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BACKGROUND: Resurgent psychedelic research has largely supported the safety and efficacy of psychedelic therapy for the treatment of various psychiatric disorders. As psychedelic use and therapy increase in prevalence, so does the importance of understanding associated risks. Cases of prolonged negative psychological responses to psychedelic therapy seem to be rare; however, studies are limited by biases and small sample sizes. The current analytical approach was motivated by the question of whether rare but significant adverse effects have been under-sampled in psychedelic research studies. METHODS: A bottom margin analysis approach was taken to focus on negative responders to psychedelic use in a pool of naturalistic, observational prospective studies (N = 807). We define negative response by a clinically meaningful decline in a generic index of mental health, that is, one standard error from the mean decrease in psychological well-being 4 weeks post-psychedelic use (vs pre-use baseline). We then assessed whether a history of diagnosed mental illness can predict negative responses. RESULTS: We find that 16% of the cohort falls into the negative responder subset. Parsing the sample by self-reported history of psychiatric diagnoses, results revealed a disproportionate prevalence of negative responses among those reporting a prior personality disorder diagnosis (31%). One multivariate regression model indicated a greater than four-fold elevated risk of adverse psychological responses to psychedelics in the personality disorder subsample (b = 1.425, p

INTRODUCTION: Subjective improvement in gastrointestinal (GI) symptoms was assessed among patients using medical marijuana (MMJ). METHODS: Participants completed surveys at 0 days, 30 days, 6 months, and 12 months with questions about the severity of their GI symptoms on a scale from 1 (mild) to 3 (severe). RESULTS: In each survey, participants reported a significant decrease in GI symptom severity when using MMJ versus when not using MMJ (p < 0.05). The most common self-reported side effects from using MMJ were increased appetite (12-21.4%), fatigue (6-16.7%), anxiety (4-11.9%), cough (4-11.9%), headache (6-7.9%), and dry mouth (4-7.1%). CONCLUSION: In patients with chronic GI symptoms, MMJ may provide persistent symptom severity improvement. Limited product availability and mild to moderate side effects are factors to consider before trialing MMJ.

BackgroundClinical trials using psilocybin therapy to treat anorexia nervosa (AN) are currently underway. The safety and tolerability of psilocybin is of utmost importance in individuals with AN who may present unique medical vulnerabilities. The purpose of this review is to describe how the common physiologic adverse effects of psilocybin may impact medical complications experienced by individuals with AN in clinical trials of psilocybin therapy.Main bodyThe physiologic underpinnings of common adverse effects following psilocybin administration are described, including tachycardia, hypertension, electrocardiogram changes, nausea, headache, and lightheadedness. These anticipated physiologic changes are described in relation to the common medical correlates seen in individuals with AN. Risk mitigation strategies for each adverse effect are proposed.ConclusionEarly evidence suggests that psilocybin therapy is well-tolerated in individuals with AN. Understanding the unique medical complications of AN, and how they may be impacted by common physiologic adverse effects of psilocybin administration, leads to tailored risk mitigation strategies to enhance safety and tolerability of this novel intervention.

In the context of drug-resistant epilepsy, deep brain stimulation (DBS) has received FDA approval. However, there have been reports of potential adverse effects, such as depression and memory impairment associated with DBS.This systematic review and meta-analysis aimed to investigate the impact of DBS on the quality of life (QoL), and seizure frequency of patients who had DRE, and assess its potential adverse events. The study followed PRISMA guidelines and thoroughly assessed databases, including Pubmed, Scopus, Embase, Web of Science, and the Cochrane Library, up to 31 July. Statistical analysis, fixed effect model analysis, performed by the Comprehensive Meta-analysis software (CMA) version 3.0. Additionally, Cochran's Q test was conducted to determine the statistical heterogeneity. The systematic review encompassed 54 studies, with 38 studies included in the subsequent meta-analysis. The total number of patients included in the studies was 999. The findings indicated a significant decrease in the mean seizure frequency of subjects following DBS (SMD: 0.609, 95% CI: 0.519 to 0.700, p-value < 0.001). Moreover, patients' QoL significantly improved after DBS (SMD: -0.442, 95% CI: -0.576 to -0.308, p-value < 0.001). The hippocampus displayed the most notable effect size among the different DBS targets. Subgroup analysis based on follow-up duration revealed increased DBS efficacy after two years. There are few reports of adverse events, such as insertional-related complications, infection, and neuropsychiatric complications, but the majority of these were temporary and non-fatal. DBS emerged as an effective and safe procedure for reducing seizure frequency and enhancing the quality of life in DRE patients, with minimal adverse events. Furthermore, the efficacy of DBS was observed to improve over time. [ABSTRACT FROM AUTHOR]

Studies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and sensitivity to context. A systematic questionnaire describing important characteristics of side effects of psychedelics and MDMA would greatly improve on previous methods. We aimed to create a standardized tool for recording clinically relevant side effects of psychedelics and MDMA, including their severity, duration, impact, and treatment-relatedness. We constructed the Swiss Psychedelic Side Effects Inventory (SPSI) based on insights from previous research. It was pilot tested in 145 participants from three studies. Structured feedback from an expert panel was used to improve validity and feasibility. The final SPSI contains 32 side effects and standardized follow-up questions about their severity, impact, treatment-relatedness, and duration. It is compatible with any study design and can be administered as an interview or self-report at any timepoint after treatment with psychedelics or MDMA. The SPSI omits relatively unimportant side effects for brevity's sake, though space for additional symptoms is given. Future studies are needed to confirm its validity in different contexts. The SPSI is available in English and German for collecting systematic data on side effects from psychedelics and MDMA. This information is vital for improving clinical decisions, informed consent, and patient safety. • Psychedelics and MDMA can cause a unique profile of side effects which are not well-captured by the methods used in previous studies. • Psychedelic side effects vary in their severity, duration, and subjective impact. • Using previous studies, pilot data, and expert feedback, we developed the Swiss Psychedelic Side Effects Inventory (SPSI). • The SPSI contains 32 side effects and assesses their severity, impact, duration, and treatment-relatedness. • The SPSI can be used at any timepoint after psychedelic administration in any study of psychedelics or MDMA. [ABSTRACT FROM AUTHOR]

AbstractPsychedelics have shown early evidence for a range of benefits and low harm profiles in extant research. However, adverse effects (AEs) research in psychedelics has been limited, leading to underspecified AE profiles, inconsistent measurement, and potential undercounting of AEs. The development of safe, effective psychedelic therapies and treatments for AEs when they occur requires a thorough assessment of psychedelic-related AEs, their phenomenology, risk factors, and longitudinal duration. This article proposes that research on meditation-related AEs, which overlap in important ways with the phenomenological and contextual characteristics of psychedelic-related AEs, has engaged many methodological challenges present in the study of psychedelic-related AEs. Thus, meditation-related AE research offers thematic and methodological insights that are valuable to psychedelic AE research. An integrative review of extant AE research in both psychedelics and meditation is provided, and an agenda for leveraging meditation research to advance the investigation of psychedelic AEs is recommended. This includes the utility of meditation-related AEs as a comparator condition for psychedelic-related AEs, as well as recommendations for the adoption of (1) detailed and comprehensive, (2) user-informed, (3) impact-based, (4) standardized, (5) unbiased, and (6) representative measures of AEs and (7) examining factors that influence their impacts and trajectories. [ABSTRACT FROM AUTHOR]

Background: Chronic subdural hematoma (CSDH) is an important medical condition characterized by the accumulation of blood in the subdural space. Several methods have been explored, including surgical intervention and administration of tranexamic acid, which is a conservative treatment option. This meta-analysis aimed to assess the effectiveness and safety of tranexamic acid in CSDH management. Methods: A systematic literature search was performed according to the PRISMA and MOOSE guidelines. This study included cohort and randomized controlled trials involving adults with chronic subdural hematoma (CSDH) who were treated with intravenous tranexamic acid. The primary outcome measures were recurrence and adverse events. Results: Six studies encompassing 2024 participants were included. Studies have shown that tranexamic acid reduced recurrence rates (OR, 0.32; 95% CI: 0.27–0.38, p = 0.16; I2 = 0%), although the result was non-significant. However, the analysis of adverse events indicated a moderate level of heterogeneity (OR, 1.14; 95% CI: 0.60–2.15, p = 0.07; I2 = 57%), suggesting a potential safety concern. Conclusion: In conclusion, this meta-analysis suggests tranexamic acid (TXA) may reduce chronic subdural hematoma (CSDH) recurrence, though significance varied across studies. Adverse effects with TXA were similar to controls. Larger trials are needed to confirm TXA's role in CSDH management. [ABSTRACT FROM AUTHOR]

