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Journal of the American Heart... Aug 2023Background Sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce atherosclerotic cardiovascular disease (ASCVD) events in patients with prior ASCVD and type 2... (Meta-Analysis)
Meta-Analysis
Background Sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce atherosclerotic cardiovascular disease (ASCVD) events in patients with prior ASCVD and type 2 diabetes; however, this benefit is uncertain in patients without established ASCVD. Methods and Results Large-scale cardiovascular outcome randomized controlled trials or their prespecified subgroup analyses were selected, evaluating SGLT2 inhibitors versus placebo for primary prevention of ASCVD (inception, March 2023). The primary outcome was atherosclerotic major adverse cardiovascular events (MACEs), which was a composite of cardiovascular mortality, myocardial infarction, and stroke. The secondary outcomes were individual components of MACEs and all-cause mortality. The outcomes were reported as random-effect relative risk (RR) with a 95% CI. This analysis, comprising 23 987 patients enrolled in 5 randomized controlled trials with a mean follow-up duration of ≈135 weeks, found no significant reduction in atherosclerotic MACEs with SGLT2 inhibitors in comparison to placebo (RR, 0.85 [95% CI, 0.71-1.01]; =0.07; I=44). There were no significant differences in cardiovascular mortality (RR, 0.93 [95% CI, 0.77-1.14]; =0.50; I=0), myocardial infarction (RR, 0.88 [95% CI, 0.69-1.11]; =0.28; I=23), and stroke (RR, 0.84 [95% CI, 0.62-1.16]; =0.29; I=46). SGLT2 inhibitors significantly improved all-cause mortality (RR, 0.85 [95% CI, 0.72-1.0]; =0.04; I=23). On subgroup analyses, the use of SGLT2 inhibitors led to significant reductions in MACEs (RR, 0.74 [95% CI, 0.61-0.89]; =0.001), myocardial infarction (RR, 0.67 [95% CI, 0.47-0.97]; =0.03), and stroke (RR, 0.61 [95% CI, 0.41-0.91]; =0.01) primarily in patients with chronic kidney disease along with type 2 diabetes, whereas these benefits were not observed in patients with type 2 diabetes without chronic kidney disease. Conclusions SGLT2 inhibitors significantly reduced atherosclerotic MACEs in subjects having both chronic kidney disease and type 2 diabetes without established ASCVD.
Topics: Humans; Atherosclerosis; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Myocardial Infarction; Primary Prevention; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Stroke
PubMed: 37581396
DOI: 10.1161/JAHA.123.030578 -
Clinical Nutrition ESPEN Jun 2024The aim of this study was to investigate the omega-3 fatty acids supplementation, and resistance training on muscle strength and mass. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND & AIMS
The aim of this study was to investigate the omega-3 fatty acids supplementation, and resistance training on muscle strength and mass.
METHODS
A review was conducted by searching relevant randomized controlled trials investigating the effects of omega-3 fatty acids supplementation and resistance training on skeletal muscle strength and mass. Three experts independently performed a thorough examination of the literature database and conducted the systematic review and meta-analysis.
RESULTS
Four studies were ultimately included in the systematic review after screening. The results of the meta-analysis revealed that the supplementation of omega-3 fatty acids and resistance training significantly improved muscle strength compared to the placebo-controlled group. However, no significant effects were observed in the effect for muscle mass.
CONCLUSIONS
The interventions of omega-3 fatty acids supplementation and resistance training show promise as a countermeasure against muscular dysfunction. While further research is warranted to investigate its effects on skeletal muscle mass, the findings of this study hold implications for maintaining and/or improving the quality of life to elderly people.
Topics: Humans; Fatty Acids, Omega-3; Resistance Training; Muscle, Skeletal; Dietary Supplements; Muscle Strength; Randomized Controlled Trials as Topic; Quality of Life
PubMed: 38777432
DOI: 10.1016/j.clnesp.2024.03.019 -
Journal of Clinical Epidemiology Dec 2023To inform clinical practice guidelines, randomized controlled trials (RCTs) of the management of pneumonia need to address the outcomes that are most important to...
OBJECTIVES
To inform clinical practice guidelines, randomized controlled trials (RCTs) of the management of pneumonia need to address the outcomes that are most important to patients and health professionals using consistent instruments, to enable results to be compared, contrasted, and combined as appropriate. This systematic review describes the outcomes reported in clinical trials of pneumonia management and the instruments used to measure these outcomes.
