Large-scale Randomized Controlled Trials Research Articles

Effect of acute kidney injury care bundle on kidney outcomes in cardiac patients receiving critical care: a systematic review and meta-analysis

BackgroundCardiac surgery is a major contributor to acute kidney injury (AKI); approximately 22% of patients who undergo cardiac surgery develop AKI, and among them, 2% will require renal replacement therapy (RRT). AKI is also associated with heightened risks of mortality and morbidity, longer intensive care stays, and increased treatment costs. Due to the challenges of treating AKI, prevention through the use of care bundles is suggested as an effective approach. This review aimed to assess the impact of care bundles on kidney outcomes, mortality, and hospital stay for cardiac patients in critical care.MethodsPubMed, Scopus, Web of Science, and EMBASE were searched up to November 2024. Inclusion criteria were studies on individuals with cardiac diseases receiving critical care, that used AKI care bundle as the intervention, and reported outcomes related to AKI, mortality, and other kidney-related events. We used the Cochrane Collaboration’s risk of bias tool 2 and the Newcastle-Ottawa scale for quality assessment. Pooled odds ratios (ORs) or risk ratios (RRs) with 95% confidence intervals (CIs) were calculated.ResultsSeven studies on total 5045 subjects, including five observational and two randomized controlled trials (RCTs) were included. The implementation of care bundles significantly reduced the incidence of all-stage AKI (OR: 0.78; 95%CI: 0.61–0.99) and moderate-severe AKI (OR: 0.56; 95%CI: 0.43–0.72). Also, the implementation of care bundle increased the incidence of persistent renal dysfunction after 30 days by 2.39 times. However, there were no significant changes in RRT, major adverse kidney events, or mortality between the groups. The mean quality assessment score for observational studies was 7.2 out of ten, while there were noted concerns in the risk of bias assessment of the RCTs.ConclusionsThe application of care bundles in patients, including those undergoing cardiac surgeries as well as non-cardiac critical illness, appears to be effective in reducing AKI, particularly in moderate and severe stages. However, given the inclusion of non-cardiac patients in some studies, the observed effect may not be solely attributable to cardiac surgery cases. Future large-scale RCTs focusing specifically on cardiac surgery patients are recommended to clarify the impact of care bundles within this subgroup.Registration ID in PROSPEROCRD42024498972.

Male Breast Cancer Biology, Screening, Treatment, and Follow-Up: A Narrative Review

Male breast cancer (MBC) is a rare type of cancer that affects men, accounting for only 1% of all cancers in men and all breast cancer cases worldwide. Its rarity is due to the differences in male endocrine function and the smaller amount of mammary tissue in males. Due to its infrequency, there is limited knowledge about the disease, and treatment recommendations are often based on extrapolation from clinical trial data involving female breast cancer patients. Men with MBC typically present in their 50s or older and may mistake a suspicious breast mass for a benign condition called gynecomastia. Various known risk factors contribute to breast cancer in men. Currently, there are no international randomized control trials (RCTs) specifically focused on MBC, and management guidelines are primarily derived from studies conducted among female patients. Localized and resectable cases of breast cancer typically require surgical intervention, followed by radiotherapy, chemotherapy, hormonal therapy, or potentially utilizing recent advancements in immune-oncology agents. A comprehensive approach that involves a multidisciplinary team ensures appropriate treatment and can lead to favorable outcomes. However, screening for MBC is limited due to the lack of large-scale international RCTs demonstrating its effectiveness in reducing MBC-related mortality.

Impact of pulmonary vein isolation on atrial arrhythmias in patients with typical atrial flutter: systematic review and meta-analysis of randomized clinical trials.

