International Journal of Basic & Clinical Pharmacology

Individual component analysis of gastrointestinal symptom rating scale for irritable bowel syndrome in irritable bowel syndrome patients treated with Bacillus coagulans SNZ 1969: additional findings from a randomized, double-blind, placebo-controlled study

Kishan P. V., Raunak J. Soman, Dhruv Soman, Sarath Chandra Gorantla — Tue, 25 Feb 2025 00:00:00 +0530

This study evaluated the therapeutic efficacy of Bacillus coagulans SNZ 1969 (B. coagulans SNZ 1969) in patients with constipation-predominant irritable bowel syndrome (IBS-C) and diarrhea-predominant IBS (IBS-D). We conducted a randomized, double-blind, placebo-controlled trial in 80 patients (40 IBS-C, 40 IBS-D) who received either B. coagulans SNZ 1969 (500 million CFU) or placebo twice daily for 60 days. Assessments were performed at baseline and on days 30, 60, and 75. Here we present the additional findings of the individual components of Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS). Results demonstrated significant reductions in all individual components of GSRS-IBS (abdominal pain, bloating, constipation, diarrhea, and satiety) in both IBS-C and IBS-D patients treated with B. coagulans SNZ 1969 compared to placebo. In conclusion, B. coagulans SNZ 1969 found to be an effective therapeutic option for IBS, demonstrating broad efficacy across multiple symptom domains.

Role of immunotherapy in cancer management

Jeeja M. Cherumanalil, Salwa Pannikkottuthodi, Jayakrishnan Thayyil — Fri, 31 Jan 2025 00:00:00 +0530

Cancer remains one of the leading causes of mortality worldwide accounting for nearly 20 million new cases and 10 million deaths, prompting continuous research for more effective treatments. In recent years’ immunotherapy has transformed the landscape of cancer treatment, with significant breakthroughs promising more targeted and durable outcomes. Unlike standard treatments, such as surgery, chemotherapy, and radiation, which directly target cancer cells, immunotherapy aims to boost or replace the immune system's natural ability to fight cancer. Since it is a new mode of therapy most of the practicing doctors are unaware of the details about it. In this context, we conducted a narrative review based on available literature. This article explores the historical background and evolution of immunotherapy, the mechanisms of various immunotherapeutic plans, recent advancements, future directions, and challenges in this field. Our paper focused on, checkpoint inhibitors, chimeric antigen receptor T (CAR-T) cell therapy, oncolytic virus therapy, and cancer vaccines. As the field continues to evolve, collaboration among researchers, clinicians, and patients is essential to drive these advancements and improve outcomes in cancer care.

Formulation and characterization studies of microspheres

Tue, 25 Feb 2025 00:00:00 +0530

In the current scenario of delivering therapeutic agents to the target site requires an efficient drug delivery carrier which can delivery the drug only on the site of action in a sustained and controlled manner among many such carriers microspheres fulfill all the parameters for a potent drug carrier. Microspheres are free flowing powders consists of proteins or synthetic polymers that are biodegradable in nature ranging between 1–1000-micron size. A well-designed controlled drug delivery system can overcome some of the problems of conventional therapy an enhanced the therapeutic efficacy of given drug. Microspheres received much attention not only for prolonged release, but also targeted anticancer drugs. Microspheres can be manufactured by various type of material such as glass, polymers and ceramics microspheres. Microspheres are various types like bioadhesive microspheres, magnetic microspheres, floating microspheres, radioactive microspheres, polymeric microspheres are prepared by methods like spray drying, solvent evaporation, single emulsion, double emulsion, solvent extraction, quassi emulsion solvent diffusion. Microspheres will play a key role in novel drug delivery in the future by fusing together a variety of other strategies especially in diseased cells, diagnostics and act as supplements as miniature versions of diseased organ and tissues in the body.

Exploring the phytochemical constituents of Aegle marmelos (bael) and their therapeutic potential against chronic diseases

Lopamudra Sahoo, Yashaswi Nayak, Sanjib Kumar Mohanty — Tue, 25 Feb 2025 00:00:00 +0530

Aegle marmelos (Bael), a highly esteemed plant in traditional medicine, is recognized for its remarkable therapeutic properties, attributed to its rich and diverse phytochemical composition. The plant contains bioactive compounds such as alkaloids, flavonoids, tannins, phenolic acids, coumarins and essential oils, which contribute to its pharmacological activities. These compounds exhibit potent antioxidant, anti-inflammatory, antidiabetic, antimicrobial, hepatoprotective and cardioprotective effects, positioning Bael as a promising natural remedy for managing chronic diseases. Bael has demonstrated significant efficacy in regulating blood glucose levels, enhancing insulin sensitivity and protecting pancreatic beta cells, making it an effective agent in diabetes management. Additionally, its strong antioxidant and anti-inflammatory activities are essential in combating oxidative stress and chronic inflammation, which are key drivers of metabolic and neurodegenerative disorders. Bael’s antimicrobial properties further expand its potential to address infections and gastrointestinal issues. However, the integration of Aegle marmelosinto mainstream medicine faces challenges, including variability in its phytochemical composition, lack of standardized formulations and insufficient clinical trials to validate its safety and efficacy. This review aims to comprehensively explore the phytochemical constituents of Aegle marmelosand their therapeutic potential, particularly against chronic diseases. By identifying research gaps and future directions, it seeks to support the development of Bael as a reliable, standardized and effective therapeutic agent for modern healthcare.

