Clinical efficacy and safety of Danhong injection for the treatment of chronic heart failure: A protocol for systematic review.
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ABSTRACT: Background
Danhong injection (DHI) has been widely in the treatment of chronic heart failure (CHF) in China; however, there is not enough clinical evidence DHI for treating CHF.Methods
Two researchers will search literatures of DHI for CHF in databases. Extracted data are analyzed with Review Manager 5.3 software. The selected studies should be conducted quality evaluation, forest plots and funnel plots will be run by RevMan5.3.Results
This systematic review validates the clinical efficacy and safety of DHI in the treatment of CHF through the analysis of New York Heart Association functional classification, left ventricular ejection fraction, left ventricular end-diastolic dimension, cardiac output, brain natriuretic peptide, adverse events.Conclusions
This systematic review will be provided a rational clinical evidence to evaluate the effectiveness and safety of DHI for the treatment of CHF.Registration number
PROSPERO CRD42019144686.
SUBMITTER: Han L
PROVIDER: S-EPMC7220450 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
Publications
Clinical efficacy and safety of Danhong injection for the treatment of chronic heart failure: A protocol for systematic review.
Han Lihua L Wang Chuan C Yao Dongfeng D Wang Bin B Zhang Zhen Z Liu Jiping J
Medicine 20200401 14
<h4>Background</h4>Danhong injection (DHI) has been widely in the treatment of chronic heart failure (CHF) in China; however, there is not enough clinical evidence DHI for treating CHF.<h4>Methods</h4>Two researchers will search literatures of DHI for CHF in databases. Extracted data are analyzed with Review Manager 5.3 software. The selected studies should be conducted quality evaluation, forest plots and funnel plots will be run by RevMan5.3.<h4>Results</h4>This systematic review validates the ...[more]
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Project description:BackgroundChronic stable angina is a leading cause of death worldwide. Danhong injection, a complementary alternative medicine for chronic stable angina, has been demonstrated to be effective in numerous studies and is widely prescribed to patients. However, the methodological quality of most prior studies was found to be, in general, low. Therefore, we designed this randomized controlled trial to evaluate the efficacy and safety of using Danhong injection to treat chronic stable angina.Methods/designThis is a randomized multicentre, double-blind, placebo-controlled, adaptive clinical trial. A total of 870 patients meeting the eligibility criteria will be randomly assigned into either the Danhong injection or the placebo group in a 2:1 ratio. Participants will then undergo a 2-week treatment regimen and a 76-day follow-up period. Because this is an adaptive trial, two interim analyses are prospectively planned. These will be performed after one-third and two-thirds of the patients, respectively, have completed the trial. Based on the results of these interim analyses, a data monitoring committee will determine how to modify aspects of the study without undermining the validity and integrity of the trial. The primary outcome measure is the proportion of patients who show a clinically significant change, which is defined as at least a 20-point improvement in angina frequency score on the Seattle Angina Questionnaire, which will be administered on day 30. Other secondary efficacy and safety outcomes will also be assessed.DiscussionThis trial will provide high-quality evidence regarding the use of Danhong injection to treat chronic stable angina.Trial registrationClinicalTrials.gov: NCT01681316 .
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Project description:ObjectiveThis study aimed to assess the adjunctive efficacy and safety of Puerarin injection (PI) on acute heart failure (AHF) based on a systematic review and meta-analysis.MethodsNine databases were searched from March 1990 to March 2022 to identify randomized controlled trials (RCTs) related to the adjunctive treatment of PI for AHF. The Cochrane collaboration tool was used to assess the risk of bias in the included studies. Meta-analysis and subgroup and sensitivity analyses were conducted by RevMan 5.3 software. The evidence's certainty was evaluated by grading recommendations assessment, development, and evaluation (GRADE) methods.ResultsA total of 8 studies were included with a total of 614 patients with AHF. The meta-analysis demonstrated that adjunctive treatment with PI on AHF was superior to conventional medicine alone. It increased the total effective rate (RR = 1.38; 95% CI, 1.22-1.55; p < 0.001) and improved left ventricular ejection fraction [SMD = 0.85; 95% CI (0.62, 1.09); p < 0.001]. Regarding safety, a total of 11.9% (23/194) adverse reactions were observed in the PI group and 9.8% (19/194) adverse reactions in the control group, and there were no significant differences in the incident rate of adverse events between both groups [RR = 1.16; 95% CI (0.66-2.05); p = 0.061]. The outcomes' evidentiary quality was assessed as "moderate."ConclusionPI had an adjunctive effect on AHF combined with conventional medicine, and it seemed to be safe and more effective than the conventional medical treatment alone for improving the total clinical effective rate and left ventricular ejection fraction. But further well-designed RCTs are required to confirm the efficacy and safety of XBP in treating AHF due to the poor methodological quality of the included RCTs.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=327636], identifier [CRD42022327636].