Cavotricuspid isthmus (CTI) ablation is the current ablation treatment for typical atrial flutter (AFL). However, post-ablation atrial tachyarrhythmias, mostly in the form of atrial fibrillation (AF), are frequently observed after CTI ablation. We aimed to evaluate the effectiveness and safety of concomitant or isolated pulmonary vein isolation (PVI) in patients with typical AFL scheduled for ablation. Electronic databases (PubMED, EMBASE, Clinicaltrials.gov) were searched through July, 2024. Randomized controlled trials (RCTs) were eligible if comparing PVI ± CTI ablation vs. CTI alone. The primary outcomes were any sustained atrial arrhythmia, typical AFL relapse, and AF. Secondary outcomes were need for redo-ablation or antiarrhythmic drugs. Random-effects and fixed-effects meta-analyses were undertaken for each individual outcome. Seven RCTs, with a total of 902 patients, were included. Comparing to CTI ablation alone, PVI ± CTI was more effective in preventing atrial tachyarrhythmias [risk ratio (RR) = 0.57, 95% CI: 0.41-0.79, P = 0.0007, I 2 = 50%, number needed to treat (NNT) = 4.1]. The results were driven mainly by a reduction of new onset/recurrent AF (RR = 0.41, 95% CI: 0.27-0.61, P < 0.0001, I 2 = 0%, NNT = 3.3), whereas there were no differences in typical AFL relapse (RR = 1.52, 95% CI: 0.63-3.66, P = 0.35, I 2 = 9%). Major complication rate was low and comparable across groups, although uncomplicated pericardial effusion was higher in PVI ± CTI (1.8% vs. 0.0%, P = 0.04). Results were comparable for the sub-analysis of PVI alone vs. CTI ablation. In patients with typical AFL, PVI ± CTI ablation is more effective than CTI alone in reducing the atrial tachyarrhythmias and subsequent AF during follow-up, without affecting major complications rate. These results set the rationale for a well-designed, larger-scale RCT comparing both strategies.

Magnetic Seizure Therapy in Refractory Psychiatric Disorders: A Systematic Review and Meta-Analysis: La thérapie par convulsions magnétiques pour la prise en charge des troubles psychiatriques réfractaires : revue systématique et méta-analyse.

To qualitatively and quantitatively synthesize the literature on the efficacy and safety of magnetic seizure therapy (MST) in psychiatric disorders. A literature search was conducted of the OVID Medline, OVID EMBASE, PsychINFO, CINAHL, Web of Science and Cochrane databases from inception to 14 January 2024, using subject headings and key words for "magnetic seizure therapy." Randomized controlled trials (RCTs), post-hoc analyses of RCTs, open-label trials, or case series investigating MST in adults with a verified psychiatric diagnosis and reporting on two possible primary outcomes (1) psychiatric symptom reduction (as measured by validated rating scale) or (2) neurocognitive outcomes (as measured by standardized testing), were included. Abstracts, individual case reports, reviews and editorials were excluded. Extracted data included: (1) basic study details; (2) study design; (3) sample size; (4) baseline demographics; (5) outcome data (including secondary outcomes of suicidal ideation and adverse events); and (6) stimulation parameters. Cochrane's risk of bias tool was applied. A quantitative analysis was conducted for the depression studies, using Hedge's g effect sizes. A total of 24 studies (n = 377) were eligible for inclusion. Seventeen studies in depression (including three RCTs), four studies in schizophrenia (including one RCT), one study in bipolar disorder, one study in obsessive-compulsive disorder and one study in borderline personality disorder were summarized. We found no significant difference in depressive symptom reduction between MST and electroconvulsive therapy (ECT) in randomized, controlled trials (g = 0.207 towards ECT, 95% confidence interval (CI) -0.132 to 0.545, P = 0.232). We found a significant reduction in depressive symptoms overall with MST in the pooled RCT and open-label analysis (g = 1.749, CI 1.219 to 2.279, P < 0.005). It is suggested that MST has modest cognitive side effects. Large-scale RCTs are necessary to confirm early signals of MST as an effective intervention in psychiatric disorders with a cognitive profile that is potentially more favourable than ECT.

Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled trial.

