https://orcid.org/0000-0002-0025-1315
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Abstract
Purpose
The aim of this study was to verify the effectiveness and explore the mechanism of Chaihu-Guizhi-Ganjiang decoction (CGGD) in the treatment of chronic non-atrophic gastritis (CNAG) with gallbladder heat and spleen cold syndrome (GHSC) by metabolomics based on UHPLC-Q-TOF/MS.
Patients and Methods
An observational controlled before-after study was conducted to verify the effectiveness of CGGD in the treatment of CNAG with GHSC from January to June 2023, enrolling 27 patients, who took CGGD for 28 days. 30 healthy volunteers were enrolled as the controls. The efficacy was evaluated by comparing the traditional Chinese medicine (TCM) syndrome and CNAG scores, and clinical parameters before and after treatment. The plasma levels of hormones related to gastrointestinal function were collected by ELISA. The mechanisms of CGGD in the treatment of CNAG with GHSC were explored using a metabolomic approach based on UHPLC-Q-TOF/MS.
Results
Patients treated with CGGD experienced a statistically significant improvement in TCM syndrome and CNAG scores (p < 0.01). CGGD treatment evoked the concentration alteration of 15 biomarkers, which were enriched in the glycerophospholipid metabolism, and branched-chain amino acids biosynthesis pathways. Moreover, CGGD treatment attenuated the abnormalities of the gastrointestinal hormone levels and significantly increased the pepsinogen level.
Conclusion
It was the first time that this clinical trial presented detailed data on the clinical parameters that demonstrated the effectiveness of CGGD in the treatment of CNAG with GHSC patients. This study also provided supportive evidence that CNAG with GHSC patients were associated with disturbed branched-chain amino acid metabolism and glycerophospholipid levels, suggesting that CNAG treatment based on TCM syndrome scores was reasonable and also provided a potential pharmacological mechanism of action of CGGD.
Graphical Abstract
Abbreviations
ACTH, adrenocorticotropic hormone; BCAA, branched-chain amino acids; BBB, blood-brain barrier; CGGD, Chaihu Guizhi Ganjiang Decoction; CNAG, chronic non-atrophic gastritis; COX-2, cyclooxygenase-2; CRF, corticotropin-releasing factor; DAG, diacylglycerol; ESI, electrospray ion source; FC, fold change; HPA axis, hypothalamic-pituitary-adrenal axis; iNOS, inducible nitric-oxide synthase; IP3, inositol triphosphate; KMO, kynurenine-3-monooxygenase; LAT1, Large Neutral Amino Acid Transporter 1; LNAA, large neutral amino acids; LPS, lipopolysaccharide; m/z, mass-to-charge ratio; NO, nitric oxide; OPLS-DA, orthogonal partial least squares discriminant analysis; PC, phosphatidylcholine; PCA, principal component analysis; PGE, prostaglandin E; QC, quality control; QUIN, quinolinic acid; RSD, relative standard deviation; RT, retention time; SSA, Saikosaponin A; TCM, traditional Chinese medicine; TEI, therapeutic effect index; TIC, total ion chromatograms; UHPLC-Q-TOF/MS, ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometer; VIP, variable importance projection; 3-HK, 3-hydroxy-kynurenine; 5-HIAA, 5-hydroxyindole acetic acid; 5-HT, serotonin.
Data Sharing Statement
The data generated in this study are available from the corresponding author upon request.
Ethics Approval and Informed Consent
The protocol of this study was approved by the Biomedical Research Ethics Committee of Shanghai Changzheng Hospital (Ethical Approval No. 2019SL033) and registered at the Chinese Clinical Trial Registry (ChiCTR2200066224). Written informed consent was signed by all the study participants.
Consent for Publication
All data sources and individual person’s datum submitted were accepted for publication.
Acknowledgments
The authors thank all the subjects who participated in this study. The clinical trial was supported by Guangdong Yifang Pharmaceutical Co., LTD., which offered the trial drugs.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.