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Project description:BackgroundDengzhan Shengmai Capsule (DZSMC) is a potential treatment for chronic heart failure (CHF). However, its specific benefits in the treatment of CHF remain unclear.MethodsRelated randomized controlled trials were searched in eight databases up to January 28, 2025, and included studies were determined according to the inclusion criteria. Subsequently, the basic characteristics and data from these studies were recorded using Excel 2010. Outcome-related data were subsequently imported into Revman 5.3 for meta-analysis.ResultsFifteen randomized controlled trials with 1606 patients were included in this meta-analysis. The results showed that compared to conventional treatment group, DZSMC combination group significantly improved the clinical effective rate [RR = 1.21, 95% CI (1.16,1.26), P < 0.00001], brain natriuretic peptide (BNP) [MD = -112.60, 95%CI (-212.23, -12.96), P = 0.03], N-terminal pro-B-type natriuretic peptide (NT-proBNP) [MD = -88.27, 95%CI (-108.11, -68.42), P < 0.00001], left ventricular ejection fraction (LVEF) [MD = 6.42, 95% CI (5.57, 7.27), P < 0.00001], left ventricular end-diastolic diameter (LVEDD) [MD = -5.72, 95% CI (-7.56, -3.87), P < 0.00001], left ventricular end-systolic diameter (LVESD) [MD = -5.33, 95% CI (-7.41, -3.26), P < 0.00001], left ventricular end-systolic volume (LVESV) [MD = -20.71, 95% CI (-34.59, -6.82), P = 0.003], and 6 min walk test [MD = 51.90, 95%CI (19.08, 84.72), P = 0.002], while adverse events had no significant difference [RR = 0.70, 95%CI (0.42, 1.17), P = 0.17]. Funnel plots indicated no publication bias for BNP, NT-proBNP, LVEF, and LVESD, while potential bias was observed for other outcomes.ConclusionDZSMC effectively improves clinical symptoms, cardiac function, and ventricular remodeling in CHF patients, with good safety, making it a potential adjuvant therapy for CHF. However, further research is needed to explore the long-term safety of DZSMC in order to enrich clinical evidence.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024507368, PROSPERO [CRD42024507368].
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Project description:Background: Sacubitril/valsartan is a first-in-class angiotensin-receptor neprilysin inhibitor used to treat heart failure with reduced ejection fraction. The evidence base for this novel medication is largely based on one pivotal phase III trial which was stopped early due to significant clinical benefits being shown. However potential limitations in the trial design have been highlighted in recent medical literature, necessitating a thorough review of the evidence base for sacubitril/valsartan. Methods: This review will be conducted using the PRISMA reporting guidelines. Relevant randomised controlled trials (RCTs) for sacubitril/valsartan will be systematically searched for in Medline (PubMed), Embase, Cochrane library, Google Scholar, Web of Science, Toxline and Scopus. Clinical trials registries will be searched, as will eight grey literature databases. In addition, unpublished clinical study reports (CSRs) of relevant trials will be requested from the European Medicines Agency (EMA) and the Clinical Study Data Request database. Studies will be included if they involve randomising adult patients with heart failure to either sacubitril/valsartan or usual care with either an active comparator or placebo as a control. All relevant clinical and safety outcomes will be reviewed, particularly hospitalisation due to heart failure and cardiovascular mortality. Two reviewers will assess eligibility of selected trials for inclusion. Data extraction will be performed separately for trial publications, clinical trial registries and for CSRs using a piloted form. Methodological quality of included trials from published sources will be assessed separately using the recently updated Cochrane Risk of Bias tool version 2. Narrative synthesis of included studies will be conducted and, if appropriate, meta-analysis for clinical efficacy and safety outcomes. Discussion: This review will collate all available RCT data on sacubitril/valsartan including published and unpublished sources in order to obtain a more complete picture of the evidence base for sacubitril/valsartan. Registration: This protocol has been submitted for registration on PROSPERO.
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Project description:BackgroundChronic heart failure (CHF), the final phase of various heart diseases, is a serious public health problem resulting in high hospitalization rates, mortality, and increasing health care costs. Nuanxin capsule (NXC), a Chinese herbal formula, has been widely used in the treatment of CHF. However, the safety and efficacy of NXC used in patients with CHF has been uncertain and there has been no standard clinical trial published to confirm this. Thus, we conduct a study to evaluate the safety and efficacy of NXC for CHF.MethodsThe reference lists of randomized controlled trials and 8 electronic databases will be independently and systematically searched by 2 review authors in May 2018. Four English databases (EMBASE, PubMed, Cumulative Index to Nursing and Allied Health Literature [CINAHL], and Cochrane Central Register of Controlled Trials [CENTRAL]) and 4 Chinese databases (Chinese Biomedical Literature Database [CBM], Chinese National Knowledge Infrastructure [CNKI], Wanfang Database, and VIP Database) will be included. The primary outcomes will be assessed according to the function classification of New York Heart Association (NYHA). Data synthesis will be precisely computed using the RevManV5.3 software when a data-analysis is allowed. Methodological quality will be assessed according to Cochrane Handbook.ResultsThis study will provide a high-quality synthesis of current evidence of NXC for CHF from different aspects including the mortality, the function classification of NYHA.ConclusionThe conclusion of this systematic review will provide evidence to prove whether NXC is an effective therapeutic intervention for patient with CHF.PROSPERO registration number: PROSPERO CRD42018090003.
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