The impact of light exposure on mental health is increasingly recognised. Modifying inpatient evening light exposure may be a low-intensity intervention for mental disorders, but few randomised controlled trials (RCTs) exist. We report a large-scale pragmatic effectiveness RCT exploring whether individuals with acute psychiatric illnesses experience additional benefits from admission to an inpatient ward where changes in the evening light exposure are integrated into the therapeutic environment. From 10/25/2018 to 03/29/2019, and 10/01/2019 to 11/15/2019, all adults (≥18 years of age) admitted for acute inpatient psychiatric care in Trondheim, Norway, were randomly allocated to a ward with a blue-depleted evening light environment or a ward with a standard light environment. Baseline and outcome data for individuals who provided deferred informed consent were used. The primary outcome measure was the mean duration of admission in days per individual. Secondary outcomes were estimated mean differences in key clinical outcomes: Improvement during admission (The Clinical Global Impressions Scale-Improvement, CGI-I) and illness severity at discharge (CGI-S), aggressive behaviour during admission (Broset Violence Checklist, BVC), violent incidents (Staff Observation Aggression Scale-Revised, SOAS-R), side effects and patient satisfaction, probabilities of suicidality, need for supervision due to suicidality, and change from involuntary to voluntary admission. The Intent to Treat sample comprised 476 individuals (mean age 37 (standard deviation (SD) 13.3); 193 (41%) were male, 283 (59%) were female). There were no differences in the mean duration of admission (7.1 days for inpatients exposed to the blue-depleted evening light environment versus 6.7 days for patients exposed to the standard evening light environment; estimated mean difference: 0.4 days (95% confidence interval (CI) [-0.9, 1.9]; p = 0.523). Inpatients exposed to the blue-depleted evening light showed higher improvement during admission (CGI-I difference 0.28 (95% CI [0.02, 0.54]; p = 0.035), Number Needed to Treat for clinically meaningful improvement (NNT): 12); lower illness severity at discharge (CGI-S difference -0.18 (95% CI [-0.34, -0.02]; p = 0.029), NNT for mild severity at discharge: 7); and lower levels of aggressive behaviour (difference in BVC predicted serious events per 100 days: -2.98 (95% CI [-4.98, -0.99]; p = 0.003), NNT: 9). There were no differences in other secondary outcomes. The nature of this study meant it was impossible to blind patients or clinical staff to the lighting condition. Modifying the evening light environment in acute psychiatric hospitals according to chronobiological principles does not change duration of admissions but can have clinically significant benefits without increasing side effects, reducing patient satisfaction or requiring additional clinical staff. Clinicaltrials.gov NCT03788993; 2018 (CRISTIN ID 602154).

Acupuncture for atopic dermatitis: a systematic review and meta-analysis

ObjectivesAtopic dermatitis is a chronic, relapsing, inflammatory skin disease that impacts patients’ quality of life and imposes substantial economic burdens on their families. Acupuncture holds promise as a viable treatment...

Midodrine for the early liberation from vasopressor support in the ICU (LIBERATE): a feasibility study

BackgroundIntravenous (IV) vasopressors are the mainstay of physiological support for hemodynamically unstable patients. However, the role of oral vasopressors remains unclear. The objective of our study was to evaluate the feasibility of evaluating midodrine for critically ill patients with IV vasopressor-dependent shock.MethodsWe conducted a single-center, concealed-allocation, parallel-group, blinded feasibility randomized controlled trial (RCT) evaluating the effect of oral midodrine versus placebo on IV vasopressor-dependent shock in the intensive care unit (ICU). The study was performed in a medical-surgical ICU at the University of Alberta Hospital from April 2021 to July 2022. We included patients aged 18 years or older admitted to the ICU with ongoing vasopressor support with decreasing vasopressor dose(s). Patients were randomly assigned 1:1 to midodrine or a placebo for the duration of their IV vasopressor therapy. The primary outcome was study feasibility and secondary outcomes included patient-centered outcomes. Feasibility was assessed through rate of recruitment, adherence to study protocol, and patient safety.ResultsTwenty patients were enrolled in the study and underwent randomization (n = 11 midodrine, n = 9 control). Recruitment was recorded at 1.2 participants per month, protocol adherence was 90%, and allocation remained concealed. No adverse events were reported in either group. Sepsis was the most common cause of shock in both groups. The midodrine group had a shorter length of ICU stay of 9.6 (SD 8.7) vs 10.4 (SD 14.5) days. Hospital mortality was lower for the midodrine group (n = 2, 18.2% vs n = 4, 37.5%). Vasopressor re-initiation after 24 h was more frequent in the midodrine group (n = 4, 36.4% vs n = 2, 25%). There were no readmissions to the ICU following discharge in either group.ConclusionsThe evaluation of midodrine for patients in the ICU is feasible and safe. This trial will inform future large-scale RCTs regarding the utility of midodrine in critically ill patients with IV vasopressor-dependent shock.Trial registrationThis pilot RCT was registered at clinicaltrials.gov (NCT04489589). Registered July 27, 2020. https://clinicaltrials.gov/study/NCT04489589

Effectiveness of Vitamin D Supplementation in Reducing Atopic Dermatitis Severity in Children: A Meta-Analysis

