1 Introduction
Coronary Heart Disease (CHD) a serious cardiovascular disease of myocardial ischemia or necrosis caused by stenosis or occlusion by coronary atherosclerosis.[1,2] [3–6] [7,8] [9–11] [12] [13]
Currently, the main treatment for CHD mainly includes drug therapy, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG).[14–17] [18] [19,20] systematic review of its efficacy and safety in the treatment of CHD. Therefore, we propose the current protocol to evaluate the effectiveness and safety of GPD on CHD, providing a reference for clinical use.
2 Methods
2.1 Inclusion criteria for study selection
2.1.1 Types of studies
All relevant randomized controlled trials (RCTs) regarding GPD for the treatment of CHD will be involved without limitations on language, publication or blinding.
2.1.2 Types of patients
We will include patients with CHD, including stable angina pectoris (SAP), unstable angina (UA), non-st-segment elevation myocardial infarction (NSTEMI), and st-elevation myocardial infarction (STEMI). There is no limit to sex, ethnicity, education, economic status, and disease severity.
2.1.3 Types of interventions
The control group was treated with conventional treatment, including clopidogrel, aspirin, angiotensin-converting enzyme inhibitor (ACEI), low molecular weight heparin, beta blockers, statins, nitrates, and combined treatment of GPD and conventional treatment was used in the experimental group.
We will include various dosage forms of GPD, including tablets, capsules, pills, powders and extracts. We will exclude RCTs in which GPD is combined with other Chinese medicine methods, such as acupuncture and moxibustion. There is no limit to dose and route of administration.
2.1.4 Types of outcome measures
2.1.4.1 Primary outcomes
The primary outcomes will be major adverse cardiovascular events (MACE), including nonfatal myocardial infarction, nonfatal cardiogenic shock, coronary revascularization, coronary heart disease death, and severe arrhythmias.
2.1.4.2 Secondary outcomes
Total effective rate of electrocardiogram, high sensitive C reaction protein (hs-CRP), Interleukin-6 (IL-6), matrix metalloproteinases-9 (MMP-9), creatine kinase isoenzyme (CK-MB), myocardial troponin I(cTnI), B-type natriuretic peptide (BNP), blood lipids, hematocrit, fibrinogen, angina pectoris attacks and intervals, left ventricular diastolic End-stage diameter, left ventricular end-systolic diameter, left ventricular ejective fraction (LVEF), cardiac output, cardiac index, cardiac per volume, and adverse drug reactions.
2.2 Search methods for the identification of studies
We will perform a comprehensive literature search of relevant databases including Cochrane Library, PubMed, EMBASE, WOS, CNKI, WangFang, CBM, and VIP from their inception to June 2020. English search terms include: Guipi decoction, coronary heart disease and RCTs. The strategy for searching the PubMed will be shown as an example in Appendix A (Supplemental Appendix A, https://links.lww.com/MD/E678
2.2.1 Searching other resources
Google Scholar and Baidu Academic will be involved to search relevant literature. We will also manually retrieve relevant literature from Clinical Trials Register. In addition, reference lists of eligible studies will be performed manually so as to avoid missing vital information.
2.3 Data collection and analysis
2.3.1 Selection of studies
Selection of studies will be performed independently by 2 researchers. First, the obvious disqualified literatures will be excluded by screening the titles and abstracts. Secondly, they will determine whether the references up to the
Standards or not by reading through the text. Any disagreements will be resolved by discussion or by consulting a third investigator if needed. The process of studies selection and meta-analysis is presented in a in an adapted PRISMA flow diagram (Fig. 1 ).
Figure 1: Preferred reporting items for systematic review and meta-analysis (PRISMA) flow chart.
2.3.2 Data extraction and management
Data extraction and management will be performed by 2 independently researchers. A standard data extraction form, including author, year of publication, ethnicity, diagnostic criteria of CHD, number of cases and controls, interventions, measurement indicators, results, and adverse events, will be created before data extraction. Any disagreement will be settled after consulting a third researcher or by discussion.
2.3.3 Assessment of risk of bias in included studies
The “risk of bias” tool recommended by the Cochrane Handbook V.5.3 will be used to assess the risk of bias by 2 researchers independently. The main items include random sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. The results of the assessment will be divided into 3 levels, such as “low risk,” “high risk,” or “uncertain”. A consensus will be reached through discussion and consultation with a third reviewer if there are any inconsistencies in the assessment.
2.3.4 Measures of treatment effect
Analysis will be based on available data of included studies, the relative data (RR) or odds ratio (OR) with 95% confidence interval (CI) will be used to analyze dichotomous data. While the standardized mean difference (SMD) or weighted mean difference (WMD) with 95% CI will be used for continuous data.
2.3.5 Dealing with missing data
We will contact the first or corresponding author to get missing information from their trials and use the available data for data synthesis. If the necessary data are unobtainable, the impact of missing data will be discussed.
2.3.6 Assessment of heterogeneity
I 2 statistic and x 2 test will be used to evaluate the heterogeneity. The heterogeneity will be divided into 3 levels: I 2 < 25% will be considered as no statistical heterogeneity;25% < I 2 < 50% means that there is moderate heterogeneity; while I 2 ≥ 50% will be taken as large heterogeneity, hence, subgroup or sensitivity analysis will be conducted.
2.3.7 Assessment of reporting bias
Funnel plot will be performed to evaluate the publication bias when there are 10 or more publications included in this study.
2.3.8 Data synthesis
RevMan software (Version 5.3, Copenhagen: The Nordic Cochrane Center, 2014) will be used to perform data synthesis. The fixed effects model will be performed for meta-analysis when there is small homogeneity (I 2 < 50%). If not, the random effects model will be conducted. Subgroup analysis, sensitivity analysis or descriptive analysis will be performed if significant heterogeneity between studies is found.
2.3.9 Subgroup analysis
Subgroup analyses will be conducted based on different factors, including interventions, participants, dose of medication, kinds of GPD, and gender.
2.3.10 Sensitivity analysis
Sensitivity analysis will be conducted if there are sufficient data available.
2.3.11 Grading the quality of evidence
The quality of evidence will be evaluated using the grading of recommendations assessment, development and evaluation (Version 3.6, The GRADE Working Group, 2010). The quality of evidence was divided into 4 levels: high, medium, low, and extremely low.
3 Discussion
With the aging of the population and the acceleration of urbanization, CHD has become a serious public health problem, which seriously affects human life and health. Drugs, PCI and CABG are the most important treatments for treating CHD. However, there are certain side effects about these treatments. GPD may be a useful treatment for primary insomnia, and it is unlikely to produce severe side effects. As far as we know, it is unclear whether GPD is effective and safe intervention for CHD. Therefore, we aim at providing evidence to clinicians so that more and more patients with CHD may also benefit from alternative interventions. However, there are some certain potential limitations in this systematic review . First, the language is limited to Chinese or English, which may result in selection bias. Second, different dosage of herbs, the age of the patient, and the severity of CHD may present a heterogeneity risk. Finally, small samples of RCTs may lead to high risks of bias.
Author contributions
Conceptualization: Huanjia Gao.
Data curation: Shuai Zhao.
Funding acquisition: Bojun Chen.
Investigation: Xue Fu.
Methodology: Dongjie Chen.
Project administration: Bojun Chen.
Software: Shiyu Liu.
Supervision: Bojun Chen.
Validation: Hairong Cai.
Writing – original draft: Huanjia Gao.
Writing – review & editing: Huanjia Gao, Shiyu Liu.
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