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Background: Epilepsy is associated with stigma and bad health-related quality of life (HR-QOL) due to this, and side effects of the drug therapy. Newer anti-epileptics are claimed to be better than the conventional. We evaluated this based on comparison of HR-QOL in patients taking the respective therapy.Methods: An observational, cross-sectional, single point study involved 127 consenting patients from Neurology OPD at V.S. General Hospital. Quality of life in epilepsy-10 (QOLIE-10) questionnaire was used to measure HR-QOL in patients. SPSS software and Graphpad prism were used to analyze the variables.Results: Patients of 20-30 age group were commonly affected (37.80%) with a male predominance (56.69%). 41.73% were unemployed. The difference in HR-QOL between patients and controls in all three domains (epilepsy effects, mental effects, role function domains) of QOLIE-10 was significant (p=0.0002), indicating better HR-QOL in controls. The worst HR-QOL scores were found in Epilepsy effects domain. Metabolic adverse effects (38.58%) were the common ADRs. Sodium valproate was the most effective in controlling seizures (last seizure episode: 15 months). HR-QOL correlation between patients receiving monotherapy and polytherapy was significant (p=0.026) with monotherapy rendering a better HR-QOL. Comparison of HR-QOL between patients taking the conventional and the newer drugs was not significant (p=0.1768).Conclusions: Our study nullifies the claims that newer drugs are better than the conventional since no such benefit was seen in HR-QOL as well as ADRs. Our findings ruled out the belief that cases of epilepsy are better controlled with polytherapy.
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Background: Parkinson's disease (PD) is a highly debilitating disease characterized by tremors, bradykinesia and rigidity. It leads to lowered self-esteem and psychological consequences which affect quality of life. The aim of this study is to study the drug utilization pattern and assess the quality of life in patients of Parkinson’s Disease.Methods: 40 patients of PD at least 1 month duration and 20 age-based controls were analyzed for quality of life using Parkinson’s Disease Questionnaire-39 (PDQ-39). Drug prescriptions were analyzed.Results: Mean number of anti-Parkinson drugs prescribed is 2.65±1.21. Of 106 anti-Parkinson drugs prescribed, 45% were levodopa and carbidopa combinations, followed by dopamine agonists (18%), anticholinergic drugs (15%), amantadine (12%), MAO inhibitors (5%) and COMT inhibitors (5%). There were significant problems in speech, performance of daily chores and daytime somnolence (p<0.0001). Depression, isolation, cognitive decline and memory loss were noteworthy in the patients as compared to controls (p<0.05). 25% patients felt embarrassed due to their disease; 59% felt affected by others’ opinion, 60% felt difficulty in communicating with others (p<0.05). Almost 2/3rd patients needed help in personal care as compared to the control group (p<0.0001).Conclusions: Quality of life of parkinsonian patients is severely affected in spite of them receiving a large number of drugs. This may be both due to disease progression as well as medication. Levodopa-carbidopa combination is the most prescribed medication. Use of levodopa and carbidopa combination must be evaluated properly. Newer guidelines and interventions are the need of the hour which may provide a better outcome on the quality of life of parkinsonian patients.
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Background: Coronary artery disease (CAD) is the consequence of atherosclerosis in which inadequate blood flow in the coronary arteries leads to myocardial necrosis. The impact of ethnic on CAD might be underestimated within Indian communities. There have never been any studies done associating them to lipid profile patterns in the Indian setup hence this study is the first of its kind to work towards attending the absence of data in this direction.The study aimed to evaluate the presence of ethnic differences in lipid profile patterns and hypolipidemic drug use in CAD patients.Methods: An 8-week cross-sectional prospective study was conducted in the cardiology OPD of a tertiary care hospital. Adult CAD patients prescribed with at least one hypolipidaemic drug, having their lipid profile values and willing to give informed consent were selected. The prescription pattern was noted, and the lipid profile values of the patients classified as per ATP III guidelines by NCEP. Atherogenic dyslipidaemia was considered when patients had triglyceride levels >150 mg/dl and HDL<40 mg/dl. The collected data was analyzed using SPSS. P value less than 0.05 was considered as statistically significant.Results: A total of 123 patients enrolled. Out of these, 115 were Hindus and among Hindus, most were Brahmins (34). The most prescribed hypolipidaemic drug was Rosuvastatin. Thirty six patients had high triglyceride levels out of which 35 were Hindus. Low HDL (<40 mg/dl) was present in 70 patients out of which 64 were Hindus. Atherogenic dyslipidaemia was seen in 44 patients. Majority of them belonged to the age group of 51-60 years (43.2%) and were Patels. Total cholesterol and LDL were high in 1 and 2 Jains respectively. Lipid values were higher in Tier-3 city patients.Conclusion: Hindu patients in this study showed a poorer lipid profile while among the castes, Jains and Patel’s fared poorly. It was seen that atherogenic dyslipidemia is on a rise in the Indian population.
