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

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.

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Yanping Wang ◽  
Xu Zhou ◽  
Xiaofan Chen ◽  
Fei Wang ◽  
Weifeng Zhu ◽  
...  

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.


2020 ◽  
Vol 7 (6) ◽  
pp. 3841-3850
Author(s):  
Hongzhou Zhang ◽  
Tieqiu Huang ◽  
Wen Shen ◽  
Xiuxiu Xu ◽  
Pingping Yang ◽  
...  

2021 ◽  
Vol 12 ◽  
Author(s):  
Xinfu Cao ◽  
Mingxue Zhou ◽  
Hongxu Liu ◽  
Xiufen Chen ◽  
Xiang Li ◽  
...  

Background: Shensong Yangxin capsule (SSYX) is a well-known traditional Chinese patent medicine for treating arrhythmia. Recently, a flurry of randomized controlled trials (RCTs) of SSYX combined with amiodarone (SSYX-amiodarone) was reported in the treatment of heart failure (HF) complicated by ventricular arrhythmia (VA) in China. However, these RCTs have not been systematically evaluated. Therefore, this study aimed to evaluate the efficacy and safety of SSYX-amiodarone in the treatment of heart failure complicated by ventricular arrhythmia (HF-VA).Methods: Seven electronic literature databases (the Cochrane Library, PubMed, EMBASE, China Biomedical database web, China National Knowledge Infrastructure Databases, Chinese Scientific Journal database and Wanfang database) were searched from their inceptions to June 1, 2020 to identify RCTs of SSYX-amiodarone in the treatment of HF-VA. The primary outcomes included the total effective rate and adverse events (ADRs). The secondary outcomes included the frequency of ventricular premature complexes, left ventricular ejection fraction, N terminal pro Btype natriuretic peptide (NT-proBNP), and QT dispersion (QTd). The quality of the included RCTs was assessed using the Cochrane risk-of-bias tool. All data was analyzed using RevMan 5.3 software. The registration number of this protocol is PROSPERO CRD42020196689.Results: There are Eighteen trials involving 1,697 patients were included in this study. Meta-analysis showed that SSYX-amiodarone group was superior to the amiodarone group in improving the total effective rate [RR = 1.21; 95%CI (1.16, 1.27); p < 0.01], meanwhile reducing the ADRs [RR = 0.65; 95%CI (0.45, 0.95); p = 0.03], VPCs [MD = 170.96; 95%CI (159.88, 182.04); p < 0.01] and QTd [MD = 8.39; 95%CI (6.91, 9.87); p < 0.01]. No significant difference of enhancing LVEF [MD = 4.32; 95%CI (−0.56, 9.20); p = 0.08] and reducing NT-proBNP [SMD = 0.17; 95%CI (−0.81, 1.14); p = 0.73] was observed between SSYX-amiodarone and amiodarone group.Conclusions: Despite the apparent positive findings reported, the evidence provided by this meta-analysis was still insufficient to support the routine use of SSYX-amiodarone for HF-VA due to the poor methodological quality of included studies. The overall effect should to be verified in further through more well-design clinical studies with reasonable sample and good methodological quality.


2020 ◽  
Author(s):  
Qiuyue Wang ◽  
Xingxin Hu ◽  
Mao Li ◽  
Qian Luo ◽  
Pingsheng Hao

Abstract Background: Chronic urticaria (CU) is a common skin disease characterized by a short-term (<24 hours) spontaneous skin rash (urticaria) with or without angioedema that lasts longer than 6 weeks. CU is not life-threatening but has been shown to have a significant impact on the physical and mental health of patients. Because of chronic itching or physical discomfort in patients with CU, symptoms such as the repeated occurrence of red, swollen, itchy, anxiety, insomnia, and psychological stress are prone to occur. Whereas, there is no related systematic review and meta-analysis. Thus, this systematic review protocol aims to describe a systematic review and meta-analysis to testify the efficacy and safety of compound glycyrrhizin (CG) combined with desloratadine in the treatment of CU.Methods: Our systematic review will search all randomized controlled trials (RCTs) for CG combined with desloratadine in the treatment of CU, electronically and manually, regardless of publication status and language, until January 14, 2020. Databases include PubMed, EMBASE, Web of Science, Cochrane Controlled Trials Register (CENTRAL), China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), Chinese Science Journal Database (VIP Database) and Wanfang database. Other sources, including reference lists of identified publications and meeting minutes, will also be searched. Manually search for grey literature, including unpublished conference articles. The main outcomes contain the total effective rate, the urticaria activity score (UAS), Itching score, the chronic urticaria quality of life questionnaire (CU-Q2oL), or other validated symptom scores and the effective rate and adverse events from baseline to the end of studies. This study will provide a comprehensive review of the available evidence for the treatment of CU with this therapy. We will assess the risk of bias with the Cochrane Risk of Bias Tool, narratively synthesize the extracted data and conduct a meta-analysis of studies with similar characteristics. Two independent raters will screen articles and assess the risk of bias.Discussion: This study will provide a high-quality synthesis of the effects of compound glycyrrhizin (CG) combined with desloratadine in the treatment of CU. We hope that this review will give more convincing proof to assist clinicians during the decision-making process when dealing with CU.Systematic review registration: PROSPERO CRD42020165478


