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Adjuvant treatment of coronary heart disease angina pectoris with Chinese patent medicine: A prospective clinical cohort study.

ABSTRACT: 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.

SUBMITTER: Liu Y

PROVIDER: S-EPMC6831431 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Adjuvant treatment of coronary heart disease angina pectoris with Chinese patent medicine: A prospective clinical cohort study.

Liu Yijia Y Li Zhu Z Shen Dandan D Song Yanqi Y Huang Mengnan M Xue Xiaoxue X Xie Jing J Jiao Ziyi Z Gao Shuming S Xu Yilan Y Gao Shan S Wang Xianliang X Xu Qiang Q Gao Sheng S Li Chunjie C Li Lin L Niu Kaijun K Yu Chunquan C

Medicine 20190801 33

<h4>Background</h4>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.<h4>Objective</h4>It is hoped that the research method with higher evidential value will be adopted to compar ...[more]

PMID: 31415432

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Project description:ObjectiveWe aimed to evaluate the effects of integrated Chinese and Western medical therapeutic modalities on clinical prognosis in a population with stable angina pectoris (SAP) of coronary heart disease (CHD).MethodsIn a prospective cohort study, 732 patients with SAP of CHD hospitalized in the Integrated Cardiology Unit of the China-Japan Friendship Hospital From October 2020 to October 2021 were included. The patients were divided into integrated treatment and conventional treatment groups according to whether they had been taking Chinese medicine for more than 6 months per year. The occurrence of composite cardiovascular events (CVEs), including cardiac death, non-fatal myocardial infarction, revascularization, stroke, all-cause death, and readmission due to angina attack, heart failure, or malignant arrhythmia, was recorded during follow-up. The effects of different treatment modalities on prognosis were evaluated using univariate and multifactorial logistic regression. Logistic regression models were evaluated using receiver operating characteristic (ROC) curves. In sensitivity analysis, the correlation between treatment modality and outcome events was corrected by rematching the two groups of patients using the propensity score matching (PSM) method.ResultsThe data from 690 patients were included in the analysis, with 327 patients in the integrated treatment group and 363 patients in the conventional treatment group. CVEs occurred in 19 patients (5.8%) in the integrated treatment group and 37 patients (10.2%) in the conventional treatment group. The proportion of outcome events was significantly lower in the combination treatment group than in the conventional treatment group (P = 0.037). Covariate correction by multimodal multifactorial logistic regression revealed a lower risk of CVEs in patients receiving integrated therapy compared with conventional therapy (OR = 0.246, 95% CI = 0.097-0.622, P = 0.003). Moreover, a history of renal insufficiency (OR = 3.991, 95% CI = 1.164-13.684, P = 0.028) and a higher Gensini score (OR = 1.039, 95% CI = 1.028-1.050, P < 0.001) were risk factors for the development of CVEs. Model evaluation showed that C-statistic = 0.955 and area under the ROC curve (AUC) = 0.955. After PSM correction, the results still showed that integrated Chinese and Western medical treatment reduced the occurrence of CVEs in patients compared with Western treatment alone (OR = 0.339, 95% CI = 0.131-0.874, P = 0.025).ConclusionIntegrated treatment based on Chinese and Western medicine might improve the prognosis and reduce the risk of CVEs in this disease population.Trial registrationChina Clinical Trials Registry, ChiCTR1800017891, Registered 20 August 2018, http://www.chictr.org.cn/showproj.aspx?proj = 30170.

Project description:BackgroundStable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris.Methods/designThis is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed.DiscussionThe primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology.Trial registrationClinical trials registrationChiCTR-TRC-13003608, registered 18 June 2013.

Dataset Information

Adjuvant treatment of coronary heart disease angina pectoris with Chinese patent medicine: A prospective clinical cohort study.

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Adjuvant treatment of coronary heart disease angina pectoris with Chinese patent medicine: A prospective clinical cohort study.

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