Introduction: Systematic collection of diverse adverse events during herbal medicine administration is crucial. The Korea Adverse Event Reporting System (KAERS) compiles spontaneously reported adverse event data for medicinal products including herbal medicines. This study focused on extracting and analyzing adverse event data specifically related to herbal medicine products from the KAERS database. Methods: Individual case safety reports (ICSRs) encompassing 84 types of herbal medicine products, identified by item codes from 2012 to 2021, were extracted from the KAERS database. Descriptive statistics were employed to analyze the characteristics of the extracted reports, and adverse event information was systematically categorized and analyzed based on the MedDRA System Organ Class and preferred term classification. Results: In total, 1,054 ICSRs were extracted, with some documenting multiple adverse events in a single ICSR, resulting in 1,629 extracted adverse events. When categorized by the MedDRA System Organ Class, gastrointestinal disorders were the most prevalent (28.7%), followed by skin and subcutaneous tissue disorders (20.1%). Based on the preferred terms, the most frequently reported adverse events were diarrhea (5.8%), urticaria (5.3%), pruritus (4.7%), rash (4.4%), and abdominal discomfort (4.2%). The most frequently reported herbal medicines were Bangpungtongseong-san (297 cases), Kyeongok-go (144 cases), and Eunkyo-san (108 cases). Conclusion: Spontaneously reported adverse events associated with herbal medicine products were systematically documented using the KAERS database. This study, which focused on voluntarily reported adverse reactions, underscores the need for additional research to estimate the incidence rate of adverse events and assess causality. [ABSTRACT FROM AUTHOR]

Introduction: Systematic collection of diverse adverse events during herbal medicine administration is crucial. The Korea Adverse Event Reporting System (KAERS) compiles spontaneously reported adverse event data for medicinal products including herbal medicines. This study focused on extracting and analyzing adverse event data specifically related to herbal medicine products from the KAERS database. Methods: Individual case safety reports (ICSRs) encompassing 84 types of herbal medicine products, identified by item codes from 2012 to 2021, were extracted from the KAERS database. Descriptive statistics were employed to analyze the characteristics of the extracted reports, and adverse event information was systematically categorized and analyzed based on the MedDRA System Organ Class and preferred term classification. Results: In total, 1,054 ICSRs were extracted, with some documenting multiple adverse events in a single ICSR, resulting in 1,629 extracted adverse events. When categorized by the MedDRA System Organ Class, gastrointestinal disorders were the most prevalent (28.7%), followed by skin and subcutaneous tissue disorders (20.1%). Based on the preferred terms, the most frequently reported adverse events were diarrhea (5.8%), urticaria (5.3%), pruritus (4.7%), rash (4.4%), and abdominal discomfort (4.2%). The most frequently reported herbal medicines were Bangpungtongseong-san (297 cases), Kyeongok-go (144 cases), and Eunkyo-san (108 cases). Conclusion: Spontaneously reported adverse events associated with herbal medicine products were systematically documented using the KAERS database. This study, which focused on voluntarily reported adverse reactions, underscores the need for additional research to estimate the incidence rate of adverse events and assess causality. [ABSTRACT FROM AUTHOR]

Background: Currently, it remains unknown whether there is an association between body mass index (BMI) and complications during screening colonoscopy; hence, it remains unclear whether BMI should be considered a risk factor in pre-procedural assessments. The aim of this study was to compare mortality and unplanned hospitalization rates before and after colonoscopy stratified by patients' BMI. Material and methods: This was a retrospective cohort study of individuals who underwent screening colonoscopy as part of the Polish Colonoscopy Screening Program (PCSP). The included individuals were followed up for mortality and hospitalization episodes from 42 days prior to colonoscopy to 30 days after the procedure. Rates for the endpoints were calculated, compared, and adjusted for available data. Weighted averages of stratum-specific rates were calculated. Additional subanalyses were performed for sex and procedure type (screening colonoscopy without biopsy, colonoscopy with biopsy, or colonoscopy with polypectomy). Results: A total of 55390 individuals who underwent colonoscopy between years 2012–2015 were included. Obese individuals had significantly more hospitalizations than non-obese patients (1.94% versus 0%, p =.038). Analysis of adjusted hospitalization rates stratified by sex revealed that obese males had significantly higher related hospitalizations' rates before or after and after colonoscopy. Unadjusted and adjusted mortality rates after screening colonoscopy did not reveal significant differences between BMI categories. Conclusions: Overweight and obesity are not clinically relevant risk factors for mortality and hospitalization six weeks before or 30 days after screening colonoscopy. Obese males may be more likely to require hospital care after colonoscopy. [ABSTRACT FROM AUTHOR]

Background: Drug-induced adverse symptoms affect patients' quality of life (QoL) during treatment. Understanding the underlying mechanisms of drug-induced adverse effects could help prevent them. As current drugs have limited effects in halting the progress of Alzheimer's disease (AD), patients are required to take these drugs over a long period. The main obstacles to long-term compliance are drug-elicited side effects that deteriorate patient QoL. Objective: Donepezil, the most popular acetylcholinesterase inhibitor (AChEI) drug for AD, induces various side effects, especially at high doses. This study aimed to identify a drug that can attenuate the side effects of donepezil and investigate the underlying mechanisms. Methods: Five-week-old Sprague-Dawley rats received daily oral donepezil and N-acetylcysteine (NAC) for four weeks. General symptoms following administration were monitored daily to address drug-related adverse effects. Cytosolic calcium influx and generation of reactive oxygen species (ROS) after drug treatment were measured in vitro using C2C12 myotubes. Results: High-dose donepezil induced numerous adverse symptoms in male and female rats, which were markedly attenuated by co-treatment with NAC. NAC significantly reduced both acute and chronic muscle-related symptoms caused by donepezil. Additionally, in vitro studies showed that high-dose donepezil increased ROS and intracellular calcium ([Ca2+]i) levels in muscle cells, contributing to these adverse effects. NAC co-treatment dramatically reduced ROS and [Ca2+]i levels in muscle cells. Conclusions: Combined treatment with NAC effectively diminishes the adverse effects elicited by donepezil by regulating ROS and [Ca2+]i levels in the skeletal muscle, which could contribute to improving donepezil treatment in patients. [ABSTRACT FROM AUTHOR]

Since the reports of the first cases of COVID-19, in less than 5 years, a huge number of documents regarding that disease and the coronavirus (SARS-CoV-2), responsible for the infection, have been published. The tremendous number of scientific documents covers many topics on different issues directly related to COVID-19/SARS-CoV-2. The number of articles—including reviews—reporting adverse/side effects of the approved COVID-19 vaccines is considerable. A wide range of adverse/side effects have been reported in humans after COVID-19 vaccination: thrombotic events/thrombocytopenia, myocarditis/pericarditis, cutaneous reactions, immune-mediated effects, psychiatric adverse events, systemic lupus erythematosus, reproductive toxicity, and other miscellaneous adverse effects. In contrast, information on nonclinical studies conducted to assess the potential toxicity/adverse effects of the COVID-19 vaccines in laboratory animals, is comparatively very scarce. The present review was aimed at revising the scientific literature regarding the studies in laboratory animals on the toxic/adverse effects of COVID-19 vaccines. In addition, the investigations reported in those specific toxicology journals with the highest impact factors have been examined one by one. The results of the present review indicate that most nonclinical/experimental studies on the adverse/toxic effects of the COVID-19 vaccines and/or potential candidates showed—in general terms—a good safety profile. Only in some animal studies were certain adverse effects found. However, a rather surprising result has been the limited number of available (in the databases PubMed and Scopus) nonclinical studies performed by the companies that have been the largest manufacturers of mRNA vaccines in the world. It is assumed that these studies have been conducted. However, they have not been published in scientific journals, which does not allow the judgment of the international scientific community, including toxicologists. [ABSTRACT FROM AUTHOR]

