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   Table of Contents - Current issue
September-October 2017
Volume 49 | Issue 5
Page Nos. 341-404

Online since Thursday, February 8, 2018

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Cosmetovigilance in India: Need of the day Highly accessed article p. 341
Phulen Sarma, Harish Kumar, Bikash Medhi
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Incorporating problem based learning into medical curriculum: An experience from a medical college in Mangalore p. 344
Nithin Kumar, Tanuj Kanchan, Bhaskaran Unnikrishnan, Rekha Thapar, Prasanna Mithra, Vaman Kulkarni, Ramesh Holla, Darshan Bhagwan, Yeshwanter Radhakrishnan
BACKGROUND: The Medical Council of India (MCI) has envisioned a change in the undergraduate medical curriculum by encouraging integrated teaching and Problem Based Learning (PBL). METHODS: In this cross-sectional study 110 medical teachers of Kasturba Medical College, Mangalore were assessed regarding their perception on PBL. Independent t-test was applied to find out the difference in the mean perception scores regarding PBL among the teachers in pre/para-clinical and clinical departments and P < 0.05 was considered statistically significant. RESULTS: PBL as a teaching method was preferred by 65.2% medical teachers. The teachers from clinical departments (Mean 4.1, SD 0.8) perceived PBL sessions to be more effective than the traditional methods than those from the pre-clinical and para clinical departments (Mean 3.7, SD 3.7) and this difference was found to be statistically significant. (P=0.028). CONCLUSION: PBL can complement integrated teaching and motivates students towards self-learning, and apply the learnt concepts of basic specialties to clinical problem solving.
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Telmisartan and esculetin combination ameliorates type 2 diabetic cardiomyopathy by reversal of H3, H2A, and H2B histone modifications p. 348
Almesh Kadakol, Vajir Malek, Santosh Kumar Goru, Anuradha Pandey, Anil Bhanudas Gaikwad
OBJECTIVES: Although cardioprotective effects of telmisartan are well explored, its effects on epigenetic alterations associated with type 2 diabetic (T2D) cardiomyopathy remain unmapped. Thus, the present study was designed to evaluate the potential of esculetin and telmisartan combination to reverse histone posttranslational modifications (PTMs) in curbing T2D cardiomyopathy. MATERIALS AND METHODS: T2D was induced by high-fat diet feeding along with low dose of streptozotocin (35 mg/kg, I.P) in male Wistar rats. T2D rats were treated with either telmisartan (10 mg/kg/day, P.O) or esculetin (50 mg/kg/day doses, P.O) or their combination for 2 weeks. Biochemical estimations, vascular reactivity, immunohistochemistry, and western blotting experiments were performed to evaluate the effects of the treatment in T2D cardiomyopathy. RESULTS: Esculetin and telmisartan combination alleviated the pathological features of T2D cardiomyopathy including metabolic perturbations, morphometric alterations, altered vascular reactivity, increased Keap1 and fibronectin expression more effectively than their respective monotherapy. This is the first report showing that telmisartan attenuates increased level of histone PTMs such as H3K9me2, H3K9Ac, H2AK119Ub, and H2BK120Ub in heart of T2D rats. The combination regimen showed a more significant reduction in augmented histone PTMs associated with T2D cardiomyopathy than their independent treatments. CONCLUSIONS: The present study demonstrates that esculetin and telmisartan combination can be an advanced pharmacological approach to ameliorate T2D cardiomyopathy which could be partially attributed to its ability to reverse the epigenetic alterations.
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Effect of aluminum chloride on blood glucose level and lipid profile in normal, diabetic and treated diabetic rats p. 357
Venugopala Rao Konda, Madhavi Eerike, R Prasanth Chary, Ruckmani Arunachalam, Venkata Ramana Yeddula, Vinayak Meti, T Sobita Devi
OBJECTIVES: The objectives of the study were to assess evaluate the effects of aluminum chloride (AlCl3) on blood glucose and lipid levels in normal, diabetic, and glibenclamide-treated diabetic rats. MATERIALS AND METHODS: Forty-two male Wistar rats were divided into seven groups of six each. Group I was normal control, Groups II and III were given AlCl350 and 100 mg/kg, and Group IV to VII were administered with streptozotocin (STZ) (60 mg/kg) intraperitoneally. Group IV was diabetic control, Group V in addition was given AlCl350 mg/kg, Group VI glibenclamide (10 mg/kg), and Group VII glibenclamide and AlCl3(50 mg/kg) per-oral daily for 28 days. Blood glucose and lipid levels were estimated at base line, after diabetes was set in and on the last day of study. Histopathological changes in pancreas, liver, and kidney were studied. RESULTS: No significant change was observed in blood glucose and lipid levels in Group I. Group II and III showed a dose-dependent significant increase in blood glucose was observed. Group V had a reduction in blood glucose but not to the nondiabetic level. Group VI had significant reduction in blood sugar. In Group VII, treated with glibenclamide and AlCl3, there was no significant change in blood glucose reduction compared to Group VI. Lipid levels were reduced in groups treated with AlCl3and glibenclamide and not in other groups. Gross tissue damage was seen in pancreas in STZ group and in liver and kidney in AlCl3groups. CONCLUSION: AlCl3administration in Wistar rats caused in significant hyperglycemia in normal rats, hypoglycemia in diabetic rats, and did not influenced hypoglycemic effect of glibenclamide and in addition, resulted in reduction in lipid levels.
