| ObjectiveIn this study,a prospective randomized controlled trial was conducted to evaluate the clinical effectiveness,efficacy,and improvement of clinical syndrome scores,anxiety and depression,quality of life,and gastrin-17 levels in patients with asthenic functional dyspepsia of the spleen and stomach treated with Guizhi plus Shaoyao decoction,which was proved to have significant clinical effects in the treatment of this disease,as well as improving the negative mood and the quality of life of patients,and providing a reference for the dialectical use of TCM in the treatment of functional dyspepsia.MethodsA total of 66 patients with splenic asthenic functional dyspepsia who met the diagnostic criteria of the study design,which consisted of the outpatients or inpatients of the Department of Gastroenterology in Foshan Chinese medicine hospital between February 2022 and December 2022,and who met the diagnostic and exclusion criteria of the study design,were sequentially numbered from 1 to 66 in order of the visiting time.We divided them into a control group(western medicine group)and a test group(Guizhi plus Shaoyao Decoction)by using a random number table,each of them had 33 patients.Patients in the two groups were given general condition collection and healthy life preaching.In the control group,33 patients were given mosapride citrate tablets(Fujian Haixi new drug creation Co.,Ltd.,Sinopharm h20203264)orally,1 tablet per time,3 times a day,and Compound azinamide enteric coated tablets(Yangzhou Yiyang Pharmaceutical Co.,Ltd.,Sinopharm h20000232)2 tablets per time,3 times a day for 2 weeks.In the test group,33 patients were treated with Guizhi plus Shaoyao Decoction,which increased and decreased with symptoms,1 dose a day,decocted with water and took 300 ml of the medicine juice,taken two times in morning and night,150 ml each time,for 2 weeks.After the 2-week treatment,we observed and compared the clinical effective rate,TCM syndrome score,anxiety and depression score,quality of life level,and improvement of gastrin-17 level between two groups before and after treatment.Finally,we analyzed the obtained clinical data statistically by using SPSS 25.0.Results1.Comparison of the overall response rate:After the end of the 2-week course,compared with before treatment,it showed that90.63% overall response rate in the test group while 74.19% in the control group,which manifested that the efficacy of the test group was significantly better than that of the control group,and the difference in efficacy between the groups was statistically significant(P < 0.01).2.TCM syndrome total points and single item scores versus each other:The aggregate score of the syndrome in both groups were lower than before treatment,with significant differences(P < 0.05),and each single item had a lower score after treatment(P < 0.05),in which the test group showed better improvement than the control group for the symptoms of epigastralgia or fullness,predilection for warmth,fatigue and weakness,lack of temperature in hands and feet,and loose stools(P < 0.05).However,in terms of alleviating the three single symptoms of postprandial fullness,eructation nausea and desire to retching,and loss of appetite,the two treatment groups showed comparable efficacy(P > 0.05).3.Comparison of scores of anxiety and depression scale:Compared with before treatment,the anxiety and depression of the people in the test group and the control group were both improved(P < 0.05),in which the score of the test group were significantly lower than the control group(P < 0.05).4.Comparison of the total score of life quality evaluation:The total score of life quality in FD patients in both groups were increased after they accepted the treatment(P < 0.01).The comparison between post-treatment groups showed that patients in the test group performed better improvement in QOL than the control group(P < 0.05).5.Comparison of gastrin-17 levels:After 2-week course ended,gastrin-17 levels in both groups decreased more than before treatment(P < 0.05),and the statistical data showed that the patients in test group had a lower level than in the control group,in which some patients with lower gastrin-17 levels in the test group had increased more than before treatment,indicating the modulation of gastrin-17 in patients by the addition of Guizhi plus Shaoyao decoction.6.Patients in both groups did not experience hepatic and renal impairment or adverse drug reactions during the period when they received the drug.ConclusionsThe clinical efficacy of Guizhi plus Shaoyao Decoction added flavor in the treatment of functional dyspepsia with asthenic spleen and stomach is exact,it shows significantly superior to the control group in the total effective rate of treatment,clinical symptoms,gastrin-17 levels,anxiety and depression,and quality of life improvement.And no serious adverse reactions occurred during the treatment of patients in both groups,indicating that the clinical safety of the addition of Guizhi plus Shaoyao decoction is good,which deserves clinical application and promotion. |