abdominal surgeries - a dose response study 2006-01: Reg. Anasth. Pain Med. 32(1): 20-6. 19. Kenneth H. Gwirtz, Jerry Wing : The safety and efficacy of intrathecal opioid analgesia for acute post-operative pain : 2005-03 - Reg. Anaesth. pain. Med. 24(2) - 10-14. 20. Kuusniemi KS, Pitkanen MT et al : The use of Bupivacaine and fentanyl for spinal anaesthesia for urologic surgeries : Anaesth. Anal.2000; 91(6) : 1452-6. 21. Lauretti GR, Maltos AL, Reis MP : Combined intrathecal fentanyl and neostigmine: Therapy for post operative abdominal hysterectomy pain relief. J. Clin. Anaesth. 1998 Jun; 10(4): 291-296. 22. Liu S: Chiu A.A. : Carpenter R.L. et al, Fentanyl prolongs lidocaine spinal anaesthesia without prolonging recovery anaesth. Analg. 1995: 80 : 730-4. 23. Manullang TR, Viscomi CM; Pace NL: "Intrathecal fentanyl superior to IV Ondensetron for PONV", Anaesth. Anal, May 2000, 90(5); 1162-66. 24. P. Tarkkilaet al, Home readiness after spinal anaesthesia with small doses of hyperbaric 0.5% Bupivacaine. Anaesthesia 1997; 52: 1157-60. NJMR│Volume 6│Issue 1│Jan – Mar 2016 of Subarachnoid fentanyl in the elderly. Anaes. 1992; 47: 558-62 . and hemodynamic effects after subarachnoid administration of Bupivacaine with epinephrine. Anaesthesia and Analgesia - 1988: 67: 784-787. 35. Wylie WD and HC Davidson - Textbook of anaesthesia - 7th edition 2003. 36. William F. Ganong Textbook of Physiology - 20th edition 2004. 37. Youngstorm R. Epidural fentanyl and Bupivacaine in labour Anaesthesiology 61: A414, 1984. 38. Yuh - Huey Chao, Kwok - On Ng-Urinary catheterisation may not be necessary in minor surgery under spinal anaesthesia with long acting local anaesthetics. Acta Anaesthesiology Taiwan - 2006 Dec. 44(4), 199-204. 39. Grant P. Raymer et al, Cooper DW et al :Nayan W.D. An- aesth. Analgesia 1994; 78, 5-10. 40. Samil K et al : Lancet 1979, 1, 1142, Samil K et al Anaesthe- siology 1979, 50, 149. 41. Vaghadia H, Mcleod D. Mitchell G et al - Small dose hypo- baric lidocaine - fentanyl spinal anaestthesia for short duration out patientlaproscopy. Anaes. Anal 1997 : 84 : 59-64. 42. Varassi G. Celleno D, Capogna G et al ventilattory effects of subarachnoid fentanyl in tthe elderly Anaestthesia 1992; 47: 558-62. 43. BromagePR : A comparison of the hydrochloride and carbon dioxide salts of lidocaine and prilocaine in epidural analgesia. Acta. Anaesthesiology Scand 1965; 16: 55-69. 44. FauziaBano, SaleemSabbar et al :Intrathecal fentanyl as ad- junct to hyperbaric bupivacaine in spinal anaesthesia for caesarean section. J. Coll. Physicians Surg. Pak 2006 Feb. 16(2) : 87-90. 45. M.S. Khanna, IK Windersingh et al : Study of intratthecal fentanyl - IJA - 2002 46(3) : 199-203 Page 68 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE SCIENTIFIC VALIDATION OF DISEASE DIAGNOSIS SYSTEM, USINGHUMAN ENERGY FIELD (AURA) FOR GIT CASES Rajeev Pahwa1, Uday Kumar Jejurikar2, Menka P. Kuril1, Barkha P. Kuril1 Authors’ Affiliations: 1Alternative Therapy Practitioner, Roopantaran Samajik Evam Jankalyan Sansth, Ujjain, 2 Professor, Dept. of Genera; Surgery, R. D. Gardi Medical College, Ujjain Correspondence: Menka Kuril Email: [email protected] ABSTRACT Introduction: HEF or Aura is our spiritual signature. Traditionally, energy-field or aura is a protective psychic and spiritual energy field that surrounds the physical body. Energy from an aura is usually not static. It is constantly flowing, flashing, vibrating, expanding, and decreasing. Biopulsar-Reflexograph is a modern day instrument used as a human energy-field (Aura) measuring device, based on the latest computer technology combined with the scientific basis of the biofeedback, reflex-zone and energy meridian teachings and with ancient healing sciences. Methodology: The biofeedback system Biopulsar-Reflexograph is a highly sensitive, biomedical measuring device, certified according to the European Guidelines for Medical Devices CE Class IIa. It is based on the latest computer technology combined with ancient healing sciences. The biofeedback sensor is a receiver for high-resolution, biomedical signals, which are taken from the reflex zones of the hand´s palm. For this particular study, we have compared general cases between the age group 20-80 years block as compare to prediagnosed cases of Dr. Uday Kumar Jejurikar. All these cases have been categorized into 10 divisions and 10 different organs are taken into consideration for the assessment of confirmation in gastro-intestinal system. The study gives the confirmation on the cases prescribed by doctor. Conclusion: It was found that the aura diagnosis machine helped a lot in confirmed diseased cases and its symptoms diagnosis for GIT cases. The technology played major role in our research and helped in the validation of our age old traditional knowledge. Key word: HEF, Aura, Gastro-intestinal System, Reflex Zones, Biofeedback, energy meridians, BiopulsarReflexograph. INTRODUCTION The aura is the multidimensional, invisible soul radiation of a person and consists of different vibrations. The physical body does not radiate the aura as commonly supposed, but the aura contains the physical body. The physical body is nothing else than condensed vibrations, which cannot be seen with the normal eye. Biopulsar-Reflexograph is a highly sensitive, biomedical measuring device, offers dynamical biofeedback of 43 organ reflex zones of the hand and support a clear and detailed syndrome diagnosis. The Biopulsar-Reflexograph not only expands your energy analysis capabilities, allowing you to Identify a wider range of existing and potential conditions, which helps to improve patient's communication, comprehension and case acceptance. The word ‘biofeedback’ is an indication for biomedical control mechanisms. It is composed by the Greek word bio = life, life processes and by the English word feedback = reaction. Reflex zones are areas on NJMR│Volume 6│Issue 1│Jan – Mar 2016 the skin surfaces, which have connections to the internal organs and body structures. For over thousands of years, Western and Eastern cultures have applied the knowledge of reflex zones in diagnoses and therapy. Indian and Chinese holistic healing sciences assume that the hand reflex zones are not only connected to the organs but also to the consciousness, the energy meridians, the energetic field (Aura) and the chakras of a person. The interpretation of the energetic situation of a reflex zone serves for diagnosis and therapy of the regulating state of the internal organs and the psyche. METHODOLOGY Study Area – Patidar Hospital and Research Centre, Ujjain. Before conducting the study, permission was taken from Institutional Ethical Committee. Study Population - We have totally observed 212 cases for this particular study and these cases are Page 69 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 compared with total 100 control cases, including both sexes, belonging to different caste, culture and occupation within age range of 20 – 80 years. Aura Picture Study Tool - Biopulsar-Reflexograph The Biopulsar-Reflexograph uses only low frequency currents for the measuring of the skin resistance. During the measuring, the body cannot be inflicted with any harmful or disturbing impulses. Each of the 48 biomedical sensor pegs is an interface, conducting the measured biofeedback parameters of each individual organ zone to the PC every 500 milliseconds (synaptic real-time measuring). Then the data is processed and presented by the software as biofeedback graphs, aura colors of the organs, dynamical chakra activity and more. A complex measuring of the whole body lasts about 1 minute. The patient does not have to undress. As the therapist does not touch the patient, no outside energies can influence the measuring of the patient’s energy field. In a very short period of time, the therapist receives a clearly arranged individual syndrome diagnosis of the entire organic network of the body. Through the organ biofeedback and the dynamic aura of the whole body, the therapist can get precise information concerning vitality as well as physical and psychological constitutions. Study Technique – We have totally observed 211 cases for this particular study and these cases are compared with total 100 control cases, including both sexes, belonging to different caste, culture and occupation within age range of 20 – 80 years. All these general and pre-diagnosed cases have been categorized into 10 divisions and 10 different organs are taken into consideration for the assessment of diseased/ infected/ imbalance state of organ in Gastro-Intestinal System. It was imbalance of 10 organs of GIT from esophagus to rectum except heart in the presentation of diseases while recording. The process of the graph, with its fine amplitudes, corresponds to the organic pulse wave. Vitality, pulse wave and performance of the elements give information about the constitution of the organs as well as of the whole body of the person. Therefore, you can derive the physical and psychological disposition of diseases.Common Energy Patterns of the Biofeedback Graphs Biofeedback amplitude ranges along harmony line: the green Harmony, pleasant lightness, homeostasis, balanced organ function. Ideal organ energetics. Ayurveda: Tridosha balance = Vata – Pitta – Kapha in harmony Biofeedback graph drops precipitously into the grey region: Cannot maintain energy and expends it quickly. Rapid exhaustion due to chronic weakness, particularly if stressed. Emptiness – inflammation. Is open, unprotected, and vulnerable. Tendency towards energetic emptiness = organ coma, even shock! NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 70 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 The biofeedback curve represents the flow of life energy in the organ. Harmony Line or Homeostasis Organ Total Case Studies Organ Esophagus Stomach Liver Small Intestine Colon Rectum Total Total 35 70 20 16 45 26 212 RESULTS General readings are selected randomly from the common public, then compared and analyzed with the pre-diagnosed cases of doctor. In general cases, balanced state is more as compared to cases of diseased recordings. Here, we are analyzing organs of GIT system, such as, esophagus, stomach, small intestine, colon and rectum. In our study, categorization is done on the basis of primary complaints that the patient is coming up with to the doctor, which is compared with the other main organs of GIT system. Stomach/ 40-60/ Total -23 (in percentage) Organ Esophagus Heart Stomach Pancreas Liver Small In- Colon Rectum testine Balance state 5 5 14 9 27 26 13 21 Imbalance/Diseased 95 95 86 91 73 74 87 79 State NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 71 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 In the above table, Pre-diagnosed cases of stomach, age group 40-50, total cases 23 are shown, and are compared with other organs of GIT, and state of balance and imbalance are analyzed. It shows that among 23 cases of stomach, 86% confirmed cases were diagnosed correct. Energy Meridian of Stomach In this way, all the other organs are compared simultaneously. The above table also shows the multiple involvements of other organs in cases of stomach. Lastly, the figure shows the track of energy me- The criteria for selection are as follows – For our study, doctor used to note his observation about cases, on the basis of his pre-diagnosed GIT cases, and then suggested the cases for aura diagnosis. They were categorized on the basis of the organ diagnosed by doctor. He did the assessment every 15 days and on the basis of his observations, cross-confirmed his diagnosis with aura observations given by Biopulsar-Reflexograph. On the basis of Dr. Uday Kumar Jejurikar’s findings, he has given following conclusions. “Firstly, it is observed that beyond 50 yrs, one infected organ affects multiple organs, so this gives us a theory of multi-organ involvement i.e. whenever patient complaints of any specific symptoms involved with certain organ, we should also look for other organs for causes and their condition. Secondly, high level of imbalance in pancreas again gives us a very important study because this organ is hidden behind the intestine, the posterior peritoneum. Normally, we are not able to look into the diseased condition of this organ except in such a graphic presentation where we are able to assess pancreas by different tools and different methods. Thirdly, the data seems to be extremely useful as it proves beyond doubt that extremely diseased cases of stomach and colon can be easily picked up by Biopulsar graphical presentation. This was the most important observation in the present study. This is very rewarding for all of us that even if the patient is complaining of the any specific organ, you can look and compare the condition of other organs also.” NJMR│Volume 6│Issue 1│Jan – Mar 2016 CONCLUSION Biopulsar-Reflexograph can be used as a disease diagnosis tool with an additional advantage that it shows energetic organ changes long before a disharmony shows itself on the physical level. Therefore, it can be used for the prevention of illness as well. In a nutshell, this health management tool is of great help in getting a preview of possible and probable health conditions, before your body experiences them in a physical way. The Aura scan machine also gives you a quick snapshot of your individual chakras, your general aura and the vitality level of various organs in the body. REFERENCES 1. Dr. Karl Erdt, Medical Doctor and Surgeon, Massing, Germany. 2. Pierrakos, J C (1977). The Core Energetic Process; New York, Institute of the New Age (Monograph). 3. Pierrakos, J. C. (1971). The Energy Field in Man and Nature; New York. Institute of Bioenergetic Analysis. 4. Brennan. B., Function of the Human Energy Field in the Dynamic Process of Health, Health and Disease. New York, Institute for the New Age, 1980. 5. Burr, H. S. 1944. “The Meaning of Bio-Electric Potentials”. Yale J. Biol. Med. 16: 353-360. 6. Dobrin R., Conway (Brennan) B. and Pierrakos J., “New Electronics Methods for Medical Diagnosis and Treatment Using the Human Energy Field.” 7. Linda Ward, Rudolf Schinnerl, Karin Kraft. Biopulsar® Technology Use in a Chinese Medicine Practice. Electrobiology Energy Therapy. Page 72 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE EVALUATION OF STRESS URINARY INCONTINENCE AMONG NON PREGNANT FEMALE PATIENTS IN A TERTIARY CARE HOSPITAL Shraddha Agarwal1, Ashwin Vacchani2, Jigisha Chauhan3, Sneha .C. Halpati4 Author’s Affiliations: 1Assistant Professor; 2Associate.Professor; 3Assistant Professor; 4Ex Senior Resident, Department of Obst and Gynec, SMIMER, Surat Correspondence: Dr. Shraddha Agarwal Email: [email protected] ABSTRACT Background: Urinary incontinence has been defined by the international continence society as a condition in which involuntary loss of urine is a social or hygienic problem and is objectively demonstrable. Stress urinary incontinence is the most common form of transurethral urinary incontinence in women. Objective: To study the probable etiological factors in diagnosed cases of Stress urinary incontinence among non pregnant female patients attending outpatient department of Gynecology in SMIMER, Surat and to evaluate the cure rate of non-surgical and surgical treatment among them Method:This study was conducted in the department of Obst amd Gynec, SMIMER, Surat from May2010 to december2012. Non pregnant patients demonstrating SUI with full bladder were included in the study. Total 40 patients were studied. Observation: Out of 40 cases 32 (80%) cases belonged to the age group of 40 to 59 years, 22 (55%) were in peri-menopausal age group and the median parity of the patients was 3. Other important observation was that 29(54.7%) patients had associated utero-vaginal prolapse with SUI and maximum had third degree prolapsed. Both non-surgical and surgical treatment was offered to patients with good results. Conclusion: This study indicates that SUI is quite common in peri-menopausal age group, it has strong association with multi parity and UV prolapse. Non-surgical management is still the acceptable mode of treatment. The TVT-O appears to be safe and effective surgical treatment for SUI. Key words: Stress urinary incontinence (SUI), TVT-O, menopause, multi parity, Utero-vaginal prolapsed Abbreviations: SUI stress urinary incontinence, UV prolapse-uterovaginal prolapse, VH-vaginal hysterectomy, HRT-hormone replacement therapy, UTIurinary tract infection INTRODUCTION Definition of SUI- The international continence society defines stress continence as a symptom, a sign and a condition. The symptom indicates the patient’s statement of involuntary urine loss during physical exertion, the sign is the objective demonstration of urine loss from the urethra synchronous with a physical exertion and condition is called “Genuine” Stress Incontinence and the urodynamic demonstration of the loss of urine when intravesical pressure exceeds the maximum urethral pressure in the absence of detrusor contraction.1 Urge Incontinence-Leakage of large amount of urine at unexpected times, including during sleep. SUI results from the anatomic displacement of the UV NJMR│Volume 6│Issue 1│Jan – Mar 2016 junction and proximal urethra outside the normal intra-pelvic location above the urogenital diaphragm.2 There are three major determinants related to the condition SUI. These include -1. The resting urethral pressure 2.The pressure transmission ratio which is the percentage of bladder pressure increase with stress that reaches the urethra and is determined by anatomic relationship.3.The amplitude of the rapid increase in intra-abdominal pressure .Most of the surgical procedures for SUI primarily affect pressure transmission ratio. There are many factors responsible for loss for pelvic support which can lead to SUI. These factors may be developmental weakness, child birth trauma3, post menopausal estrogen deficiency4, obesity5, spinal cord lesion6, UTI, drugs side effects7, etc. To demonstrate SUI, Stress Test is done in which the patient with full bladder is asked to cough. If the patient loses a spurt of urine synchronous with cough and ending abruptly with cessation of cough, almost certainly she has pure anatomical incontiPage 73 NATIONAL JOURNAL OF MEDICAL RESEARCH nence. The investigations8 which may be needed in the patient’s assessment are urine, routine, microscopic and culture sensitivity, USG9, uroflowmetry10, cystometry10, urethral pressure and urethral closure pressure profile10 etc. Urodynamic testing is not necessary in women with pure SUI(society of obstetrics and gynecologists, canada2013) There are various non-surgical and surgical methods of treatment for SUI depending upon it’s severity. Non-surgical methods include lifestyle changes, pharmacological agents, prosthesis, Kegel’s exercises11, 12urinary bladder training etc. The latest surgical procedure for SUI are midurethral sling procedures13 which can be TVT (tension free vaginal tape) or TVT-O (transobturator approach)14-17. TVT-O is comparatively easier and has lesser complication rate. METHODOLOGY This prospective retrospective study was conducted in dept. of Obst & Gynec, SMIMER Hospital, Surat from May 2010 to Dec 2012. Total 40 patients were studied fulfilling the inclusion criteria i.e. demonstrable SUI with comfortably full bladder & patient’s consent for study .Patients with pregnancy, urge incontinence or voiding difficulty were not included. All subjects were inquired for detailed menstrual & obstetric history with special emphasis on the number and mode of delivery. Past history of bronchialasthama, bronchitis & chronic constipation was looked for. H/O smoking, tobacco, antihypertensive drug was noted. Detailed general, systemic &local examination was done in all subjects . Local examination was done in dorsal position with comfortably full bladder, after repositioning of utero-vaginal prolapse when the patient was asked to cough, a spurt of urine through external urethral meatus on coughing was considered as a positive objective evidence of SUI. Thus SUI was confirmed by stress test. Routine investigations were done for surgical fitness. Special attention was given to urine analysis to exclude UTI. All patients were counseled and given option for non-surgical and surgical management of SUI. In non-surgical methods antibiotics, HRT, local estrogen, kegel exercises and Duloxetine was given according to the need on outpatients bases. In surgical management TVT-O (trans obturator ap- print ISSN: 2249 4995│eISSN: 2277 8810 proach) was done along with other surgeries like vaginal hysterectomy, anterior and posteiror colporrhaphy as needed. The time taken for TVT-O was noted from opening to closure of the sub urethral vaginal mucosa only. Intra operative complications like heavy bleeding, bladder injury, urethral injury etc were noted. Early postoperative complication (up to 14 days) like UTI,fever, local hematoma, urinary retention