scholarly journals Efficacy and Safety of Shengmai Injection for Chronic Heart Failure: A Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Yanping Wang ◽  
Xu Zhou ◽  
Xiaofan Chen ◽  
Fei Wang ◽  
Weifeng Zhu ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Chronic Heart Failure ◽  
Western Medicine ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Shengmai Injection ◽  
Randomized Controlled

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.

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

scholarly journals Efficacy and Safety of Oral Anticoagulants in Patients with Systolic Heart Failure in Sinus Rhythm: A Systematic Review and Meta-analysis of Randomized Controlled Trials and Cohort Studies

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e383-e392
Author(s):  
Marie H. Nygaard ◽  
Anne-Mette Hvas ◽  
Erik L. Grove
Keyword(s):  
Heart Failure ◽  
Sinus Rhythm ◽  
Cohort Studies ◽  
Antiplatelet Therapy ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
All Cause Mortality

Abstract Introduction There is conflicting evidence on the risk–benefit ratio of oral anticoagulants (OAC) in heart failure (HF) patients without atrial fibrillation. We aimed to evaluate the efficacy and safety of OAC in HF patients in sinus rhythm. Methods A systematic literature search was conducted using PubMed and Embase. We included randomized controlled trials (RCT) and cohort studies, comparing OAC with antiplatelet or no treatment/placebo in patients with HF. Outcomes evaluated were stroke, myocardial infarction (MI), all-cause mortality, and major bleeding. Results Five RCTs and three cohort studies were included. OAC was associated with a reduced risk of ischemic stroke when compared with no treatment/placebo (odds ratio [OR] = 0.67, 95% confidence interval [CI]: [0.47, 0.94]) and antiplatelet therapy (OR = 0.55, 95% CI: [0.37, 0.81]). No significant reduction was found in MI, when OAC was compared with no treatment/placebo (OR = 0.82, 95% CI: [0.63, 1.07]) or antiplatelet therapy (OR = 1.04, 95% CI: [0.60, 1.81]). The all-cause mortality analysis showed no significant reduction when comparing OAC with no treatment/placebo (OR = 0.99, 95% CI: [0.87, 1.12]) or antiplatelet therapy (OR = 1.00, 95% CI: [0.86, 1.16]). The nonsignificant effect of OAC on all-cause mortality was supported by a meta-analysis of the three cohort studies (OR = 1.02, 95% CI: [0.75, 1.38]). Patients treated with OAC had a significantly higher risk of major bleeding than patients receiving antiplatelet therapy (OR = 2.16, 95% CI: [1.55, 3.00]) and a numerically higher risk when compared with no treatment/placebo (OR = 2.38, 95% CI: [0.87, 6.49]). Conclusion The present study does not support the routine use of OAC in patients with HF in sinus rhythm.

Efficacy and safety of iron therapy in patients with chronic heart failure and iron deficiency: a systematic review and meta-analysis based on 15 randomised controlled trials

2020 ◽  
pp. postgradmedj-2019-137342
Author(s):  
Junyi Zhang ◽  
Shengda Hu ◽  
Yufeng Jiang ◽  
Yafeng Zhou
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Iron Therapy ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
6Mwt Distance ◽  
Randomised Controlled

