Potential Effectiveness of Chinese Patent Medicine Tongxinluo Capsule for Secondary Prevention After Acute Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
ABSTRACT: Background: Chinese patent medicine Tongxinluo capsule (TXL) is commonly used for cardio-cerebrovascular diseases. Previous research had demonstrated that TXL exhibited great clinical effects on the treatment of acute myocardial infarction (AMI), however there is a lack of systematic review. The purpose of this study was to evaluate the potential effectiveness and safety of TXL for secondary prevention in patients with AMI. Method: We searched 6 databases to identify relevant randomized controlled trials (RCTs) from inceptions to December 30, 2017. Two review authors independently assessed the methodological quality and analyzed data by the RevMan 5.3 software. The publication bias was assessed through funnel plot and Begg's test. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for evaluating the quality of evidence. Results: We included 19 RCTs in this review and performed a meta-analysis based on 16 studies. There were statistical differences of TXL treatment group in reducing primary cardiovascular events (cardiac death [RR = 0.27, 95%CI: 0.08~0.95, I2 = 0%], recurrent myocardial reinfarction [RR = 0.38, 95%CI: 0.20~0.74, I2 = 0%], arrhythmia [RR = 0.44, 95%CI: 0.30~0.66, I2 = 0%], recurrent angina pectoris [RR = 0.34, 95%CI: 0.17~0.69, I2 = 0%]). TXL could improve cardiac function (LVEF [MD = 4.10, 95%CI: 3.95~4.25, I2 = 0%]), regulate blood lipid TC [MD = -0.66, 95%CI: -0.94 ~ -0.37, I2 = 74%], TG [MD = -0.38, 95%CI: -0.62 ~ -0.14, I2 = 70%], LDL-C[-0.40, 95%CI: -0.65 ~ -0.16, I2 = 88%), decrease the level of hs-CRP (4-week: MD = -0.78, 95%CI: -0.97 ~ -0.60, I2 = 20%; Over 4-week: MD = -1.36, 95%CI: -1.55 ~ -1.17, I2 = 20%). However, TXL has little effects on revascularization [RR = 0.45, 95%CI: 0.13~1.56, I2 = 0%], recurrent heart failure (RR = 0.83, 95%CI: 0.27~2.57, I2 = 0%), and HDL-C (MD = 0.14, 95%CI: 0.00 ~0.29, I2 = 73%). Furthermore, TXL treatment group was more prone to suffer gastrointestinal discomfort. Conclusion: Chinese patent medicine TXL seemed beneficial for secondary prevention after AMI. This potential benefit needs to be further assessed through more rigorous RCTs. Systematic review registration number in the PROSPERO register: CRD42017068417.
Project description:Background:There are emerging observational studies (OSs) to assess real-world comparative effectiveness and safety of direct oral anticoagulants (DOACs) in cancer associated thrombosis (CAT). We conducted a pooled and interaction analysis to compare the treatment effect estimates of DOACs between OSs and randomized controlled trials (RCTs). Methods:We systematically searched PUBMED, EMBASE and Cochrane Library for OSs and RCTs that reported recurrent venous thromboembolism (VTE) and/or major bleeding events in CAT patients receiving DOACs and conventional anticoagulants [warfarin or low molecular-weight heparins (LMWHs)]. Relative risks (RRs) for OSs and RCTs were calculated using random-effects models separately, and interaction analyses were afterward applied to assess the comparability between OSs and RCTs. Results:Baseline characteristic was comparable between identified 10 OSs (35,142 patients) and 8 RCTs (2,602 patients). Overall, no significant difference of treatment effect estimates between OSs and RCTs was detected (Pinteraction: 0.42 for recurrent VTE; Pinteraction: 0.38 for major bleeding). DOACs significantly decreased the risk of recurrent VTE compared with conventional anticoagulants in CAT patients (RR: 0.74, 95% CI: 0.63-0.86, I2: 0% for OSs; RR: 0.65, 95% CI: 0.49-0.86; I2: 0% for RCTs), without increasing major bleeding risk (RR: 0.90, 95% CI: 0.76-1.07, I2: 24.0% for OSs; RR: 1.17, 95% CI: 0.72-1.88, I2: 26.2% for RCTs). Whereas, increased risk of gastrointestinal bleeding (GIB) was found with DOACs versus conventional anticoagulants in CAT patients (RR: 2.77, 95% CI: 1.35-5.68, I2: 0% for RCTs). Analyses of subgroups, based on comparators and follow-up duration, did not significantly affect results. Conclusions:In this study, effectiveness and safety of DOACs versus conventional anticoagulants in CAT from OSs are in agreement with those from RCTs, confirming a low risk of recurrent VTE and similar risk of major bleeding in CAT patients receiving DOACs.
