scholarly journals Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Pan-pan Tian ◽  
Qing-juan Wu ◽  
Jun Li ◽  
Heng-wen Chen ◽  
Ji Wu ◽  
...  
Keyword(s):  
Placebo Group ◽  
Angina Pectoris ◽  
Herbal Medicine ◽  
Blood Stasis ◽  
Intervention Group ◽  
Common Type ◽  
Blood Stasis Syndrome ◽  
Efficacy And Safety ◽  
Chinese Herbal ◽  
Conventional Medication

Abstract Introduction Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China’s medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP. Methods and analysis This is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization. Discussion This trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP. Trial registration ClinicalTrials.govNCT04661709. Registered on 30 November 2020

scholarly journals Efficacy and Safety of a Chinese Herbal Medicine Formula (RCM-104) in the Management of Simple Obesity: A Randomized, Placebo-Controlled Clinical Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
George Binh Lenon ◽  
Kang Xiao Li ◽  
Yung-Hsien Chang ◽  
Angela Weihong Yang ◽  
Clifford Da Costa ◽  
...  
Keyword(s):  
Placebo Group ◽  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Chinese Herbal ◽  
Simple Obesity ◽  
Obese Subjects ◽  
Chinese Herbal Medicine Formula

Objective.This study was to evaluate the efficacy and safety of a Chinese herbal medicine formula (RCM-104) for the management of simple obesity.Method.Obese subjects aged between 18 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial. Subjects were randomly assigned to take 4 capsules of either the RCM-104 formula (n=59) or placebo (n=58), 3 times daily for 12 weeks. Measures of BW, BMI and WC, HC, WHR and BF composition were assessed at baseline and once every four weeks during the 12 week treatment period.Results. Of the 117 subjects randomised, 92 were included in the ITT analysis. The weight, BMI and BF in RCM-104 group were reduced by 1.5 kg, 0.6 kg/m2and 0.9% and those in the placebo group were increased by 0.5 kg, 0.2 kg/m2and 0.1% respectively. There were significant differences in BW and BMI (P<0.05) between the two groups. Eleven items of the WLQOQ were significantly improved in the RCM-104 group while only 2 items were significantly improved in the placebo group. Adverse events were minor in both groups.Conclusion. RCM-104 treatment appears to be well tolerated and beneficial in reducing BW and BMI in obese subjects.

scholarly journals Efficacy and safety of acupuncture combined with Chinese herbal medicine in the treatment of angina pectoris of coronary heart disease: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Shuang Wang ◽  
◽  
Aidong Liu ◽  
Zhilei Wang ◽  
Yue Zhang
Keyword(s):  
Systematic Review ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Angina Pectoris ◽  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Meta Analysis ◽  
Biomedical Literature ◽  
Efficacy And Safety ◽  
Chinese Herbal

Review question / Objective: This study is the protocol for a systematic review to evaluate the Efficacy and safety of acupuncture combined with Chinese herbal medicine in the treatment of angina pectoris of coronary heart disease: a systematic review and meta-analysis. we conducted a systematic review and meta-analysis of published randomized clinical trials (RCTs) of such combined therapy in the treatment of angina pectoris of coronary heart disease, It provides a reliable scientific basis for clinicians to use this approach to treat angina pectoris of coronary heart disease. Information sources: We conducted a systematic search for relevant documents in the Chinese and English databases, and the search time is limited to November 23, 2021. The following eight databases are included : PubMed,EMBASE, Web of Science, The Cochrane Library, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang Database.Relevant journals were searched to trace the references included in the study. Other resources will be searched if necessary.

