The Efficacy of Chaihu-Guizhi-Ganjiang Decoction on Chronic Non-Atrophic Gastritis with Gallbladder Heat and Spleen Cold Syndrome and Its Metabolomic Analysis: An Observational Controlled Before-After Clinical Trial.

Tao Pang, Mingming Li, Xiaoqiang Yue, Tao Wen, Wansheng Chen, Xuan Liu, Feng Zhang, Zhipeng Wang, Guangyang Jiao, Xiangcheng Fan, Jigui Tang, Ci'an Zhang

Journal: Drug design, development and therapy 2024;18():881-897

PMID: 38529263

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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.

Address: Department of Pharmacy, Changzheng Hospital, Naval Medical University, Shanghai, People's Republic of China.; Oncology-Department, Shanghai Guanghua Hospital of Integrative Medicine, Shanghai, People's Republic of China.; The SATCM Key Laboratory for New Resources & Quality Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.; Department of Traditional Chinese Medicine, Changzheng Hospital, Naval Medical University, Shanghai, People's Republic of China.; Department of Pharmacy, Changzheng Hospital, Naval Medical University, Shanghai, People's Republic of China.; The SATCM Key Laboratory for New Resources & Quality Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.; Shanghai Key Laboratory for Pharmaceutical Metabolite Research, Shanghai, People's Republic of China.; Department of Pharmacy, Changzheng Hospital, Naval Medical University, Shanghai, People's Republic of China.; Shanghai Key Laboratory for Pharmaceutical Metabolite Research, Shanghai, People's Republic of China.

DOI: 10.2147/DDDT.S446336

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MeSH Terms: Humans, Drugs, Chinese Herbal, Gallbladder, Gastritis, Atrophic, Glycerophospholipids, Hot Temperature, Spleen, Controlled Before-After Studies, Case-Control Studies