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Background: In a hot and humid country like India, the prevalence of superficial mycotic infections is on the rise due to contributing environmental and demographic factors. In this study, we sought to assess the efficacies of two oral antifungal drugs, Itraconazole (a traditional azole) and Terbinafine (the only orally available allylamine). The two drugs were analyzed to see whether they differed significantly in their cure rates of tinea cruris. Since data, that compares only systemically administered Itraconazole and Terbinafine in the treatment of tinea cruris, is limited, this study becomes imperative.Methods: 60 patients, all clinically confirmed cases of tinea cruris and belonging to the age group of 18-65 years, were recruited for this prospective study. Patients were then randomly divided into groups A and B and followed-up for a month. Group A received cap. Itraconazole 100 mg, twice a day, for 15 days while group B received tab. Terbinafine 250 mg, once a day, for 4 weeks. Both groups were given topical 2% Sertaconazole that had to be continued for 8 weeks. During the 4 visits, scores for the 3 parameters (erythema, pruritis and scaling) were calculated and recorded for statistical analysis.Results: Authors observed that majority of the patients were exposed to hot and humid environment that contributed to sweating and poor personal hygiene. The changes in scores of erythema, pruritis and scaling from the baseline visit for both, Itraconazole and Terbinafine, were statistically significant at week 4 with P < 0.05 for all parameters. But the difference between the scores of the two drugs was not found to be statistically significant.Conclusions: Although the sample size of this study was small and the data was limited, findings of this study supported that both Itraconazole and Terbinafine were highly effective in the treatment of tinea cruris.
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Background: Glutamate modulators are having immense potential and are newer entities for treating drug resistant depression. The objectives were to generate statistical evidence on basis of existing data of ketamine, memantine, riluzole and d-cycloserine in resistant depression.Methods: A total of 14 RCTs following PRISMA guidelines and matching inclusion and exclusion criteria were collected of ketamine (5), memantine (3), riluzole (2) and d-cycloserine (4) vs placebo in drug resistant depression. Only RCTs with primary diagnosis of drug resistant depression (Previously on two standard antidepressant therapy) were included. Studies with treatment response rate, 50% reduction in total score of the depression rating scale-Montgomery-Åsberg Depression Rating Scale or the Hamilton Depression Rating Scale or Beck Depression Inventory was chosen as clinical outcome measure. RevMan 5.3 software was used for the analysis.Results: In ketamine group using random effect model SMD was 2.122 (95% CI 0.659-3.584). P-value was statistically significant (random effect p <0.005 and in fixed effect <0.001). In memantine group, using random effect model -0.963 was SMD and (95% CI -1.958-0.0324). P-value was <0.001, significant in fixed effect. In riluzole group, SMD was -0.564 with (95% CI -3.927-2.799) in random effect. P-value was 0.741. In d-cycloserine group SMD was 0.316 with (95% CI -1.252-1.885) in random effect. P-value was 0.690.Conclusions: Ketamine showed best efficacy followed by memantine. Riluzole and DCS as such have no efficacy although its acts by same glutamate pathway. More molecular based research is required in use of glutamate modulators in resistant depression.
