Recent Randomized Controlled Trials Research Articles

Cost-effectiveness of faecal microbiota transplantation compared with vancomycin monotherapy for early Clostridioides difficile infection: economic evaluation alongside a randomised controlled trial.

For Clostridioides difficile infection (CDI), faecal microbiota transplantation (FMT) is currently recommended for patients with three or more CDI episodes. A recent randomised controlled trial (RCT) show that FMT may be considered early, defined as intervention during the first or second CDI episode. Compared with standard care for first or second CDI, patients randomised to FMT had €1,645 lower hospital costs over 26 weeks owing to fewer admissions and hospital contacts and less medication use.

Abstract 4147610: Efficacy and Safety of Selective Cardiac Myosin Inhibitors in Symptomatic Hypertrophic Obstructive Cardiomyopathy: A Meta-Analysis of Randomized Controlled Trials

Background: Hypertrophic Obstructive Cardiomyopathy (HOCM) is an autosomal dominant inherited condition with limited management options, primarily focusing on symptom improvement through beta blockers. A novel selective cardiac myosin inhibitor, Mavacamten has been shown to improve exercise tolerance and NYHA functional class as compared to placebo in multiple randomized controlled trials (RCTs). A recent RCT from 2024 studied another oral cardiac myosin inhibitor, Aficamten which potentially decreases left ventricular outflow tract obstruction (LVOTO) in symptomatic HOCM. One limitation of all these RCTs, for obvious reasons, is the small sample size, which poses a challenge in its actual clinical significance. Aims: To analyze the efficacy and safety of novel selective cardiac myosin inhibitors in symptomatic HOCM patients Methods: We included 4 RCTs, comparing the efficacy and safety of selective cardiac myosin inhibitors and placebo groups. These studies were selected through a detailed search of the MEDLINE, COCHRANE, and PUBMED databases. We compared various common primary and secondary endpoints between both the groups: changes in exercise tolerance, NYHA functional class, and Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS). The results were reported as Odds Ratios (OR) with 95% confidence intervals (CI), using a random effects model. Results: The outcomes from 704 HOCM patients, which consisted of 361 patients who received a myosin inhibitor and 343 who received a placebo were analyzed. The primary endpoint in all the studies was improvement in exercise tolerance [measured as 1.5 mL/kg per min or greater increase in peak oxygen consumption (pVO2)], which was not statistically significant in our study (OR: 1.75, 95% CI: 0.89-3.43, p:0.1). There was a statistically significant improvement in ≥1 NYHA functional Class (OR: 3.9, 95% CI:2.49-6.12 p<0.05). There was no significant change seen in KCCQ-CSS (OR: 1.26, 95% CI: 0.75-2.12, p:0.3) and1 or more Serious Adverse Events (OR: 0.75, 95% CI: 0.42-1.32, p:0.3). (Figures A-D) Conclusion: Novel cardiac myosin inhibitors have shown statistically significant results in improving NYHA functional class, but not much difference in objective criteria like pVO2 with no significant adverse events. While these results appear promising and 2024 ACC/AHA guidelines have Class 1 Recommendation regarding their use for symptomatic HOCM, further analysis from a large population is needed.

Surgical management of first-time patellar dislocations in paediatric patients may lower rates of redislocation compared to conservative management: A systematic review and meta-analysis.

The purpose of this study is to assess whether early surgical intervention for first-time patellar dislocations in paediatric patients is superior to conservative management. We hypothesized that surgical intervention would lead to lower redislocation rates compared to conservative treatment. Three online databases (PubMed, MEDLINE and EMBASE) were searched from inception to 14 March 2024 to identify studies investigating the management options for acute first-time patellar dislocations in paediatric patients. Data pertaining to patient demographics, patient management, redislocation rates and Kujala scores, evaluating function, were abstracted. Weighted means and meta-analyses were conducted to compare rates of redislocation, as well as Kujala scores. The quality of included studies was assessed using the methodological index for non-randomized studies criteria for non-randomized studies and the ROB2 tool for randomized controlled trials (RCTs). A total of 11 studies and 761 patients were included in this review. The weighted mean post-operative combined rates of redislocation in the surgical group was 25.1%, compared to 46.4% in the conservative group at a mean follow-up of 53.2 months (12-168). The relative risk (RR) of redislocation was 0.82 (95% confidence interval [CI]: 0.65-1.04, I2 = 0%, p = 0.11), favouring surgery compared to conservative management. A subgroup meta-analysis of two recent RCTs with 110 patients demonstrated an RR of redislocation of 0.53 (95% CI: 0.31-0.91, I2 = 0%, p = 0.02), favouring surgery. Kujala scores among three comparative studies showed a mean difference of -2.7 (95% CI: -6.1 to 0.68, I2 = 0%, p = 0.12), favouring conservative treatment. The weighted mean redislocation rate in 131 patients undergoing medial patellofemoral ligament reconstruction (MPFLR) was 3.1%, compared to 39.4% in 203 patients undergoing other surgical procedures, such as lateral release and medial imbrication, Roux-Goldwaith and MPFL repair. Furthermore, the conservative groups experienced a complication rate of 0.9% compared to 2.9% across the surgical groups. Surgical management for first-time patellar dislocations in a paediatric population, particularly MPFLR, may be more beneficial in lowering redislocation rates than conservative management. No significant differences in Kujala scores were found. Level IV.