Project description:Recent trials have assessed the efficacy and safety of novel monoclonal antibodies such as reslizumab and benralizumab. However, the overall efficacy and safety anti-interleukin (IL) 5 treatment in asthma have not been thoroughly assessed.Randomized controlled trials (RCTs) of anti-IL-5 treatment on patients with asthma published up to October 2016 in PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) that reported pulmonary function, quality of life scores, asthmatic exacerbation rate, blood and sputum eosinophil counts, short-acting ?-agonist (SABA) rescue use, and adverse events were included. The pooled mean difference, and relative risks (RR), and 95% confidence intervals (CIs) were calculated using random-effects models.Twenty studies involving 7100 patients were identified. Pooled analysis revealed significant improvements in FEV1 (first second forced expiratory volume) (MD = 0.09, 95% CI: 0.06-0.12, I2 = 10%), FEV1% (MD = 3.75, 95% CI: 1.66-5.83, I2 = 19%), Asthma Quality of Life Questionnaire (AQLQ) score (MD = 0.22, 95% CI: 0.15-0.30, I2 = 0%), decreased blood, sputum eosinophils and asthmatic exacerbation (RR = 0.66, 95% CI: 0.59-0.73, I2 = 51%); peak expiratory flow (PEF) (MD = 5.45, 95% CI: -2.83-13.72, I2 = 0%), histamine PC20 (MD = -0.62, 95% CI: -1.92-0.68, I2 = 0%) or SABA rescue use (MD = -0.11, 95% CI: -0.3-0.07, I2 = 30%) were unaffected; adverse events were not increased (RR = 0.93, 95% CI: 0.89-0.98, I2 = 46%). No publication bias was observed (Egger's P = 0.78).Anti-interleukin 5 monoclonal therapies for asthma could be safe for slightly improving FEV1 (or FEV1% of predicted value), quality of life, and reducing exacerbations risk and blood and sputum eosinophils, but have no significant effect on PEF, histamine PC20, and SABA rescue use. Further trials required to establish to clarify the optimal antibody for different patients.
Project description:<h4>Background</h4>Heart failure (HF) prognosis without therapy is poor, however introduction of a range of drugs has improved it. We aimed to perform a systematic review on the effects and safety of sodium-glucose transporter 2 inhibitors (SGLT2i) in HF patients.<h4>Methods</h4>We carried out a systematic review of randomized controlled trials (RCTs) on SGLT2i compared to placebo for HF patients. We searched in PubMed, Scopus, Web of Science and EMBASE, with no language restriction, from inception to 31 August 2020. We included nine RCTs comprising three arms (empagliflozin, dapagliflozin and placebo). Effects sizes for continuous variables were expressed as mean differences (MDs) and 95% confidence intervals (CIs). Effects sizes for dichotomous variables were expresses as risk ratio (RR) and 95% CIs. We used random-effect models with the inverse variance method. We performed subgroup meta-analyses by intervention drug and follow-up period.<h4>Results</h4>SGLT2i significantly reduced all-cause mortality (RR: 0.88, 95%CI 0.79-0.98, I2 = 0%), cardiovascular mortality (RR: 0.87, 95%CI 0.77-0.99, I2 = 0%), HF hospitalization (RR: 0.73, 95%CI 0.66-0.81, I2 = 0%) and emergency room visits due to HF (RR: 0.40, 95%CI 0.21-0.76, I2 = 0%), as well as composite outcomes including the previous ones. Besides, it significantly improved the score of the Kansas City Cardiomyopathy Questionnaire (KCCQ, MD: 1.70, 95%CI 1.67-1.73, I2 = 54%). SGLT2i reduced any serious adverse events, blood pressure and weight. However, it increased hematocrit and creatinine. The meta-analysis of RCTs of > 12 weeks of follow-up showed that SGTL2i significantly reduced NT-proBNP.<h4>Conclusions</h4>SGLT2i showed to improve critical outcomes in HF patients, and it is apparently safe.
