Venetoclax adverse event monitoring: a safety meta-analysis of randomized controlled trials and a retrospective evaluation of the FAERS.

Concerns persist about venetoclax's long-term safety in larger populations, with limited evidence of infrequent and delayed adverse events (AEs). The study integrated safety data on venetoclax in leukemia patients from randomized controlled trials (RCTs) and FDA adverse event monitoring system (FAERS). We systematically reviewed RCTs reporting safety outcomes of venetoclax in adult leukemia patients of any gender, either monotherapy or in combination, applying advanced search on databases like PubMed, EMBASE, and ClinicalTrial.gov. The quality assessment was done using the Cochrane Risk of Bias Tool. We utilized a random effect meta-analysis to calculate risk ratio (RR) with 95% confidence intervals (CI). The Open Vigil 2.1 MedDRAv24 was used to search the FAERS database, with data available until September 2023. The disproportionality was calculated using the proportional reporting ratio and the reporting odds ratio. The study protocol for meta-analysis was registered with PROSPERO; CRD42022378006. For the safety meta-analysis, seven RCTs with available AEs were examined. A total of 942 AEs were found associated with the venetoclax group; 79% of them were in grade three or above. Venetoclax significantly increased the risk of neutropenia grade three or above (RR = 1.34, 95% CI: 1.10-1.64, p: 0.0033) compared with the control group. In FAERS, 26,436 patients were reported with AEs associated with venetoclax. Significant signal scores were observed in hematological, cardiac, vascular, and gastrointestinal disorders. 11 out of 30 generated signals, failed to meet the signal criteria upon refinement. The current study updated and improved the safety profile of venetoclax in the post-marketing period, assisting in risk evaluation and mitigation for the best possible patient health care.

Estimating the active and lifetime prevalence and incidence of epilepsy in Asian Countries: A systematic review and meta-analysis.

OBJECTIVE: In the current era of the World Health Organization's Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders 2022-2031 (IGAP), precise and updated estimates of epilepsy burden are vital in formulating policies to improve the care of persons with epilepsy, especially in Asian countries with significant treatment gap. Hence, we aimed to consolidate the available data and quantify epilepsy prevalence and incidence estimates in Asian countries. METHODS: We systematically searched PubMed, Embase, Ovid, and Scopus databases from inception until March 2023 for studies reporting epilepsy prevalence and incidence in Asian countries. We applied random effects meta-analysis to generate the pooled prevalence and incidence using the Meta package in R. Additionally, we performed a subgroup meta-analysis to explore the potential sources of heterogeneity. A meta-regression analysis was conducted to examine the trend of epilepsy over time. RESULTS: A total of 99 studies with 100,654,124 participants were included in the meta-analysis. The pooled prevalence was 5.6 per 1000 (95 % confidence interval (CI) 4.4-6.8) for active epilepsy and 6.7 per 1000 (95 % CI 5.7-7.9) for lifetime epilepsy. The pooled incidence rate of epilepsy was 52.5 per 100,000 person-years (95 % CI 42.7-79.4). The subgroup analysis revealed a higher prevalence of active epilepsy (6.7/1000) and lifetime epilepsy (8.6/1000) in West Asia than in other regions. The funnel plot and Egger's test (p-value =<0.0001) revealed publication bias for active epilepsy. CONCLUSION: Our findings highlight a high prevalence of active and lifetime epilepsy in West Asia and emphasize the necessity of implementing and formulating specific strategies to tackle the epilepsy burden in this region. Furthermore, high-quality epidemiological studies incorporating economic burdens and comorbidities associated with epilepsy in Asia are still needed.

Opioid sparing strategies for perioperative pain management other than regional anaesthesia: A narrative review.

