OBJECTIVE To study the clinical efficacy of Professor Li Bingmao's Tongfu Xiere Quyu Shuli Prescription in the treatment of patients with functional dyspepsia (FD) of spleen and stomach damp-heat and qi stagnation and blood stasis type.

METHODS A total of 206 patients with functional dyspepsia of spleen and stomach damp-heat and qi stagnation and blood stasis type diagnosed by Hengshui People's Hospital were included in the study and randomly divided into a study group and a control group with 103 cases in each group. During the treatment, 3 cases dropped out in each group. The control group adopted the conventional Western medicine treatment plan for functional dyspepsia (mosapride + rabeprazole), and the study group took Tongfu Xiere Quyu Shuli Prescription on the basis of the treatment of the control group. The treatment course of both groups was 4 weeks. The traditional Chinese medicine (TCM) syndrome scores, psychological status, and quality of life of the two groups of patients before and after treatment were observed and the clinical efficacy was evaluated; serum motilin (MTL), ghrelin, gastrin (GAS), corticotropin-releasing hormone (CRH) and pepsinogen (PG Ⅰ, PG Ⅱ) were measured by enzyme-linked immunosorbent assay; changes in gastric motility indexes were analyzed by electrogastrogram analyzer; changes in intestinal flora were detected by instillation method. The occurrence of adverse reactions in the two groups of patients was monitored during treatment.

RESULTS After treatment, the TCM syndrome scores of the two groups were significantly reduced (P < 0.05, P < 0.01), and the score in the study group was lower than that in the control group (P < 0.01). The total effective rate of the study group was significantly higher than that in the control group (P < 0.01). After treatment, the expression levels of MTL, Ghrelin, GAS, PG Ⅰ and PG Ⅱ in the two groups increased, and CRH decreased, and the improvement degree of the study group was better than that of the control group (P < 0.01). After treatment, the main frequency and slow wave percentage of the electrogastrogram increased in the two groups, and the study group was better than that of the control group (P < 0.01). After treatment, the number of bifidobacteria and lactobacilli in the two groups increased, and the number in the study group was greater than that in the control group, while the number of enterobacteria, enterococci and yeast decreased, and the number in the study group was less than that in the control group (P < 0.01). There was no significant difference in adverse reactions between the two groups (P>0.05).

CONCLUSION Tongfu Xiere Quyu Shuli Prescription is effective in the treatment of FD patients with spleen and stomach damp-heat syndrome, and can improve FD clinical symptoms, quality of life, anxiety and depression symptoms, regulate gastrointestinal hormone expression levels, gastric motility and intestinal flora expression, and does not increase adverse reactions, and is safe and reliable.