Atrial fibrillation detection on implantable loop recorders in embolic stroke of undetermined source

Abstract Introduction Embolic stroke of undetermined source (ESUS) represents 17% of all ischaemic strokes, and has a 5% annual stroke recurrence risk. Recent large randomised control trials failed to demonstrate a benefit of empirical anticoagulation for all ESUS patients, with sub-analyses supporting the need for a tailored approach to those patients at greatest risk of atrial fibrillation (AF) development. Understanding how the increased incidence of ILR-detected AF in the ESUS cohort, compares with ILR-detected AF in other cohorts is an essential step in understanding the significance of this finding. Purpose To compare the incidence of ILR-detected AF following ESUS against patients undergoing ILR implantation for non-stroke indications for example syncope and palpitations. Methods We retrospectively studied all patients without known AF who were referred to our institution for ILR implantation following ESUS, syncope or palpitations from 2009 to 2019. The primary endpoint was any detection of AF or atrial flutter (AFL) by ILR. Kaplan-Meier and multivariable Cox-regression analyses were utilised to account for time-to-event. Results A total of 750 patients were included and followed up for a mean of 731 days (SD 443). An ILR was implanted following ESUS in 323 patients and for another reason in 427 patients (figure 1). The incidence of AF was significantly higher among patients with ESUS compared to the non-ESUS group; 48.6% versus 13.8% (for any duration of AF) and 32.2% versus 12.4% (for AF lasting > 30 seconds) both p <0.001. Kaplan-Meier analysis (figure 2), showed significantly higher incidence of AF for ESUS for any duration of AF. This was driven predominantly by AF duration <6 minutes and between 5.5 hours and 24 hours. Importantly, in a multivariable Cox regression analysis, ESUS independently conferred an almost 5-fold increase in the hazard for any duration of AF (Hazard Ratio 4.948, 95% confidence interval 3.587 – 6.825, p<0.001). Conclusion The incidence of AF is significantly higher amongst ESUS versus non-ESUS patients monitored constantly by an ILR. A high number of ESUS survivors have short duration AF episodes. Further work is needed to determine the optimal treatment strategy of these AF episodes in ESUS considering AF duration and overall burden.

High-flow nasal cannulas versus standard oxygen therapy for moderate bronchiolitis: a quasi-experimental analysis.

In the last decades none of the medical therapies investigated have shown clear efficacy in the treatment of bronchiolitis, and literature agrees on a general de-implementation of pharmacological therapies, recognizing an effective role only to nutritional support and oxygen therapy. High-flow nasal cannulas (HFNC) has become increasingly popular in the last decade, despite its lack of clear efficacy. Recent randomized controlled trials (RCT) comparing standard oxygen therapy (SOT) and HFNC did not demonstrate significant benefit of HFNC. To acquire more clinical data on HFNC efficacy we performed a retrospective, quasi-experimental analysis of patients admitted for bronchiolitis in the epidemic seasons 2021-2022 and 2022-2023. To assess the efficacy of SOT and HFNC we used a pragmatic approach, a fuzzy regression discontinuity design, which is a quasi-experimental test. Unlike RCTs, this process is not a true randomization, but may be interpreted as quasi-randomization in an observational setting. HFNC did not reduce length of oxygen therapy (LOO) nor length of hospitalization (LOS) (respectively, p: 0.383 and p: 0.454). Treatment failure was not significantly different in the treatment groups (p: 0.354). It is crucial to perform additional RCTs with uniform protocols to determine the efficacy of HFNC more accurately in the treatment of bronchiolitis. HFNC does not reduce LOO, suggesting that early use of HFNC does not change the course of disease in moderate bronchiolitis. In view of the greater complexity and higher cost, HFNC should not be routinely used as first-line treatment in children with moderate respiratory distress and mild hypoxemia.