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease that commonly affects children, with increasing prevalence worldwide. Vitamin D has demonstrated immunomodulatory effects, suggesting a potential role in AD management. This meta-analysis aimed to evaluate the effectiveness of vitamin D supplementation in reducing AD severity in children. Methods: A systematic search of PubMed, Science Direct, and Cochrane databases was conducted for randomized controlled trials (RCTs) published between 2012 and 2024, investigating the effects of vitamin D supplementation on AD in children. The primary outcome was the change in SCORAD (SCORing Atopic Dermatitis) or EASI (Eczema Area and Severity Index) scores. Meta-analysis was performed using Review Manager (RevMan 5.4) software. Results: Four RCTs met the inclusion criteria, comprising a total of 234 participants. The meta-analysis revealed a significant reduction in SCORAD scores (-2.83; 95% CI: -4.9, -0.76) and EASI scores (-0.41; 95% CI: -0.70, -0.13) in the vitamin D supplementation groups compared to the control groups. A combined analysis of both scoring systems further confirmed the overall significant effect of vitamin D in reducing AD severity (-1.57; 95% CI: -2.78, -0.36). Conclusion: Vitamin D supplementation is effective in improving AD symptoms in children. Further large-scale RCTs are warranted to determine the optimal dosage and duration of vitamin D supplementation for AD management in children.

Comparative efficacy of Chinese tonic medicines for treating sepsis or septic shock: A systematic review and Bayesian network meta-analysis of randomized controlled trials

BackgroundSepsis or septic shock is a life-threatening medical emergency with a poor prognosis and a high economic burden for both individuals and healthcare resources. Evidence suggests that Chinese tonic medicines (CTMs), as adjuvant treatments, are effective in treating this disease. Nevertheless, the ongoing discourse regarding the optimal CTMs persists. This study was conducted to further explore the comparative effectiveness of CTMs for patients with sepsis or septic shock. MethodsWe systematically searched Pubmed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang database, VIP database from inception to November 15, 2023. Primary outcomes encompassed the delta Sequential Organ Failure Assessment (ΔSOFA) score at day 7 after interventions and 28-day mortality. Secondary outcomes included delta serum lactate (ΔLac) and delta mean arterial pressure (ΔMAP) levels at day 7 after interventions, as well as the duration of vasoactive drug administration. The safety outcome was adverse drug reactions or adverse drug events (ADRs/ADEs). The risk ratio (RR) and mean difference (MD) with a 95 % confidence interval (95 %CI) were selected as effect measures. The Bayesian network meta-analysis was conducted by R version 4.2.2 software. The surface under the cumulative ranking curve (SUCRA) values were used to rank each treatment. The Cochrane Risk of Bias V.2.0 tool was employed to assess the within-study risk of bias. The CINeMA (Confidence in Network Meta-Analysis) web application was utilized to assess the quality of evidence. This protocol was prospectively registered in PROSPERO (CRD4202348572). ResultsA total of 45 randomized controlled trials (RCTs) involving 3433 patients were identified in this study. Seven CTMs including Shenfu injection (SF), Shenmai injection (SM), Sini decoction (SN), Shenfu and Shengmai granules (SF+SGM), Shengmai injection (SGM), Yiqifumai injection (YQFM), and Shenqifuzheng injection (SQFZ) were involved. Regarding the ΔSOFA score, interventions combining SM with Western medicine (WM) (MD, −2.77; 95 %CI, −3.28 to −2.27), YQFM+WM (MD, −1.76; 95 %CI, −2.73 to −0.79), SGM+WM (MD, −1.11; 95 %CI, −1.88 to −0.34), and SF+WM (MD, −0.98; 95 %CI, −1.17 to −0.78) demonstrated superiority over WM alone. According to the SUCRA values, SM+WM (99.28 %) achieved the highest ranking for the ΔSOFA score. Concerning 28-day mortality, SM+WM (RR, 0.51; 95 %CI, 0.35 to 0.72) and SF+WM (RR, 0.73; 95 %CI, 0.65 to 0.83) exhibited a superior effect in reducing 28-day mortality. Based on the SUCRA values, SM+WM (82.49 %) secured the top ranking for 28-day mortality. Among the secondary outcomes, SM+WM (MD, −2.50; 95 %CI, −4.15 to −0.83; SUCRA, 94.27 %) emerged as the most favorable in reducing serum lactate levels. SF+WM (MD, 10.78; 95 %CI, 3.11 to 18.71; SCURA, 78.3 %) exhibited superior effectiveness compared to other treatments in improving mean arterial pressure (MAP). The certainty of evidence for these outcomes was assessed as low. ConclusionCTMs combined with WM led to a significant improvement in ΔSOFA score and MAP, as well as a reduction in 28-day mortality and serum lactate levels. SM+WM emerged as the optimal treatment regimen for enhancing ΔSOFA, reducing 28-day mortality, and lowering serum lactate levels. Additionally, SF+WM exhibited superiority in improving MAP. Nevertheless, there is a need for large-scale, multicenter, and direct comparative RCTs to generate higher-quality evidence.

Conduction system pacing in heart failure: Time for a paradigm shift?