Aim: We aimed to investigate the long‐term impact of glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) on thyroid function, cardiovascular health, renal outcomes and adverse events in individuals with obesity and without type 2 diabetes (T2D). Materials and Methods: In this observational cohort study, we used propensity score matching to construct comparable cohorts of individuals with obesity and without T2D who were new to GLP‐1 RA treatment and those who did not receive glucose‐lowering medications. In total, 3,729,925 individuals with obesity were selected from the TriNetX Global Network, with an index event between 1 January 2016 and 31 March 2024. The primary outcomes were safety, cardiovascular, thyroid and clinical biochemical profile outcomes occurring within 5 years following the index event. Results: After propensity score matching, the study included 12,123 individuals in each group. GLP‐1 RA treatment was associated with a significantly lower risk of all‐cause mortality (hazard ratio 0.23; 95% confidence interval 0.15–0.34) and several cardiovascular complications, including ischaemic heart disease, heart failure, arrhythmias, hypertension, stroke and atrial fibrillation (all p < 0.05). GLP‐1 RAs were also associated with a lower risk of acute kidney injury and allergic reactions. These protective effects were consistent across various subgroups and regions. Conclusions: In this large observational study, GLP‐1 RAs showed long‐term protective effects on cardiovascular health, renal outcomes and adverse events in individuals with obesity and without T2D. Our findings suggest that GLP‐1 RAs may offer a comprehensive approach to managing obesity and its related comorbidities, potentially improving overall health and survival in this population. [ABSTRACT FROM AUTHOR]

Background and objective: Systemic sclerosis (SSc) is a highly heterogeneous disease whose treatment is based mainly on immunosuppressants, antifibrotics, and vasodilators. Intravenous immunoglobulin (IVIG) have proved effective in other autoimmune diseases. The objective of this study is to evaluate the efficacy and safety of IVIG in SSc. Methods: The systematic review was conducted according to the PRISMA Statement. Medline, Embase and Cochrane Library databases were searched until March 2024. We assessed the quality of included studies using the Cochrane Risk of Bias 2.0 tool (RoB 2) for randomised clinical trials and the Cochrane Risk in non-randomized studies (ROBINS-I) tool for observational studies. Results: From 1242 studies identified, 15 studies were included, of which 14 were observational studies. In total, 361 patients with SSc were included, and 295 received treatment with IVIG. Most of the studies used a dose of 2 g/kg IVIG. Ten studies, including the clinical trial, showed high risk of bias, and five had a critical risk. Skin involvement was assessed using modified Rodnan skin score, in 11 studies and the authors reported cutaneous efficacy in 9 of them. The 6 studies that assessed muscle involvement reported an improvement. Six studies reported data on gastrointestinal efficacy. Other domains such as lung and joint involvement and steroid-sparing effect were evaluated. The most frequent adverse events were mild, including headache, abdominal pain, fever, and skin rash. Conclusion: Treatment with IVIG in SSc patients could be helpful and safe in patients with cutaneous, muscular, or digestive manifestations. [ABSTRACT FROM AUTHOR]

Background: Human papillomavirus (HPV) vaccination has been offered in over a hundred countries worldwide (including the United Kingdom, since September 2008). Controversy around adverse effects persists, with inconsistent evidence from follow-up of randomized controlled trials and confounding by indication limiting the conclusions drawn from larger-scale observational studies. This study aims to estimate the association between receiving a quadrivalent HPV vaccine and the reporting of short-term adverse effects and to demonstrate the utility of regression discontinuity design for examining side effects in routine data. Methods: We applied a novel regression discontinuity approach to a retrospective population-based cohort using primary care data from the UK Clinical Practice Research Datalink linked to hospital and social deprivation data. We examined the new onset of gastrointestinal, neuromuscular, pain, and headache/migraine symptoms using READ and International Classification of Diseases, tenth revision diagnostic codes. For each year between 2012 and 2017, we compared girls in school year 8 (born July/August) who were eligible to receive the vaccine with girls in year 7 (born September/October) who were not eligible. Results: Of the 21,853 adolescent girls in the cohort, 10,881 (50%) were eligible for HPV vaccination. There was no evidence of increased new gastrointestinal symptoms (adjusted odds ratio [OR]: 0.99; 95% confidence interval [CI]: 0.85, 1.15), headache/migraine symptoms (OR: 0.84; 95% CI: 0.70, 1.01), or pain symptoms (OR: 1.05; 95% CI: 0.95, 1.16) when comparing those eligible and ineligible for HPV vaccination. Conclusion: This study found no evidence that HPV vaccination eligibility is associated with reporting short-term adverse effects among adolescent girls. [ABSTRACT FROM AUTHOR]

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Background Given the rapid expansion of research into digital health interventions (DHIs) for severe mental illness (SMI; eg, schizophrenia and other psychosis diagnoses), there is an emergent need for clear safety measures. Currently, measurement and reporting of adverse events (AEs) are inconsistent across studies. Therefore, an international network, iCharts, was assembled to systematically identify and refine a set of standard operating procedures (SOPs) for AE reporting in DHI studies for SMI. Design The iCharts network comprised experts on DHIs for SMI from seven countries (United Kingdom, Belgium, Germany, Pakistan, Australia, United States, and China) and various professional backgrounds. Following a literature search, SOPs of AEs were obtained from authors of relevant studies, and from grey literature. Results A thorough framework analysis of SOPs (n = 32) identified commonalities for best practice for certain domains, along with significant gaps in others; particularly around the classification of AEs during trials, and the provision of training/supervision for research staff in measuring and reporting AEs. Several areas which could lead to the observed inconsistencies in AE reporting and handling were also identified. Conclusions The iCharts network developed best-practice guidelines and a practical resource for AE monitoring in DHI studies for psychosis, based on a systematic process which identified common features and evidence gaps. This work contributes to international efforts to standardize AE measurement and reporting in this emerging field, ensuring that safety aspects of DHIs for SMI are well-studied across the translational pathway, with monitoring systems set-up from the outset to support safe implementation in healthcare systems. [ABSTRACT FROM AUTHOR]

Background Digital health interventions (DHIs) have significant potential to upscale treatment access to people experiencing psychosis but raise questions around patient safety. Adverse event (AE) monitoring is used to identify, record, and manage safety issues in clinical trials, but little is known about the specific content and context contained within extant AE reports. This study aimed to assess current AE reporting in DHIs. Study Design A systematic literature search was conducted by the iCharts network (representing academic, clinical, and experts by experience) to identify trials of DHIs in psychosis. Authors were invited to share AE reports recorded in their trials. A content analysis was conducted on the shared reports. Study Results We identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were preidentified by those who shared AEs as being related to the intervention or trial procedures. While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% of studies did not report information on relatedness for all or at least some AEs; 9.6% of AE reports were coded as unclear because it could not be determined what had happened to participants. Conclusions The results support the safety of DHIs, but AEs must be routinely monitored and evaluated according to best practice. Individual-level analyses of AEs have merit to understand safety in this emerging field. Recommendations for best practice reporting in future studies are provided. [ABSTRACT FROM AUTHOR]

Metamizole, as known as dipyrone or novaminsulfone is widely used, especially in Latin America, for its analgesic and antipyretic function. However, several countries have banned it due to the risk of agranulocytosis, skin necrosis, and other serious adverse effects. To assess the safety of metamizole compared to other commonly used non-opioid analgesics (paracetamol, ibuprofen, and acetylsalicylic acid). An overview of systematic reviews. The searches were performed in the PubMed, Cochrane Library, Embase, Scopus and LILACS databases. Systematic reviews of randomized and nonrandomized clinical trials with adult patients with mild to moderate pain that assessed the adverse effects of metamizole were included. A methodological quality assessment was performed through ROBIS. The protocol of this systematic review was submitted to the International Prospective Register of Systematic Reviews (Prospero, CRD42021295272). Of 387 identified studies, four were included, with a total of 20,643 participants, all submitted to a single dose by oral, intramuscular, or intravenous route. No study reported a serious adverse effect. However, 60 of 778 patients (7.7%) who used metamizole; 120/828 (14.5%) who used acetylsalicylic acid; 56/443 (12.6%) who used paracetamol; and 27/213 (12.7%) who used ibuprofen had mild adverse effects. A complementary statistical analysis showed that metamizole, at any dose, has a 38.8% lower chance of adverse effects compared to paracetamol and 46.8% compared to acetylsalicylic acid. The results shows that metamizole is a safe drug with evidence of a lower incidence of adverse effects compared to paracetamol and acetylsalicylic acid. [ABSTRACT FROM AUTHOR]