Potential of Coriandrum sativum in management of diabetes and hyperlipidemia: a comprehensive review of pharmacological evidence and mechanisms

Sanjaya Kumar Y. R., Deepak Lamba, Shruti Khanduri, Srikanth N. — Tue, 25 Feb 2025 00:00:00 +0530

Diabetes mellitus, obesity, and hyperlipidaemia are interconnected metabolic disorders with rising prevalence worldwide, posing significant public health challenges. These conditions often coexist, forming a metabolic syndrome characterized by elevated glucose levels, excess body fat, and abnormal lipid profiles, leading to severe complications such as cardiovascular diseases and organ dysfunction. Coriandrum sativum (coriander), a culinary herb with a long history of medicinal use in traditional systems like Ayurveda, has shown promising therapeutic potential in managing these metabolic disorders. Rich in bioactive compounds such as flavonoids, polyphenols, and essential oils, coriander exhibits antidiabetic and antihyperlipidemic activities. Its efficacy has been demonstrated in various experimental models of diabetes and Hyperlipidemia, with significant reductions in blood glucose levels, lipid parameters, and oxidative stress markers. The mechanisms underlying these effects include stimulation insulin secretion, inhibition of α-glucosidase activity, modulation of lipid metabolism, and antioxidant activity. This review comprehensively evaluates the pharmacological actions and mechanisms of coriander, including its seed and leaf extracts, essential oils, and dietary incorporation, in mitigating hyperglycaemia, dyslipidaemia, and obesity-associated complications. By integrating traditional knowledge with modern scientific evidence, this article highlights the therapeutic potential of Coriandrum sativum as a natural remedy for addressing the escalating burden of metabolic disorders.

N-acetylcysteine in skin picking disorders

Kanesan Vickneswaran, Helen Wiseman, Rabi Nambi — Fri, 31 Jan 2025 00:00:00 +0530

We have come across a selection of case studies referencing the effective use of N-Acetylcysteine (NAC) in the treatment of skin picking disorder and other impulsive behaviours. NAC’s pivotal roles in modulating oxidative stress, influencing inflammatory pathways and supporting skin barrier function are thought to be contributing factors in resolving skin picking disorders. Skin picking disorder (SPD) is a “repetitive skin manipulation, resulting in visible tissue damage and the impairment of social functioning”. Despite the huge impact of this condition on quality of life, there have been inconsistent results in successfully treating this condition using current therapeutic modalities.

Contribution of clinical pharmacy to the rational and safe use of medicines in the neonatology unit of the pediatric university hospital Charles de Gaulle of Ouagadougou, Burkina Faso

Tue, 25 Feb 2025 00:00:00 +0530

Background: Newborns are exposed to drug therapeutic risks due to off-label prescribing and immaturity. The purpose of this study is to identify drug-related problems through the prescription and administration of drugs in the neonatology Unit and identify the need for pharmaceutical interventions.

Methods: To assess drug-related problems, a cross-sectional observational study was conducted over five days at the neonatology Unit of the Pediatric University Hospital Charles de Gaulle in Burkina Faso. The study population consisted of newborns receiving drug prescriptions and treatment for five days.

Results: Prematurity (50%) and early neonatal infection (53.3%) were the most common reasons for admission. A total of 380 prescription lines were recorded. Injectable and oral forms represented 72.1% and 26.3% respectively. Prescription lines in 16.8% were off-label medicines. An accuracy of drug dosages at 6.1% and an accuracy of prescribed doses at 52.7%, characterized therapeutic regimens. The prescribed drug administrations were performed in 80.0% with compliant doses and administration scheduled time 1 hour in 53.4 % and 54.6 %, respectively. Prescribers and nurses accepted 92.6% and 93.9% of proposed pharmaceutical interventions to solve drug-related problems.

Conclusion. Our study emphasizes the importance of a clinical pharmacist within the health care team for the safe and efficient prescription and administration of newborn medication.

In vivo antibacterial activity and biochemical effects of methanol extract of Annona muricata leaves against multidrug- resistant Salmonella Typhimurium in Wistar rats

Tue, 25 Feb 2025 00:00:00 +0530

Background: The increasing antibiotic resistance and paucity of new antibiotics has contributed greatly to the high morbidity and mortality of salmonellosis necessitating the search for alternative treatments. Annona muricata has shown promising activity against multidrug-resistant (MDR) Salmonella in vitro but in vivo studies are rare. This study evaluated the activity of A. muricata, against MDR Salmonella Typhimurium in vivo.

Methods: The minimum inhibitory concentration (MIC) of a methanol crude extract of A. muricata was determined by micro-dilution assay against a characterized MDR clinical S. Typhimurium strain. Wistar rats infected with 3 x 108 CFUs/mL of the MDR strain were treated with 50-200 mg/kg body weight of extract for 10 days. Faecal load of S. Typhimurium colonies was determined by the direct plate count technique on days 1, 5 and 10. Animals were sacrificed and blood was collected for biochemical analyses. Data were analysed using GraphPad Prism Software.

Results: The S. Typhimurium strain was multidrug-resistant and the extract recorded a MIC of 2 mg/ml The extract produced a significant (p<0.001) dose-dependent reduction in Salmonella colonies in faeces of treated rats with a 100% inhibition recorded at 200 mg/kg body weight on day 10. Liver and renal function tests did not indicate any abnormalities (p<0.05).

Conclusions: This is the first report of in vivo activity of A. muricata leaves against multidrug-resistant Salmonella. The high activity and lack of adverse toxicity supports it use in traditional medicine and hence is a potential treatment for resistant Salmonella infections.

Liver biomarkers of silymarin milk thistle on paracetamol induced liver toxicity in adult albino rats (Rattus norvegicus)

Davis Kiprono Ngetich, Scolastica Korir — Tue, 25 Feb 2025 00:00:00 +0530

Background: Paracetamol is the most common analgesic that is readily available with or without prescription over the counter and its toxicity is due to misuse or overdose associated with liver damage. Silymarin milk thistle is an edible herb believed to have antioxidant, scavenging and regulation of glutathione contents within the cell. Aim of the study was to determine the effects of different doses of silymarin milk thistle on liver biomarkers of paracetamol induced liver toxicity among albino rats.

