Da-chai-hu-tang (DCHT) is one of the insurance-covered herbal extracts, which proved the effect on reducing serum triglycerides (TG) and Low-density lipoprotein (LDL) cholesterol levels in animal experiment and small clinical trials. The aim of this study was to evaluate the efficacy and safety of DCHT in high-risk, statin-treated patients with residual hypertriglyceridemia.
This was a 12-week, randomized, active-controlled, open-label, investigator-initiated, single center trial. A total of 50 patients were screened. After a 2-week run-in period, 42 of these patients with high cardiovascular risks whose LDL cholesterol levels were controlled by statin treatment, but TG levels of 200 to 500mg/dL were randomly assigned 1:1 to the OMEGA3 (1000mg twice a day) group or DCHT (1 pack (3g) three times a day) group for 12 weeks. The primary endpoint was defined as the percentage change of TG at 12 weeks compared to the baseline, and changes in other lipid profiles and endothelial cell function by reactive hyperemic index (RHI) were included as secondary endpoints. Safety analyses were also performed.
The baseline characteristics were similar in both groups. In the OMEGA3 group, the average TG level decreased from 294.4 (71.9) to 209.9 (107.8) mg/dL (p = 0.004), and in the DCHT group, from 288.7 (59.0) to 227.5 (98.0) mg/dL (p = 0.001). The percentage change of TG was − 27.5 and − 22.4 (p = 0.575), respectively, and there was no significant difference between the both groups. LDL cholesterol in the OMEGA3 group decreased from 88.6 (21.7) to 80.8 (17.5) mg/dL (p = 0.049), and from 86.1 (21.5) to 82.8 (15.4) mg/dL (p = 0.406) in the DCHT group. The difference was not significant. RHI also showed no significant change at the baseline and end of treatment, from 1.588 to 1.764 in the OMEGA3 group and from 1.901 to 1.858 in the DCHT group. There were no severe adverse events in both groups, and at 12 weeks, there was one patient in each group whose LFT increased more than twice compared to baseline.
In high-risk, statin-treated patients with residual hypertriglyceridemia, administration of OMEGA3 or DCHT for 12 weeks showed a significant reduction in TG, and the effect of DCHT was not inferior to OMEGA3.
The study protocol was approved by the Ethics Review Board of Kyung Hee University Hospital (KHUH 2019-07-035-003), and the study was conducted in accordance with the principles of the Declaration of Helsinki.