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Background: Medical practitioners utilize drug promotional materials from pharmaceutical companies as a major source of information especially in developing countries. These promotional materials can be highly informative as long as they are critically appraised but when they are accepted without question, they lead to irrational prescribing. Aim: To sensitize the students regarding WHO criteria for medicinal drug promotion and to determine the impact of teaching critical appraisal of medicinal drug promotion to medical students. Design: The medical students of second year were given a pre test questionnaire to identify the violations in generic labeling, pharmacological information, claims, relevance and references cited in the drug advertisements. Later they were sensitized about the WHO criteria for medicinal drug promotion and how to critically appraise a drug advertisement. This was followed by a post test questionnaire with the same drug advertisement. Result: The number of students answering the post test correctly was significantly (p

Background: Medical practitioners utilize drug promotional materials from pharmaceutical companies as a major source of information especially in developing countries. These promotional materials can be highly informative as long as they are critically appraised but when they are accepted without question, they lead to irrational prescribing. Aim: To sensitize the students regarding WHO criteria for medicinal drug promotion and to determine the impact of teaching critical appraisal of medicinal drug promotion to medical students. Design: The medical students of second year were given a pre test questionnaire to identify the violations in generic labeling, pharmacological information, claims, relevance and references cited in the drug advertisements. Later they were sensitized about the WHO criteria for medicinal drug promotion and how to critically appraise a drug advertisement. This was followed by a post test questionnaire with the same drug advertisement. Result: The number of students answering the post test correctly was significantly (p<0.05) more than that of pre test. Conclusion: Education of medical students regarding critical analysis of drug advertisements should be a part of the medical curriculum.

To identify the medications that medical students, interns and casualty medical officers are likely to prescribe when treating an adult patient with anaphylaxis, and to ascertain the dose and route of administration of adrenaline they would use. Design: A questionnaire study survey. Setting: Kasturba medical college hospital, Manipal (Udupi District) and public health centers of Udupi district, Karnataka. Subjects: Data collected from 39 second year medical students, 35 interns and 35 casualty medical officers. Main outcome measure: To determine the percentage of use of adrenaline for the treatment of anaphylaxis in the correct dose, strength and route. Results: Majority (73 .3%) of participants correctly opted to use adrenaline. Only 9 participants have written the correct dose, route and concentration of adrenaline. 41.28% and 66.05% participants preferred to use antihistamines and corticosteroids respectively. Conclusion: This study has shown that confusion exists regarding the correct route of administration and dose of adrenaline to be used when treating anaphylaxis. This confusion applied to medical students, interns and medical officers. Therefore doctors must be made aware of the guidelines to treat anaphylaxis effectively.

Background and Aim: A significant cause of arsenic poisoning is polluted groundwater. Arsenic poisoning results in the suppression of spermatogenesis and the liver and kidneys are vulnerable to the toxic effects as well. Mucuna pruriens has been identified to have fertility-enhancing and anti-lipid peroxidation properties. Based on these properties of M. pruriens , this study aimed to investigate the efficacy of M. pruriens seed extract in reducing sodium arsenite-induced testicular impairment and hepato-renal histopathology in rats., Materials and Methods: The study was divided into two groups; short-term (45 days) and long-term (90 days) treatment groups and each group was divided into nine subgroups. Subgroups 1 and 2 served as normal and N-acetyl cysteine (NAC) controls, respectively. Subgroups 3-9 received sodium arsenite in the drinking water (50 mg/L). Subgroup-4 received NAC (210 mg/kg body weight [BW]) orally once daily. Subgroups 5-7 received aqueous seed extract of M. pruriens (350, 530, and 700 mg/kg BW, respectively) orally once daily. Subgroups 8 and 9 received a combination of NAC and aqueous seed extract (350 and 530 mg/kg BW, respectively) orally once daily. Following the treatment, animals were sacrificed and sperm parameters and DNA damage were evaluated. Testis, liver, and kidneys were analyzed for histopathology., Results: Sodium arsenite-induced a significant reduction in sperm parameters and increase in the abnormal architecture of spermatozoa. Histology revealed tissue necrosis. The M. pruriens seed extract ameliorated the damaging effects of sodium arsenite with respect to tissue architecture and sperm parameters when coadministered., Conclusion: Mucuna prurien s has beneficial effects against the deleterious effects of sodium arsenite on various tissues. Thus, M. pruriens (530 and 700 mg/kg BW) supplementation would reduce the adverse changes observed with sodium arsenite exposure., Competing Interests: The authors declare that they have no competing interests., (Copyright: © Concessao, et al.)