Opioids play a crucial role in pain management in spite of causing increased hospital morbidity and related costs. It may also cause significant risks such as postoperative nausea and vomiting (PONV), sedation, sleep disturbances, urinary retention and respiratory depression (commonly referred to as opioid related adverse effects) in postoperative patients. In order to evade these opioid related side effects and also improve pain management, multimodal analgesia i.e., combination of different analgesics, was introduced more than a decade ago. Both pharmacological and non-pharmacological techniques are available as opioid sparing analgesia. Research from around the world have proved pharmacological techniques ranging from acetaminophen, NSAIDs (non-steroidal anti-inflammatory drugs), N-methyl-D-aspartate receptor antagonists (NDMA), alpha-2 agonists, anticonvulsants such as gamma aminobutyric acid analogues, beta-blockers, capsaicin, lignocaine infusion to glucocorticoids to be effective. On the other hand, non-pharmacological methods include techniques such as cognitive behavioral therapy, transcutaneous electrical nerve stimulation (TENS), electroanalgesia, acupuncture and hypnosis. However, research regarding the effect of these non-pharmacological techniques on pain management is still needed.

Neuropathic Pain Assessment with the PainDETECT Questionnaire: Cross-Cultural Adaptation and Psychometric Evaluation to Hindi.

OBJECTIVE: The contribution of neuropathic pain (NeP) in chronic pain conditions is increasingly emphasized with the development of multiple questionnaire-based measurement scales. The painDETECT questionnaire (PDQ) is a frequently used self-reported outcome measure to assess NeP in patients with chronic pain conditions in research and regular clinical practice. The aim of the study was to translate and cross-culturally adapt the PDQ into Hindi (Hi-PDQ) for use in India and to investigate its psychometric properties. METHODS: PainDETECT questionnaire translation into the Hindi language was carried out according to standard guidelines. Patients suffering from chronic pain attending a pain clinic were recruited. Patients completed the Hi-PDQ at baseline and were retested was conducted after 3 days Exploratory factor analysis (EFA) was carried out to assess the factor structure of the Hi-PDQ. Measurement properties, including floor and ceiling effects, discriminative validity, and psychometric properties, were also assessed. RESULTS: A total of 160 patients with chronic pain were recruited, including 80 in each NeP and non-NeP group. The retest was completed in 82 patients. Mean Hi-PDQ scores were significantly higher in the NeP group compared with the non-NeP group (20.7 [SD 5.9] vs. 9.9 [SD 5.9]; P < 0.01). EFA revealed a 2-factor structure explaining 56.9% variance. The Hi-PDQ was found to have adequate internal consistency (Cronbach's alpha = 0.83), test-retest reliability (intraclass correlation coefficient = 0.94), and excellent discriminant validity (area under the curve = 0.88), with an optimal cutoff value of > 18 (sensitivity and specificity of 82.5% and 91.2%, respectively). CONCLUSION: The PDQ was successfully translated into the Hindi language. The Hi-PDQ showed good discriminative validity and psychometric properties. The Hi-PDQ is a reliable instrument to assess NeP in chronic pain conditions.

Translation, Adaptation, and Validation of Hindi Version of the Pain Catastrophizing Scale in Patients with Chronic Low Back Pain for Use in India.

OBJECTIVES : This study translates the Pain Catastrophizing Scale (PCS) into Hindi and examines the psychometric properties of the translated version (Hindi PCS [Hi-PCS]) in patients with chronic low back pain (CLBP). METHODS : Forward and backward translations were performed from English to Hindi according to standard methodology. A final version was evaluated by a committee of clinical experts and Hi-PCS was then pilot-tested in 10 patients with CLBP. Cross-cultural validation of the resulting adapted Hi-PCS was done by administering Hi-PCS at baseline to 100 patients with CLBP (≥ 12 weeks pain) who were able to read and write in Hindi, and re-administering Hi-PCS after 3 days. Construct validity was assessed using factor analysis. Psychometric properties including internal consistency; test-retest reliability; and convergent validity with pain severity, functional disability, and health-related quality of life (HRQoL) were also assessed. RESULTS : Principal component analysis observed a three-factor structure, which explained 58% of the variance. Confirmatory factor analysis elicited the best fit as judged by the model fit indices. Hi-PCS as a whole was deemed to be internally consistent (Cronbach's α = 0.76). Intraclass correlation coefficient for the Hi-PCS is 0.923 (95% CI: 0.875-0.953). Hi-PCS was moderately correlated with pain intensity (r = 0.651) and functional disability (r = 0.352), and negatively correlated with QoL (r = -0.380). CONCLUSIONS : PCS translation and cross-cultural adaptation to Hindi demonstrated good factor structure along adequate psychometric properties and could be recommended for use in CLBP research in India.