was noted. The indwelling Foley catheter was removed on the second post op day. On the day of discharge the postvoid residual urine was measured which if less than 100ml was considered normal. Patients were followed on 7th post op day, at 3 months,6 months and 12 months after surgery. A negative stress test was the objective measure of success used in this study. The outcome of treatment was classified in four categories-cure of SUI, improvement, failure and recurrence. Cure of SUI after the procedure was defined as the absence of a subjective complaint of leakage and absence of objective leakage on Stress Testing. Improvement was defined as no urine loss on the Stress Test plus the subject’s report of some leakage but there was overall subject satisfaction. Failure- No improvement or symptom aggravation. Recurrence- The development of leakage again during the follow-up after initially achieving a cure. The study was approved by institutional ethical committee. RESULTS Out of 40 subjects the median age of the patients was 46.5 years with the range between 35 to 56 years.32 patients(80%)belonged to age group of 40 to 59 years. The mean parity of the patient was 3 with the SD of 0.87. The median parity of the patient was 3 with range between 2 to 5.28 patients (70%) with SUI were third para or above. In our study 22(55%) of the subjects were in peri-menopausal age group, which shows that SUI is quite common before menopause. According to the place of delivery 25(62.5%) of the subjects had home delivery leading to repeated trauma to ligaments and hence and increased incidence of SUI. Table 1: Distribution according to type of non-surgical treatment taken and its out come Variable Antibiotics (UTI) HRT No. 3 2 3 months No SUI No SUI Duloxetine + exercise 7 3-not improved 2-partially improve 2-totally improve NJMR│Volume 6│Issue 1│Jan – Mar 2016 6 months No SUI 1-No SUI 1-partially improve 2-surgical treat 2-loss of follow up 3-totally improve 12 months No SUI 1-no SUI 1-loss to follow up 4-no SUI 3-loss to follow up Page 74 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 Table 2: Distribution of subjects according to intra-operative complications Variable Difficulty in passing needle Excessive bleeding Bladder/urethral injury Total No. (%) 3 (10.00) 2 (6.67) 0 5 Table 3: Distribution of subjects according to objective assessment of SUI Result of objective assessment No SUI SUI present Lost to follow-up Not completed 12 months after treatment Total 3 Months 38/38 00 02 00 6 Months 33/33 00 06 01 12 months 29/29 00 08 03 40 40 40 Table 4: Distribution of subjects according to final outcome of surgery Outcome of surgery Cure Improved Failure Recurrence 3 months (%) 34/38 (89.47) 4 (10.53) 0 0 6 months (%) 31/33 (93.55) 2 (6.45) 0 0 12 months (%) 29/29 (100) 0 0 0 We found that , 29(54.7%)of subjects had associated urogenital prolapse which may be due to common etiological factors like trauma due to repeated child birth.13 out of 40(32.5%) had 3rd degree uterineprolapse ,while 9 out of 40(22.5%)had second degree prolapse, 13(24.5%) subjects had isolated SUI,27 subjects(67.5%)had a cystocele with SUI. As seen in table-1, out of 40 patients 12(30%) had non-surgical management and 28(70%) had surgical management. Out of 12 managed conservatively,3 was given antibiotics for UTI,2 were given HRT for menopausal symptoms and 7 were treated with tablet Duloxetine + Kegel exercise. After 12 months, 8 patients were totally improved of which 2 had surgery due to intolerance to Duloxetin & 4 subjects lost to follow up. TVT-O was done for SUI alone or along with concomitant surgery like VH, NDVH, ant colporraphy, AP repair etc. The intra-operative time taken for TVT-O in 21 subjects (70%) was 5-10 minutes, in 4 subjects (13.34%) time taken was 10 -15 minutes, only in 5patients more than 15 min were taken. As shown in table 2, Intra-operative complications noted were difficulty in passage of needle (in 3 patients i.e.10%) &heamorrhage (in 2 patients i.e. 6.67%).No case had bladder or urethral injury. Early post operative complications were urinary retention & fever. Late post operative complications were tape erosion, groin NJMR│Volume 6│Issue 1│Jan – Mar 2016 pain, dyspareunia & de novo urgency. The median hospital stay of the patient was 4 days with range of 2 to 5 days. After surgical and no-surgical treatment, patients were followed at 3 months, 6 months and 12 months. As shown in table 3, all patients examined at 3 months (n=38), 6 months (n=31) & 12 months (n=29) showed no objective evidence of SUI when they were examined in supine as well as erect position ,giving an objective cure rate of 100%. As shown in table4, at three months follow up, 34/38 subjects (89.47%) were completely cured i.e. they neither had subjective nor objective evidence of SUI and 4/38 subjects (10.53%) had improvement i.e. though subjectively they reported some degree of urinary incontinence, there was no evidence of SUI. At 6 months, 31 out o 33 available subjects had cure, 2 out of 31(6.45%) had improvement. And at 12 months follow up, 29 out of 29 available subjects had cure. DISCUSSION In our study maximum number of subjects (45%)were from 40-49 years which indicates increased incidence of SUI in the elderly women which can be due to decreased urethral vascularity and abnormal smooth and skeletal muscle efficiency resulting in low resting urethral pressure and abnormal stress response. 70% subjects had parity of 3 and above indicating SUI more common in mutiparous patients. This is because repeated vaginal deliveries causes damage to pelvicfloor and permanent elongation of pubourethral supporting ligaments. In our study SUI was common in premenopausal and postmenopausal suggesting estrogen deficiency to be the cause of SUI. SUI was associated with uterovaginal prolapse in 54.9% cases, in which 3rd degree utrine descent was most common. This association could be because the contributory factor to both has been seen to be multi-parity leading to repeated trauma during child birth. Out of 12 subjects who accepted medical treatment 8 subjects were completely improved. Most common concomitant surgery associated with TVT-O was VH+AP repair (11 subjects that is 36.7%). In 70% patients TVT-O was completed in 5-10 minutes with minimal complications. So TVT-O is a relatively safe surgery as far as intraoperative complications are concerned.The false passage was the only intraoperative complication noted in 3 subjects(1o%) which was slightly higher as compared to studies of TeoR etal14 (4.9%), Sola et al15 (0%), and Lim et al17 (0%). None of the subject had an objective evidence of SUI on 3, 6 and 12 months follow up-giving cure rate of 100%. Page 75 NATIONAL JOURNAL OF MEDICAL RESEARCH CONCLUSION print ISSN: 2249 4995│eISSN: 2277 8810 8. DC Dutta : Textbook of Gynec (3rd ed.),New Delhi ,JayPee Pblisher,1994. P-358 This study of Evaluation of SUI indicates that SUI s 9. Shashi Gupta.PK Gupta:Perineal @ introital sonography for quite common in perimenoposal age group, assoevaluation of SUI.obs&gynec today vol-3 no, 10 ,oct ciated with multi parity and utreovaginal prolapse. 1998,626-627 Non-surgical management is still the acceptable 10. Emil A tanagho, marsell I Stoller;Urodynamic cystometry mode of treatment. The TVT-O appears to be a safe and urethral closer pressure profile, urogynecology and uroand effective surgical modality of treatment and can dynamic, theory and practice (3rd ed), William & wilkins, 1991,122-142. be performed with other gynec surgery. REFERENCES 1. L. Lewis Wall. Urinary stress incontinence Te-Linde’s Operative Gynecology, 10th edition.Lippincott Williams & Wilkins; 2012. p 942-959. 2. Richard C. Bump: Urinary tract disorders. Post reproductive Gynecology; 1990.p 301-354. 3. Dietz HP, Bennet MJ, The effect of child birth on pelvic organ mobility,Obstet gynecol 2003; 102;223.k 4. Grodestein F, Lifford K, rensik NM et al Postmenopausal hormone therapy and risk of developing urinary incontinence,obstet gynec 2004; 103; 254. 5. Sudak LL, whitcomb E shen H et al Weight loss; a novel and effective treatment for incontinence, journal urol 2005; 174: 190. 6. Narender N. Bhatia: Neurologogy and Dynamics sphincter electromyography and electrophysiologocal testing. Urogynecology and Urodynamics; Theory and practical, 3rd Edition, William & wilkins, 1991, 143-162 7. Viktrup I bump RC, Pharmological agent used for treatment for stress incontinence ,Curr med res opin, 2003;19;485 NJMR│Volume 6│Issue 1│Jan – Mar 2016 11. Kegel AH progressive resistant exercise in the functional restoration of perineal muscle. Am jour obs gynec, 1948;56:238 12. Kegel AH. Stress incontinence of urine in women; physiologic treatment. J int coll, surg,1956;25,p 487 13. Nicolette s horback; suburethral sling procedura; urogynaecology and urodynamic theory and practice, William & wilkins, 1991,102-107 14. Teo R:randomized trial of TVT and TVT-O for the treatment of female incontinence,2nd ed urodynamic stress incontinence in women;Eur Urol,2003,44:724-730 15. Vicente Sola; TVT vs. TVT-O for minimally invasive surgical correction of SUI; international Braz J Urol, vol 33 (2), March April 2007. 246-253. 16. Nader gad: The TVT-O procedure with the cough test in theatre; Pelviperineology, a multidisciplinary pelvic floor journal, 2008.27:135 to 138. 17. Lim J, Cornish A, Carry M: clinical and quality of life outcomes in women treated by TVT-O.BJOG 2006;113: 13151320 Page 76 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE INCIDENCE AND TREATMENT ABANDONMENT IN TEEN AND YOUNG ADULT CANCERS (Col) Prakash.G Chitalkar1, Rakesh Taran2,. Prashant Kumbhaj3, Deepak Singla3 Author’s Affiliations: 1Professor; 2Associate Professor; 3Senior Resident, Department of Medical Oncology, Sri Aurobindo Institute of Medical Sciences,Indore,Madhya Pradesh Correspondence: Dr Prashant Kumbhaj Email: [email protected] ABSTRACT Background: The cancer patterns in teen and young adults (TYA) differ from those in children and older adults. The incidence of those affected is increasing rapidly although this has not been much focus of attention in cancer control and prevention .Treatment abandonment is the common problem in teen and young adult cancer patients, reasons of treatment anandonement varies depending upon socioeconomic background. Material and method: It is a a retrospective observational study and data were collected from records of TYA Patients registered from January 2013 to December 2015 at cancer center Sri Aurobindo Medical College and postgraduate Institute Indore. TYA Patients age between 15 to 39 were included in the study. The cases were analyzed for Age, sex, number of cases year wise , diagnosis of malignancy according to international classification of disease (ICD),number of undiagnosed and abandoned cases .The findings were compared with other similar studies Results: On analyzing data of three years ,hematolymphoid malignancy(28%) cases are the most common cases seen followed by Breast (10%) and head and neck (10%),cervix(6%),CNS(5%) ,Bone( 4%). 38% TYA cancer patients abandoned treatment . Telephonic tracking, financial support, counseling of whole family are methods employed in reducing abandonment. Key words- Teen and young adolescents, hematolymphoid cancer,treatment abandonment. INTRODUCTION Patients aged 15 to 39 years old at their initial diagnosis constitute the adolescent and young adult (TYA) cancer population, which includes approximately 700,000 patients diagnosed each year, or 2 percent of all invasive cancers diagnosed and less than 10 percent of all cancer survivors1 .The cancer pattern in Teen and young adults (TYA) differ from those in children and older adults 1.The cancers involved are more likely related to genetic predisposition, specific health behavior / lifestyle among young people exposing themselves to causative agents2. When diagnosed,TYA suffer from adverse psychosocial effects 3. Survival rates for AYAs have not improved to the extent that they have for younger children or older adult cancer populations 4. Some data suggest that the poorer outcomes in AYAs (particularly those with colon or breast cancer) are in part related to their biology, including different genomic risks, tumor histopathology, oncogenic pathway deregulation, and chemotherapy sensitivities 5,6.In addition, there appears to be a tendency for AYA patients to be diagnosed at later stages compared with older patients 7,8. Although the incidence of invasive NJMR│Volume 6│Issue 1│Jan – Mar 2016 cancer in AYAs is lower than in younger children or older adults, the psychosocial needs of AYAs often exceed those seen in older adults. TYA suffer from adverse psychosocial effects because most of their potential years of life ahead of them has to be spent with effects of cancer, its treatment or tragically shortened lives with major repercussions on their families and society in general2-3The psychosocial effects has components of worry about recurrence, hypervigilance about symptoms, concerns about family and finances, and the stress of managing health needs, as well as changes in self-perceptions, body image, and feelings of vulnerability. Treatment abandonment is the common problem in teen and young adult cancer patients ,reasons of treatment anandonement varies from psychological issues to socioeconomic background.The incidence of those affected is increasing rapidly although this has not been much focus of attention in cancer control and prevention 11.We have done a retrospective observational study of incidence and treatment abandonment TYA cancer patient’s at Sri Aurobindo Medical college ,Indore. Page 77 NATIONAL JOURNAL OF MEDICAL RESEARCH METHODOLOGY It is a retrospective observational study and data were collected from records of TYA Patients registered from Jan 2013 to December 2015 at cancer center Sri Aurobindo Medical College and postgraduate Institute Indore.It is a medical college hospital including a multi disciplinary cancer centre. Patients from 17 districts have access to this centre.TYA Patients age between 15 to 39 were included in the study.The cases were analyzed for Age, sex,year wise number of cases, diagnosis of malignancy,number of undiagnosed and abandoned cases .The findings were compared with other similar studies. Institutional ethical clearance was obtained for conducting this study. Approximately 800 new cancers patients present to this centre every year. During years 2013, 2014 and 2015 a total of 2376 patients with a cancer diagnosis were enrolled for a cancer diagnosis, out of which 947 were TYA age group. The median age was 22 years (range 2-87years), 591 were males and 356 females, 604 from rural background and 343 from urban background. Table 1 shows Age, sex, socioeconomic status wise proportion of TYA patients. It also shows socioeconomic background of abandoned TYA patients. Of 947, TYA patients 62% were male and 38% female . Table 1: TYA Patients demographics Abandoned at Diagnosis and therapy Male (%) 60(10.0) 67(11.0) 110(19.0) 140 (23.0) 214 (36.0) 591(62.0) Urban(%) 343(36.0) Urban(%) 56(15.0) Female(%) 50(14.0) 40(11.0) 70(20.0) 90(25.0) 96(27.0) 356(38.0) Rural(%) 604(64.0) Rural(%) 312(85.0) Table 2: Showing total number & types of TYA cancer cases TYA Cancer Total Hematolymphoid(C-81-96) Head & Neck (C-00-14) CNS (C-71) Breast (C-50) Cervix (C-53) Bone (C40-41) Undiagnosed Abandoned In males 36 % were in the age group of 35-39, much more amenable to factors of lifestyle.Followed by 23 % in the age group of 30-34 yrs, while in female 27% in age group of 35-39 yrs, followed by 25% in the age group of 30-34 yrs. Table 2 TYA Cancers shows data about site wise TYA cancer patients coming to SAIMS Year 2013, 2014, 2015,number of patients abandoned diagnosis and therapy .On analyzing data of three years ,hematolymphoid malignancy (C-81-96) (28%) cases are the most common cases seen followed by breast (C-50) (10%) and head and neck(C-76) (10%), cervix (C-53) (6%), CNS (C-72) (5%), Bone (C40-41) (4%). Surprisingly 38% TYA cancer patients abondoned treatment. DISCUSSION RESULTS Age in Years 15-19 20-24 25-29 30-34 35-39 Total Socioeconomic Status print ISSN: 2249 4995│eISSN: 2277 8810 2013 267 80(38.0) 23(8.0) 16(6.0) 20(8.0) 7(2.0) 7(2.0) 114(36) 137(52) Figure in parenthesisi indicate percentage. 2014 337 69(21.0) 27(8.0) 19(6.0) 30(9.0) 26(7.0) 20(6.0) 146(43) 151(47) NJMR│Volume 6│Issue 1│Jan – Mar 2016 2015 343 120(35) 40(12.0) 15(5.0) 40(12.0) 25(7.0) 13(3.0) 90(26) 80(23) Approximately 69,212 adolescents and young adults (AYAs) ages 15–39 were diagnosed with cancer in 20119.It is six times the number of cases diagnosed in children ages 0–14. Specific cancer types incidence varies dramatically across the TYA age continuum. Leukemia, lymphoma, testicular cancer (germ cell tumors), and thyroid cancer are the most common cancer types in younger TYAs (15–24 years old). By ages 25–39, breast cancer and melanoma comprise a growing share of cancers among TYAs10. Transitions in anatomy, the evolving hormonal milieu, maturing development, increase demand in work place, family responsibility and acquiring new lifestyle and habits in a particular region before the old do and also the short period of exposure between the beginning of life and cancer diagnosis giving rise to unique cancer pattern in TYA11.There is increase use of tobacco and alcohol in both genders with onset of this habit at very young age especially in low socioeconomic group. Majority of our patients belong to rural background socioeconomic group. The incidence is increasing faster than the increase in either children or older adults and not been much focus of attention in cancer control and prevention11.The risk factors responsible in this age group are infection, adolescent growth spurts, hormones, growth and development factors associated with genetic predispositions . This is the age of cross over from predominance of nonepithelial cancers in childhood to predominance of epithelial cancers in older adults 11. In our study hematolymphoid cancer is the most common in TYA 28%,breast and head and neck both comprising 10% of total AYA population followed by Cervix cancer(6%) and CNS tumors(5%). The pattern of incidence of TYA is quite similar in our study compare to TYA cancer showing in SEER data .Our study is showing hematolymphoid cancer as a maximum diagnosis in TYA Population whereas SEER data also showing leukemia lymphoma as maximum no of cases. In compare to germ cell tuPage 78 NATIONAL JOURNAL OF MEDICAL RESEARCH mor and thyroid cases which are common in 15-24 years in SEER Data , our study does not have such cases. After hemotolymphoid case our study has breast and head & neck cases in majority which has been also supported by SEER Data.In our study head and neck cases are also common in TYA population but this is not shown as a common cancer in AYA population in SEER data. This is due to very common practice of chewing tobacco and smoking habits in Indian population. In contrast to SEER data we don’t find any melanoma cases in our study which is very rare in Indian population. Our study showed 38% TYA cancer patients abandoned treatment . Abandonment of treatment is very common in Indian TYA population. The reason behind in most of the cases are lack of awareness, lack of financial sources for treatment , distance, lack of transportation facility , cultural beliefs. 85% abandoned cases were of rural background, where as 15% cases were from urban background. Abandonment in rural areas is particularly frequent ( 85%) ,and is consequent to factors like, close and hierarchical family structure, interdependency of the extended family. and inability to multi task, while balancing the pressure of cancer and the need to earn a living . In contrast, the urban patient tend to manage the pressure of keeping treatment appointments and other needs, due to inherent lifestyle characteristics and better resources and awareness and fear of loosing fertility are some reasons for treatment delay and abandonment . In low- and middle-income countries, treatment abandonment has been consistently reported as an important contributor to treatment failure and death12,13. print ISSN: 2249 4995│eISSN: 2277 8810 lowed by breast and head and neck both comprising 10% of total TYA patient population.Abandonment of treatment is very common in TYA population due to lack of awareness, Distance ,lack of transportation , lack of financial sources for treatment and cultural beliefs. REFERENCES 1. Bleyer A, Viny A, Barr R (2006). Cancer in 15 to 29 years olds by Primary site. Oncol, 11, 590-601 2. Cancer incidence in young adults.Special topic from Canadian Cancer Statistics 2002. 2003-2005 National Cancer Institute of Canada (Last updated on 09 August 2003). 