Clinical Study Of Functional Food-? As A Kind Of Adjuvant Therapy For Functional Constipation

Background and Objective Functional constipation(FC)is a common kind of functional bowel disorder,the characteristic manifestations of which are decrease of spontaneous bowel movements(SBMs),hard or lumpy stools,and/or difficult defecation.The predominant medication therapy of FC is laxative,besides,prokinetic agents,dietary fiber,probiotics and prebiotics are also administrated to treat FC.Functional food-II mainly contains dietary fiber,probiotics and prebiotics.In this study,with the use of polyethylene glycol-electrolytepowder(PEG)alone as a control,we evaluated the effects of Functional food-II combined with PEG in FC,hoping to find a more convenient and effective treatment for FC.Material and Methods This was a multi-center,randomized controlled clinical trial.The gastroenterology department of 3 hospitals including Peking Union Medical College Hospital,Qilu Hospital of Shandong University and Wuhan Union Hospital participated in this study.102 subjects with functional constipation according to Rome III criteria were randomized to receive PEG alone(control group)or Functional food-II and PEG(test group).After the observation of baseline situation for 2 weeks,the test group took Functional food-II lbag bid and PEG 1 bag qd for 4 weeks,while the control group took PEG 1 bag qd during the same time.All of the subjects were requested to record diary of constipation symptoms throughout the 6 weeks,and we followed up them every 2 weeks to assess their bowel movements,Bristol stool form scales and constipation symptoms(difficult defecation,incomplete defecation,anorectal blockage feeling,defecation by manual maneuvers,abdominal bloating and abdominal discomfort).The subjects in the test group were asked to finish a questionnaire to evaluate the effects of Functional food-II at the end of the study.Results 8 subjects were excluded because they didn't take medications as required,and 6 subjects missed follow-up after taking medications for 2 weeks.47 subjects in each of the test group and the control group finished the first 2-week treatment and 44 subjects in each group finished the whole 4-week treatment.According to the decrease of the global scores of constipation,the response rates in the test group and the control group were 88.6%vs 68.2%(p<0.05).After taking medications for 2 weeks,there were more subjects having improvement in the number of bowel movements and the stool form scale in the test group(p<0.05).The improvements of difficult defecation,incomplete defecationwere more obvious in the test group(<0.05),and the improvement of anorectal blockage feeling and defecation by manual maneuvers tended to be more obvious in the test group(p>0.05).However,the improvement of abdominal bloating in the test group tended to be less than that in the control group(p>0.05),and the aggravation rate of abdominal bloating in the test group tended to be higher than that in the control group(p>0.05).The improvement of abdominal discomfort was limited in both groups,and the aggravation rate of abdominal discomfort in the test group tended to be higher(p>0.05).In the end of the study,37 subjects from the test group answered the questionnaire,among whom 91.8%thought Functional food-II effective,86.5%felt satisfied with it,and 62.2%were willing to continue to take it.Conclusions Functional food-II had relatively definite effects on the improvement of bowel movements,stool consistency,difficult defecation,besides,anorectal blockage feeling,incomplete defecation and defecation by manual maneuverscan also be improved to a certain extent.However,abdominal bloating and abdominal discomfort could be aggravated in some subjects.Therefore,Functional food-II was not recommended to patients with obvious abdominal bloating and abdominal discomfort.Functional food-II was well accepted.