Effect of intranasal dexmedetomidine or oral midazolam premedication on sevoflurane EC50 for successful laryngeal mask airway placement in children: a randomized, double-blind, placebo-controlled trial.

INTRODUCTION: This study was conducted to determine the effect of oral midazolam (OM) or intranasal dexmedetomidine (IND) on the EC50 of sevoflurane for successful laryngeal mask airway placement in children. We hypothesize that premedication with either agent might reduce the sevoflurane EC50 for laryngeal mask airway placement in children to a similar extent. METHODS: Fifty-two American Society of Anesthesiologists (ASA) I children (aged 1-6 years) scheduled for general anesthesia with laryngeal mask airway were randomized to one of the three groups: group M received 0.5 mg · kg(-1) OM with honey and intranasal saline, group D received 2 µg · kg(-1) IND along with oral honey, and group P received oral honey and intranasal saline at least 30 min prior to induction of anesthesia. Anesthesia was induced with incremental sevoflurane up to 8% in 100% O2 . A predetermined target endtidal sevoflurane (ETsevo ) concentration (2% in the first child of all three groups) was sustained for 10 min before the attempt of laryngeal mask airway insertion by adjusting dial concentration. No intravenous anesthetic or neuromuscular blockade was used. ETsevo was increased/decreased (step size 0.2%) using Dixon's and Massey's up and down method in next patient depending upon previous patient's response. Placement of the laryngeal mask airway without movement, coughing, biting, or bucking was considered as successful. EC50 of sevoflurane was calculated as the average of the crossover midpoints in each group, which was further confirmed by probit analysis. RESULTS: The EC50 of sevoflurane for laryngeal mask airway placement after OM (1.66 ± 0.31) and IND (1.57 ± 0.14) premedications was significantly lower than the placebo group (2.00 ± 0.17, P < 0.0001). The EC95 (95% CI) derived from probit regression analysis was 2.34% (2.22-2.51%) with OM, 1.88% (1.77-2.04%) with IND, and 2.39% (2.25-2.35%) with placebo group. CONCLUSIONS: Oral midazolam and IND premedications significantly reduce the sevoflurane EC50 for laryngeal mask airway insertion in children by 17% and 21%, respectively.

End-tidal concentrations of sevoflurane and desflurane for ProSeal laryngeal mask airway removal in anaesthetised adults: a randomised double-blind study.

