Comparison of Buyang Huanwu granules and Naoxintong capsules in the treatment of stable angina pectoris: rationale and design of a randomized, blinded, multicentre clinical trial

Abstract

Background Stable angina pectoris (SAP) currently seriously threatens the health of humans, and mortality is continuously rising. Current treatment strategies mainly include pharmaceutical therapy and revascularization. In China, Buyang Huanwu granules (BYHW) and Naoxintong capsules (NXT) have been used in the treatment of SAP, but it is not clear which agent is better in terms of relieving symptoms and improving quality of life. Therefore, we designed a clinical trial to compare the efficacy and safety of NXT and BYHW in the treatment of SAP. Methods This is a randomized, blinded, parallel controlled, multicentre clinical trial protocol. On the basis of standardized Western medicine treatment, a total of 128 SAP patients will be randomly divided into intervention group 1 (NXT group), intervention group 2 (BYHW group), and a control group (placebo group) at a 2:1:1 ratio. A 2-week run-in period is required prior to randomization, and a 1-week baseline period and 4-week treatment period are included in this study. The primary outcome is the efficacy rate of stable angina symptom score improvement; the secondary outcomes include the effect on electrocardiograms, Seattle Angina Questionnaire scores, and nitroglycerine consumption. Discussion This study will evaluate the efficacy and safety of NXT and BYHW in the treatment of SAP. The results will provide critical evidence for using Chinese herbal medicines to treat SAP. Trial registration Chinese Clinical Trials Registry ChiCTR1800015191. Registered on 13 March 2018. http://www.chictr.org.cn/showproj.aspx?proj=25818. All the registration items can be found within the protocol.

Naoxintong capsule for treating cardiovascular and cerebrovascular diseases: from bench to bedside

“…CSA, characterized by chest pain or discomfort, is a major symptomatic presentation in about 50% of patients with CHD ( Gao et al, 2021 ). In China, the prevalence rate of CSA was about 3.6% in 2017 and the numbers are still rapidly increasing in recent years due to ageing as well as multiple risk factors such as diabetes mellitus, hypertension, etc., ( Wang et al, 2022 ). Currently, guideline-directed therapy for CSA mainly includes antiplatelet agents, statins, calcium channel blockers and nitrates ( Healthcare Engineering, 2023 ).…”

Protective effects of paeoniflorin on cardiovascular diseases: A pharmacological and mechanistic overview

“…Relevant clinical studies and meta-analysis have proved that its therapeutic effect on stable angina pectoris (SAP)and stroke ( Zhang et al, 1995 ; Gao et al, 2021 ; Wang et al, 2022a ). Recently, Wang et al (2022b) designed a randomized, blinded, parallel controlled, multicenter clinical trial to compare the efficacy and safety of NXT and BYHW in the treatment of SAP. The results of the trial have yet to be published.…”

Yangxin decoction for the treatment of angina pectoris of coronary heart disease: A systematic review of randomized controlled trial

“…[9–11] It consists of 2 types: stable and unstable angina. [12,13] According to theory of traditional Chinese medicine (TCM), AP belongs to the “ Xiong Bi ,” “chest arthralgia,” and “heartache.” Its major pathogenesis is explained by “heart pulse stasis” and “Qi statsis.” [14–20] Clinical practice has proven that Yangxin Decoction (YXD) has unique advantages for the management of patients with AP of CHD. [21–29]…”

“…Its major pathogenesis is explained by "heart pulse stasis" and "Qi statsis." [14][15][16][17][18][19][20] Clinical practice has proven that Yangxin Decoction (YXD) has unique advantages for the management of patients with AP of CHD. [21][22][23][24][25][26][27][28][29] Previous studies have reported that YXD can improve the AP of CHD by increasing the levels of serum 6-Keto-PGF 1α, high-density lipoprotein cholesterol, and apolipoprotein A.…”