Purpose To assess the safety of zoledronic acid (ZOL) and denosumab (Dmab) administered following hip fracture in a hospital setting. Methods Patients older than 65 years were treated by a fracture liaison service following hip fracture. Generally, patients who had a glomerular filtration rate (eGFR) > 35 mL/min were treated with ZOL, whereas patients who had previously received bisphosphonates or had a eGFR between 20 and 35 mL/min were treated with Dmab. Adverse events included hypocalcemia (calcium corrected for albumin less than 8.5 mg/day), renal functional impairment (0.5 mg/dL or more increase in serum creatinine) within 30 days of treatment, or a fever (>38 °C) within 48 hours of drug administration. Results Two hundred twenty-eight and 134 patients were treated with ZOL and Dmab, respectively. Mean body temperature was elevated following ZOL administration (0.18 °C P <.001) but remained below 38 °C. Hypocalcemia occurred in 18% and 29% of the ZOL and Dmab groups, respectively (P =.009). Renal functional impairment was observed in 9 and 6 patients (4% and 5%) in the ZOL and Dmab groups, respectively (P =.8). Pretreatment calcium above 9.3 mg/dL was associated with a lower risk of posttreatment hypocalcemia (odds ratio 0.30, 95% confidence interval 0.13-0.68, P =.004). While the absolute risk of hypocalcemia was higher in the Dmab group, multivariate analysis did not find that the choice of drug was predictive of hypocalcemia. Conclusion In-hospital parenteral osteoporosis treatment was rarely associated with fever or renal function impairment but was associated with hypocalcemia. Posttreatment hypocalcemia risk did not vary significantly between patients receiving ZOL or Dmab. [ABSTRACT FROM AUTHOR]

Thermal runaway propagation (TRP) in lithium batteries poses significant risks to energy‐storage systems. Therefore, it is necessary to incorporate insulating materials between the batteries to prevent the TRP. However, the incorporation of insulating materials will impact the battery thermal management system (BTMS). In this article, the influence of aerogel insulation on liquid‐cooled BTMS is analyzed employing experiments and simulations. In the experiment results, it is revealed that aerogel reduces heat dissipation from liquid‐cooled battery packs, leading to elevated peak temperatures and steeper temperature gradients. Simulation of battery pack discharge warming based on the 3D model shows that the result matches very well with that in the experiment., indicating a maximum temperature rise from 34.92 to 42.57 °C at 2C when aerogel thickness is increased to 5 mm, alongside a temperature differential expansion from 11.11 to 17.50 °C. Nonetheless, beyond 3 mm thickness, further increases in aerogel thickness cause negligible (<0.1 °C) temperature alterations, defining the saturation thickness of aerogel. Furthermore, maintaining consistent thickness and stacking more aerogel layers do not mitigate its detrimental effects. Interestingly, augmenting the battery's through‐thickness thermal conductivity counteracts the adverse outcomes of aerogel usage. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the prevalence of potentially inappropriate medications (PIMs) in nursing home residents across eight countries and investigate differences between residents with and without cognitive impairment, as well as those with and without life expectancy of six months or less. Methods and deign: The study utilized the second edition of the STOPP-Frail criteria to operationalize PIMs in the baseline assessment of nursing home residents participating in the Services and Health for Elderly in Long TERm care (SHELTER) project. The data were collected between 2009 and 2012. The project was conducted in eight countries: Czech Republic, England, Finland, France, Germany, Italy, the Netherlands, and Israel. Cognitive impairment was measured by the cognitive performance scale (CPS). The presence of end-stage disease with a life expectancy of six months or less was recorded. The study included residents aged 60 years or older who underwent a valid medication assessment. Results: Among the 3,832 eligible residents, 87.9% had at least one PIM. Specifically, 24.3%, 23.5%, 18.8%, and 19.3% of residents had one, two, three, and four or more PIMs, respectively. On average, each person was prescribed 2.16 PIMs. Cognitively impaired residents (n = 1999) had an average of 1.96 PIMs (SD 1.49) per person, while residents with a low CPS score (n = 1783) had an average of 2.40 PIMs (SD 1.57) per person, showing a statistically significant difference (P < 0.001). Similarly, NH residents with life expectancy of six months or less had an average of 1.66 PIMs (SD 1.30), whereas those without had an average of 2.17 PIMs (SD 1.55) (p < 0.001). The average number of PIMs varied across countries, ranging from 3.23 in Finland to 2.15 in the UK (P < 0.001). Anti-platelets and aspirin were the most prescribed PIMs, accounting for over 38.0% of prescriptions. Conclusions: This study highlights the high prevalence of PIMs among nursing home residents. However, PIMs were somewhat lower in residents with cognitive impairment and life expectancy of six months or less. Efforts must continue to improve the rationale behind prescribing practices in nursing homes. [ABSTRACT FROM AUTHOR]

Background: Methotrexate (MTX) intolerance in juvenile idiopathic arthritis (JIA) frequently leads to discontinuation due to anticipatory and associative gastrointestinal symptoms. Eye Movement Desensitization and Reprocessing (EMDR) has successfully been used in MTX intolerance, with lasting effects but frequently diminishing efficacy over time. BLAST (bi-lateral alternating stimulation tactile) wristbands utilize a similar process to EMDR. The aim of this study was to determine if utilization of BLAST wristbands could improve and prolong the effect of EMDR on patients with MTX intolerance. Methods: Consecutive patients admitted to the German Center for Pediatric and Adolescent Rheumatology with JIA and signs of MTX intolerance from October 2016 until March 2024 were included in this study. Treatment was performed using an adapted 8 phase EMDR protocol implementing BAST wristbands. Initial patients were treated with EMDR, subsequent patients additionally with BLAST wristbands. Health-related quality of live was determined using the PedsQL. Measurements of MISS (Methotrexate Intolerance Severity Score) and PedsQL were taken at 4 time points: directly before and after (MISS only) treatment, as well as 4 and 12 months after treatment. Changes in MISS and PedsQL were compared using descriptive statistics and repeated measures ANOVA. Results: 87 patients with MTX intolerance were included, 53 in group 1 without BLAST wristbands and 34 in group 2 which were concurrently treated with BLAST wristbands. All patients reported marked improvement of MTX intolerance symptoms (mean MISS score group 1: 15.0 ± 5.5 before treatment, 1.3 ± 1.5 after treatment, group 2: 16.8 ± 5.6 and 2.5 ± 2.5, respectively). After 4 and 12 months, MISS in group 1 was 8.1 ± 7.1 and 8.7 ± 8.4, and in group 2: 7.1 ± 6.3 and 6.5 ± 5.7. A repeated measures ANOVA showed a significant difference between the MISS results over time (F(3,114) = 64.6, p < 0.001), and also demonstrated a significant difference of the PedsQL results between the two groups over time (F(2,64) = 8.9, p < 0.001). Conclusion: Treatment with Eye Movement Desensitization and Reprocessing (EMDR) could present an effective treatment of MTX intolerance, and using BLAST wristbands, further potential improvement is possible. [ABSTRACT FROM AUTHOR]

Background: Docetaxel (DOC) and ramucirumab (RAM) is one of the most effective regimens for advanced non-small cell lung cancer (NSCLC) treatment. In our previous study, baseline anemia was identified as a preventive factor against the development of severe adverse effects during the first treatment cycle. It was hypothesized that anemia directly promotes tumor angiogenesis, leading to the elevation of RAM efficacy with increased DOC delivery to tumors, while reducing DOC delivery to other organs, potentially mitigating severe adverse effects. If this hypothesis is correct, patients with baseline anemia may have better clinical outcomes than those with normal hemoglobin levels. In this study, we aimed to investigate the effect of baseline anemia on the efficacy of DOC + RAM in treating advanced NSCLC in a real-word setting. Methods: Patients with advanced NSCLC receiving DOC + RAM (n = 72) were retrospectively assessed. They were categorized into a control group with normal baseline hemoglobin levels and an anemia group with baseline anemia. The primary endpoint was progression-free survival (PFS) evaluation. Results: Patients in the anemia group had a significantly shorter PFS than that of patients in the control group (median PFS: 3.2 and 6.2 months; 95% confidence interval [CI]: 2.2–4.8 and 4.3–9.9 months, respectively;P = 0.008). In addition, the disease control rate in the anemia group was 65.8%, which was significantly lower than that in the control group (93.6%; P = 0.007). Overall survival tended to be shorter in patients with anemia than in controls, although the difference was not statistically significant (P = 0.07). Multivariate Cox hazard analysis suggested that baseline anemia was a singular risk factor for poor PFS (adjusted hazard ratio 1.84, 95% CI 1.08–3.13; P = 0.02). The incidence of severe adverse effects did not differ between the two groups. Conclusions: This study suggests that the PFS of patients with anemia treated with DOC + RAM for advanced NSCLC is shorter than that of those without the symptoms. [ABSTRACT FROM AUTHOR]