BACKGROUND: The optimal end-tidal sevoflurane and desflurane concentration for successful ProSeal laryngeal mask airway (PLMA) removal in unpremedicated anaesthetised adults has not been determined. OBJECTIVES: We determined end-tidal sevoflurane and desflurane concentration in 50% of anaesthetised adults (EC50: concentration at which there is 50% chance of patients showing 'no movement' response) for smooth PLMA removal. DESIGN: Randomised controlled double blind study. SETTING: Operating theatre of a government tertiary care institute. The study period was December 2011 to January 2013. PATIENTS: Thirty nine unpremedicated American Society of Anesthesiologists (ASA) physical status I and II women with cervical carcinoma (aged 30 to 60 years) scheduled for implantation of intracavity caesium under general anaesthesia with PLMA as an airway device were included in the study. INTERVENTIONS: The participants were randomised to one of the two groups receiving either desflurane or sevoflurane for anaesthesia maintenance. Anaesthesia induction was performed with intravenous propofol. Predetermined end-tidal sevoflurane concentration (initiating at 2%) or desflurane (initiating at 4%) was sustained for 10 min before PLMA removal was attempted. End-tidal concentrations were increased/decreased (step-size 0.2% for sevoflurane and 0.5% for desflurane) using Dixon and Massey up and down method in the next patient depending upon previous patient's response. Patient responses to PLMA removal were classified as 'movement' or 'no movement'. MAIN OUTCOME MEASURES: EC50 was calculated as the mean of the crossover pairs' midpoints in each group and further confirmed by probit regression analysis. RESULTS: EC50 (95% confidence interval) of sevoflurane and desflurane for PLMA removal were 1.58% (0.669 to 2.060) and 2.79% (2.733 to 2.841), respectively. CONCLUSION: Predicted EC50 and EC95 of sevoflurane and desflurane for smooth removal for the PLMA were 1.58 (0.669 to 2.060), 2.27 (1.859 to 21.16), 2.79 (2.733.2.841) and 3.27% (3.173 to 3.395), respectively. TRIAL REGISTRATION: Registered with Clinical Trial Registry of India (URL: http://www.ctri.in), Registry ref no: CTRI/2012/12/004285.

Comprehensive safety profile of dipeptidyl peptidase-4 inhibitors: a post-marketing study based on FAERS database using signal detection algorithms.

BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: This is a retrospective study which explored the FAERS database till March 2023 for the collection of safety reports. The disproportionality analysis was performed using signal detection algorithms (SDAs) incorporating frequentist-based data mining approach such as relative reporting ratio (RRR), reporting odds ratio (ROR) and proportional reporting ratio (PRR) with 95% confidence interval (CI). RESULTS: A total of 14,573 adverse event reports were reported in the FAERS public dashboard associated with all the included DPP-4 inhibitors. The computed PRR, ROR, and RRR indicated positive signals for DPP-4 inhibitors with cardiac failure, pancreatitis, pemphigoid, hypoglycemia, acute kidney injury and lactic acidosis. Saxagliptin showed a higher signal score for cardiac failure, while sitagliptin was more associated with pancreatitis. Moreover, alogliptin exhibited an elevated signal score associated with pancreatic carcinoma. CONCLUSION: Several significant disproportionality signals were observed with DPP-4 inhibitors. However, clinicians have to consider the comorbidities and concomitant drugs while prescribing these drugs.

Trends estimation of obesity prevalence among South Asian young population: a systematic review and meta-analysis.

The premise for effective prevention and treatment of obesity is the availability of accurate prevalence figures. However, the prevalence of pediatric obesity and overweight in South Asian countries has seldom been analyzed. This article provides a comprehensive review and meta-analysis of studies on overweight and obesity to provide a more precise prevalence estimate. The study protocol was registered on PROSPERO (CRD42022320625). PubMed and Embase databases were comprehensively searched from inception till September 2023. The random-effects model was utilized to derive the pooled prevalence of obesity and overweight. Subgroup meta-analysis was used to assess variations in prevalence estimates across subgroups. A meta-regression analysis was also performed to assess the trend of overweight and obesity over the years. 152 studies were included with 489,525 participants. The pooled prevalence was 12.4 (95% CI 11.1-13.6) for overweight, 6.6% (95% CI 5.6-7.8) for obesity, and 19.3% (95% CI 17.1-21.7) for obesity and overweight. In subgroup analysis, Bangladesh reported a higher prevalence for both obesity (8.9%; 95% CI 4.9-13.9) and overweight (13.6%; 95% CI 9.2-18.8). Meta-regression analysis found a significant association between obesity prevalence and the publication year (ß = 0.004; p = 0.03; R2 = 2.74%). The results of this study indicate a relatively higher prevalence of childhood obesity in South Asia, emphasizing the necessity for large-scale awareness efforts and context-specific preventative methods.

Comparative efficacy and safety of alpha-blockers as monotherapy for benign prostatic hyperplasia: a systematic review and network meta-analysis.