3. Vickie Williams (2005). Cancer in young adults. Oncology, 50. (9/12/2009 4. Bleyer A, O'Leary M, Barr R, et al. Cancer epidemiology in older adolescents and young adults 15 to 29 years of age, including SEER incidence and survival: 1975 - 2000. Bethesda, MD, National Cancer Institute, 2006. NIH Pub. No. 06-5767 5. Blanke CD, Bot BM, Thomas DM, et al. Impact of young age on treatment efficacy and safety in advanced colorectal cancer: a pooled analysis of patients from nine first-line phase III chemotherapy trials. J Clin Oncol 2011; 29:2781. 6. Bleyer A, Barr R, Hayes-Lattin B, et al. The distinctive biology of cancer in adolescents and young adults.Nat Rev Cancer 2008; 8:288. 7. Hubbard JM, Grothey A. Adolescent and young adult colorectal cancer. J Natl Compr Canc Netw 2013;11:1219. 8. Steele SR, Park GE, Johnson EK, et al. The impact of age on colorectal cancer incidence, treatment, and outcomes in an equal-access health care system. Dis Colon Rectum 2014; 57:303. 9. An estimated projection calculated by the Surveillance, Epidemiology and End Results (SEER) Program using SEER 18, 2007-2011. Table.2 shows percentage of abandoned cases declining per year, as in 2013 total abandoned cases were 10. Data from the SEER Program.1975-2000. 52% of TYA Population followed by 47% in 2014 Wu, Frank D Groves, Colleen C Mclaughlin, et al and 23% in 2015. There is thus a declining trend in 11. Xiaocheng (2005). Cancer incidence patterns among adolescents and abandonment on preliminary analysis among TYA young adults in the united states. Cancer Causes Control, 16, cancer patients at our centre .Telephonic tracking, 309-20. financial support, counseling of whole family are me- 12. Gupta S, Yeh S, Martiniuk A, Lam CG, Chen HY, Liu YL, et thods employed in reducing abandonment. al. The magnitude and predictors of abandonment of therapy CONCLUSION This epidemiological study helps to know the incidence of cancer and treatment abandonment in AYA in the western part of the Madhya Pradesh. Hematolymphoid cancer is the most common in TYA fol- NJMR│Volume 6│Issue 1│Jan – Mar 2016 in paediatric acute leukaemia in middle-income countries: A systematic review and meta-analysis. Eur J Cancer. 2013. Epub 2013/04/20. doi: 10.1016/j.ejca.2013.03.024 . 13. Arora RS, Eden T, Pizer B. The problem of treatment abandonment in children from developing countries with cancer. Pediatr Blood Cancer. 2007;49(7):941–6. Epub 2007/01/26. doi: 10.1002/pbc.21127. Page 79 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE A RADIOGRAPHIC STUDY OF RIB ANOMALIES IN PATIENTS OF VARIOUS CHEST DISEASES BELONGING TO NORTH INDIAN POPULATION AT A TERTIARY CARE CENTRE Darshan K Bajaj1, Shailesh K Singh2, Abhishek Dubey3, Anand Srivastava1, Surya Kant4, Ajay K Verma1, Ved Prakash5, Mona Asnani6 Author’s Affiliations: 1Assistant Professor, 3Research Associate; 4Professor; 5Associate Professor, Dept. of Respiratory Medicine; 2Assistant Professor, Dept. of Radio-diagnosis; 6Assistant Professor, Dept. of Obstetrics & Gynaecology, King George’s Medical University, Lucknow Correspondence: Dr Surya Kant Email: [email protected] ABSTRACT Background:Though congenital rib anomalies are reported to be of rare occurrence, these are now and then encountered as an incidental finding in chest X-rays, however in most of these cases patients are having other health issues rather than things directly related to the rib anomalies. Aims: The aims of the study were to observe the detection rate of various kinds of rib anomalies, their association with gender, body side, other thoracic bony anomalies and associated symptoms. Material and methods:5,000 plain chest skiagrams were studied including 2,628 males and 2,372 females from September 2013 to September 2015. Results:Out of 5,000 total patients 82 patients (1.64%) were found with cervical rib, 22 patients out of 82 were having bilateral cervical rib(0.44%), bifid ribs were found in 59 patients(1.18%) out of which 3 patients (0.06%)were having both the anomalies, only one patient was seen with fused rib(0.02%),one with two ribs having less space in between(0.02%) and one patient was having rib with spur(0.02%). The occurrence (detection rate) of cervical rib on either side as well as bilaterally was higher in males. Bifid rib detection rate was higher on the right side in males and on left side in females.None of these patients were having any symptom related to their rib anomalies. Conclusion: there was a little higher detection rate seen regarding the presence of cervical rib in north Indian population however it was observed that the symptoms reported in literature in relation to the rib anomalies seemed to be overreported. Key words: Cervical rib,bifid rib,anomalies,supernumerary INTRODUCTION Though congenital rib anomalies are reported to be of rare occurrence, these are now and then encountered as an incidental finding in chest X-rays, however in most of these cases patients are having other health issues rather than things directly related to the rib anomalies. “Cervical or neck rib” is an extra or supernumerary rib which is generally smaller and runs from 7th cervical vertebra to the first true rib or to the sternum but usually it is present posteriorly to a short distance. It is present since birth but is usually incidentally diagnosed until and unless it is a cause of neurovascular compression at the thoracic inlet with which it has an inconstant association of roughly 10%.1 Sometimes diagnosis of NJMR│Volume 6│Issue 1│Jan – Mar 2016 cervical rib is difficult when just a fibrous band is present. Many times the treating clinician may miss this incidental finding as he is more focused towards his area of interest. “Bifid rib” or bifurcated rib or sternum bifidum is a congenital abnormality of rib cage in which muscles and nerves can also be involved although rarely and occurs in about 1.2% of humans.The sternal end is cleaved into two parts and it is almost always unilateral. In samoans i.e a polynesian ethnic group of the samoan islands sharing genetics, language history and culture the occurrence of bifid ribs was seen upto 8.4%.2 Bifid ribs doesn’t cause any symptoms usually and are often incidentally discovered like cervical ribs on chest skiagrams however very rarely effect of this neuroskeletal anomaly can include respiratory and Page 80 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 neurological difficulties. Another association of this anomaly has been seen with jaw cyst and may become a part of nevoid basal cell carcinoma syndrome. Other anomalies of the ribs may include fusion of adjacent ribs, supernumerary intrathoracic and transthoracic ribs have also been described previously although very little data and research is available. Purpose of the study was to study the detection rate of various kinds of rib anomalies, their association with gender, body side, other thoracic bony anomalies and associated symptoms in studied subjects. METHODOLOGY After taking ethical clearance from institutional etical committee(IEC) of the institute, a careful thorough examination of 5,000 chest skiagrams was carried out inclusive of 2,628 males and 2,372 females.The subjects were patients who presented to the department of respiratory medicine for various chest related ailments or referrals during the period from September 2013 to September 2015. All the radiographs were seen thoroughly on a view box with systematic approach, the skiagrams were seen combinedly by chest specialist and radiologist (Department of Radiodiagnosis) from the same institute. Chest radiographs were especially seen for the presence of congenital rib anomalies, the other structural deformities secondary to the respiratory diseases were not included in the study however those patients were dealt carefully for their ailments. The data regarding age, sex and presence of cervical rib, bifid rib, fused ribs and any other suspected deformity was taken into account. The data analysis was done using Pearson's chi-squared test applying statistical setting at p<0.05 using SPSS. Settings and Design:A hospital based cross sectional study Statistical analysis used: Pearson's chi-squared test applying statistical setting at p<0.05 using SPSS. RESULTS In 5,000 studied subjects, 82 patients (47 males and 35 females) were seen with cervical rib. Cervical rib was seen on right side in 28 patients (17 males and 11 females) and on left side in 32 patients (18 males and 14 females). Cervical rib was seen bilaterally in 22 patients (12 males and 10 females). A total of 59 patients out of all studied subjects were having bifid ribs. In these 59 patients, 33 patients were males while 26 patients were females. Bifid rib was seen on right side in 36 patients (22 males and 14 females) and on left side in 23 patients (11 males and 12 females). Only 3 patients were having presence of both the bifid and cervical ribs and all of them were males. One male patient was seen with fused rib on the right side and one male patient was seen with reduced intercostal space in between two ribs on right side in total studied population.One patient was having rib with spur in same population. The occurrence (detection rate) of cervical rib on both sides as well as bilaterally was higher in males(Table 1). Bifid rib detection rate was higher on the right side in males and on left side in females (Table 2). Table 1: Cervical rib analysis (N=5000) Subjects with cervical rib Number (%) Total 82(1.64) Bilateral 22(0.44) Right side 28(0.56) Left side 32(0.64) OR=Odds ratio, CI=Confidence interval Male (%) (n=2628) 47(1.79) 12(0.46) 17(0.65) 18(0.68) Females (%) (n=2372) 35(1.47) 10(0.42) 11(0.46) 14(0.59) OR (CI) p-Value 1.22(0.78-1.89) 1.08(0.467-2.512) 1.40(0.653-2.990) 1.16(0.576-2.341) 0.384 0.852 0.386 0.675 Table2: Bifid rib analysis Subjects with bifid rib Number (%) Total Right side Left side 59(1.18) 36(0.72) 23(0.46) Male (%) (n=2628) 33(1.25) 22(0.84) 11(0.42) DISCUSSION Congenital rib anomalies are reported to be of rare occurrence 3Cervical rib or neck rib is asupernumerary rib which arises from the costal element of the seventh cervical vertebra.4-6It is usually an incidental finding on chest skiagrams. The NJMR│Volume 6│Issue 1│Jan – Mar 2016 Females (%) (n=2372) 26(1.09) 14(0.59) 12(0.50) OR (CI) p-Value 1.15(0.684-1.924) 1.42(0.726-2.785) 0.83(0.364-1.877) 0.602 0.302 0.649 detection rate of cervical rib has been seen in different population like prevalence in a London population was 0.74% out of 1,352 chest radiographs examination.7 In a chennai population based study the percentage of its occurrence was 1.16%.8Other studies done on central Indian population and Page 81 NATIONAL JOURNAL OF MEDICAL RESEARCH Population around Lucknow claimed the incidence to be 1.2%and 0.6%respectively.9-10 According to the embryologists it is reported to be present always in fetuses and disappears just before birth.11 Association of cervical rib with Thoracic Outlet Syndrome (TOS) is reported which is claimed to be overdiagnosed and underdiagnosed by few authors. In general the clinicians have a lack of knowledge regarding the rib anomalies, they may discover it incidentally but have least of idea as to what to do further and may probably correlate them with something they are not associated with, sometimes patients are referred from these practitioners giving a lot of undue importance to the anomalies making the patients unnecessarily anxious, coming to cervical rib which has been found to be associated with TOS which is a term used to describe a group of disorders occurring due to compression, injury or irritation of nerves and/or blood vessels in lower neck and upper chest area, this syndrome can be due to presence of an extra first rib or collarbone fracture, apart from these other risk factors include tumors or enlarged lymph nodes, injury to shoulder, neck or back, improper weightlifting, defective postures and sleep disorders. The signs and symptoms of TOS are pain, tingling and numbness. Pain of TOS is to be differentiated from angina pain which worsens on walking or exertion in the latter whereas increases on raising the affected arm in the former. TOS most commonly affect the nerves however uncommonly it may affect veins and arteries. The arterial TOS is least common but most serious. Most of the cases of neurogenic TOS, which is the most common of the three, respond to physiotherapy and pain relieving medications, surgery may be required in a few cases. Cervical ribs can also cause symptoms by compression of subclavian artery causing ischaemia of the arms and brachial plexus causing neurogenic symptoms.4,5 Pain is the main symptom and treatment ranges from conservative to surgical resection depending on the severity and vascular symptoms like ischaemia.5,6Cervical ribs are reported to be associated with brachial plexus pathology in infants, studies are ongoing regarding the association of childhood cancer and cervical ribs. Bifid rib or sternum bifidum is a congenital abnormality of the anterior chest wall with the sternal end cleaved into two. It is frequently asymptomatic and like the cervical rib it is too an incidental finding on the chest skiagram however very rarely effect of this neuroskeletal anomaly can include respiratory and neurological difficulties. The estimated overall prevalence of bifid rib is 0.15% to 3.4% and it accounts for 20 percent of all congenital rib variations.12Since the rib has mesodermal origin, malformation in organs like heart and kidney may be associated congenital anomalies.13 Another association of this anomaly has been seen with jaw cyst and may become a part of Gorlin-Goltz NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 syndrome (nevoid basal cell carcinoma syndrome).13,14 Apart from these well known rib anomalies there can be presence of supernumerary ribs, short ribs, defect in bone density and abnormal rib shapes.15We observed cervical ribs, bifid ribs, fused rib, rib with spur and ribs with lesser intercostal space in between in our study of 5,000 subjects. The clinical significance of the rib anomalies lies in the fact that though they are uncommonly related with neurogenic or vascular implications but their association can’t be denied and if the patients presents to the clinician with symptoms as described above then one should look for these anomalies. Secondly this study gives an insight to the clinicians about the detection rate of rib anomalies and other very rare associations like that of bifid rib with the Gorlin-Goltz syndrome. Some other anomalies were also found which were probably seen for the first time and the previously reported literature doesn’t give much detail about them.The patients presenting to the clinicians with rib anomalies are from different backgrounds, there are many patients in which it is incidentally discovered, these patients have come to consult the clinician for something else, some patients come to the doctor specifically questioning for the rib anomalies, these are the candidates who should be appropriately counselled,reassured and can be advised to avoid sports injuries and defective postures which apart from cervical rib are other risk factors for TOS. CONCLUSIONS Few relevant conclusions were drawn from this study like the detection rate of cervical ribs unilateral as well as bilateral was higher in north Indian population(1.64%) than the previously reported data in available literature. Its possible explanation may be missing out of these incidental findings by the treating doctors who are rather more focused for their area of interest. Bifid rib detection rate (1.18%) co-related with the previously reported literature and was found mostly on the third and fourth ribs on the right side. No significant difference was observed in detection rate of cervical &bifid rib between studied male and female subjects. Rest of the congenital anomalies are extremely rare, none of the patients had any complaints in relation to the rib anomalies which suggests that the previous literature for association of cervical rib with thoracic outlet syndrome may be overreported so most of the times the patients who present to the doctor with the incidental rib anomalies may be simply reassured. No association of rib anomalies with other thoracic bony anomalies was observed except that both cervical rib and bilateral rib were found in 3 patients. Page 82 NATIONAL JOURNAL OF MEDICAL RESEARCH REFERENCES 1. Leffert RD. Thoracic outlet syndromes. Hand Clin. 1992; 8:285-297. 2. Michael P McKinley,Valerie Dean O'Loughlin. Human Anatomy,2nd ed . Newyork, US: McGraw-Hill; 2008. p 214. 3. 4. 5. 6. Galis F. Why do almost all mammals have seven cervical vertebrae?Developmental Constraints,Hox genes, and cancer.JExpZool. 1999; 285:19-26. Hooper TL, Denton J, McGalliard MK, Brismée JM, Sizer PS Jr. Thoracic outlet syndrome: A controversial clinical condition. Part 1: anatomy, and clinical examination/ diagnosis. J Man ManipTher. 2010; 18:74-83. Ravikumar BL, Jose V. Francisco Menezes. “Cervical RIBUpper Limb Ischaemia”. J. Evolution Med. Dent. Sci.2014; 3:1732-38. Cooke RA. Thoracic outlet syndrome-aspects of diagnosis in the differential diagnosis ofhand-arm vibration syndrome. Occup Med (Lond). 2003; 53:331-336. 7. Brewin J, Hill M, Ellis H. The prevalence of cervical rib in London population. Clin Anat.2009; 22:331-336. 8. Venkatesan V,Prabhu KP, Ram Kumar B, Joseph C Incidence of cervical rib in Chennai population World J. Med. Sci.2014; 10 : 250-253. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 9. Sharma DK, Vishnudutt, Sharma V, Rathore M. Prevalence of ‘Cervical Rib’ and its association with gender, body side, handedness and other thoracic bony anomalies in a population of central India. Indian Journal of Basic and Applied Medical Research. 2014; 3:593-597. 10. Gupta A, Gupta DP, Saxena DK, Gupta RP. Cervical Rib: It’s prevalence in Indian Population around Lucknow(UP). J. Anat. Soc. India .2012 ; 61: 189-191. 11. Keith L. Moore. The Developing Human-Clinically oriented Embryology,7thed.Philadelphia, US :Saunders; 2003. p393. 12. Charles I, Scott J. Pectoral girdle, spine, rib and pelvic girdle,1sted.New York,US :Oxford University Press; 1993. p655. 13. Song WC, Kim SH, Park DK, Koh KS. Bifid rib: Anatomical considerations in three cases. Yonsei Med J. 2009; 50:300-303. 14. Scheepers S,Andronikou S- Beware the bifid rib! SA Journal of Radiology. 2010;4:104. 15. Glass RB, Norton KI, Mitre SA, Kang E. Pediatric ribs: A spectrum of abnormalities.Radiographics. 