Objective: To analyze the efficacy and safety of anti-fibrosis therapy in patients with fibrotic interstitial lung disease (FILD) in the real world and the risk factors of disease progression. Methods: Patients who were first diagnosed with FILD and started oral pirfenidone or nintedanib anti-fibrosis treatment were included. The patients were followed up for 2 years. The clinical data of the patients were collected and the baseline characteristics were analyzed, including gender, age, smoking history, basic lung function [forced vital capacity (FVC), diffusing capacity of the lungs for carbon monoxide (DLCO)], complications and shared drugs. Lung function was recorded at the beginning of anti-fibrosis, 12 months and 24 months after anti-fibrosis treatment, and the annual decline rates of FVC and DLCO were analyzed. Drug-related adverse reactions and tolerance were collected.Logistic regression model was established to analyze the relationship between clinical variables and disease progression. Results: After 12 months of anti-fibrosis treatment, there was no significant difference in FVC and DLCO between 167 patients with FILD and before treatment (P>0.05). The FVC and DLCO of 67 patients with FILD decreased after 24 months of anti-fibrosis treatment, but there was no statistical difference (P>0.05). A total of 98 adverse events occurred in 110 patients treated with pirfenidone, and 70 adverse events occurred in 57 patients treated with nintedanib. Only some adverse events led to drug withdrawal. The most common side effect of both anti-fibrosis drugs was diarrhea. Compared with pirfenidone, the discontinuation rate of nintedanib due to adverse events was significantly higher (P<0.05). Logistic regression analysis showed that the risk factors of disease progression within 12 months after anti-fibrosis treatment were smoking and patients with idiopathic pulmonary fibrosis (IPF), while DLCO was a protective factor for disease progression. Conclusion: In the real world, anti-fibrosis therapy can maintain the stability of FVC and DLCO in FILD patients, and the adverse reactions related to anti-fibrosis drugs can be tolerated with high safety. Smoking and IPF patients are more prone to disease progression, and higher DLCO is a protective factor for disease progression in FILD patients. [ABSTRACT FROM AUTHOR]

Pulmonary sarcomatoid carcinoma (PSC), a rare non-small cell lung cancer (NSCLC) subtype, poses diagnostic and treatment difficulties. Current research explores targeted therapies and immunotherapy to improve patient outcomes. This case report details a male patient diagnosed with PSC via pathology. Tests revealed high levels of PD-L1, a marker suggesting potential benefit from immune checkpoint inhibitors. However, despite bronchoscopic intervention, his advanced stage IIIB cancer (cT3N2bM0) progressed quickly, with progression-free survival (PFS) under 3 months. Following progression, the patient received tislelizumab (anti-PD-1 antibody) and anlotinib (an anti-angiogenic drug) as second-line therapy. This combination showed promise, achieving near-partial remission after the first cycle. Subsequent scans documented continued tumor shrinkage until the patient experienced fatal hemoptysis. This case highlights the potential benefits of combining tislelizumab with anlotinib for PSC. However, it also represents the first reported case of fatal hemoptysis with this specific treatment regimen. This finding emphasizes the need for increased awareness of this potential complication, especially in patients with centrally located PSC treated with anti-angiogenic agents like anlotinib. [ABSTRACT FROM AUTHOR]

Objective To analyze the adverse effects (AEs) of CD19 chimeric antigen receptor T (CAR⁃T) cell drugs on the market, so as to provide evidence for clinical treatment. Methods The United States Food and Drug Administration's adverse event reporting system (FAERS) database was used to obtain the baseline data and the AE results of four marketed CD19 CAR ⁃T drugs from the first quarter of 2017 to the fourth quarter of 2023 after data retrieval, screening, deduplication, collation and analysis. The reporting odds ratio (ROR) and proportional ADR reporting ratio (PRR) were used to analyze and compare the AE results. Results A total of 5, 335 reports of 4 marketed CD19 CAR ⁃ T drugs included Axicabtagene ciloleucel (Axi ⁃ cel), Tisagenleucel (Tisa ⁃ cel), Brexucabtagene autoleucel (Brexu⁃cel) and Lisocabtagene maraleucel (Liso⁃cel) were obtained from the FAERS database. The proportion of the four CD19 CAR⁃T drugs in males was higher than that in females; the age distribution was above 18 years old; and the body weight was mostly concentrated in 50-100 kg. CD19 CAR⁃T drugs were involved in 23 types of system organ classification (SOC), mainly focusing on neurological diseases and immune system diseases, among which cytokine release syndrome (CRS) and immune effector cell⁃associated neurotoxicity syndrome (ICANS) were the most common. In addition, some AEs not listed in the label were also found in this study, such as myelodysplastic syndromes (MDS), acute kidney injury (AKI), and sepsis. Conclusions In clinical practice, attention should also be paid to the possible unlisted AEs, such as MDS, AKI and sepsis, in addition to the AEs mentioned in the drug label. [ABSTRACT FROM AUTHOR]

Background: Airway management in children is challenging because of the smaller size, different proportions of anatomical structures compared to adults, and a higher risk of hypoxemia. Efforts to improve the efficiency of pediatric intubation can be made by manually twisting a spiral endotracheal tube (ETT) using a flexible stylet to manipulate its shape and angle. Methods: This controlled trial randomized fifty children aged one month to six years who underwent elective surgery under general anesthesia into two groups (spiral ETT [sETT] and no-stylet ETT/standard ETT). The sETT was formed by twisting the ETT using a handmade tool. The primary objective was to determine the effectiveness of the sETT compared to the standard ETT in reducing intubation time. Secondary objectives were ETT placement accuracy, first-attempt intubation success rate, and adverse effects. Results: The mean total tube handling time in the sETT group was significantly shorter compared to the no-stylet ETT group (sETT 16.8 ± 3.6 vs. standard ETT 18.8 ± 3.7 seconds; P = 0.049). sETT placement had a significantly greater central placement accuracy (odds ratio, 4.846; 95% confidence interval, 1.287-18.255; P = 0.015). However, first-attempt successful intubation rate (sETT 80% vs. standard ETT 64%, P = 0.208) and total intubation time (sETT: 46.5 ± 5.2 vs. standard ETT 48.4 ± 4.9 seconds; P = 0.205) were not significantly different. No adverse effects were observed for either ETT type. Conclusions: Spiral ETT effectively reduces total tube handling time and improves ETT placement accuracy in children using video laryngoscopy. [ABSTRACT FROM AUTHOR]

The optimal oxygen target during general anesthesia remains difficult to define in pediatric and adult patients. Although access to pediatric patients has become difficult owing to a decrease in birth rate, pediatric anesthesia remains an important part of anesthesiology, and oxygenation related to general anesthesia is an essential part of any anesthesiologist. The use of oxygen has increased survival rates in adults and children; however, the side effects related to oxygen use have also increased. This review addresses the considerations of oxygenation in pediatric patients undergoing general anesthesia. [ABSTRACT FROM AUTHOR]

Background: Remimazolam, an ultra-short-acting anesthetic with flumazenil as a reversal agent, typically facilitates patient awakening postoperatively. However, our case reveals an unusual occurrence: despite flumazenil initially restoring consciousness, re-sedation due to remimazolam ensued six hours later. Case: A 65-year-old woman underwent total intravenous general anesthesia with remimazolam and remifentanil during the 140-min surgery. Despite an initially smooth recovery, she progressively became drowsy upon transfer to the general ward, eventually reaching a stuporous state. Multiple interventions, including opioid reversal (intravenous patient-controlled analgesia discontinuation, and naloxone administration) were attempted. Neurological consultation revealed no issues; however, immediate improvement after flumazenil administration suggested remimazolam’s involvement. The patient was discharged without complications. Conclusions: This case challenges our understanding of remimazolam’s dynamics, emphasizing the necessity for vigilant post-anesthesia monitoring, even in seemingly low-risk cases. It advocates for standardized response protocols to promptly manage unforeseen events and ensure patient safety. [ABSTRACT FROM AUTHOR]