Methods: Twenty-four adult albino rats were randomly grouped into four groups each group consisting of six animals. Paracetamol-only group given high dose paracetamol-750 mg/kbwt and control group received water and food only. The experimental group, were divided into three subgroups with all receiving high dose paracetamol for five days and thereafter given varying doses of silymarin milk thistle. SIL-G1 given 200 mg/kbwt of silymarin milk thistle, SIL-G2 given 400 mg/kbwt of silymarin milk thistle and SIL-G3 was given 600 mg/kbwt of silymarin milk thistle. All the animals were fed with standard rodent foods and water ad libitum. After completion of 24 hours of the last drug administration, they were humanely sacrificed, serum biochemical analysis of liver biomarkers (ALP, ALT and AST) was determined.

Results: High dose of paracetamol induced liver toxicity. Upon administration of high dose of silymarin milk thistle, there was restoration of ALP, AST and ALP of all these biomarkers in relation to the control group.

Conclusions: These findings showed that high dose (600 mg/kbwt) of silymarin milk thistle was found to have restorative effects and normalized liver biomarkers of ALP, AST and ALT.

Assessing anticancer drug utilization patterns through WHO prescribing indicators at a specialized cancer hospital in Peshawar

Tue, 25 Feb 2025 00:00:00 +0530

Background: Efficient utilization of anticancer agents is crucial for effective malignancy treatment and cost management. WHO Prescribing Indicators provide a standardized measure for assessing drug usage. This study aimed to evaluate anticancer drug utilization patterns in a specialized oncology hospital using these indicators.

Methods: A cross-sectional analysis involved reviewing medical records of anticancer drug prescriptions at a designated cancer treatment facility. Key WHO prescribing indicators, including drug per prescription average, proportions of anticancer drugs and generics usage, were assessed.

Results: Analysis of 900 prescriptions revealed an average of 8.36 drugs per prescription, with 2.27 being anticancer drugs and 4.93 adjuvants. Notably, 71% of medications were prescribed generically 85% were on the Essential Medicines List. Opportunities for enhancing efficiency, like promoting generic drugs and reducing injectable anticancer agents, were identified.

Conclusions: This study highlights the value of WHO Prescribing Indicators in analysing anticancer drug utilization trends. Addressing prescribing deficiencies can refine treatment protocols, promote judicious pharmaceutical use and elevate patient care standards. Future efforts should focus on targeted strategies to rectify these shortcomings, emphasizing ongoing research and quality improvement in oncologic pharmacotherapy.

Preclinical hematological profile studies of an ayurvedic medicine Krishna Chaturmukha after chronic administration to male Sprague-Dawley rats

Tue, 25 Feb 2025 00:00:00 +0530

Background: Krishna Chaturmukha (KMC) is an ayurvedic formulation predominantly used as a traditional medicine in the rural population to get relief from various neurological disorders.

Methods: The acute pharmacological test of KMC recorded no death or any signs of effectivity even at the highest dose of 4000 mg/kg body weight. The effect of chronic administration of KMC on hematological parameters was determined by administrating chronically to the male Sprague-Dawley rats at a dose of 100 mg per kg body weight for 40 days.

Results: There was a (10.12 %) decrease in the number of white blood cell count of the male rats, which, although not statistically significant yet it was prominent (p=0.248). Similarly, a negligible (0.12 %) decrease in the red blood cell count was observed, which was not statistically significant at all (p=0.965). Conversely, the platelets count showed a (4.99 %) increase in the experimental animals, while this increase was not significant, yet it was prominent (p=0.296). Furthermore, a (1.89 %) decline was observed in the platelet volume distribution width of the experiment rats, which, although not significant, yet it was noticeable (p=0.076).

Conclusions: From this study, it is evident that there is no significant change in the hematological parameters in the body of the treated rats, therefore it is safe to use in usual dose. Further research and analysis with biochemical parameters should be done to reconfirm the safety of this ayurvedic medicine.

Synergizing sodium-dependent glucose transporter inhibitors with dipeptidyl-peptidase 4 inhibitor and metformin: a novel approach to diabetes management in India

Thu, 16 Jan 2025 00:00:00 +0530

Background: The rising prevalence of diabetes in India necessitates effective and targeted management strategies. This article explores the efficacy of synergistic action of key antidiabetic agents, including metformin, sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, and dipeptidyl-peptidase-4 (DPP-4) inhibitors, in a fixed dose combination.

Methods: The current survey obtained the opinion of the health care professionals (HCPs) on the benefits and significance of the triple fixed dose combinations (FDCs) of dapagliflozin, sitagliptin, and metformin in type 2 diabetes mellitus (T2DM) management.

Results: The poll indicates that ~97% of the healthcare practitioners agreeing on the importance of achieving better time in range with the FDC and the potential benefits of early initiation of the FDC for improved glycemic control and cardio-renal outcomes. Majority of HCPs (77%) express confidence in the safety profile of the combination in T2DM. Almost all (99%) of the HCPs agree on the need for collating real-world data from HCPs to understand the effectiveness of FDC in India and for devising evidence based strategies.

Conclusions: The triple FDC of dapagliflozin, sitagliptin, and metformin stands out as a promising approach for diabetes management. The study also underscores the importance of conducting extensive, large scale real-world studies to gather more data, contributing to evidence based strategies for diabetes management in the Indian population.

Comparative study to evaluate efficacy and safety of topical alcaftadine 0.25% versus topical olopatadine 0.2% eye drops in patients with allergic conjunctivitis in a tertiary care teaching hospital, Haldwani

Tue, 07 Jan 2025 00:00:00 +0530

Background: Ocular component is the most prominent and disabling feature of allergy leading to symptoms like itching and watering of eyes causing significant irritation^. Allergic conjunctivitis (AC) is one of the most common ocular conditions affecting adult and pediatric patients that requires treatment by ophthalmologists. AC and its debilitating symptoms like itching, watering of eyes and ropy discharge have interfered their day to day activities, difficulty in concentrating in work and has adversely affect the quality of life. Aim and objectives were to study and compare the efficacy and safety profile of topical alcaftadine versus topical o lopatadine eye drops in patient with AC. To compare efficacy of topical alcaftadine versus topical olopatadine eye drops, to observe adverse drug reaction of both eye drops.