Efficacy and safety of Chinese herbal medicine Guanxinshutong capsule for the treatment of chronic heart failure with ejection fraction decrease (<50%) caused by coronary heart disease: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Yu Wang ◽  
Jiaping Xu ◽  
Jie-hong Yang ◽  
Ling Zhang ◽  
Yuan-jiang Pan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Chronic Heart Failure ◽  
Herbal Medicine ◽  
Ejection Fraction ◽  
Intervention Group ◽  
Efficacy And Safety ◽  
Chinese Herbal

Abstract Background Chronic Heart failure (CHF) is a global epidemic and common cardiovascular disease with high mortality and poor prognosis, which bring heavy burdens to society and family. Traditional Chinese medicine (TCM) has been extensively used in China as an adjunct treatment for CHF. Guanxinshutong capsule (GXST), approved by the China Food and Drug Administration (CFDA) in 2002 (No. Z20020055), is commonly used Chinese herbal medicine (CHM) for the treatment of coronary heart disease (CHD) currently. Both experimental research and small-sample clinical trials have shown that GXST could attenuate CHF. However, the effects of GXST on CHF as an adjunct therapy are lack of high-quality clinical evidence. This study is a large-scale, multi-center, double-blinded clinical trial to explore the efficacy and safety of GXST in CHF with ejection fraction decrease (<50%) caused by CHD. Methods This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. After 1week baseline period, a total of 480 participants will be randomly assigned to the intervention group and placebo group in ratio 2:1. Based on routine medications, the intervention group will be treated with GXST while the control group will be treated with placebo (both 0.3g/capsule, op, 3 capsules/time, thrice daily) for 12 weeks, and then be followed-up for another 40 weeks. The primary outcome is the effect of 6 min walk test (6MWT). The secondary outcomes include NT-proBNP, classification of the New York Heart Association (NYHA) heart function, Minnesota heart failure quality of life scale (MLHFQ), echocardiographic parameters, blood stasis syndrome symptom scale and clinical endpoint events. Metabolomics and proteomics will also be assessed. Adverse events (AEs) will be monitored throughout the trial. All the data will be recorded in electronic case report forms (eCRF) system database and analyzed in accordance with a predefined statistical analysis plan. Ethical approval of this trial has been granted by the Research Ethics Committee of the Second Affiliated Hospital of Zhejiang Chinese Medical University (ID: 2019-Y-003-02). Written informed consent of patients will be required. The results will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion This study integrates the advantages of TCM and western medicine in the treatment of CHF, the result of this study will offer the efficacy and safety evidence of GXST on CHF with ejection fraction decrease (<50%).

scholarly journals An Overview of Systematic Reviews of Chinese Herbal Medicine for Alzheimer’s Disease

2021 ◽  
Vol 12 ◽  
Author(s):  
Nanyang Liu ◽  
Tingting Zhang ◽  
Jiahui Sun ◽  
Jiuxiu Yao ◽  
Lina Ma ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Herbal Medicine ◽  
Systematic Reviews ◽  
Chinese Herbal Medicine ◽  
Methodological Quality ◽  
Efficacy And Safety ◽  
Quality Of Evidence ◽  
Chinese Herbal

Background: Multiple systematic reviews (SRs) have been conducted to evaluate the efficacy and safety of Chinese herbal medicine (CHM) in patients with Alzheimer’s disease (AD). Here, we aim to perform an overview to assess the methodological quality and quality of evidence of the SRs to provide convincing data on the treatment of AD with CHM.Method: Six electronic databases including Chinese and English were searched, until April 31, 2021. Two researchers independently screen documents and extract data according to the predesigned rules. A Measure Tool to Assessment System Reviews 2 (AMSTAR-2) was used to investigate the methodological quality, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to determine the quality of evidence for outcomes.Results: Twelve qualified SRs including 163 randomized controlled trials were reviewed. The methodological quality of the included SRs was considered extremely low assessed through AMSTAR-2. Compared with western medicines (WM) alone, CHM as an adjuvant treatment has shown significant effects in improving Mini-mental State Examination, Alzheimer’s Disease Assessment Scale-Cognitive, and Clinical Dementia Rating scores. The same is true for CHM alone. Regarding the effect on Activities Daily Living, neither the single CHM nor the combination with WM has an obvious effect. For the total effective rate, both single CHM and the combination with WM shown significant effects. Nine SRs suggested that CHM as adjuvant therapy or single-use had fewer adverse events than WM. Additionally, the quality of evidence for the main outcome was reviewed as low or extremely low according to GRADE profiler data.Conclusion: Current evidence suggests that CHM may be beneficial in improving the cognitive function of AD patients. However, we should be cautious about the evidence due to methodological flaws and low quality. High-quality RCTs are further needed to confirm the efficacy and safety of CHM for AD.

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