Prenatal adversaries like stress are known to harm the progeny and oxidative stress, which is known to be one of the causative factors. N -acetyl cysteine (NAC), which is a potent antioxidant, has been shown to play a neuroprotective role in humans and experimental animals. This study examines the benefits of NAC on the prenatal stress-induced learning and memory deficits and alteration in brain neurotransmitter in rat pups. Pregnant dams were restrained (45 min; 3 times/day) during the early or late gestational period. Other groups received early or late gestational restrain stress combined with NAC treatment throughout the gestational period. At postnatal day (PND) 28, offspring were tested in a shuttle box for assessing learning and memory, which was followed by a brain neurotransmitter (dopamine, norepinephrine, and serotonin) estimation on PND 36. Late gestational stress resulted in learning deficits, the inability to retain the memory, and reduced brain dopamine content while not affecting norepinephrine and serotonin. NAC treatment in prenatally stressed rats reversed learning and memory deficits as well as brain dopamine content in offspring. These findings suggest that NAC protect the progeny from an undesirable cognitive sequel associated with prenatal stress.

Background & Objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India., Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India. Seven hundred and forty questionnaires fulfilling the minimum quality criteria were included in the final analysis., Results: Four hundred and sixteen (56.2%) physicians prescribed pioglitazone. Of these, 281 used it in less than the recommended dose of 15 mg/day. Most physicians (94.3%) were aware of recent regulatory events. However, only 333 (44.8%) changed their prescribing pattern. Seventeen of the 416 (4.1%) physicians who prescribed pioglitazone admitted having come across at least one type 2 diabetes mellitus patient (T2DM) who had urinary bladder carcinoma, and of these 13 said that it was in patients who took pioglitazone for a duration of more than two years. Only 7.8 per cent of physicians (n=58) categorically advocated banning pioglitazone, and the rest opined for its continuation or generating more evidence before decision could be taken regarding its use in T2DM., Interpretation & Conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM., Competing Interests: None

In letter to the editor "Comment on: Statin use and risk of diabetes mellitus" authors found the statement "pravastatin 40 mg/d reduced the risk of diabetes by 30% in West of Scotland Coronary Prevention study" erroneous. As per our opinion the statement is right but had been referenced incorrectly., Competing Interests: Conflict-of-interest statement: The authors declare that they don’t have any conflict of interest.

Epigenetics deals with the interactions between genes and the immediate cellular environment. These interactions go a long way in shaping up each and every person's individuality. Further, reversibility of epigenetic interactions may offer a dynamic control over the expression of various critical genes. Thus, tweaking the epigenetic machinery may help cause or cure diseases, especially cancer. Therefore, cancer epigenetics, especially at a molecular level, needs to be scrutinised closely, as it could potentially serve as the future pharmaceutical goldmine against neoplastic diseases. However, in view of its rapidly enlarging scope of application, it has become difficult to keep abreast of scientific information coming out of various epigenetic studies directed against cancer. Using this review, we have attempted to shed light on two of the most important mechanisms implicated in cancer, that is, DNA (deoxyribonucleic acid) methylation and histone modifications, and their place in cancer pathogenesis. Further, we have attempted to take stock of the new epigenetic drugs that have emerged onto the market as well as those in the pipeline that offer hope in mankind's fight against cancer.

Aim: To assess the intraocular penetration of 0.5% moxifloxacin hydrochloride into aqueous humour after oral and topical administration., Methods: A prospective, interventional study of 42 patients scheduled to undergo cataract surgery was carried out. Out of the 42 subjects, 21 were randomly categorised into Group I and received one drop of 0.5% topical moxifloxacin four times, at 15 min intervals starting 75 min before the surgery. Another 21 subjects were categorised into Group II and all subjects in this group were administered a single tablet of 400 mg of moxifloxacin, 12 h before the surgery. Estimation of moxifloxacin in aqueous samples was carried out using high-performance liquid chromatography. Results were analysed using Student unpaired 't' test and analysis of variance. The value of p<0.05 was considered to be significant., Results: Mean aqueous concentration of moxifloxacin attained in the oral group (n=21) was 0.504±0.30 μg/mL while that in the topical group (n=21) was 2.04±0.72 μg/mL, and this difference in levels was statistically significant (p<0.005). The levels attained by both the groups well exceeded the MIC90 (minimum inhibitory concentration of antibiotic required to inhibit growth of 90% of bacteria strains) levels for most of the organisms causing endophthalmitis. Penetration of moxifloxacin in aqueous in both the groups was not affected by gender, intraocular pressure or comorbidities significantly. However, aqueous levels were found to be higher among the younger subjects within the topical group., Conclusions: Moxifloxacin has an impressive spectrum of coverage and this pharmacokinetic study reinforces its potential as a prophylactic drug against intraocular infections, given the high aqueous levels post topical administration., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

