Double-blinded, randomized clinical trial of Gegen Qinlian decoction pinpoints Faecalibacterium as key gut bacteria in alleviating hyperglycemia

• Published in: Precision clinical medicine 2024-03, Vol.7 (1), p.pbae003-pbae003
• Main Authors: Gao, Zezheng, Zhang, Wenhui, He, Lisha, Wang, Han, Li, Yufei, Jiang, Xiaotian, D I, Sha, Wang, Xinmiao, Zhang, Xuan, Han, Lin, Liu, Yanwen, Gu, Chengjuan, Wu, Mengyi, He, Xinhui, Cheng, Lei, Wang, Jun, Tong, Xiaolin, Zhao, Linhua
• Format: Article
• Language: English
• ISSN: 2096-5303; 2516-1571
• DOI: 10.1093/pcmedi/pbae003

Abstract Background Accumulating evidence suggests that metabolic disorders, including type 2 diabetes mellitus (T2DM), can be treated with traditional Chinese medicine formulas, such as the Gegen Qinlian decoction (GQD). This study elucidates the mechanisms by which gut microbes mediate the anti-diabetic effects of GQD. Methods We conducted a double-blind randomized clinical trial involving 120 untreated participants with T2DM. During the 12-week intervention, anthropometric measurements and diabetic traits were recorded every 4 weeks. Fecal microbiota and serum metabolites were measured before and after the intervention using 16S rDNA sequencing, liquid chromatography-mass spectrometry, and Bio-Plex panels. Results Anti-diabetic effects were observed in the GQD group in the human trial. Specifically, glycated hemoglobin, fasting plasma glucose, and two-hour postprandial blood glucose levels were significantly lower in the GQD group than in the placebo group. Additionally, Faecalibacterium was significantly enriched in the GQD group, and the short-chain fatty acid levels were higher and the serum inflammation-associated marker levels were lower in the GQD group compared to the placebo group. Moreover, Faecalibacterium abundance negatively correlated with the levels of serum hemoglobin, fasting plasma glucose, and pro-inflammatory cytokines. Finally, the diabetes-alleviating effect of Faecalibacterium was confirmed by oral administration of Faecalibacterium prausnitzii (DSMZ 17677) in T2DM mouse model. Conclusions GQD improved type 2 diabetes primarily by modulating the abundance of Faecalibacterium in the gut microbiota, alleviating metabolic disorders and the inflammatory state. Trial registration Registry No. ChiCTR-IOR-15006626. Graphical Abstract Graphical Abstract