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Background: Electrolytes play an important role in various physiological functions of the body. Electrolyte disturbances are one of the most common problems encountered in critically ill patients. Drugs are also known to cause adverse electrolyte consequences. These drugs could be anti-hypertensive agents, hormones, antipsychotics or steroids. There is paucity of published literature on electrolyte disturbances caused by drugs. The purpose of our study was to evaluate the electrolyte disturbances caused by various drugs in critically ill patients.Methods: Following approval of the Institutional Ethics Committee, data collection was started. Adverse Drug Reactions (ADRs) presenting as an electrolyte disturbance in emergency medicine department or occurring in hospitalized patients in the Intensive care unit (ICU) of our hospital was be collected. ADRs resulting into electrolyte disturbances were identified and analysed in detail for demographic details, types of electrolyte disturbances, seriousness, severity, causality and preventability of ADRs. Fisher's exact test was done to find out the statistical difference between the electrolyte disturbances and different drugs.Results: Total 58 ADRs were reported as an electrolyte disturbance. Mean age of the patients affected was 52.48 years. Highest number of ADRs were observed in the age group of 61 to 70 years. Hypokalemia constituted 32 cases (55.2%) followed by hyponatremia (25.9%), hyperkalemia (6.9%), hypernatremia (6.9%), hypocalcemia (1.7%), hypomagnesemia (1.7%) and hypophosphatemia (1.7%). Insulin was associated with maximum cases of ADRs (27.6%).Conclusions: Electrolyte disturbances constitutes a major chunk of ADRs especially in critically ill patients. The physicians must be well-versed with the dynamics of fluid-electrolyte balance.
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Drug Therapeutic failure is a rare condition which is underreported in recent scenario. It is important for the chronic diseases like Hypertension where it could lead to fatal outcome. In our case report elderly male patient taking tablet Amlodipine once daily as antihypertensive medication and had 2 years without any events. Patient came to the emergency department with the complaint of altered sensorium and elevated blood pressure. The mechanism for sudden increase in blood pressure (Decreased Therapeutic Response) in patient with ongoing treatment with amlodipine could be due to sympathetic over activity (e.g. stress), pharmacokinetic variation or counterfeit drug.
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To have a better quality of life and to fight with the diseases evolved the concept of clinical trials. A test of any new or existing drug on human being through different phases to check the efficacy and safety of the molecule is clinical trial. To cope up with the defects in drug system, India introduced Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules in 1945. Objective: To compare and contrast the different GCP guidelines and law suits, penalties, worldwide. We reviewed different internet databases and resources to find out the various penalties. The death occurring during clinical trials shook the pillars of credibility of clinical trials and led the government to make some regulatory provisions. The outcome is that now the ethics committee has to be accredited by a competent authority. This step led many problems for upcoming as well as the existing ethics committee and trial sites. The objective of the review article is to know the roles and responsibilities of different players of clinical trials i.e. the investigator, the sponsor and the ethics committee and to know the laws governing their responsibilities and the penalties affiliated to it. Since now the clinical trials in India are becoming more and more stricter there is a dire need to make aware the ethics committee members, sponsor and the investigator of their rights and duties towards one another and towards the patient/subject, so the tragedies in the clinical trials can be minimized.
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Background: Benzodiazepines (BZD) is one of the commonly used drug groups for certain neurological diseases. As sometimes, the anti-epileptic drugs (AEDs) may be used concomitantly with BZD there is a potential for drug-drug interactions. Study aimed to study potential drug-drug interactions between four commonly used AEDs (phenytoin, carbamazepine (CBZ), phenobarbitone, sodium valproate) and BZD (diazepam, clonazepam) in mice using maximal electroshock seizure (MES) method and pentylenetetrazole (PTZ) method. Methods: Adult male albino mice were divided into four different groups of six animals each and anti-epileptic activity was assessed using MES method and PTZ method. Group I acted as a control, Group II received any one of the four AEDs (phenytoin, CBZ, phenobarbitone or sodium valproate) in sub-effective doses, Group III received diazepam or clonazepam alone, Group IV received a combination of diazepam or clonazepam with any one of the AEDs. Results: In MES method, the groups receiving combination of diazepam with phenytoin and CBZ showed significant protection compared to the control group (p<0.01 and p<0.02), respectively. However, diazepam in combination with sodium valproate and phenobarbitone did not show any significant protection compared to the control group and individual antiepileptic group. All the four antiepileptic showed significant protection against MES seizure in combination with clonazepam when compared to control group. In PTZ method, combination of sodium valproate with clonazepam showed significant protection compared to control group (p<0.02). However, this was not observed with diazepam-valproate combination. Conclusion: Clonazepam potentiates the action of all the four anti-epileptics while diazepam potentiates only phenytoin and CBZ against MES seizures. Clonazepam but not diazepam potentiates the action of sodium valproate against PTZ seizures.