Depilation through laser hair removal has gained popularity due to its long-lasting effects, which can last for several months and, in some cases, be considered permanent. This method also improves quality of life. However, common complications include blistering, pigmentary changes, and scabbing. Folliculitis is rare, with most cases being mild and transient. We hereby report on a 33-year-old healthy Thai male who rapidly developed severe folliculitis one day after undergoing diode laser treatment, which combined three wavelengths (755 nm, 810 nm, and 1,064 nm) into a single pulse. The condition improved significantly following a short course of prednisolone and topical benzoyl peroxide. At the 4-week follow-up, the lesions had nearly resolved, with only a few erythematous papules and hyperpigmented follicular macules remaining and no scarring. Further studies are needed to clarify the mechanism of folliculitis after hair removal laser treatment, enabling more effective prevention and management for patients. [ABSTRACT FROM AUTHOR]

Gastroesophageal reflux disease (GERD) significantly affects the health-related quality of life and healthcare costs. The prevalence of this disease is increasing in Asia, leading to a rapid increase in the demand of proton pump inhibitors (PPIs). Despite effective symptom management during initial treatment, relapse rates after PPI cessation remain high in patients with GERD, warranting longterm maintenance therapy. Concerns regarding potential side effects related to the long-term use of PPIs are escalating with increased usage. Studies have reported diverse side effects of PPIs, such as increased fracture risk, cardiovascular concerns, enteric infections, neurological diseases, and potential associations with gastric cancer. However, definitive causal relationships remain unclear. This review comprehensively summarizes the latest knowledge on the potential risks associated with long-term use of PPIs. Continuous or noncontinuous therapy can be used as a maintenance treatment modality for GERD. For patients with mild GERD, including those with nonerosive and mildly erosive reflux disease, on-demand therapy following a sufficient period of continuous maintenance therapy is recommended as a long-term maintenance treatment option. [ABSTRACT FROM AUTHOR]

Regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognize pharmacogenetics as a key tool in their pharmacological guidelines for pharmaceutical counseling. In this context, community pharmacies play a crucial role in addressing this healthcare need, which could lead to a significant improvement in patients' quality of life by preventing ineffective or contraindicated treatments. In this work, we conducted a systematic review of the available scientific evidence regarding druggene interactions relevant to community pharmacy. We identified the main genes and polymorphisms associated with treatment response and adverse effects in primary care. Finally, we propose a model for implementing pharmacogenetic services in community pharmacies. [ABSTRACT FROM AUTHOR]

Introduction: Prescribing testosterone for gender affirming hormone therapy (GAHT) has been increasing in Australia with much of this practice done by general practitioners (GPs) and there are current AusPATH guidelines on how this can be done appropriately. There has been limited data collected from GPs about how well these patients are monitored and the adverse effects (AEs) that are experienced by this population of patients. Objectives: The primary objective of this study was to collect data about monitoring and adverse effects of GAHT provided in GP settings. Methods: The PUSH! Audit was a cross-sectional study that collected data from 9 GP Clinics across 5 Australian cities who provided GAHT with testosterone. Data was also collected about cisgender men who were prescribed testosterone for testosterone deficiency (TD) as a comparison group (n = 209). Results: The patients in the GAHT group (n = 277) tended to be younger (29.8 vs 54.9), with significant prevalence of smoking (21.8%) and anxiety/depression (37.2%) although this was not significantly higher that the comparison group. Most of the GAHT group had a testosterone level recorded in their file (90.6%) and the most common route of administration of testosterone was by intra-muscular injection (89.9%). The testosterone levels were mainly in the target range for males (75.7%) with only a small percentage registering levels above the target range (5.6%). Of the measured AEs, whilst there were significant prevalence of liver abnormalities and hypercholesterolemia, this was not significantly different to the TD group. The hypertension prevalence was lower in the GAHT group. Of the reported AEs, acne (10.1%) and balding (4.7%) were the only two AEs that were significantly reported. Conclusion: This study shows that GAHT with testosterone can be provided effectively in general practice with high levels of success and very low levels of AEs. [ABSTRACT FROM AUTHOR]

Objective: Seizures have been reported as an adverse event of the COVID‐19 vaccine. However, there is no solid evidence of increased seizure occurrence compared to the general population. This study was undertaken to investigate seizure occurrence among COVID‐19 vaccine recipients compared to unvaccinated controls. Methods: A systematic search was made of PubMed, Web of Science, Scopus, and Cochrane Library up to April 9, 2024. Studies reporting seizure occurrence following COVID‐19 vaccination were included. This study is reported according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses framework and was conducted using random‐ and common‐effect models. The risk of bias in the studies was evaluated by the Newcastle–Ottawa Scale. The outcome of interest was new onset seizure incidence proportion compared among (1) COVID‐19 vaccine recipients, (2) unvaccinated cohorts, and (3) various types of COVID‐19 vaccines. Results: Forty studies were included, of which seven entered the meta‐analysis. Results of the pooled analysis of the new onset seizure incidence (21‐ or 28‐day period after vaccination) in 13 016 024 vaccine recipients and 13 013 262 unvaccinated individuals by pooling the cohort studies did not show any statistically significant difference between the two groups (odds ratio [OR] =.48, 95% confidence interval [CI] =.19–1.20, p =.12, I2 = 95%, τ2 =.7145). Pooling four studies accounting for 19 769 004 mRNA versus 47 494 631 viral vector vaccine doses demonstrated no significant difference in terms of new onset seizure incidence between the groups (OR = 1.18, 95% CI =.78–1.78, p =.44, I2 = 0%, τ2 =.004). Significance: This systematic review and meta‐analysis shows no statistically significant difference in the risk of new onset seizure incidence between COVID‐19 vaccinated individuals and unvaccinated individuals. [ABSTRACT FROM AUTHOR]

Background: Psychedelic-assisted therapy (PAT) is permitted in Switzerland under its limited medical use program. Data from patients in this program represent a unique opportunity to analyze the real-world practice of PAT. Aims: This study compared the subjective effects of lysergic acid diethylamide (LSD) and psilocybin between patients undergoing PAT and healthy volunteers. For the patients, it also investigated the relationship between antidepressant effects and six measures of acute drug effects. Methods: We compared data on acute psychedelic drug effects between 28 PAT patients with data from 28 healthy participants who participated in a randomized, double-blind crossover trial. All participants received varying doses of psilocybin and LSD. Subjective effects were assessed on an hourly basis during the acute drug effects, and the Mystical Experience Questionnaire (MEQ) was completed retrospectively. For patients, depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Results: Ratings of overall drug effect and mystical experience were similar across groups. Compared with healthy controls, patients reported lower ratings of ego dissolution. Patients showed a significant decrease in MADRS scores, and the greatest predictor of antidepressant outcome was relaxation during the PAT session. We did not observe a relationship between mystical-type experiences and antidepressant effects. Most patients experienced mild adverse effects which resolved within 48 h. Conclusion: PAT reduced depressive symptoms in this heterogeneous patient group. Patients may experience more challenging psychedelic effects and reduced ego dissolution. Hourly assessment of drug effects may predict clinical outcomes better than retrospectively assessed mystical experiences, and the impact of relaxation during PAT should be investigated further. [ABSTRACT FROM AUTHOR]

Pharmacovigilance helps determine when a treatment might cause novel or unintended effects. Patients, clinicians, regulators, and pharmaceutical companies have a stake in determining how the causality of treatment-induced effects should be established and when effects should be noted in settings from the academic literature to a medicine's label. There have been different approaches to this task in different jurisdictions, with reporting to companies more common in the United States and reporting to regulators more common in Europe. Over time, pharmacovigilance has switched from being primarily a clinical enterprise to being a regulatory one, which has led to the elimination of the names of those suffering from an adverse event and the outsourcing of the job of recording the details of events to private companies, which appears likely to reduce the recognition of adverse events. This article calls for a restoration of clinical input on adverse events aimed at increasing reporting and recognition rates for important behavioral events. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Finding effective treatment regimens for bipolar disorder is challenging, as many patients suffer from significant symptoms despite treatment. This study investigated the risk of relapse (psychiatric hospitalization) and treatment safety (non‐psychiatric hospitalization) associated with different doses of antipsychotics and mood stabilizers in persons with bipolar disorder.Individuals aged 15–65 with bipolar disorder were identified from Finnish national health registers in 1996–2018. Studied antipsychotics included olanzapine, risperidone, quetiapine, aripiprazole; mood stabilizers lithium, valproic acid, lamotrigine, and carbamazepine. Medication use was divided into three time‐varying dose categories: low, standard, and high. The studied outcomes were risk of psychiatric hospitalization (relapse) and the risk of non‐psychiatric hospitalization (treatment safety). Stratified Cox regression in within‐individual design was used.The cohort included 60,045 individuals (mean age 41.7 years, SD 15.8; 56.4% female). Mean follow‐up was 8.3 years (SD 5.8). Of antipsychotics, olanzapine and aripiprazole were associated with a decreased risk of relapse in low and standard doses, and risperidone in low dose. The lowest adjusted hazard ratio (aHR) was observed for standard dose aripiprazole (aHR 0.68, 95% CI 0.57–0.82). Quetiapine was not associated with a decreased risk of relapse at any dose. Mood stabilizers were associated with a decreased risk of relapse in low and standard doses; lowest aHR was observed for standard dose lithium (aHR 0.61, 95% CI 0.56–0.65). Apart from lithium, high doses of antipsychotics and mood stabilizers were associated with an increased risk of non‐psychiatric hospitalization. Lithium was associated with a decreased risk of non‐psychiatric hospitalization in low (aHR 0.88, 95% CI 0.84–0.93) and standard doses (aHR 0.81, 95% CI 0.74–0.88).Standard doses of lithium and aripiprazole were associated with the lowest risk of relapse, and standard dose of lithium with the lowest risk of non‐psychiatric hospitalization. Quetiapine was not associated with decreased risk of relapse at any dose. [ABSTRACT FROM AUTHOR]

