| ObjectiveThe trial is conducted to observe the clinical efficacy and recent recurrence rate of treating Gastroesophageal reflux disease(GERD)with liver depression and spleen deficiency in use of Tiaogan Jianpi decoction and Lansoprazole.The trial aims to comprehensively evaluate the benefits of Traditional Chinese Medicine(TCM)treatment for GERD in relieving symptoms of reflux,anxiety and depressive,reducing recurrence rate and improving quality of life,so as to enrich the understanding and application of Tiaogan Jianpi theory in treating GERD.MethodsIn this trial,66 patients with GERD of liver depression and spleen deficiency type who were first diagnosed at the Affiliated TCM Hospital of Guangzhou Medical University from June 2020 to September 2020 were selected and randomly divided into 2 groups by using random number table method.The 33 patients in control group was given Lansoprazole,while 33 patients in treatment group was given Lansoprazole and Tiaogan Jianpi decoction for 8 weeks.We analyzed the data of RDQ,GERD-HRQL,HAMA,HAMD and TCM before and after treatment,as well as the recurrence rate to draw conclusion.Results1.Comparison of completion:29 cases were completed in the treatment group,and 4 cases were withdrawn due to poor compliance.31 cases were completed in the control group,and 2 cases were withdrawn due to poor compliance.There was no significant difference in two groups(P>0.05).2.Comparison of baseline indexes:There was no statistically significant difference in the comparison of age,gender,BMI and disease duration between the two groups(P>0.05).3.Comparison of outcomes:(1)The mean rank of RDQ score,GERD-HRQL score,HAMA score,HAMD score,and TCM evidence score before treatment were not significantly different between the two groups(P>0.05).The mean rank of RDQ score,GERD-HRQL score,HAMA score,HAMD score,and TCM evidence score after treatment were smaller than those of the control group.The mean rank of the difference of RDQ score,GERD-HRQL score,HAMA score,HAMD score and TCM evidence score in the treatment group was greater than that in the control group,and the mean rank of TCM efficacy grade,total effective rate and significant rate in the treatment group were greater than those in the control group.The differences of the above effect indicators between the two groups were statistically significant(P<0.05).(2)The recurrence rate of the treatment group was lower than that of the control group at the 3-month follow-up after drug.discontinuation,and the difference was statistically significant(P<0.05).4.Comparison of safety indicators:There were no allergic reactions,gastrointestinal adverse reactions,low blood cells,drug-related liver damage and renal damage occurred during the treatment period in both groups.Conclusion1.The treatment of Tiaogan Jianpi decoction and Lansoprazole led to great reductions of reflux symptoms,anxiety and depression and improvement in quality of life.Thus,the treatment is worthy of further study and promotion.2.The treatment reduced 3-month recurrence rate of GERD with liver depression and spleen deficiency by combining Tiaogan Jianpi decoction with Lansoprazole.Thus,it is beneficial to prevent recent recurrence of GERD. |