Clinical Efficacy Of Jiawei Sinisan In The Treatment Of Gastroesophageal Reflux Disease Overlapping Functional Dyspepsia Of Disharmony Between Liver-stomach

Objective:This project is based on the clinical treatment experience of our supervisor,Xu Yi,to observe the effects of Jiawei Sinisan combined with Rabeprazole Sodium Enteric-coated Tablets and Rabeprazole Sodium Enteric-coated Tablets on the symptoms,signs and quality of life of patients with the liver and stomach disharmony of gastroesophageal reflux disease overlapping functional dyspepsia(epigastric pain syndrome),to objectively evaluate the clinical effectiveness and safety of Jiawei Sinisan,and to supplement the existing treatment protocols so that patients can have more clinical benefits.Methods:Sixty subjects were randomly divided into two groups of 30 subjects each,and the treatment group was given Jiawei Sinisan combined with Rabeprazole Sodium Enteric-coated Tablets,while the control group was given rabeprazole sodium enteric tablets with a treatment course of 8 weeks.Data were collected on the first day of treatment,2 weeks of treatment,8 weeks of treatment and 4 weeks of drug withdrawal.RDQ integrals,TCM syndrome integrals and SF-36 Quality of Life Questionnaire integrals between the two groups to objectively and comprehensively evaluate the efficacy,safety and long-term efficacy of Jiawei Sinisan in patients with GERD overlapping EPS.Results:1.RDQ integrals:At 2 weeks of treatment,RDQ integrals in both groups decreased significantly compared with the first day of treatment(P<0.01),and there was no difference between groups(P>0.05).At 8 weeks of treatment,RDQ integrals in the treatment group decreased significantly compared with the control group(P<0.01).2.Total TCM syndrome integrals:At 2 weeks of treatment,the total TCM syndrome integrals(P<0.01)and the total secondary syndrome integrals(P<0.05)in the treatment group decreased compared with the control group,and the improvement of the total primary syndrome integrals in the two groups was comparable(P>0.05).At 8 weeks of treatment,the total TCM syndrome integrals,the total primary syndrome integrals and the total secondary syndrome integrals in the treatment group decreased compared with the control group(P<0.01).After 4 weeks of drug discontinuation,the total integrals of TCM symptoms,the total integrals of primary symptoms and the total integrals of secondary symptoms in the treatment group did not increase significantly compared with the end of treatment(P>0.05),while the total integrals of secondary symptoms in the control group did not increase significantly,and the total integrals of TCM symptoms and the total integrals of primary symptoms all increased significantly at the end of treatment(P<0.01).3.TCM single symptom integrals:At 2 weeks of treatment,both groups had effective improvement except belching and nausea and vomiting symptoms(P<0.01),and the treatment group had better efficacy than the control group in improving the distention and fullness of both sides of the chest(P<0.01).At 8 weeks of treatment,all TCM single symptoms in the treatment group had improved compared with those at 2 weeks(P<0.01),all TCM single symptoms in the treatment group had improved compared with those at 2 weeks(P<0.01),and the control group had improved compared with the previous one except for the distention and fullness of the chest(P<0.01)The treatment group was better than the treatment group in improving chest distension and fullness,belching,heartburn,poor appetite,Chest tightness sigh,nausea and vomiting(P<0.01).After 4 weeks of discontinuation of the drug,all symptoms such as acid reflux,heartburn and stomach pain were more obvious in the control group than before than at the end of treatment(P<0.01),and all symptoms in the treatment group were similar to those at the end of treatment(P>0.05),and all symptoms were more obvious in the control group than in the treatment group(P<0.01).SF-36 quality of life integrals:The health status of both groups improved after the end of treatment in 8 dimensions such as physical functioning,role physical,bodily pain,general health,vitality,social functioning,role emotional,and mental health than before(P<0.01),and the treatment group improved in 3 dimensions of social functioning(P<0.01),role emotional(P<0.05),and mental health(P<0.01)health status was better than the control group.5.Comparison of total effective rate:The total effective rate of the treatment group was 96.7%and the control group was 80%,and the treatment group was significantly better than the control group(P<0.01).6.Long-term efficacy evaluation:The recurrence rate was assessed at the follow-up visit after 4 weeks of drug discontinuation,and was 6.90%in the treatment group and 33.33%in the control group,which was lower than the control group(P<0.05).7.Safety evaluation:No adverse events occurred in subjects of both groups,and the safety was good in both groups.Conclusion:Jiawei Sinisan combined with Rabeprazole Sodium Enteric-coated Tablets can effectively improve the liver and stomach disharmony of gastroesophageal reflux disease overlapping functional dyspepsia(upper abdominal pain syndrome)patients’ clinical symptoms,reduce the TCM syndrome integrals,improve the quality of life and reduce the recurrence rate,treatment based on syndrome differentiation of traditional Chinese medicine has its unique clinical advantages,to provide more effective solutions to disease treatment,bring more clinical benefit for patients.