A questionnaire based study on the knowledge, attitude and the practices of pharmacovigilance among the postgraduate students at a tertiary care hospital in south India

Background: Adverse drug reactions (ADRs) are common cause of morbidity in the practice of medicine. Pharmacovigilance is the science of detection, assessment and understanding and prevention of adverse effects or any drug related problems. Post graduates are perhaps the first to notice ADRs in outpatient/inpatient setup as they spend most of the time bedside. Thus, this study was conducted to assess the knowledge, attitude and practices (KAP) of postgraduates about Pharmacovigilance.Methods: A prevalidated and pretested questionnaire with 20 questions related to KAP of pharmacovigilance is administered to postgraduate students after obtaining their consent. All the completed and returned questionnaires were analysed for results using appropriate statistics.Results: 180 pretested questionnaires were distributed among postgraduates out of which, 122 were returned from postgraduates of all major medical and surgical allied departments. 90.2 % defined pharmacovigilance correctly, 83.6% thought reporting ADRs is a professional obligation, while only 65.6% knew regarding the existence of national pharmacovigilance program. 58.4% have experienced ADRs, of which only 24.6% reported ADR to pharmacovigilance centre. Major reasons for under reporting are lack of time to report and difficulty to decide whether ADR has occurred or not.Conclusions: In this study, the knowledge and attitude related to Pharmacovigilance is good amongst postgraduates, but practical implementation in reporting of ADRs is poor. Sensitization programs on pharmacovigilance practice in tertiary care hospitals and regular review meetings to ensure ADR reporting to pharmacovigilance centre will strengthen the health care setup

EVALUATION OF A HIGHLY STANDARDIZED WITHANIA SOMNIFERA EXTRACT ON ENDOTHELIAL DYSFUNCTION AND BIOMARKERS OF OXIDATIVE STRESS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY

Background: Type 2 Diabetes mellitus is a multisystem disorder with oxidative stress and endothelial dysfunction. Withania somnifera Dunal (Ashwagandha) is shown to have potent antioxidant, hypoglycemic and hypolipidemic effects in several studies. The present study was planned to compare the effect of Withania somnifera on endothelial dysfunction and biomarkers in patients with diabetes mellitus. Materials and Methods: After taking IEC approval and written informed consent, 66 eligible patients, who are on metformin therapy, were randomized to receive either one capsule of highly standardized aqueous extract of Withania somnifera 250mg twice daily, one capsule of Withania somnifera 500mg twice daily or Placebo for a duration of 12 weeks. Primary efficacy parameter was a change in endothelial function (measured as change in reflection index of more than 6 %) performed by salbutamol challenge test at baseline and after 12 weeks of treatment. Secondary end points were change in biomarkers of oxidative stress (malondialdehyde, nitric oxide and glutathione), high sensitivity C-reactive protein and change in lipid profile. Safety lab parameters were measured, at baseline and after 12 weeks of treatment. Results: A total of 60 patients completed the study. Twelve weeks of treatment with Withania somnifera 250mg and 500mg produced significant reduction in reflection index (-2.52±1.32% to -7.49±3.49%) and (-2.24±1.00% to -9.03±2.42%) respectively, suggesting improvement in endothelial function versus placebo (-2.11±1.62% to -0.81±2.86%). Similarly a significant improvement in biomarkers of oxidative stress, systemic inflammation, lipid parameters and HbA1c levels, compared to baseline and placebo, was observed with Withania somnifera. All treatments are well tolerated. Conclusion: Withania somnifera showed significant improvement in endothelial function, reduction in biomarkers of oxidative stress and systemic inflammation and can be used as a therapeutic adjunctive in patients with type 2 Diabetes mellitus

A study on treatment outcomes in MDR-TB patients on long term regimen in West Godavari district