Trials studying iron administration in patients with chronic heart failure (CHF) and iron deficiency (ID) have sprung up these years but the results remain inconsistent. The aim of this meta-analysis was to comprehensively evaluate the efficacy and safety of iron therapy in patients with CHF and ID. A literature search was conducted across PubMed, Embase, Cochrane Library, OVID and Web of Science up to 31 July 2019 to search for randomised controlled trials (RCT) comparing iron therapy with placebo in CHF with ID, regardless of presence of anaemia. Published studies reporting data of any of the following outcomes were included: all-cause death, cardiovascular hospitalisation, adverse events, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), N-terminal pro b-type natriuretic peptide, peak oxygen consumption, 6 min walking test (6MWT) distance and quality of life (QoL) parameters. 15 RCTs with a total of 1627 patients (911 in iron therapy and 716 in control) were included. Iron therapy was demonstrated to reduce the risk of cardiovascular hospitalisation (OR 0.35, 95% CI 0.12 to 0.99, p=0.049), but was ineffective in reducing all-cause death (OR 0.59, 95% CI 0.33 to 1.06, p=0.078) or cardiovascular death (OR 0.80, 95% CI 0.39 to 1.63, p=0.540). Iron therapy resulted in a reduction in NYHA class (mean difference (MD) −0.73, 95% CI −0.99 to −0.47, p<0.001), an increase in LVEF (MD +4.35, 95% CI 0.69 to 8.00, p=0.020), 6MWT distance (MD +35.44, 95% CI 11.55 to 59.33, p=0.004) and an improvement in QoL: EQ-5D score (MD +4.07, 95% CI 0.84 to 7.31, p=0.014); Minnesota Living With Heart Failure Questionnaire score (MD −19.47, 95% CI −23.36 to −15.59, p<0.001) and Patients Global Assessment (PGA) scale (MD 0.71, 95% CI 0.32 to 1.10, p<0.001). There was no significant difference in adverse events or serious adverse events between iron treatment group and control group. Iron therapy reduces cardiovascular hospitalisation in patients with CHF with ID, and additionally improves cardiac function, exercise capacity and QoL in patients with CHF with ID and anaemia, without an increase of adverse events.

scholarly journals Efficacy and Safety of L-Carnitine Treatment for Chronic Heart Failure: A Meta-Analysis of Randomized Controlled Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Xiaolong Song ◽  
Huiyan Qu ◽  
Zongguo Yang ◽  
Jingfeng Rong ◽  
Wan Cai ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Serum Levels ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled

Background. Whether additional benefit can be achieved with the use of L-carnitine (L-C) in patients with chronic heart failure (CHF) remains controversial. We therefore performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effects of L-C treatment in CHF patients. Methods. Pubmed, Ovid Embase, Web of Science, and Cochrane Library databases, Chinese National Knowledge Infrastructure (CNKI) database, Wanfang database, Chinese Biomedical (CBM) database, and Chinese Science and Technology Periodicals database (VIP) until September 30, 2016, were identified. Studies that met the inclusion criteria were systematically evaluated by two reviewers independently. Results. 17 RCTs with 1625 CHF patients were included in this analysis. L-C treatment in CHF was associated with considerable improvement in overall efficacy (OR = 3.47, P<0.01), left ventricular ejection fraction (LVEF) (WMD: 4.14%, P=0.01), strike volume (SV) (WMD: 8.21 ml, P=0.01), cardiac output (CO) (WMD: 0.88 L/min, P<0.01), and E/A (WMD: 0.23, P<0.01). Moreover, treatment with L-C also resulted in significant decrease in serum levels of BNP (WMD: −124.60 pg/ml, P=0.01), serum levels of NT-proBNP (WMD: −510.36 pg/ml, P<0.01), LVESD (WMD: −4.06 mm, P<0.01), LVEDD (WMD: −4.79 mm, P<0.01), and LVESV (WMD: −20.16 ml, 95% CI: −35.65 to −4.67, P<0.01). However, there were no significant differences in all-cause mortality, 6-minute walk, and adverse events between L-C and control groups. Conclusions. L-C treatment is effective for CHF patients in improving clinical symptoms and cardiac functions, decreasing serum levels of BNP and NT-proBNP. And it has a good tolerance.

scholarly journals Do continuous forms of intra-operative ultrafiltration enhance recovery after adult cardiac surgery with cardiopulmonary bypass? A protocol for systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Joel Bierer ◽  
David Horne ◽  
Roger Stanzel ◽  
Mark Henderson ◽  
Leah Boulos ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
High Risk ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Inflammatory Syndrome ◽  
Adult Cardiac Surgery