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Background: Use of anti-emetic drugs in pediatric population is often warranted, but choice of drug remains questionable within pediatricians. Objective of current study is: to study prescribing pattern and to calculate cost of antiemetic drug therapy in pediatric wards. Methods: A prospective, observational study was conducted in pediatric wards of a tertiary care hospital of over 14 month’s duration. Institutional ethics committee approval was obtained and written informed consent of parents/guardians was taken. Data of any pediatric patient receiving anti-emetic agent were included in the study. Results: A total of 218 prescriptions were collected. Mean age of patients was 4.39±3.16 (range 4 months to 12 years). Gastroenteritis was the most frequently diagnosed disease in 137(63%) patients. Domperidone was prescribed in 52.4% and ondansetron in 47.6% children. Oral liquid dosage formulation was prescribed in 109 (48.4%) followed by solid dosage form 47 (20.9%). Mean cost of domperidone therapy was 25.34±6.55 INR and for ondansetron it was 36.62±17.94 INR. Conclusions: Gastroenteritis was most frequent indication for use of anti-emetics. Domperidone pharmacotherapy was cheaper and most frequently prescribed than ondansetron.
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Background: Various combinations of analgesics antipyretic drugs are available in the market for treatment of various musculoskeletal disorders and pain relief. Diclofenac and paracetamol combination is most commonly used combination and its rationality is questionable. The objective of this study was to compare the analgesic, anti-inflammatory and anti-pyretic activities of diclofenac, paracetamol and their combination. Methods: Experimental animals were divided into 4 different groups – control, diclofenac, paracetamol and their combination. Analgesic activity was compared by using tail-clip method in rats and writhing test in mice, anti-inflammatory activity was compared by carrageenan paw edema method using plethysmometer and anti-pyretic action was compared using TAB vaccine induced pyrexia and measuring the rectal temperature. Different doses of diclofenac (1mg/kg and 2mg/kg) and paracetamol (10mg/kg and 20mg/kg) used and same doses were used in combination group. Results: Diclofenac sodium (1mg/kg) showed significantly higher analgesic activity using tail-clip and writhing method compared to paracetamol (10mg/kg) (p<0.0001) and the combination group (p<0.05). Diclofenac sodium (2mg/kg) showed significantly higher analgesic activity using tail-clip and writhing method compared to paracetamol (20mg/kg) (p<0.0001) and the combination group (p<0.1). Diclofenac has no significant difference in anti-inflammatory activity using carrageenan induced paw edema when compared to the combination group (p<0.1) for both doses. But diclofenac when compared to paracetamol for anti-inflammatory effect, it was highly significant (p<0.0001 and p<0.0004) for both doses at 1st and 3rd hour. Paracetamol 20mg/kg was superior antipyretic (p<0.05,0.01 and 0.01 ) when compared to the combination group at 1hr, 2hr and 3hr duration after injecting TAB vaccine. Conclusion: Diclofenac and paracetamol combination was either equal or inferior in all three activities studied as compared to the individual drugs.
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OBJECTIVES: This study aimed to analyze the pattern of surgical chemoprophylaxis, surgical site infection rate, and to check rationality of surgical chemoprophylaxis based on Kunin's criteria. MATERIALS AND METHODS: A prospective, observational study was performed on patients undergoing surgery, in a tertiary care teaching hospital. Data were collected in a pro-forma which included the patients' details, prescriptions from date of admission to discharge or any other outcome and operative notes. Surgical site infection as defined by Centre for Disease Control criteria was recorded. Rationality was assessed based on Kunin's criteria. RESULTS: Total 220 patients were enrolled over a period of one year. Mean hospital stay was 8.67 ± 5.17 days. A total of 2294 drugs were prescribed out of which 840 (36.61%) were antimicrobials. Mean duration for pre-operative intravenous antimicrobial therapy was 0.75 ± 0.45 day and for post-operative intravenous antimicrobial therapy was 3.33 ± 2.24 days while post-operative oral antimicrobial therapy was 4.58 ± 3.34 days. Third generation cephalosporins were prescribed most frequently 64.74% and 64.40% pre-operatively and post-operatively respectively. Antimicrobial prescribing was inappropriate in 52.28%. Total of 19 patients developed surgical site infection. Surgical site infection rate was significantly higher (13.04%) in patients receiving inappropriate chemoprophylaxis (p < 0.01). Surgical site infection adds 9.98 days of hospital stay (p < 0.0001) and 3.57 extra drugs (p < 0.0001) compared to group without surgical site infection. CONCLUSION: Inappropriate use of antimicrobials is highly prevalent in surgical chemoprophylaxis leading to higher surgical site infection rate. Adoption of international standard and formulation of locally feasible guidelines can help overcome this situation.