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Efficacy and Safety of TCMI in Patients With Combined Coronary Heart Disease and Heart Failure: A Systematic Review and Network Meta-Analysis.

ABSTRACT: Objective: To compare the efficacy and safety of conventional treatments (CTs) to those that included traditional Chinese medicine injections (TCMIs) in patients with combined coronary heart disease and heart failure (CHD-HF). Methods: Eight electronic literature databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure Database, Chinese Scientific Journal Database, Wanfang Database, Chinese Biomedical Database) were searched from their inceptions to May 18, 2021, to identify relevant randomised controlled trials (RCTs). The primary outcomes analyzed included the total effectiveness rate and adverse events (ADRs). The secondary outcomes analyzed included the left ventricular ejection fraction (LVEF), N-terminal pro-brain natriuretic peptide (NT-proBNP), brain natriuretic peptide (BNP), and 6-min walk test (6MWT). Cochrane risk-of-bias tool was used to assess quality of the analyzed RCTs. Stata and OpenBUGS software were used to prior to the systematic review and network meta-analysis. Results: Sixty-one eligible trials involved 5,567 patients and one of the following 15 TCMIs: Shuxuetong, Shenmai, Shenfu, Shengmai, Danshenduofenyansuan, Danhong, Dazhuhongjingtian, Xinmailong, Dengzhanxixin, Gualoupi, Shuxuening, Xuesaitong, Yiqi Fumai, Shenqi Fuzheng, Huangqi. Network meta-analysis revealed that Shuxuetong injection + CT group was superior to CT only in improving the total effectiveness rate [odds ratio (OR): 7.8, 95% confidence interval (CI): 1.17-27.41]. Shenmai injection + CT was superior to CT only for LVEF (OR: 8.97, CI: 4.67-13.18), Xinmailong injection + CT was superior to CT only for NT-proBNP (OR: -317.70, CI: -331.10-303.10), Shenqi Fuzheng injection + CT was superior to CT only for BNP (OR: -257.30, CI: -308.40-242.80); and Danhong injection + CT was superior to CT only for 6MWT (OR: 84.40, CI: 62.62-106.20). Different TCMIs had different toxicity spectrums. Conclusion: TCMIs combined with CT are better than CT alone in treating CHD-HF. Different TCMIs improve different outcomes. Additional properly designed RCTs are needed to conduce a more refined comparison of various TCMIs. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42021258263].

SUBMITTER: Wei P

PROVIDER: S-EPMC8652334 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Aim of the studyTo evaluate the clinical efficacy and safety of commonly used oral Chinese patent medicines for the treatment of coronary heart disease combined with hyperlipidemia in clinical practice through a network meta-analysis.Materials and methodsPubMed, Embase, Cochrane Library, Web of Science, Wanfang, VIP, SinoMed, and CNKI databases were searched for all published randomized controlled trials (RCTs) on the treatment of coronary heart disease combined with hyperlipidemia using Chinese patent medicines. NoteExpress software was used to screen the literature obtained from the databases according to the inclusion and exclusion criteria. The Cochrane risk of bias assessment tool was used to evaluate the quality of the included studies. A network meta-analysis was performed using R 4.2.1. Subgroup analyses of outcome indicators were made based on conventional treatment (CT) methods. The incidence of adverse events in the included RCTs was statistically analyzed. A funnel plot was drawn using RevMan 5.4.1 software for the assessment of bias in the total clinical effectiveness rate. Finally, the quality of evidence for interventions with statistically significant differences was evaluated using the GRADE system.ResultsA total of 78 RCTs were included, involving 7,955 cases and 8 types of Chinese patent medicines, which were Tongxinluo Capsule, Naoxintong Capsule, Compound Danshen Dripping Pill, Shexiangbaoxin Pill, Songling Xuemaikang Capsule, Xuezhikang Capsule, Yindan Xinnaotong Capsule, and Zhibitai Capsule. A total of 24 RCTs reported the incidence of adverse events, but no statistically significant difference in the incidence of adverse events was found between the experimental and control groups in each study (P > 0.05). There was no obvious publication bias in all studies, but the overall quality of evidence in the included RCTs was low. Comparison of different intervention measures showed that Naoxintong Capsule + CT improved the cardiac index and cardiac output, and lowered the low-density lipoprotein cholesterol and total cholesterol levels. Tongxinluo Capsule + CT raised high-density lipoprotein cholesterol levels and reduced triglyceride levels. Xuezhikang Capsule + CT improved the total clinical effectiveness rate. Subgroup analyses showed that differences in CT did not cause heterogeneity in the results.ConclusionCompared with the use of CT alone, the combined use of Chinese patent medicines with CT can effectively improve the symptoms in patients with both coronary heart disease and hyperlipidemia.

