دورية أكاديمية
Efficacy and safety of Qingda granule versus valsartan capsule in Chinese grade 1 hypertensive patients with low-moderate risk: A randomized, double-blind, double dummy, non-inferiority, multi-center trial.
| العنوان: | Efficacy and safety of Qingda granule versus valsartan capsule in Chinese grade 1 hypertensive patients with low-moderate risk: A randomized, double-blind, double dummy, non-inferiority, multi-center trial. |
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| المؤلفون: | Qu H; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China; National Cardiovascular Clinical Medical Research Center of Traditional Chinese Medicine, China., Shen AL; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, China; Fujian Key Laboratory of Integrative Medicine on Geriatrics, Fujian University of Traditional Chinese Medicine, China., Yang K; Beijing Jiaotong University, China., Huang MY; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China; National Cardiovascular Clinical Medical Research Center of Traditional Chinese Medicine, China., Li HZ; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China., Yang WW; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China., Fan SY; Beijing Jiaotong University, China., Tan L; The Eighth Affiliated Hospital of Sun Yat-sen University, China., Wang J; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China., Peng YX; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China., Chu JF; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, China; Fujian Key Laboratory of Integrative Medicine on Geriatrics, Fujian University of Traditional Chinese Medicine, China., Peng J; Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, China; Fujian Key Laboratory of Integrative Medicine on Geriatrics, Fujian University of Traditional Chinese Medicine, China., Fu CG; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China; National Cardiovascular Clinical Medical Research Center of Traditional Chinese Medicine, China. Electronic address: fucgbs@163.com., Long LZ; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China. Electronic address: qixiang830803@163.com., Chen KJ; Xiyuan Hospital, China Academy of Chinese Medical Sciences, China; National Cardiovascular Clinical Medical Research Center of Traditional Chinese Medicine, China. |
| المصدر: | Pharmacological research [Pharmacol Res] 2024 Feb; Vol. 200, pp. 107052. Date of Electronic Publication: 2024 Jan 04. |
| نوع المنشور: | Equivalence Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8907422 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-1186 (Electronic) Linking ISSN: 10436618 NLM ISO Abbreviation: Pharmacol Res Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oct. 2015- : Amsterdam ; Elsevier Original Publication: London ; San Diego : Academic Press, c1989- |
| مواضيع طبية MeSH: | Antihypertensive Agents*/adverse effects , Drugs, Chinese Herbal* , Hypertension*, Humans ; Blood Pressure ; China ; Double-Blind Method ; Tetrazoles/adverse effects ; Valsartan/adverse effects |
| مستخلص: | Background: The efficacy and safety of Qingda granule (QDG) in managing blood pressure (BP) among grade 1 hypertensive patients with low-moderate risk remain uncertain. Methods: In the randomized, double-blind, double dummy, non-inferiority and multicenter trial, 552 patients with grade 1 hypertension at low-moderate risk were assigned at a ratio of 1:1 to receive either QDG or valsartan for 4 weeks, followed up by a subsequent 4 weeks. Results: Post-treatment, clinic systolic/diastolic BPs (SBP/DBP) were reduced by a mean change of 9.18/4.04 mm Hg in the QDG group and 9.85/5.05 mm Hg in the valsartan group (SBP P = 0.47, DBP P = 0.16). Similarly, 24-hour, daytime and nighttime BPs were proportional in both groups (P > 0.05) after 4 weeks treatment. After discontinuing medications for 4 weeks, the mean reduction of clinic SBP/DBP were 0.29/0.57 mm Hg in the QDG group compared to -1.59/-0.48 mm Hg in the valsartan group (SBP P = 0.04, DBP P = 0.04). Simultaneously, the 24-hour SBP/DBP were reduced by 0.9/0.31 mm Hg in the QDG group and -1.66/-1.08 mm Hg in the valsartan group (SBP P = 0.006, DBP P = 0.02). And similar results were observed regarding the outcomes of daytime and nighttime BPs. There was no difference in occurrence of adverse events between two groups (P > 0.05). Conclusion: QDG proves to be efficacious for grade 1 hypertension at a low-to-medium risk, even after discontinuation of the medication for 4 weeks. These findings provide a promising option for managing grade 1 hypertension and suggest the potential for maintaining stable BP through intermittent administration of QDG. Trial Registration: ChiCTR2000033890. Competing Interests: Declaration of Competing Interest The authors declare that the study was conducted in the absence of any business or financial relationships that could be construed as potential conflicts of interest. (Copyright © 2024. Published by Elsevier Ltd.) |
| فهرسة مساهمة: | Keywords: Adverse event; Blood pressure; Grade 1 hypertension; Qingda granule |
| المشرفين على المادة: | 0 (Antihypertensive Agents) 0 (Drugs, Chinese Herbal) 0 (qingda granules) 0 (Tetrazoles) 80M03YXJ7I (Valsartan) |
| تواريخ الأحداث: | Date Created: 20240105 Date Completed: 20240215 Latest Revision: 20240215 |
| رمز التحديث: | 20240216 |
| DOI: | 10.1016/j.phrs.2023.107052 |
| PMID: | 38181857 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1096-1186 |
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| DOI: | 10.1016/j.phrs.2023.107052 |