Clinical Medicine Division, Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon.
Department of Oriental Neuropsychiatry, Dong-eui University College of Korean Medicine, Busanjin-gu, Busan, Republic of Korea.
Medicine (Baltimore). 2020 Dec 18;99(51):e23367. doi: 10.1097/MD.0000000000023367.
Recent experimental and clinical studies have suggested that Hwangryunhaedok-tang (HHT), an herbal formula, could improve the lipid profiles in patients with dyslipidemia. This systematic review aimed to evaluate the effectiveness and safety of HHT monotherapy or adjunctive HHT therapy with conventional lipid-lowering drugs in managing dyslipidemia.
Twelve English, Korean, Chinese, and Japanese databases were comprehensively searched from their inception to January 2020. Randomized controlled trials (RCTs) using HHT monotherapy or adjunctive HHT therapy for dyslipidemic patients were included. The primary outcome was the low-density lipoprotein cholesterol (LDL-C) level. Descriptive analyses of participant details, interventions, and outcomes were conducted and where appropriate data were available, a meta-analysis was performed and presented as a risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). The risk of bias was assessed using the Cochrane risk of bias tool and the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
Nine RCTs with 536 participants were included. In comparison with lipid-lowering drugs alone, HHT as an adjunctive therapy to lipid-lowering drugs or as a monotherapy showed significantly superior (MD -1.15 mmol/L, 95% CI -1.25 to -1.05) or inferior results (MD 0.23 mmol/L, 95% CI 0.09 to 0.38), respectively, for LDL-C levels. The incidence of adverse events was significantly lower when HHT was used in addition to lipid-lowering drugs, in comparison to that with lipid-lowering drugs alone. No serious adverse events were reported in the HHT group. Most included studies showed a high risk of performance bias and the quality of evidence was rated generally "low" because of the high risk of bias and inconsistency or imprecision of the meta-analysis results.
Current evidence suggests that HHT may be beneficial for patients with dyslipidemia and may reduce the adverse events associated with lipid-lowering drugs. However, due to the high risk of bias of the included studies and low quality of evidence for the main findings, no definitive conclusion could be reached. Further rigorous, high-quality, and placebo-controlled RCTs should be conducted to assess the efficacy of HHT.
PROSPERO CRD42020164563.
最近的实验和临床研究表明，黄莲解毒汤（HHT）作为一种草药配方，可以改善血脂异常患者的血脂谱。本系统评价旨在评估 HHT 单药治疗或联合降脂药物辅助 HHT 治疗血脂异常的疗效和安全性。
全面检索了从创建到 2020 年 1 月的 12 个英文、韩文、中文和日文数据库。纳入使用 HHT 单药治疗或联合降脂药物治疗血脂异常患者的随机对照试验（RCT）。主要结局指标为低密度脂蛋白胆固醇（LDL-C）水平。对参与者详情、干预措施和结局进行描述性分析，在适当的情况下进行荟萃分析，并以风险比（RR）或均数差（MD）表示，置信区间（CI）为 95%。使用 Cochrane 偏倚风险工具评估偏倚风险，并使用 Grading of Recommendations Assessment, Development, and Evaluation（GRADE）方法评估证据质量。
纳入了 9 项 RCT 研究，共 536 名参与者。与单独使用降脂药物相比，HHT 作为降脂药物的辅助治疗或单药治疗，分别显著改善（MD-1.15mmol/L，95%CI-1.25 至-1.05）或降低（MD0.23mmol/L，95%CI0.09 至 0.38）LDL-C 水平。与单独使用降脂药物相比，HHT 联合降脂药物使用时，不良反应的发生率显著降低。HHT 组未报告严重不良事件。大多数纳入的研究显示出高偏倚风险，由于偏倚风险高以及荟萃分析结果不一致或不精确，证据质量总体被评为“低”。
目前的证据表明，HHT 可能对血脂异常患者有益，并可能降低与降脂药物相关的不良反应。然而，由于纳入研究的高偏倚风险和主要发现的证据质量低，因此无法得出明确的结论。应进行进一步严格、高质量、安慰剂对照的 RCT 以评估 HHT 的疗效。
PROSPERO CRD42020164563。
