Efficacy and Safety of Chinese Herbal Medicine Compared With Losartan for Mild Essential Hypertension: A Randomized, Multicenter, Double-Blind, Noninferiority Trial
单位：[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.).
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.
基金：
Chengdu Kanghong Pharmaceutical Group Co, Ltd, Chengdu, China
第一作者单位：[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