Lee Boram, Kwon Chan-Young
Clinical Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon 34054, Republic of Korea.
Department of Oriental Neuropsychiatry, Dong-eui University College of Korean Medicine, 62 Yangjeong-ro, Busanjin-gu, Busan 47227, Republic of Korea.
Evid Based Complement Alternat Med. 2020 Sep 9;2020:9101864. doi: 10.1155/2020/9101864. eCollection 2020.
For situations in which effective and safe natural-derived products to treat hypertension are needed, recent studies suggest that an herbal medicine, Sihogayonggolmoryeo-tang (SYM), can improve both hypertension and concurrent mood symptoms. We aimed to evaluate the effectiveness and safety of SYM in treating hypertension.
Thirteen English, Korean, and Chinese databases were comprehensively searched from their inception to May 2020. Randomized controlled trials (RCTs) using SYM as a monotherapy or adjunctive therapy for hypertension were evaluated. The primary outcome was the systolic and diastolic blood pressure (BP). Descriptive analyses of the relevant data were conducted, and where appropriate data were available, a meta-analysis was performed, and the results were presented as a risk ratio or mean difference with 95% confidence intervals. 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.
Seven RCTs with 711 participants were included. Compared with placebo, SYM significantly lowered systolic and diastolic BP and concurrent depression. SYM significantly lowered systolic and diastolic BP compared with active controls; however, subgroup analysis revealed no differences between SYM and antihypertensives. In addition, SYM significantly decreased the level of concurrent depression compared with antidepressants. There was no consistent difference in BP reduction between SYM combined with antihypertensives and antihypertensives alone. No serious adverse events were reported following SYM administration. Most of the included studies had an unclear risk of bias, and the quality of evidence was generally rated "low."
Current evidence suggests that SYM may have the potential to lower hypertension and concurrent depressive symptoms without serious adverse events. Additional high-quality, placebo-controlled RCTs should be conducted to confirm the efficacy of SYM.
对于需要有效且安全的天然衍生产品来治疗高血压的情况，近期研究表明，一种草药四和加用五苓汤（SYM）可改善高血压及并发的情绪症状。我们旨在评估SYM治疗高血压的有效性和安全性。
全面检索了13个英文、韩文和中文数据库，检索时间从建库至2020年5月。对使用SYM作为高血压单一疗法或辅助疗法的随机对照试验（RCT）进行评估。主要结局是收缩压和舒张压（BP）。对相关数据进行描述性分析，在有合适数据的情况下进行荟萃分析，结果以风险比或平均差及95%置信区间表示。使用Cochrane偏倚风险工具评估偏倚风险，采用推荐分级、评估、制定与评价（GRADE）方法评估证据质量。
纳入了7项RCT，共711名参与者。与安慰剂相比，SYM显著降低了收缩压和舒张压以及并发的抑郁症状。与活性对照相比，SYM显著降低了收缩压和舒张压；然而，亚组分析显示SYM与抗高血压药物之间无差异。此外，与抗抑郁药相比，SYM显著降低了并发抑郁的水平。SYM联合抗高血压药物与单独使用抗高血压药物在降低血压方面没有一致的差异。服用SYM后未报告严重不良事件。大多数纳入研究的偏倚风险不明确，证据质量总体评为“低”。
目前的证据表明，SYM可能有降低高血压及并发抑郁症状的潜力，且无严重不良事件。应开展更多高质量、安慰剂对照的RCT以证实SYM的疗效。
