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

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

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

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

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

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

Comparison of safety and efficacy of desidustat with erythropoietin in newly diagnosed patient of anemia in chronic kidney disease: a prospective, open label, randomized controlled trial

Background: Anemia is a frequent complication of chronic kidney disease (CKD), affecting quality of life and increasing cardiovascular risks. Erythropoiesis-stimulating agents (ESAs) like erythropoietin are standard treatments but raise concerns about safety and long-term outcomes. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), such as desidustat, have emerged as potential alternatives. This study compared the safety and efficacy of desidustat with erythropoietin in adults with CKD-associated anemia. Methods: A randomized controlled trial was conducted in the Departments of Nephrology and Pharmacology at Dr. R.P.G.M.C. Kangra at Tanda. Adult CKD patients (>18 years) with anemia, whether on dialysis or not, were enrolled. Participants received either oral desidustat (50 mg thrice weekly) or subcutaneous erythropoietin alfa (50 IU/kg two to three times weekly). Doses were adjusted to maintain haemoglobin (Hb) between 10-11 g/dl. Hematological and biochemical parameters were assessed at baseline, one month and three months. Results: A total of 109 patients were randomized: 54 to desidustat and 55 to erythropoietin. Baseline characteristics, including age, weight and BMI, were comparable. Both groups showed a significant increase in haemoglobin from baseline to follow-ups (p<0.001). At three months, mean Hb rose by 1.65 g/dl in the desidustat group and by 1.31 g/dl in the erythropoietin group. Conclusions: Desidustat demonstrated efficacy and safety comparable to erythropoietin in managing CKD-associated anemia. Its oral administration offers practical advantages, supporting its role as a promising alternative pending further large-scale studies

Breaking the blisters: a comprehensive guide to treating bullous pemphigoid

In adapting the treatment plan, the severity of the disease in correlation with the patient should be put onto consideration. Recent RCTs demonstrated adjuvant treatment with doxycycline, dapsone, and immunosuppressants for the treatment of bullous pemphigoid is of advantage and safe in terms of diminished total steroid dose and mortality. The British association of dermatologists has produced dermatologists’ guidelines. These provide evidence-based treatment recommendations with respect to candidness, and offer a summary on, among others, epidemiological features, diagnosis, and research. The evidence on which the guidelines rest was retrieved from Medline, Embase, the Cochrane Library, literature searches, and the authors' 10 years of experience treating patients with bullous pemphigoid in general and special clinics. However, it should be noted that findings from the literature should be interpreted with great care as only six randomized controlled trials with small patient groups are available.

A rare disease gets a breakthrough: Ctexli approved for cerebrotendinous xanthomatosis

Cerebrotendinous xanthomatosis (CTX) is a rare, autosomal recessive lipid storage disorder caused by mutations in the CYP27A1 gene, leading to sterol 27-hydroxylase deficiency and cholestanol accumulation. Ctexli’s features range from infantile diarrhea to adult-onset neurodegeneration. Early diagnosis and treatment with chenodeoxycholic acid (CDCA) can significantly improve outcomes. Recently, the FDA approved Ctexli (chenodiol), a synthetic form of CDCA, as the first standardized treatment for CTX. Clinical trials demonstrated its efficacy in reducing plasma cholestanol and urinary bile alcohols. Ctexli’s approval represents a significant advancement, enabling more consistent therapy and highlighting the importance of early intervention in managing CTX

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

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

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

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

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

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

Knowledge, attitude and perception of the public towards COVID-19 vaccine in UAE

Background: The Corona virus pandemic spread across the globe in 2019, alarming the world due to the virus’s elevated severity and the emergence of its new strains. Vaccination became a necessity to combat the pandemic, however, there is still hesitancy among the public to accept vaccines. This study aims to assess the knowledge, attitude and perception of the public towards the COVID-19 vaccine in the UAE. Methods: We assessed the readiness and willingness of the public to take the vaccine. Our data was collected using a cross-sectional study. The study was conducted during the period of February 2021 to May 2021 to collect data on the readiness of the population to take the COVID-19 vaccine. Results: We received 392 responses, and two thirds (250, 63.8%) were females, non-Emirati (374, 95.4%), and with a bachelor degree (263, 67.1%). Slightly more than half (211, 53.7%) reported being frightened of the pandemic. The majority (388, 99%) of the participants know the precautionary measures, but only 313 (79.8%) are committed to the measures and 159 (40.6%) think the available vaccines are safe. There was not a dominant response by the survey participants on whether the vaccine should be compulsory or not. Long-term safety (115, 29.3%), side effects (109, 28.8%), and thinking not at a high risk were the main concerns that prevented some respondents from taking the vaccine. Around 40% of the participants took two doses of various vaccines, but similar percentage of participants do not plan taking the vaccine. Conclusions: Government priorities should be directed toward increasing general public interest in the vaccine, as well as raising awareness regarding the general public’s concern about the pandemic and vaccination program