Despite the availability of various drugs for benign prostatic hyperplasia (BPH), alpha(α)-blockers are the preferred first-line treatment. However, there remains a scarcity of direct comparisons among various α-blockers. Therefore, this network meta-analysis (NMA) of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of α-blockers in the management of BPH. A comprehensive electronic search covered PubMed, Embase, Ovid MEDLINE, and Cochrane Library until August 2023. The primary endpoints comprised international prostate symptom score (IPSS), maximum flow rate (Qmax), quality of life (QoL), and post-void residual volume (PVR), while treatment-emergent adverse events (TEAEs) were considered as secondary endpoints. This NMA synthesized evidence from 22 studies covering 3371 patients with six kinds of α-blockers with 12 dose categories. IPSS has been considerably improved by tamsulosin 0.4 mg, naftopidil 50 mg and silodosin 8 mg as compared to the placebo. Based on the p-score, tamsulosin 0.4 mg had the highest probability of ranking for IPSS, PVR, and Qmax, whereas doxazosin 8 mg had the highest probability of improving QoL. A total of 297 adverse events were reported among all the α-blockers, silodosin has reported a notable number of TEAEs. Current evidence supports α-blockers are effective in IPSS reduction and are considered safer. Larger sample size with long-term studies are needed to refine estimates of IPSS, QoL, PVR, and Qmax outcomes in α-blocker users.

Mobile health applications for epilepsy in Indian app stores: A systematic review and content analysis using the mobile app rating scale.

OBJECTIVE: The growing prevalence of smartphones may prompt individuals with epilepsy to pursue unfulfilled healthcare requirements through mobile health (mHealth) apps, but the content and quality of these mHealth apps are rarely analysed. Hence, this study aimed to identify and assess the quality of epilepsy apps for patients with epilepsy (PWE), their caregivers, and healthcare practitioners (HCPs) available in the Play Store and App Store of India. METHODS: We performed a systematic search on the Google Play Store and Apple App Store of India to identify the mHealth apps for epilepsy which were released and updated till May 2023. The identified applications were downloaded and the quality was assessed using a Mobile app rating scale (MARS) for the overall quality, Aesthetics, Engagement, Functionality, and Information by three independent reviewers. The intraclass correlation coefficient (ICC) was calculated to assess the interrater reliability between the reviewers. An unpaired t-test was calculated to analyse the difference in mean scores for Android and iOS applications. RESULTS: The systematic search yielded a total of 2518 apps, out of which 26 were selected for inclusion in the study. Among these, 9 apps were compatible with Android, 11 with iOS, and 6 on both platforms. The mean (SD) MARS score of the apps was 3.5 (0.6) and the ICC for the overall app quality was 0.90 (95% CI: 0.82-0.96). Overall, apps scored highest in functionality (3.9), followed by aesthetics (3.6), information (3.3), and engagement (3.2). Among the included apps, the overall quality score was found to be higher for iOS apps than Android (MD = 0.54; 95% CI: 0.02 - 1.07; p-value: 0.042). CONCLUSION: Our study identified twenty-six mHealth applications for epilepsy that integrated various aspects of epilepsy self-management. The results of this study emphasize the importance of ensuring that current and future applications offer evidence-based information, integrate features that align with patient preferences, and generate evidence regarding the effectiveness of application usage.

Societal costs of illness for infantile epileptic spasms syndrome and evolutionary cost prediction in the era of WHO's IGAP.

