| Objective: On the basis of previous research,based on the theory of Brain-Gut Axis,the effect of Lichang Decoction(LCD)on IBS-SSS score,IBS-QOL score,SP,and 5-HT in IBS-D patients with liver depression and spleen deficiency syndrome was further evaluated.The differences of intestinal electrical activity parameters before and after treatment were observed by electroenterogram,and the possible mechanism of action of LCD in the treatment of IBS-D was discussed.Methods:1.From September 2020 to October 2021,66 patients in the outpatient department of Spleen and Stomach Diseases of the Affiliated Hospital of Shandong University of TCM met the inclusion criteria of IBS-D with liver depression and spleen deficiency syndrome were collected.According to the ratio of 2:1,they were randomly divided into two groups,in which the TCM group was given LCD,400 ml of water decoction,1 dose a day,while the WM group was given Pinaverium bromide tablets,3times/d,50mg/time,as well as Bifidobacterium triple viable capsules,2 times/d,630mg/time.The treatment course was last for 4 weeks,and the IBS symptom severity score(IBS-SSS),IBS quality of life score(IBS-QOL),TCM syndrome score in the two groups were evaluated at 0,2,4,8,and 12 weeks after treatment.2.10 subjects were randomly selected from the two groups,and serum SP and 5-HT levels were detected by Enzyme-linked immunosorbent assay(ELISA)before and after treatment.3.The intestinal electromyography of the patients before and after treatment for 5 minutes fasting and 30 minutes after a meal was detected,and the spectrum analysis was performed on the intestinal electromyography of different intestinal segments for 5 minutes fasting and 10 minutes,20 minutes,and 30 minutes after meals,respectively.4.Check blood routine,urine routine,stool routine,alanine aminotransferase,urea nitrogen before and after treatment,and record adverse drug reactions for safety evaluation.5.All data are statistically analyzed using SPSS 23.0 software.Results:2 cases in the TCM group dropped out,1 case lost,a total of 41 patients completed the clinical study.While in the control group,2 cases dropped out,20 patients completed finally.1.There was no statistical difference between the two groups of patients before treatment,such as gender,age,Job nature,education distribution,BMI index and other general information,as well as the course of disease,IBS-SSS,IBS-QOL,TCM syndrome score,intestinal electrical activity parameters,5-HT,SP,and they were comparable(P>0.05).2.Comparison of efficacy indicators:The cure rate,significant rate of curative effect,and total effective rate were 19.51%,60.98%,95.12% in the TCM group,respectively,and 5%,20%,75% in the WM group.The cure rate between two groups was no significance(P>0.05).The significant rate of curative effect,the total effective rate of the TCM group and the comprehensive curative effect was better than the other group to varying degrees(P<0.01,P<0.05).(1)Comparison of IBS symptom severity score(IBS-SSS):The total score at each time point in the two groups was significantly lower than that before treatment(P<0.01),and both reached the peak of efficacy in the 4th week of taking the drug.During the follow-up period,the total scores of the two groups rebounded to varying degrees.Among them,there was no recurrence trend in the TCM group,and there was a recurrence trend in the WM group.The total score at each time point in the TCM group was significantly better than the other group(P<0.01).In terms of the improvement of single symptom score,after 4weeks of intervention,abdominal pain,abdominal pain days,abdominal distension,defecation satisfaction,and life distress scores in both groups were significantly improved compared with those before treatment(P<0.01).The improvement of abdominal pain days,abdominal distension degree,abdominal pain degree,life distress and defecation satisfaction score in the TCM group was better than that in the WM group in different degrees(P<0.01,P<0.05).(2)Comparison of IBS Quality of Life Score(IBS-QOL):In terms of the improvement of the total score,the total score at each time point after treatment in the two groups was significantly higher than that before treatment(P<0.01),and reached the best level after 4 weeks of medication.During the follow-up period,both groups decreased,among which,the trend of decrease in the TCM group was relatively slow.The improvement of the total score at each time point in the TCM group was better than that in the WM group(P<0.05).In terms of the improvement of single score,after 4 weeks of intervention,dysthymia,behavior disorder,self-intention,health worry,eating avoidance,social function,and relationship expansion was significantly improved in the two groups(P<0.01).The TCM group was better than the WM group in terms of bad mood,behavior disorder,health worry,eating avoidance,and self-intention improvement(P<0.05),but there was no statistical difference between the two groups in the improvement of social function and relationship expansion(P>0.05).(3)Comparison of TCM syndrome points:In terms of the improvement of the total score,the total score at each time point after treatment in the two groups was significantly lower than that before treatment(P<0.01),and all reached the trough at the 4th week.The total score at each time in the TCM group was significantly better than that the other group(P<0.01).In terms of improvement of individual syndrome scores,after 4 weeks of administrition,all syndrome scores were significantly improved in TCM group(P<0.01).In the WM group,the main symptoms were significantly improved(P<0.01),and the secondary symptoms were chest and flank distention,fatigue and fatigue were improved(P<0.05),and belching and loss of appetite were not improved(P>0.05).After treatment,the improvement of stool diarrhea,painful diarrhea,depression,irritability,belching,loss of appetite,fatigue,abdominal distension and abdominal pain in the TCM group was better than that in the WM group(P<0.05),and there was no statistical difference between the two groups in chest and flank pain(P>0.05).3.Comparison of intestinal electrical indexes:There was an obvious peak of intestinal wave amplitude at 10 minutes and 30 minutes after meals in both groups,which was significantly different from that at 20 minutes after meals(P<0.01).The amplitude of sigmoid colon was significantly higher than others before treatment(P<0.01).After treatment,the amplitude difference between each lead was reduced.And the amplitude and frequency of each lead were significantly decreased After treatment in both group(P<0.01).There was no significant difference between them(P>0.05),indicating that both LCD and WM could significantly negatively regulate the intestinal electrical activity in patients with IBS-D,and the two were equally effective.4.Comparison of brain-gut peptide detection results:The level of SP and 5-HT in the TCM group were decreased to varying degreesafter treatment(P<0.05,P<0.01).The content of SP in the WM group after treatment was lower than that before treatment(P<0.05),and the content of 5-HT was not significantly different from that before treatment(P>0.05).There was no significant difference between the two groups after treatment(P>0.05),but the reduction of 5-HT in the TCM group before and after treatment was significantly better than that in the WM group(P<0.01).It shows that TCM can significantly down-regulate 5-HT,and it is comparable to the WM group in regulating SP.5.Safety: There were no adverse events related to the clinical trial drugs in the two groups of patients during treatment and follow-up,and there were no significant abnormalities in blood,urine,stool routine,ALT,and BUN before and after treatment,indicating that both treatment methods are safe.Conclusion:Based on previous research,this study not only confirms once again that LCD has a significant effect on TCM syndromes of IBS-D with liver stagnation and spleen deficiency,but also further shows that the prescription can effectively alleviate the defecation and life troubles of IBS-D patients,improve their psychological state,and significantly improve their quality of life and has certain long-term efficacy,no obvious adverse reactions.At the same time,LCD can down-regulate the serum SP and 5-HT levels in patients with IBS-D,and can significantly reduce the amplitude and frequency of colonic electrical activity.Therefore,it is speculated that intervening in the Brain-gut axis and regulating colonic motility may be one of the mechanisms of action of LCD in the treatment of IBS-D. |
PDF Full Text Request