Dataset Information

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

ABSTRACT:

Background

Stable 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/design

This 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.

Discussion

The 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 registration

Clinical trials registration

ChiCTR-TRC-13003608, registered 18 June 2013.

SUBMITTER: Zhang Z

PROVIDER: S-EPMC4233055 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

Zhang Zhe Z Zhang Fan F Wang Yang Y Du Yi Y Zhang Huiyong H Kong Dezhao D Liu Yue Y Yang Guanlin G

Trials 20141030

<h4>Background</h4>Stable 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 an ...[more]

PMID: 25359307

Similar Datasets

Project description:IntroductionPrevious reviews indicate that the effect of acupuncture on stable angina pectoris (SAP) remains controversial. The results of trials published in the past 5?years may possibly change this situation, but an updated systematic review is not available. We therefore designed this study to systematically assess the efficacy and safety of acupuncture for treating SAP.Methods and analysisNine online databases will be searched without language or publication status restrictions from their inception to September 2017. Randomised controlled trials that include patients with stable angina receiving acupuncture therapy versus a control group will be deemed eligible. The selection of studies, data extraction and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan V.5.3 software with either a fixed effects model or random effects model, depending on the heterogeneity test. Evidence quality will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. The efficacy-effectiveness spectrum for each included trial will be rated using the Rating of Included Trials on the Efficacy-effectiveness Spectrum tool. Outcomes of interest include the improvement of weekly angina attacks and reduction of nitroglycerin medication use after receiving acupuncture treatment, the incidence of cardiovascular events, heart rate variability, pain intensity measured on a visual analogue scale, total workload and exercise duration at peak exercise, safety and adverse events. A meta-analysis will be conducted if no considerable heterogeneity is detected. The results will be presented as risk ratios with 95% CIs for dichotomous data and weighted mean differences or standardised mean differences with 95% CIs for continuous data.Ethics and disseminationThis systematic review will not involve private information from individuals or endanger their rights, and therefore does not necessarily require ethical approval. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.Trial registration numberCRD42015016201.

Project description:BackgroundTraditional Chinese medicine (TCM), including Chinese herbal medicine (CHM) and acupuncture, exhibits beneficial effects on stable chronic obstructive pulmonary disease (COPD) such as improving lung function and reducing exacerbation. Previous research studies have examined either CHM or acupuncture alone, which are not the usual practice in TCM clinic setting. We conduct a systematic review for evaluating the clinical effectiveness and safety of TCM by combining CHM and acupuncture.MethodsDatabases are searched from inception to November 2019. Randomized controlled trials examining either acupuncture or CHM on stable COPD are included. Primary outcomes include lung functions, exacerbations, and COPD assessment test. Secondary outcomes include quality of life, TCM syndrome score and effective rate, and 6-minute walk distance. Two independent reviewers extract data and assess the quality of evidence and generate meta-analysis and risk of bias by STATA. This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines.Results100 randomized controlled trials (8291 participants) were included to compare add-on Chinese medicine treatment with conventional treatment (CT). Combining CHM with CT improves FEV1 (MD: 0.18, 95% CI: 0.08, 0.28), exacerbation rate (MD: -0.29, 95% CI: -0.61, 0.03), COPD assessment test (MD: -2.16, 95% CI: -3.44, -0.88), TCM syndrome score (MD: -3.96, 95% CI: -5.41, -2.51) and effective rate (RR: 0.89, 95% CI: 0.80, 0.93), and 6-minute walk test (MD: 37.81, 95% CI: 20.90, 54.73). No serious adverse events were reported. Risk of bias: low to unclear.ConclusionsThis review identifies sufficient moderate-to-low-quality evidence to suggest TCM as an adjunct treatment for stable COPD patients. Though heterogeneity was low among studies, the results were limited and the quality of evidence was low or very low based on small sample sizes and risk of bias. Future studies with larger sample sizes are warranted. The trial is registered with CRD42019161324.

Dataset Information

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Clinical trials registration

Publications

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets