Efficacy and safety of Qiangli Dingxuan tablet combined with amlodipine besylate for essential hypertension: a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial

Frontiers in Pharmacology

Pharmacology

Yue Deng¹  Shuangdi Li¹  Shaoxiang Xian²  Hui Wu²  Tianhui Yuan²  Bin Li³  Xingjiang Xiong⁴  Dongsheng Zhong⁴  Jinju Zhang⁴  Qingqing Wang⁴  Kuiwu Yao⁵  Jianguo Lin⁶  Xiaoliu Xie⁷  Dongqing An⁷ 

[1] Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China;First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China;First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China;Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China;Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China;Eye Hospital China Academy of Chinese Medical Sciences, Beijing, China;Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China;Tianjin University of Traditional Chinese Medicine, Tianjin, China;Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China;

关键词: traditional Chinese medicine;    Qiangli Dingxuan tablet;    hypertension;    randomized controlled trial;    classic herbal formula;    integrated traditional Chinese and western medicine;   

DOI  :  10.3389/fphar.2023.1225529

 received in 2023-05-19, accepted in 2023-06-30,  发布年份 2023

来源: Frontiers

【 摘 要 】

Background: Hypertension, a major cardiovascular risk factor, severely impacts patients’ quality of life. Qiangli Dingxuan tablet (QDT) is a formally approved Chinese patent medicine, which has been widely used as an adjunctive treatment for hypertension. This study aimed to investigate the antihypertensive efficacy and safety of QDT combined with amlodipine besylate in patients with essential hypertension.Methods: In this randomized, double-blind, placebo-controlled, parallel-group, multicenter trial conducted in China, patients diagnosed with grade 1 to 2 essential hypertension were randomly assigned in a 1:1 to the treatment of QDT or placebo for 12 weeks, alongside their ongoing treatment with amlodipine besylate. The primary outcome was the change in office blood pressure (BP) from baseline to 12 weeks. In addition, safety analysis included the assessment of vital signs and laboratory values.Results: At baseline, 269 patients were randomly assigned to the QDT group (n = 133) or the placebo group (n = 136), and there were no significant differences in baseline characteristics between the two groups. The primary outcome based on the full analysis set from baseline to 12 weeks showed that the mean difference in the change of office systolic BP reduction between the two groups was 6.86 mmHg (95%CI, 4.84 to 8.88, p < 0.0001), for office diastolic BP, the mean difference in the change of office diastolic BP reduction between the two groups was 4.64 mmHg (95%CI, 3.10 to 6.18, p < 0.0001). In addition, traditional Chinese medicine symptom scores were significantly decreased in the QDT group compared with the placebo group. No severe adverse events attributable to QDT were reported.Conclusion: The combination of QDT and amlodipine besylate demonstrates superior efficacy compared to amlodipine besylate monotherapy in the management of essential hypertension. QDT shows potential as an adjunctive treatment for essential hypertension. However, further rigorous clinical trials are warranted to validate these findings.Clinical Trial Registration: [https://clinicaltrials.gov/study/NCT05521282?cond=NCT05521282&rank=1]; Identifier: [NCT05521282]

【 授权许可】

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Copyright © 2023 Lin, Wang, Zhong, Zhang, Yuan, Wu, Li, Li, Xie, An, Deng, Xian, Xiong and Yao.