LDL cholesterol-lowering effect of Daeshiho-tang in patients with dyslipidemia: A pilot randomized, double-blind, placebo-controlled trial

Dyslipidemia, a major risk factor for atherosclerotic cardiovascular disease, can be prevented by lowering low-density lipoprotein cholesterol (LDL-C) levels. The lipid improvement effects of Daeshiho-tang (DSHT), a herbal formula, have been proven through various preclinical studies based on anti-obesity and anti-inflammatory properties, however, clinical trials were few. This preliminary study aimed to assess the lipid-lowering effect of DSHT in patients with dyslipidemia and examine its safety profile. The study was a randomized, double-blind, placebo-controlled trial. The trial included 60 patients with untreated dyslipidemia: total cholesterol (TC) > 200 mg/dL, triglyceride (TG) > 150 mg/dL, LDL-C >130 mg/dL, or high-density lipoprotein cholesterol (HDL-C) <40 mg/dL. Participants (mean age, 44.7 ± 13.7 years) consumed DSHT extract or an equivalent placebo at a dose of 3 g, thrice a day for 8 weeks. Participants underwent blood tests assessing serum lipid and apolipoprotein (apo) levels, including LDL-C, HDL-C, TC, TG, apoA1, and apoB, at baseline and 4 and 8 weeks. Levels of biochemical safety markers, including AST, ALT, GGT, creatinine, and eGFR, were assessed throughout the study. Between the two groups, significant differences were observed in the changes of LDL-C, TC, and apoB concentrations from baseline to post-intervention. Compared with the placebo group, DSHT-administered participants showed significantly reduced LDL-C by 14.0 ± 4.66 mg/dL (p < 0.01), TC by 13.7 ± 4.73 mg/dL (p < 0.01) and apolipoprotein-B by 7.03 ± 3.23 mg/dL (p < 0.05). No significant changes were observed in the safety biochemical parameters in either group. DSHT treatment for 8 weeks improved LDL-C levels and reduced apoB concentrations without severe adverse events.