Project description:BackgroundControversy has persisted over the clinical benefits of low-dose sacubitril/valsartan in patients with heart failure (HF).HypothesisLow-dose sacubitril/valsartan might also be effective and safe in HF patients.MethodsElectronic databases including PubMed, Ovid, and Cochrane Library were systematically retrieved from inception to August 5, 2021. Review manager 5.4 and Stata 15.1 were employed in this systematic review and meta-analysis. Key efficacy outcomes of interest included HF hospitalization, all-cause mortality, left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP), together with New York Heart Association (NYHA) functional class. The safety outcome was systolic blood pressure (SBP). The grading of recommendations assessment, development, and evaluation approach was conducted to evaluate the quality of evidence for each outcome.ResultsA total of 1269 studies were screened and 9 real-world studies met the inclusion criteria were included in the meta-analysis, with 1697 participants. Compared with low-dose sacubitril/valsartan, high-dose sacubitril/valsartan significantly reduced the risk of HF hospitalization (odds ratio [OR]: 0.4, 95% confidence interval [CI]: 0.27-0.61, p < .0001) and the risk of all-cause mortality (OR: 0.23, 95% CI: 0.11-0.47, p < .0001). However, there were no appreciable differences in improvements of NYHA (OR: 0.59, 95% CI: 0.15-2.35, p = .45), changes of LVEF (mean difference [MD]: 2.73%, 95% CI: -2.24% to 7.7%, p = .28), changes of NT-proBNP (MD: 43.09, 95% CI: -28.41 to 114.59, p = .24) and changes of SBP (MD: 3.01, 95% CI: -4.62 to 10.64, p = .44) between groups with low-dose and high-dose sacubitril/valsartan.ConclusionsCompared with high-dose sacubitril/valsartan, low-dose sacubitril/valsartan was associated with increased risks of HF hospitalization and all-cause mortality. However, no distinct between-group differences in improvements of NYHA, changes of LVEF, changes of NT-proBNP and changes of SBP were observed.

Project description:Objective: This study aimed to clarify the efficacy and safety of Xinbao pill (XBP) as an adjunctive treatment for chronic heart failure (CHF). Methods: Randomized controlled trials (RCTs) on the efficacy and safety of XBP in the treatment of CHF were searched from the six databases. The risk of bias assessment tool recommended by Cochrane Handbook 5.1 were used to assess the methodological quality of the included studies. RevMan 5.3 software was used for meta-analysis. The subgroup and sensitivity analyses were also performed. The grading recommendations assessment, development, and evaluation (GRADE) technique were used to assess the evidence's certainty. Results: Nine RCTs with a total of 882 patients were identified in this study. The meta-analysis demonstrated that XBP as adjunctive therapy was superior to conventional medicine alone for the treatment of CHF in improving the left ventricular ejection fraction (LVEF; MD = 5.34; 95% CI 4.68 to 5.99; p < 0.001), the total effective rate (RR = 1.21; 95% CI, 1.14 to 1.29; p < 0.001), the cardiac output (MD = 0.56; 95% CI 0.42 to 0.70; p < 0.001), the stroke volume (MD = 3.42; 95% CI 2.03 to 4.81; p < 0.001) and the 6-min walking distance (6-MWD; MD = 31.95; 95% CI 21.83 to 42.06; p < 0.001), meanwhile reducing the left ventricular end-diastolic diameter (LVEDD; MD = -3.22; 95% CI -4.03 to -2.42; p < 0.001) and left ventricular end-systolic dimension (LVESD; MD = -2.93; 95% CI -3.80 to -2.06; p < 0.001). Regarding safety, a total of 2.4% (11/456) adverse reactions occurred in the XBP groups while 3.9% (18/456) in the control group. The outcomes' evidentiary quality ranged from "very low" to "moderate". Conclusion: This study indicated that XBP as adjunctive therapy combined with conventional medicine seemed to be safe and more effective than conventional medicine alone in treating CHF. However, due to the poor methodological quality of the included RCTs, further well-designed RCTs are required to confirm the efficacy and safety of XBP.