2002;22:87-104. Page 83 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE STUDY OF CLINICAL PROFILE AND COMPLICATIONS OF DENGUE FEVER IN TERTIARY CARE HOSPITAL OF PUNE CITY Pradnya Mukund Diggikar1, Prasanna Kumar Satpathy1, Gaurav Dinesh Bachhav2, Kanishka Dinesh Jain2, Anuja Mukesh Patil2, Prafull Chajjed2 Author’s Affiliations: 1Professor; 2Resident, Dr. D. Y. Patil Medical College and Research Centre, Pune Correspondence: Dr Pradnya Mukund Diggikar Email: [email protected] ABSTRACT Background: Dengue is an important mosquito borne infection in terms of morbidity and mortality. In recent years it has become a major public health concern. The present study was conducted with an objective to study to the clinical profile, laboratory profile and presentations of dengue fever. Methodology: The study was conducted in Padmashree Dr.D.Y.Patil hospital and Research center, Pimpri, Pune from June 2011 to October 2013. A total number of 50 adult patients were included and their clinical and laboratory profile are noted. Results: The various symptoms associated were fever (100%), myalgia (80%), Arthralgia (46%), Retero orbital pain (26%), vomiting (22%), skin rashes (22%), headache (20%), bleeding tendancies (10%), Malena (12%), hematuria (6%), altered senses (2%). In this study, 92% (46 cases) recovered, whereas mortality was noted in remaining 8% (4 cases), the cause of mortality being MODS and ARDS. Conclusion: Fever was the most common symptom followed by myalgia, arthralgia, retero-orbital pain, vomiting, skin rashes, headache, malena, and hematuria. The most common age group affected was 21-30 years with male preponderance. Key words: Dengue fever, clinical profile, laboratory profile INTRODUCTION Dengue is an important mosquito borne infection in terms of morbidity and mortality. In recent years it has become a major public health concern. The dengue virus is a anthropod borne virus arbovirus, belonging to the family Flaviviridae and genus Flavivirus. It is a mosquito borne viral infection and is transmitted, primarily by Aedes aegypti and sometimes by Aedes albopictus.1 Dengue is caused by four distinct serotypes of viruses; DEN-1, DEN-2, DEN3 and DEN- 4.2 Dengue virus causes a spectrum of illness ranging from inapparent, self-limiting classical dengue fever (DF) to life threatening dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS).2 From being a sporadic illness, epidemics of dengue have become a common occurrence worldwide. Dengue fever and dengue hemorrhagic fever is endemic in areas of South East Asia i.e. Bangladesh, India, Indonesia, Maldives, Myanmar, Srilanka and Thailand. Dengue is a major cause of hospitalization and death, especially among children in these regions.3 NJMR│Volume 6│Issue 1│Jan – Mar 2016 India is endemic for DF and DHF. All the four serotypes are found in the country. Case fatality rates in endemic countries are 2.5%.3 During epidemics of dengue, attack rates among susceptible are 4090%.The incidence of dengue and global distribution of dengue have greatly increased in recent years.4 The present study was conducted with an objective to study to the clinical profile, laboratory profile and presentations of dengue fever. METHODOLOGY The study was conducted in Padmashree Dr.D.Y.Patil Hospital and Research Center, Pimpri, Pune from June 2011 to October 2013. A total number of 50 adult patients were included in this study. Adult male and female patients having the clinical manifestations of dengue fever as mentioned in the clinical case definitions of dengue with serological evidence in the form of dengue IgM or both IgM and IgG positive by MAC-ELISA, and/ or dengue Ns1 antigen were included in the study. Dengue positive patients less than 12 years of age were excluded. Page 84 NATIONAL JOURNAL OF MEDICAL RESEARCH Patients who were IgG positive but IgM negative; that is those who did not have recent evidence of dengue infection were excluded from the study. A written informed consent of each patient at the time of admission was obtained. Patients who were seropositive for dengue were classified on the basis of WHO criteria as follows: Dengue fever (DF), Dengue fever with unusual bleed (DFB)-bleeding tendencies not satisfying WHO criteria for DHF, Dengue Haemorrhagic fever (DHF)including patients with Fever, Haemorrhagic manifestations including a positive tourniquet test, Thrombocytopenia and Haemoconcentration and Dengue shock syndrome (DSS)-DHF along with evidence of peripheral circulatory failure. The patients were assessed for their demographic features (age/sex etc.) and clinical profile (various signs and symptoms). Patients of DHF and DSS were closely monitored for the progression of fever, blood pressure, level of consciousness, hydration, and bleeding tendency; and the complications occurring at any stage were studied. Hess’s capillary fragility test was performed in all the patients. The patients were subjected to usual laboratory tests like, Hb, TLC, DLC, Haematocrit, Platelet count, Liver function tests, Renal function tests, PT, Serum Proteins like serum albumin, urine routine and microscopy. Their ECG’s and CXR were also studied. Serological confirmation of dengue was done with the help of MAC-ELISA kit (PAN-BIO) which gave titres for dengue IgG and IgM. For the Ns1 antigen detection the commercial platelet Dengue Ns1 Ag EIA assay (Bio rad) kit was used. RESULTS Among the 50 cases, total of 12% cases were noted in the month of July, 36% cases were noted in the month of August and 30% in September respectively. It is clear that majority of the cases have occurred during the months of July, August and September i.e., in the monsoon and post- monsoon season. There were 37 males (74%) and 13 females (26%) were observed and the male:female ratio was found to be 2.84:1. From table 2 and graph 2, it is clear that majority of the cases having dengue infection belong to the age group of 21-30 years, wherein 38 % belong to 21-30 years age group and 30% belong to 3140 years age group and 28% belong to the age group of 11-20 years. It was seen that all the cases had fever (100%), myalgia (80%), arthralgia (46%) and retro-orbital pain (26%) (Table 2). The duration of fever varies from 29 days, where maximum cases (34%) presented with 5 days of fever. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 Table 1: Age wise distribution of dengue positive cases (n=50) Age group 11 – 20 yrs 21 – 30 yrs 31 – 40 yrs 41 – 50 yrs Male 11 13 12 1 Female 3 6 3 1 Total (%) 14 (28) 19 (38) 15 (30) 2 (4) Table 2: Symptom wise presentation of cases Symptoms Fever Myalgia Arthralgia Headache Retro orbital pain Vomiting Skin rashes Bleeding tendencies Abdominal pain Malena Hematuria Altered senses Frequency (%) 50 (100) 40 (80) 23 (46) 10 (20) 13 (26) 11 (22) 11 (22) 5 (10) 5 (10) 6 (12) 3 (6) 1 (2) Table 3: Platelet level among the dengue suspected cases Platelets range Less than 20000 20000 -40000 40000 – 60000 60000 – 80000 80000 – 100000 1 - 1.2 Lac 1.2 - 1.4 Lac Above 1.4 La Frequency (%) 2 (4) 5 (10) 14 (28) 12 (24) 6 (12) 5 (10) 2 (4) 4 (8) Table 4: Clinical Spectrum of Dengue cases Diagnosis Dengue Fever Dengue Shock Syndrome(DSS) Dengue Haemorrhagic Fever (DHF) DSS +AKI DSS+DIC+ARDS DSS+ARDS DSS+MODS P.Vivax + Dengue Fever No (%) 38 (76) 2 (4) 5 (10) 1 (2) 1 (2) 1 (2) 1 (2) 1 (2) It was found that 24% of cases had platelets in the range of 40-60 thousand and 4% of cases had severe thrombocytopenia (platelets <20,000) (Table 3). It is seen that 76% of the cases had Dengue fever, 12% cases had Dengue Dengue Sock Syndrome, 10% had Dengue haemorrhagic fever, 2% had dengue fever associated with plasmodium vivax malaria (table 4). Outcome of Dengue cases shows that improvement was observed in 92% of the cases and death was observed in 8% and the relation between them was not significant (p > 0.05). Page 85 NATIONAL JOURNAL OF MEDICAL RESEARCH Diagnostic evaluation shows that 74% of the cases were positive for Ns1 antigen testing method and 52% cases were positive for Dengue IGG and IGM antibodies and the relation between them was significant (p < 0.05). Temperature distribution shows that 36% cases had temperature of 1000 f, 28% of cases had temperature of 990f and 24% cases had temperature of 1010f. DISCUSSION The South East Asian regions have recorded increasing incidence of dengue and have contributed to the major portion of global disease burden. Dengue hemorrhagic fever and dengue shock syndrome are endemic to these regions and pose a severe threat to global health. The most common age group affected in this study was 21 – 30 years (21- 30 = 38%). This was comparable to the study of Sing NP5, where the mean age of the patients was 26 +/- 10 years. Similar study done by Joshi PT6, revealed that all age groups and both the genders were affected equally 33.3%. However other studies of Gore MM7 and Dash PK et al2 revealed a high number of cases in the pediatric age group. This indicates that the virus had been introduced to a non-exposed population and disease was not endemic. In this study the disease was more seen in case of males (74 %) than to the females (26 %). This was corresponding to the other studies by Dash PK et al2 and Neeraja M et al1. The reason for this may be due to more exposure of the males to the bite of vector Aedes aegypti, due to their clothing habits or outdoor activities. In this study, total of 92% (46 cases) recovered whereas mortality was observed in 8% (4 cases), in comparison with Agarwal A8, where mortality of 6% was observed. In the the study done by Singh N P5, a mortality of 2.7% was observed. This was corresponding to the study done by Neerja M et al1 where the patients with dengue infection manifested with DF (85%), DHF (5%) and DSS (10%). The study done by Pancharoen et al9 showed more number of DHF and DSS patients and less number of DF patients . The study done by Aggar- NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 wal et al8 showed 67% of cases of DHF and 33% of cases of DSS. CONCLUSION Fever was the most commonest symptom followed by myalgia, arthralgia, retero-orbital pain, vomiting, skin rashes, headache, malena, hematuria. The most common age group affected was 21-30 years with male preponderance. Maximum number of patients was observed to have Dengue fever, whereas the incidence of Dengue hemorrhagic fever and Dengue shock syndrome was comparatively less. REFERENCES 1. Neeraja M, Lakshmi V, Teja VD, Umabala P and Subbalakshmi MV.Serodiagnosis of dengue virus infection in patients presenting to a tertiary care hospital. Indian J Med Microbiol 2006; 24: 280-2. 2. Dash PK, Saxena P, Abhavankar A, Bhargava R and Jana AM. Emergence of dengue virus type 3 in Northern India. Southeast Asian J Trop Med Public Health 2005; 36: 370-77. 3. Park K. Epidemiology of Communicable Diseases. In: Park’s textbook of Preventive and Social Medicine. 19th ed. Jabalpur, India: M/s Bhanarsidas Bhanot; 2007: 206-9. 4. Chaturvedi UC, Shrivastava R. Dengue hemorrhagic fever: A global challenge. Indian J Med Microbiol 2004; 22 (1): 5-6. 5. Sing NP, Jhamb R, Agarwal SK, Gaiha M, Dewan R, Daga MK. The 2003 outbreak of dengue fever in Delhi, India. South east Asian J Trop Med Public Health 2005; 36 (5): 1174-78. 6. Joshi PT, Pandya AP and Anjan TK. Epidemiological and entomological investigation in dengue outbreak area of Ahmedabad district. J Commun Dis 2000; 32 (1): 22-27. 7. Gore MM. Need for constant monitoring of dengue infection. Indian J Med Res 2005; 121: 9-12. 8. Aggarwal A, Chandra J, Aneya S, Patwari AK and Dutta AK. An epidemic of dengue hemorrhagic fever and shock syndrome in children in Delhi. Indian Pediatr 1998; 35: 727-32. 9. Panchareon C and Thisyakora U. Neurological manifestations in dengue patients. Southeast Asian J Trop Med Public Health 2001; 32 (2): 341-45. Page 86 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE A STUDY OF VISUAL PROBLEMS IN CHILDREN SCORING LOW GRADES AND THOSE WITH LACK OF CONCENTRATION AT SCHOOL IN PUNE CITY Radhika Ramchandra Paranjpe1, Rupali Darpan Maheshgauri2, Shraddha Ramadhar Yadav3, Bhargav Jitendra Kotadia4, Nimrita Gyanchand Nagdev4, Kanisha Girish Jethwa4 Author’s Affiliations: 1Assistant Professor; 2Associate Professor; 3Intern; 4PG Student, Dept. of ophthalmology, Dr.D.Y.Patil Medical College, Pimpri, Pune Correspondence: Dr Radhika Ramchandra Paranjpe Email: [email protected] ABSTRACT Background: A good vision is important for a student to reach his/her full academic potential. Roughly 80 percent of what a child learns in school is information that is presented visually, hence good vision is essential. Methodology: The present study was a cross-sectional study conducted on 100 children within the age group of 5 to 10 completed years and scoring low grades at school exams. The study was conducted with the help of predesigned semi-structured questionnaire which was to be filled by parents. The selected students also undergone vision testing, Colour vision testing, refractive errors, Anterior and Posterior segment examination, squint evaluation by us. Results: Out of the 100 children, 35% children were without any eye problem whereas 65% children showed some kind of vision related problem. It was seen that 55% boys had vision problems compared to 45% in girls. The major visual problems are allergic conjunctivitis (15%), Myopia (22%), convergence weakness (22%), squint (4%) and hypermetropia (4%). Roughly 60% parents were aware about some vision problem in their child. Conclusion: Of 100 students with low performance in our study, 65% had treatable visual problems. The low performance can be attributed to the low vision but long term follow up is needed to see the improvement in scores and studies. Key words: visual problem, school children, low grades INTRODUTION A good vision is important for a student to reach his/her full academic potential. Roughly 80 percent of what a child learns in school is information that is presented visually, hence good vision is essential.1 Children may suffer from myopia, hypermetropia or astigmatism which are refractive errors. These can be corrected with eye glasses or contact lenses. Deficits of functional visual skills can cause blurred or double vision, eye strain and headaches that can affect learning.2 Convergence insufficiency is a specific type of functional vision problem that affects the ability of the two eyes to stay accurately and comfortably aligned during reading. Visual perception includes understanding what you see, identifying it, judging its importance and relating it to previously stored information in brain.3 Colour blindness can also cause problems if colour matching or identifying specific colours is required in classroom activities. For this reason, a colour blind examination should be done prior to starting school.4 NJMR│Volume 6│Issue 1│Jan – Mar 2016 The U.S. Individuals with Disabilities Education Act (IDEA) says learning disabilities do not include learning problems that are primarily due to visual, hearing or motor disabilities.5 Mental retardation and emotional disturbances are also excluded as learning disabilities, along with learning problems related environmental, cultural or economic disadvantage. But specific vision problems can contribute to a child’s learning problems, whether he has been diagnosed or not diagnosed as a “learning disabled”. In other words, a child struggling in school may have a specific learning disability,a learning related vision problem or both. 6 Early recognition and referral to qualified professionals for evidence based evaluations and treatments are necessary to achieve the best possible outcome. The present study was conducted with an objective to identify children with learning disabilities or those with poor grades in school by means of a questionnaire and subject them for eye examination and evaluate which ocular problems are predominant in that group. Page 87 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 MATERIALS AND METHODS DISCUSSION The present study was a cross-sectional study conducted on 100 children within the age group of 5 to 10 completed years. The study was conducted with the help of predesigned semi-structured questionnaire which was to be filled by parents. The students which were selected for the study were those who scored low grades at school exams. The selected students also had undergone vision testing, Colour vision testing, refractive errors (myopia, hypermetropia, and astigmatism), Anterior and Posterior segment examination, squint evaluation by us. Children with the known history of suffering from Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, Dyslexia and Learning disabilities were also included in the study. This was done to conclude whether poor performance was due to vision problems or other learning disability. Children above 10 years and less than 5 years of age, without valid consent and scoring high grades at school are excluded from the study. The study was conducted in June-July 2014. The Institutional ethics committee clearance was undertaken before beginning the study. During ophthalmic examination, 63 children gave vision on Snellens chart, 12 gave on Kay picture chart and the rest were not co-operative for vision. A total of 22 myopes were found of which 17 were using spectacles already but 6 of which were old glasses. Four children were given spectacle correction. A very high percentage of children suffering from allergic conjunctivitis were found in our study (15%) who was irritable and constantly rubbing their eyes which led to led to lack of concentration. They were treated with anti-allergic and lubricating eye drops. Four children suffering from squint were given spectacle correction and one was advised pencil push up exercise. Two children had hypermetropia which was corrected with glasses and occlusion therapy. However the improvement of performance in school needs to be followed up long term. Similar to7 other studies, the childs IQ score was not taken consideration in our study. Moreover since our study group consisted of normal school children, congenital ocular abnormalities, optic atrophy and nystagmus were not found. RESULTS CONCLUSION Out of the 500 questionnaire which was distributed in the school to be filled by parents and teachers, 130 children were evaluated as slow learners. Among these 130 students, 100 turned at the OPD of our hospital of ophthalmic examination. This indicates lack of awareness or interest in parents. The eye problem of the participants is as shown in table 1. Of 100 students with low performance in our study, 65% had treatable visual problems. The low performance can be attributed to the low vision but long term follow up is needed to see the improvement in scores and studies. Table 1: Proportion of students having visual problems (n=100) Eye problem Normal Allergic conjunctivitis Myopia Convergence weakness Squint Hypermetropia Number 35 15 22 22 4 2 Out of the 100 children, 35% children were without any eye problem whereas 65% children showed some kind of vision related problem. Selection of children for eye examination was based on the questionnaire. About 65% were selected on the basis of question filled by the parents and remaining 35% by the help of information provided by the questionnaire filled by teachers. It was seen that 55% boys had vision problems compared to 45% in girls. Roughly 60% parents were aware about some vision problem in their child. NJMR│Volume 6│Issue 1│Jan – Mar 2016 REFERENCES 1. Emerson E, Robertson J. Estimating prevalence of visual impairment among people with learning disabilities in the UK. University:Centre for Disability Research, 2011. 2. Emerson E, Hatton C. People with Learning Disabilities in England.CeDR Research 2008. 3. Joint Committee on Human Rights. A life like any other? the Human rights of adults with learning disabilities,2008. 4. Sellar W. Who should care for people with learning disabilities.BMJ 2000;321:1297. 5. Emerson E,hatton C.Estimating the current need/demand for support for people with learning disabilities in England.Lancaster,2004. 6. Rourke,B.P.”Neuropsychological Assessment of Children with Learning Disabilities:Measurement Issues.” 7. Gogate P, Soneji FR, Kharat J, Dulera H, Deshpande M, Gilbert C, Gogate P, Soneji FR, Kharat J, Dulera H, Deshpande M, Gilbert C. Ocular disorders in children with learning disabilities in special education schools of Pune, India. Indian J Ophthalmol 2011;59:223-8. Page 88 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE A STUDY ON COMPARISON OF INTRAVENOUS BUTORPHANOL WITH INTRAVENOUS FENTANYL FOR PREMEDICATION IN GENERAL ANESTHESIA Hemangini M Patel1, Bansari N Kantharia2 Author’s Affiliations: 1Associate Professor; 2Additional Professor, Dept. of Anesthesia, Government Medical College, Surat, Gujarat Correspondence: Dr Hemangini M Patel Email: [email protected] ABSTRACT Background: An ideal premedicant drug is anxiolytic, sedative, amnesic, reduces salivary and respiratory tract secretions, analgesic as well as residual post-operative analgesia. The present study was undertaken to compare the effects of intravenous butorphanol and intravenous fentanyl as a premedicant drug in general anesthesia. Methodology: A comparative study between butorphanol and fentanyl was conducted in 100 patients of either sex at Government Medical College, Surat who belong to ASA physical status I or II, in the age group of 18-65 years. Post-operatively respiratory rate, tidal volume, sedation score, oxygen saturation and assessment of pain score was done in the recovery room. Results: When comparing both the groups the patients in the butorphanol group were found to be more sedated upto 60 minutes postoperatively. The difference between the two was statistically significant (p<0.001). In group F, 82% patients had analgesia for 60-120 minutes while remaining 18% of patients had analgesia for 121-180 minutes. In group F, 44% patients had analgesia for 121-180 minutes while 56% of patients had analgesia for 181-240 minutes. In group F, 82% patients had pain (VAS ≥5) by 30 minutes in the postoperative period whereas none of the patients in Group B had significant pain (VAS ≥5) by 30 minutes. Conclusion: We conclude that Butorphanol 20 µg/kg gives better attenuation of the hemodynamic response, longer duration of postoperative pain relief, without producing excessive sedation and with negligible side effects in comparison with fentanyl 1 µg/kg when given intravenously as premedicant for general anesthesia. Key words: Premedicant, fentanyl, butorphanol, general anesthesia INTRODUCTION Premedication refers to the administration of drugs before induction and maintenance of anesthesia.1 An ideal premedicant drug is anxiolytic, sedative, amnesic, reduces salivary and respiratory tract secretions, analgesic as well as residual post-operative analgesia.2 Although morphine like alkaloids had been used for analgesia and sedation for centuries, the problem with these drugs were respiratory depression, addition, nausea and vomiting.3 These side-effects were overcome by the introduction of mixed agonistantagonist opioid analgesics like butorphanol. Butorphanol is a morphinan chemically related to analgesic levorphanol. It is considered to be safer than pure agonist opioids because of their ceiling effect for respiratory depression and their lower addiction potential. Butorphanol also produces significantly lesser gastrointestinal effects like nausea and vomiting than morphine. Moreover, it produces neither pruritis nor urinary retention. NJMR│Volume 6│Issue 1│Jan – Mar 2016 The present study was undertaken to compare the effects of intravenous butorphanol and intravenous