Noh Ji-Won, Lee Byung-Cheol
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea.
Heliyon. 2023 Aug 19;9(8):e19162. doi: 10.1016/j.heliyon.2023.e19162. eCollection 2023 Aug.
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.
血脂异常是动脉粥样硬化性心血管疾病的主要危险因素，降低低密度脂蛋白胆固醇（LDL-C）水平可预防该病。大柴胡汤（DSHT）作为一种中药配方，其改善血脂的作用已通过基于抗肥胖和抗炎特性的各种临床前研究得到证实，但临床试验较少。这项初步研究旨在评估DSHT对血脂异常患者的降脂效果并检查其安全性。该研究是一项随机、双盲、安慰剂对照试验。试验纳入了60例未经治疗的血脂异常患者：总胆固醇（TC）>200mg/dL、甘油三酯（TG）>150mg/dL、LDL-C>130mg/dL或高密度脂蛋白胆固醇（HDL-C）<40mg/dL。参与者（平均年龄44.7±13.7岁）每天三次服用3g DSHT提取物或等效安慰剂，持续8周。参与者在基线、第4周和第8周接受血液检查，评估血清脂质和载脂蛋白（apo）水平，包括LDL-C、HDL-C、TC、TG、apoA1和apoB。在整个研究过程中评估生化安全指标水平，包括谷草转氨酶（AST）、谷丙转氨酶（ALT）、γ-谷氨酰转肽酶（GGT）、肌酐和估算肾小球滤过率（eGFR）。两组之间，从基线到干预后，LDL-C、TC和apoB浓度的变化存在显著差异。与安慰剂组相比，服用DSHT的参与者LDL-C显著降低14.0±4.66mg/dL（p<0.01），TC降低13.7±4.73mg/dL（p<0.01），载脂蛋白B降低7.03±3.23mg/dL（p<0.05）。两组的安全生化参数均未观察到显著变化。DSHT治疗8周可改善LDL-C水平并降低apoB浓度，且无严重不良事件。
