The effect of Qi-Shao-Tong-Mai-An-Shen herbal paste on coronary heart disease patients with depression and/or anxiety: Study protocol for a randomized controlled trial

Ying Chen, Xiang Xiao, Lin Li, Chao-Zeng Si, Hong Jiang, Ming-Jing Shao, Xiao-Yan Lu, Shu-Liang Zheng, Tian-Gu Dai, Qing He, Li Huang
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Abstract

Coronary heart disease (CHD) poses a significant threat to human life and well-being. The presence of psycho-cardiology diseases not only exacerbates the progression of CHD but also imposes a substantial financial burden. Consequently, there is a pressing need to prioritize the prevention and management of psycho-cardiology conditions. Given the complex adverse effects associated with antidepressants, it is imperative to investigate alternative, safer, and more efficacious early interventions for psycho-cardiology diseases. The trial will randomly divide 99 patients who meet the inclusion criteria into two groups in a ratio of 1:2. Both groups will be administered standard western medicine treatment for CHD. The Qi-Shao-Tong-Mai-An-Shen (QSTMAS) group will be treated with an additional 30 mL QSTMAS herbal paste orally twice daily for up to 12 weeks. The primary endpoints are the changes of Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9 scores after the intervention for 12 weeks. The secondary endpoints include the scores of Traditional Chinese medicine syndromes, 6-min walking test, Insomnia severity index sleep scale, laboratory tests, and other examinations of both groups after the intervention for 12 weeks. The QSTMAS herbal paste exhibits potential and promise as a treatment modality for mild-to-moderate psychological disorders within the department of cardiology. The implementation of a rigorous trial design will facilitate an objective and scientific assessment of the clinical effectiveness and safety of combining QSTMAS herbal paste with standard western medicine for CHD patients with depression and/or anxiety. Trial Registration: China Clinical Trial Registry, ChiCTR2200065179. Registered 31 October 2022.

Abstract Image

芪芍通麦安神膏对伴有抑郁和/或焦虑的冠心病患者的影响:随机对照试验研究方案
冠心病(CHD)对人类的生命和福祉构成重大威胁。心身疾病的存在不仅会加剧冠心病的恶化,还会造成巨大的经济负担。因此,迫切需要优先预防和管理心血管精神疾病。鉴于抗抑郁药的复杂不良反应,研究其他更安全、更有效的早期干预措施来治疗心血管心理疾病势在必行。该试验将把 99 名符合纳入标准的患者按 1:2 的比例随机分为两组。两组患者都将接受标准的西医治疗。芪芍通麦安神(QSTMAS)组将额外口服 30 毫升芪芍通麦安神(QSTMAS)中药糊剂,每天两次,最长治疗 12 周。主要终点是干预 12 周后广泛性焦虑症-7 和患者健康问卷-9 评分的变化。次要终点包括干预 12 周后两组患者的中医综合征评分、6 分钟步行测试、失眠严重程度指数睡眠量表、实验室检查和其他检查。QSTMAS中药贴剂作为心内科轻度至中度心理障碍的一种治疗方式,具有潜力和前景。实施严格的试验设计将有助于客观、科学地评估将 QSTMAS 中药膏与标准西药相结合治疗患有抑郁症和/或焦虑症的心脏病患者的临床有效性和安全性。试验注册:中国临床试验注册中心,ChiCTR2200065179。注册日期:2022年10月31日。
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