Current Trends in the Treatment of Acute Uncomplicated Diverticulitis.

Introduction: Acute diverticulitis represents a significant disease burden in the United States and developed world. This article examines current trends in the treatment of acute diverticulitis and concentrates on the utility of antibiotics in acute uncomplicated cases managed in the outpatient setting. Methods: The literature was reviewed for randomized controlled trials (RCTs) to discern the best practice and recommendations for antibiotics for diverticulitis. The time period included relevant RCTs after 2000. Results: Four recent RCTs examine the use of antibiotics in acute uncomplicated diverticulitis. The AVOD study was an RCT that managed inpatients with either antibiotics or IV fluids alone and demonstrated non-inferiority of non-antibiotic management with respect to recovery, complication rates, or recurrence. The DIABLO trial randomized first episodes of acute uncomplicated diverticulitis admitted to the hospital with antibiotics or supportive care and found no difference in morbidity or mortality between the two groups and longer hospital stay for patients treated with antibiotics. The DINAMO study examined outpatients managed with antibiotics by mouth or without and found no difference in morbidity in 90 day follow-up. The STAND study was the only of these four to use a placebo and found no difference between hospital stay or other adverse events at 30 days. In response to this, the ASCRS, AAFP and other societies now recommend against the routine use of antibiotics in acute uncomplicated diverticulitis. Conclusions: Several quality studies found similar outcomes in cases of acute uncomplicated diverticulitis treated with or without antibiotics. Based on these findings, societal guidelines do not recommend routine antibiotics for acute diverticulitis.

Employment Effects of Skills Trainings in Sub-Saharan Africa: A Systematic Review of Recent Randomized Controlled Trials

AbstractThis study provides a comprehensive systematic review of recent randomized controlled trials (RCTs) to evaluate the employment effects of skills training programs in sub-Saharan Africa. The review focuses on studies conducted between 2019 and 2024, a period marked by a significant increase in the number of RCTs of training interventions in this region, and we thus fill a gap left by earlier reviews that did not reflect this recent surge in experimental studies. We employ the standard SPIDER approach for defining search terms and the PRISMA procedure for search and selection to systematically analyze the impact of these training programs on employment outcomes. The findings reveal a shift towards a more optimistic assessment compared to previous analyses, suggesting that many recent skills training programs do contribute to improving employment-related outcomes.

8197 A Captivating Case Report of Teprotumumab Induced Hyperglycemic Hyperosmolar State

Abstract Disclosure: K.M. Tuna: None. J.P. Perdomo Rodriguez: None. Introduction: Teprotumumab, a monoclonal antibody targeting the IGF-1 receptor, is increasingly utilized for moderate to severe thyroid eye disease. Initial trials noted mild hyperglycemia in patients with diabetes, while recent trials revealed a significant elevation in Hemoglobin A1c (HbA1c) among those with diabetes or pre-diabetes post-infusion. Here, we discuss a case of a patient with diet-controlled diabetes who developed hyperglycemic hyperosmolar state (HHS) two months after Teprotumumab infusion. Case Presentation: A 43-year-old male, with class III obesity, obstructive sleep apnea, dyslipidemia, coronary artery disease, and diet-controlled diabetes (HbA1c 6.5%) presented with worsening proptosis, decreased color vision, severe visual field depression. Laboratory evaluation revealed elevated TSH (6.3 mIU/ml), normal free T4 (0.67 ng/dl, ref: 0.60-1.2 ng/dl), and undetectable Thyroid Stimulating Immunoglobulin (<0.1 IU/L). Blood cell count, renal and liver function tests were normal. Due to high clinical suspicion of thyroid eye disease, he was treated with timolol, dorzolamide, brimonidine, and methylprednisolone 1g daily for 3 days. Glycemic control was achieved with 30 units of daily insulin while on pulse steroids. On outpatient ophthalmology follow-up, Teprotumumab was initiated and he received 2 doses. Eight weeks later, the patient was hospitalized with altered mental status caused by HHS (glucose 617 mg/dl, serum osmolality 316 osm). HbA1c was found to be significantly increased to 12% and the patient required 150 units total daily insulin and metformin upon discharge. Of note, the patient did not have significant weight changes during this time. GAD, IA2, and Zinc Transporter-8 antibodies were obtained prior to discharge and results are pending. Discussion: The IGF-1 receptor, a partial homologue of the insulin receptor, plays a pivotal role in glucose homeostasis. Inhibiting this receptor can lead to hyperglycemia. Initial randomized controlled trials (RCTs) reported a 10% incidence of mild hyperglycemia. A recent RCT from a cohort of 42 patients demonstrated a 50% incidence of hyperglycemia, in which two-thirds of the patients remained in a dysglycemic state with one patient with pre-existing prediabetes developing diabetic ketoacidosis (DKA). Our patient mirrored this scenario with no identifiable confounding factors. Conclusion: Teprotumumab-induced hyperglycemia, though rare, can lead to life-threatening complications. Baseline glycemic assessment, identification of high-risk patients, and comprehensive discussions on risks and benefits are crucial before initiating therapy. Close monitoring, especially in those with prediabetes, is recommended. Patient education plays a pivotal role in early symptom recognition, averting delayed diagnoses, and subsequent hospitalization. Presentation: 6/3/2024

