| Objective:1.To assess the clinical efficacy of a traditional Chinese herbal medicine,Xiangsha Liujunzi decoction(XSLJZD),in the treatment of patients with postprandial discomfort syndrome(PDS)of spleen deficiency and qi stagnation syndrome.2.To observe the changes of plasma acyl ghrelin(AG)and motilin(MTL)levels before and after treatment,and to explore the relationship between plasma AG,MTL and PDS.3.To explore the possible mechanism of XSLJZD.Methods:1.This was a randomized,controlled trial,including 72 PDS patients of spleen deficiency and qi stagnation syndrome from February 2019 to January 2020 that were divided traditional Chinese medicine(TCM)treatment group(n=36)and Western medicine control group(n=36).In addition,36 healthy volunteers from the hospital’s physical examination center were taken as the healthy control group.2.Patients in TCM treatment group received oral administration of XSLJZD,and others in the Western medicine control group received Mosapride.The treatment lasted for 4 weeks.3.Collected the general data of the patient’s age,gender,BMI,course of disease,et al.TCM symptoms scores were observed and recorded before and after treatment.The ELISA method was used to detect plasma AG and MTL.Results:1.Comparison of general data: There was no statistically significant difference in age,gender,BMI and course of disease between the two group.2.Comparison of TCM syndrome efficacy: The total effective rate of TCM treatment group was better than that of the western medicine control group(85.3% vs.75.8%,P<0.05).3.Comparison of TCM symptom score: Before treatment,there was no significant difference between the two groups in TCM symptom total scores and single symptom scores(P>0.05).The improvement degree of TCM syndrome total scores in TCM treatment group was better than that in western medicine group(P<0.05).The TCM group was superior to the western medicine control group in relieving symptoms of poor appetite,mental fatigue,shortness of breath,lazy speech,nausea and loose stool(P<0.05),and the two groups had similar effect in improving postprandial fullness,belching and acid regurgitation(P>0.05).4.Comparison of plasma AG and MTL contents: The plasma AG and MTL contents of PDS patients in both groups were lower than those in healthy control group(P<0.01).There was no statistical difference in the two plasma contents between the two groups before treatment(P>0.05).After 4 weeks of treatment,the levels of AG and MTL in both groups were significantly increased(P<0.01),and the levels in TCM group was higher than that in the western medicine group(P<0.05).5.Correlation analysis:The total scores of TCM syndromes of PDS patients with spleen deficiency and qi stagnation before and after treatment was negatively correlated with plasma AG and MTL contents(P<0.05).The single symptoms including postprandial fullness,poor appetite,nausea,eructation and acid regurgitation were all negatively correlated with AG and MTL(P<0.01).In addition,other symptoms such as mental fatigue,shortness of breath and lazy speech,loose stool were not correlated with the two plasma indexes(P>0.05).Thecontent of plasma AG and MTL were positively correlated(P<0.05).In conclusion:1.XSLJZD has a good clinical effect on PDS patients with spleen deficiency and qi stagnation,without obvious adverse reactions.2.Regulating the contents of AG and MTL in plasma may be one of the mechanisms of XSLJZD in treating PDS of spleen deficiency and qi stagnation.3.The levels of plasma AG and MTL in PDS patients with spleen deficiency and qi stagnation were lower than those in healthy volunteers,and were negatively correlated with the severity of symptoms. |