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CC BY 4.0 · Chinese medicine and natural products 2024; 04(03): e106-e116
DOI: 10.1055/s-0044-1790289
Original Article

Multicenter Clinical Randomized Controlled Trial and Network Pharmacology Analysis of Zhenzhu Qingyuan Granules for the Treatment of Gastroesophageal Reflux Disease

Mengge Li
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Zhibo Dang
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Peiguo Qian
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Zhenhuan Yang
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Lei Luo
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Bo Li
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Xingzhou Xia
2   Department of Gastroenterology, the Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
,
Yingjie Ma
3   Department of Gastroenterology, the Fifth People's Hospital of Zhengzhou, Zhengzhou, Henan, China
,
Zhongqin Dang
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
,
Yuliang Wang
1   The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, Henan, China
› Author Affiliations Funding National Administration of Traditional Chinese Medicine Evidence-Based Capacity Building Project (2019XZZX-XH005), Special Project on Traditional Chinese Medicine Scientific Research of Health Commission of Henan Province (2022ZY2022), Henan Provincial Top Talents Cultivation Project in Traditional Chinese Medicine Discipline of Henan Provincial Traditional Chinese Medicine Inheritance and Innovation Talents Project (Zhongjing Project) (Henan Health Traditional Medicine Letter [2021] No. 15), and Special Project on Traditional Chinese Medicine Scientific Research of Health Commission of Henan Province (2023ZY2062).
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Abstract

Objective To evaluate the clinical efficacy and safety of Zhenzhu Qingyuan Granules through a clinical randomized controlled trial and to analyze the potential action targets and pathways of this formula using network pharmacology.

Methods Patients with gastroesophageal reflux disease (GERD) of liver–stomach stagnant heat pattern who met the inclusion and exclusion criteria were randomly divided into the control group and the observation group. The control group received oral rabeprazole, whereas the observation group were given Zhenzhu Qingyuan Granules in addition to the rabeprazole. The treatment duration was 8 weeks. Clinical efficacy was observed in both groups after 8 weeks. Network pharmacology was used to analyze the action targets of Zhenzhu Qingyuan Granules and the genes related to GERD, and core targets were inferred. Gene Ontology and Kyoto Encyclopedia of Genes and Genomes enrichment analyses were conducted to explore the potential mechanisms of this formula.

Results The clinical research results showed that the total effective rate in the treatment group was 92.68%, compared with 70.00% in the control group, with a statistically significant difference (p < 0.05). After treatment, both Chinese medicine syndrome score and endoscopic score improved in both groups compared with before treatment (p < 0.05), and the treatment group showed greater improvement than the control group (p < 0.05). Network pharmacology identified effective components of Zhenzhu Qingyuan Granules for treating GERD, including quercetin, luteolin, and β-sitosterol, with potential action targets such as tumor protein 53 (TP53), protein kinase B (AKT1), and tumor necrosis factor.

Conclusion Zhenzhu Qingyuan Granules can significantly improve clinical symptoms in patients with GERD of liver–stomach stagnated heat pattern, enhance clinical efficacy, and have high safety. This formula may exert therapeutic effects through multiple targets and pathways.

Keywords

gastroesophageal reflux disease - Zhenzhu Qingyuan Granules - liver–stomach stagnated heat syndrome - randomized controlled trial - network pharmacology

CRediT Authorship Contribution Statement

Mengge Li: methodology, investigation, and writing-original draft. Zhibo Dang: methodology and writing-original draft. Peiguo Qian: project administration, investigation, and resources. Zhenhuan Yang and Lei Luo: formal analysis. Bo Li, Xingzhou Xia, and Yingjie Ma: investigation and resources. Zhongqin Dang and Yuliang Wang: conceptualization, resources, and writing-review and editing.




Publication History

Received: 11 April 2024

Accepted: 19 June 2024

Article published online:
30 September 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
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