| Objective:To observe the clinical efficacy and safety of Xinsihe decoction with addition and subtraction in the treatment of gastroesophageal reflux disease,and to study its effect on patients’ psychological status and health-related quality of life,so as to provide reference for the clinical treatment of gastroesophageal reflux disease.Methods:1.Thirty-five patients who attended the outpatient clinic of the Department of Splenic and Gastrointestinal Diseases at Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from March 2022 to March 2023 were collected as the experimental group,and 35 patients who attended the outpatient clinic of the Gastroesophageal Reflux Disease Specialist at China-Japan Friendship Hospital during the same period were collected as the control group.Among them,7 cases were not treated according to the agreed protocol,and finally a total of 63 cases were enrolled,30 cases in the test group and 33 cases in the control group.2.The experimental group was treated with Xinsihe decoction plus or minus treatment,and the drug composition was as follows:Zisugeng 12g,Xiangfu 10g,Chenpi 10g,Gancao 6g,Huanglian 6g,Wuzhuyu 3g,Gualou 30g,Xiebai 10g,Fabanxia 10g,Haipiaoxiao 20g,Zhebeimu 12g.The basic formula of Xinsihe decoction was plus or minus with the disease,1 day/dose,decocted in water,morning and evening 200ml each.The control group was given Vonola fumarate tablet,20mg/time,1 time/day,after breakfast.Diet and lifestyle guidance were given to both groups,and the intervention was treated for 4 weeks.The reflux diagnostic questionnaire(RDQ),self-rating anxiety scale(SAS),Self-rating depression scale(SDS),and the MOS item short from health survey(SF-36)were assessed before and after treatment,respectively,and observed for the occurrence of adverse reactions,and the recurrence was recorded at the follow-up visit at week 12 after the end of treatment3.SPSS 22.0 software was used to analyze the data:measurement data were first tested for the type of data distribution,and t-test was used if they obeyed a normal distribution with homogeneous variance,otherwise non-parametric test was used;chi-square test was used for counting data;rank sum test was used for rank data.Results:1.For the comparison of individual symptom scores,there was no statistically significant difference between the two groups in the comparison of each symptom score before and after treatment(P>0.05).There was a statistically significant difference(P<0.05)in the improvement of acid reflux,heartburn and retrosternal pain symptom scores after treatment between the two groups;there was no statistically significant difference(P>0.05)in the improvement of reflux symptom scores.The difference was statistically significant(P<0.05).The difference was not statistically significant(P>0.05)when comparing the improvement of acid reflux symptom scores before and after treatment between the two groups.2.There was no significant difference in RDQ scores between the two groups before and after treatment(P>0.05).RDQ scores in both groups were lower after treatment than before treatment,and the difference was statistically significant(P<0.05).There was no statistical difference in RDQ score difference between the experimental group and the control group before and after treatment(P>0.05).3.In terms of clinical efficacy,the total effective rate of the experimental group was 90.0%,and the total effective rate of the control group was 97.0%.After calculation,there was a statistical difference between the two groups(P<0.05).4.In terms of psychological state,there was no statistically significant difference in S AS and SDS scores between the two groups before treatment(P>0.05),while there was statistically significant difference in SAS and SDS scores after treatment(P<0.01).There was a statistically significant difference(P<0.01)between the two groups in terms of decreased SAS and SDS scores after treatment within the groups.The degree of reduction in SAS and SDS scores before and after treatment in the test group was better than that in the control group,with statistically significant differences(P<0.01).5.In terms of health-related quality of life,there were statistically significant differences in 8 dimensions of SF-36 scale between the two groups before treatment(P>0.05).After treatment in the two groups,there was a statistically significant difference in the scores of the 7 dimensions between the groups,except for the vitality dimension(P<0.01).The scores of 8 dimensions in the experimental group were increased after treatment,and there were statistically significant differences in intra-group comparison(P<0.01).After treatment,in the control group,the scores of the other 6 dimensions were increased except for physiological function and social function,and there was statistically significant difference in intra-group comparison(P<0.01).The degree of increase in the scores of 8 dimensions before and after treatment in the test group was better than that in the control group,except for physical function and social function,and there was a statistically significant difference(P<0.01).6.In terms of recurrence,the recurrence rate of the experimental group was 13.3%,and that of the control group was 23.3%.After calculation,there was a statistical difference between the two groups(P<0.05).7.During the trial,no adverse reactions occurred in either group.Conclusion:The clinical application of Xinsihe decoction in the treatment of GERD has clear curative effect,which can significantly improve clinical symptoms,relieve anxiety and depression,improve health-related quality of life,and reduce the occurrence of relapse.No adverse reactions were observed during the treatment,and the safety is good,worthy of clinical reference. |
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