Abstract Background Cardiac surgery with cardiopulmonary bypass (CPB) is associated with a systemic inflammatory syndrome that adversely impacts cardiopulmonary function and can contribute to prolonged postoperative recovery. Intra-operative ultrafiltration during CPB is a strategy developed by pediatric cardiac specialists, aiming to dampen the inflammatory syndrome by removing circulating cytokines and improving coagulation profiles during the cardiac operation. Although ultrafiltration is commonly used in the pediatric population, it is not routinely used in the adult population. This study aims to evaluate if randomized evidence supports the use of continuous intra-operative ultrafiltration to enhance recovery for adults undergoing cardiac surgery with CPB. Methods This systematic review and meta-analysis will include randomized controlled trials (RCT) that feature continuous forms of ultrafiltration during adult cardiac surgery with CPB, specifically assessing for benefit in mortality rates, invasive ventilation time and intensive care unit length of stay (ICU LOS). Relevant RCTs will be retrieved from databases, including MEDLINE, Embase, CENTRAL and Scopus, by a pre-defined search strategy. Search results will be screened for inclusion and exclusion criteria by two independent persons with consensus. Selected RCTs will have study demographics and outcome data extracted by two independent persons and transferred into RevMan. Risk of bias will be independently assessed by the Revised Cochrane Risk-of-Bias (RoB2) tool and studies rated as low-, some-, or high- risk of bias. Meta-analyses will compare the intervention of continuous ultrafiltration against comparators in terms of mortality, ventilation time, ICU LOS, and renal failure. Heterogeneity will be measured by the χ2 test and described by the I2 statistic. A sensitivity analysis will be completed by excluding included studies judged to have a high risk of bias. Summary of findings and certainty of the evidence, determined by the GRADE approach, will display the analysis findings. Discussion The findings of this systematic review and meta-analysis will summarize the evidence to date of continuous forms of ultrafiltration in adult cardiac surgery with CPB, to both inform adult cardiac specialists about this technique and identify critical questions for future research in this subject area. Systematic review registration This systematic review and meta-analysis is registered in PROSPERO CRD42020219309 (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020219309). 

scholarly journals Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

2021 ◽  
Vol 15 ◽  
Author(s):  
Xinglin Ruan ◽  
Fabin Lin ◽  
Dihang Wu ◽  
Lina Chen ◽  
Huidan Weng ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Dopamine Agonists ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Motor Fluctuations ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Troublesome Dyskinesia

Background: Movement fluctuations are the main complication of Parkinson's disease (PD) patients receiving long-term levodopa (L-dopa) treatment. We compared and ranked the efficacy and safety of dopamine agonists (DAs) with regard to motor fluctuations by using a Bayesian network meta-analysis (NMA) to quantify information from randomized controlled trials (RCTs).Methods and Findings: We carried out a systematic review and meta-analysis, and only RCTs comparing DAs for advanced PD were included. Electronic databases (PubMed, Embase, and Cochrane Library) were systematically searched for relevant studies published until January 2021. Two reviewers independently extracted individual study data and evaluated studies for risk of bias using the Cochrane Risk of Bias tool. Network meta-analyses using a Bayesian framework were used to calculate the related parameters. The pre-specified primary and secondary outcomes were efficacy (“ON” time without troublesome dyskinesia, “OFF” time, “ON” time, “UPDRS-III,” and “UPDRS-II”) and safety [treatment-emergent adverse events (TEAE) and other adverse events] of DAs. The results are presented as the surface under the cumulative ranking (SUCRA) curve. A total of 20 RCTs assessing 6,560 patients were included. The general DA effects were ranked from high to low with respect to the amount of “ON” time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%).Conclusions: This network meta-analysis shows that apomorphine increased “ON” time without troublesome dyskinesia and decreased “OF” time for advanced PD patients. The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased “ON” time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD.

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