Methods: A prospective, open labelled comparative hospital based study was conducted in the department of ophthalmology in collaboration with department of pharmacology GMC Haldwani, Uttarakhand. Patients with AC (n=120) were randomised into two groups: Alcaftadine 0.25% eye drop and olopatadine 0.2% eye drop once daily. Patients were assessed on the first day 2^nd week and 4^th week. Reduction in total severity score and efficacy was measured in both treatment groups. Safety was assessed by observing adverse drug reaction using WHO UMC Causality assessment scale and modified Hartwig Siegel’s severity scale.

Results: A trend in significant improvement in patients treated with alcaftadine eye drop in comparison to patients treated with olopatadine eye drop at both second week and fourth week follow up. No adverse effects were reported with either eye drops in both groups.

Conclusions: Alcaftadine eye drop showed higher efficacy than olopatadine eye drop in relieving signs and symptoms of AC. Both treatment groups were found to be safe and effective.

Frequency and management of non pain symptoms, in cancer patients receiving palliative care: a prospective, observational and cross-sectional study in a tertiary care institute

Asra Kichloo, Shabnam Choudhary — Tue, 07 Jan 2025 00:00:00 +0530

Background: Cancer is the second most common cause of death caused by non-communicable diseases around the world, causing serious stress in both patients and caregivers including physical, psychological, social, and economic problems. Advanced cancer patients often experience a range of debilitating non-pain symptoms that significantly impact their quality of life. These symptoms can be due to the disease itself or the side effects of treatment. Effective management of these symptoms is crucial for palliative care (PC). The main aim of this study was to identify the frequency and management strategies of common non-pain symptoms in patients with cancer admitted to the oncology ward and inpatient PC patients, receiving PC.

Methods: A prospective, observational study was conducted involving 100 patients, admitted to the oncology ward and inpatient PC patients, receiving PC. Structured interviews and questionnaires were used to collect data on non-pain symptoms experienced. The frequency of symptoms was analyzed using specific statistical methods and the effectiveness of various management approaches was evaluated.

Results: The majority of the admitted patients were poly-symptomatic. The two most prevalent non-pain symptoms reported were lack of appetite (52%) and fatigue (51%) followed by nausea and vomiting, insomnia, constipation, shortness of breath, and anxiety. Ondansetron is the most common antiemetic and hydrocortisone is the most common steroid prescribed in the study population.

Conclusions: In the findings of our survey significant prevalence of non-pain symptoms among cancer patients was seen, with fairly controlled symptoms after the management. This emphasizes the need for a comprehensive assessment of symptoms and routine monitoring of symptom management strategies in cancer patients.

Antibiotic prescription assessment in geriatrics using anatomical therapeutic chemical/defined daily dose classification and World Health Organization-essential medicines list AWaRe guidelines: a prospective and observational study

Thu, 16 Jan 2025 00:00:00 +0530

Background: Geriatric patients are individuals with compromised overall functioning. The objective of this study was to assess the prescribing pattern and evaluate the therapeutic efficacy of the prescribed antibiotics.

Methods: The prescribed antibiotics were grouped using anatomical therapeutic chemical classification (ATC) and World Health Organization defined daily dose (WHO DDD)/100-bed days was calculated to analyse consumed antibiotics. The neutrophils and lymphocyte count before and after therapy was used to assess the therapeutic efficacy.

Results: Disease frequency was categorised using the International classification of disease (ICD-11) which reported 126 diseases, with 50 cases grouped under respiratory system. Selection of antibiotic was mainly definitive (37.14%) with dual therapy (55.71%) and with antibiotic sensitivity test (61.43%). Cephalosporins, was the most prescribed antibiotic class, specifically ceftriaxone. For every 100 bed days, 6.7 DDD of antibiotics were consumed in which 103 antibiotics were administered via intravenous route and 42 oral routes. The deviation of prescribed daily dose (PDD) from the DDD was performed for prescribed antibiotics of varying doses. Significant percentage deviation was observed for azithromycin (-70%) and piperacillin+tazobactam (-4.79%). The negative sign of the deviation indicates that the mean PDDs were higher than their respective WHO DDD. Furthermore, 81.38% of consumed antibiotic was from watch category of WHO essential medicine list (EML). Interestingly, the decrease in neutrophils and increase in lymphocytes prove the therapeutic efficacy of antibiotics.

Conclusions: Watch antibiotics was the most prescribed and therapeutic efficacy was frequent with dual antibiotics therapy and in monotherapy of piperacillin-tazobactam.

A prospective observational study on loop diuretic utilization in a tertiary care hospital setting

Hemant Nayak, Waseem Hussain Bhat, B. R. Prabhudev, Balakeshwa Ramaiah — Fri, 14 Feb 2025 00:00:00 +0530

Background: Loop diuretics are essential for managing fluid overload in conditions like heart failure and chronic kidney disease. However, data on their utilization and adverse outcomes in resource-limited settings are scarce. To evaluate utilization patterns, adverse drug reactions (ADRs), and outcomes of loop diuretic therapy in a tertiary care hospital.

Methods: A prospective observational study was conducted on 100 inpatients from January 2023 to October 2023. Data on demographics, clinical indications, ADRs, and prescription patterns were analyzed.

Results: Furosemide was most prescribed (70%), followed by torsemide (20%) and bumetanide (10%). Main indications included congestive heart failure (40%), hypertension (24%), and chronic kidney disease (20%). Common ADRs were hypokalemia (16%), hypotension (10%), and dehydration (6%). Symptomatic improvement was noted in 70% of cases, with 20% showing no change and 10% worsening. Economic costs exceeded ₹1,000/month for 30% of patients, despite high medication adherence (80%).

Conclusions: Furosemide remains the most used diuretic, but ADRs and economic burdens highlight the need for regular monitoring and cost-effective strategies. Personalized therapy can optimize outcomes, and further multicenter studies are required for broader insights.