STUDY DESIGN AND SETTING
Based on a prospective protocol, we searched MEDLINE/PubMed, Cochrane CENTRAL and clinical trial registries for ongoing or completed clinical trials evaluating pneumonia management in adults in any clinical setting. We grouped reported outcomes thematically and classified them following the COMET Initiative's taxonomy. We describe instruments used for assessing each outcome.
RESULTS
We found 280 eligible RCTs of which 115 (41.1%) enrolled critically ill patients and 165 (58.9%) predominantly noncritically ill patients. We identified 43 distinct outcomes and 108 measurement instruments, excluding nonvalidated scores and questionnaires. Almost all trials reported clinical/physiological outcomes (97.5%). Safety (63.2%), mortality (56.4%), resource use (48.6%) and life impact (11.8%) outcomes were less frequently addressed. The most frequently reported outcomes were treatment success (60.7%), mortality (56.4%) and adverse events (41.1%). There was significant variation in the selection of measurement instruments, with approximately two-thirds used in less than 10 of the 280 RCTs. None of the patient-reported outcomes were used in 10 or more RCTs.
CONCLUSION
This review reveals significant variation in outcomes and measurement instruments reported in clinical trials of pneumonia management. Outcomes that are important to patients and health professionals are often omitted. Our findings support the need for a rigorous core outcome set, such as that being developed by the European Respiratory Society.
Topics: Adult; Humans; Pneumonia; Treatment Outcome; Clinical Trials as Topic
PubMed: 37898460
DOI: 10.1016/j.jclinepi.2023.10.011 -
Frontiers in Immunology 2024At present, several important trials have been published show that perioperative immunotherapy combined with chemotherapy can improve the prognosis of patients with... (Meta-Analysis)
Meta-Analysis
Efficacy and safety of neoadjuvant immunotherapy plus chemotherapy followed by adjuvant immunotherapy in resectable non-small cell lung cancer: a meta-analysis of phase 3 clinical trials.
OBJECTIVE
At present, several important trials have been published show that perioperative immunotherapy combined with chemotherapy can improve the prognosis of patients with resectable non-small cell lung cancer, which further optimizes treatment options. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of perioperative immunotherapy combined with chemotherapy in resectable non-small cell lung cancer.
METHODS
The following databases were searched for relevant studies: PubMed, EMBASE, Cochrane library (updated 12 October 2023). All randomized trials comparing perioperative immunotherapy combined with chemotherapy versus chemotherapy alone in resectable non-small cell lung cancer were eligible for inclusion. Data were analyzed using Review Manager 5.4.1 (Cochrane collaboration software). Primary outcomes and measures included overall survival (OS), event-free survival (EFS), pathological complete response (pCR), major pathological response (MPR), R0 resection rate, rate of underwent surgery and adverse events (AEs).
RESULTS
A total of 2912 patients (1453 receiving perioperative immunotherapy plus chemotherapy and 1459 receiving chemotherapy alone) were included in this systematic review and meta-analysis. The result showed that compared with chemotherapy alone, combined therapy significantly improved OS (HR = 0.68;95% CI: 0.56-0.83), EFS (HR = 0.58;95% CI: 0.51-0.65), pCR (OR = 7.53;95% CI: 4.63-12.26), MPR (OR = 5.03;95% CI: 3.40-7.44), R0 resection (OR = 1.58;95% CI: 1.152.18) and rate of underwent surgery (OR = 1.25;95% CI: 1.04-1.49). However, combination therapy was associated with higher risk of severe adverse event (OR = 1.46;95% CI: 1.19-1.78; P=0.0002), grade 3 and higher treatment-related adverse event (TRAE) (OR = 1.25;95% CI: 1.06-1.49; P=0.010), TRAE that led to interruption (OR = 1.90;95% CI: 1.34-2.68; P=0.0003) and immune-related adverse event (OR = 2.78;95% CI: 2.18-3.55; P<0.00001). Significant benefits were observed across most subgroups of EFS and pCR. However, no statistical differences were observed for EFS of never smoked (HR = 0.73;95% CI: 0.51-1.05) and EGFR-mutation positive (HR = 0.35;95% CI: 0.04-3.03).
CONCLUSION
This systematic review and meta-analysis found superior efficacy associated with perioperative immunotherapy plus chemotherapy compared with chemotherapy alone in both tumor regression and prolonged survival in resectable NSCLC, but increased the risk of TRAE, so monitoring for adverse events is warranted.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero, identifier (CRD42023476786).
