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Xinxing Lai # 1 2 3, Zhenyu Dong # 4, Shengxian Wu 2, Xiaohua Zhou 5 6, Genming Zhang 2, Shangquan Xiong 7, Wei Wu 8, Rui Cao 4, Xiaolong Wang 9, Qi Hua 10, Jinhang Du 11, Jinying Fan 12, Jingyuan Mao 13, Weimin Jiang 1 14, Huishu Yuan 15, Yushan Chen 16, Yong Xu 17, Zhanquan Li 18, Jun Zhang 19, Guiying Dong 20, Hui Zhen 21, Ru Ding 22, Zonggui Wu 22, Ying Gao 1 2
Affiliations
1Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China (X.L., Y.G.).
2Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (X.L., S.W., G.Z., Y.G.).
3Institute for TCM-X, MOE Key Laboratory of Bioinformatics/Bioinformatics Division, BNRIST, Department of Automation, Tsinghua University, Beijing, China. (X.L.).
4Department of Traditional Chinese Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China (Z.D., R.C.).
5Department of Biostatistics, Beijing International Center for Mathematical Research, Peking University, China (X.Z.).
6Department of Biostatistics, School of Public Health, Peking University, Beijing, China (X.Z.).
7Department of Cardiology, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, China (S.X.).
8Department of Cardiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China (W.W.).
9Department of Cardiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China (X.W.).
10Department of Cardiology, Xuanwu Hospital, Capital Medical University, Beijing, China (Qi Hua).
11Department of Cardiology of Integrated Chinese and Western Medicine, China-Japan Friendship Hospital, Beijing, China (J.D.).
12Department of Cardiology, Yantaishan Hospital, Yantai, China (J.F.).
13Department of Cardiology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China (J.M.).
14Department of Cardiology, Jiangsu Province Hospital of TCM, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China (W.J.).
15Department of Cardiology, The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China (H.Y.).
16Department of Cardiology, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, China (Y.C.).
17Department of Cardiovascular Medicine, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China (Y.X.).
18Department of Cardiology, People's Hospital of Liaoning Province, Shenyang, China (Z.L.).
19Department of Cardiology, Chengdu First People's Hospital, Chengdu, China (J.Z.).
20Department of Hypertension, Jinan Hospital of Traditional Chinese Medicine, Jinan, China (Guiying Dong).
21Technical Center for Drug Research and Evaluation, China Association of Traditional Chinese Medicine, Beijing, China (H.Z.).
22Department of Cardiology, Shanghai Changzheng Hospital, The Second Military Medical University, Shanghai, China (R.D., Z.W.).
#Contributed equally.
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.
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.
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.
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.
URL: www.chictr.org.cn; Unique identifier: ChiCTR-IPR-16008108.
Research
