The Effect of Qi-Shao-Tong-Mai-An-Shen (QSTMAS) Herbal Paste in Coronary Heart Disease Patients with Depression and/or Anxiety: A Randomized Controlled Clinical Trial Protocol

Abstract

Background Coronary heart disease (CHD) is a major disease threatening human life and health. Psycho-cardiology diseases aggravate not only the burden of finance but also the progression of CHD. Nowadays, a growing chorus of cardiovascular experts have come to call for an emphasis on the prevention and control of psycho-cardiology. Due to intricate adverse effects of antidepressants, it is urgent to explore a safe and effective early intervention method for psycho-cardiology diseases. Our medical team sought help from traditional Chinese medicine (TCM) and planned to explore the use of QSTMAS herbal paste in the treatment of CHD patients with Qi deficiency and blood stasis syndrome combined with depression and/or anxiety. Methods The single-blind, single-center, randomized controlled trial is designed to recruit 99 patients from China-Japan Friendship Hospital. All patients will be randomly assigned in a 1:2 radio. Both groups will receive standard western medicine treatment for CHD. The test group 2 will be treated with an additional 30ml QSTMAS herbal paste, orally twice daily for up to 12 weeks. The primary endpoints of the study are the changes in GAD-7 and PHQ-9 scores before and after the 12 weeks of intervention. The secondary endpoints included the clinical efficacy of TCM Syndromes of CHD, 6-minute walking test (6MWT), ISI Sleep Scale, laboratory tests, and examinations of the two groups before and after the 12 weeks intervention. Discussion QSTMAS herbal paste is a potential and promising treatment option for the treatment of mild and moderate psychological disorders in the cardiology department. The strict trial design will ensure the objective and scientific evaluation of the clinical efficacy and safety of the combination of QSTMAS herbal paste and standard western medicine in the treatment of CHD patients with Qi deficiency and blood stasis syndrome combined with depression and/or anxiety. Trial registration: China Clinical Trial Registry, ChiCTR2200065179, Version 2.0, Registered on 31 October 2022. http://www.chictr.org.cn/listbycreater.aspx.