Topics: Humans; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Chemotherapy, Adjuvant; Clinical Trials, Phase III as Topic; Combined Modality Therapy; Immunotherapy; Lung Neoplasms; Neoadjuvant Therapy; Treatment Outcome
PubMed: 38646542
DOI: 10.3389/fimmu.2024.1359302 -
Clinics and Research in Hepatology and... Dec 2023To assess the efficacy and safety of endoscopic retrograde appendicitis treatment (ERAT) for acute appendicitis (AA) by conducting a meta-analysis of clinical randomized... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To assess the efficacy and safety of endoscopic retrograde appendicitis treatment (ERAT) for acute appendicitis (AA) by conducting a meta-analysis of clinical randomized trials (RCTs).
METHODS
Eight electronic databases were searched. Study quality was assessed using the Cochrane risk of bias tool. RevMan5.3 and STATA14 software were used to for statistical analysis.
RESULTS
Twenty-six RCTs with 2236 subjects were analyzed. First, operative time, length of hospital stay and duration of bed rest were shorter in the ERAT groups than in the control groups, with the pooled MD and 95 % CI being -13.22(-20.09, -6.35)(p = 0.0002), -2.13 (-2.47, -1.80)(p < 0.00001) and -3.15 (-3.76, -2.53)(p < 0.00001), respectively. Second, patients in the ERAT groups had a lower incidence of complications than the control groups, with a pooled RR and 95 % CI of 0.25(0.18, 0.35)(p < 0.00001). Third, patients who received ERAT returned to normal temperature faster than the control groups, the pooled MD and 95 % CI was -3.39(-4.36, -2.42)(p<0.00001). Finally, the result showed that the recurrence rate in the ERAT groups was approximately twice that of control groups, with the pooled RR and 95 % CI being 2.10(1.02, 4.32)(p < 0.00001).
CONCLUSIONS
ERAT results in fewer complications and shorter recovery time. And compared to appendectomy, ERAT reduces operative time and intraoperative bleeding. However, the recurrence of acute appendicitis after ERAT remains a concern. And more multicenter and large-scale RCTs are needed to confirm the benefits of ERAT.
SYSTEMATIC REVIEW REGISTRATION
We have registered on the PROSPERO [https://www.crd.york.ac.uk/PROSPERO/], and the registration number is CRD42023420171.
Topics: Humans; Appendicitis; Treatment Outcome; Endoscopy; Appendectomy; Acute Disease; Multicenter Studies as Topic
PubMed: 37925019
DOI: 10.1016/j.clinre.2023.102241 -
A systematic review and meta-analysis of macrolides in the management of adult patients with asthma.Allergology International : Official... Jul 2024The efficacy of macrolides in the management of asthma has been studied but remains controversial. We conducted a systematic review and meta-analysis of macrolides in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The efficacy of macrolides in the management of asthma has been studied but remains controversial. We conducted a systematic review and meta-analysis of macrolides in the management of adult patients with asthma.
METHODS
Randomized controlled trials of macrolides used in adult patients with asthma were searched for in MEDLINE, EMBASE, PsycINFO, Cochrane Library, CINAHL, and Igaku Chuo Zasshi databases to evaluate the efficacy and safety of macrolides.
RESULTS
Seventeen reports with macrolide treatment durations ranging from 6 to 48 weeks were included. Macrolides did not reduce exacerbations requiring hospitalization, severe exacerbations, or rescue use of short-acting beta-2 agonist inhalers; improve lung function; decrease peripheral blood or sputum neutrophil counts; or decrease fractional exhaled nitric oxide compared to placebo. Macrolides statistically improved asthma control and quality of life but by less than the minimal clinically important difference. Peripheral blood eosinophil counts as well as serum and sputum eosinophilic cationic protein concentrations were significantly decreased with macrolides compared to placebo. The improvement of asthma symptoms and airway hyperresponsiveness varied by study. The safety profile of macrolides was comparable to that of placebo.
CONCLUSIONS
Although macrolides have some useful clinical aspects, there is not sufficient evidence to recommend their use in the management of adult patients with asthma.
Topics: Humans; Asthma; Macrolides; Adult; Treatment Outcome; Anti-Asthmatic Agents; Randomized Controlled Trials as Topic; Quality of Life
PubMed: 38296770
DOI: 10.1016/j.alit.2024.01.002 -
Probiotics and Antimicrobial Proteins Aug 2023Heart failure (HF) is a global pandemic with increasing prevalence and mortality rates annually. Its main cause is myocardial infarction (MI), followed by rapid cardiac... (Meta-Analysis)
Meta-Analysis
Anti-Inflammatory, Antioxidant, Metabolic and Gut Microbiota Modulation Activities of Probiotic in Cardiac Remodeling Condition: Evidence from Systematic Study and Meta-Analysis of Randomized Controlled Trials.