Objectives: Hysterosalpingography (HSG) is widely used for evaluating the fallopian tubes; however, controversies regarding the use of water- or oil-based iodine-based contrast media (CM) remain. The aim of this work was (1) to discuss reported pregnancy rates related to the CM type used, (2) to validate the used CM in published literature, (3) to discuss possible complications and side effects of CM in HSG, and (4) to develop guidelines on the use of oil-based CM in HSG. Methods: A systematic literature search was conducted for original RCT studies or review/meta-analyses on using water-based and oil-based CM in HSG with fertility outcomes and complications. Nine randomized controlled trials (RCTs) and 10 reviews/meta-analyses were analyzed. Grading of the literature was performed based on the Oxford Centre for Evidence-Based Medicine (OCEBM) 2011 classification. Results: An approximately 10% higher pregnancy rate is reported for oil-based CM. Side effects are rare, but oil-based CM have potentially more side effects on the maternal thyroid function and the peritoneum. Conclusions: 1. HSG with oil-based CM gives approximately 10% higher pregnancy rates. 2. External validity is limited, as in five of nine RCTs, the CM used is no longer on the market. 3. Oil-based CM have potentially more side effects on the maternal thyroid function and on the peritoneum. 4. Guideline: Maternal thyroid function should be tested before HSG with oil-based CM and monitored for 6 months after. Clinical relevance statement: Oil-based CM is associated with an approximately 10% higher chance of pregnancy compared to water-based CM after HSG. Although side effects are rare, higher iodine concentration and slower clearance of oil-based CM may induce maternal thyroid function disturbance and peritoneal inflammation and granuloma formation. Key Points: • It is unknown which type of contrast medium, oil-based or water-based, is the optimal for HSG. • Oil-based contrast media give a 10% higher chance of pregnancy after HSG, compared to water-based contrast media. • From the safety perspective, oil-based CM can cause thyroid dysfunction and an intra-abdominal inflammatory response in the patient. [ABSTRACT FROM AUTHOR]

Introduction: Adjuvant treatment with aromatase inhibitors (AI) in oestrogen receptor-positive and/or progesterone receptor-positive breast cancer (BC) has been shown to increase overall survival. However, arthralgias and myalgias are common adverse effects in patients treated with AI. Objective: To evaluate the frequency and characteristics of arthralgias and myalgias in patients with early BC-treated adjuvantly with AI in the Mastology Unit of the Oncology Service of the Hospital de Clínicas and the Departmental Hospital of Soriano. Materials and methods: A prospective, cross-sectional and descriptive study was performed. A questionnaire was administered to patients to assess the presence and characteristics of arthralgias and myalgias associated with AI. Statistical analysis: 'Age' was described with measures of central tendency and dispersion. Qualitative variables were presented in absolute and relative frequencies. Logistic models were used to evaluate the association between patient characteristics, tumour characteristics, treatment characteristics and the presence of pain. Results were presented by odds ratio and p-value, using R software (version 4.1.2) with a significance threshold of 5%. Results: 83 patients were included, with a median age of 69 years. 75.9% presented arthralgias and/or myalgias related to treatment, with an average intensity of 5-7. 80.9% received non-steroidal anti-inflammatory drugs (NSAIDs), achieving satisfactory analgesia. The presence of arthralgias and myalgias was significantly associated with age and time since the last menstrual period (LMP), being more frequent in patients older than 50 years and those with more than 5 years since the LMP. Conclusion: Approximately 70% of the patients presented arthralgias or myalgias. These findings suggest a possible role of oestrogen withdrawal in its mechanism of development. Multidisciplinary and translational research is crucial to evaluate the ethology and therapeutic options for patients with AI-related arthralgia. [ABSTRACT FROM AUTHOR]

Many people have associated e-cigarettes with adjectives such as trendy and cool, and regarded vaping as "a safer alternative to cigarette smoking". Compared with the conventional cigarettes, the public is less familiar with the dangers of e-cigarettes. E-cigarettes produce an aerosol by heating the e-liquid (usually comprising nicotine, flavorings, propylene glycol, vegetable glycerin, and other additives). Harmful substances are generated during the vaporization, such as formaldehyde. Cellular damages and DNA hypermethylation are also found to be associated with vaping. We reviewed the clinical neoplastic cases of patients with vaping history (three oral squamous cell carcinomas, one conjunctival squamous intraepithelial neoplasia, and one thoracic NUT-midline carcinoma). These patients tend to be younger than the average cancer patients. Although the exact relations between the cellular damages or DNA hypermethylation and vaping still need further investigations, we should be very careful about the dangers of using e-cigarettes as aids for cigarette smoking cessation. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) is a chronic disease characterized by persistent pain and joint deformation. Effective pain management in patients with OA necessitates accurate diagnosis and appropriate treatment planning, considering the prolonged therapy required for OA. Although non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management in patients with OA, their long-term use can lead to various adverse effects that warrant careful consideration. Current Concepts: NSAIDs inhibit cyclo-oxygenase (COX) enzymes and produce an anti-inflammatory and analgesic effect. However, this mechanism of action can produce adverse gastrointestinal, cardiovascular, and renal effects. The relative risk of gastrointestinal and cardiovascular adverse events depends on the COX selectivity of NSAIDs. Consequently, selective COX-2 inhibitor or concomitant proton pump inhibitor administration is recommended in patients at a high risk of gastrointestinal complications. Minimizing NSAID use is advised in patients at a high risk of cardiovascular adverse events; however, if this is unavoidable, short-term administration of naproxen or low-dose celecoxib should be considered. COX selectivity is not associated with adverse renal events. Therefore, acetaminophen is preferred in patients with impaired renal function, and short-term use of NSAID patches or topical formulations may be useful. Discussion and Conclusion: The choice of NSAIDs for OA should be tailored to patients' needs, considering their risk factors, potential drug interactions, and other relevant factors. Additionally, incorporation of nonpharmacological interventions can minimize the NSAID dosage and reduce the risk of adverse effects, and regular monitoring is essential to identify adverse effects. [ABSTRACT FROM AUTHOR]

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This article reviews the implementation challenges to the American Society of Clinical Oncology's ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the incentive structure that encourages inclusion of biopsies. Principles of research stewardship require that the clinical trials community correctly articulate the scientific goals of any research biopsies, especially those that are required for the patient to enroll on a trial and receive an investigational agent. Furthermore, it is important to sufficiently justify the characterization of secondary (as distinguished from exploratory) endpoints, protect the interest of research participants, and report accurate and complete information to ClinicalTrials.gov and the published literature. [ABSTRACT FROM AUTHOR]