The 3-hydroxy-methylglutaryl coenzyme A reductase inhibitors, statins, are widely used in the primary and secondary prevention of cardiovascular diseases to lower serum cholesterol levels. As type 2 diabetes mellitus is accompanied by dyslipidemia, statins have a major role in preventing the long term complications in diabetes and are recommended for diabetics with normal low density lipoprotein levels as well. In 2012, United States Food and Drug Administration released changes to statin safety label to include that statins have been found to increase glycosylated haemoglobin and fasting serum glucose levels. Many studies done on patients with cardiovascular risk factors have shown that statins have diabetogenic potential and the effect varies as per the dosage and type used. The various mechanisms for this effect have been proposed and one of them is downregulation of glucose transporters by the statins. The recommendations by the investigators are that though statins can have diabetogenic risk, they have more long term benefits which can outweigh the risk. In elderly patients and those with metabolic syndrome, as the risk of diabetes increase, the statins should be used cautiously. Other than a subset of population with risk for diabetes; statins still have long term survival benefits in most of the patients.

Lisinopril and fosinopril were compared on scopolamine-induced learning and memory deficits in rats. A total of eighty-four male Wistar rats were divided into seven groups. Group I received 2% gum acacia orally for 4 weeks, group II received normal saline, and group III received scopolamine (2 mg/kg/ip) as single dose. Groups IV and V received lisinopril ( 0.225 mg/kg and 0.45 mg/kg), while Groups VI and VII received fosinopril (0.90 mg/kg and 1.80 mg/kg), respectively, orally for four weeks, followed by scopolamine (2 mg/kg/ip) given 45 minutes prior to experimental procedure. Evaluation of learning and memory was assessed by using passive avoidance, Morris water maze, and elevated plus maze tests followed by analysis of hippocampal morphology and quantification of the number of surviving neurons. Scopolamine induced marked impairment of memory in behavioral tests which correlated with morphological changes in hippocampus. Pretreatment with fosinopril 1.80 mg/kg was found to significantly ameliorate the memory deficits and hippocampal degeneration induced by scopolamine. Fosinopril exhibits antiamnesic activity, indicating its possible role in preventing memory deficits seen in dementia though the precise mechanism underlying this effect needs to be further evaluated.

Background: Directly observed treatment short course (DOTS) and self-administered therapy (SAT) are the treatment options available for tuberculosis (TB). Studies conducted worldwide have shown difference in treatment outcome with these two treatment modalities., Aim: The study was undertaken to compare treatment outcome of DOTS and SAT in patients of pulmonary TB taking SAT from a tertiary care hospital and DOTS from the DOTS centre of a government hospital., Materials and Methods: It was a retrospective comparative study. The case record files of patients with pulmonary TB diagnosed from March 2011 to February 2012 were analysed as per the proforma. The sample size of patients was 150 (75 each from DOTS and SAT)., Results: The treatment outcome in DOTS group was cured 70.7%, treatment completed 1.3%, failure 5.3%, deaths 10.7%, defaulters 8% and transferred out 4% whereas in SAT group, cure was seen in 68% and 4% completed the treatment, 1.3% had treatment failure, and 26.7% were lost to follow up which included deaths, defaulters and those patients who switched over to other hospitals. The treatment success rate was similar (72%) in both groups. There was no statistically significant difference observed in the average weight gain at the end of treatment between the two groups. A total of 11 adverse drug reactions (4 DOTS, 7 SAT) were recorded in the study., Conclusion: The study shows no statistically significant difference between success rate in patients taking DOTS and SAT.

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.

Background: Ankle edema is a common adverse effect of amlodipine, an L-type calcium channel blocker (CCB). Cilnidipine is a newer L/N-type CCB, approved for treatment of essential hypertension., Aim: This study was designed to determine whether cilnidipine can produce resolution of amlodipine-induced edema while maintaining adequate control of hypertension., Materials and Methods: A prospective study was performed on 27 patients with essential hypertension with amlodipine-induced edema. Concomitant nephropathy, cardiac failure, hepatic cirrhosis, or other causes of edema, and secondary hypertension were excluded by appropriate tests. Amlodipine therapy was substituted in all the cases with an efficacy-equivalent dose of cilnidipine. Clinical assessment of ankle edema and measurement of bilateral ankle circumference, body weight, blood pressure, and pulse rate were performed at onset of the study and after 4 weeks of cilnidipine therapy., Results: At completion of the study, edema had resolved in all the patients. There was a significant decrease in bilateral ankle circumference and body weight (P < 0.001). There was no significant change in mean arterial blood pressure and pulse rate., Conclusions: Therapy with cilnidipine resulted in complete resolution of amlodipine-induced edema in all the cases without significant worsening of hypertension or tachycardia. Cilnidipine is an acceptable alternative antihypertensive for patients with amlodipine-induced edema.