Heart failure (HF) is a global pandemic with increasing prevalence and mortality rates annually. Its main cause is myocardial infarction (MI), followed by rapid cardiac remodeling. Several clinical studies have shown that probiotics can improve the quality of life and reduce cardiovascular risk factors. This systematic review and meta-analysis aimed to investigate the effectiveness of probiotics in preventing HF caused by a MI according to a prospectively registered protocol (PROSPERO: CRD42023388870). Four independent evaluators independently extracted the data using predefined extraction forms and evaluated the eligibility and accuracy of the studies. A total of six studies consisting of 366 participants were included in the systematic review. Probiotics are not significant in intervening left ventricular ejection fraction (LVEF) and high-sensitivity C-reactive protein (hs-CRP) when compared between the intervention group and the control group due to inadequate studies supporting its efficacy. Among sarcopenia indexes, hand grip strength (HGS) showed robust correlations with the Wnt biomarkers (p < 0.05), improved short physical performance battery (SPPB) scores were also strongly correlated with Dickkopf-related protein (Dkk)-3, followed by Dkk-1, and sterol regulatory element-binding protein 1 (SREBP-1) (p < 0.05). The probiotic group showed improvement in total cholesterol (p = 0.01) and uric acid (p = 0.014) compared to the baseline. Finally, probiotic supplements may be an anti-inflammatory, antioxidant, metabolic, and intestinal microbiota modulator in cardiac remodeling conditions. Probiotics have great potential to attenuate cardiac remodeling in HF or post-MI patients while also enhancing the Wnt signaling pathway which can improve sarcopenia under such conditions.
Topics: Humans; Antioxidants; Gastrointestinal Microbiome; Quality of Life; Stroke Volume; Hand Strength; Sarcopenia; Ventricular Remodeling; Ventricular Function, Left; Randomized Controlled Trials as Topic; Probiotics; Anti-Inflammatory Agents
PubMed: 37349622
DOI: 10.1007/s12602-023-10105-2 -
Cardiovascular Diabetology Jan 2024Numerous clinical studies have explored sodium-glucose cotransporter 2 inhibitor (SGLT2i) in patients with chronic heart failure (CHF), with or without type 2 diabetes... (Meta-Analysis)
Meta-Analysis
PURPOSE
Numerous clinical studies have explored sodium-glucose cotransporter 2 inhibitor (SGLT2i) in patients with chronic heart failure (CHF), with or without type 2 diabetes mellitus (T2DM), and SGLT2i were proved to significantly reduce CHF hospitalization, cardiovascular death, cardiovascular mortality, all-cause mortality and myocardial infarction in patients with or without T2DM. However, only a limited few have investigated the effects of SGLT-2i on HF disease-specific health status and cardiac function. This meta-analysis aims to assess the effects of SGLT2i on disease-specific health status and cardiac function in CHF patients.
METHODS
A comprehensive search was conducted of trials by searching in PubMed, EMBASE, CENTRAL, Scopus, and Web of Science, and two Chinese databases (CNKI and Wanfang), Clinical Trials ( http://www.
CLINICALTRIALS
gov ) were also searched.
RESULTS
A total of 18 randomized controlled trials (RCTs) involving 23,953 participants were included in the meta-analysis. The effects of SGLT2 inhibitors were compared with control or placebo groups in CHF with or without T2DM. The SGLT2 inhibitors group exhibited a significant reduction in pro b-type natriuretic peptide (NT-proBNP) levels by 136.03 pg/ml (95% confidence interval [CI]: -253.36, - 18.70; P = 0.02). Additionally, a greater proportion of patients in the SGLT2 inhibitors group showed a ≥ 20% decrease in NT-proBNP (RR = 1.45, 95% CI [0.92, 2.29], p = 0.072). However, no statistically significant difference was observed for the effects on B-type natriuretic peptide (BNP). The use of SGLT-2 inhibitors led to a noteworthy improvement in LVEF by 2.79% (95% CI [0.18, 5.39];P = 0.036). In terms of health status, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance, SGLT2 inhibitors led to a significant improvement in KCCQ clinical summary (KCCQ-CS) score (WMD = 1.7, 95% CI [1.67, 1.73], P < 0.00001), KCCQ overall summary (KCCQ-OS) score (WMD = 1.73, 95% CI [0.94, 2.52], P < 0.00001), and KCCQ total symptom (KCCQ-TS) score (WMD = 2.88, 95% CI [1.7, 4.06], P < 0.00001). Furthermore, the occurrence of KCCQ-CS and KCCQ-OS score increases ≥ 5 points had relative risks (RR) of 1.25 (95% CI [1.11, 1.42], P < 0.00001) and 1.15 (95% CI [1.09, 1.22], P < 0.00001), respectively. Overall, SGLT2 inhibitors increased the 6-minute walk distance by 23.98 m (95% CI [8.34, 39.62]; P = 0.003) compared to control/placebo from baseline.