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Sitagliptin–Moringa oleifera coadministration did not delay the progression nor ameliorated functional and morphological anomalies in alloxan-induced diabetic nephropathy p. 366
Comfort Omoigemete Olurishe, Helen Ochuko Kwanashie, Abdulkadiri Umar Zezi, Nuhu Mohammed Danjuma, Bisalla Mohammed
OBJECTIVE: Sitagliptin (ST) and Moringa oleifera (MO) Lam (Moringaceae) are used concomitantly by diabetic patients, with no study ascertaining for potential favorable or otherwise renal implications. We investigated the effect of coadministration of ST and MO leaf extract on functional and morphological biomarkers of alloxan-induced diabetic nephropathy (DN). MATERIALS AND METHODS: Diabetes was induced with a single dose of 150 mg/kg of alloxan intraperitoneally. Seven groups of eight rats per group were used, with Groups I, II, and VII as normal (NS), diabetic control (DC), and postprandial controls. Groups III, IV, V, and VI were diabetic rats on ST, MO, ST and MO (SM), for 42 days with 2 weeks delayed treatment in a postprandial hyperglycemic group (PPSM), respectively. Serum urea, albumin, electrolyte levels, lipid profile, and kidney tropism were determined in addition to histological examinations. RESULTS: There was a significant increase (P < 0.05) in kidney tropism comparing all drug-treated groups and DC to normal rats. Significant increases in serum urea were observed (P = 0.02) in DC, MO-treated, and SM-treated rats compared to normal rats and also in serum triglyceride (P < 0.05) in MO-treated and SM-treated rats compared to controls and other drug-treated groups. A mild reduction in severity of pathologic lesions was observed (glomerulosclerosis Grade 1) in SM-treated rats compared to a marked necrosis in DC (Grade 3). CONCLUSION: The coadministration of ST–MO did not delay the progression of functional anomalies and renal injury nor ameliorated the lesions associated with chronic DN in Wistar rats.
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Comparison of online reporting systems and their compatibility check with respective adverse drug reaction reporting forms p. 374
Vikas Maharshi, Pravesh Nagar
AIM: Different forms and online tools are available in different countries for spontaneous reporting, one of the most widely used methods of pharmacovigilance. Capturing sufficient information and adequate compatibility of online systems with respective reporting form is highly desirable for appropriate reporting of adverse drug reactions (ADRs). This study was aimed to compare three major online reporting systems (US, UK, and WHO) of the world and also to check their compatibility with the respective ADR reporting form. MATERIALS AND METHODS: A total of 89 data elements to provide relevant information were found out from above three online reporting systems. All three online systems were compared regarding magnitude of information captured by each of them and scoring was done by providing a score of “1” to each element. Compatibility of ADR reporting forms of India (Red form), US (Form 3500), and UK (Yellow card form) was assessed by comparing the information gathered by them with that can be entered into their respective online reporting systems, namely, “VigiFlow,” “US online reporting,” and “Yellow card online reporting.” Each unmatching item was given a score of “−1”. RESULTS: VigiFlow scored “74” points, whereas online reporting systems of the US and UK scored “56” and “49,” respectively, regarding magnitude of the information gathered by them. Compatibility score was found to be “0,” “−9,” and “−26” in case of ADR reporting systems of US, UK, and India, respectively. CONCLUSION: Our study reveals that “VigiFlow” is capable of capturing the maximum amount of information but “Form 3500” and “Online reporting system of US” are maximally compatible to each other among ADR reporting systems of all three countries.
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Comparison of clinical effectiveness and safety of newer nonsteroidal anti-inflammatory drugs in patients of osteoarthritis of knee joint: A randomized, prospective, open-label parallel-group study p. 383
Yashika Garg, Jatinder Singh, HS Sohal, Rajeshwari Gore, Arun Kumar
OBJECTIVE: Osteoarthritis (OA) is a chronic progressive degenerative disease of weight-bearing joints and the leading cause of disability in elderly. Current medical management of OA is mostly palliative with nonsteroidal anti-inflammatory drugs (NSAIDs) being the mainstay of therapy. Reports of gastrointestinal adverse effects with traditional NSAIDs and cardiovascular adverse effects associated with selective cyclooxygenase-2 (COX-2) inhibitors have prompted the hunt for a better NSAID with no or minimal adverse effects. This study compares the clinical effectiveness and safety of newer NSAIDS etodolac and lornoxicam to diclofenac which has been a standard therapy in patients of OA of knee joint. MATERIALS AND METHODS: It was a randomized, prospective, open-label, parallel-group study conducted in 90 patients of OA of knee joint diagnosed according to the American College of Rheumatology criteria. After obtaining the informed consent, they were randomized in three groups of 30 patients each who received tablet etodolac 400 mg b.i.d, tablet lornoxicam 8 mg b.i.d, and tablet diclofenac sodium 50 mg t.i.d, respectively. The duration of the study was 12 weeks. Data were tabulated and analyzed using analysis of variance (ANOVA) test, and level of significance was determined by its P value. RESULTS: After 12 weeks of treatment, pain intensity and functional indices in terms of visual analog scale and Western Ontario and McMaster Universities Osteoarthritis score were significantly better (P < 0.05) in lornoxicam group as compared to etodolac or diclofenac group along with lesser rate of adverse effects. CONCLUSION: It was concluded that lornoxicam was more effective and better tolerated NSAID than etodolac and diclofenac in treatment of knee joint OA.