2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Qin-hong Zhang ◽  
Jin-huan Yue ◽  
Ming Liu ◽  
Zhong-ren Sun ◽  
Qi Sun ◽  
...  

Objectives. This study aims to assess the effectiveness and safety of moxibustion for the correction of nonvertex presentation.Methods. Records without language restrictions were searched up to February 2013 for randomized controlled trials (RCTs) comparing moxibustion with other therapies in women with a singleton nonvertex presentation. Cochrane risk of bias criteria were used to assess the methodological quality of the trials.Results. Seven of 392 potentially relevant studies met the inclusion criteria. When moxibustion was compared with other interventions, a meta-analysis revealed a significant difference in favor of moxibustion on the correction of nonvertex presentation at delivery (risk ratio (RR) 1.29, 95% confidence interval (CI) 1.12 to 1.49, andI2=0). The same findings applied to the cephalic presentation after cessation of treatment (RR 1.36, 95% CI 1.08 to 1.71, andI2=80%). A subgroup analysis that excluded two trials with a high risk of bias also indicated favorable effects (RR 1.63, 95% CI 1.42 to 1.86, andI2=0%). With respect to safety, moxibustion resulted in decreased use of oxytocin.Conclusion. Our systematic review and meta-analysis suggested that moxibustion may be an effective treatment for the correction of nonvertex presentation. Moreover, moxibustion might reduce the need for oxytocin.


Author(s):  
Lingxin Li ◽  
Yao Zheng ◽  
Chengqi He ◽  
Yanmin Zhao

OBJECTIVE: The aim of this study was to examine the efficacy and safety of kinesiology tape in treating hemiplegic shoulder pain. METHODS: Web of Science, MEDLINE, Embase, Cochrane Library, six other English databases and three Chinese databases (CNKI, VIP, Wan Fang) were searched for randomized controlled trials published prior to December 13, 2020 in English or Chinese on the use of kinesiology tape for hemiplegic shoulder pain. RESULTS: Fourteen randomized controlled trials (679 patients) of good PEDro quality (6.43 ± 1.09) were included in this meta-analysis. The pooled results for pain (SMD -0.92, 95% CI -1.10 to -0.74, P< 0.001, 10 RCTs, 539 patients), range of motion (SMD 2.27, 95% CI 1.23 to 3.32, P< 0.001, 7 studies, 320 patients), the acromion humeral distance (SMD -0.62, 95% CI -0.88 to -0.37, P< 0.001, 7 RCTs, 246 patients) and the FMA-UE score (SMD 0.66, 95% CI 0.41 to 0.91, P< 0.001, 5 RCTs, 263 patients) suggested that therapeutic kinesiology tape relieved pain, increased ROM, shortened the acromion humeral distance and improved upper extremity motor function to a greater extent than the sham or blank control conditions. The pooled results for individual activity (SMD 0.42, 95% CI -0.22 to 1.07, P= 0.199, 5 RCTs, 199 patients) and quality of life (SMD 0.308, 95% CI -0.288 to 0.903, P= 0.311, 1 RCT, 44 patients) showed that the kinesiology tape group was not significantly different from the sham or blank control group. Publication bias was not observed. No adverse events were reported in any of the included studies. CONCLUSION: KT relieved pain and improved the ROM, DAH and FMA-UE score in patients with HSP to a greater extent than did the sham KT or blank control conditions. The effects on independence in activities of daily living and quality of life and whether this method is superior to active treatment in patients with HSP were not verified. More rigorous, reasonably designed RCTs with large sample sizes are still needed in the future.


Sign in / Sign up

Export Citation Format

Share Document