BACKGROUND: To achieve the goal of improving the quality of life for persons with epilepsy within the framework of the WHO's Intersectoral Global Action Plan (IGAP), our study aimed to assess the societal financial burden linked to infantile epileptic spasms syndrome (IESS), ensuring that children afflicted with IESS receive high-quality healthcare without enduring substantial financial constraints. METHODS: Between August 2022 and March 2023, 92 children with IESS (male: female: 2:1), recently diagnosed or previously followed-up, were recruited. We gathered costs for drugs, tests, and medical services, along with legal guardians' monthly income. Total expenditure was determined by multiplying unit costs by the yearly service usage commencing from the onset. Time series analysis was utilised to forecast the financial burden from 2022 to 2032. RESULTS: Clinicians' first choice of treatment was ACTH (n = 60, 65·2%), prednisolone (n = 25, 27·2%), and vigabatrin (n = 7, 7·6%) and the median cost of treatment during the initial year was INR 39,010 [USD 479·2]. The median direct medical, direct non-medical, and indirect cost were INR 31,650 [USD 388·4], INR 6581 [USD 80·8], and INR 10,100 [USD 124·07], respectively. Families lost a median of 12 days of work annually. Drug costs and loss of wages were the key factors in the financial burden. The projected and adjusted figures exhibited an incremental growth rate of 2·6% tri-annually. INTERPRETATION: This pioneering study in developing countries, the first of its kind, evaluates the societal cost, financial hardship, and trajectory of incremental cost in IESS. The primary drivers of the financial burden were pharmacological treatment and family work adjustments. The government shoulders 62% of the financial burden, and projected a triannual growth of 2·6% from 2022 to 2032. Our results rationalize policymakers' focus on incorporating IESS into social security programs, particularly in developing countries.

Normative data for insulin-like growth factor-1 (IGF-1) in healthy children and adolescents from India.

BACKGROUND: Serum IGF-1 is an important biochemical tool to diagnose and monitor GH-related disorders. However, ethnic-specific Indian data following consensus criteria for the establishment of normative data, are not available. Our objective was to generate chronological age (CA)-, bone age (BA)- and Tanner stage-specific normative data for IGF-1 in healthy Indian children and adolescents. METHODS: A cross-sectional epidemiological study was conducted in schools and the community, which enrolled apparently healthy children and adolescents with robust exclusion criteria. The outcome measure was serum IGF-1 assessed using an electro-chemiluminescence immunoassay (ECLIA). The 2.5th, 5th, 10th, 25th, 50th (median), 75th, 90th, 95th, and 97.5th centiles for IGF-1 were estimated using generalized additive models. RESULTS: We recruited 2226 apparently healthy participants and following exclusion, 1948 (1006 boys, 942 girls) were included in the final analysis. Girls had median IGF-1 peak at CA of 13 years (321.7 ng/mL), BA of 14 years (350.2 ng/mL) and Tanner stage IV (345 ng/mL), while boys had median IGF-1 peak at CA of 15 years (318.9 ng/mL) BA of 15 years (340.6 ng/mL) and Tanner stage III (304.8 ng/mL). Girls had earlier rise, peak and higher IGF-1 values. The reference interval (2.5th-97.5th percentile) was broader during peri-pubertal ages, indicating a higher physiological variability. CONCLUSION: This study provides ethnicity-specific normative data on serum IGF-1 and will improve the diagnostic utility of IGF-1 in the evaluation and management of growth disorders in Indian children and adolescents.

Translation, Adaptation, and Validation of Hindi version of Quality of Life of the Infant (QUALIN) for Use in Infants and Toddlers.

OBJECTIVES: To translate Quality of Life of the Infant (QUALIN), cross-culturally adapt the Hindi version of QUALIN (Hi-QUALIN), and evaluate its psychometric properties in children. METHODS: This cross-sectional study was performed at the tertiary-care center in North India over 21 mo (April 2019 to January 2021). Healthy children (aged 3 to 36 mo) visiting the hospital for vaccination, minor ailments, routine health checkup, and accompanying an ill sibling were included. Children with infantile spasms in same age group were also included. Hindi translations were carried out by bilingual translators who could fluently communicate and write in Hindi and English. Standard Hindi was used to avoid the misinterpretation or misunderstanding. Discriminant and Construct validity was determined utilizing the known-groups method and factor analysis. Reliability was analysed as internal consistency and test-retest reliability. RESULTS: Four hundred and sixty-four children were recruited through opportunity sample selection method with statistically significant difference between healthy and unhealthy children in total score of Hi-QUALIN (3-12 mo) and (13-36 mo). Finally, Hi-QUALIN (3-12 mo and 13-36 mo) consisted of 29 and 30 items constituting the five extracted factors respectively. Overall internal consistency was excellent (α = 0.92 and 0.88, respectively). Intra-class correlation coefficients (ICC) were 0.84 (95% CI: 0.78-0.89; p <0.0001) and 0.94 (95% CI: 0.93-0.96; p <0.0001) indicating excellent test-retest reliability. CONCLUSIONS: Hi-QUALIN has good psychometric properties and can be used for health-related quality of life (HRQoL) measurement in young children.

