Taruna Sharma

A double-blind, randomized, controlled trial to compare the efficacy and tolerability of fixed doses of ropinirole, bupropion, and iron in treatment of restless legs syndrome (Willis-Ekbom disease)

Background: We aimed to compare the efficacy of fixed doses of bupropion and ropinirole and iron alone for the treatment of restless legs syndrome (RLS) and to look for the tolerability of these medications. Materials and Methods: Patients diagnosed with RLS were randomly divided into three groups with thirty patients in each group (Group A: Bupropion [300 mg/day], Group B: Ropinirole [0.25-0.5 mg/day], and Group C: Oral iron [150 mg elemental iron] along with folic acid [500 μg]). Each participant was then assessed for severity of RLS, as well as RLS-related quality at the baseline, and thereafter, every 14 th day till 6 weeks based on the International Restless Legs Scale (IRLS) severity rating scale and Restless Legs Syndrome Quality of Life (RLSQoL) Questionnaire, respectively. Results: IRLS scores differed significantly from baseline visit to last (F = 4.85; P = 0.01). The interaction between the time x treatment group was significant (F = 10.37; P < 0.001) showing an improvement with the therapy in all the groups. Pair-wise comparison depicted that ropinirole group differed from other two groups in IRLS score (F = 7.06; P = 0.001), which were comparable to each other. Regarding quality of life of these cases, within each group scores differed among all the four visits (F = 5.12; P = 0.002). Unlike IRLS, there was no significant difference among the RLSQOL scores between groups at any point of time (F = 1.2; P = 0.28). Conclusion: RLS severity decreased across time in all three groups; however, the ropinirole treatment was better than the bupropion and iron-folate therapy. Moreover, RLS-related quality of life although improved among all groups, it was comparable among three groups.

Melioration in Anti-staphylococcal Activity of Conventional Antibiotic(s) by Organic Acids Present in the Cell Free Supernatant of Lactobacillus paraplantarum

In view of emerging drug resistance in pathogens, there is a need to explore alternative strategies to combat infections. Use of probiotics is one such option. In this regard, efficacy of Lactobacillus plantarum has been reported against Staphylococcus aureus. Here, we propose that cell free supernatant (CFS) of Lactobacillus paraplantarum when used in combination with conventional antibiotics viz. ampicillin and oxacillin [to which the methicillin resistant Staphylococcus aureus (MRSA) strains were originally resistant] reduce the minimum inhibitory concentrations of these antibiotics, rendering the combination either synergistic or additive against the tested MRSA strain. The anti-staphylococcal activity was observed to be due to organic acids (acetic acid and lactic acid as confirmed by HPLC analysis) present in the CFS, as neutralization of the CFS with an alkali, sodium hydroxide (NaOH), caused the complete abrogation of its activity. The role of H2O2 and bacteriocin present in the CFS was also ruled out. The findings of this study suggest that cell free supernatant and ampicillin/oxacillin combination(s) might help in rejuvenating the use of conventional anti-staphylococcal antibiotics for the treatment of multi-drug resistant strains.

Poetry in teaching pharmacology: Exploring the possibilities

Objectives: To explore poetry as a tool for active learning in linking knowledge and affective domains and to find if correlating learning with imagination can be used in “assessment for learning.” Materials and Methods: After taking a conventional lecture on Asthma, a creative writing assignment in the form of poetry writing was given to the students. Different triggers were given to the students to channelize their thought pattern in a given direction that was linked to specific areas of academic relevance. Students were asked to reflect on this learning experience and the faculty was asked to evaluate the student assignment on a 5-point Likert scale. Results: Most student groups scored well in the “overall assessment” of creative assignments and were rated as good or fair by the faculty. Students reflections were very informative and revealed that more than 90% of the students liked the exercise and many were too exuberant and liberal with emotional reactions that breathed positive. Around 5% students found the exercise average and another 5% found it very childish. Conclusion: Poetry writing turned out to be like a simulation exercise that linked academic knowledge, creativity, and the affective domain in an assumed scenario, rehearsed in free locales of mind. The metaphorical transition embedded in its subtle creation helped assess deeper understanding of the subject and the logical sequence of thought pattern.

