Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial

作者：Lai, Xinxing; Dong, Zhenyu; Wu, Shengxian; Zhou, Xiaohua; Zhang, Genming; Xiong, Shangquan; Wu, Wei; Cao, Rui; Wang, Xiaolong; Hua, Qi; Du, Jinhang; Fan, Jinying; Mao, Jingyuan; Jiang, Weimin; Yuan, Huishu; Chen, Yushan; Xu, Yong; Li, Zhanquan; Zhang, Jun; Dong, Guiying; Zhen, Hui; Ding, Ru; Wu, Zonggui^*; Gao, Ying^*

来源：Circulation. Cardiovascular quality and outcomes, 2022, 15(3): E007923.

DOI：10.1161/CIRCOUTCOMES.121.007923

• blood pressure
• hypertension
• losartan
• medicine, Chinese traditional
• randomized controlled trial

BACKGROUND: Hypertension is one of the most challenging public health problems worldwide. Previous studies suggested that the Songling Xuemaikang capsule (SXC)-a Chinese herbal formula-was effective for essential hypertension. However, the efficacy of SXC monotherapy for hypertension remains unclear. We aimed to compare the blood pressure (BP)-lowering efficacy and safety of SXC versus losartan in patients with essential hypertension. @@@ METHODS: In this multicenter, randomized, double-blind, noninferiority trial in China, patients 18 to 65 years of age with mild essential hypertension were randomly allocated to receive either SXC or losartan for 8 weeks. The primary outcome was the change in sitting diastolic BP from baseline to 8 weeks, with a predefined noninferiority margin of -2.5 mm Hg. @@@ RESULTS: Of the 755 patients who entered a 2-week run-in period, 628 patients (327 women and 301 men; mean [SD] age, 52.6 [9.2] years) were randomly assigned to the SXC (n=314) or losartan (n=314) group. The primary analysis based on the intention-to-treat principle showed that the change in diastolic BP from baseline to 8 weeks was similar between the SXC and losartan groups (-7.9 [8.0] versus -8.1 [7.9]). The lower boundary of 95% CI (mean difference, -0.24 [95% CI, -1.51 to 1.03]) was above the margin of -2.5 mm Hg, showing noninferiority. Results were consistent with per-protocol analysis. SXC produced greater improvements in total hypertension symptom score (-5.7 [4.2] versus -5.0 [4.0]; P=0.020) and total cholesterol (-0.1 [1.0] versus 0.1 [1.2]; P=0.025). There were no differences between groups in the other BP and patient-reported outcomes. Incidence and severity of adverse events were similar between groups. @@@ CONCLUSIONS: SXC was well tolerated and demonstrated noninferior to losartan in BP lowering in patients with mild hypertension. SXC might be an alternative for mild hypertension, particularly for patients with a preference for natural medicine.

• 单位
  清华大学; y; 广州中医药大学; 北京大学; 1; 5