Heart failure (HF) is a major clinical challenge characterized by significant morbidity and mortality. Electrical conduction abnormalities play a critical role in HF pathophysiology and progression, often leading to suboptimal outcomes with conventional pacing techniques. Con-duction system pacing (CSP), encompassing His bundle pacing and left bundle branch area pacing, has emerged as a novel approach. Despite data come from observational studies, recent guidelines recommend that a specific population may benefit from CSP. However, significant practical considerations and challenges need to be clarified before CSP can be routinely implemented in clinical practice. The reliance on observational studies means that long-term clinical outcomes for HF patients remain uncertain until data from randomized controlled trials (RCTs) become available. Current CSP practices face challenges with lead implantation, mechanical stress on leads, and the need for more advanced tools and artificial intelligence integration to improve procedure efficacy and safety. Future large-scale RCTs are essential to identify optimal candidates and address these technical challenges, potentially leading to a paradigm shift in HF management.

Outcomes of endovascular thrombectomy for acute ischaemic stroke in patients aged ≥80 years: A Hong Kong stroke center experience

BackgroundElderly patients contribute to the large proportion of ischaemic stroke worldwide. Currently, treatment for elderly stroke remains aggressive, as the exact age cutoff for endovascular thrombectomy (EVT) has not been well established due to a lack of large-scale randomized control trials. In this study we investigate the difference in outcome after EVT in the octogenarian and above, compared to their younger counterparts. MethodsEVT patients were divided into two groups, the octogenarian group and younger group (below age of 80). Primary outcome were the 90-days post-thrombectomy functional independence (modified Rankin scale), and Barthel index. Secondary and safety outcomes of post-thrombectomy were also analyzed, including reperfusion status (modified Thrombolysis in Cerebral Infarction (TICI) score), National Institutes of Health Stroke Scale (NIHSS), major complications and mortality rate. ResultsA total 340 patients were included from 2020 to 29 Feb 2024, and patients’ demographics were obtained. Poorer neurological outcome and functional independence were noted in octogenarian group compared with younger counterpart (OR 0.33; 95 % CI 0.14-0.51; p < 0.001). A slightly higher trend of overall post-procedural death was also identified in elder group compared with the younger group (OR 1.48; 95 % CI 0.85-2.60, p = 0.08). Subgroup analysis with more advanced age cutoff at 90 took a step further and proposed that advanced age resulting in more devastating neurological outcome. ConclusionOutcomes after endovascular thrombectomy in the elder group were significantly worse than their younger counterparts. More than 80 % of elder group who were treated with EVT required moderate functional dependence, and one in four were dead within 90-days post-EVT.

The Effects of Non-Pharmacological Therapies for Dysphagia in Parkinson's Disease: A Systematic Review.

Parkinson's disease (PD) is currently the second most common degenerative neurological disorder globally, with aspiration pneumonia caused by difficulty swallowing being the deadliest complication. The patient's subjective experience and the safety of swallowing have been the main focus of previous evaluations and treatment plans. The effectiveness of treatment may be attributed to the brain's ability to adapt and compensate. However, there is a need for more accurate assessment methods for dysphagia and further research on how treatment protocols work. This systematic review was designed to assess the effectiveness and long-term impact of published treatment options for swallowing disorders in patients with PD. In adherence to the Preferred Reporting Items for Reviews and Meta-analysis (PRISMA) guidelines, we conducted a systematic review where we thoroughly searched multiple databases (PubMed, Web of Science, Elsevier, and Wiley) for clinical studies published in various languages until December, 2023. Two reviewers evaluated the studies against strict inclusion/exclusion criteria. This systematic review included a total of 15 studies, including 523 participants, involving six treatment approaches, including breath training, deep brain stimulation, reduction of upper esophageal sphincter (UES) pressure, transcranial magnetic stimulation, postural compensation, and video-assisted swallowing therapy. Primary outcomes included video fluoroscopic swallowing study (VFSS), fiberoptic endoscopic evaluation of swallowing (FEES), high-resolution pharyngeal impedance manometry (HPRIM), and functional magnetic resonance imaging (fMRI). Treatments that reduce UES resistance may be an effective way to treat dysphagia in PD patients. HRPIM can quantify pressure changes during the pharyngeal period to identify patients with reduced swallowing function earlier. However, due to the limited number of randomized controlled trials (RCTs) included and the high risk of bias in some studies, large-scale RCTs are needed in the future, and objective indicators such as HRPIM should be used to determine the effectiveness and long-term impact of different therapies on dysphagia in PD patients.