With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can have, that subjects are duly compensated, and credible data generated. Most importantly, each institution/hospital should have a strong Human Research Protection Program to safe guard the trial subjects. In order to look at research with a comprehensive objective approach, there is a need for a formal auditing and review system by a recognized body. As of now, only the sponsors are monitoring/auditing their respective trials; however, there is an increasing need to perform a more detailed review and assessment of processes of the institution and the Ethics Committee. This challenge can be addressed by going for accreditation by a reputed association that encompasses-the institutions, the ethics committees, and researcher/research staff. Starting their journey for the accreditation process in late 2010, Kasturba Medical College and Hospital [KMC], Manipal, and Manipal Hospital Bangalore [MHB] received full Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation in Dec 2011-a first in India. This article delves into the steps involved in applying for AAHRPP accreditation from an Indian Perspective, the challenges, advantages, and testimonials from the two hospitals on the application experience and how the accreditation has improved the Human Research Protection Program at these hospitals.

Objective: To investigate the effects of Celastrus paniculatus seed oil in preventing the onset of chronic aluminum induced cortico-hippocampal neurodegeneration and oxidative stress., Materials and Methods: An animal model of senile dementia of Alzheimer's type was produced by administering aluminum as aluminum chloride (4.2 mg/kg) intraperitoneally to male Wistar rats for 60 days and results compared to untreated control. Neurobehavioral investigations of Morris water maze tests, passive avoidance test, rotarod test and biochemical estimations of acetylcholineterase, malondialdehyde, glucose-6-phosphate dehydrogenase, superoxide dismutase, and hemoglobin in blood were performed fortnightly which gauged the extent of global oxidative stress and progressive neural damage. Findings were fortified by the above enzyme assays and histology of brain at necropsy. Prophylactic oral C. paniculatus in two doses 0.5 ml and 1 ml, were given to animals and the results were analyzed in comparison to a similar rodent model with standard drug donepezil (0.5 mg/kg) intraperitoneally., Results: C. paniculatus showed a significant prevention in onset of aluminum induced neural insult and overall systemic oxidative stress which was corroborated by the enlisted neurobehavioral, biochemical, and histological evidence., Conclusion: C. paniculatus is a putative decelerator of Al-mediated Alzheimer's like pathobiology.

Ethnopharmacological Relevance: Traditional Siddha medicine literature claims that the Amaranthus spinosus Linn. (family: Amaranthaceae) whole plant possesses diuretic property., Aim of the Study: To evaluate the diuretic potential of Amaranthus spinosus aqueous extract (ASAE) in rats., Material and Methods: Different concentrations of ASAE (200, 500, 1000, 1500mg/kg), thiazide (10mg/kg) and vehicle were orally administered to rats (n=6 animals per group) and their urine output was collected after 24h. Volume, pH, Na(+), K(+) and Cl(-) concentrations of urine were estimated., Results: ASAE produced increase in Na(+), K(+), Cl(-) excretion, caused alkalinization of urine, showed strong saluretic activity and carbonic anhydrase inhibition activity. These effects were observed predominantly at 500mg/kg dose and there was no dose-response relationship., Conclusion: Our study strongly suggests that the Amaranthus spinosus is acting as a thiazide like diuretic with carbonic anhydrase inhibitory activity which restates the claim as diuretic herb in Siddha medicine., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Data from hospital records of 96 neonates hospitalised with sepsis were analysed using SPSS 11.5 version to identify sepsis--its signs and symptoms with which they were admitted, bacterial isolates and antibiotic susceptibility patterns among neonates admitted during 2007-2009. The retrospective data revealed that majority of the neonates 61 (63.5%) were males. Of the 96 neonates 52 (54.2%) were pre-term, and 44 (45.8%) were referred from various institutes after initial trial of management for the same. Majority ie. 66 (68.8%) had respiratory distress. Lethargy was noted in 56 (58.30%), fever among 10 (10.4%) and jaundice was reported among 6 (6.2%). Blood culture and sensitivity revealed that pseudomonas infection claimed to have triggered early signs and symptoms of sepsis among 11 (11.46%) neonates and Staphylococcus aureus was responsible for triggering late signs and symptoms ofsep is among 11 (11.46%) neonates.