Background: MDR-TB is defined as a TB patient whose biological specimen is resistant to isoniazid and rifampicin with or without resistant to other first line drugs, based on results from quality assured laboratory. The main aim of this study was to study the treatment outcomes of longer regimen for MDR-TB patients.Methods: This is a retrospective observational cohort study. After obtaining ethical committee approval from Institutional ethics committee, data was collected from district TB centre from 2011-2016. Outcomes of a regimen is measured in terms of cured, treatment completed, number of defaulters, treatment failure, number of patients shifted to XDR-TB regimen, number of patients died for patients on longer regimen of MDR-TB. The collected data was entered in Microsoft excel 2007 and analysed using SPSS version 20 software.Results: Out of 211 patients, 167 were males and 44 were females. The total numbers of patients registered from rural areas were 123 and from urban areas were 88. The association between geographical distribution and treatment outcome was measured using Chi-square test and X2=12.1026, p=0.0005 which was significant. Out of 211 patients registered, 87 (41.2%) were cured of disease, 55 (26%) died, 2 (0.9%) patients shifted to XDR. 18 (8.5%) patients were defined as defaulters and 2 (0.9%) patients were defined as treatment failures.Conclusions: Our study findings have indicated that treatment outcomes in drug resistant TB may be influenced by rural and urban distribution

The utility of serial serum cholinesterase as a prognostic marker in organophosphorus compound poisoning

Background: Acute organophosphorus (OP) poisoning is one of the most common poisonings in India contributing to significant morbidity and mortality. Irreversible inhibition of cholinesterase enzymes is attributed to the serious clinical outcomes in these patients, which is assessed by the estimation of serum cholinesterase (SChE) levels. The present study was undertaken to evaluate the utility of serial estimation of SChE levels in patients of OP poisoning in predicting the clinical outcome.Methods: Medical records of 31 patients from January 2013 to December 2013 admitted in our institute with acute OP poisoning were analyzed for SChE at admission, 48 hrs, 72 hrs and 120 hrs after admission. Data regarding clinical findings at admission and outcomes were recorded.Results: Monocrotophos (55%) was the most commonly used OP compound. Mean serial SChE levels (in KU/L) at admission, 48, 72, and 120 hrs in patients who survived are 0.18±0.10, 0.28±0.14, 0.41±0.21, 0.46±0.16 and in patients who expired are 0.02±0.01, 0.05±0.02, 0.03±0.02, 0.03±0.02, respectively. SChE levels at admission in survived group, compared to those in expired group were statistically significant (p<0.001). About 92% patients in moderate to severe grade of poisoning (SChE levels <0.2 KU/L) were mechanically ventilated. The relationship between serial SChE levels in survival group and was found to be statistically significant (p<0.01).Conclusion: In the present study, significant increase in serial SChE levels were correlating with better clinical outcome as evidenced by an improvement with mechanical ventilation and survival rates in acute OP poisoning

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFECT OF AQUEOUS EXTRACT OF TERMINALIA CHEBULA, A PROPRIETARY CHROMIUM COMPLEX, AND THEIR COMBINATION IN SUBJECTS WITH JOINT DISCOMFORT

Objective: To evaluate the analgesic effect of an aqueous extract of Terminalia chebula (TCE), a proprietary chromium complex (PCC), and theircombination in subjects with joint discomfort.Methods: A total of 100 patients with knee joint discomfort were randomized into five treatment groups - TCE 500 mg BID, TCE 500 mg BID+PCC400 µg OD, PCC 400 µg OD alone, placebo, and TCE 250 mg BID, for 12 weeks in a double-blinded manner. Assessment of symptoms of knee joint painand discomfort was done by modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) and knee swelling index (KSI); visualanalog scale (VAS) was used for subjective assessment of pain, stiffness, and disability. Statistical analysis was done with GraphPad Prism 6.Results: Absolute reduction in mWOMAC score in TCE 500 mg (19.82±8.35), TCE 500 mg+PCC 400 µg (13.10±5.69), PCC 400 µg (8.30±3.81), placebo(2.45±3.07), and TCE 250 mg (10.47±4.43), respectively, at the end of 12 weeks as compared to the baseline values. Absolute reduction in KSI inTCE 500 mg (28.95±16.82), TCE 500 mg+PCC 400 µg (19.14±9.50), PCC 400 µg (12.7±4.86), placebo (10.03±3.8), and TCE 250 mg (18.24±6.86),respectively, at the end of 12 weeks as compared to the baseline values (p&lt;0.001). Similar results were seen with VAS assessments for pain, stiffness,and disability. All the treatments were well tolerated.Conclusion: TCE and PCC reduce joint discomfort.Keywords: Terminalia chebula extract, Proprietary chromium complex, Western Ontario and McMaster Universities Arthritis Index

Correlation between endothelial dysfunction, inflammatory status, oxidative stress and total (nitrite/ nitrate) in subjects with diabetes mellitus type 2

