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Effectiveness and safety of oral Chinese patent medicines as adjuvant treatment for unstable angina pectoris on the national essential drugs list of China: a protocol for a systematic review and network meta-analysis.

ABSTRACT: INTRODUCTION:Achieving efficacious and safe treatments for unstable angina pectoris (UAP) is still a challenging clinical problem. The availability of different oral Chinese patent medicines frequently poses a practical challenge to clinicians, namely, which one to choose as first-line regimen for treatment. This study aims to examine the comparative effectiveness and safety of oral Chinese patent medicines for UAP on the national essential drugs list of China. METHODS AND ANALYSIS:We will conduct a network meta-analysis (NMA) of all randomised controlled trials to evaluate the use of oral Chinese patent medicines as adjuvant for the treatment of UAP. We will explore eight electronic databases from their inception to June 2018 and search for grey literature. Primary outcomes include mortality and the cardiovascular events. Secondary outcomes include: (1) symptom improvement; (2) ECG improvement; (3) frequency of acute angina attack; (4) duration of angina; (5) adverse effects. Two independent authors will screen titles and abstracts, review full texts, extract data, assess the risk of bias using the Cochrane risk of bias tool and assess the quality of evidence and strength of the recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). If adequate data are available, NMA will be performed with Bayesian analysis methods. ETHICS AND DISSEMINATION:The NMA will help us to reduce the uncertainty of interventions and help clinicians to make optimal and more accurate therapeutic decisions for adults with UAP. Therefore, we will publish the findings of this study in a peer-reviewed journal. No ethics approval is necessary for this study based on the nature of its design. TRIAL REGISTRATION NUMBER:CRD42018092822.

SUBMITTER: Hua Z

PROVIDER: S-EPMC6756357 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Effectiveness and safety of oral Chinese patent medicines as adjuvant treatment for unstable angina pectoris on the national essential drugs list of China: a protocol for a systematic review and network meta-analysis.

Hua Zhen Z Zhai Feng-Ting FT Tian Jinhui J Gao Cheng-Fei CF Xu Peng P Zhang Fan F Liu Si-Jia SJ Dong Kun K Du Xiao-Feng XF Zhang Zhe Z Yang Guanlin G

BMJ open 20190920 9

<h4>Introduction</h4>Achieving efficacious and safe treatments for unstable angina pectoris (UAP) is still a challenging clinical problem. The availability of different oral Chinese patent medicines frequently poses a practical challenge to clinicians, namely, which one to choose as first-line regimen for treatment. This study aims to examine the comparative effectiveness and safety of oral Chinese patent medicines for UAP on the national essential drugs list of China.<h4>Methods and analysis</h ...[more]

PMID: 31542734

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Project description:Objective: Dazhu hongjingtian [DZHJT, Rhodiola wallichiana var. cholaensis (Praeger) S.H. Fu] preparation as an add-on therapy has been applied to the treatment of angina pectoris. We aimed to evaluate the efficacy and safety of DZHJT as adjuvant therapy for the treatment of unstable angina pectoris (UAP). Methods: An extensive literature search was conducted on PubMed, Emase, Cochrane Library, Wanfang, CNKI, and VIP databases from inception to January 2019. Randomized controlled trials (RCTs) comparing DZHJT in combination with Western medicine with Western medicine alone were included. Two authors independently performed the literature search, data extraction and risk of bias assessment of included studies, and conducted the statistical analysis. Results: A total of 18 RCTs involving 1,679 patients were included in the meta-analysis. Adjuvant treatment with DZHJT significantly decreased ?80% reduction in the frequency of angina attacks [risk ratio (RR) 1.57; 95% CI 1.36-1.81], weekly frequency of angina attacks [mean difference (MD) -1.03 times; 95% confidence interval (CI) -1.51 to -0.55], marked improved abnormal electrocardiogram (RR 1.46; 95% CI 1.23-1.74). In addition, DZHJT significantly reduced the whole-blood viscosity (MD -0.70 mPa.s; 95% CI -0.84 to -0.55), plasma viscosity (MD -0.28 mPa.s; 95% CI -0.38 to -0.19), serum level of fibrinogen (MD -0.67 g/L; 95% CI -0.79 to -0.54), thromboxanes B2 (MD -14.01 ng/L; 95% CI -20.86 to -7.15), and C-reactive protein (MD -1.48 mg/L; 95% CI -2.72 to -0.25). No significant differences in headache/dizziness (RR 0.72; 95% CI 0.31-1.67) were observed between two groups. Conclusion: Adjuvant treatment with DZHJT has an add-on effect in reducing angina pectoris attacks in patients with UAP. The beneficial effect may be correlated with regulating whole-blood viscosity, plasma viscosity, fibrinogen, thromboxanes B2, and CRP level. However, future well-designed prospective, randomized, double-blind placebo-controlled trials with large sample sizes are required to evaluate the evidence.

Project description:BACKGROUND:Patients with coronary heart disease (CHD) angina pectoris are in critical condition, which can cause sudden death, myocardial infarction, and other adverse events, and bring serious burden to families and society. Timely treatment should be given to improve the condition. Western medicine treatment of angina pectoris failed to meet the demand of angina symptom control. OBJECTIVE:It is hoped that the research method with higher evidential value will be adopted to compare the short-term, medium-term, and long-term effects of Chinese patent medicine combined with conventional western medicine and conventional western medicine alone in the treatment of CHD angina pectoris, so as to tap the clinical efficacy advantages of traditional Chinese medicine (TCM) and provide reliable data support for its clinical application. METHODS:A prospective cohort study was conducted among patients with CHD angina pectoris who were treated with oral Chinese patent medicine and conventional western medicine. The patients were divided into exposed group and nonexposed group according to whether or not the patients with CHD angina pectoris were treated with Chinese patent medicine. The exposed group was treated with TCM combined with conventional western medicine, while the nonexposed group was treated with conventional western medicine alone. Patients need to be hospitalized for 2 weeks as the introduction period and whether to enter the group is determined according to the treatment and medication conditions of the patients. The follow-up time points were 0th, 4th, 12th, 24th, and 48th weeks. The main events and secondary events were used as the evaluation criteria for clinical efficacy of CHD angina pectoris. In the experimental study, we will use strict indicators to detect standard operation procedure for multinomics and bacterial flora detection. CONCLUSION:This study will provide evidence for the clinical efficacy advantages of Chinese patent medicine and reliable support for its clinical application through test data.

Dataset Information

Effectiveness and safety of oral Chinese patent medicines as adjuvant treatment for unstable angina pectoris on the national essential drugs list of China: a protocol for a systematic review and network meta-analysis.

Publications

Effectiveness and safety of oral Chinese patent medicines as adjuvant treatment for unstable angina pectoris on the national essential drugs list of China: a protocol for a systematic review and network meta-analysis.

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