fentanyl as a premedicant drug in general anesthesia. The hemodynamic response to laryngoscopy and intubation, the effects on respiration as well as postoperative sedation and analgesia were evaluated. METHODOLOGY A comparative study between butorphanol and fentanyl was conducted in 100 patients of either sex at Government Medical College, Surat. All the patients belonged to ASA physical status I or II, in the age group of 18-65 years. Informed consent was obtained from all the subjects. Patients with liver, renal or hematological disease, females of childbearing age, and patients with a history of tolerance of or dependence on narcotic drugs and those judged to be mentally of limited competence, with poor physical sta- Page 89 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 tus, neurosurgery and cardiac surgery were excluded from the study. On the day before operation, preoperative assessment was carried out. A complete systemic examination was carried out, to rule out any major systemic dysfunction. All the patients were premedicated with Inj.Glycopyrrolate 0.2 mg intramuscularly half an hour before induction of anesthesia. In the preoperative holding area vital signs and tidal volume were noted. All the patients were familiarized with the visual analogue scale. Patients were randomly divided into two groups of 50 patients each. Two minutes before induction of anesthesia, patients received the study drug. In Group B: Inj.Butorphanol 20 ug/kg intravenously In Group F: Inj.Fentanyl 1 ug/kg intravenously Induction of anesthesia was done with Inj.Thiopentone sodium 4-7mg/kg intravenously upto to the loss of eyelid reflex followed by tracheal intubation facilitated with Inj.Succinylcholine 2mg/kg i.v. Anesthesia was maintained with 60% nitrous oxide in oxygen, isoflurane and Inj.Vecuronium bromide. At the end of the procedure, residual neu- romuscular blockade was reversed with Inj. Neostigmine 0.05 mg/kg intravenously and Inj. Glycopyrrolate 0.008 mg/kg intravenously. Intra-operatively, pulse rate, oxygen saturation via pulse oximetry, systolic and diastolic blood pressure were monitored continuously. Post-operatively respiratory rate, tidal volume, sedation score, oxygen saturation and assessment of pain score was done in the recovery room. Presence of any adverse effects was noted following direct questioning of the patients in the recovery room. Sedation was assessed on the basis of Ramsay scale of sedation score and pain was assessed on the basis of visual analogue scale. All the patients were interviewed 24 hours after the operation in the ward to get the information regarding their experiences of post-operative pain and adverse effects if any. RESULTS In the fentanyl group, the mean age was 31.48±13.12 years and in Butorphanol group, the mean age was 25.56±7.78. Other parameters are as depicted in Table 1. Table 1: Physical parameters of the study groups Parameters Age (yrs) Weight (Kg) Male Female Duration of Surgery (min) Duration of anesthesia (min) Group F 31.48±13.12 48.8±8.54 22 (44) 28 (56) 73.4±24.92 88.4±23.89 Group B 25.56±7.78 51.1±11.1 22 (44) 28 (56) 86.11±37.98 99.44±40.42 P value >0.05 >0.05 Table 2: Postoperative sedation score Parameters Baseline 2 min after premedication Postoperative 0 min 30 min 45 min 60 min 90 min 120 min 180 min Group F 1.98 ±0.14 2.00 ±0 Group B 1.96 ±0.19 2.00 ±0 P value >0.05 >0.05 2.12 ±0.59 1.94 ±0.55 2.04 ±0.19 2.00 ±0 2.00 ±0 1.98 ±0.14 2.00 ±0 2.90 ±0.30 2.72 ±0.45 2.26 ±0.53 2.04 ±0.34 1.98 ±0.32 2.00 ±0 2.00 ±0 <0.05 <0.001 <0.001 <0.05 >0.05 >0.05 >0.05 The mean pulse rate before the administration of premedication was 89.54 15.2 in Group F and 91.98 13.91 in Group B. The difference between the groups was statistically insignificant. (p>0.05) On comparing the two groups, the rise in pulse rate was more in the fentanyl group compared to the butorphanol group. The difference between the two groups was statistically significant for upto 5 minutes NJMR│Volume 6│Issue 1│Jan – Mar 2016 after intubation (p<0.01). Thereafter it was insignificant upto 30 minutes (p>0.05). In postoperative period also, the increase in the mean pulse rate in fentanyl group was highly significant compared to butorphanol group (p<0.001). The mean respiratory rate before the administration of premedication of drug was 17.92±1.51 in Group Page 90 NATIONAL JOURNAL OF MEDICAL RESEARCH F and 18.00±2.21 in group B, which was statistically comparable (p>0.05). Postoperatively, there was insignificant difference between mean respiratory rate between the two groups for various time intervals for 3 hours. (p>0.05) The mean tidal volume before the administration of premedication was 472±59.0 ml in group F and 451±62.2 ml in group B, which was statistically comparable (p>0.05). In the postoperative period, no statistically significant difference was observed between the two groups at various intervals of time (p>0.05) When comparing both the groups the patients in the butorphanol group were found to be more sedated upto 60 minutes postoperatively. The difference between the two was statistically significant (p<0.001). Thereafter the difference was insignificant upto 3 hours postoperatively. Table 3: Assessment of total postoperative pain by visual analogue scale Time 0 15 30 45 60 90 120 180 >180 Group F (%) 9 (18) 19 (38) 13 (26) 5 (10) 3 (6) 1 (2) - Group B (%) 4 (8) 7 (14) 10 (20) 9 (18) 12 (24) 8 (16) In group F, 82% patients had analgesia for 60-120 minutes while remaining 18% of patients had analgesia for 121-180 minutes. In group F, 44% patients had analgesia for 121-180 minutes while 56% of patients had analgesia for 181-240 minutes. In group F, 82% patients had pain (VAS ≥5) by 30 minutes in the postoperative period whereas none of the patients in Group B had significant pain (VAS ≥5) by 30 minutes (Table ). print ISSN: 2249 4995│eISSN: 2277 8810 minutes and in Group B it was 208±29.57 minutes. The total requirement analgesia in the postoperative period did not differ much in both the groups. Beverly K Phillip4 compared butorphanol 20 µg/kg and fentanyl 1µ g/kg in general anesthesia. They noted 90% postoperative pain in Group B and 93% in Group F. The requirements for additional analgesia in the postoperative period were also not different. In the study conducted by Hammad Usmani5, significant postoperative pain in the recovery room was experienced by 12 (40%) patients receiving fentanyl and in only 5 (17%) patients in butorphanol group (p<0.05). In our study, there was statistically significant difference (p<0.001) in the sedation score in butorphanol group upto 45 minutes postoperatively. More patients in the butorphanol group had sedation score ≥2 than in the fentanyl group. Our findings correlate with Beverly K Philip4 who noted more sedation in butorphanol group than fentanyl for 45 minute in the recovery room as well as long time for return to baseline levels of sedation at 60 minutes. Hammad Usmani5 noted excessive drowsiness in 7 patients who received 40 µg/kg butorphanol and in 5 patients in fentanyl group, who received 2 µg/kg of fentanyl, one hour after admission to the recovery room. CONCLUSION We conclude that Butorphanol 20 µg/kg gives better attenuation of the hemodynamic response, longer duration of postoperative pain relief, without producing excessive sedation and with negligible side effects in comparison with fentanyl 1 µg/kg when given intravenously as premedicant for general anesthesia REFERENCES 1. Tripathi KD. Essential of Medical pharmacology, 3rd ed; 7. 2. Paul Arun Kumar. Drugs and equipments in anesthetic practice, 3rd edition; 3. For postoperative analgesia, injection diclofenac sodium 1.5 mg/kg intramuscularly was given when pain score ≥ 5. 24 hours post-operative analgesia consumption was similar I both groups (p>0.05) 3. Atkinson RS, Rushman GB and Davies NJH. Lee’s synopsis of Anesthesia, 11th ed;86. DISCUSSION 5. Usmani Hammad, Quadir A, Jamil SN. Comparison of butorphanol and fentanyl for balanced anesthesia in patients undergoing laproscopic cholecystectomy. J Anesthesia Clin. Pharmacol. 2004: 20 (3):251-254. The difference in the total duration of analgesia was statistically significant in Group F it was 108±22.15 NJMR│Volume 6│Issue 1│Jan – Mar 2016 4. Philip Beverly K, Scott David A, Freiberger Dubraka et al. Butorphanol compared with fentanyl in general anesthesia for ambulatory laproscopy. Can J Anesthesia.1991, 38:2;1836. Page 91 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE COMPARISON OF HAEMODYNAMIC FLUCTUATION OF INTRAVENOUS KETAMINE WITH INTRAVENOUS PROPOFOL – FENTANYL COMBINATION IN SHORT SURGICAL PROCEDURE Madhavi S Mavani, Sudevi Desai Author’s Affiliations: Assistant Professor, Department of Anaesthesia, GCS Medical College, Ahmedabad Correspondence: Dr Madhavi S Mavani E-mail: [email protected] ABSTRACT Background: An increasing interest in intravenous anesthetic agent has resulted from the availability of more effective intravenous agents. Objectives: Comparison of intravenous Ketamine with combination of intravenous Propofol and Fentanyl in ASA Gr. 1 patients of middle age in minor surgical procedures, To compare the haemodynamic fluctuation of intravenous Ketamine with intravenous propofol – fentanyl combination in short surgical procedure and to compare recovery and side-effective in postoperative period of intravenous Ketamine with intravenous propofol- Fentanyl combination in short surgical procedures. Methodology: This observational study includes 20 patients of ASA Grade I of either sex, especially those who were coming for minor surgery. Patients divided in group A: Patients were preoxygenated with 100% oxygen. Induction was done with injection Ketamine 2 mg/kg intravenous. O 2 was given throughout surgery and group B: Patients were preoxygenated with 100% oxygen. Induction was done with inj. Fentanyl citrate I µg/kg over 1 minute followed after 3 minute by propofol 2.5 mg/kg O 2 was given throughout surgery. Results: Highest patients belong to 21-30 years age group. Female were higher in both the group that male. Most of (18) patients belongs to 51 to 40 kg group. Falling in blood pressure and pulse was more in Group B than Group A patients. Post-operative side effects more seen Group A than Group B patients. Conclusion: Inspite of more side effects and more change in hemodynamics parameters in Propofol-fentanyl group than Ketamine group, Both Ketamine and Propofol–fentanyl combinations produce rapid, pleasant and safe anesthesia with only a few untoward side effects and only minor hemodynamic effects. Key word: Ketamine, Propofol, Fentany, Minor Surgical Procedures, Haemodynamic Fluctuation INTRODUCTION An increasing interest in intravenous anaesthtic agent has resulted from the availability of more effective intravenous agents. Ketamine1-5 has intrinsic analgesic and amnestic properties, protects airway reflexes, and can be administered by multiple routes of administration. However, it has the potential for undersirable side effects that include unpleasant emergence sequelae, hallucinations and emesis6 Ketamine is alos relatively contraindicated in patients with hypertension, inceased intracranial pressure, respiratory tract infection, or underlying neurosychiatric condition such as sezures or psychoses.7 Propofol is an intravenous (IV) sedative-hypnotic agent with amnesic properties that causes loss of consciousness reliably and rapidly. It is structurally unrelated to other hypnotics such as barbiturates and benzodiazepines and represent a new class of sedative hypnotics called diisopropyphenol. It has been shown to have a synergistic hypnotic effect when NJMR│Volume 6│Issue 1│Jan – Mar 2016 used in conjunction with other classes of analgesic/ sedative agents as barbiturates, benzodiazepines, opioids, and Ketamine8-10. So this study was conducted with the objectives of to comparison of intravenous Ketamine with combination of intravenous Propofol and Fentanyl in Americal Society of Anesthesiologist (ASA) Gr. 1 patients of middle age in minor surgical procedures, To compare the haemodynamic fluctuation of intravenous Ketamine with intravenous propofol – fentany combination in short surgical procedure, To compare recovery and sideeffective in postoperative period of intravenous Ketamine with intravenous preopofol- fentranyl combination in short surgical procedures. METHODOLOGY The study includes 20 patients of ASA Grade I of either sex, especially those coming for minor surgery. Selection of Patients: Patients scheduled for minor surgical procedures were selected. Exclusion Criteria: Page 92 NATIONAL JOURNAL OF MEDICAL RESEARCH Patients below 20 years of age, pregnant women, lactating mothers, patients with a history of epilepsy or any convulsive disorder, psychosis, hypertension, major cardiac problems, those with a known allergy to these drugs. Pre-anesthetic Check Up: A pre-anesthetic check up was done including detailed history and physical examination, Baseline measurements of pulse, systolic and diastolic blood pressure, respiratory rate and body weight, routine investigations. The proposed anesthetic technique and induction procedure were explained to the patient. After obtaining their consent they were advised overnight fasting as with routine anesthesia. Premedication: Patients divided in Group A and Group B. In Group A: Patients were preoxygenated with 100% oxygen. Induction was done with injection Ketamine 2 mg/kg intravenous. O 2 was given throughout surgery. In Group B: Patients were preoxygenated with 100% oxygen. Induction was done with inj. Fentanyl citrate I µg/kg over 1 minute followed after 3 minute by propofol 2.5 mg/kg O 2 was given throughout surgery. Injection glycopyrrolate 0.2 mg i.v. and injection Midazolam 1 mg i.v was given to all patients in group A and B 5 minutes before induction of anaesthesia. Injection xylocard 2% 2 CC.I. given 1 minute before inj. Propofol to reduce pain during propofol injection. Induction: Patients to be operated were reexamined for pulse, blood pressure find and consent checked prior to commencement of anaesthesia I.V line was secured. Findings were duly recorded in Performa. ECG monitor and pulse oximetry were attached. Maintenance of Anaesthesia: Pulse rate, blood pressure and respiratory rate were recorded every five minutes throughout the operative procedures. Other parameter noted were involuntary movements, hypertonicity, lacrimation, salivatin, nausea and vomiting. At the end of operation, duration of surgery, duration of anaesthesia and type of supplementation needed was noted in proforma. Postoperatively: Upto 12 hours level of consciousness and vital signs were monitored. Incidence of nausea, vomiting, delirium and presence of hypertonic reflexes were observed and tabulated. 12 hours follow up was done for any memory of preoperative, intra operative and immediate postoperative events, incidence of nausea, vomiting. Dizziness, blurred vision and irrational behavior were noted. RESULTS Highest patients belong to 21-30 years age group (table 1). Female were higher in both the group that male and higher patients belongs to 51 to 40 kg group. Group A have comparatively more significant NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 change that group B regarding pulse and blood pressure. In Group A, Abut 60% patients showed rise in pulse rate upto 10/min while 40% showed rise in pulse rate of more than 10/min and in group B, 10% patients had a rise in pulse rate upto 10/min while 90% patients has a fall in pulse rate upto 10/min. 20% patients had a rise in B.P. upto 10 mm Hg. In group B, 10% patients had a significant (<0.05) rise in pulse rate upto 10/min while 90% patients has a fall in pulse rate upto 10/min. Almost 20% patients had a significant (<0.05) rise in B.P. upto 10 mm Hg while 80% had a fall in B.P. upto 10 mmHg. Table 1: Socio-demographic characteristics and clinical parameters of Participants (N= 40) Variable Group A Group B P value* Age 21-30 years 9 8 0.68 31-40 years 6 4 45-50 years 5 7 Gender Male 9 7 0.74** Female 11 13 Weight (kg) 31-40 3 2 0.78 41-50 9 8 51-60 8 10 Type of surgery STG 8 9 0.85 Dressing 5 3 Incision and Drainage 5 5 Dilation and Evacuation 2 3 Duration of Surgical Intervention (minutes) Up to 10 6 4 0.7 10 to 20 8 8 20 to 30 6 8 Total Dose (mg) 100-150 9 2 0.0001 150-200 11 4 200-250 0 7 250-300 0 7 Post- operative change in Pulse (per minute) Rise (0-10) 12 2 0.0001 Rise (>10) 8 2 Fall (0-10) 0 18 Post- operative change in Pulse (mmhg) Rise (0-10) 7 4 0.0001 Rise (>10) 13 0 Fall (0-10) 0 16 Incidence of post-operative side effects Salivation 4 0 0.34 Nausea 4 2 Delirium 2 0 Hyper-tonicity 1 0 Hallucination 5 0 Group A -Ketamine Group) & Group B-Propofol Fentanyl) * Chi-square test ** Fisher’s Exact test Page 93 NATIONAL JOURNAL OF MEDICAL RESEARCH Post-operative side effects were more in group A than group B but change was non-significant. Propofol – Fentanyl combination is more suitable in minor surgical procedures because of Stable hemodynamics, Less post operative nausea and vomiting, Rapid recovery, Less postoperative psychomotor disturbances. DISCUSSION & CONCLUSION The present study compares the effect of i.v. Ketamine with i.v. Propofol –F Fentanyl combination for minor surgincal procedure. A total of 40 patients were divided in 2 groups of 20 patients each with group A receiving inj. Ketamine and grop B receiving Inj. Propofol – Fentanyl combination. The advantages of a Propofol - Fentanyl combination are :i) Rapid onset of action. ii) Short duration of action. iii) Easily controllable. iv) No significant accumulation. Effect on blood pressure & Pulse : Study was found that after i.v. Ketamine, there was an increase in pulse rate and blood pressure. This findings are consistent with the findings of study fone by Suri YV (1982)9 & Virtue Alanis (1967)10 which was found that the effect of Ketamine infusion increase the pulse rate, blood pressure. Study was found that after i.v. Propofol , there was an decrease in pulse rate and blood pressure. This finding are consistent with study done by Thomas JE et.al. 199211 who had also observed larger decline in blood pressure (almost 8 mmhg in systolic and 4 mmhg in diastolic blood pressure). Similar findings had also observed by Sukhminder JSB et.al 201012, Mayor M et.al 199013, Mi WD et.al. 199814, Billard V. et.al. 199415. Side effects : Group A had much more incidence of side effects compared to group B. In group A 20% patients had increased salivation, 20% patients had nausea, 5% patients had hypertonicity, 10% patients had delirium and 25% patients had hallucinations. This finding are almost consistent with study done by Ghabash M. et.al. 199616. Inspite of more side effect and more change in hemodynamics parameters in Propofol-fentanyl group than Ketamine group, Both Ketamine and Propofol–fentanyl combinations produce rapid, pleasant and safe anesthesia with only a few untoward side effects and only minor hemodynamic effects. REFERENCES 1. Adams H.A. Ketamine. Circulatory interaction during total intravenous anaesthesia and anaigesia sedation Anasthetis 1997 Dec. 46(12) : 108-7. NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 2. Cohen, Dale MD et, at. Modulating effects of propofol on metabolic and cardiopulmonary response to stressful intensive care unit procedures. Critical care medicine 24 : 612617 April 1996. 3. Crozier TA, et al, The effect of total intravenous anaesthesia with Ketamine / propofol on hemodynamic endocrine and metabolic stress reaction in comparison with alfentanil / propofol in laparotomy. Anaesthetis 1996 Nov 45(11) : 1015-23. 4. Kato H. et at, The effect of propofol on left ventricular systolic and diastolic function during induction of anaesthesia – a thoracic echocardiographic study Masui : 2004 Jul 53(7) : 761-6. 5. L.D. Sanders et at, propofol in short gyndecological procedures. Anaesthesia 1991 volume 46, page 451-455. 6. Mayer M, The effect of propofol – Ketamine anaesthesia on hemodynamics and analgesia in comparison with propofol fentanyl, Anaesthesist 1990 Dec 39(12): 609-16. 7. Paul S. Myles et al, Serum lipid and glucose concentrations with a propofol infusion for cardiac surgery, Journal for cardiothoracic, and vascular Anaesthesia Vol. 9 No. 4 (Aug) 1995; pp 373-378. 8. Romano R et at Effect of propofol on human heart electrical system: a transesophageal pacing electrophysiologic study. P Acta Anaesthesiol Scan. 1994 Jan, 38(I) : 30-2. 9. Suri Y V et al, Anaesthestic technique of Ketamine infusion : clinical and biochemical evaluation J. Postgrad. Med 198228 184-93. 10. Virtue RW, Alanis JM, Mori M, La-Fargue RT, Vosel JH, Metcalf DR. "An Anaesthetic Agent: 2-(0-chloropyhenyl)-2(methylamino) cyclohexanone Hcl (CI581) Anesthesiology. 1967;28:823–823. 11. Thomas JE, Judith E, Hall MA. The effects of increasing plasma concentration of dexedetomidine in humans. Anesthesiology. 2009;93:382. 12. Sukhminder JSB, Sukhwinder KB, Jasbir K. Comparison of two drug combinations in total intravenous anesthesia: Propofol–ketamine and propofol–fentanyl. Saudi J Anaesth. 