Despite all the progress made by science in the prevention and treatment of cardiovascular diseases and cancers, these are still the main reasons for hospitalizations and death in the Western world. Among the possible causes of this situation, disorders related to hyperinsulinemia and insulin resistance (Hyperin/IR) are still little-known topics. An analysis of the literature shows that this condition is a multiple risk factor for type 2 diabetes, cardiovascular diseases, cellular senescence and cancer, and neurodegenerative diseases. Hyperin/IR is progressively increasing worldwide, and its prevalence has now exceeded 50% of the general population and in overweight children. Asymptomatic or poorly symptomatic, it can last for many years before manifesting itself as diabetes, cardiovascular disease, neoplasm, cognitive deficit, or dementia, therefore leading to enormous social and healthcare costs. For these reasons, a screening plan for this pathology should be implemented for the purpose of identifying people with Hyperin/IR and promptly starting them on preventive treatment. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to determine the psychometric properties of the Spanish-language version of the HIV-Symptom Index (HIV-SI) questionnaire in Spanish patients undergoing antiretroviral therapy. Methods: Between 2014 and 2016, an observational, multicenter, prospective cohort study was conducted in seventeen Spanish hospitals to validate HIV-SI questionnaire in terms of: construct validity (confirmatory factor analysis), internal consistency (Cronbach's alpha), convergent validity (Pearson's correlation coefficient) and Known-group validity. In addition, a sensitivity to change analysis was also performed. Results: A total of 232 patients were included in the study. They had a mean age of 46.17 (SD9.82) and were 75% male. The median overall score for the HIV-SI was 10 (IQR 4– 19.5) and the most common symptoms reported were feelings of nervousness or anxiety, fatigue or energy loss, feeling sad or depressed, stomach pain or bloating, and difficulty sleeping. In the current study, the Spanish HIV-SI questionnaire showed a high internal consistency (α = 0.89) and adequate construct validity (CFI and TLI > 0.90). When contrasted with the MOS-HIV questionnaire, an inverse correlation was found. It showed a good association with the mental (r=-0.61; P < 0.0001) and physical score (r=-0.60; P < 0.0001). In a multivariate analysis, the age of the patient, female condition, hepatitis C coinfection, concomitant treatment and non-adherence resulted in a higher HIV-SI score. Conclusions: Our study has shown that the Spanish HIV-SI is a valid and reliable self-administered PROM for routine measurement of patient- reported symptoms among Spanish patients on antiretroviral treatment. [ABSTRACT FROM AUTHOR]

Cryolipolysis (CL) is a noninvasive technique in which applicators cool tissue to temperatures that selectively destroy adipocytes. Since its introduction to the market, it has rapidly become one of the leading nonsurgical modalities to reduce fat in the aesthetic industry. Paradoxical adipose hyperplasia (PAH) is a rare adverse reaction to CL, in which there is initial reduction in fat volume, followed by abnormal fat growth exceeding the original volume in the treated area. The incidence of PAH is thought to be underreported, and its pathophysiology and management remains unclear. The objective of this study was to present a series of PAH cases and review efficacy of management modalities. Level of Evidence: 4 [ABSTRACT FROM AUTHOR]

Background: Telemedicine represents an important strategy to facilitate access to medication abortion (MAB) procedures, reduces distance barriers and expands coverage to underserved communities. The aim is evaluating the self-managed MAB (provided through telemedicine as the sole intervention or in comparison to in-person care) in pregnant people at up to 12 weeks of pregnancy. Methods: A literature search was conducted using electronic databases: MEDLINE, Embase, Cochrane (Central Register of Controlled Trials and Database of Systematic Reviews), LILACS, SciELO, and Google Scholar. The search was based on the Population, Intervention, Comparison, Outcome, and Study Design (PICOS) framework, and was not restricted to any years of publication, and studies could be published in English or Spanish. Study screening and selection, risk of bias assessment, and data extraction were performed by peer reviewers. Risk of bias was evaluated with RoB 2.0 and ROBIS-I. A narrative and descriptive synthesis of the results was conducted. Meta-analyses with random-effects models were performed using Review Manager version 5.4 to calculate pooled risk differences, along with their individual 95% confidence intervals. The rate of evidence certainty was based on GRADE recommendations. Results: 21 articles published between 2011 and 2022 met the inclusion criteria. Among them, 20 were observational studies, and 1 was a randomized clinical trial. Regarding the risk of bias, 5 studies had a serious risk, 15 had a moderate risk, and 1 had an undetermined risk. In terms of the type of intervention, 7 compared telemedicine to standard care. The meta-analysis of effectiveness revealed no statistically significant differences between the two modalities of care (RD = 0.01; 95%CI 0.00, 0.02). Our meta-analyses show that there were no significant differences in the occurrence of adverse events or in patient satisfaction when comparing the two methods of healthcare delivery. Conclusion: Telemedicine is an effective and viable alternative for MAB, similar to standard care. The occurrence of complications was low in both forms of healthcare delivery. Telemedicine services are an opportunity to expand access to safe abortion services. Plain English summary: Globally, unsafe abortion causes 47,000 deaths and 5 million sexual and reproductive dysfunctions in young pregnant people due to complications of the procedure. This practice is related to barriers to accessing safe abortion services secondary to health system limitations and inequities in the distribution of resources. Telemedicine has proven to be an efficient care alternative to reduce distancing gaps, decrease waiting time and rationalize the costs derived from the procedure. Consequently, several health systems in the world use this model with differences in treatment schemes, weeks of gestation, pregnancy confirmation methods and measurement of reported outcomes. For this reason, evaluating the effectiveness and safety of self-managed medication abortion (MAB) by telemedicine is a support for decision makers who consider implementing or expanding remote care services. This systematic review integrated studies that evaluated MAB only by Telemedicine or in comparison with standard care on pregnant people with 12 weeks gestation or less. Available studies until January 2023 were chosen. Screening and selection of studies, data extraction, and risk of bias assessment were performed by expert reviewers. Aspects such as the effectiveness, safety, and satisfaction of the procedure, among other outcomes, were reviewed. A narrative and descriptive synthesis was carried out, as well as several meta-analyses of the differences in risks between Telemedicine and in-person care. The meta-analysis of studies comparing telemedicine care with standard services reveals that the type of care provided does not affect the effectiveness and safety of MAB, nor does it affect user satisfaction, follow-up, or medication adherence. [ABSTRACT FROM AUTHOR]

Background: Angiotensin-converting enzyme inhibitors (ACEIs) are prescribed for individuals with high cardiovascular (CV) risk; however, persistent cough limits the use of ACEIs in a large number of patients. The current study aimed to identify the genetic variants in the SLCO1B1 gene that might be associated with ACEI-related cough in a Pakistani hypertensive population. Methods: A prospective cohort study was conducted at a tertiary care hospital in Pakistan. A total of 74 patients who had been treated with ACEIs were recruited through a convenient sampling method. The study was approved by the Institutional Review Board & Ethics Committee of the Shifa International Hospital, Islamabad. Patients provided 2 ml of blood for sequencing after signing informed consent. Partial gene sequencing of SLCO1B1 was carried out to find single nucleotide polymorphisms (SNPs) and haplotypes. Results: It was found, through a structured questionnaire, that thirty-eight (38) patients experienced cough within 2 weeks of ACEI administration and were considered as a case group (cough), and thirty-six (36) patients were considered as a control group (no cough). The incidence of cough was 51%. We found six different SNPs and 9 haplotypes in the partial gene sequences of SLCO1B1. Haplotype H4 was associated significantly with cough after adjusting for sex and smoking status. Other SNPs and haplotypes were not significantly associated with ACE-Is-induced cough. Conclusion: These findings emphasize the significance of SLCO1B1 genetic variants, specifically H4, as a potential predictor of ACEI-induced cough. It could be included in clinical practice as a possible risk factor for ACEI-induced cough once confirmed in larger clinical trials with bigger sample sizes. The replication of these findings in larger and more diverse populations is likely to contribute to the therapeutic use of ACEIs by predicting ACEI-induced cough. [ABSTRACT FROM AUTHOR]

Compound 1 was previously identified by our team as a glycogen phosphorylase (GP) inhibitor with glucose-lowering activity and demonstrated to have protective effects against myocardial and cerebral ischemia. However, its impact on muscle function has not been clarified. This study is the first to evaluate the long-term effects of GP inhibitors on muscle function and metabolism. After a 28-day administration of Compound 1, we performed assays to assess muscle function and biochemical parameters in rats. We observed reductions in peak holding force, duration, tetanic contraction force, single-contraction force, and electromyographic signals under 20 s and 10 min contraction stimuli. The metabolic analysis showed no significant effects on muscle glycogen, ATP, lactic acid, and uric acid levels at low doses. In contrast, medium to high doses resulted in increased glycogen, decreased ATP, and reduced lactic acid (only at high doses), without affecting uric acid. These findings suggest that Compound 1 may adversely affect muscle function in rats, potentially due to the glycogen inhibition effects of GP inhibitors. This study provides crucial safety data and insights into the long-term effects of GP inhibitors on rat muscles, which will guide future developments and applications. [ABSTRACT FROM AUTHOR]