Efficacy and safety of Tongxin formula in the treatment of coronary microvascular disease: A randomized, double-blind, placebo-controlled clinical trial study.

Objective: The objective of this study was to evaluate the efficacy and safety of Tongxin Formula in the treatment of coronary microvascular disease. Methods: We conducted a randomized, double-blind, placebo-controlled study simultaneously in two hospitals, consisting of 80 participants. Using a random number table, we assigned patients to the treatment and control groups. Patients in both groups received conventional Western medicine for coronary microvascular disease. In addition, those in the treatment group received Tongxin formula granules, while those in the control group received a placebo. The treatment course for both groups was three months, and the follow-up duration was six months. The primary efficacy indicators were coronary blood flow reserve and cardiovascular adverse events; the secondary efficacy indicators were the traditional Chinese medicine (TCM) syndrome score, the angina symptom score, the Seattle Angina Questionnaire (SAQ) score, left ventricular function, and adverse reactions. Results: After treatment, patients in the treatment group showed significantly higher variation in the coronary flow reserve (CFR) levels (CFR >2) and improvement of diastolic function (peak filling rate, or PFR >2.5) than those in the control group (P < 0.05). After 6 months of follow-up, the incidence of cardiovascular events in the treatment group was significantly lower than that in the control group (P < 0.05). After 3 months of treatment and 6 months of follow-up, the total effective rates of TCM symptoms and angina symptoms, as well as the total SAQ standard scores, in the treatment group were higher than those in the control group (P < 0.05). There were no serious adverse reactions in either group before or after treatment, and there was no significant change (P > 0.05). Conclusion: We found that Tongxin Formula combined with conventional Western medicine can significantly improved the level of coronary blood flow reserve, reduced the occurrence of cardiovascular adverse events, improved the clinical symptoms of patients, and enhanced the quality of life of patients with coronary microvascular disease with favorable safety.

Efficacy and safety of Tongxin formula after stent implantation for acute coronary syndrome: A multicenter, double-blind, placebo-controlled randomized trial.

OBJECTIVE: The aim of this study is to comprehensively evaluate both the efficacy and safety profile of integrating the Tongxin formula with optimal medical therapy (OMT) for patients experiencing acute coronary syndromes subsequent to coronary stenting, over the course of one year. METHODS: We enrolled 150 patients diagnosed with acute coronary syndromes who had received stent placement within one month and exhibited a TCM syndrome characterized by Qi deficiency and blood stasis. This group comprised patients with unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction. The participants were divided equally, allocating 75 to the Tongxin formula group and 75 to a placebo-controlled group. After undergoing percutaneous coronary intervention (PCI) surgery, both groups received conventional Western medical care, including dual antiplatelet therapy and lipid-lowering medications. The placebo-controlled group received a placebo, while the Tongxin formula group were administered Tongxin formula granules orally. Both study cohorts were monitored for a duration of 6 months. The primary endpoints included the occurrence of major adverse cardiovascular events and the rate of lumen diameter reduction post-treatment in both groups, with the Seattle Angina Scale serving as a secondary assessment tool. Safety evaluations encompassed the measurement of liver and kidney function, coagulation parameters, and other relevant indicators. RESULTS: The rate of adverse cardiovascular events in the placebo-controlled group was 42.46 % within a year of surgery, whereas it was 16.90 % in the Tongxin formula group (P < 0.05). Comparing the Tongxin formula group to the placebo-controlled group, there was a decrease in the frequency of unstable angina and readmission due to cardiovascular events (P < 0.05). Coronary angiography performed 6 months after surgery revealed that the Tongxin formula group had considerably less lumen loss than the placebo-controlled group in a number of segments, including the entire segment, within the stent, at the proximal end, and at the distal end (P < 0.05). Six months after surgery, the Seattle angina score was higher in the Tongxin formula group than in the placebo-controlled group (P < 0.05). There were no significant changes in indicators such as liver and renal function as well as coagulation indexes in both groups within the first 12 months after surgery (P > 0.05). CONCLUSION: Tongxin formula has been shown to lower the occurrence of major adverse cardiovascular events, minimize narrowing of blood vessel lumen, enhance clinical symptoms, and enhance the quality of life of patients following PCI surgery, all while maintaining a good safety profile.

The cardioprotective effect of Shengmai Zhenwu decoction on patients with chronic heart failure based on the levels of soluble interleukin 1 receptor-like 1.

Objective: The purpose of this study was to evaluate the protective effect of Shengmai Zhenwu decoction on patients with chronic heart failure (CHF) based on the levels of soluble interleukin 1 receptor-like 1 (ST2). Methods: We included a total of 80 outpatients and inpatients with CHF who were undergoing treatment at the Shanghai Municipal Hospital of Traditional Chinese Medicine between March 2020 and March 2022. We randomly divided them into the observation group (n = 40) and the control group (n = 40). Patients in the control group received treatments as per conventional Western medicine, while those in the observation group were treated with the Shengmai Zhenwu decoction in conjunction with Western medicine for eight consecutive weeks. We then compared the pre- and post-treatment levels of ST2 and N-terminal pro-brain natriuretic peptide (NT-proBNP) of the patients in the two groups. Results: There were no significant differences in the pre-treatment levels of ST2 and NT-proBNP indexes between the two groups (P > 0.05), while the post-treatment comparison between the two groups in terms of ST2 and NT-proBNP levels suggested that the effect in the observation group was better, with statistical significance (P < 0.05). Conclusion: Shengmai Zhenwu decoction was beneficial in patients with CHF, suggesting that it could be a promising and effective method for the treatment of CHF.