Endovascular treatment in ischemic strokes with large infarct core: an updated systematic review and meta-analysis of randomized controlled trials.

Endovascular treatment (EVT) is recommended for acute ischemic stroke due to large-vessel occlusion (LVO) and an ASPECTs ≥ 6. Recent randomized controlled trials (RCTs) have become available on effect of EVT in patients with LVO-related large core infarct stroke (ASPECTS 0-5). We conducted a systematic review and meta-analysis of trials on patients with large core infarct treated with thrombectomy compared to best medical therapy (BMT). The study followed PRISMA guidelines. Primary endpoint was functional independence at 90days (modified Rankin Scale mRS < 3). Secondary endpoints were 3-month moderate disability (mRS < 4), excellent outcome (mRS < 2) and change in mRS (shift analysis). Safety outcomes were: symptomatic intracranial hemorrhage (sICH) and 3-month mortality. Seven RCTs were included with a total of 1964 patients. Functional independence was significantly more frequent in EVT vs BMT group (19.4% vs 8%; OR = 2.72, 95%CI = 2.06-3.61, pheterogeneity = 0.08; I2: 47%). Moderate outcome was also more prevalent in EVT group (OR = 2.00; 95%CI = 1.61 - 2.48, pheterogeneity = 0.17; I2: 46%) as well as excellent outcome (OR: 1.54, 95%CI = 1.07 - 2.22, pheterogeneity = 0.13; I2: 40%). Shift analysis was also significant with OR 1.59 (CI = 1.33-1.82 and p < 0.001). Finally sICH, that occurred in 68 patients, was more frequent in EVT (OR = 1.63, 95%CI = 0.99 - 2.69, pheterogeneity = 0.68; I2: 0%) while 3m mortality was reduced in EVT (31% vs 37,1%, OR 0.76 CI = 0.62-0.92). This updated pooled data show that, in LVO-stroke patients with a large core infarct, EVT plus BMT (as compared to BMT alone) increases significantly the chances of achieving a good functional outcome at 90days and reduces the 3- month mortality despite a marginal increase in acute sICH.

A Clinicians Guide to Recommending Common Cholesterol-Lowering Dietary Supplements.

The US dietary supplement (DS) market has expanded exponentially since 1994, with an estimated 50,000-80,000 individual products currently available. Many DS claim cholesterol or cardiovascular benefits. Overall, well-designed randomized controlled trials (RCTs) with DS are lacking, while studies with favorable results are commonly performed outside of the USA, resulting in inconsistent findings. The expansion of the DS market has limited the ability of the Food and Drug Administration to regulate and prevent substandard products. Eicosapentaenoic acid and docosahexaenoic acid are components of DS fish oil. Recent RCTs utilizing prescription fish oil have provided mixed findings and small but significant safety concerns. Hence, the role of DS fish oil is limited and no longer recommended by major cardiovascular guidelines. Concerns have also been observed from RCTs utilizing prescription niacin, resulting in a negligible role for DS niacin in lipid management. Red yeast rice has demonstrated significant low-density lipoprotein cholesterol (LDL-C) reductions in studies performed worldwide, including the USA. However, quality concerns and inconsistent study results have been reported on multiple occasions. Other common DS have produced modest reductions in LDL-C and may provide other cardiometabolic benefits, including garlic, phytosterols, psyllium, and berberine. Yet inconsistent study results and quality concerns continue to be reported for most. Nonetheless, there is a need for alternative therapies that can safely and effectively reduce cardiovascular risk. However, until DS routinely match label claims and are free of contaminants, the agents have a limited role in clinical practice.

