Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.
机构：[1]Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China (X.L., Y.G.).[2]Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (X.L., S.W., G.Z., Y.G.).[3]Institute for TCM-X, MOE Key Laboratory of Bioinformatics/Bioinformatics Division, BNRIST, Department of Automation, Tsinghua University, Beijing, China. (X.L.).[4]Department of Traditional Chinese Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China (Z.D., R.C.).北京朝阳医院[5]Department of Biostatistics, Beijing International Center for Mathematical Research, Peking University, China (X.Z.).[6]Department of Biostatistics, School of Public Health, Peking University, Beijing, China (X.Z.).[7]Department of Cardiology, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, China (S.X.).[8]Department of Cardiology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China (W.W.).[9]Department of Cardiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China (X.W.).[10]Department of Cardiology, Xuanwu Hospital, Capital Medical University, Beijing, China (Qi Hua).首都医科大学宣武医院[11]Department of Cardiology of Integrated Chinese and Western Medicine, China-Japan Friendship Hospital, Beijing, China (J.D.).[12]Department of Cardiology, Yantaishan Hospital, Yantai, China (J.F.).[13]Department of Cardiology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China (J.M.).[14]Department of Cardiology, Jiangsu Province Hospital of TCM, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China (W.J.).江苏省人民医院[15]Department of Cardiology, The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China (H.Y.).[16]Department of Cardiology, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, China (Y.C.).[17]Department of Cardiovascular Medicine, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China (Y.X.).[18]Department of Cardiology, People's Hospital of Liaoning Province, Shenyang, China (Z.L.).[19]Department of Cardiology, Chengdu First People's Hospital, Chengdu, China (J.Z.).[20]Department of Hypertension, Jinan Hospital of Traditional Chinese Medicine, Jinan, China (Guiying Dong).[21]Technical Center for Drug Research and Evaluation, China Association of Traditional Chinese Medicine, Beijing, China (H.Z.).[22]Department of Cardiology, Shanghai Changzheng Hospital, The Second Military Medical University, Shanghai, China (R.D., Z.W.).
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. Registration: URL: www.chictr.org.cn; Unique identifier: ChiCTR-IPR-16008108.
第一作者机构：[1]Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China (X.L., Y.G.).[2]Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (X.L., S.W., G.Z., Y.G.).[3]Institute for TCM-X, MOE Key Laboratory of Bioinformatics/Bioinformatics Division, BNRIST, Department of Automation, Tsinghua University, Beijing, China. (X.L.).
通讯作者：
通讯机构：[1]Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China (X.L., Y.G.).[2]Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (X.L., S.W., G.Z., Y.G.).
推荐引用方式(GB/T 7714)：
Lai Xinxing,Dong Zhenyu,Wu Shengxian,et al.Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.[J].CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES.2022,15(3):doi:10.1161/CIRCOUTCOMES.121.007923.
APA：
Lai Xinxing,Dong Zhenyu,Wu Shengxian,Zhou Xiaohua,Zhang Genming...&Gao Ying.(2022).Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial..CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES,15,(3)
MLA：
Lai Xinxing,et al."Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial.".CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES 15..3(2022)
医学