Background: Diabetes Mellitus is a systemic metabolic disorder associated with Endothelial dysfunction and increased systemic inflammatory state with oxidative stress leading to increased Cardiovascular risk. This study planned to correlate the level of Endothelial dysfunction with oxidative stress and inflammatory status.Methods: Study was conducted in 60 Diabetes Mellitus subjects of both genders with duration of more than two years. Endothelial dysfunction assessed as Augmentation Pressure and Augmentation Index generated from Radial artery waveforms by tonometer using Spygmocor PWA system. Plasma Total Nitrite/ Nitrate, High sensitive C - Reactive Protein, Malondialdehyde and Glutathione were measured.Results: Out of total 60 Diabetes Mellitus subjects 16 subjects were with Coronary Artery Disease. There was no significant difference in High sensitive C - Reactive Protein, Glutathione, Malondialdehyde and Total Nitrite/ Nitrate between Diabetes Mellitus with Coronary Artery Disease and without Coronary Artery Disease, however significant difference (p=0.02) was observed Augmentation Pressure between Diabetic alone (12.8±5.19 mm of Mercury) and diabetics with Coronary Artery Disease (16.13±33.47 mm of Mercury) and Augmentation Index (p=0.04) between Diabetic alone (29.8±5.68 mm of Mercury) and diabetics with Coronary Artery Disease (40.01±5.74). As endothelial function is age dependent the subjects were divided into three age groups (20-40 years, 40-60 years and more than 60 years). High sensitive C - Reactive Protein, Glutathione, Malondialdehyde, Total Nitrite/ Nitrate and Augmentation Index did not differ in the three age groups while Augmentation Pressure (p=0.0096) showed significant difference between age group 20-40 years (10.59±3.24) and age group more than 60 years (15.83±3.92).Conclusions: There is significant endothelial dysfunction observed in Diabetes Mellitus subjects and Diabetes Mellitus with coronary artery disease showed greater endothelial dyfunction. Thereby concluding that Diabetes Mellitus subjects were at higher risk for development of coronary artery disease and as endothelial dysfunction is an early event, it may have some prognostic value

Thioridazine: a potential adjuvant in pharmacotherapy of drug resistant tuberculosis Ki

Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. Despite advances in control strategies, inadequate treatment and failure to comply with drug regimens have resulted in TB to emerge as one of the most common and deadly infectious diseases worldwide. The emergence of drug-resistant TBhas evolved as a formidable obstacle for comprehensive TB control. Drug-resistant TB can be classified as multi-drug-resistant TB, extensively drug-resistant TB and totally drug resistant TB (TDR-TB). There is a paucity in the development of new drugs against drug-resistant mycobacteria. The focus has shifted to the exploration of anti-mycobacterial properties of drugs approved for other indications. Thioridazine, a drug approved for use in schizophrenia is one such potential agent, which has shown anti-mycobacterial activity. There is evidence of anti-mycobacterial action of Thioridazine in in-vitro and mouse models. There is a compelling need for new anti-mycobacterial drugs that are more effective and have less toxicity. Further clinical trials are advocated favoring the use of thioridazine as an adjuvant in the treatment of TB, especially TDR-TB

A randomized, double-blind, placebo-controlled, cross-over study to evaluate analgesic activity of Terminalia chebula in healthy human volunteers using a mechanical pain model

Background and Aims: To evaluate analgesic activity and safety of single oral dose (1000 mg) of Terminalia chebula using a mechanical pain model in healthy human volunteers. Material and Methods: Twelve healthy volunteers were randomized to receive either single oral dose of 2 capsules of T. chebula 500 mg each or identical placebo capsules in a double-blinded manner. Mechanical pain was assessed using Ugo basile analgesy meter (Randall–Selitto test) before and 3 h after administration of test drug. The parameters evaluated were pain threshold force and time; pain tolerance force and time. A washout period of 1-week was given for crossover between active drug and placebo. Results: Terminalia chebula significantly increased the mean percentage change for pain threshold force and time, and pain tolerance force and time compared to placebo (P < 0.001). The mean percentage change for pain threshold force and time (20.8% and 21.0%) was increased more than that of pain tolerance force and time (13.4% and 13.4%). No adverse drug reaction was reported with either of the study medications during the study period. Conclusion: T. chebula significantly increased pain threshold and pain tolerance compared to placebo. Both the study medications were well tolerated. Further multiple dose studies may be needed to establish the analgesic efficacy of the drug in patients suffering from osteoarthritis, rheumatoid arthritis and other painful conditions