Project description:BACKGROUND:We conducted a systematic review to assess the effectiveness of smoking cessation, physical activity (PA), diet, and alcohol reduction interventions delivered by mobile technology to prevent non-communicable diseases (NCDs). METHODS:We searched for randomised controlled trials (RCTs) of mobile-based NCD prevention interventions using MEDLINE, EMBASE, Global Health, CINAHL (Jan 1990-Jan 2016). Two authors extracted data. FINDINGS:71 trials were included: smoking cessation (n = 18); PA (n = 15), diet (n = 3), PA and diet (n = 25); PA, diet, and smoking cessation (n = 2); and harmful alcohol consumption (n = 8). 4 trials had low risk of bias. The effect of SMS-based smoking cessation support on biochemically verified continuous abstinence was pooled relative risk [RR] 2.19 [95% CI 1.80-2.68], I2 = 0%) and on verified 7 day point prevalence of smoking cessation was pooled RR 1.51 [95% CI 1.06-2.15], I2 = 0%, with no reported adverse events. There was no difference in peak oxygen intake at 3 months in a trial of an SMS-based PA intervention. The effect of SMS-based diet and PA interventions on: incidence of diabetes was pooled RR 0.67 [95% CI 0.49, 0.90], I2 = 0.0%; end-point weight was pooled MD -0.99Kg [95% CI -3.63, 1.64] I2 = 29.4%; % change in weight was pooled MD -3.1 [95%CI -4.86- -1.3] I2 0.3%; and on triglyceride levels was pooled MD -0.19 mmol/L [95% CI -0.29, -0.08], I2 = 0.0%. The results of other pooled analyses of the effect of SMS-based diet and PA interventions were heterogenous (I2 59-90%). The effects of alcohol reduction interventions were inconclusive. CONCLUSIONS:Smoking cessation support delivered by SMS increases quitting rates. Trials of PA interventions reporting outcomes ?3 months showed no benefits. There were at best modest benefits of diet and PA interventions. The effects of the most promising SMS-based smoking, diet and PA interventions on morbidity and mortality in high-risk groups should be established in adequately powered RCTs.
Project description:Background:Shengmai injection (SMI) is made from purified ginseng, Radix Ophiopogonis, and Schisandra chinensis. It has cardiotonic effects and is clinically used for the adjuvant treatment of chronic heart failure (CHF). However, its efficacy and safety are uncertain. The purpose of this study was to systematically evaluate the existing efficacy and safety evidence in randomized controlled trials (RCTs) that studied SMI for the treatment of CHF. Methods:PubMed, Embase, Cochrane Library, clinicaltrials.gov, CNKI, Wanfang, VIP, and CBM databases were searched up to September 10, 2019. RCTs that compared basic Western medicine treatment with SMI?+?basic Western medicine were included. The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias in the RCTs. The meta-analysis used the random effects model; the mean difference (MD) and 95% confidence intervals (CIs) were combined using the inverse variance method, and the Mantel-Haenszel method was used to combine the relative risk (RR) and 95% CIs. Heterogeneity was assessed using I2 and Q tests, and the source of heterogeneity was explored by analyzing three preset subgroup hypotheses. Results:A total of 20 RCTs were included (n?=?1562), with a moderate-to-high risk of bias. The meta-analysis showed that, compared with Western medicine alone, SMI adjuvant therapy significantly improved cardiac function indicators, including left ventricular ejection fraction (MD 6.8%, 95% CI 4.68 to 8.91), stroke volume (MD 9.81?ml, 95% CI 5.67 to 13.96), cardiac output (MD 0.96?L/min, 95% CI 0.66 to 1.25), and cardiac index (MD 0.53?L/min, 95% CI 0.36 to 0.70); heterogeneity was generally high among these outcomes. Compared with the controls, patients receiving SMI adjuvant therapy also had a higher response to treatment (RR 2.89, 95% CI 2.10 to 3.99; I2?=?0%), a greater decrease in brain natriuretic peptide levels (MD -284.66?ng/l, 95% CI -353.73 to -215.59, I2?=?0%), and a greater increase in six-minute walk test performance (MD 70.67?m, 95% CI 22.92 to 118.42; I2?=?84%). Nine studies reported mild adverse events, such as gastrointestinal reactions, and no serious adverse events were reported. Conclusion:Currently, available evidence indicates that SMI, as an adjuvant for basic Western medicine treatment, can improve the cardiac function of patients with CHF with good safety outcomes. Because of the high risk of bias among the included RCTs and the large heterogeneity of partial outcomes, the findings of this study must be verified by high-quality studies with large sample sizes.
