Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Althoug...Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.展开更多
Background β-blocker (BB) therapy is a cornerstone for the treatment of coronary heart disease (CHD).The evidence of the benefit from long-term BB therapy in diabetic patients with stable CHD is scarce.This meta-anal...Background β-blocker (BB) therapy is a cornerstone for the treatment of coronary heart disease (CHD).The evidence of the benefit from long-term BB therapy in diabetic patients with stable CHD is scarce.This meta-analysis summarizes the evidence relating to the BB therapy in diabetic patients with stable CHD.Methods A meta-analysis was performed according to PRISMA and MOOSE guidelines for reporting of systematic reviews of observational studies.PubMed,Embase,and Cochrane central were searched and two authors independently screened studies for eligibility.The quality of studies was assessed with the Newcastle Ottawa scale.The primary outcome of interest was all-cause mortality,cardiovascular (CV) mortality and major adverse cardiovascular events (MACE) in diabetic patients with and without BB therapy.A generic inverse variance model was used to pool odds ratio or hazards ratio from included studies to calculate the overall effect estimate.The significance threshold was set at P-value < 0.05.Heterogeneity was assessed by I2.Results Four non-randomized studies with 9515 participants were selected for the analyses.Four studies were post-hoc analyses of randomized controlled trials,and one article was an analysis of a nationally representative survey.In a fixed effects model,BB therapy in diabetic patients with stable CHD was found to be associated with increased risk of CV mortality,and MACE (27% and 32% respectively;P-value < 0.05) and was not associated with a reduction in all-cause mortality (HR 1.12;95% CI: 0.94–1.33;P-value = 0.22).Conclusion BB therapy in diabetic patients with stable CHD appears to be linked to higher mortality.Large randomized trials are needed in this population to confirm these findings.展开更多
文摘Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.
文摘Background β-blocker (BB) therapy is a cornerstone for the treatment of coronary heart disease (CHD).The evidence of the benefit from long-term BB therapy in diabetic patients with stable CHD is scarce.This meta-analysis summarizes the evidence relating to the BB therapy in diabetic patients with stable CHD.Methods A meta-analysis was performed according to PRISMA and MOOSE guidelines for reporting of systematic reviews of observational studies.PubMed,Embase,and Cochrane central were searched and two authors independently screened studies for eligibility.The quality of studies was assessed with the Newcastle Ottawa scale.The primary outcome of interest was all-cause mortality,cardiovascular (CV) mortality and major adverse cardiovascular events (MACE) in diabetic patients with and without BB therapy.A generic inverse variance model was used to pool odds ratio or hazards ratio from included studies to calculate the overall effect estimate.The significance threshold was set at P-value < 0.05.Heterogeneity was assessed by I2.Results Four non-randomized studies with 9515 participants were selected for the analyses.Four studies were post-hoc analyses of randomized controlled trials,and one article was an analysis of a nationally representative survey.In a fixed effects model,BB therapy in diabetic patients with stable CHD was found to be associated with increased risk of CV mortality,and MACE (27% and 32% respectively;P-value < 0.05) and was not associated with a reduction in all-cause mortality (HR 1.12;95% CI: 0.94–1.33;P-value = 0.22).Conclusion BB therapy in diabetic patients with stable CHD appears to be linked to higher mortality.Large randomized trials are needed in this population to confirm these findings.
