Clinical Observation On Hewei Xiaopi Decoction In The Treatment Of Functional Dyspepsia With Syndrome Of Intermingled Cold And Heat And Liver Depression

Research backgroundFunctional Dyspepsia(FD)is a very common chronic digestive system disease in clinic,which accounts for a high proportion in digestive diseases.In recent years,with the development of society and the increase of mental pressure,the incidence rate of FD is increasing.The pathogenic factors and pathological mechanism of the disease are complex and have not been clarified;In terms of treatment,western medicine still focuses on symptomatic treatment.Although it has certain curative effect,it is easy to repeat and has many side effects.According to the main symptoms of FD,TCM classifies it into "Epigastric Pain","Fullness Syndrome" and other categories.It is considered that the disease is mainly located in the gastrointestinal tract,which is closely related to the spleen and liver.Its basic pathogenesis is that the Qi mechanism of the spleen and stomach is unfavorable and the ascending and descending are abnormal.Traditional Chinese medicine is based on the overall concept,combined with disease differentiation and syndrome differentiation,which can effectively alleviate the discomfort symptoms of patients.It has unique advantages in the treatment of such diseases and helps to improve the quality of life of patients.On the basis of understanding the etiology and pathogenesis of FD,combined with clinical practice,we summarized an effective prescription for FD-Hewei Xiaopi decoction.This study observed the clinical effect of this prescription in the treatment of FD cold and heat syndrome of liver depression,and compared with western medicine treatment,in order to summarize the TCM treatment scheme of FD cold and heat syndrome of liver depression which reflects the advantages of TCM theory and clinical characteristics.Research objectiveTo study the clinical efficacy and long-term efficacy of Hewei Xiaopi Decoction in the treatment of Functional Dyspepsia with syndrome of intermingled cold and heat and liver depression by simple randomized controlled trial.Research methodsAccording to Rome IV diagnostic criteria of functional dyspepsia and TCM syndrome diagnostic criteria,patients with functional dyspepsia of intermingled cold and heat and liver depression syndrome who visited the outpatient department of spleen and stomach department of Guang’anmen Hospital of China Academy of Chinese Medical Sciences from March 2020 to March 2021 were selected as the research objects,and they were randomly divided into treatment group and control group according to their visiting order.The treatment group was treated with Hewei Xiaopi Decoction(Prescription granules),One dose a day,twice a day,30 minutes after meals.The control group was given mosapride citrate tablets,three times a day,5mg each time,before meals.The treatment time of the two groups was 4 weeks.The observation indexes included general indexes,efficacy indexes and safety indexes.General indicators:height,weight,respiration,pulse,heart rate,body temperature,blood pressure,etc.Efficacy indicators:1)overall efficacy of patients after treatment;2)changes of TCM symptom score before and after treatment;3)recurrence of patients after drug withdrawal.Safety indicators:Patients with adverse reactions should be registered in time,combined with the condition of comprehensive analysis and judgment,and timely treatment.The data were input by Excel 2003,and then analyzed by spss 26.0.Research results1 General information comparisonA total of 68 subjects completed the clinical trial,including 35 cases in the treatment group and 33 cases in the control group.There was no significant difference in age,gender,course of disease and total score of symptoms before treatment between the two groups(p>0.05).2 Efficacy evaluationAfter the treatment,the total effective rate of the treatment group was 97.14%,and that of the control group was 81.82%.The total effective rate of the treatment group was higher than that of the control group,and the difference was statistically significant(p<0.05).From the total score of symptoms before and after treatment,the total score of symptoms in the two groups was significantly lower than that before treatment,and the difference was statistically significant(p<0.05).From the change of symptom score,the symptom scores of the two groups were lower than before treatment in one week,two weeks,three weeks and four weeks after treatment,and the difference was statistically significant(p<0.05).The symptom score of treatment group was lower in two weeks,one week,three weeks and two weeks,four weeks and three weeks after treatment,and the difference was statistically significant(p<0.05).The difference was statistically significant(p<0.05)and the difference was not statistically significant(p>0.05)between the two weeks of treatment and the second week of treatment,the four weeks and the three weeks of treatment.The symptom scores of the treatment group and the control group were compared in the treatment week,treatment two weeks,treatment three weeks and four weeks treatment respectively.There was no significant difference in symptom scores between the two groups after one week and two weeks of treatment(p>0.05);the symptom score of the treatment group was lower than that of the control group at three weeks and four weeks of treatment,and the difference was statistically significant(p<0.05).From the single symptom point of view,after treatment,the symptoms of the treatment group were significantly improved than before treatment,and the difference was statistically significant(p<0.05);In the control group,the symptoms of postprandial fullness,early satiety,epigastric burning,noisy and belching were significantly improved than before treatment,and the difference was statistically significant(p<0.05);The symptoms of warm stomach,loose stools,dry mouth and bitter mouth,emotional failure,two flank fullness were not significantly improved compared with those before treatment,and the difference was not statistically significant(p>0.05).The improvement degree of the treatment group was better than that of the control group in the aspects of loose,dry and bitter mouth,belching,emotional failure and two flank fullness,and the difference was statistically significant(p<0.05).In terms of recurrence,after 4 weeks of drug withdrawal,the recurrence rate of the treatment group was 17.14%,and that of the control group was 42.42%.The recurrence rate of the treatment group was significantly lower than that of the control group,and the difference was statistically significant(p<0.05).During the treatment,there were no adverse reactions in the treatment group and the control group.Research conclusion(1)Hewei Xiaopi decoction has definite curative effect on Functional Dyspepsia with syndrome of intermingled cold and heat and liver depression,and can significantly improve the related clinical symptoms.(2)Hewei Xiaopi decoction has low recurrence rate and significant long-term effect.(3)Hewei Xiaopi decoction is safe and has no adverse reaction during the study period,so it can be applied in clinical practice.