| Objective:To observe the clinical efficacy and safety of Jiawei Tongxieyaofang in treating IBS-D(Diarrhea L-predominant irritable bowel syndrome)with liver depression and spleen deficiency,and provide theoretical basis for treating IBS-D with traditional Chinese medicine.Method:Using randomized controlled design,80 patients with IBS-D(syndrome of liver depression and spleen deficiency)accompanied by anxiety and depression were randomly divided into treatment group and control group.The treatment group was given Jiawei Tongxieyaofang,while the control group was given Trimebutine maleate(Suliqineng)+Flupentixol melitracen tablets(Deanxit)for 4 weeks.After 8 weeks of treatment,the patients were followed up to observe the long-term curative effect.Observation indexes include TCM syndrome score,IBS-SSS,IBS-QOL,HAMA,HAMD,recurrence rate and safety evaluation.SPSS26.0 software was used to analyze the data statistically,and P<0.05 was considered to be statistically significant.Results:(1)A total of 80 cases were collected in this experiment.During the study period,one case in the control group was excluded because the patient stopped taking the medicine by himself,and finally 79 cases were included in the statistical analysis,including 40 cases in the treatment group and 39 cases in the control group.After inspection,before treatment,there was no statistical difference(P > 0.05)between the two groups in gender,age,course of disease,TCM syndrome score,IBS-SSS score,IBS-QOL score,HAMA score and HAMD score,which were comparable.(2)TCM symptom score: After treatment,there were significant differences in the total score and single score between the two groups(P < 0.05).Compared between the two groups,the treatment group has obvious advantages in improving the total score of TCM syndromes,abdominal pain discomfort,defecation characteristics,defecation frequency,fullness of chest and hypochondriac,anorexia,fatigue and burnout,and the difference is statistically significant(P < 0.05),while the two groups have similar curative effects in improving irritability(P > 0.05).(3)TCM syndrome curative effect: the total effective rates of the treatment group and the control group were 87.50% and 69.23% respectively.After inspection,the total curative effect of the two groups was statistically different(P < 0.05).(4)IBS severity questionnaire(IBS-SSS): After treatment,there were differences in IBS-SSS total score and single score between the two groups(P < 0.05).Compared between the two groups,the treatment group has obvious advantages in the total score and improvement of abdominal pain discomfort,stool satisfaction and life troubles,with statistical difference(P < 0.05),and the curative effect of the two groups is similar in the days of abdominal pain and abdominal distension discomfort(P > 0.05).(5)IBS-QOL: After treatment,there were differences in the scores of various fields between the two groups(P < 0.05).Compared with the two groups,the treatment group has obvious advantages in improving behavior disorder,self-image,social function,sexual behavior and relationship development(P < 0.05),and the two groups have similar curative effects in improving bad mood and health worries(P > 0.05).(6)HAMA,HAMD scale: After treatment,there were differences between the two groups(P < 0.05).In HAMA,the curative effect of the two groups was similar(P > 0.05).In the aspect of HAMD,the control group has obvious advantages,with statistical difference(P< 0.05).(7)Long-term curative effect: After 8 weeks after the end of the treatment period,the recurrence rate of the treatment group was 11.43%,and that of the control group was 37.04%,with statistical difference(P < 0.05).(8)Safety: Before and after treatment,the vital signs of the patients in the two groups were stable and there was no adverse reaction,which indicated that the two groups of drugs were safe in treating this disease.Conclusion:1 Jiawei Tongxieyao Prescription can significantly improve the clinical symptoms of IBS-D(liver depression and spleen deficiency syndrome),improve the clinical curative effect,reduce the severity of the disease,improve the quality of life,effectively improve the anxiety state,with good long-term curative effect and high safety.2 Comparing TCM syndromes,Jiawei Tongxieyaofang group has obvious advantages in abdominal pain discomfort,defecation characteristics,defecation frequency,fullness of chest and hypochondrium,anorexia,fatigue and burnout;Compared with IBS-SSS,Jiawei Tongxieyaofang group has obvious advantages in abdominal pain discomfort,stool satisfaction and life troubles.Compared with IBS-QOL,Jiawei Tongxieyaofang group has obvious advantages in behavior disorder,self-image,eating evasion,social function,sexual behavior and relationship.Compared with HAMA,the curative effect is similar to that of the control group,which can improve the anxiety state of patients.In the long-term curative effect,the recurrence rate of Jiawei Tongxieyaofang group is low and the long-term curative effect is good.The treatment is safe and reliable,and it is an effective prescription for treating IBS-D with liver depression and spleen deficiency. |