Introducing structured viva voce examination in medical undergraduate pharmacology: A pilot study

Objective: Viva voce examination is an important tool of evaluation in medical examinations marred by high subjectivity. Gross subjectivity in viva voce assessment can be reduced by structuring it. Materials and Methods: The marks obtained in theory and viva voce (traditional viva voce examination [TVVE]) of I sessional, II MBBS students were compared and a huge disparity was identified. A structured viva voce examination (SVVE) was then proposed and experimented as an objective and standardized alternative. Sets of equitable question cards for SVVE were prepared, each having eight questions with two parts each, arranged successively with increasing difficulty, domains of learning, and appropriate marks. The percentage variation in scoring in viva versus theory marks was calculated for both TVVE and SVVE, and students were grouped as Group I (+100 to +51%); Group II (+50 to −50%); Group III (−51 to −100%); Group IV (−101 to −150%); Group V (−151 to −200%); and Group VI (< −200%) variation, as? inappropriate, appropriate, inappropriate, erroneous, more erroneous and most erroneous respectively. Student’s feedback on the SVVE was also obtained. Results: In TVVE (n = 128), the students distributed were:none,17.2%, 23.4%, 22.7%, 11.7% and 25% in Group I, II, III, IV, V, and VI in contrast to SVVE (n = 107) as 7.5%, 57.9%, 19.6%, 6.5%, 5.6%, and 2.8%, respectively. Marked disparity of TVVE was annulled with SVVE. Student’s feedback was quite encouraging with 83% overall acceptability and almost 66% preferred SVVE. Conclusion: SVVE was more realistic as compared to TVVE. Most of the students favored this approach.

Role of concept map in teaching general awareness and pharmacotherapy of HIV/AIDS among second professional medical students

Objective: Medical students as future doctors will play an important role in caring for HIV-infected patients. This study assessed and evaluated the existing level of knowledge of MBBS students about HIV/AIDS given through lecture delivery methods and by use of concept map (CM). Materials and Methods: This study was carried out on 150 professional MBBS students of tertiary care hospital. A pretest was conducted by giving 10 multiple choice questions (MCQ) of general awareness and 15 questions regarding pharmacotherapy of HIV/AIDS. In between pre- and post-test, a session of 1-week integrated teaching module was organized. After completion of integrated teaching, 2 h session of CM on general awareness and pharmacotherapy of HIV/AIDS was taken. A posttest was conducted using MCQs and problem-based question (PBQ) to assess the effect of integrated teaching and CM on their knowledge about HIV/AIDS. Feedback was also taken from the students to regarding their views about CM. Results: There was a significant increase in student’s score in MCQ test after integrated teaching than pretest (P < 0.05). There was also significant improvement in PBQ score after CM than that of after integrated teaching (P < 0.05). Students’ perception about the effectiveness of CM was positive. Conclusion: CM can make a significant improvement in the knowledge of medical students and were motivated and developed interest in the subject.

Translation and validation of restless leg syndrome quality of life questionnaire in Hindi language

BACKGROUND Restless legs syndrome (RLS) itself as well as the problems that are secondary to RLS may worsen the quality of life. AIM The aim of this study is to translate and validate the Restless Legs Syndrome Quality of Life (RLS-QOL) questionnaire in Hindi language. SETTINGS AND DESIGNS Patients attending psychiatry OPD and sleep clinic in a tertiary care teaching hospital. MATERIALS AND METHODS Thirty four consecutive patients of RLS and twenty nine control subjects were included in the study. Permission for translation and validation of RLS-QOL questionnaire scale was obtained. Translation was done according to the guidelines provided by the publisher. After translation, the final version of the scale was applied in both the groups to find the reliability and validity. STATISTICAL ANALYSIS SPSS, version 17.0 was used for the analysis. Independent sample t test was used to compare age. Chi-square test was applied to compare non-parametric variables. Pearsons and Spearmans correlations were used to find out the correlation between parametric and non-parametric items, respectively. Reliability analysis was done by using Cronbachs alpha. RESULTS Among the RLS subjects, mean Insomnia Severity Index (ISI) score, International Restless Legs Syndrome Severity Rating Scale (IRLS) score and Computed Score of RLS-QOL questionnaire were 25.43 (7.39), 12.7 (8.34) and 29.8 (8.39), respectively. A statistically significant difference was observed between both the groups on all these scores (ISI: t= -11.2, P<0.001, 95% CI= -22.62 to -15.76; IRLS: t = -8.1, P< 0.001, 95% CI =-15.81 to -9.58; RLS-QOL: t =-19.07, P<0.001 with 95% CI = -32.69,- 28.83). A significant correlation between ISI and RLS-QOL (r² = 0.59; P< 0.001) was seen. Most of the items also showed good correlation with each other. Internal consistency done by Cronbachs alpha showed good correlation (0.85). CONCLUSION Hindi version of the Restless Legs Syndrome Quality of Life (RLS-QOL) questionnaire is a valid and reliable tool for the assessment of the quality of life in patients with RLS.