Acupuncture for patients with Alzheimer's disease: An evidence map of randomized controlled trials, systematic reviews, and meta-analysis.

Background: Acupuncture is an effective complementary treatment for Alzheimer's disease (AD). This review aims to summarize the available evidence provided by randomized controlled trials (RCTs) and systematic reviews (SRs) or meta-analyses (MAs) on the effect of acupuncture on AD. Objective: To systematically summarize and combine clinical research evidence on AD distribution. Methods: We conducted a comprehensive search of various databases, including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Data, Chinese BioMedical Literature Database (CBM) and Chonqing VIP (CQVIP), from their inception to September 2023. Relevant literature about acupuncture for AD was included, and the characteristics of the evidence map were presented through charts and textual analyses. Results: In total, 117 RCTs and 17 SRs or MAs were included. The results were divided into three categories: basic characteristics of the included literature, clinical characteristics and quality assessment of the included RCTs, and clinical characteristics and quality assessment of the included SRs and MAs. Conclusions: Acupuncture as a therapeutic measure for AD has some advantages in improving cognition and quality of life; thus, it is imperative to conduct multi-center, large-scale RCTs to enhance the evidence supporting the use of acupuncture in AD. This is the first evidence map exploring acupuncture treatment for AD, providing insights into the current clinical research landscape on acupuncture treatment for AD. Furthermore, the findings of this study highlight research gaps in this field and serve as a valuable reference for guiding the planning and selection of topics for future research.

Abstract 4137870: Nasal Etripamil Spray efficacy for Acute Paroxysmal Supraventricular Tachycardia: A Systematic Review, Meta-Analysis and Trial Sequential Analysis.

Background: Acute paroxysmal supraventricular tachycardia (PSVT) is a common arrhythmia. Etripamil, a novel calcium channel blocker via nasal spray, has shown promise for PSVT management. This meta-analysis and trial sequential analysis (TSA) evaluates the efficacy and safety of nasal Etripamil for treating PSVT. Methods: We systematically searched Pubmed, Embase, and Cochrane databases for studies assessing the efficacy and safety of Etripamil for PSVT. The main outcome was conversion to sinus rhythm(CSR) within 15 minutes. Secondary outcomes included adverse events(AE). Meta-analysis was performed using random-effects models, and TSA was employed to assess the robustness of the evidence and required information size. Results: Three randomized controlled trials (RCTs) and two extensive trials involving 1,652 participants were analyzed. Nasal Etripamil significantly increased the CSR within 15 minutes compared to placebo (RR 1.87 95% CI; 1.39-2.52, p &lt;0.001; Figure A). Outcome TSA suggested a low risk of type 1 error; therefore, this result may be conclusive (Figure B). For the AEs both a pairwise and single-arm meta-analysis of studies was performed with 1 AEs being statistically significant in the single-arm plot, Nasal Discomfort (22.11 95% CI; 16.02-29.70 events per 100 observations, p &lt;0.01 Figure C). In the pairwise, the overall was statistically significant and it favored placebo (RR 3.93, 95% CI; 2.46-6.27, p &lt;0.001 Figure D). Conclusion: Nasal Etripamil is effective and safe for the treatment of acute PSVT, offering a non-invasive alternative to traditional therapies. Larger-scale RCTs are warranted to confirm these findings and explore long-term outcomes.

Abstract 4137306: Percutaneous Coronary Intervention Versus Optimal Medical Therapy for Vulnerable Atherosclerotic Coronary Plaques: A Pilot Meta-Analysis of Randomized Controlled Trials

Background: Vulnerable coronary plaques are identified as thin-capped fibroatheromas with substantial plaque and a lipid-enriched necrotic core. These plaques are often non-flow-limiting on assessment; however, they have been associated with future adverse clinical outcomes, such as unstable angina, myocardial infarction, and sudden cardiac death. Current guidelines do not recommend revascularization of such coronary plaques; however, percutaneous coronary intervention (PCI) can theoretically slow atherosclerotic progression and potentially reduce future adverse events. Methods: Major electronic databases were searched for randomized controlled trials (RCTs) that compared PCI to optimal medical therapy (OMT) for vulnerable coronary plaques. The outcomes were pooled using a random-effects model, and the results were expressed as risk ratios (RR) with corresponding 95% confidence intervals (CI). Results: 3 RCTs with 1811 patients (909: PCI and 902: OMT) were included. PCI demonstrated a statistically insignificant trend towards a decreased risk of all-cause mortality [RR: 0.40; 95% CI: 0.13, 1.27; p=0.12], cardiovascular mortality [RR: 0.17; 95% CI: 0.02, 1.38; p=0.10], myocardial infarction [RR: 0.78; 95% CI: 0.35, 1.72; p=0.53], target vessel-related myocardial infarction [RR: 0.68; 95% CI: 0.04, 11.27; p=0.79], ischemia-driven target vessel revascularization [RR: 0.22; 95% CI: 0.04, 1.22; p=0.08], and major adverse cardiovascular events [RR: 0.41; 95% CI: 0.14, 1.18; p=0.10] compared to OMT. Conclusion: This study concluded that PCI was comparable to OMT in patients with vulnerable atherosclerotic coronary plaques. Further large-scale RCTs with longer follow-up durations are required to confirm these findings.

