Prevention Of Recurrence Of Colorectal Polyps(adenoma) By Polyp-elimi Nation Decoction:a Single-center Randomized Controlled Clinical Study

ObjectiveTo evaluate the effects of modified Polyp-elimination Decoction in the Prevention of colorectal polyps(adenoma)recurrence one year after colorectal polypectomy.MethodsThis single-center randomized controlled clinical trial was done in the endoscopy center of the Guangdong TCM hospital from January 26,2018 to December 31,2018.410 individuals who met the inclusion/exclusion criteria were recruited and randomly assigned(1:1)to receive Polyp-elimination Decoction(Polyp-elimination group)3 months or no medicine(control group)via randomisation.Participants were to undergo a follow-up colonoscopy one year after enrolment.The primary efficacy endpoint was the recurrence of adenomas at the follow-up colonoscopy.Compared the number,size,location and pathology of adenomas of the two groups,recorded TCM symptomatic integrals before and after treatment in all patients and observed any adverse reactions.Results359 patients completed the test,176 in Polyp-elimination group and 183 in the control group.①The recurrence rate of adenoma one year after polypectomy was 45.5%(80/176)in Polyp-elimination group,lower than that in the control group 61.7%(113/183),the difference was statistically significant(p<0.05).In terms of pathology,the proportion of non-advanced adenoma and advanced adenoma in Polyp-elimination group was 98.8%(79/80)and 1.3%(1/80),respectively.The control group was 94.7%(107/113)and 5.3%(6/113),respectively,the difference between the two groups was not statistically significant(P>0.05).In terms of the number of recurrent adenomas,in Polyp-elimination group,there were 56(70.0%)cases had recurrent adenomas≤3,and 24(30.0%)cases had more than 3 recurrent adenomas.In the control group,there were 71(62.8%)and 42(37.2%)cases respectively.The difference between the two groups was not statistically significant(P>0.05).In terms of the location of recurrent adenomas,in Polyp-elimination group,34(42.5%)patients had recurrent adenomas located in the left semicolon,17(21.3%)patients in the right semicolon and 29(36.3%)patients in the whole colon.In the control group,there were 43 cases(38.1%)in the left half colon,29 cases(25.7%)in the right half colon and 41 cases(36.3%)in the whole colon.There was no difference in the location distribution of recurrent adenomas between the two groups(P>0.05).②One year after polypectomy,the syndromes were all improved in both groups(p<0.05),the TCM symptomatic integrals of patients in Polyp-elimination group were 0.62±1.343 points,lower than those in the control group(1.22±2.062 points,p<0.05).③Single-fa ct or analysis showed that group,adenoma number,adenoma size,adenoma location and adenoma pathology were the risk factors for recurrence of colorectal adenoma.Multivariate analysis suggested that Polyp-elimination was a protective factor for adenoma recurrence,and the number of adenomas(>3),distribution of adenomas throughout the colon,and advanced adenomas were risk factors for adenoma recurrence.④During the treatment,no adverse reactions were found in Polyp-elimination group.ConclusionPolyp-elimination Decoction showed certain effects in reducing the recurrence rate of colorectal adenoma of patients after polypectomy,reduced the number of recurrent polyps and the proportion of advanced adenoma,and improved the TCM syndrome of patients,which is worthy of further research and promotion.