AUTHOR=Xu Xuan , Tian Wende , Duan Wenhui , Pan Chaoxin , Huang Mingjian , Wang Qinggao , Yang Qinghua , Wen Zhihao , Tang Yu , Xiong Yao , Zhu Zhiyun , Liu Yuanyuan , Wei Dan , Qi Wenqiang , Ouyang Xiaochao , Ying Shaozhen , Wang Xiaohua , Zhou Zhigang , Li Xiaofeng , Cui Yu , Yang Shuyin , Xu Hao 

TITLE=Quanduzhong capsules for the treatment of grade 1 hypertension patients with low-to-moderate risk: A multicenter, randomized, double-blind, placebo-controlled clinical trial

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 13 - 2022

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1014410

DOI=10.3389/fphar.2022.1014410

ISSN=1663-9812

ABSTRACT=Background: Duzhong (DZ [Eucommia ulmoides Oliv.]) is regarded as a traditional Chinese medicine with a history dating back more than 2000 years. This herb is considered a nourishing herb in China and is commonly used as a tonic to strengthen muscles and bones, nourish the kidneys and liver, and soothe miscarriages. Moreover, there is evidence that DZ is capable of regulating blood pressure (BP), and several compounds isolated from DZ have been shown to have a BP-lowering effect. Quanduzhong capsules contain an extract of DZ that is effective in treating hypertension. This multicenter, randomized, double-blind, placebo-controlled clinical trial sought to evaluate the clinical efficacy of Quanduzhong capsules in the treatment of low-to-moderate risk grade 1 hypertension patients.
Materials and methods: A total of 60 patients from 3 centers with documented low-to-moderate risk grade 1 hypertension were randomly assigned in a 1:1 ratio to the test group or the control group. After a one-week lead-in period using sham Quanduzhong capsules, all patients who met the entry criteria (29 cases in the test group and 29 cases in the control group) entered the 4-week test period. The test group took Quanduzhong capsules, and the control group continued to take sham Quanduzhong capsules.
Results: After a 4-week test period, a significant difference in the DBP CV between the two groups was observed (-2.49±4.32 vs. 0.76±4.3; P<0.05). Moreover, the mean office SBP change was -7.62±9.32 mmHg, and the mean DBP change was -4.66±6.03 (P<0.05). Among the 3 subjects with abnormal homocysteine levels in the test group, homocysteine levels decreased by 6.23±9.15 μmol/L after treatment. No differences were observed between the two groups in any other indicators. After four weeks of treatment, there were no significant differences between the groups in terms of safety indicators (P>0.05). No abnormal vital signs (except BP) or severe liver or renal function impairment were observed during the treatment periods; in addition, adverse events and drug reactions were mild.
Conclusion: Treatment with Quanduzhong capsules reduced office SBP and DBP as well as DBP CV determined by 24-hour ambulatory BP monitoring in patients with grade 1 hypertension at low-to-moderate risk.