CONCLUSIONS
The SGLT2 inhibitors treatment offers an effective strategy for improving NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire scores and 6-minute walk distance in CHF with or without T2DM. These findings indicate that SGLT2i improve cardiac function and health status in CHF with or without T2DM, and provide valuable guidance for clinicians making treatment decisions for patients with CHF.
Topics: Humans; Sodium-Glucose Transporter 2 Inhibitors; Natriuretic Peptide, Brain; Heart Failure; Health Status; Diabetes Mellitus, Type 2; Chronic Disease; Cardiomyopathies; Randomized Controlled Trials as Topic
PubMed: 38172861
DOI: 10.1186/s12933-023-02042-9 -
Medicine Aug 2023This systematic review and meta-analysis aimed to evaluate the clinical effectiveness of low-dose aspirin combined with calcium supplements for the prevention of... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aimed to evaluate the clinical effectiveness of low-dose aspirin combined with calcium supplements for the prevention of preeclampsia.
METHODS
China National Knowledge Infrastructure, VIP, Wanfang, PubMed, EMBASE, and Cochrane Library databases were searched from inception until December 2022. Randomized controlled trials investigating the preventive use of aspirin in combination with calcium supplementation for preeclampsia in high-risk pregnant women were included. The quality of the literature was evaluated, and a meta-analysis was conducted using RevMan 5.3 software to analyze the clinical efficacy of low-dose aspirin combined with calcium supplementation in preventing preeclampsia.
RESULTS
Seven randomized controlled trials were included in this meta-analysis, and compared with the control group, the experimental group had lower incidence rates of preeclampsia with gestational hypertension (odds ratios [OR]: 0.17, 95% confidence interval [CI]: 0.11-0.28), preeclampsia (OR: 0.20, 95% CI: 0.10-0.37), gestational hypertension (OR: 0.15, 95% CI: 0.07-0.31), preterm birth (OR: 0.26, 95% CI: 0.16-0.44), postpartum hemorrhage (OR: 0.15, 95% CI: 0.08-0.27), and fetal growth restriction (OR: 0.16, 95% CI: 0.08-0.33).
CONCLUSION
Compared with aspirin alone, low-dose aspirin combined with calcium supplementation was more effective in preventing preeclampsia, reduced the risk of preterm birth and postpartum hemorrhage, and promoted fetal growth. This intervention has clinical value and should be considered for high-risk pregnant women.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Calcium; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Postpartum Hemorrhage; Premature Birth; Calcium, Dietary; Aspirin; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 37653760
DOI: 10.1097/MD.0000000000034620 -
Diabetes Care Dec 2023The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated.
PURPOSE
To evaluate the efficacy and safety of AID systems in children and adolescents in outpatient settings.
DATA SOURCES
PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched until 4 May 2023. This study was registered with PROSPERO (2023, CRD42023395252).
STUDY SELECTION
Randomized controlled trials that compared AID systems with conventional insulin therapy in outpatient children and adolescents with T1D and reported continuous glucose monitoring outcomes were selected.
DATA EXTRACTION
Percent time in range (TIR) (3.9-10 mmol/L), time below range (TBR) (<3.9 mmol/L), and time above range (TAR) (>10 mmol/L) were extracted. Data were summarized as mean differences (MDs) with 95% CIs.
DATA SYNTHESIS
Twenty-five trials (1,345 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (MD, 11.38% [95% CI 9.01-13.76], P < 0.001; high certainty). The favorable effect was consistent whether AID was used over 3 months (10.46% [8.71-12.20]) or 6 months (10.87% [7.11-14.63]). AID systems had a favorable effect on the proportion of TBR (-0.59% [-1.02 to -0.15], P = 0.008; low certainty) or TAR (-12.19% [-14.65 to -9.73], P < 0.001; high certainty) compared with control treatment.
LIMITATIONS
Substantial heterogeneity was observed in most analyses.
CONCLUSIONS
AID systems are more effective than conventional insulin therapy for children and adolescents with T1D in outpatient settings. The favorable effect is consistent both in the short term and long term.
Topics: Child; Adolescent; Humans; Diabetes Mellitus, Type 1; Blood Glucose Self-Monitoring; Outpatients; Blood Glucose; Randomized Controlled Trials as Topic; Insulin
PubMed: 38011519
DOI: 10.2337/dc23-0504