Abstract
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.
Highlights
Previous studies have shown that residual cardiovascular risks persist in patients with optimal LDL cholesterol levels, and other lipid indicators such as triglycerides (TG), non-high-density lipoprotein, and remnant cholesterol have emerged [3–7]
There are no treatments for hyperTG, which have been found to reduce cardiovascular diseases (CVD) cases in double-blind, randomized studies conducted on patients who are already undergoing statin treatment [15,16]
There were no significant differences in baseline total cholesterol, LDL, HDL, Apo A-1, non-HDL, remnant cholesterol, and reactive hyperemic index (RHI), the mean Apo B level was slightly higher in the OMEGA3 group (p = 0.018) (Table 2)
Summary
Dyslipidemia is a major risk factor for well-known cardiovascular diseases (CVD), especially LDL cholesterol [2]. Previous studies have shown that residual cardiovascular risks persist in patients with optimal LDL cholesterol levels, and other lipid indicators such as triglycerides (TG), non-high-density lipoprotein (non-HDL), and remnant cholesterol have emerged [3–7]. Hypertriglyceridemia (hyperTG) is known as an independent risk factor for coronary artery disease [8–12]. OMEGA3 fatty acid is a drug that has been proven to reduce TG in patients with hyperTG, known through several RCTs for its effectiveness and safety in single-dose or combination with statin treatments [13]. There are no treatments for hyperTG, which have been found to reduce CVD cases in double-blind, randomized studies conducted on patients who are already undergoing statin treatment [15,16]. Further study will be needed on other drugs that are effective for hyperTG [17]
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