Clinical Observation Of Soothing Liver,Clearing Heat And Harmonizing Stomach In Treatment Of Non-erosive Reflux Disease With Liver-Stomach Dampness-Heat Syndrome

Objective:To evaluate the efficacy and safety of soothing liver,clearing heat and harmonizing stomach(Shugan Qingre Hewei formula)in treating Non-erosive Reflux Disease with Liver-stomach Dampness-heat Syndrome,and provide a new therapeutic regime and basis for TCM treatment of this disease.Method:60 cases of Non-erosive Reflux Disease with Liver-stomach Dampness-heat Syndrome which used to received in Hospital of Traditional Chinese and Western Medicine during July 2020 to February 2021 were divided randomly into treatment group(30 cases)and control group(30 cases).The treatment group was given Shugan Qingre Hewei Decoction while the control group was given Pantoprazole enteric-coated capsules,The course of treatment was4 weeks and the follow-up was 4 weeks.The reflux diagnostic questionnaire and TCM symptom scale of the two groups were recorded before and after treatment,and the patient’s reflux diagnostic questionnaire was followed up for 4 weeks after the treatment.Safety tests were performed before and after 4 weeks of treatment in both groups(monitor blood pressure,heart rate and respiration,finish blood analysis,urine analysis,stool routine,liver function,renal function,ECG)。 The curative effect were compared between the two groups before and after the treatment by evaluating the reflux diagnostic questionnaire and TCM symptom scale,and evaluated the recurrence rate and the safety of the treatment plan.Result:1.Analysis of general conditions:there was no statistical difference between the two groups of patients in gender,age,body mass index,total score of reflux diagnostic questionnaire,total score of TCM syndrome before treatment(P>0.05),and the two groups were comparable.2.The efficacy evaluation of clinical symptom: the two groups were evaluated before and after treatment by analysing reflux diagnostic questionnaire and TCM symptom scale,there were significant differences(P < 0.05),the score after treatment was lower than before treatment.The results showed that the two groups of treatment can effectively ease the symptoms of reflux and Liver-stomach Dampness-heat symptom.There was no significant difference in the total score of reflux diagnostic questionnaire and TCM symptom scale between the two groups after treatment(P >0.05),indicating that there was no significant difference in the improvement of the symptoms of reflux and Liver-stomach Dampness-heat symptom between the two groups after treatment.The total effective rate of reflux diagnostic questionnaire score improvement in the experimental group and the control group was89.66% and 90.00% respectively.The total effective rate of TCM symptom score improvement in the experimental group and the control group was 90.00% and 83.33% respectively.There was no significant difference in the effective rate between the two groups(P > 0.05),indicating that there was no significant difference in the total effective rate between the two groups.It shows that the total effective rate of reflux diagnostic questionnaire score improvement and TCM symptom score improvement of the two groups are both high,and there is no significant difference between the two groups.3.The evaluation of the recurrence rate after 4 weeks of treatment:the recurrence rate of the experimental group and the control group were 11.1% and 40.0% respectively;the recurrence rate of the two groups was statistically significant(P < 0.05),the results showed that the traditional Chinese medicine group was more effective than the western medicine group in reducing the recurrence rate of Non-erosive Reflux Disease with Liver-stomach Dampness-heat Syndrome.4.Safety evaluation: there was no obvious abnormality in the safety examination results of the two groups before and after treatment,and there was no adverse reaction related to the study drug during the medication period of the two groups,so the drug safety was good.Conclusion:soothing liver,clearing heat and harmonizing stomach(Shugan Qingre Hewei formula)and Western medicine both can ease the symptoms of reflux and Liver-stomach Dampness-heat symptom,with high effective rate,there was no significant difference between the two groups.The recurrence rate after 4 weeks of treatment of the experimental group was lower than the control group.Both the safety of the two groups was good.