Abstract 4147434: Efficacy and Safety of Tirofiban for the Management of Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs)

Background: Tirofiban is a GP IIb/IIIa inhibitor, an anti-platelet drug that is used after ischemic episodes like stroke or acute coronary syndromes. We are assessing the safety and efficacy of the drug in patients who have suffered an acute ischemic stroke. Methods: A comprehensive search of PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception to April 2024 yielded randomized controlled trials (RCTs) comparing Tirofiban and control in patients with acute ischemic stroke. We assessed the risk of bias using the revised Cochrane “Risk of bias” tool for randomized trials (RoB 2.0). We analyzed the outcomes using RevMan 5.4, with risk ratio (RR) as the effect measure. Results: A total of eight RCTs with 3678 patients were included in our meta-analysis. According to our meta-analysis, the Tirofiban group was associated with a statistically significant increase in the patients showing functional independence at 90 days, measured by patients with Modified Rankin Score (mRS) of 0-2 (RR 1.14; CI = 1.05-1.25; I 2 = 38%). We found no difference between the two groups regarding excellent outcome (mRS score 0-1) at 90 days (RR 1.15; CI = 0.99-1.33; I 2 = 51%) and mortality (RR 0.86; CI = 0.50-1.46; I 2 = 56%). The tirofiban group did not increase the incidence of both intracranial hemorrhage (ICH) (RR 1.23; CI = 1.04-1.46; I 2 = 0%) and symptomatic ICH (RR 1.41; CI = 0.93-2.14; I 2 = 0%). Conclusion: According to our analysis of acute ischemic stroke patients, Tirofiban increased the number of patients with functional independence with no increase in adverse events as compared to the control group. Large-scale RCTs are needed to better ascertain the role of Tirofiban in acute ischemic stroke.

Abstract 4136033: High-Dose Folic acid Supplementation in Acute Myocardial Infarction - A systematic review

Background: Folic acid, a B vitamin, is essential for DNA synthesis and repair, and its role in reducing homocysteine levels has been linked to cardiovascular health. Elevated homocysteine is a risk factor for cardiovascular diseases, including acute myocardial infarction (MI) and coronary artery disease (CAD). Despite evidence suggesting that folic acid supplementation may lower homocysteine levels, its clinical benefits in reducing cardiovascular events remain unclear. Methods: A comprehensive literature search was conducted in PubMed/Medline, Google Scholar, and Cochrane Library databases for studies published from 2000 to 2024 using MeSH terms related to “folic acid,” “B vitamin,” “acute myocardial infarction,” “cardiac arrest,” “heart attack,” and “coronary heart disease.” Only randomized controlled trials (RCTs) and observational studies in English involving adult patients with acute MI or CAD were included. Exclusion criteria were applied to poor-quality studies, irrelevant outcomes, overlapping populations, and non-English texts. Data on study characteristics and patient demographics were extracted, and study quality was assessed using the RoB2 tool. Outcomes were pooled using RevMan 5.3.4 software. Results: Fourteen studies on all-cause mortality showed a risk ratio (RR) of 0.99 [95% CI: 0.94-1.04], indicating no significant difference between folic acid and control groups. Eight studies on cardiovascular mortality yielded a RR of 0.90 [95% CI: 0.82-0.99], suggesting a significant reduction in cardiovascular deaths with folic acid supplementation. Analyses of sudden death, coronary artery bypass graft (CABG) events, revascularization procedures, stroke, and recurrent MI found no significant associations with folic acid supplementation. Conclusions: High-dose folic acid supplementation appears to reduce cardiovascular mortality in post-MI patients but shows no significant impact on other clinical outcomes. This meta-analysis’s limitations include potential publication bias, heterogeneity among included studies, and variability in folic acid dosages and treatment durations. Furthermore, the lack of comprehensive homocysteine level data constrained the analysis. Future large-scale RCTs are needed to fully ascertain the therapeutic potential of folic acid supplementation in secondary prevention of cardiovascular events.