Comparative evaluation of dexmedetomidine with tramadol for post spinal anaesthesia shivering: a prospective randomized comparative study

Shivangi Ganjoo, Lalit Mohan Sharma, Raghav Gupta — Tue, 25 Feb 2025 00:00:00 +0530

Background: Shivering after spinal anaesthesia is an unpleasant complication that also results in increased oxygen demand. Researchers have looked at various dosages of tramadol to see whether it helps with shivering after spinal anaesthesia. We compared dexmedetomidine with tramadol 1 mg/kg for the management of post-spinal anaesthesia shivering.

Methods: We selected 50 patients who developed shivering after subarachnoid block and split them in half; each group had 25 individuals. One group was administered 1mg/kg intravenous tramadol diluted in 100 ml normal saline, while the other group received 0.5 mcg/kg of dexmedetomidine diluted in 100 ml normal saline. Response time, defined as the duration until shivering stopped after drug administration, was the primary outcome measure. Response rate (defined as a complete cessation of shivering within 15 minutes of administering the drug), recurrence of shivering, changes in clinical parameters and pharmacological side effects were considered secondary outcomes.

Results: When compared to tramadol (8.91±1.36 minutes), dexmedetomidine (6.74±1.38 minutes) had a considerably shorter response time (p<0.001). Both groups showed a 96% response rate and 8% recurrence of shivering. There was 1 case of hypotension with dexmedetomidine and 2 cases of nausea with tramadol. All patients in group T recorded a sedation level of 1, whereas all patients in group D recorded a sedation score of 2 (p<0.001).

Conclusions: Both dexmedetomidine and tramadol are effective in treating post spinal anaesthesia shivering, but the time taken for shivering to stop completely was significantly lesser with dexmedetomidine(0.5 μg/kg) than with tramadol(1 mg/kg).

Prospective observational study of blood pressure variation and malnutrition using body composition monitor in hemodialysis patient in tertiary care hospital

Shuaib Hussain, Blessy K. George, Balakeswa Ramaiah — Tue, 25 Feb 2025 00:00:00 +0530

Background: Blood pressure (BP) variations and malnutrition are critical concerns in hemodialysis patients, significantly impacting morbidity, mortality and quality of life. Accurate assessments using tools such as the Body Composition Monitor (BCM) can guide effective interventions to improve outcomes. This study aimed to evaluate BP variations and malnutrition in hemodialysis patients using BCM, analysed dialysis-related complications and assess the impact of targeted interventions on patient outcomes.

Methods: A prospective observational study was conducted on 125 hemodialysis patients at a tertiary care hospital. Data on BP variations, nutritional status and complications were collected using BCM and the Medical Outcomes Study Short Form-36 (MOS SF-36) questionnaire. Pharmacological and non-pharmacological interventions were tailored based on findings. Follow-up data assessed changes in body composition and complication rates.

Results: Hypertension was the most prevalent BP variation (63.2%), followed by hypotension (26.4%) and intradialytic hypotension (IDH) (8%). Malnutrition affected 24.8% of patients, primarily older males. During follow-up, patients with normal indices of lean tissue (28 to 54), fat tissue (28 to 54) and BMI (28 to 54) increased significantly. The most common dialysis-related complications were cramps (43.2%), itching (28%) and edema (20.8%). Targeted interventions, including nutritional supplementation and BCM-guided fluid management, reduced complications and improved nutritional and hemodynamic parameters.

Conclusions: The study highlights the high prevalence of hypertension and malnutrition among hemodialysis patients and underscores the utility of BCM in optimizing patient management. BCM-guided interventions were associated with improved nutritional status and reduced complications, emphasizing the need for individualized care strategies. Further multicenter studies are recommended to validate these findings and expand their applicability.

Comparison of safety and efficacy of lithium and lithium with SSRI in bipolar disorder

Tue, 25 Feb 2025 00:00:00 +0530

Background: Bipolar disorder is a serious psychiatric illness resulting in depression and mania that affects approximately 1.5% of the world population and represents a significant source of individual morbidity and mortality. Hence the present study was undertaken to compare the safety and efficacy of Lithium and Lithium with SSRI in Bipolar disorder.

Methods: Study was conducted in outpatient department, Department of Psychiatry, Basaveshwar Teaching and General Hospital attached to Mahadevappa Rampure Medical College, Kalaburagi, Karnataka. After obtaining Informed and written consent, Total 60 patients were selected after inclusion and exclusion criteria. Patients were diagnosed according to MINI and were divided into 2 groups, Group 1: Patients receiving Lithium 800-1200 group 2: Patients receiving Lithium + Escitalopram 20 mg/those intolerants to Escitalopram were given Sertraline 100 mg. Both groups were followed up regularly at interval of 1, 3, 5 and 8 weeks

Results: Findings were tabulated according to comparative tools like MADRS, YMRS, C-SSRS, CGI- BP & QOLS, they were subjected to t-test and ANOVA to verify the outcome

Conclusions: Patients treated with Lithium + SSRI showed to have better quality of life and had a lower risk of switch to manic episodes.

Drug-related problems among type 2 diabetes mellitus patients with hypertension: a prospective observational study

Subhajyoti Samanta, Waseem Hussain Bhat, Jeeva George, Balakeshwa Ramaiah — Tue, 25 Feb 2025 00:00:00 +0530

Background: Type 2 diabetes mellitus (T2DM) and hypertension (HTN) are common comorbid conditions that pose significant management challenges due to drug-related problems (DRPs), which can adversely affect clinical outcomes. This study aimed to evaluate the prevalence and types of DRPs in T2DM and HTN patients, analyse drug utilization patterns and identify factors influencing DRPs.

Methods: A prospective observational study was conducted over six months at a multi-specialty hospital in Bengaluru. Data from 110 adult patients with T2DM and HTN were collected, including demographics, clinical history and medication records. DRPs were identified using the Pharmaceutical Care Network Europe (PCNE) and Hepler-Strand classifications.