Does Silodosin Improve Primary Ureteroscopy Access and Outcomes: Meta-Analysis of Randomized Controlled Trials.

Background: Ureteroscopy (URS) is a widely utilized procedure for the management of urinary stones, though failed access due to ureteral orifice tightness or spasms can be a potential outcome. Silodosin, an alpha-1A adrenergic receptor antagonist, has shown promise in recent randomized controlled trials (RCTs) in improving URS outcomes by relaxing ureteral smooth muscle. Objective: This systematic review and meta-analysis aims to determine whether preoperative administration of silodosin enhances ureteroscopy outcomes, including ureteral access rates, operative time, complication rates, and stone-free rates. Methods: After PROSPERO registration, a comprehensive search of PubMed, EMBASE, and the Cochrane Library was conducted for RCTs comparing silodosin with placebo or no medication before URS. Data extraction and bias assessment were performed independently by two reviewers. Statistical analysis was undertaken by Review Manager V5.4, employing random-effects models for heterogeneous variables. Results: Eight RCTs with a total of 892 patients (416 in the silodosin group and 476 in the control group) met the inclusion criteria. Silodosin significantly reduced operative time by 15.74 minutes (p < 0.00001). The access rate was higher in the silodosin group (96.9%) compared with the control group (87.2%)(p = 0.0004). Total complication rates were lower in the silodosin group (14.39% vs 27.47%, p < 0.00001), as were moderate to significant complications (5.0% vs 11.7%, p = 0.003). Stone-free rates were also higher in the silodosin group (92.16% vs 81.5%, p < 0.0001). Conclusion: Preoperative administration of silodosin significantly improves URS outcomes by reducing operative time, increasing access rates, decreasing complication rates, and enhancing stone-free rates. These findings support the integration of silodosin into clinical practice guidelines for URS, potentially improving procedural efficiency and patient outcomes.

Meta-analysis on Effectiveness of Palliative Care versus Conventional Care amongst Advanced Gynaecological Patients with Cancer and Caregivers

In cancer patients, physical and psychological issues are very common. There is a need for family support and high utilisation of healthcare resources commonly. Palliative care (PC) has grown in popularity to better fulfil of needs of patients and their families and potentially lowering hospital costs. Given that the majority of patients still die in hospitals, there is a need for an effective model of PC for advanced gynaecological cancer, as well as the wise allocation of scarce resources. The main aim of this study was to compare the efficacy of PC to conventional treatment for adults with cancer, including gynaecological cancers, and their caregivers. Four randomised controlled trials (RCTs) were identified by searching PubMed, PubMed Central, Clinical Key, Embase and other grey literature from a duration of 2011–2021. Cochrane criteria were used to calculate the risk of bias, and the Grade Profiler Guideline Development Tool was used to check the quality of the included studies. Standardised mean differences (SMDs), I2 value and forest plot were prepared by using Review Manager 4.0. A total of four RCTs were extracted by following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and found to have a high risk for bias and low to poor quality of evidence. Included study sample sizes ranged from 22 to 104 participants, including 670 people in total, including 289 patients with advanced cancer patients, including gynaecological cancer and 381 unpaid caregivers. Results also showed that PC enhances patients’ quality of life (SMD = 0.26; 95% confidence interval [CI] = −0.29–0.80; I2 = 76%), lowered symptom burden amongst patients (SMD = −0.75, 95% CI = −1.75–0.25; I2 = 89%), reduces patient depression (SMD = 0.08, 95% CI = −0.19–0.34; I2 = 0%) and decreases depression in unpaid caregivers (SMD = −0.16, 95% CI = −0.56–0.24; I2 = 59%). PC treatment increases patients’ quality of life and lowers their symptom burden. In comparison to conventional care, it also reduces depression among patients and caregivers. We believe that the findings should be viewed with care until more recent exclusive RCTs are available.