Project description:Object:The purpose of this study was to fully assess the role of statins in the primary prevention of coronary heart disease (CHD). Methods:We searched six databases (PubMed, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Database, and Chinese Scientific Journal Database) to identify relevant randomized controlled trials (RCTs) from inception to 31 October 2017. Two review authors independently assessed the methodological quality and analysed the data using Rev Man 5.3 software. Risk ratios and 95% confidence intervals (95% CI) were pooled using fixed/random-effects models. Funnel plots and Begg's test were conducted to assess publication bias. The quality of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results:Sixteen RCTs with 69159 participants were included in this review. Statins can effectively decrease the occurrence of angina (RR=0.70, 95% CI: 0.58~0.85, I2 =0%), nonfatal myocardial infarction (MI) (RR=0.60, 95% CI: 0.51~0.69, I2 =14%), fatal MI (RR=0.49, 95% CI: 0.24~0.98, I2 =0%), any MI (RR=0.53, 95% CI: 0.42~0.67, I2 =0%), any coronary heart events (RR=0.73, 95% CI: 0.68~0.78, I2=0%), coronary revascularization (RR=0.66, 95% CI: 0.55~0.78, I2 = 0%), and any cardiovascular events (RR=0.77, 95% CI: 0.72~82, I2 = 0%). However, based on the current evidence, there were no significant differences in CHD deaths (RR=0.82, 95% CI: 0.66~1.02, I2=0%) and all-cause mortality (RR=0.88, 95% CI: 0.76 ~1.01, I2 =58%) between the two groups. Additionally, statins were more likely to result in diabetes (RR=1.21, 95% CI: 1.05~1.39, I2 =0%). There was no evidence of publication biases, and the quality of the evidence was considered moderate. Conclusion:Statins seemed to be beneficial for the primary prevention of CHDs but have no effect on CHD death and all-cause mortality.
Project description:BACKGROUND:Statins may improve outcomes in patients with cirrhosis. We performed a systematic review and meta-analysis to evaluate the effect of statins on patients with cirrhosis and related complications, especially portal hypertension and variceal haemorrhage. METHODS:Studies were searched in the PubMed, Embase and Cochrane library databases up to February 2019. The outcomes of interest were associations between statin use and improvement in portal hypertension (reduction >20% of baseline or <12 mm Hg) and the risk of variceal haemorrhage. The relative risk (RR) with a 95% CI was pooled and calculated using a random effects model. Subgroup analyses were performed based on the characteristics of the studies. RESULTS:Eight studies (seven randomised controlled trials (RCTs) and one observational study) with 3195 patients were included. The pooled RR for reduction in portal hypertension was 1.91 (95% CI, 1.04 to 3.52; I2=63%) in six RCTs. On subgroup analysis of studies that used statin for 1 month, the RR was 2.01 (95% CI, 1.31 to 3.10; I2=0%); the pooled RR for studies that used statins for 3 months was 3.76 (95% CI, 0.36 to 39.77; I2=75%); the pooled RR for studies that used non-selective beta-blockers in the control group was 1.42 (95% CI, 0.82 to 2.45; I2=64%); the pooled RR for studies that used a drug that was not reported in the control group was 4.21 (95% CI, 1.52 to 11.70; I2=0%); the pooled RR for studies that used simvastatin was 2.20 (95% CI, 0.92 to 5.29; I2=69%); RR for study using atorvastatin was 1.82 (95% CI, 1.00 to 3.30). For the risk of a variceal haemorrhage, the RR based on an observational study was 0.47 (95% CI, 0.23 to 0.94); in two RCTs, the pooled RR was 0.88 (95% CI, 0.52 to 1.50; I2=0%). Overall, the summed RR was 0.64 (95% CI, 0.42 to 0.99; I2=6%). CONCLUSION:Statins may improve hypertension and decrease the risk of variceal haemorrhage according to our assessment. However, further and larger RCTs are needed to confirm this conclusion.
Project description:BACKGROUND:Pressure support ventilation (PSV) is the prevalent weaning method. Proportional assist ventilation (PAV) is an assisted ventilation mode, which is recently being applied to wean the patients from mechanical ventilation. Whether PAV or PSV is superior for weaning remains unclear. METHODS:Eligible randomized controlled trials published before April 2020 were retrieved from databases. We calculated the risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CIs). RESULTS:Seven articles, involving 634 patients, met the selection criteria. Compared to PSV, PAV was associated with a significantly higher rate of weaning success (fixed-effect RR 1.16; 95% CI 1.07-1.26; I2?=?0.0%; trial sequential analysis-adjusted CI 1.03-1.30), and the trial sequential monitoring boundary for benefit was crossed. Compared to PSV, PAV was associated with a lower proportion of patients requiring reintubation (RR 0.49; 95% CI 0.28-0.87; I2?=?0%), a shorter ICU length of stay (MD -?1.58 (days), 95% CI -?2.68 to -?0.47; I2?=?0%), and a shorter mechanical ventilation duration (MD -?40.26 (hours); 95% CI -?66.67 to -?13.84; I2?=?0%). There was no significant difference between PAV and PSV with regard to mortality (RR 0.66; 95% CI 0.42-1.06; I2?=?0%) or weaning duration (MD -?0.01 (hours); 95% CI -?1.30-1.28; I2?=?0%). CONCLUSION:The results of the meta-analysis suggest that PAV is superior to PSV in terms of weaning success, and the statistical power is confirmed using trial sequential analysis.