Efficacy and Safety of Dietary Therapies for Childhood Drug-Resistant Epilepsy: A Systematic Review and Network Meta-analysis.

Importance: Despite advances in the understanding of dietary therapies in children with drug-resistant epilepsy, no quantitative comparison exists between different dietary interventions. Objective: To evaluate the comparative efficacy and safety of various dietary therapies in childhood drug-resistant epilepsy. Data Sources: Systematic review and network meta-analysis (frequentist) of studies in PubMed, Embase, Cochrane, and Ovid published from inception to April 2022 using the search terms ketogenic diet, medium chain triglyceride diet, modified Atkins diet, low glycemic index therapy, and refractory epilepsy. Study Selection: Randomized clinical trials comparing different dietary therapies (ketogenic diet, modified Atkins diet, and low glycemic index therapy) with each other or care as usual in childhood drug-resistant epilepsy were included. Abstract, title, and full text were screened independently by 2 reviewers. Data Extraction and Synthesis: Data extraction was conducted following Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. Cochrane risk-of-bias tool was used to assess the study quality. Effect sizes were calculated as odds ratio with 95% CI using random-effects model. The hierarchy of competing interventions was defined using the surface under the cumulative ranking curve. Main Outcomes and Measures: Short-term (≤3 months) 50% or higher and 90% or higher reduction in seizure frequency and treatment withdrawal due to adverse events were the primary efficacy and safety outcomes. Results: Of 2158 citations, 12 randomized clinical trials (907 patients) qualified for inclusion. In the short term, all dietary interventions were more efficacious than care as usual for 50% or higher seizure reduction (low glycemic index therapy: odds ratio [OR], 24.7 [95% CI, 5.3-115.4]; modified Atkins diet: OR, 11.3 [95% CI, 5.1-25.1]; ketogenic diet: OR, 8.6 [95% CI, 3.7-20.0]), while ketogenic diet (OR, 6.5 [95% CI, 2.3-18.0]) and modified Atkins diet (OR, 5.1 [95% CI, 2.2-12.0]) were better than care as usual for seizure reduction of 90% or higher. However, adverse event-related discontinuation rates were significantly higher for ketogenic diet (OR, 8.6 [95% CI, 1.8-40.6]) and modified Atkins diet (OR, 6.5 [95% CI, 1.4-31.2]) compared with care as usual. Indirectly, there was no significant difference between dietary therapies in efficacy and safety outcomes. Conclusions and Relevance: This study found that all dietary therapies are effective in the short term. However, modified Atkins diet had better tolerability, higher probability for 50% or higher seizure reduction, and comparable probability for 90% or higher seizure reduction and may be a sounder option than ketogenic diet. Direct head-to-head comparison studies are needed to confirm these findings.

Identifying Risk Factors and Health Concerns Associated With Chronic Low Back Pain Among Northern Indians: A Community-based Study.

