Clinical Observation Of Chailian Granule In The Treatment Of Non-Erosive Reflux Disease (Liver And Stomach Stagnation Syndrome)

Objectives By comparison with the positive group(rabeprazole enteric-coated tablets),to observe the clinical efficacy and safety of Chailian Granules in the treatment of non-erosive reflux disease liver and stomach stagnation syndrome at the end of the 4th week,the long-term efficacy of the 8th week and the 12 th week.And to provide relevant evidence-based medical evidence for the preparation of traditional Chinese medicine preparations.Methods Through the randomized,positive control,parallel design clinical trial,120 cases of non-erosive reflux disease with the liver and stomach stagnation syndrome.were collected.They were randomly divided into the trial group(Cai Lian granule)and the control group(Rabeprazole sodium enteric-coated tablets),each of which was treated for 4 weeks.TCM syndrome scores and Gerd Q scores of the two groups before treatment,the 4th,the 8th and the 12 th weekend of treatment were recorded.And the database was established by SPSS20.0 software for relevant statistical analysis.Results1.case: A total of 107 patients completed the entire trial,55 in the trial group and 52 in the control group.2.Baseline: The basic conditions of gender,age,BMI,course of disease,and condition of the two groups were compared.The difference was not statistically significant(P>05.0),suggesting a balanced comparability between the two groups.3.Main efficacy indicator: The TCM syndrome scores of the two groups were compared within the 4th week of treatment and before treatment.The difference was statistically significant(P<0.05),suggesting that both groups were effective.At the end of the 4th week of treatment,the efficacy of TCM syndromes between the two groups was compared,The difference was statistically significant(P < 0.05),The total effective rate was 83.64%and 61.55% respectively,suggesting that the efficacy of the trial group was better than that of the control group.4.Gerd Q scores,efficacy indicators: Gerd Q scores of the two groups were compared within the 4th week of treatment and before treatment,the difference was statistically significant(P< 0.05),suggesting that both groups were effective.At the end of the 4th week of treatment,the difference in the efficacy of Gerd Q between the two groups was statistically significant(P < 0.05),and the total effective rate was 85.45% and 63.46%respectively,suggesting that the efficacy of the trial group was better than that of the control group.5.Single symptom efficacy indicator: The effect of single symptom between the two groups at the end of the 4th week of treatment,the difference between the two groups in the main symptoms of noisy,acid reflux,sternal burning pain,the difference was statistically significant(P<0.05),The total effective rate of the test group was 87.76%,90.00% and84.79%,and that of the control group was 60.00%,61.70% and 60.42%.Suggesting that the efficacy of the trial group was better than that of the control group.In the treatment of secondary gastroparesis,abdominal distension,antifeeding,and irritability,the difference was statistically significant(P<0.05),suggesting that the trial group was superior to the control group.In the efficacy of dry mouth and bitterness,the difference was not statistically significant(P > 0.05),suggesting that there was no significant difference between the two groups.6.Quality of life indicator: The distribution of the number of cases with positive influences of ?3 points in the three visits at the 4th,8th,and 12 th weeks between the two groups was statistically significant(P<0.05).The trial group was superior to the control group in improving the quality of life at three visits.7.Long-term efficacy indicator: follow-up at the 8th and 12 th weeks,the difference in TCM syndrome scores between the two groups,the difference was statistically significant(P<0.05),suggesting that during the follow-up period,the trial group was better than the control group in reducing TCM syndrome scores.There was no significant difference in recurrence between the two groups at the end of the 8th week of treatment(P > 0.05),suggesting that there was no significant difference in recurrence rates between the two groups at the end of the 8th week of treatment.At the end of the 12 th week of treatment,the difference was statistically significant(P<0.05),The recurrence rates of the two groups were 15.22% and 37.50% respectively.Indicating that the recurrence rate of the trial group at the 12 th week of treatment was lower than that of the control group.8.Safety indicator: No abnormalities were found in the two groups during the whole test,suggesting that the Chailian particles are safe.Conclusions Chai Lian Granule is safe and effective in the treatment of non-erosive reflux disease liver and stomach stagnation syndrome.It can significantly improve the quality of life of patients and improve long-term efficacy.