Results: The mean age of the participants was 63.45±13.66 years, with a nearly equal gender distribution. Monotherapy (37.27%) and dual therapy (33.63%) were the most common T2DM treatments, while calcium channel blockers (37.27%) and beta blockers (36.36%) were the predominant antihypertensives. DRPs were observed in 36.36% of patients, with untreated indications (14.54%) and drug-drug interactions (13.63%) being most common. Factors such as smoking and alcohol consumption were associated with higher DRP prevalence.

Conclusions: DRPs significantly impact the management of T2DM and HTN, highlighting the need for regular medication reviews and targeted interventions to optimize therapeutic outcomes in these patients.

Navigating medications: a prospective study on drug use in rheumatoid arthritis management

Ashok Kumar, Mohammad Nadeem Khan — Tue, 25 Feb 2025 00:00:00 +0530

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease-causing joint inflammation, pain, and potential joint damage. Effective management requires a combination of pharmacologic treatments to reduce disease activity and improve patient outcomes.

Methods: This prospective study investigated drug utilization patterns, medication adherence, and their impact on RA management. Data were collected over one year from 510 RA patients visiting the orthopaedic department at Raichur Institute of Medical Sciences. Demographic details, clinical characteristics, medication regimens, adherence levels, and adverse drug reactions were recorded.

Results: Female patients, primarily aged 51-65 years, were predominantly affected by RA. Non-steroidal anti-inflammatory drugs (NSAIDs) were the most commonly prescribed medications, with oral administration being preferred. Family history and older age were significant risk factors. Disease-modifying anti-rheumatic drugs (DMARDs), especially in combination, were preferred for managing RA. NSAID usage led to adverse effects like gastric discomfort, underscoring the need for careful monitoring.

Conclusions: This study highlights the importance of early detection, personalized treatment strategies, and the need for further research into novel therapies. It offers valuable insights into drug utilization and medication adherence, with implications for improving RA management and patient outcomes.

Knowledge, attitude and practice towards self-medication among pharmacy students in tertiary care hospital

Tue, 25 Feb 2025 00:00:00 +0530

Background: Self-medication, which is when the public treats health problems on their own without consulting a doctor, is very common. The objective of this study is to analyze pharmacy students' self-medication practices, attitudes, and knowledge in a tertiary care hospital.

Methods: Data will be collected from the B. Pharmacy, M. Pharmacy and Pharm. D with their consent by request to them to complete the questionnaire (self-administrated).

Results: A total of 339 responses from participants were prospectively collected and documented. The participant characteristics such as demographic information (age, gender, and education) was collected.

Conclusions: Insufficient understanding regarding appropriate self-medication exists, yet changes can be made in this situation with the existing positive attitude of the respondents. Seminars and workshops can be utilised to effectively distribute knowledge to students, while implementing robust policies to curb the increasing trend.

A prospective study on identification, assessment, and spontaneous reporting of adverse drug reactions at a tertiary care hospital

Aruna Gurung, Balakeshwa Ramaiah — Tue, 25 Feb 2025 00:00:00 +0530

Background: Adverse drug reactions (ADRs) significantly contribute to global morbidity and mortality. Voluntary ADR reporting is crucial for the Pharmacovigilance Programme of India (PvPi), which identifies and quantifies medication risks. This study monitors ADRs from various departments of a tertiary care hospital, assessing them for causality, preventability, and severity before reporting to the Indian Pharmacopoeia Commission (IPC).

Methods: This prospective study was conducted over six months at a tertiary care hospital, which is an approved ADR Monitoring Centre (AMC). Data was collected by PharmD students, who assessed each ADR for causality, severity, and preventability using the World Health Organization (WHO) scale, Hartwig’s severity scale, and Schumock and Thornton scales. Descriptive statistics were used for analysis.

Results: A total of 358 suspected ADRs were evaluated. Most reactions (87.98%) were classified as "moderate" in severity, with 45.53% considered not preventable. The majority of ADRs were categorized as probable (84.07%), with Class J drugs (Anti-infectives) being the most associated (29.89%). Most reports came from General Medicine (53.35%), and the primary affected organ systems were metabolic and nutritional (21%).

Conclusions: Most ADRs in this study were caused by antimicrobials, highlighting the need for careful prescribing and patient monitoring. Type A ADRs were often underreported, with healthcare professionals focusing primarily on Type B and H reactions. This study emphasizes the importance of voluntary ADR reporting and the vital role of clinical pharmacists in assessing and documenting these reactions.

An observational comparative study on the immediate, deferred, and no use of antiepileptics in the management of seizure

Himangi Shrestha, Athira Krishnan, Balakeshwa Ramaiah — Tue, 25 Feb 2025 00:00:00 +0530

Background: The rationale for starting AEDs in patients with seizure and early epilepsy is still unclear. The decision to start and stop the drugs in patients with single seizures remains controversial. This study aims to compare the efficacy, safety, and short-term outcome of the immediate, deferred, and no use of AEDs in patients presenting with seizure.

Methods This observational study, included 87 patients with either gender or age group with first or multiple seizures to investigate immediate, deferred, or no AED use. Detailed demographics, history, and diagnostic test reports were recorded. Drug use patterns and outcomes of seizure recurrence and safety were evaluated.

Results: Out of 87 patients (56 male, 31 female), there were 26 paediatrics, 47 adults, and 15 elderly. Immediate AED treatment was given to 75%, 16% deferred, and 9% received no/SOS AED. Levetiracetam was commonly prescribed (78% in ED, 86% in wards, 63% at discharge). For immediate AEDs: 49% had good seizure control, 25% had recurrence, and 9% had breakthrough seizures. Deferred AEDs showed 36% good control/recurrence and 7% breakthrough. Without AEDs: 63% had good control and 25% had recurrence. AEs were higher in the immediate AED group (42%) vs. deferred (15%).

