Efficacy and safety of Linggui Zhugan decoction in the treatment of chronic heart failure with Yang deficiency

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.

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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/9571627 ◽

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.

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