Project description:IntroductionAFFIRM-AHF and IRONMAN demonstrated lower rates of the combined endpoint recurrent heart failure (HF) hospitalizations and cardiovascular death (CVD) using intravenous (IV) ferric carboxymaltose (FCM) and ferric derisomaltose (FDI), respectively in patients with HF and iron deficiency (ID) utilizing prespecified COVID-19 analyses.Material and methodsWe meta-analyzed efficacy, between trial heterogeneity and data robustness for the primary endpoint and CVD in AFFIRM-AHF and IRONMAN. As sensitivity analysis, we analyzed data from all eligible exploratory trials investigating FCM/FDI in HF.ResultsFCM/FDI reduced the primary endpoint (RR = 0.81, 95% CI 0.69-0.95, p = 0.01, I2 = 0%), with the number needed to treat (NNT) being 7. Power was 73% and findings were robust with fragility index (FI) of 94 and fragility quotient (FQ) of 0.041. Effects of FCM/FDI were neutral concerning CVD (OR = 0.88, 95% CI 0.71-1.09, p = 0.24, I2 = 0%). Power was 21% while findings were fragile with reverse FI of 14 and reversed FQ of 0.006. The sensitivity analysis from all eligible trials (n = 3258) confirmed positive effects of FCM/FDI on the primary endpoint (RR = 0.77, 95% CI 0.66-0.90, p = 0.0008, I2 = 0%), with NNT being 6. Power was 91% while findings were robust (FI of 147 and FQ of 0.045). Effect on CVD was neutral (RR = 0.87, 95% CI 0.71-1.07, p = 0.18, I2 = 0%). Power was 10% while findings were fragile (reverse FI of 7 and reverse FQ of 0.002). Rate of infections (OR = 0.85, 95% CI 0.71-1.02, p = 0.09, I2 = 0%), vascular disorder (OR = 0.84, 95% CI 0.57-1.25, p = 0.34, I2 = 0%) and general or injection-site related disorders (OR = 1.39, 95% CI 0.88-1.29, p = 0.16, I2 = 30%) were comparable between groups. There was no relevant heterogeneity (I2 > 50%) between the trials for any of the analyzed outcomes.ConclusionsUse of FCM/FDI is safe and reduces the composite of recurrent HF hospitalizations and CVD, while effects on CVD alone are based on available level of data indeterminate. Findings concerning composite outcomes exhibit a high level of robustness without heterogeneity between trials with FCM and FDI.

Project description:BackgroundQiliqiangxin (QLQX) capsules are a commonly used proprietary Chinese medicine for the adjuvant treatment of chronic heart failure (CHF) in China. In recent years, several randomized controlled trials (RCTs) have reported on the efficacy and safety of QLQX combined with sacubitril/valsartan for CHF.ObjectiveThe purpose of this study was to systematically analyze the clinical efficacy and safety of QLQX combined with sacubitril/valsartan in the management of CHF and to provide clinicians as well as scientists with optimal evidence-based medical evidence.MethodsWe searched RCTs to evaluate the efficacy and safety of QLQX combined with sacubitril/valsartan in the treatment of CHF in the Wanfang Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, PubMed, Embase, and Cochrane Library databases from their inception until January 8, 2022. RCTs on QLQX in combination with sacubitril/valsartan for CHF were included. The outcome measures considered were total effective rate, left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDD), 6-minute walking distance (6-MWD), and adverse events. The quality of the included RCTs was assessed thereafter using the Cochrane risk of bias tool. RevMan 5.3 software was used to conduct the meta-analysis.ResultsThe meta-analysis included 17 trials involving 1427 CHF patients. The results indicated that with sacubitril/valsartan administration combined with QLQX treatment, the total effective rate (relative risk (RR) = 1.24; 95% confidence interval (CI) (1.17, 1.31); p < 0.01), LVEF (mean difference (MD) = 6.20; 95% CI (5.36, 7.05; p < 0.01)), and 6-MWD (MD = 55.87; 95% CI (40.66, 71.09); p < 0.01) of CHF patients were significantly increased, and the LVEDD value of CHF patients was noted to be significantly reduced (MD = -3.98; 95% CI (-4.47, -3.48); p < 0.01). Moreover, there was no increase in the number of adverse events during treatment (RR = 0.67; 95% CI (0.33, 1.34); p < 0.01).ConclusionsThis study indicated that in CHF patients, on the basis of sacubitril/valsartan treatment, combination with QLQX can potentially enhance the total effective rate, improve LVEF and 6-MWD, and reduce LVEDD values, with good safety. However, considering the poor quality of the included studies, a multicenter, randomized, double-blind controlled study is needed for further confirmation.

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Efficacy and Safety of TCMI in Patients With Combined Coronary Heart Disease and Heart Failure: A Systematic Review and Network Meta-Analysis.

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