2010; 4(2): 72-79. 13. Mayer M, Ochmann O, Doenicke A, Angster R, Suttmann H. The effect of propofol-ketamine anesthesia on hemodynamics and analgesia in comparison with propofol-fentanyl. Anaesthesist. 1990;39:609–16. [PubMed] 14. Mi WD, Sakai T, Takahashi S, Matsuki A. Haemodynamic and electroencephalograph responses to intubation during induction with propofol or propofol/fentanyl. Can J Anaesth. 1998;45:19–22. [PubMed] 15. Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation: Propofol/fentanyl interaction. Anesthesiology. 1994; 81: 1384-93. [PubMed] 16. Ghabash M, Matta M, Kehhaleh J. Depression of excitatory effects of propofol induction by fentanyl. Middle East J Anesthesiol. 1996;13:419–25. [PubMed] Page 94 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 ORIGINAL ARTICLE TRENDS OF NOSOCOMIAL INFECTIONS IN A PRIVATE HOSPITAL OF SURAT, GUJARAT Latika N Purohit1, Prashant V Kariya2 Author’s Affiliations: 1Assistant Professor, Dept. of Microbiology; 2Assistant Professor, Dept. of Pediatric, Government Medical College, Surat, Gujarat Correspondence: Dr Latika N. Purohit Email: [email protected] ABSTRACT Background: Nosocomial infection or hospital acquired infection refers to the infection occurring in patients after admission at the hospital that was neither present nor incubating at the time of admission. Infection occurring more than 48 hours after admission is usually considered nosocomial. These nosocomial infections (NI) occur among 7-12% of the hospitalized patients globally with more than 1.4 million people suffering from the infectious complications acquired in the hospital. Methodology: The current study was done in a multi speciality hospital of Surat, Gujarat. This hospital is having Surgery, Obs & Gynec, Medicine, Orthopedic speciality under one roof. All patients admitted in the hospital from January 2015 to June 2015 were analysed for Nosocomial Infections. CDC (Centre for disease control & prevention) guidelines were used to identify nosocomial infections. Total 125 patients were enrolled in the study. Result: In our study, total 125 patients were diagnosed as having nosocomial infections in two years. Out of these, 58 (46.4%) were female and 67 (53.6%) were male. Thus, male predominance was observed. We observed that Urinary tract infection (UTI) was the most common Nosocomial infection. Out of total 125 patients, 48 (38.4%) were having UTI. Surgical site infection (SSI) was the second most common culprit. SSI was observed in 32 (25.6%) patients. It was followed by sepsis (20%). It was observed that E.Coli was the most common micro-organism isolated from UTI and SSI patients. Whereas, Staph. Aureus and Klebsiella were the most common micro-organism isolated from patients of Sepsis and LRTI respectively. In patients of UTI and SSI, Psedomonas and Klebsiella were other common organisms isolated. From many samples, more than 1 micro-organism was isolated. Key words: Nosocomial Infection, Surgical site infection, Urinary tract infection INTRODUCTION Nosocomial infection or hospital acquired infection refers to the infection occurring in patients after admission at the hospital that was neither present nor incubating at the time of admission. Infection occurring more than 48 hours after admission is usually considered nosocomial. It is one of the public health problems throughout the world. The infection causes the patient’s physical and mental sickness that makes the patient stay longer in the hospital without necessity.1 Studies throughout the world document that nosocomial infections are a major cause of morbidity and mortality. A high frequency of nosocomial infections is evidence of a poor quality of health service delivery, and leads to avoidable costs. Many factors contribute to the frequency of nosocomial infections hospitalized patients are often immunoNJMR│Volume 6│Issue 1│Jan – Mar 2016 compromised, they undergo invasive examinations and treatments, and patient care practices and the hospital environment may facilitate the transmission of microorganisms among patients. The selective pressure of intense antibiotic use promotes antibiotic resistance. While progress in the prevention of nosocomial infections has been made, changes in medical practice continually present new opportunities for development of infection. Infections acquired in the hospital account for major causes of death, morbidity, functional disability, emotional suffering and economic burden among the hospitalized patients. These nosocomial infections (NI) occur among 7-12% of the hospitalized patients globally with more than 1.4 million people suffering from the infectious complications acquired in the hospital.2 The most frequent nosocomial infections are infections of surgical wound, urinary tract infections and lower respiratory tract infections.3 Surgical Page 95 NATIONAL JOURNAL OF MEDICAL RESEARCH site infections (SSI) are the third most commonly reported nosocomial infection and they account for approximately a quarter of all nosocomial infections.4 Surgical site infections are the most common nosocomial infections in surgical patients- accounting for about 24% of the total number of nosocomial infections. 4,5,6 It’s rate has varied from a low of 2.5% to high of 41.9%.7 The present study was done with objective of documenting rate of Nosocomial infections and identifying common micro-organisms associated with it in specified population. METHODOLOGY The current study was done in a multi speciality hospital of Surat, Gujarat. This hospital is having Surgery, Obs & Gynec, Medicine, Orthopedic speciality under one roof. All patients admitted in the hospital from January 2015 to June 2015 were analysed for Nosocomial Infections. CDC (Centre for disease control & prevention) guidelines were used to identify nosocomial infections.8 Permission was obtained from hospital administration. Written informed consent was taken from patients after explaining the study. All patients admitted in hospital for more than 7 days were checked for possible Nosocomial infection. Clinical and demographic information of each patient was noted . Clinical specimens like urine, pus, blood, sputum, pleural fluid, other fluids & tips of invasive devices were processed in microbiology laboratory. Identification of clinical isolates & their antimicrobial profile was performed by standard microbiological methods.9 print ISSN: 2249 4995│eISSN: 2277 8810 Total 145 patients were identified as having Nosocomial Infections. Out of these, 20 were not ready to give informed written consent and those patients were excluded from the study. Thus, 125 patients were enrolled in the study. RESULTS In our study, total 125 patients were diagnosed as having nosocomial infections in two years. Out of these, 58 (46.4%) were female and 67 (53.6%) were male. Thus, male predominance was observed. Most of the patients were from the age group of 30 to 40 years. Table 1: Distribution of patients according to type of Nosocomial Infections (N=125) Type of Infection Urinary tract Infection (UTI) Surgical site infection (SSI) Sepsis Lower respiratory track infection (LRTI) Liver Abscess Other Cases (%) 48 (38.4) 32 (25.6) 25 (20.0) 9 (7.2) 4 (3.2) 7 (5.6) Table 1 shows distribution patients according to type of Nosocomial infections. We observed that Urinary tract infection (UTI) was the most common Nosocomial infection. Out of total 125 patients, 48 (38.4%) were having UTI. Surgical site infection (SSI) was the second most common culprit. SSI was observed in 32 (25.6%) patients. It was followed by sepsis (20%). Thus, UTI, SSI and sepsis together constitute 84% of Nosocomial infection. Apart from these, Lower respiratory track infection (LRTI), Liver abscess etc. were also having share in Nosocomial infection. Table 2: Distribution of micro-organism according to identified site Microorganism E.Coli Acinetobacter Psedomonas Klebsiella Proteus Staph. Aureus Candida Other More than 1 UTI 46.2% 6.2% 20.2% 16.8% 4.5% 2.1% 6.4% 3.0% 15.4% SSI 22.4% 15.8% 20.5% 17.2% 7.5% 18.5% 7.2% 2.5% 12.4% Table 2 shows distribution of micro-organism according to identified site. It was observed that E.Coli was the most common micro-organism isolated from UTI and SSI patients. Whereas, Staph. Aureus and Klebsiella were the most common micro-organism isolated from patients of Sepsis and LRTI respectively. In patients of UTI and SSI, Psedomonas and NJMR│Volume 6│Issue 1│Jan – Mar 2016 Sepsis 10.2% 12.1% 0 11.4% 0 36.4% 12.3% 15.2% 18.2% LRTI 14.8% 10.0% 20.0% 25.5% 0 0 12.4% 7.2% 14.7% Liver Abscess 35.2% 0 6.8% 52.4% 0 3.1% 2.8% 3.5% 10.8% Klebsiella were other common organisms isolated. From many samples, more than 1 micro-organism was isolated. From liver abscess, most common organism isolated was Klebsiella (52.4%). E.coli was also isolated from 35.2% of patients of Liver Abscess. Page 96 NATIONAL JOURNAL OF MEDICAL RESEARCH DISCUSSION Nosocomial infection is emerging as a new threat to public health. This depends on severity of illness, length of hospital stay, therapeutic procedure, irrational use of antimicrobial agents etc. We found that among nosocomial infections, UTI, SSI, Sepsis and LRTI are most common. In a similar study done by Mukherjee et al, urinary infection (45%) was the most common infection followed by pulmonary infections (30%), blood stream infections (16%) & skin infections (3.75%). 10 Our SSI rate was favorably compared with SSI rate of Shrivastava et al (10.19%), shaw et al (16.9%) and desa LA et al (18.92%). 11, 12, 13 Predominance of skin & surgical site infection in our study could be due to the reason that majority of patients were from surgical ward & were using invasive devices. Another study by Rosineide et al reported, skin & surgical site infection (56%) as the most frequent infection and most of the patients were from surgical wards. 14 print ISSN: 2249 4995│eISSN: 2277 8810 this phenomenon can be extensive & indiscriminate use of antibiotics.15 CONCLUSION It was concluded from this study that Urinary tract infections and Surgical Site Infections were the most common Nosocomial infections. E.Coli, Pseudomonas and Klebsiella were the mast common microorganisms isolated from the specimens. REFERENCES 1. Luksamijarulkul P, Parikumsil N, Poomsuwan V, et al. Nosocomial Surgical Site Infection among Photharam. J Med Assoc Thai 2006; 89 (1): 81-9. 2. Kamat US, Ferreira V, Savio R, et al. Antimicrobial resistance among nosocomial isolates in a teaching hospital in Goa. Indian J Community Med 2008; 33(2): 89-92. 3. Ducel G, Fabry J, Nicolle L. Prevention of hospital acquired infections - a practical guide, 2 nd ed. Geneva: WHO; 2002. One of the most common risk factor of Nosocomial infection may be the use of invasive devices In 56.9% patients, nosocomial infections were associated with use of invasive devices such as urinary & CVP catheters, ventilators & surgery. These findings indicate that nosocomial infections are often associated with the use of invasive devices. Therefore to effectively reduce burden of these infections, the use of invasive devices should be minimized and specific disinfection precautions should be taken during application of devices. The length of hospitalization, which is a well known risk factor related to severity of disease and affects health costs, was also a risk factor for development of hospital acquired infections. Use of antibiotics prior to infection and associated chronic morbidities were other risk factors for nosocomial infections in elderly patients. Similar risk factors were implicated in a study reported by Mukherjee et al.10 4. Green J, Wenzel RP. Post operative wound infection. Ann surg. 1977; 185: 264-8. In our study we found that E.Coli was the most common micro-organism isolated from UTI and SSI patients. Whereas, Staph. Aureus and Klebsiella were the most common micro-organism isolated from patients of Sepsis and LRTI respectively. In patients of UTI and SSI, Psedomonas and Klebsiella were other common organisms isolated. From many samples, more than 1 micro-organism was isolated. In contrast to this mukherjee et al reported Pseudomonas and Richards et al reported Candida as most common organism associated with UTI. 10, 14 These differences could be explained by differences in geographic location & health care system. 10. Mukherjee T, Pramod K, Gita S, Medha YR. Nosocomial infections in geriatric patients admitted in ICU. J. of Ind,Acad. of Geriatircs 2005;2:61-64 Multi drug resistance was also observed in our study. Similar observations were also reported by Mohanasundaram et al. The most likely explanation for 15. Mohanasoundaram KM. Retrespective analysis of the incidence of nosocomial infections in the ICU. J of Clinical & Diagnostic Research 2010; 4:3378-3382. NJMR│Volume 6│Issue 1│Jan – Mar 2016 5. Haley RW. The scientific basis for using surveillance and risk factor data to reduce nosocomial infection rates. J Hosp infect 1995; 30(suppl): 3-14. 6. Everett JE, Wahoff DC, Statz CL, et al. Characterization and impact of wound infection after pancreas transplantation. Arch Surg. 1994; 129: 1310-17. 7. Lilani SP, Jangale N, Chaudhary A, et al. Surgical site infection in clean and clean-contaminated cases. Ind J Med Microbiol 2005; 23(4): 249-52 8. Gamer JS, Jarvis WR, Horan TC, Hughes IM. CDC definitions of nosocomial infections. Am J Infect Control 1988; 16:128-140 9. Performance Standards for Antimicrobial Susceptibility Testing; 20th Informational Supple- ment, Clinical and Laboratory Standards Institute (CLSI) M100-S20: Vol. 30, No.1.Wayne, PA: Clinical and Laboratory Standards Institute; 2010 11. Shrivastava SP, Atal PR and singh RP. Studies on hospital infection. Ind J Surg 1969; 31: 612-21. 12. Shaw D, Doig CM and Douglas D. Is airbone infection in the operating theatre an important cause of wound infection in general surgery? The Lancet 1973; 1: 17-21. 13. deSa LA, Sathe MJ and Bapat RD. Factors influencing wound infection (a prospective study of 280 cases). J Postgrad Med 1984; 30 (4): 232-6. 14. Rosineide M, Ribas & Paulo, Gontijo Filho. Comparing hospital infections in elderly vs younger adults.The Brazilian J of Infect Dis 2003;7:210-215. Page 97 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 REVIEW ARTICLE USING THE METHODOLOGY OF WAVELET ANALYSIS FOR PROCESSING IMAGES OF CYTOLOGY PREPARATIONS Vyacheslav V Lyashenko1, Asaad Mohammed Ahmed abd allah Babker2, Oleg A Kobylin3 Author’s Affiliations: 1Laboratory “Transfer of Information Technologies in the risk reduction systems”; 2Department of Informatics Kharkov National University of RadioElectronics, Kharkov, Ukraine; 3Department of Medical Laboratory Science, Al-Ghad International Collage for Medical Sciences, Al-Madinah AlMunawarah, Sudia Arabia Correspondence: Asaad Mohammed Ahmed abd allah Babker E-mail: [email protected] ABSTRACT Processing of microscope images in medicine is one of the priority research areas. This is due to the fact that such studies allow conducting comprehensive diagnosis of human health state, identifying and preventing the development of diseases in the early stages, providing additional research in non-standard symptomatic forms of rare diseases. In this connection, first of all image processing of cytology preparations holds a special place as one of the common set of microimages in medicine. However, the specific complexity of visualization process of cytology preparations and their subsequent processing with the use of automated processing determines the necessity to study new possibilities to use new approaches to image processing. Exactly this fact was the basis for considering the possibility to use wavelet analysis as a tool for processing cytology preparations images. On certain examples of cytology preparation images the results of application of one of the wavelet analysis procedures is shown. Keywords: wavelet analysis, image, contrast enhancement, cell, medicine, cytology preparation. INTRODUCTION Processing real objects’ images, processes and phenomena is one of the ways of perception of the world around us. At the same time, image processing allows studying the processes that cannot be seen or analyzed by means of human vision. One such directions of application of a common ideology of image processing is medicine. In this case, images of real objects are those of different organs, tissues, parts of human skeleton, obtained with the help of special methods of their visualization: X‐ray microtomography, positron emission tomography, ultrasonic analysis, light and electron microscopy.1-5 Among the many real objects that allow studying human body, one can underline the cytology preparations images. It is connected with the following facts. On the one hand, cytology preparations are objects of microcosm, which allow for a more in-depth studies of the human body, to study the dynamics of its operation and to diagnose possible diseases in the early stages of their development; On the other hand, these are special images that differ in their visualization of microcosm objects, which necessitates the use of a variety of image processing techniques to obtain information about objects, processes, and phenomenon under study. NJMR│Volume 6│Issue 1│Jan – Mar 2016 The General Ideology of Post-Processing of Cytology Preparations Images (Literature Review) As an example of separate works that use the ideology of imaging processing for studying of cytology preparations the following research work can be provided. B. Krawczyk and P. Filipczuk, which deals with the cytological image segmentation to isolate the cell nucleus.6 A. Gençtav, S. Aksoy and S. Önder, discussing the issues of segmentation and classification of cells cytology preparations images, where segmentation process involves automatic thresholding to separate the cell regions from the background.7 S. Singh and R. Gupta, which examines the possibility of applying the texture analysis methods for cytology preparations.8 E. Ensink et. al, who study the issues of the selection of threshold for image segmentation of cytology preparations.9 Y. M. George et. al, offering to conduct automated segmentation of cells in the images of the cytology preparation under study, where authors talk about the necessity to change the histogram of the input image in order to enhance its contrast.10 R. Malviya et. al, which deals with nucleus localization in the cytology preparations images under study.11 Nevertheless, the many authors point out that there may be some ambiguity while localizing nucleus. The reason for such ambiguity is the emerging difference in the relative staining intensity of the clinical samples examined. Possible errors in segmentation of Page 98 NATIONAL JOURNAL OF MEDICAL RESEARCH cells on cytology preparations images as a result of the arising differences in relative intensity of their staining is also studied by E. M. van Ingen et. al.12 At the same time N. Dey et. al, talk not only about the possible influence of the relative staining intensity of the preparations under study on the quality of their image processing.13 N. Dey et. al, determine the whole range of problems connected with the processing of microscopic images in medicine, where the primary goal is to obtain high quality image for its further thematic processing.13 Thus, the overall ideology of cytology preparations image processing pursues its goal as the selection of certain parts of the image (cells, nucleus) for further study of their changes (changes in cell shape, the change in the area of a cell) or for the calculation of certain quantitative characteristics (number of cells, the number of nuclei, cells’ area). At the same time, particular attention is paid to the methods of cytology preparations source images (filtering, change of contrast, histogram equalization) in order to enhance the information they contain. However, it should be noted that by simply changing the brightness, contrast or by filtering it is impossible to solve arising issues with proper quality while processing cytology preparation images. Based on noted above, the following objectives of this study can be pointed out: – Explanation of method of cytology preparation images processing; – Reviewing the ideology of preprocessing of cytology preparation images for their processing method under discussion; – Conducting experiments based on the suggested method of cytology preparation images processing. Basics of Wavelet Analysis for Image Processing In order to solve the set of issues connected with cytology preparations image processing the methodology of wavelet analysis will be considered. The selection of wavelet analysis method for further cytology preparations images processing is based on the fact that wavelet processing allows taking into account the particular characteristics of the images under study by decomposing source data into a plurality of approximate and detail coefficients, in particular