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Pediatric pharmacovigilance in an institute of national importance: Journey has just begun p. 390
Pramod Kumar Sharma, Arup Kumar Misra, Neeraj Gupta, Daisy Khera, Ajay Gupta, Pushpinder Khera
OBJECTIVE: The objective of this study is to determine the nature and severity of adverse drug reactions (ADRs) in pediatric patients. MATERIALS AND METHODS: In this retrospective cohort study, we extracted the data from all the available pediatric ADR forms submitted to ADR monitoring center (AMC) from May 2014 to December 2016. The data including nature, frequency, causality (World Health Organization [WHO] causality scale), and the severity (Hartwig and Siegel scale for severity) of ADR were extracted. We also assessed the preventability of the event on modified Schumock and Thornton scale of ADR preventability. RESULTS: There were a total of 20 pediatric ADRs reported during this period. Nearly two-thirds of the ADRs occurred in patients who were receiving multiple drugs (polytherapy). Antimicrobial agents were the most commonly implicated drugs. The most common ADRs were skin rash (maculopapular, erythematous, and urticaria, itching, etc.). The severity and preventability scales indicated that most reactions (18/20) were moderate in nature and all were preventable. Four reactions were “certainly” and ten ADRs were “probably” related to the suspected drug as determined by the WHO causality assessment. CONCLUSION: Frequency of ADR increased with number of medications patient was receiving. Health-care providers (HCPs) involved in the care of children must be aware of this fact and should use additional drugs when absolutely necessary. They should be involved in pharmacovigilance program by exchanging and updating each other through sharing constructive information, communication, and education concerning the appropriate use of drugs in children. Pediatric pharmacovigilance is the need of the hour and should be given utmost importance for monitoring the safety of drugs in children. Motivating HCPs for voluntary reporting of ADRs for preventing the morbidity and mortality in this vulnerable population could be of immense importance.
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Fatal dapsone hypersensitivity syndrome with hypothyroidism and steroid-induced diabetes mellitus p. 396
Sarayu Pai, Renuka Munshi, Chitra Nayak
Dapsone has been part of the World Health Organization multidrug therapy for the treatment of leprosy. While it has been efficacious in the management of leprosy, there are many patients who develop adverse drug reactions to the drug including life-threatening reactions such as dapsone hypersensitivity syndrome (DHS). We report a case of a patient who was prescribed dapsone as part of multidrug therapy for leprosy following which she developed DHS. Her condition worsened after tapering the oral steroids given to manage the DHS, and she was detected to have hypothyroidism. She developed diabetes mellitus and succumbed to septic shock.
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Magnesium valproate-induced pedal edema on chronic therapy: A rare adverse drug reaction p. 399
Himani Prajapati, Dinesh Kansal, Rajan Negi
Valproate-related pedal edema is usually regarded as a problem occurring after long-term administration of valproate. Valproate has been a drug of choice for the treatment of generalized or partial seizures as monotherapy or adjunctive therapy, bipolar disorder, for the prophylaxis of migraine headache in adults. This case report described patient-acquiring bilateral pedal edema after long-term use of magnesium valproate. Discontinuing valproate resulted in rapid improvement of the condition. This adverse reaction to the best of our knowledge is first reported a case of bilateral pedal edema cause by magnesium valproate in low dose. The dose of magnesium valproate was 1200 mg/day. No previous case as reported with the same dose.
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Are your capsules vegetarian or nonvegetarian: An ethical and scientific justification p. 401
Ajay Prakash, Hariom Soni, Abhishek Mishra, Phulen Sarma
Capsules are important component of day to day health management. But recently an issue came up whether the capsule you are using is of vegetarian or non-vegetarian origin. Capsule shell can be divided into vegetarian and non-vegetarian origin on the basis of their origin. Gelatin capsule shell are typically of animal origin and HPMC or starch based shells are of vegetarian origin. CDSCO received one proposal to replace all non veg capsule with capsule of vegetarian origin. CDSCO has invited comments from different stakeholders regarding this. So, in this editorial, we are addressing different issues lying behind veg and non-veg capsules and scientific justification of the same.
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