| Objective: To observe and verify the efficacy and safety of Xiaopi Shenzhu decoction in the treatment of functional dyspepsia with spleen deficiency and qi stagnation,so as to lay a foundation for expanding clinical use.Methods: 80 enrolled patients were randomly divided into two groups.The observation group was treated with Xiaopi Shenzhu decoction and the control group was treated with Mosapride tablets for 2 weeks.The differences of gender,age,course of disease,the TCM symptom score,the TCM syndrome efficacy,quality of life,mental and psychological status,recurrence rate and safety of subjects in the two groups were compared and analyzed.Results: Before and after treatment,there were statistically significant differences in relevant indicators between the two groups(P<0.05).The observation group was significantly better than the control group in terms of reducing the TCM symptom scores(the total TCM symptom scores,and the single TCM symptom score of abdominal swelling or distending pain,belching and fatigue),HAMA and HAMD index,and increasing NDLQI(P<0.01).The observation group was better than the control group in reducing the TCM symptom score of loose stool(P<0.05).There was no significant difference between the observation group and the control group in terms of reducing the TCM symptom score of anorexia,sallow complexion(P>0.05).The total effective rate in the observation group was 95.00%,which was significantly higher than that in the control group 80.00%(P<0.01).Three months after treatment,the recurrence rate in the observation group was 7.50%,which lower than that in the control group 27.50%(P < 0.05).No adverse reactions or adverse events were reported during the study period in both groups.Conclusion: Xiaopi Shenzhu decoction has definite and safe efficacy in the treatment of FD with spleen deficiency and qi stagnation.Compared with Moxapride tablets,Xiaopi Shenzhu decoction has a better therapeutic effect,which has the advantages of significantly improving the clinical symptoms of patients,improving the quality of life of patients,improving the anxiety and depression of patients,reducing the relapse of patients,high safety and fewer adverse reactions,and is worthy of clinical application. |