Testosterone and the prevention of type 2 diabetes mellitus: therapeutic implications from recent trials.

Type 2 diabetes (T2D) is increasing to epidemic proportions and frequently associated with obesity and a low serum testosterone concentration in men. This review valuates recent randomized controlled trials (RCTs) investigating the effect of testosterone treatment on glycemic control and T2D prevention. The 2-year Testosterone for the Prevention of Type 2 diabetes Trial (T4DM) study showed that in men aged 50 years and over with visceral obesity and impaired glucose tolerance, testosterone treatment on the background of a lifestyle intervention reduced T2D risk by 40%. The Testosterone Effects on Atherosclerosis Progression in Aging Men and Testosterone Trials demonstrated modest improvements in insulin sensitivity and body composition. However, the Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men trial found no significant glycemic benefits over 2 years. Recent data from the Diabetes Prevention Program Outcome Study support the cost efficacy and durability of metformin. In men at high risk of T2D, treatment with testosterone prevents the disease; however, there are caveats to its use and other approaches may be more applicable. Differences in trial designs, age groups, and outcome measures contribute to varying results. HbA1C is a suboptimal outcome measure. Future research should explore potential synergies between testosterone and GLP-1 receptor agonists in T2D management, while considering cost-effectiveness.

Therapeutic Effects, Side Effects, and Adverse Effects of Neuropsychiatric Drugs in the Context of Treating Cancer-Related Anorexia With Olanzapine and Mirtazapine.

Drugs have actions that may be classified as therapeutic effects and side effects; side effects are actions that do not contribute to therapeutic benefit. Some side effects are neutral; others, experienced as undesirable or unpleasant, are recorded as adverse effects. Some drug actions are therapeutic for some disorders and adverse for others; or therapeutic during acute illness and adverse during maintenance treatment. As an example, anticholinergic action may be adverse when a tricyclic antidepressant is used to treat depression but therapeutic when the drug is used to treat irritable bowel syndrome with diarrhea. In clinical practice, side or adverse effects of a drug may be leveraged to manage troublesome symptoms. As an example, the sedative effect of a low dose of trazodone may be useful for some patients with insomnia. With this background, studies have examined whether the increase in appetite and weight associated with olanzapine and mirtazapine may be effective against anorexia and cachexia associated with cancer and cancer chemotherapy. The subject is important because cachexia may be present in 30%-50% of patients with cancer (with higher prevalence in patients with more advanced cancer) and because the presence of cachexia is associated with a higher risk of disease progression and mortality. Many randomized controlled trials (RCTs) have examined pharmacologic interventions such as progestins, corticosteroids, anamorelin, and medical cannabis for cancer related cachexia; most results have been disappointing. A recent RCT found that olanzapine (2.5 mg/d for 12 weeks) improved appetite, weight, other nutritional parameters, and quality of life in patients with locally advanced or metastatic cancer treated with chemotherapy. Another RCT, however, found that mirtazapine (30 mg/d for 8 weeks) brought no nutritional or anthropometric gain in patients with cancer and anorexia. It is concluded that olanzapine but not mirtazapine merits further investigation in patients with cancer who have anorexia and cachexia.

Evaluating Modern Therapeutic Interventions for Migraine Management: A Systematic Review.

This systematic review evaluates the efficacy and safety of contemporary migraine treatments, synthesizing evidence from recent randomized controlled trials (RCTs). The focus is on both pharmacological interventions, such as calcitonin gene-related peptide (CGRP) monoclonal antibodies and non-specific oral migraine preventives, and non-pharmacological approaches like myofascial release. Through a detailed examination of the studies, this review identifies superior strategies for acute and preventive migraine management, assessing their impact on patient-reported outcomes and determining the prevalence of associated adverse events. Findings suggest that while CGRP monoclonal antibodies show promise as first-line treatments due to their efficacy and safety, myofascial release offers considerable benefits for pain and disability in tension-type and cervicogenic headaches. Challenges such as the variability in individual response and potential side effects emphasize the need for personalized treatment plans. This review underscores the importance of integrating new therapeutic discoveries into clinical practice to enhance the quality of care for migraine sufferers.

Blood pressure management after endovascular thrombectomy: Insights of recent randomized controlled trials.

