Objective: Evaluate the clinical effect and safety of Modified Banxia Houpu Decoction(MBHD)in treating gastroesophageal reflux disease(GERD)with Qi depression and phlegm obstruction,and to explore the traditional Chinese medicine(TCM)theoretical basis of MBHD for the treatment of GERD with Qi depression and phlegm obstruction.It provides a comprehensive and feasible clinical solution for the treatment of this disease,and lays a clinical foundation for further in-depth basic research.Methods: The 84 patients who met the inclusion criteria were stochastic classified into a test group and a control group of 42 patients according to the order of the visits.The test group was treated with MBHD jointed with RabeprazoleSodiumEnteric-coatedCapsules,and the control group was treated with RabeprazoleSodiumEnteric-coatedCapsules.Both groups were treated for 8 weeks.Objectively evaluate the changes in TCM symptom scores,Gastroesophageal reflux disease questionnaire(GerdQ)scale scores,and HRM indicators before and after treatment in the two groups of patients,and monitor and record safety indicators before and after treatment and adverse reactions during the trial.During the treatment process,2 cases were excluded from the test group,2 cases were removed from the control group,and 2 cases fell off.Therefore,a total of 78 cases were brought into the medical statistical analysis.Results: 1.Comparison of clinical efficacy: the total effective rate of the test group was 92.50%,and the total effective rate of the control group was 71.05%.The comprehensive effect of TCM in the test group than the control group(P <0.05);Comparison of TCM Syndrome Points: The TCM Syndrome Points of the two groups of patients improved after treatment(P <0.05),and the test group was better than the control group(P <0.05);Comparison of individual symptoms scores in TCM: The single symptom score of TCM in both groups of patients can be improved(P <0.05),however,for throat discomfort such as phlegm infarction,chest discomfort,belching or reflux,hoarseness,and choking in the middle of the night,the experimental group was better than the control group(P <0.05).2.GerdQ scale score: The GerdQ scale score of the two groups of patients improved after treatment(P <0.05),and the test group was better than the control group(P <0.05).3.HRM index: After treatment,the lower esophageal sphincter resting pressure(LESP)and distal contractile integral(DCI)were improved(P <0.05),but there was no obvious improve in the control group(P >0.05).4.Safety analysis: No adverse reactions occurred after treatment in the two groups of patients.Conclusion: 1.MBHD combined with Proton pump inhibitor(PPI)can effectively improve the clinical symptoms,TCM syndrome score and GerdQ scale score of GERD with Qi depression and phlegm obstruction,and MBHD can improve the LESP and DCI of patients.2.MBHD combined with PPI for GERD with Qi depression and phlegm obstruction has a definite clinical effect,high safety,and better clinical efficacy than PPI alone,which is suitable for clinical promotion. |