The Clinical Study Mid-term Analysis Of Tiao-Chang Ke-Min Decoction In The Treatment Of Diarrhea Irritable Bowel Syndrome

Objective(1)Using standardized randomized,double-blind,placebo-controlled clinical research design methods,evaluate the clinical efficacy of Tiao-Chang Ke-Min Decoction in the treatment of diarrhea-type irritable bowel syndrome.(2)Based on the adverse events in the early stage of the trial,conduct a mid-term analysis of the efficacy and safety of the clinical trial of Tiao-Chang Ke-Min Decoction in the treatment of diarrhea-type irritable bowel syndrome.Methods(1)Using a randomized,double-blind,placebo-controlled clinical research design method,the treatment group was given Tiao-Chang Ke-Min granules,and the control group was given placebo simulated granules.The whole study was divided into washout period,treatment period and follow-up period,washout period lasts 1 week,the treatment period lasts 4 weeks,the follow-up period lasts 3 months.The main efficacy indicator of the trial was AR response rate,and the secondary efficacy indicator was IBS-SSS response rate,IBSQOL total score,and HAD score,recurrence,etc.(2)The α-consumption function method was used in interim analysis of the main outcome indicators(AR response rate),and the adverse events were observed and analyzed.ResultsEvaluation of the efficacy of Tiao-Chang Ke-Min Decoction in the treatment of IBS-D.A total of 68 patients were enrolled in the study,including the Tiao-Chang Ke-Min granule group of 35 cases,and 33 cases in the placebo-simulated granule group.After 4 weeks of treatment period,the results of the two groups were analyzed as follows:(1)Main efficacy indicators:AR response rate:AR response is defined as "yes" to AR at least 2 weeks out of the 4 weeks of the treatment period,and no response in other cases.This study compares the AR response rate of the two groups of patients during the treatment period(1-4 weeks).The treatment results showed that the AR response rate of the Tiao-Chang Ke-Min granules group was 60%,and the placebo simulated granules group was 48.48%.The AR response rate of the Tiao-Chang Ke-Min granules group was higher than that of the placebo simulated granules group.(2)Secondary curative effect indicatorsIBS-SSS response rate:According to the difference in IBS-SSS scores between the two groups of patients before and after treatment,the IBS-SSS score reducing by 50 as the response,compared the IBS-SSS response rate of the two groups.The response rate of the Tiao-Chang Ke-Min granule group was 57.1%,and the placebo simulated granules group was 40.6%.The Tiao-Chang Ke-Min granules group was higher than the placebo-simulated granules group in terms of IBS-SSS response rate.IBS-QOL score:The total scores of IBS-QOL before and after treatment were compared between the two groups.But there was no significant difference in the total scores between the two groups after treatment period(P>0.05).HAD score:There was no significant difference in scores between the two groups of patients before and after treatment on HAD-A and HAD-D score(P>0.05).(3)Subgroup analysis:Using AR response as the efficacy indicators,the patients were divided into groups by their main causes,predisposing factors,symptoms,etc.There was no statistically significant difference in AR response in each subgroup.In terms of IBS-SSS response,the IBS-SSS response rate of patients with dietary predisposing factors in the TiaoChang Ke-Min granule group was higher than that of the placebo granule group,and the difference between the two groups was statistically significant.After grouping various dietary factors,it was found that the response rate of patients in Tiao-Chang Ke-Min group with cold diet,milk and milk product sensitivity was higher than the placebo granule group,and the difference between the two groups was statistically significant.(4)Recurrence:The recurrence of Tiao-Chang Ke-Min decoction was evaluated by comparing the recurrence rate,complete remission time,time first recurrence interval,and overall recurrence times between the two groups of patients.The recurrence rate of TiaoChang Ke-Min granules group was 33.3%,the recurrence rate of placebo simulated granules group was 43.43%,and the recurrence rate of Tiao-Chang Ke-Min granules group was lower than that of placebo simulated granules group;Comparing the complete remission time of the two groups of patients,the complete remission time of the Tiao-Chang Ke-Min granule group was shorter than that of the placebo granule group,and the difference between the two groups was statistically significant(P<0.05);in terms of the time to first relapse and the number of recurrences,the difference between the two groups was no statistically significant(P>0.05).Interim analysis(1)Using the α-consumption function method,combining the five α-consumption formulas of the α-consumption function proposed by Lan-Demets,taking α=0.0296,and comparing the AR response rates of the two groups after treatment,P>0.0296,The difference between the two groups is not significant.The result of the interim analysis is recommended to continue the test.(2)Safety analysis:The three routine tests,liver function,kidney function,and electrocardiogram were normal or abnormal before and after treatment for the two groups of patients.There was no statistically significant difference between the two groups of patients before and after treatment.Tiao-Chang Ke-Min granules and placebo simulated granules are safe for clinical application.(3)Analysis of adverse events:There were adverse events in both groups of patients.There were 13 adverse events in this trial,of which 1 case was definitely drug-related,and 4 cases might be drug-related.The clinical manifestations of adverse events that are definitely or possibly related to the drug are vomiting,nausea,abdominal distension,abdominal pain,and acute gastroenteritis.There were no serious adverse events during the experiment.ConclusionTiao-Chang Ke-Min granules has a certain curative effect in the treatment of IBS-D,and its clinical effect is safe.In the interim analysis,α=0.0296 was used as the test level.There was no significant difference in the overall efficacy of the two groups of patients.The interim analysis recommended that the trial continue.