BACKGROUND: Chronic low back pain (CLBP) is a common and significant cause of disability globally. In their lifetime, 70% to 80% of adults will have low back discomfort at some point. Even though CLBP is a very disabling disorder, information about its prevalence and associated factors is sparse in the literature. OBJECTIVES: We aimed to determine the prevalence of CLBP and its risk factors among an adult population, as well as related health concerns and health-seeking behaviors. STUDY DESIGN: Cross-sectional study. SETTING: A tertiary care setting in Chandigarh, India from November 2017 through February 2020. METHODS: Adults of either gender who provided informed consent were included in the study. Sociodemographic and CLBP awareness data were collected using a standard questionnaire. Prevalence was expressed as proportion of sample, with 95% CI. For categorical and quantitative data, the chi squared and independent t test were utilized. Logistic regression was applied to identify significant risk variables and outcomes. A P value of <= 0.05 was considered significant. RESULTS: A total of 2,847 patients were enrolled, with a mean (SD) age of 38 (14) years; 61% of them were men. These patients had a CLBP lifetime prevalence of 16% (95% CI, 15-17; 457/2,847). In addition, 62% (285/457) of these patients visited their doctor/physician more than 10 times and 23% (103/457) sought the advice of 2 physicians to treat their CLBP. Increasing age (odds ratio[OR], 1.040, 95% CI, 1.032-1.049; P < 0.001), being underweight (OR, 3.315; 95% CI, 1.494-7.359; P < 0.003) and increasing pain frequency (OR, 1.616; 95% CI, 1.139-2.293; P < 0.007) were identified as potential CLBP risks. LIMITATIONS: The study was carried out in a single tertiary hospital in northern India; hence its results cannot be extrapolated. Also, we were unable to categorize CLBP based on how severe the symptoms were, such as complaint-only or debilitating. CONCLUSION: An effective, supervised program addressing the younger productive population to maintain a healthy weight, give up smoking, and encourage an active lifestyle should be implemented. KEY WORDS: Chronic low back pain, prevalence, health concerns, risk factors, public health.

Care of Children with Infantile Epileptic Spasms Syndrome and Applicability of Telemedicine Amidst the COVID-19 Pandemic.

This ambispective, observational study evaluated the impact of the COVID-19 pandemic on managing children with Infantile epileptic spasms syndrome (IESS) and the feasibility of telemedicine-based management for IESS. Caregivers of children with IESS were telephonically interviewed using a structured questionnaire and various relevant indices were compared between the study population and a pre-pandemic cohort from the same center. There was a significant increase in diagnostic lag during the pandemic (p = 0.04). Adrenocorticotropic hormone was the first-line antiseizure medication of choice in both cohorts and the response to treatment was also similar. Telemedicine was utilized by around 80% of caregivers and satisfaction rates with telemedicine were high. However, caregivers continued to rate physical consultations higher in preference.

Statin use and risk of breast cancer: a meta-analysis of observational studies.

Emerging evidence suggests that statins' may decrease the risk of cancers. However, available evidence on breast cancer is conflicting. We, therefore, examined the association between statin use and risk of breast cancer by conducting a detailed meta-analysis of all observational studies published regarding this subject. PubMed database and bibliographies of retrieved articles were searched for epidemiological studies published up to January 2012, investigating the relationship between statin use and breast cancer. Before meta-analysis, the studies were evaluated for publication bias and heterogeneity. Combined relative risk (RR) and 95 % confidence interval (CI) were calculated using a random-effects model (DerSimonian and Laird method). Subgroup analyses, sensitivity analysis, and cumulative meta-analysis were also performed. A total of 24 (13 cohort and 11 case-control) studies involving more than 2.4 million participants, including 76,759 breast cancer cases contributed to this analysis. We found no evidence of publication bias and evidence of heterogeneity among the studies. Statin use and long-term statin use did not significantly affect breast cancer risk (RR = 0.99, 95 % CI = 0.94, 1.04 and RR = 1.03, 95 % CI = 0.96, 1.11, respectively). When the analysis was stratified into subgroups, there was no evidence that study design substantially influenced the effect estimate. Sensitivity analysis confirmed the stability of our results. Cumulative meta-analysis showed a change in trend of reporting risk of breast cancer from positive to negative in statin users between 1993 and 2011. Our meta-analysis findings do not support the hypothesis that statins' have a protective effect against breast cancer. More randomized clinical trials and observational studies are needed to confirm this association with underlying biological mechanisms in the future.