Meta-Analysis of Renal Denervation Therapy During Pulmonary Vein Isolation in Atrial Fibrillation

Pulmonary vein isolation (PVI) has been established as a first-line therapy for symptomatic atrial fibrillation (AF) in selected patients with symptomatic AF as well as in those who failed antiarrhythmic drugs. However, AF recurrence rates following PVI remain high, prompting the exploration of adjunct therapies such as renal denervation (RDN) to improve outcomes. This meta-analysis aims to assess the efficacy of RDN as an adjunct to PVI in reducing AF recurrence. A comprehensive search of randomized controlled trials (RCTs) comparing RDN plus PVI to PVI alone was conducted, yielding nine studies with 955 patients. The primary endpoint was freedom from AF at 12 months. Results showed that 61.7% of patients in the RDN+PVI group were free from AF, compared to 52.6% in the PVI-alone group (RR 1.32, 95% CI 1.07–1.61, I²=48%). These findings support the potential of RDN to enhance PVI efficacy; however, further large-scale RCTs with standardized methodologies and longer follow-up periods are necessary to confirm these results and establish the role of RDN in the treatment of AF.

Comparison of nonimplantable electrical stimulation in women with urinary incontinence: a systematic review and network meta-analysis of randomized controlled trials.

This study examined the effectiveness of various electrical stimulation methods in alleviating symptoms and enhancing the quality of life for women with urinary incontinence. We conducted a systematic search of PubMed, Cochrane Library, PEDro, EMBASE, and ClinicalTrials.gov from inception to August 2024. Randomized controlled trials (RCTs) that meet following criteria were included, urinary continence in women, using various electric stimulation treatments and evaluated outcomes related to symptoms, quality of life. Thirty RCTs were subjected to risk of bias assessment, certainty of evidence, and network meta-analysis. Statistical analysis was performed using a random-effects model, with continuous variables expressed as standardized mean difference (SMD) and 95% confidence interval (CI). Percutaneous tibial stimulation (SMD - 1.86, 95% CI - 2.77 to - 0.96) and intravaginal stimulation (SMD - 0.97, 95% CI - 1.55 to - 0.38) significantly reduced symptom severity. Additionally, percutaneous tibial, intravaginal, transcutaneous tibial, and trans-sacral stimulations improved quality of life. Percutaneous tibial stimulation was the most effective, followed by intravaginal stimulation. Despite moderate to low confidence in the evidence, large-scale RCTs are needed to evaluate long-term benefits of these treatment.

Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility randomised trial.

The increasing prevalence of mental health disorders in the United Kingdom necessitates the exploration of novel treatment modalities. This study aimed to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) evaluating the efficacy of four osteopathic interventions on psychophysiological and mental health outcomes. A mixed-methods feasibility study with an explanatory sequential design was implemented. The quantitative phase involved randomising 42 participants into four intervention groups: (1) high-velocity and articulation techniques (HVAT), (2) soft-tissue massage (STM), (3) craniosacral therapy (CST), and (4) a combination approach. Primary outcome measures encompassed recruitment rate, assessment duration, questionnaire completion, intervention attrition, and adverse events. Secondary outcomes included validated assessments of depression, anxiety, stress, psychological flexibility, heart rate variability (HRV), and interoception, administered pre- and post-intervention. Analysis of variance (ANOVA) was employed to evaluate pre-post intervention changes. The qualitative phase comprised semi-structured interviews analysed using thematic analysis. The study achieved a recruitment rate of 21 eligible participants per month, with 54.8% of respondents meeting eligibility criteria. All 33 participants who completed the study underwent interventions and assessments within the allocated one-hour timeframe, with full questionnaire completion. The attrition rate was 21%. No adverse events were reported. Qualitative analysis revealed positive participant experiences, with themes highlighting good practitioner communication, intervention accessibility, and increased bodily awareness. Some participants found the questionnaire battery burdensome. Exploratory quantitative analyses showed variations in effects across interventions for heart rate variability, interoceptive accuracy, and mental health measures, but these results should be interpreted cautiously due to the small sample size. This study provides evidence supporting the feasibility and acceptability of a larger-scale RCT investigating osteopathic interventions for individuals presenting with mild psychological symptoms. The preliminary findings suggest potential efficacy in improving mental health outcomes, warranting further investigation. Trial registration NCT05674071, registered 06/01/2023.