Conclusions: The study indicates that immediate use of antiepileptic drugs (AEDs) reduces short-term seizure recurrence but may increase adverse effects. In cases of reversible causes, it may be best to forgo AEDs. Decisions regarding AED therapy should be tailored to the patient's preferences and risk considerations.

Evaluation of adverse drug reactions in a tertiary care hospital in India

Tue, 25 Feb 2025 00:00:00 +0530

Background: Adverse drug reaction (ADR) is a major concern in the healthcare system and has been a persistent issue in the health sector. This study aimed to evaluate and assess the ADRs reported, the system organ class (SOC) affected, seriousness, outcomes, causality.

Methods: A retrospective observational study in a tertiary care hospital from April 2021 to May 2024. A descriptive analysis of reactions, causality of suspected drugs was carried out according to the setting analysed.

Results: Out of 7,396 individual case safety report (ICSR) reported, the highest number of ADRS was reported in the age group of 18-65 years (57.8%) and male patients (51.1%). Using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale, 67.1% events were possible. A significant majority of drug reported as ‘certain’ were of anti-infective class (51.03%). Most frequently affected SOC was blood and lymphatic system disorders (15.9%), Of all events, greater part of the reactions was non-serious (95.3%), the most drugs causing ADRs was anti neoplastic and immunodulating agents (40.4%) and 47.2% of drugs were high alert medications. The greater part of ADRs reporting was carried out by clinical pharmacists (95.9%).

Conclusions: The results highlighted the importance of clinical pharmacist in monitoring and spontaneous reporting of ADRs. Awareness and educational programs may help in active reporting among all healthcare providers.

Comparison of safety and efficacy of pantoprazole alone with pantoprazole plus amitriptyline in functional dyspepsia patients: a randomized control trial

Neelam Kumari, Atal Sood, Swatantara Gupta, Sushma Swaraj, Nitin Patiyal — Tue, 25 Feb 2025 00:00:00 +0530

Background: The term functional dyspepsia refers to ulcer-like symptoms in patients who lack overt gastro duodenal ulceration. Functional dyspepsia can be subdivided into: postprandial distress syndrome (PDS), epigastric pain syndrome (EPS), and based on the presence of symptoms related to meals. It is defined as the presence of one or more of the following: postprandial fullness, early satiation, epigastric pain or burning, and no evidence of structural disease. Pantoprazole alone is compared with pantoprazole plus amitriptyline to relieve dyspepsia symptoms in functional dyspepsia patients.

Methods: The study was a randomized, prospective, open label, comparative interventional study. The study was conducted in the Department of Pharmacology and Department of Gastroenterology and Hepatology at Dr. R.P.G.M.C. Kangra at Tanda Himachal Pradesh, India which is 700 bedded multispecialty tertiary health care from August 2023 to May 2024 and follow -up was done for 4 weeks after initiation of treatment, to compare the safety and efficacy of pantoprazole with pantoprazole plus amitriptyline in functional dyspepsia patients.

Results: In our study compared to pantoprazole group, pantoprazole plus amitriptyline group has statistically significant reduction in all the 3 scores viz. Glasgow dyspepsia severity score (GDSS) (4.26±1.14 versus 3.3±1.37, p=0.002), short form leads dyspepsia questionnaire (SF-LDQ) (4 [3-5] versus 3 [2-4], p=0.005), and visual analogue pain score (VAS) (1 [1-2] versus 1 [0-1], p=0.0009).

Conclusions: The combination of pantoprazole and amitriptyline was more effective than pantoprazole alone in improving symptoms of functional dyspepsia, with no significant safety concerns.

Antibacterial prescription pattern and adverse drug reactions in childhood pneumonia

Christy George Thalakkottor, Prabitha Panattil, Suresh S. Vadakkedom — Tue, 25 Feb 2025 00:00:00 +0530

Background: Antibacterial drugs play an important role in the treatment of Pneumonia-a leading cause of death globally among children. To determine the class, dosing schedule, Adverse Drug Reactions (ADRs), selection criteria and World Health Organisation (WHO) prescribing indicators of antibacterials used for pneumonia.

Methods: Following the Institutional Review Board (IRB) clearance, 18 months long descriptive study was conducted among 432 paediatric patients admitted with Pneumonia in a tertiary care center. Details on antibacterial prescription with selection criteria and associated ADRs were collected. Causality, preventability and severity of ADRs were assessed. WHO prescribing indicators were calculated. Data analysed using SPSS software.

Results: Aminopenicillins (61.2%) were the major antibacterial class prescribed and the major antibacterial was Ampicillin (34.6%) with dosage regimen 32-66 mg/kg Intravenously four times daily (34.4%) with mean treatment duration 3.6±1.26 days. Major route of administration was intravenous (57%) and 99% patients received empirical treatment. The ADRs reported were Gentamicin & Ampicillin induced Hypersensitivity reactions and Vancomycin induced Redman Syndrome. WHO prescribing indicators: Average number of antibacterials per encounter 2.42, Antibacterials prescribed by generic name 96.56%, Encounters with injection 98.37%, Antibacterials from Essential Medicines List (EML) 90.9%.

Conclusions: Aminopenicillins were the major antibacterial class, Ampicillin was the major antibacterial, Inj. Ampicillin 32-66 mg/kg intravenously four times daily with mean duration 3.6±1.26 days was the commonest dosage regimen prescribed. Most antibacterials were from EML, prescribed in generic name, selected empirically and administered intravenously. Three ADRs were reported. Prescribing indicators were calculated.

A prospective study to assess the usage of intravenous fluids in patients presenting to the emergency department

Tue, 25 Feb 2025 00:00:00 +0530

Background: Intravenous (IV) fluid therapy is a common and critical component in the emergency management of patients. However, inappropriate prescribing and management of IV fluids can result in adverse outcomes.

Methods: This was a prospective observational study involving 132 patients who received IV fluids in the ED. The type of IV fluids, indications, infusion rates and the demographic characteristics of patients were recorded and analyzed.

