| Objective:To evaluate the clinical efficacy and safety of xiangsha Liujunzi Decoction combined with acupuncture and moxibustion in the treatment of functional dyspepsia with spleen deficiency and qi stagnation.Methods:A total of 105 FD patients who met the inclusion criteria of this study were randomly divided into treatment group 1(n=35),treatment group 2(n=35)and control group(n=35).The treatment group 1 was treated with Xiangsha Liujunzi Decoction combined with acupuncture and moxibustion and moxabili citrate;treatment group 2 was treated with Xiangsha Liujunzi Decoction plus Moxabili Citrate;control group was treated with Moxabili Citrate alone.The treatment course of all three groups was 4 weeks.At the end of the trial,the TCM single symptom score,TCM total symptom score,HAMA(Hamilton Anxiety Scale)score,safety index and other data of the three groups before and after treatment were summarized and sorted out,and the total effective rate was calculated.The obtained data were analyzed and compared using SPSS26.0 software to evaluate the clinical efficacy and safety of Xiangsha Liujunzi Decoction combined with acupuncture in the treatment of functional dyspepsia with spleen deficiency and qi stagnation.Results:1.Case collection completion: In this study,105 cases were enrolled in the group,and 95 cases were actually enrolled in the group,of which the number of cases in treatment group 1,treatment group 2 and control group were 32,31 and 32 respectively,and the shedding rate was 9.5%.It meets the shedding standard of less than 10% established before the trial.2.General data: Before treatment,the distribution of sex,age,course of disease,TCM single symptom score,TCM syndrome total score and HAMA score of the three groups were statistically analyzed.The results showed that p > 0.05.The difference was not statistically significant and comparable.3.Overall efficacy:The total effective rate of treatment group 1,treatment group 2 and control group was 93.75%,70.97%,62.50%,respectively.The comparison between treatment group 1 and treatment group 2 was p=0.034(< 0.05),and between treatment group 1 and control group was p=0.002(<0.05),the differences were statistically significant.There was no significant difference between treatment group 2 and control group(p=1.000(>0.05)).4.Total score of TCM syndromes: The p values of total score of TCM syndromes in the three groups before and after treatment were all less than 0.05,with statistically significant differences.pairwise comparison between groups: p=0.037(< 0.05)between treatment group 1 and treatment group 2,p=0.000(< 0.05)between treatment group 1 and control group,with statistically significant differences.While p=0.350(> 0.05)between treatment group 2 and control group,with no statistically significant difference.5.Single TCM syndrome score: The p values of single TCM score in the three groups before and after treatment were all less than 0.05,and the differences were statistically significant.pairway comparison between groups showed that the p values of treatment group 1,treatment group 2and control group were all less than 0.05 in terms of two main diseases(Epigastric distension or distension pain,postprandial fullness)and three secondary diseases(Belching,Nausea and Vomiting,Loose stool).Compared with the control group,the p value of treatment group1 and treatment group 2 was less than 0.05,and the difference was statistically significant.The p values of the three groups were all greater than 0.05 in terms of the primary symptoms of insufficient eating and lethargy and the secondary symptoms of early satiety,and the difference was not statistically significant.6.HAMA score : The HAMA scores of the three groups before and after treatment were all less than 0.05,and the differences were statistically significant.The pairwise comparison between treatment group 1 and treatment group 2 and control group was 0.000(P<0.05),and between treatment group 2 and control group was 0.004(P<0.05),the difference was statistically significant.7.Safety analysis: A total of 95 patients in the three groups before and after treatment showed vital signs such as body temperature,respiration,blood pressure and heart rate as well as three routine tests of blood,urine and feces,and no significant abnormalities in safety indicators such as liver,kidney function and electrocardiogram,and no obvious adverse reactions during treatment.Conclusion:In terms of overall efficacy,the total effective rate of Xiangsha Liujunzi Decoction combined with acupuncture and moxibustion is better than oral Xiangsha Liujunzi Decoction plus Mosapride Citrate Tablets or Mosapride Citrate Tablets alone;The treatment group 1 was significantly better than the treatment group in terms of improving the total score of TCM symptoms,five TCM single symptoms(epigastric fullness or distending pain,postprandial fullness,belching,nausea and vomiting,loose stools)and HAMA score.2 and the control group,it is stated that5 Mingxiangsha Liujunzi Decoction combined with acupuncture and moxibustion can better relieve the clinical symptoms and regulate bad emotionsstate of the patients than the other two intervention treatments,and the clinical effect is better;during the test period,there was no obvious difference in the three groups.Adverse reactions.The modified Xiangsha Liujunzi Decoction combined with acupuncture and moxibustion has definite curative effect and high safety in the treatment of functional dyspepsia of spleen deficiency and qi stagnation,and is worthy of clinical promotion and application. |