The ideal blood pressure (BP) target in patients who undergo endovascular thrombectomy (EVT) with successful reperfusion is uncertain. Observational studies show that elevated BP during this period is associated with a higher risk of intracranial hemorrhage (ICH) and worse clinical outcomes. Several randomized controlled trials (RCTs) have explored whether intensive BP lowering improves clinical outcomes in these patients. This review aims to summarize the recent RCTs that compare intensive and conventional BP management strategies following EVT and discuss the innovative directions to improve. The recently published RCTs failed to demonstrate the benefit of intensive BP control on the functional outcome and decreasing the risk of ICH. The complex mechanism in cerebral blood flow regulation and the inappropriate BP range chosen in RCTs may be the reasons behind the inconsistent results between observational studies and RCTs. Individualized BP management, reducing BP variability, and multi-stage BP management should be paid more attention in future exploration. Intensive BP target did not improve clinical outcomes after successful EVT as compared with a conventional BP target. Further research is required to identify the optimal BP management strategy after reperfusion.

Frailty in Oncology: Updated Recommendations for Clinical Practice

Frailty is a clinical condition associated with aging and resulting in increased risk of adverse outcomes upon exogenous or endogenous stressors. In oncology, cancer treatment itself can be a stressor event. In older cancer patients, frailty therefore not only enhances the probability of age-related health events such as institutionalization or falls, but also of treatment complications such as toxicity and interruption or discontinuation of therapy. As demonstrated by recent randomized-controlled trials conducted in older cancer patients receiving systemic treatment, the evaluation of frailty by geriatric assessment (GA) followed by an adjustment of the oncological therapy as well as targeted frailty interventions help to improve cancer treatment tolerability and feasibility. Based on these data, the American Society of Clinical Oncology (ASCO) updated the clinical practice guidelines for the assessment and management of vulnerabilities in older adults receiving systemic cancer therapy. The guideline recommends the use of a new GA-tool named 'practical geriatric assessment' (PGA) to foster the implementation of GA-based frailty assessment and management in routine cancer care. This article describes the background and key aspects of these recent advances.

Application of optical coherence tomography in cardiovascular diseases: bibliometric and meta-analysis.

Since the advent of Optical Coherence Tomography (OCT) two decades ago, there has been substantial advancement in our understanding of intravascular biology. Identifying culprit lesion pathology through OCT could precipitate a paradigm shift in the treatment of patients with Acute Coronary Syndrome. Given the technical prowess of OCT in the realm of cardiology, bibliometric analysis can reveal trends and research focal points in the application of OCT for cardiovascular diseases. Concurrently, meta-analyses provide a more comprehensive evidentiary base, supporting the clinical efficacy of OCT-guided Percutaneous Coronary Intervention (PCI). This study employs a dual approach of Bibliometric and Meta-analysis. Relevant literature from 2003 to 2023 was extracted from the Web of Science Core Collection (WoSCC) and analyzed using VOSviewer, CiteSpace, and R for publication patterns, countries, institutions, authors, and research hotspots. The study compares OCT-guided and coronary angiography-guided PCI in treating adult coronary artery disease through randomized controlled trials (RCTs) and observational studies. The study has been reported in the line with PRISMA and AMSTAR Guidelines. Adhering to inclusion and exclusion criteria, 310 publications were incorporated, demonstrating a continual rise in annual output. Chinese researchers contributed the most studies, while American research wielded greater influence. Analysis of trends indicated that research on OCT and angiography-guided PCI has become a focal topic in recent cohort studies and RCTs. In 11 RCTs (n = 5,277), OCT-guided PCI was not significantly associated with a reduction in the risk of Major Adverse Cardiac Events (MACE) (Odds ratio 0.84, 95% CI 0.65-1.10), cardiac death (0.61, 0.36-1.02), all-cause death (0.7, 0.49-1.02), myocardial infarction (MI) (0.88, 0.69-1.13), target lesion revascularization (TLR) (0.94, 0.7-1.27), target vessel revascularization (TVR) (1.04, 0.76-1.43), or stent thrombosis (0.72, 0.38-1.38). However, in 7 observational studies (n = 4,514), OCT-guided PCI was associated with a reduced risk of MACE (0.66, 0.48-0.91) and TLR (0.39, 0.22-0.68). Our comprehensive review of OCT in cardiovascular disease literature from 2004 to 2023, encompassing country and institutional origins, authors, and publishing journals, suggests that OCT-guided PCI does not demonstrate significant clinical benefits in RCTs. Nevertheless, pooled results from observational studies indicate a reduction in MACE and TLR.