Prescribing pattern of oral anti-diabetic agents in type 2 diabetes mellitus patients in a tertiary care hospital

Medically unsuitable, ineffective and non-economical use of pharmaceutical products is commonly observed in clinical practice throughout the world and especially in developing countries. The rational use of drugs requires the patients to receive medicines appropriate to their clinical needs, in doses that meet their individual requirements, for an adequate period of time and at the lowest possible cost. Rational prescribing forms the foundation of successful implementation of the rational use of drugs.

Comparative efficacy and safety of DPP-4 inhibitors and α-glucosidase inhibitors as add on therapy in type 2 diabetes

DM is a group of common metabolic disorders that are characterized by hyperglycemia. Contributory factors leading to hyperglycemia are reduced insulin secretion, decreased glucose utilization and increased glucose production. The worldwide prevalence of DM has risen drastically over the past two decades, from an estimated 30 million cases in 1985 to 382 million in 2013. Based on current trends, the International Diabetes Federation projects that 592 million individuals will have diabetes by the year 2035. Although the prevalence of both type 1 and type 2 DM is increasing worldwide, the prevalence of type 2 DM is rising much more rapidly, presumably because of increasing obesity and reduced physical activity.

Comparison of the efficacy and safety of Glimepiride and Glipizide as add-on therapy with metformin in patients of type 2 diabetes mellitus

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder carrying an enormous burden of morbidity and mortality because of its characteristic complications, many of which are preventable with strict glycaemic control. Initial management of T2DM consists of non-pharmacological interventions; it those fail, an oral anti-diabetic drug, most typically metformin, is started. Combination therapy is initiated only when monotherapy fails to achieve glycaemic control. Glipizide and glimepiride, a second and a third generation sulphonylurea respectively, are the commonest drugs added to metformin when the latter fails to achieve euglycaemia on its own. Aims and Objectives of the study were to compare the efficacy and safety of glimepiride and glipizide as add-on therapy to metformin in patients of uncontrolled T2DM. Methods: This prospective, observational and analytical study was conducted by the Department of Pharmacology among patients attending the Internal Medicine OPD of a tertiary-care hospital. Fifty patients were assigned to two groups of 25 patients each: Group A - Glimepiride + Metformin and Group B - Glipizide + Metformin. Patients were followed up for three months. Data were analysed by Students t-test. Results: There was a significant decrease in the HbA1c, FBS and 2h-PPBS in both groups. However there was no significant difference between the two groups during the three-month period of follow-up. Conclusions: The combination of glimepiride and metformin is just as effective and safe as the combination of glipizide and metformin in patients not controlled on monotherapy with metformin.

Knowledge attitude and practice of pharmacovigilance among nursing professionals in a tertiary care teaching hospital in Dehradun, Uttarakhand

Background: Pharmacovigilance deals with identification, assessment and prevention and reporting of adverse drug reaction (ADR), play a pivotal role in ensuring safe use of drugs. However, in spite of having well established ADR reporting system in India and worldwide, the ADR underreporting is a big challenge till date. It is therefore very important to assess the level of awareness of Pharmacovigilance among healthcare professionals to identify the factors affecting ADRs reporting. The objective of the study was to evaluate knowledge, attitude and practice of pharmacovigilance among nursing professionals in a tertiary care teaching hospital in Dehradun, India. Methods: It was a cross sectional observational study conducted at HIMS over a period of 1 year. Nursing professionals who work in internal medicine, Surgery, PAC and intensive care unit (ICU) were included in this study. A self-administered questionnaire comprising of 15 items related to ADRs and Pharmacovigilance programme of India (PvPI) activity was provided to them and sufficient time to fill the questionnaire was given. The completely filled questionnaire was collected and data was analyzed using SPSS ver.20.0. Results: A total of 415 participants were included in the study. The mean age of the participant was 28.52 years. The number of female was more than male participants. Majority of participant (56%) couldn’t answer the meaning of pharmacovigilance. Only 25% participants were aware about ADR reporting process to ADR monitoring centre (AMC). Although majority of the participants understand the necessity of ADR reporting and aware about AMC centre and PvPI, but most of them showed unfamiliarity about ADR reporting form and previous experience of any kind of ADR. The most common reason for not reporting the ADR was difficulty in deciding the nature of adverse effects (AE) (44%) followed by lack of time (30%). Majority of participant (67%) denied any previous pharmacovigilance training and almost all (98%) have shown their interest in PvPI training. Conclusions: Nursing professionals in our hospital may lack adequate knowledge about ADR reporting and may need more education and training on the National Pharmacovigilance System and ADR reporting process.