Results: Out of 132 patients, 80 were female and 52 were male. The most frequently used fluid was Normal Saline (NS) (81%). The primary indication for IV fluid administration was hydration (63.50%). Infusion rates were most commonly bolus infusions (86.13%).

Conclusions: The study revealed that the majority of patients were administered IV fluids for hydration, with NS being the most common fluid. Proper education on fluid management in the ED can improve patient safety and treatment outcomes.

Evaluation of the mechanism of action of Aegle marmelos in a murine model of 3% dextran sulphate sodium induced acute colitis

Tue, 25 Feb 2025 00:00:00 +0530

Background: An earlier study by us in a murine model of dextran sulphate sodium (DSS) induced acute colitis showed that aqueous extract of unripe fruit of Aegle marmelos (780 mg/kg/day) was comparable with Sulfasalazine. In this study we evaluated the same extract for anti-inflammatory, anti-oxidant, and prebiotic activity in the same model.

Methods: 48 adult swiss albino mice (>6 weeks age) of either sex (18-25 grams) were divided into four groups (n=12/) i.e., normal control (distilled water-10 ml/kg/day), Disease control (Distilled water-10 ml/kg/day), Positive Control (Sulfasalazine-100 mg/kg/day) and Test drug (A. marmelos-780 mg/kg/day). The drug/vehicle was administered orally for 14 days from day 1 through day 14. Acute colitis was induced by adding 3% DSS in drinking water from day 8 to 14 in all groups except normal control. The animals were euthanized on day 15, each group were divided into two batches (n=6). One batches were used to estimate colonic myeloperoxidase (MPO) and TNF-α. The other batch was used to cultivate lactobacilli and aerobic microbiota from colonic contents, three animals from this batch were also used to estimate colonic MPO and TNF-α.

Results: Mice administered A. marmelos, and sulfasalazine showed significantly higher colon lengths, colon weight/ length ratios, colonic TNF-α and MPO levels, and both were significantly better than disease control. Lactobacilli and aerobic bacteria counts were significantly higher in A. marmelos group compared to the disease control and were comparable to normal control. However, sulfasalazine showed no improvement in the colonic microbiota counts.

Conclusions: A. marmelos showed anti-inflammatory, anti-oxidant, and prebiotic activity.

Assessment of predisposing factors and prescribing pattern in coronary artery disease patients at a tertiary care hospital of Southern Rajasthan

Ayushi Purohit, Sourabh Sharma — Tue, 25 Feb 2025 00:00:00 +0530

Background: Coronary artery disease (CAD) is the leading cause of mortality globally. The risk factors for the development of cardiovascular disease include lifestyle changes, diabetes mellitus, hypertension, smoking, hyperlipidemia, obesity and psychosocial stress. Drug regime plays an important role in declining the untimely deaths and enhances the quality of life. Few studies have been done on the prescribing patterns of CAD; hence the main objective of the study was to scrutinize various risk factors and therapy patterns for CAD patients.

Methods: A non-interventional prospective study was conducted among 120 patients, to assess the risk factors and prescribing pattern in CAD patients. Information regarding patients was recorded in data collection form. Data was statistically analyzed using IBM statistical package for the social sciences (SPSS) software.

Results: Majority of the patients were male (77.5%). Most of the patients (59.20%) were in age range of 50-69 years. Most common co-morbidities found were hypertension and diabetes. Body mass index (BMI), tobacco chewing, smoking were major risk factors. Majorly prescribed drugs were antiplatelets, anticoagulants, statins, antibiotics, nitrates, antihypertensive, PPI’s and analgesics. Average number of drugs encountered per prescription was 8.70. While number of encounters with a drug indicated in CAD was 5.66. Number of drugs prescribed with an injection and generic name were 4 and 1 respectively. As per DDD calculation, Heparin was consumed in highest amount.

Conclusions: Polypharmacy was practiced. Generic prescribing was low. Major risk factors included BMI, tobacco chewing, smoking, diabetes and hypertension. Findings of this study can be used to develop a framework for ongoing prescription assessment in a healthcare setting.

Ischemic priapism induced by a fixed drug combination of tamsulosin and tadalafil

Tue, 25 Feb 2025 00:00:00 +0530

Priapism, a persistent erection lasting more than 4 hours, can be caused by various factors, including medications. This case report presents a 23-year-old male who developed ischemic priapism after taking tablet Contiflo-T, a combination of tamsulosin and tadalafil. The patient required multiple interventions, including aspiration and intracavernosal phenylephrine injections, to resolve the condition. The combination of these drugs, which are commonly used for urinary tract symptoms and erectile dysfunction, likely contributed to the priapism by increasing blood flow to the penis and preventing its return to a flaccid state. This case highlights the potential for adverse drug interactions and the importance of careful monitoring when prescribing medications for these conditions.

Ethosuximide associated drug reaction with eosinophilia and systemic symptoms syndrome masqueraded as adenovirus infection

Emi R. Abraham, Serena M. Varghese, Gopika M. Chandran, Dinu Varghese — Tue, 25 Feb 2025 00:00:00 +0530

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a serious adverse reaction due to drugs. Due to the rarity of this condition particularly in children, DRESS can be often misdiagnosed. An 8-year-old boy was referred to our paediatrics department with the complaints of persisting fever and rashes. He was tested positive for Adenovirus infection and was provisionally diagnosed with urticaria due to viral infection, for which he was started with antiviral and antipyretics. The child was also recently diagnosed with Myoclonic Absence Epilepsy and was started on syrup Ethosuximide. Despite being treated with antiviral and antipyretics his fever spikes were consistent with itchy rashes. Multidisciplinary medical consultations were done to finally rule out DRESS associated with Ethosuximde and the drug was stopped. The child showed significant improvement from the next day with no further episodes of fever spike. Hence, we present this case to provide an alert for the need of early differential diagnosis of DRESS syndrome in case of concomitant viral infection.