Objective: Memory loss is universal and is the first symptom to manifest in majority of the patients suffering from Alzheimer's disease. This study is designed to investigate the effect of Ferula asafoetida linn. (F. foetida) extract on learning and memory in rats., Materials and Methods: Learning and memory were evaluated using elevated plus maze and passive avoidance paradigm after the oral administration of two doses (200 mg/kg and 400 mg/kg) of F. foetida aqueous extract with rivastigmine as positive control. Brain cholinesterase activity, serum thiols and cholesterol were also estimated., Results: Extract produced significant improvement in memory score i.e. step through latency at 400 mg/kg dose in passive avoidance model (P< 0.05) and dose-dependent improvement of transfer latency in elevated plus maze model (P< 0.001). Dose-dependent inhibition of brain cholinesterase (P< 0.001) and significant improvement in antioxidant levels (P< 0.05) were also noted., Conclusions: Memory enhancing potential of F. foetida can be attributed to acetylcholinesterase inhibiting and antioxidant properties. Hence, dietary usage of F. foetida is beneficial and can also be employed as an adjuvant to existing anti-dementia therapies.

Background: Treatment of cancers with cytotoxic agents such as tyrosine kinase inhibiting drugs often, but not always, result in transient to permanent testicular dysfunction. Germ cells are important targets of many chemicals. Most of the drugs are genotoxins and induce irreversible effect on genetic makeup. These mutagenic changes are proportionally related to carcinogenesis. This is alarmingly dangerous in youth and children, since these effects last longer, affecting fertility or forming basis for carcinogenesis. There is paucity of reports on planned studies of imatinib on the testicular function. Hence, the study was planned to assess the effects of imatinib on biochemical markers of testicular functions in male Swiss albino mice., Materials and Methods: Male Swiss albino mice were treated with imatinib and sacrificed at the end of first, second, fourth, fifth, seventh, and tenth week after the last exposure to imatinib. The testis were removed, weighed, and processed for biochemical analysis., Results: The intratesticular testosterone level was significantly (P<0.001) reduced in treated groups and severe effect was observed on week 4 and 5. The intratesticular lactate dehydrogenase (LDH) level was significantly increased by imatinib in all treated groups up to week 5., Conclusion: Imatinib does affect testosterone and LDH level significantly, but this effect is reversible once the drug is withdrawn. This finding may help the clinicians to plan and address the fertility-related issues in young patients of reproductive age who are being treated with imatinib for gastrointestinal tumors and chronic myeloid leukemia.

To evaluate the effect of phenytoin on burn wounds and to compare the effect of the combination of topical phenytoin preparation in dexamethasone treated burn wounds in rats, partial thickness thermal burn wounds were inflicted upon five groups of six rats each. Group I was assigned as control, Group II received the standard silver sulphadiazine, Group III was given topical phenytoin and Group IV received injection dexamethasone, Group V received the combination of the phenytoin and the dexamethasone. The parameters observed were epithelialization period, percentage of wound contraction and histopathological analysis as indicative of the process of healing. Phenytoin group showed significant improvement in burn wound contraction in comparison to standard silver sulphadiazine group, the combination group of topical phenytoin and dexamethasone also showed significant contraction compared to dexamethasone group. The period of epithelialization also decreased significantly in groups II, III and V. In conclusion, phenytoin promotes burn wound healing as evidenced by decrease in period of epithelialization and faster wound contraction.

Alcoholic extract of Kaempferia galanga was tested for analgesic and antiinflammatory activities in animal models. Three doses, 300 mg/kg, 600 mg/kg and 1200 mg/kg of the plant extract prepared as a suspension in 2 ml of 2% gum acacia were used. Acute and sub acute inflammatory activities were studied in rats by carrageenan induced paw edema and cotton pellet induced granuloma models respectively. In both models, the standard drug used was aspirin 100 mg/kg. Two doses 600 mg/kg and 1200 mg/kg of plant extract exhibited significant (P<0.001) antiinflammatory activity in carrageenan model and cotton pellet granuloma model in comparison to control. Analgesic activity was studied in rats using hot plate and tail-flick models. Codeine 5 mg/kg and vehicle served as standard and control respectively. The two doses of plant extract exhibited significant analgesic activity in tail flick model (P<0.001) and hot plate model (P<0.001) in comparison to control. In conclusion K. galanga possesses antiinflammatory and analgesic activities.