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

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.