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比较补充和替代疗法对冠心病伴焦虑或抑郁障碍的疗效和安全性:贝叶斯网络荟萃分析方案。

Comparison of efficacy and safety of complementary and alternative therapies for coronary heart disease complicated with anxiety or depression disorder: A protocol for Bayesian network meta-analysis.

机构信息

First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province.

Experimental Research Center, China Academy of Chinese Medical Sciences, Beijing.

出版信息

Medicine (Baltimore). 2021 Mar 26;100(12):e25084. doi: 10.1097/MD.0000000000025084.

Abstract

BACKGROUND

With the acceleration of the pace of life, the phenomenon of anxiety and depression in patients with coronary heart disease (CHD) is more and more common, and "psycho-cardiology" arises spontaneously. At present, the drug treatments of psycho-cardiology are difficult to achieve satisfactory results, and the side effects are obvious. Complementary and replacement therapies of CHD complicated with anxiety or depression disorder play an increasingly positive role, but there is a lack of comparison among different complementary and alternative therapies. In this study, Bayesian network meta-analysis (NMA) analysis method will be used for the first time to synthesize all the evidences of direct and indirect comparison among a variety of interventions, and rank their effectiveness and safety.

METHODS

Two independent researchers will search from the beginning to January 2021 mainly including randomized controlled trials (RCTs) and closely related ongoing RCTs of complementary and alternative therapies for CHD complicated with anxiety or depression disorder. And then identify, select and extract the data. The primary outcome measures are frequency of acute attack angina, severity of angina pectoris; the changed score in the validated scales, which can assess severity of anxiety or depression. Secondary outcomes include total efficacy rate, electrocardiogram improvement, traditional Chinese medicine symptoms score, changes of dosage of nitroglycerin and adverse effects. Using softwares WinBUGS 1.4.3 and STATA 16.0 for pairwise meta-analysis and NMA to comprehensively evaluate various interventions. The quality of evidences will be evaluated through the Grading of Recommendations Assessment, Development and Evaluation.

RESULTS

This NMA will comprehensively compare and rank the efficacy and safety of a series of complementary and alternative therapies in the treatment of CHD complicated with anxiety or depression disorder.

CONCLUSION

Supplementary and replacement therapies play an essential role in improving CHD complicated with anxiety or depression disorder. We expect that the NMA will provide reliable evidences of evidence-based medicine for treatment of CHD complicated with anxiety or depression disorder.

PROTOCOL REGISTRATION NUMBER

INPLASY202120046.

ETHICAL APPROVAL

This review does not require ethical approval.

摘要

背景

随着生活节奏的加快,冠心病(CHD)患者焦虑、抑郁的现象越来越普遍,“心身医学”应运而生。目前,心身医学的药物治疗难以取得满意的效果,且副作用明显。CHD 合并焦虑或抑郁障碍的补充和替代治疗发挥着越来越积极的作用,但不同补充和替代治疗方法之间缺乏比较。本研究将首次采用贝叶斯网状meta 分析(NMA)方法对各种干预措施的直接和间接比较的所有证据进行综合,并对其有效性和安全性进行排序。

方法

两名独立的研究人员将主要从开始到 2021 年 1 月检索补充和替代治疗 CHD 合并焦虑或抑郁障碍的随机对照试验(RCT)及密切相关的正在进行的 RCT,并对其进行识别、选择和提取数据。主要结局指标为急性发作性心绞痛的频率、心绞痛的严重程度;验证量表评估焦虑或抑郁严重程度的评分变化。次要结局指标包括总有效率、心电图改善、中医症状评分、硝酸甘油用量变化及不良反应。采用 WinBUGS 1.4.3 和 STATA 16.0 软件进行两两 meta 分析和 NMA 综合评价各种干预措施。证据质量通过推荐评估、制定和评价进行评估。

结果

本 NMA 将全面比较和排序一系列补充和替代疗法治疗 CHD 合并焦虑或抑郁障碍的疗效和安全性。

结论

补充和替代疗法在改善 CHD 合并焦虑或抑郁障碍方面发挥着重要作用。我们期望 NMA 能为 CHD 合并焦虑或抑郁障碍的治疗提供可靠的循证医学证据。

注册编号

INPLASY202120046。

伦理审批

本综述不需要伦理审批。

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