by image edge detection.14 In addition, image processing results obtained with the help of wavelet analysis, are often more informative.15,16 Wavelet analysis is based on wavelet transform. Wavelets are obtained by shifting and scaling a single function – parent wavelet.17 If the signal is discontinuous, only those wavelets will have high amplitudes, which maxima will appear near the discontinuity point. This allows detecting image edge on the image under study. The sharper the transition, the higher NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 the derivative value is. Smooth transitions will have small derivative values. Behind the formalization of the continuous wavelet transform (CWT) there’s the use of two continuous and integrable along the whole axis t functions:17,18 – wavelet – function ξ ( t ) with zero integral value ∞ ∫ ξ (t )dt = 0 , (1) −∞ determining the details of the signal and generating extended fractions; – scaling function ϕ ( t ) with a unit value of integral ∞ ∫ ϕ (t )dt = 1 , (2) −∞ determining a rough approximation of signal and generating approximation coefficients. However, CWT function can be applied only for one-dimensional signals, and image is a twodimensional signal. Therefore, in order to be able to apply CWT to detect image edges it is suggested to consider the following analysis and edge detection procedure:14 - let’s perform calculation for horizontal discontinuities of the original image F , represented by matrix defined by its readings f ij ∈ {0,1,..., P}, i = 1,2,..., N, j = 1,2,..., M on a square lattice P × K . To do this, we use the following formula to get the so-called matrix of wavelet spectrogram W (based on the sequential processing of each line of the original image F ): W f ij = [ ] 1 where ξ( +∞ t−b ∫ f ijξ ( a )dt , a −∞ (3) t−b ) is a mother wavelet that meets the a condition (1), a , b – scale and center of temporary localization which determine the scale and bias function ξ ( t ) in accordance with the terms of scaling (2); [fij ] indicates the number of the processed string of the original image F to get a plurality of values of its wavelet spectrogram. Parameters a , b are chosen so that the corresponding linear dimensions of the matrix of wavelet spectrogram W correlate with linear dimensions of the Page 99 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 original image F , and at the same time possible parameter of wavelet transform are taken into account. Test Images and Their Preprocessing Before Wavelet Analysis Then, based on the analysis of the obtained spectrogram ( W for each raw of the original image F ) we select its certain line PP based on the condition: In order to identify the possibility of using wavelet analysis as a processing tool for cytology preparations images, some images have been selected. The images are publicly available on the Internet (Fig. 1 and Fig 2). PP = max( where 1 P ∑ w ij ) , P i =1 (4) w ij is the element of wavelet spectrogram of the analyzed row (line) of the original image F . This selection is determined by the fact that we select that part of spectrum of the original image row (line), which corresponds to the largest discontinuity area of the original signal between its readings (see comments above). The selected in such a way line (row), will correspond to the line (row) in matrix Fg which characterized the matrix of horizontal discontinuities of the original image F . Processing of all lines of the original image F allows obtaining the matrix of horizontal discontinuities Fg through the following sequence of transformations: Fig.1. Image No.1 F CWT lines W selection line Fg - in a similar war we calculate the vertical discontinuities of the original image F for each column. For this purpose, use formula (3) and the formula similar to formula (4) to select certain line from the obtained wavelet spectrograms of each column of the original image F : KK = max( 1 K ∑ w ij ) . K i =1 (5) Processing of all columns of the original image F allows as a result obtaining the matrix of vertical discontinuities Fv , due to the following sequence of transformations: F CWT column W selection column Fv . - add matrixes of vertical and horizontal discontinuities into one matrix that displays the edge of the original image based on CWT methods. For visual clarity, matrixes are horizontal, vertical discontinuities, as well as generalized matrix showing the edge of the original image can be inverted. In this work, to consider the possibility of using wavelet analysis as a tool for processing cytology preparations images, parameter a = 20 , and parameter b ( b = P or b = K ) correlates with the linear dimensions of the original image in accordance with the procedure of constructing the matrix of wavelet spectral pattern for rows and columns of the image respectively. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Fig.2. Image No.2 The presented images of cytology preparations are different in their structure and complexity of perception, which allows evaluating the possibility of using wavelet analysis methodology as a tool for their processing. Moreover, all images are presented in color. However, the implementation of certain functions of the general methodology of wavelet analysis involves the work with gray-level images. Therefore, all the original images must be submitted in the form of corresponding gray-level (halftone) images. This is the first stage of the original images pre-processing. As noted above, one of the necessary stages of preprocessing of microscopic images in medicine is their contrasting. Changing the contrast of the image allows improving both image perception accuracy, as well as the accuracy (efficiency) of its further processing. It is very important for microscopic images in medicine, an example of which are images of Page 100 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 cytology preparations. Therefore, to further analyze the halftone images, they all were contrasted. At the same, the selection of different levels of contrast enhancement for the images under study is first of all determined by the necessity to test the possibility of using wavelet analysis for cytology preparation image processing. Results of Wavelet Transform of Cytology Preparations Images and Discussion Thus, wavelet transform of cytology preparations images will be held on halftone images, one of which is the source (primary) image obtained from the corresponding color image, and the second one is a contrasted image of the original grayscale (halftone) image. As a wavelet transform of cytology preparations images the method of selecting special features of the images was used, described in the part “Basics of wavelet analysis for image processing”. Fig. 4a). Results of wavelet transform for image No.2 Fig. 3 shows the results of wavelet transform for image No.1 (a – processing of the original halftone image, b – processing of contrasted halftone image). Fig. 4b:. Results of wavelet transform for image No.2 Fig.3a). Results of wavelet transform for image No.1 Fig.3b). Results of wavelet transform for image No.1 Fig. 4 shows the results of wavelet transform for image No.2 (a – processing of the original halftone image, b – processing of contrasted halftone image). NJMR│Volume 6│Issue 1│Jan – Mar 2016 As it can be seen from data on Fig. 3 and Fig. 4 the described method of image wavelet transform allows detecting first of all edges of separate objects represented on the corresponding images. The used wavelet transform also allows highlighting the specific features of cytology preparaions of separate objects (cells) in the images. At the same time, on basis of shown in Fig. 3 and Fig. 4, it can be stated that the use of the studied wavelet transform provides more information for images that have been contrasted. In the case where wavelet processing was applied to a less contrasted image, the result was the allocation of the darkest areas in the original images. This corresponds wither to cell edge detection (Fig. 4a). In the case where wavelet processing was applied to a more contrasted image, the result is not only more accurate cell edge detection, but the allocation of the internal structure of these cells (Fig. 3b). This allows for a more detailed qualitative and quantitative analysis of the internal structure of the cells represented in the images of cytology preparations. In particular, it is possible to analyze the textural changes that occur within the cell, to analyze in more details the individual elements of cells’ structure, to calculate the dynamics of change in the cell nucleus, the nucleolus, intracellular filaments, etc. Nevertheless, it is possible to combine the results of wavelet processing of images with different contrast. This will help solving different problems: from localizing only cell nuclei to the study of the internal Page 101 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 structure of cells. Then the general ideology of the procedure for the use of wavelet analysis as a tool for cytology preparations images processing can be presented as follows: 2. Gaemperli O, Shalhoub J, Owen D, Lamare F, Rimoldi OE, Davies AH, Camici PG. Imaging intraplaque inflammation in carotid atherosclerosis with 11C-PK11195 positron emission tomography/computed tomography. European heart journal. 2012;33.15:1902-1910. the necessity to transform the original image is determined; color image is converted to halftone (gray-level) image; the necessity to change contrast of the original halftone image is determined; wavelet transform of the original halftone image and of contrasted halftone image is conducted; Conclusions are made on basis of wavelet transform results (additional processing procedures are applied to the obtained images in this case: calculating cell nuclei, cells, cells’ area, etc.). 3. Sikdar S, Rangwala H, Eastlake EB, Hunt I, Nelson A J, Devanathan J, Pancrazio JJ. Novel method for predicting dexterous individual finger movements by imaging muscle activity using a wearable ultrasonic system. Neural Systems and Rehabilitation Engineering, IEEE Transactions on. 2014;22.1:69-76. 4. Eklund A, Dufort P, Forsberg D, LaConte SM. Medical image processing on the GPU–Past, present and future. Medical image analysis. 2013;17.8:1073-1094. 5. Ciresan D, Giusti A, Gambardella LM, Schmidhuber J. Deep neural networks segment neuronal membranes in electron microscopy images. In Advances in neural information processing systems. 2012:2843-2851. 6. Krawczyk B, and Filipczuk P. Cytological image analysis with firefly nuclei detection and hybrid one-class classification decomposition. Engineering Applications of Artificial Intelligence. 2014;31:126-135. 7. Gençtav A, Selim A, Önder S. Unsupervised segmentation and classification of cervical cell images. Pattern Recognition. 2012;45.12:4151-4168. 8. Singh S, Gupta R. Identification of components of fibroadenoma in cytology preparations using texture analysis: a morphometric study. Cytopathology. 2012;23.3:187-191. 9. Ensink E et al. Segment and Fit Thresholding: A New Me- In any case, the discussed above one the procedures of wavelet analysis shows that it is possible and feasible to use wavelet analysis as a tool for processing cytology preparations images in order to obtain additional information to conduct diagnostics and assess the state of human health. CONCLUSIONS thod for Image Analysis Applied to Microarray and ImmuIn summary, the paper deals with the possibility and nofluorescence Data. Analytical chemistry. 2015;87.19:9715feasibility issues of applying wavelet analysis for 9721. processing cytology preparations images. As a separate wavelet analysis procedure, which is proposed to 10. George YM, Bagoury BM, Zayed HH, Roushdy MI. Automated cell nuclei segmentation for breast fine needle aspirabe applied to processing of cytology preparations tion cytology. Signal Processing. 2013;93.10:2804-2816. images, the procedure of allocating specific features 11. Malviya R, Karri SPK, Chatterjee J, Manjunatha M, Ray AK. on the presented images is discussed. Computer assisted cervical cytological nucleus localization. TENCON 2012-2012 IEEE Region 10 Conference. IEEE, The proposed procedure of processing of cytology 2012:1-5. preparations images allows to qualitatively (in terms van Ingen EM, Leyte-Veldstra L, Al I, Wielenga G, Ploem IS. of their visualization) allocating: cells’ edges, cell nuc- 12. Automated Cytology Using a Quantitative Staining Method lei, revealing in more detail textural features of cells’ Combined with a TV-based Image Analysis Computer. Canimages, which allows analyzing cell structure. cer Control: Proceedings of the 12th International Cancer At the same time, one of the specifics of application of wavelet transform for cytology preparation images analysis has been marked out. Such specific feature is the necessity to process halftone images and feasibility of changing contrast of halftone image. Inparticular, the article shows different results of wavelet processing for original and contrasted halftone images. Nevertheless, it does not narrow, but instead extends the potential of using wavelet analysis for processing cytology preparations images depending in the context of the problem. REFERENCES 1. Schlüter S, Sheppard A, Brown, K, Wildenschild D. Image processing of multiphase images obtained via X‐ray microtomography: a review. Water Resources Research. 2014;50.4:3615-3639. NJMR│Volume 6│Issue 1│Jan – Mar 2016 Congress, Buenos Aires, 1978. Elsevier, 2013:45-67. 13. Dey N, Ashour AS, Ashour AS, Singh A. Digital Analysis of Microscopic Images in Medicine. Journal of Advanced Microscopy Research. 2015;10.1:1-13. 14. Kobylin O, Lyashenko V. Comparison of standard image edge detection techniques and of method based on wavelet transform. International Journal of Advanced Research. 2014;2(8):572-580. 15. Lyashenko V, Deineko Z, Ahmad A. Properties of wavelet coefficients of self-similar time series. International Journal of Scientific and Engineering Research. 2015;6(1):1492-1499. 16. Lyashenko V, Kobylin O, Ahmad MA. General Methodology for Implementation of Image Normalization Procedure Using its Wavelet Transform. International Journal of Science and Research (IJSR). 2014;3(11):2870-2877. 17. Kingsbury N. Image processing with complex wavelets. Philosophical Transactions of the Royal Society of London A: Mathematical, Physical and Engineering Sciences. 1999;357(1760):2543-2560. 18. Heil CE, Walnut DF. Continuous and discrete wavelet transforms. SIAM review. 1989;31(4):628-666. Page 102 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 CASE REPORT ACUTE DISSEMINATED ENCEPHALOMYELITIS IN CHICKEN POX Arijit Sinha1, Suvrendu Sankar Kar2, Tirtha Pratim Purkait1, Uttam Kumar Pandit3 Author’s Affiliations: 1Assistant Professor; 3Resident, Department of Medicine, Infectious Disease Hospital; Assistant Professor, Department of Medicine, R.G.Kar Medical College, Kolkata Correspondence: Dr Suvrendu Sankar Kar Email: [email protected] ABSTRACT An 11 years old male was admitted with upper motor type of weakness of both lower limbs, retention of urine, impaired consciousness, tremor and convulsion on 11th day after vesicular eruption of chickenpox. He was investigated and treated. MRI Brain and Spine suggests encephalitis and myelitis. Other causes were excluded by relevant investigations. Patient was improved satisfactorily. Key words: Chickenpox, Acute Disseminated Encephalomyelitis BACKGROUND Chickenpox or varicella is a contagious disease caused by varicella zoster virus. Infections are usually self limiting but complications may occur like pneumonia, encephalitis or secondary pyogenic skin infection etc. CNS complications rate varies from 0.1 to 0.7% in several series1 Acute disseminated encephalomyelitis (ADEM) is one of the rare CNS complications of chicken pox. ADEM is a demyelinating disease of the CNS which can occur following viral infections like chicken pox, measles, rubella, mumps, influenza, Epstein Barr virus, HIV and mycoplasma; following vaccination or spontaneously. Classically ADEM is a monophagic disease but it may have a recurring course also.2 It is associated with small foci of scattered, perivenular inflammation and demyelination of brain and spinal cord.3 In our case, the patient was admitted at Infectious Disease Hospital, Kolkata on 11thday of illness. sent. His respiratory, cardiovascular, abdominal findings were within normal limits. Figure 1: Hyperintensities on T2 image involving bilateral parafalcine region of both frontal lobes with mild surrounding oedema (suggestive of encephalitis) CASE REPORT An 11 year male patient was suffering from Chickenpox and treated at home without antiviral drugs. On 11thday he noticed sudden weakness of both lower limbs with band sensation at nipple level of the chest and retention of urine. Gradually his consciousness level became impaired, tremor of upper limbs and convulsion developed. He was of average built with normal birth and developmental milestones, not immunized against chickenpox, no history of recent vaccination and no significant past illness. Examination: Patient had impaired consciousness (GCS 4); blood pressure (100/70), heart rate (88/min) was normal. He was not pale and clubbing, lymphadenopathy, icterous, oedema, fever were abNJMR│Volume 6│Issue 1│Jan – Mar 2016 Figure 2: MRI (T2 image) of cervico-dorsal spinal cord showing long segment intramedullary hyperintensities (long segment myelitis) Page 103 NATIONAL JOURNAL OF MEDICAL RESEARCH Positive findings on examination of nervous system were—impaired consciousness, lateral gaze nystagmus,tremor, loss of muscle power,flaccidity,loss of abdominal reflex,extensor planter responseand diminished sensation below D4 dermatome. Investigations: Patients investigation reports were as follows : Haemoglobin 10.6 gm/dl, leucocyte count 6400/cumm (N58, L40, E2), ESR50 mm, total bilirubin 0.98 mg%, SGPT 46 IU /L, urea 36mg/dl, creatinine 0.8 mg /dl, Na 136 Meq/L, K 4.8 Meq/L, PO4 3.8 Meq/L, Mg 1.5 Meq/L, Ca 10.8 Meq/L, HIV1 & 2 negative, ANF negative, antiphospholipid antibody negative, IgM VZV positive in 1: 128 dilution, CSF cellcount 56/cumm with 90% lymphocytes, sugar 40 mg/dl, protein 68mg/dl, ADA 4 IU/L, no oligoclonal band. Chest X ray normal and ECG were normal. MRI Brain and Spine revealed abnormal T2 hyperintensities involving bilateral parafalcine region of both frontal lobes with mild surrounding oedema, suggestive of encephalitis (Figure1) and abnormal intramedullary long segment T2 hyperintensities involving the cervico-dorsal spinal cord suggestive of long segment myelitis (Figure2). Treatment and course: Patient was treated with injectable Acyclovir and methylprednisolone, phenytoin and other supportive management. He was improved satisfactorily and discharged on 7th day of hospital admission with mild weakness of lower limbs and mild dysarthria. On follow up after one month he was fine, without any neurodeficit. DISCUSSION Encephalitis, cerebellitis, meningitis, optic neuritis, G B Syndrome, transverse myelitis, stroke, mono or polyneuritis are common CNS complication of chickenpox. ADEM is a rare but serious complication of chickenpox. Children are most sufferers.4,5 Association of ADEM following chickenpox may be delayed up to two weeks.6 In our case age of the patient was 11 years and complication started on 11thday after appearance of rash. ADEM following chickenpox is abrupt in onset with rapid progression, usually when examthema is fading. Fever, headache, meningismus, seizure, ataxia, tremor, nystagmus, impaired consciousness are the usual presentation. There may be features of hemiparesis, paraparesis, quadriparesis, cerebellitis, extensor planter, loss or increased tendon reflexes, sensory loss or brain stem involvement. CSF shows lymphocytic pleocytosis with elevated protein, transient oligoclonal band.7 CT scan Brain may be normal.Clinical signs of cerebellar involvement may be normal in MRI. In ADEM there are extensive changes in brain and spinal cord, whitematter hyperintense signal in T2, FLAIR sequence with NJMR│Volume 6│Issue 1│Jan – Mar 2016 print ISSN: 2249 4995│eISSN: 2277 8810 gadolinium enhancement on T1 weighted sequences.8 Treatment of ADEM is supportive and use of high dose of methyl prednisolone with tapering is beneficial. Plasma exchange and intravenous immunoglobulin may be used in steroid non responder cases. Role of methyl prednisolone is established but of acyclovir is controvertial.9 In our case, patient’s onset was acute and presented with features of encephalitis, cerebelitis and myelitis with rapid recovery on methyl prednisolone treatment. Follow up at one month was uneventful. CONCLUSION We present a case report on a 11-year old boy who presented with neurological complications on 11th day following the appearance of rash of chicken pox. He was diagnosed as acute disseminated encephalomyelitis and was managed successfully with antiviral and steroid. Acknowledgment: I would like to acknowledge the patient, his parents and record keeping staff of ID & BG Hospital. REFERENCES 1. Gücüyener K, Kula S, Serdaroglu A et al. Acute disseminated encephalomyelitis exacerbated by varicella. Acta Paediatr Jpn. 1997 Oct;39(5):619-23. 