Project description:Introduction:Catheter ablation has shown to reduce mortality in patient with atrial fibrillation (AF) and heart failure (HF) with reduced ejection fraction. Its effect on mortality in patients without HF has not been well elucidated. Methods:Thirteen randomized controlled trials encompassing 3856 patients were selected using PubMed, Embase and the CENTRAL till April 2019. Estimates were reported as random effects risk ratio (RR) with 95% confidence intervals (CI). Results:Compared with medical therapy, catheter ablation did not reduce the risk of all-cause mortality (RR, 0.86, 95% CI, 0.62-1.19, P=0.36; I2=0), stroke (RR, 0.55, 95% CI, 0.18-1.66, P=0.29; I2=0), need for cardioversion (RR, 0.84, 95% CI, 0.66-1.08, P=0.17; I2=0) or pacemaker (RR, 0.59, 95% CI, 0.34-1.01, P=0.06; I2=0). However, ablation reduced the RR of cardiac hospitalization (0.37, 95% CI, 0.18-0.77, P=0.01; I2=86), and recurrent atrial arrhythmia (0.46, 95% CI, 0.35-0.60, P<0.001; I2=87). There were non-significant differences among treatment groups with respect to major bleeding (RR, 1.89, 95% CI, 0.59-6.08, P=0.29; I2=15), and pulmonary vein stenosis (RR, 3.00, 95% CI, 0.83-10.87, P=0.09; I2=0), but had significantly higher rates of pericardial tamponade (RR, 4.46, 95 % CI, 1.70-11.72, P<0.001; I2=0). Conclusions:Catheter ablation did not improve survival compared with medical therapy in patients with AF without HF. Catheter ablation reduced cardiac hospitalization and recurrent atrial arrhythmia at the expense of pericardial tamponade.
Project description:BACKGROUND:We aimed to assess the association between inhaled corticosteroids (ICSs) and the risk of upper respiratory tract infection (URTI) in patients with chronic obstructive pulmonary disease (COPD). METHODS:PubMed, Embase, Cochrane Library and Clinical Trials.gov were searched from inception to October 2019. Randomized controlled trials (RCTs) of any ICSs vs control for COPD with reporting of URTI as an adverse event were included. The study was registered with PROSPERO prospectively (#CRD42020153134). RESULTS:Seventeen RCTs (20,478 patients) were included. ICSs significantly increased the risk of URTI in COPD patients (RR, 1.13; 95% CI 1.03-1.24; P?=?0.01; heterogeneity: I2?=?7%). Futher subgroup analyses suggested that short-term use of ICSs increased the risk of URTI (RR, 1.29; 95% CI 1.06-1.56; P?=?0.01; heterogeneity: I2?=?14%) but not for long-term use (RR, 1.08; 95% CI 0.97-1.2; P?=?0.14; heterogeneity: I2?=?0%). Short-term use of high-dose fluticasone increased the risk of URTI (RR, 1.33; 95% CI 1.03-1.71; P?=?0.03; heterogeneity: I2?=?0%) but not for long-term use (RR, 1.12; 95% CI 0.97-1.29; P?=?0.13; heterogeneity: I2?=?50%). Medium-dose (RR, 0.97; 95% CI 0.71-1.32; P?=?0.84; heterogeneity: I2?=?0%) and low-dose (RR, 1.39; 95% CI 0.92-2.1; P?=?0.12; heterogeneity: I2?=?30%) fluticasone did not increase the risk of URTI regardless of duration. Neither mometasone (RR, 1.05; 95% CI 0.87-1.26; P?=?0.61; heterogeneity: I2?=?0%) nor budesonide (RR, 1.08; 95% CI 0.77-1.5; P?=?0.67; heterogeneity: I2?=?46%) increased the risk of URTI, regardless of dosage or duration. CONCLUSIONS:Long-term use of ICSs does not increase the risk of URTI in patients with COPD. Short-term use of high-dose fluticasone increases the risk of URTI in patients with COPD, but not mometasone or budesonide.