Efficacy and Safety of Da-Chai-Hu-Tang in Lipid Profiles in High-Risk, Statin-Treated Patients with Residual HyperTG: A 12-Week, Randomized, Active-Control, Open Clinical Study

Da-Chai-Hu-Tang (DCHT) is a herbal extract that has been shown to reduce serum triglyceride (TG) levels in animal experiments as well as small clinical trials. This study aimed to evaluate the efficacy and safety of DCHT in high-risk, statin-treated patients with residual hypertriglyceridemia (hyperTG). This was a 12-week, randomized, active-controlled, open-label, single-center trial. Of these patients, 42 had high cardiovascular risks whose LDL cholesterol levels were controlled by statin treatment; however, with TG levels of 200 to 500 mg/dL they were randomly assigned 1:1 to the OMEGA3 or DCHT group. The primary endpoint was defined as the percentage change in TG at 12 weeks, and changes in other lipid profiles and endothelial cell function were included as secondary endpoints. Safety analyses were also conducted. In the OMEGA3 group, the average TG level decreased from 294.5 +/- 72.0 to 210.0 +/- 107.8 mg/dL (p = 0.004), and in the DCHT group, from 288.7 +/- 59.1 to 227.5 +/- 98.1 mg/dL (p = 0.001). The percentage change in TG was -27.6 +/- 33.6 and -22.4 +/- 24.1 (p = 0.58), respectively, and there was no significant difference between the two groups. There were no severe adverse events in either group. In high-risk, statin-treated patients with residual hyperTG, the administration of OMEGA3 or DCHT for 12 weeks resulted in a significant reduction in TG, and the effect of DCHT was not inferior to that of OMEGA3.