2. Marchioni E, Ravaglia S, Piccolo G et al. Postinfectious inflammatory disorders: subgroups based on prospective follow-up. Neurology. 2005 Oct 11;65(7):1057-65. 3. Alvord BC Jr: Demyelinating disease, In Vinken PJ, Bruyen GW eds Handbook of Clinical Neurology, Elsevier PublisherBV, Amsterdam, 1985,3,467-502 4. Whitley J Richard, Varicella-Zoster virus infections, In Harrison’s Principles of Internal Medicine, 18th edition, vol 1, 1462-66 5. Miller HG, Stanton JB, Gibbons JL, Para infectious encephalomyelitis and related syndromes, a critical review of neurological complication of certain specific fevers, Q J Med, 1956,25(100),427-505 6. LaRovere KL, Raju GP, Gorman MP, Post varicella acute transverse myelitis in a previously vaccinated child, Pediatric Neurol,208,38(5),370-72 7. deSeze J,Debouverie M, Zephir H et al, Acute fulminant demyelinating disease: a descriptive study of 60 patients, Arch Neurol 2007,64(10),1426-32 8. Hynson JL, Kornberg AL, Coleman LT et al ,Clinical and neurologic features of acute disseminated encephalomyelitis in children, NNeurology ,2001,56(10),1308-12 9. Saabire G, Hollenberg H, Meyer L,Huault G, Landrieu P, Tardieu M, High dose methyl prednisolone in severe acute myelopathy, Arch Dis Child,1997,76(2)167-68 Page 104 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 CASE REPORT RETROCAVAL /CIRCUMCAVAL URETER: RARE CONGENITAL ANOMALY OF URETER OR INFERIOR VENA CAVA Samir M Shah1, Chirag K Patel2, Smit M. Mehta2, Vikram B Gohil3 Author’s Affiliations: 1Professor & Head; 2Resident doctor; 3Associate Professor, Department of General Surgery, Govt. Medical College, Bhavnagar Correspondence: Dr Chirag K Patel Email: [email protected] ABSTRACT Retrocaval ureter also referred to as pre-ureteral vena cava is a rare congenital anomaly with the ureter passing posterior to the inferior vena cava and coming medial to it. Though it is a congenital anomaly, patients do not normally present with symptoms until the 2nd and 3rd decades of life from various presenting complain resulting due to hydronephrosis. We present a case reported in Bhavnagar, Gujarat; a 19-year-old male presented with right flank pains of 2 yr and associated right moderate hydronephrosis. Diagnoses were confirmed with intravenous pyelography (IVP) and computed tomography of abdomen with IVP. And patient was treated with open surgery, including resection of stenosed retrocaval ureter and spatulated end to end ureterouereterostomy in front of IVC. Key words: Retrocaval ureter, Circumcaval ureter, Flank pain, Hydronephrosis, uretero-ureterostomy INTRODUCTION Retrocaval ureter also referred to as circumcaval ureter or preureteral vena cava is a rare congenital anomaly with the ureter passing posterior to the inferior vena cava. The ureter classically course medially behind the inferior vena cava winding around it and then passes laterally in front of it to then course distally to the bladder. Though it is a congenital anomaly, patients do not normally present with symptoms until the 2nd and 3rd decades of life, with various complain resulting due to back pressure changes leads to hydronephrosis. The hydronephrosis may be due to kinking of the ureter, a ureteric segment that is adynamic or compression of inferior vena cava. It was initially considered as aberration in ureteric development; however current studies in embryology have led to it being considered as an aberration in the development of the inferior vena cava.1,2 Hence it is being suggested that the anomaly be referred to as a pre-ureteral vena cava.3 CASE HISTORY A 19 year old male patient, presented with history of right flank pain since 2 year, and taking analgesics from general practitioner for right flank pain, gradually pain was increase. Patient had no any other complains and no operative intervention in the past. There were no significant findings on general and per NJMR│Volume 6│Issue 1│Jan – Mar 2016 abdominal examination. Full blood count, urinalysis and blood urea and creatinine were normal. Abdominal ultrasonography revealed a right moderate hydronephrosis and right upper hydroureter. An intravenous pyelography showed right moderate hydronephrosis and hydroureter of the proximal ureter with non-visualization of the rest of the right ureter with normal left kidney and ureter (figure 1). As we were suspecting a benign cause of ureteric stricture or external compression of ureter, patient was subjected to computed tomography with intravenous pyelography which was suggestive of right circumcaval ureter with right hydronephrosis and right upper hydroureter (figure 2). Patient was undergone laprotomy and excision of retrocaval stenosed segment of right ureter and spatulated end to end ureterouereterostomy with double J stent kept insitu. Post operative course was normal. Patient was discharge from hospital on 4th post operative day. Stitch removal on 8th post operative day. Double J stent removed on 21th post operative day. Follow up ultrasonography after 2 month showed normal, no hydronephrosis and hydroureter. With normal renal function test. DISCUSSION Retrocaval ureter is a rare congenital anomaly occurring with incidence of about 1 in 1500 people with a three to four times male predominance in autopsy Page 105 NATIONAL JOURNAL OF MEDICAL RESEARCH studies.4 Though few clinical cases have been reported worldwide. The first observed case of retrocaval ureter was described by Hochstetter in 18935. Though initially thought of as an anomaly of ureteric development studies in embryology has revealed an anomaly related to the development of the inferior vena cava. The appropriate term giving the correct description of the anomaly is preureteral vena cava. The anomaly predominantly involves the right ureter, as was observed in this reported case. If it involves the left ureter then it is usually associated with either partial or complete situs inversus or duplication of the inferior vena cava (IVC).6 The ureter typically deviates medially behind the inferior vena cava, winding about and crossing in front of it from a medial to a lateral direction, to resume a normal course, distally, to the bladder. The renal pelvis and upper ureter typically appear elongated and dilated in a “J” or fishhook shape before passing behind the vena cava. Although it is a congenital anomaly it normally presents in the second and third decade of life as typified by the ages of the presented cases. Majority of patients presenting with symptoms, present with flank or abdominal pain that can be intermittent, dull and aching and is commonly due to ureteric obstruction and associated hydronephrosis. Some patients may present with recurrent urinary tract infection and haematuria. Renal calculi and pyonephrosis may complicate the condition. Some cases are found incidentally during radiographic imaging for other conditions. Retrocaval ureter classify into two clinical types. Type 1 is commonest and has moderate to severe hydronephrosis in about 50% of cases with extreme medial deviation of middle ureteric segment and the ureter assuming an S or ‘fish hook’ deformity. Type 2 print ISSN: 2249 4995│eISSN: 2277 8810 has less medial deviation of the ureter with mild or no associated hydronephrosis and forms about 10% of cases7. Surgical management is reserved for the type 1 cases that are usually symptomatic. Retrocaval ureter has hence been defined as a rare congenital anomaly that requires surgical correction in the symptomatic patient. Abdominal ultrasound demonstrates hydronephrosis. IVU usually does not demonstrate the middle and distal ureter may require a retrograde ureteropyelogram to demonstrate the ureter. Spiral CT scan may define the ureter and inferior vena cava anomalies obviating the need for a retrograde ureteropyelogram and is considered an investigation of choice. Important differential diagnosis includes retroperitoneal fibrosis and retro peritoneal masses displacing the ureter from its normal course. Abdomino pelvic CT scan is helpful in excluding these conditions.MRI can nicely demonstrate the course of a preureteral vena cava and may be a more detailed and less invasive imaging modality, without exposure to radiation, when compared with CT and retrograde ureteropyelography. Treatment is surgical and involves division of the ureter and repositioning it anterior to the inferior vena cava. This may be achieved through an anastomosis between the renal pelvis and the ureter or a uretero-ureteric anastomosis over a double-J stent. The segment behind the inferior vena cava which may be aperistaltic is either excised or left in situ. In this reported case, the segment was excised. Surgical intervention is for symptomatic cases and changes of hydronephrosis and altered renal function. Patients with minimal caliceal dilatation and no significant symptoms do not need surgery but need to be followed up. Figure 1: Intravenous pyelography of patient, showing right side moderate hydronephrosis and upper hydroureter with kinking of upper ureter NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 106 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 have been reported worldwide. Treatment is surgical allowing for correction of the anomaly with resolution of symptoms. There is the need to research whether it is developmental anomaly of ureter of inferior vena cava. REFERENCES Figure 2: CT Scan of abdomen with IVP showing abnormal course of right ureter, coming posterior and medial to inferior vena cava CONCLUSION 1. Chuang VP, Mena CE, Hoskins PA. Congenital anomalies of the inferior vena cava. Review of embryogenesis and presentation of a simplified classification. Br J Radiol. 1974; 47:206–213. 2. Schlussel RN, Retik AB. Preureteral Vena Cava. In: Kavoussi LR, Novick AC, Partin AW, Peters CA, editors. Campbell-Walsh Urology. 9th ed. Elsevier Saunders; 2007. pp. 3418–3420. . 3. Dreyfuss W. Anomaly simulating a retrocaval ureter. J Urol. 1959; 82:630. 4. Heslin JE, Mamonas C. Retrocaval ureter: Report of four cases and review of literature. J Urol.1951; 65:212–222. 5. Olson RO, Austen G., Jr N Engl J Med. 1950; 242:963– 968. 6. Watanabe M, Kawamura S, Nakada T, et al. Left preureteral vena cava (retrocaval or circumcaval ureter) associated with partial situs inversus. J Urol. 1991; 145:1047–1048. 7. Bateson E, Atkinson D. Circumcaval ureter: a new classification. Clin Radiol. 1969; 20:173–177. Retrocaval ureter is a rare congenital anomaly that presents clinically late in the second and third decades of life. Very few clinically symptomatic cases NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 107 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 CASE REPORT MESENTERIC PANNICULITIS – A CASE REPORT Amol Jagdale1, Saurav Mittal2, Krutik Patel2, Azhar Shaikh2 Author’s Affiliations: 1Professor & Head; 2Resident, Department of Radiology, Dr. Vasantrao Pawar Medical College, Aadgaon, Nashik Correspondence: Dr Saurav Mittal Email: [email protected] ABSTRACT Introduction: It is a benign fibro-proliferative process that involves the adipose tissue surrounding the mesentry.It is also known as Mesenteric lipodystrophy or scelrosing mesenteritis.1,2 It is sometimes called as a variant of Weber Christian Disease.1 Key words: Mesentery, Inflammation, Panniculitis, CT, USG, Fibrosis, Inflammation, Fat. INTRODUCTION CASE REPORT Mesenteric panniculitis is a benign fibroinflammatory process involving the adipose tissue of the mesentry and is characterized by fat necrosis, chronic inflammation and fibrosis.1, 2, 3 It was first described by Jura in 1924.4 It has a variety of synonyms most common being Mesenteric lipodystrophy and sclerosing mesenteritis.1, 2 When pathologic component is inflammatory or fatty, the disease is known as Mesenteric panniculitis.2,5 When fibrosis is the dominant component, it is known as Retractile mesenteritis.2, 4, 5 A 65 year old male came to the department of radiodiagnosis for sonography of abdomen and for the complaints of pain in left hypochondrium and left lumbar region since 1 year.The pain was nonradiating and had no aggravating or relieving factors. There was no alteration in bowel and bladder habits. The patient is under regular treatment for the past three years for diabetes and hypertension. Sonography was performed on Siemens Acuson 300x machine. Retractile mesenteritis is the more invasive form of Mesenteric panniculitis, which is complicated by fibrosis and retraction. 5 Most patients present as a benign, slowly progressive course. The outcome of the disease is usually favourable.3 It is a non-specific inflammation. 5 The cause of the disease is unclear 5, it is said to be an auto-immune response to unknown sources, or collagen vascular disease; Ischemia of the mesentery may also be responsible. 4, 5 Mesenteric panniculitis is usually associated with idiopathic inflammatory conditions like retro-peritoneal fibrosis, sclerosing cholangitis, reidel’s thyroiditis and orbital pseudotumor. 2 Mesenteric panniculitis is also reported in association with malignancy. It usually involves the root of mesentery of the small bowel, but can occasionally involve the mesocolon. 2 CLINICAL FEATURES Patients may present with abdominal pain, intestinal obstruction, ischemia, mass or diarrhea. 2 Increased ESR or anemia may be seen as the predominant laboratory finding. However, laboratory tests are non-specific. NJMR│Volume 6│Issue 1│Jan – Mar 2016 USG Findings: Ill defined hyperechoic diffuse area seen in left lumbar region. The lesion was surrounded by a hypo-echoic rim, s/o tumour pseudocapsule. Vessels were seen traversing through the lesion. No bowel dilatation or ascites was seen. Considering ultrasound findings, diagnosis of mesenteric panniculitis was suspected and patient was advised CT scan abdomen for further evaluation. Abdominal CT examination was performed on Siemens Somatom Emo 6 machine with 6 mm and 2 mm sections after bowel opacification using oral and i.v iopamidol. CT Findings: Ill defined area of increased attenuation was seen involving small bowel mesentry in central abdomen below the level of pancreas. The area measured approx 13.0 x 7.5 x 1.4 cm and separate firm adjacent normal mesenteric fat by tumor pseudocapsule. Mesenteric vessels appear traversing through the lesion. Rim of mesenteric fat seen around mesenteric vessels with surrounding increased density, s/o “ Fat ring sign.” No obvious displacement of vessels. Few oval intralesional lymph nodes were seen. Adjacent small bowel loops appear normal. No bowel dilatation or ascites was noted. Page 108 NATIONAL JOURNAL OF MEDICAL RESEARCH print ISSN: 2249 4995│eISSN: 2277 8810 1a) 2b) 1b) 2c) 1c) Fig 1a-c: Ultrasonography images of the case 2d) Fig 2a-d: CT images of the case 2a) NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 109 NATIONAL JOURNAL OF MEDICAL RESEARCH DISCUSSION Mesenteric panniculitis can also be called as “Mesenteric manifestation of Weber Christian disease”.1 This is because of the pathologic microscopic similarity between the affected fatty tissue and that of Weber Christian disease. 1 It mainly affects males 2,3 and is usually seen between 6th and 7th decades of life. 3 It mainly affects the mesentery of small intestine, large intestine is rarely involved. 1 CT Features in Mesenteric panniculitis. CT features vary depending on the predominant tissue component (Fat ,inflammation ,fibrosis) 2 Two CT features are somewhat specific for this disease. These are – There is no specific treatment, it regresses spontaneously. 7 It usually responds to steroids, immunosuppressive threrapy and antibiotics. 1, 2, 7 CONCLUSION Mesenteric panniculitis is a rare disease of unknown etiology and is usually associated with idiopathic diseases. Left half of the abdomen is more frequently involved and this is consistent with orientation of jejunal mesentery. Mesenteric panniculitis has a propensity for jejunal mesentery. REFERENCES 1. FAT RING sign – This sign reflects that fat around the mesenteric vessels are preserved. 2. TUMOR PSEUDOCAPSULE 3,7 Other CT features are print ISSN: 2249 4995│eISSN: 2277 8810 2,5,7 1. Popkharitov I Angel, Chomov N Georgi–Mesenteric panniculitis- A case report and review of the literature; Journal of Medical case reports, 2007, 1:108. 2. Horton M. Karen, Lawler Leo P, -CT findings in Mesenteric panniculitis : Spectrum of disease, Radiographics, November 2003, volume 23, Issue 6. 3. Ferrari Terresa Christina A,CoutoM.Carolina, FariaC.Louciana, VilacaTatiane S, Xavier Marcelo A. P –An unusual presentation of Mesenteric panniculitis; Clinics volume 63, Number 6, Sao Paulo 2008. 4. IssaIyad, Baydoun Hassan - Mesenteric panniculitis : Various presentations and treatment regimens. 5. Daskalogiannaki M. Voloudaki A. Prassopoulos P.Magkanas E. Stefanaki K. Apostolaki E. Gourtsoyiannis N. – CT evaluation of Mesenteric panniculitis, Prevalence and associated diseases, American Journal of Radiology, Feb 2000, Vol 174, Number 2. 6. Shah D.M, Patel S.B, Shah S.R,Goswami K.G -Mesenteric panniculitis- A case report and review of literature,; Indian Journal of Radiology and Imaging, 2005, volume 15, Issue 2. 7. RummanNisreen, George Rumman, DisiNimer, Zagha Rami, SharabatiBarakat -Mesenteric panniculitis in a child misdiagnosed as appendicular mass: A case report and review of literature; Springer plus 2014, 3:73. – - Solitary well defined mass composed of inhomogenous fatty tissue with CT attenuation higher than those of retroperitoneal fat at the root of small bowel mesentery. - Engulfment of superior mesenteric vessels without vascular involvement. - No evidence of invasion of adjacent small bowel loops even if they are displaced. - Calcification within the mass. - Subtle increase in attenuation in the mesentery without evidence of discrete soft tissue mass (Misty mesentery). 2 It is not specific for Mesenteric panniculitis. The diagnosis is mainly made by abdominal exploration. A biopsy is usually necessary for confirmation of the diagnosis. 1, 3 NJMR│Volume 6│Issue 1│Jan – Mar 2016 Page 110 NATIONAL JOURNAL OF MEDICAL RESEARCH Reference Citation Articles in Journals a) Standard journal article (for up to six authors): Shukla N, Husain N, Agarwal GG, Husain M. Utility of cysticercus fasciolaris antigen in Dot ELISA for the diagnosis of neurocysticercosis. Indian J Med Sci 2008;62:222-7. b) Standard journal article (for more than six authors): Same as above. Only exception is instead of listing all authors, list the first six authors followed et al. For example: Nozari Y, Hashemlu A, Hatmi ZN, Sheikhvatan M, Iravani A, Bazdar A, et al. c) Volume with supplement: Shen HM, Zhang QF. Risk assessment of nickel carcinogenicity and occupational lung cancer. Environ Health Perspect 1994; 102 Suppl 1:275-82. d) Issue with supplement: Payne DK, Sullivan MD, Massie MJ. Women's psychological reactions to breast cancer. Semin Oncol 1996; 23 (1, Suppl 2):89-97. Books and Other Monographs a) Personal author(s): Ringsven MK, Bond D. Gerontology and leadership skills for nurses. 2nd ed. Albany (NY): Delmar Publishers; 1996. b) Editor(s), compiler(s) as author: Norman IJ, Redfern SJ, editors. Mental health care for elderly people. New York: Churchill Livingstone; 1996. c) Chapter in a book: Phillips SJ, Whisnant JP. Hypertension and stroke. In: Laragh JH, Brenner BM, editors. Hypertension: pathophysiology, diagnosis, and management. 2nd ed. New York: Raven Press; 1995. pp. 465-78. Electronic Sources as reference a) Journal article on the Internet Abood S. Quality improvement initiative in nursing homes: the ANA acts in an advisory role. Am J Nurs [serial on the Internet]. 2002 Jun [cited 2002 Aug 12];102(6):[about 3 p.]. Available from: http://www.nursingworld.org/AJN/2002/june/Wawatch.htm b) Monograph on the Internet Foley KM, Gelband H, editors. Improving palliative care for cancer [monograph on the Internet]. Washington: National Academy Press; 2001 [cited 2002 Jul 9]. Available from: http://www.nap.edu/books/0309074029/html/ . c) Homepage/Web site Cancer-Pain.org [homepage on the Internet]. New York: Association of Cancer Online Resources, Inc.; c2000-01 [updated 2002 May 16; cited 2002 Jul 9]. Available from: http://www.cancer-pain.org/ . d) Part of a homepage/Web site American Medical Association [homepage on the Internet]. Chicago: The Association; c1995-2002 [updated 2001 Aug 23; cited 2002 Aug 12]. AMA Office of Group Practice Liaison; [about 2 screens]. Available from: http://www.amaassn.org/ama/pub/category/1736.html Volume 6│Issue 1│ Jan – March 2016 NJMR│print ISSN: 2249 4995│eISSN: 2277 8810 Official Website: www.njmr.in Online Submission: www.njmr.in or http://my.ejmanager.com/njmr/ Credential: Creative Commons Attribution-NonCommercial 3.0 Unported License