Embolic Stroke of Undetermined Source: New Data and New Controversies on Cardiac Monitoring and Anticoagulation.

Embolic strokes of undetermined source (ESUS) represent 9%-25% of all ischemic strokes. Based on the suspicion that a large proportion of cardioembolic sources remain undetected among embolic stroke of undetermined source patients, it has been hypothesized that a universal approach of anticoagulation would be better than aspirin for preventing recurrent strokes. However, 4 randomized controlled trials (RCTs), with different degrees of patient selection, failed to confirm this hypothesis. In parallel, several RCTs consistently demonstrated that prolonged cardiac monitoring increased atrial fibrillation detection and anticoagulation initiation compared with usual care in patients with ESUS, and later in individuals with ischemic stroke of known cause (e.g., large or small vessel disease). However, none of these trials or subsequent meta-analyses of all available RCTs have shown a reduction in stroke recurrence associated with the use of prolonged cardiac monitoring. In this article, we review the clinical and research implications of recent RCTs of antithrombotic therapy in patients with ESUS and in high-risk populations with and without stroke, with device-detected asymptomatic atrial fibrillation.

O-188 Conventional in vitro fertilisation versus intracytoplasmic sperm injection in first cycle patients without severe male factor infertility (INVICSI): a randomised, controlled, open-label, multicentre trial

Abstract Study question Is the cumulative live birth rate (CLBR) after ICSI superior to conventional IVF (c-IVF) in first cycle fertility patients without severe male factor infertility? Summary answer In couples without severe male factor infertility, ICSI does not improve the CLBR compared to c-IVF after transfer of embryos from the first oocyte collection What is known already The ICSI procedure, originally developed for addressing severe male factor infertility, has seen expanded utilisation across various causes of infertility. Large retrospective studies and a recent randomised controlled trial (RCT) demonstrated comparable reproductive outcomes between ICSI and c-IVF in couples without male factor infertility. In approximately half of infertility cases, a male factor is involved, with about one-third attributed to male factor alone. Despite this, ICSI currently constitutes two-thirds of all assisted reproductive technology treatments worldwide Study design, size, duration Open-label, two-armed, multicentre RCT. A sample size of 784 women was required to detect a clinically relevant change of 10 percentage points with 80% power. Accounting for an expected 5% exclusion rate (dropouts and unexpected severely decreased quality sperm samples on the day of oocyte retrieval), 824 women were recruited from six public fertility clinics in Denmark between Nov 29, 2019, and Dec 14, 2022 Participants/materials, setting, methods Eligible participants were women aged 18-42 years and in their first treatment cycle with a partner/donor with normal or lightly to moderately decreased sperm quality. Randomisation was performed in a 1:1ratio between ICSI and c-IVF. The primary outcome was CLBR. Follow-up continued until the primary outcome was achieved or for a minimum of one year after the last participant’s inclusion.The primary outcome was assessed in an intention to treat (ITT) and a per protocol analysis Main results and the role of chance In total, 414 and 410 women were randomised to ICSI and c-IVF, respectively. Results include fresh as well as frozen-thawed embryo transfers from the first oocyte collection and are displayed as ITT. All transfers were elective single embryo transfers or single embryo transfers. The cumulative probability of achieving a live birth for couples/women undergoing ICSI was not different compared to those undergoing c-IVF (CLBR: ICSI 42.0% vs. c-IVF 46.6%, Risk ratio: 0.90, 95% CI: 0.77-1.05). The median time from inclusion to live birth did not differ between ICSI and c-IVF (309 days (IQR 268-378) vs 308 days (IQR 269-356); p = 0.12). Total fertilisation failure was seen in 4.9% of the ICSI group compared to 3.8% in the c-IVF group (Risk ratio: 1.29, 95% CI: 0.68-2.54) Limitations, reasons for caution This study was designed with 80% power to identify a 10% percentage point difference in CLBR between ICSI and c-IVF. We cannot dismiss the possibility of a smaller difference between the two methods Wider implications of the findings Our study, supported by prior research, shows that c-IVF rather than ICSI should be the first choice in initial cycles for patients without severe male factor infertility. Fertility staff should inform first cycle patients that ICSI does not increase the live birth rate for couples without severely decreased sperm quality Trial registration number NCT04128904