| BackgroundThe incidence of FC is increasing in modern society,which is closely related to unhealthy lifestyle.The treatment of functional constipation mainly includes lifestyle intervention,drug therapy and surgery.In clinical practice,it is found that the concept of lifestyle intervention is too broad and not specific enough,which leads to difficulties in implementation in practice.In addition,the application of drugs alone can not actually achieve long-term relief of constipation,and form drug dependence,and a large number of patients are not satisfied with the existing drug treatment.Surgical treatment is too invasive,high risk,is not widely accepted by doctors and patients.Professor Yao Shukun has unique experience in the treatment of this disease and summarized the combination of light vegetarian method and Qingjiangtiao Changfang to intervene functional constipation.Vegetarian method is a set of detailed and specific diet treatment program,Qingjiangtiaochang prescription is a Chinese medicine prescription.The clinical observation shows that this scheme has good effect in improving intestinal motility,defecation frequency and stool hardness.From the point of view of health economics,increasing lifestyle intervention can reduce the medical expenditure of patients.Therefore,this scheme is worth popularizing and should be verified by randomized controlled trials.Under the guidance of Professor Yao Shukun and several statistical experts,we completed the design and implementation of this study in order to provide better evidence for clinical treatment.Purpose1.Analyze relevant data of enrolled FC patients to obtain their clinical characteristics.2.A randomized controlled study was conducted to evaluate the efficacy of light vegetarian diet and Qingjiangtiaochang prescription in the treatment of functional constipation.3.To explore the effects of light vegetarian diet and Qingjiangtiaochang prescription on the content of short-chain fatty acids in the feces of FC patients.Study 1:From September 2020 to March 2021,a total of 91 constipation patients meeting the inclusion criteria were enrolled in the Department of Gastroenterology of China-Japan Friendship Hospital.There were 31 in the Chinese medicine group,30 in the Chinese medicine+diet group,and 30 in the Chinese medicine+diet group.Subjects signed informed consent,filled out baseline data questionnaire,completed colonoscopy,high-resolution anorectal manometry,48-hour gastrointestinal passage time,and kept a fresh stool for short-chain fatty acid content detection.Study 2:This is a prospective randomized controlled clinical trial of a drug and placebo combined with a lifestyle intervention that enrolled patients at a single center.This study was approved by the Ethics Committee of Clinical Research of China-Japan Hospital.The participants were randomly assigned to three groups:the Chinese medicine group,the Chinese medicine+diet group,and the Chinese medicine+ diet group.Both the drug and placebo were given twice daily at 10 a.m.and 4 p.m.Follow-up and electronic diary were required during the intervention.The course of treatment was 28 days.On-site follow-up was conducted on day 14 and 28 of the intervention.At the end of day 28,patients were reexamined for gastrointestinal motility tests.The primary efficacy measure was the mean number of complete spontaneous bowel movements per week.Secondary outcome indicators include:spontaneous defecation frequency per week,Bristol stool scores,constipation patients quality of life scale,constipation symptoms self evaluation scale,the degree of constipation symptoms rating scale,TCM syndrome integral,gastrointestinal through 48 hours time,short chain fatty acid changes before and after the treatment,this study also includes the safety index and dietary adherence index.SPSS 23 was used for statistical analysis.Study 3:Fecal samples from patients with high compliance during treatment were selected to detect the content of short-chain fatty acids.Test contents include acetic acid,propionic acid,butyric acid,isobutyric acid,valeric acid,iso-valeric acid,caproic acid.By comparing the changes of the content of short-chain fatty acids in feces before and after intervention,the possible mechanism of constipation improvement was revealed from the perspective of metabolomics,so as to provide evidence for the clinical application of the method.ResultStudy 1:1.General(demographic)data(gender,age,body mass index,waist-hip ratio,waist circumference,educational background)of constipation patients in the three groups were not statistically different.Symptom severity no statistical difference of three groups of patients(including Roman Ⅳ functional constipation diagnosis questionnaire,weekly completely spontaneous defecation frequency,frequency of spontaneous bowel movements per week,stool Bristol grading the quality of life scale,constipation,constipation patients degree of the self-assessment lists of symptom,constipation symptoms rating scale,TCM syndrome integral,gastrointestinal through 48 hours time,high resolution,the anus Rectal manometry).There was no statistical difference in mental state among the three groups(Self-Rating Anxiety Scale(SAS),Self-Rating Depression Scale(SDS),Pittsburgh Sleep Quality Index(PSQI)).There was no statistical difference in dietary habits among the three groups of constipation patients.Study 2:1.Main Outcome Indicators:The frequency of complete spontaneous defecation was significantly improved in the TCM group,placebo+diet group,and TCM+diet group.The effect of Chinese medicine+diet group was better than that of Chinese medicine group and placebo+diet group.2.Secondary outcome indicators.(1)Weekly frequency of spontaneous defecation:Chinese medicine group,placebo+diet group and Chinese medicine+diet group could significantly improve the frequency of spontaneous defecation in constipation patients.The effect of TCM+diet group and placebo+diet group was better than that of TCM group.(2)Bristol score:Chinese medicine group,placebo+diet group and Chinese medicine+diet group could significantly improve the Bristol score of constipation patients.The effect of Chinese medicine+diet group was better than that of Chinese medicine group and placebo+diet group.(3)Quality of life scale for constipation patients:the Chinese medicine group,placebo+diet group and Chinese medicine+diet group could significantly reduce the PAC-QOL score.(4)The self-rating quality of life scale for constipation patients:the Chinese medicine group,the placebo+diet group and the Chinese medicine+diet group could significantly reduce the PAC-SYM score.(5)Constipation-related symptom scale:Chinese medicine group,placebo+diet group,Chinese medicine+diet group can significantly reduce the severity of constipation score.(6)TCM syndrome score:TCM symptom score was significantly reduced in the TCM group,placebo+diet group,and TCM+diet group.(7)48-hour gastrointestinal passage time(48h GITT):Chinese medicine group,placebo+diet group and Chinese medicine+diet group could significantly increase the 48h GITT barium bar excretion rate.3.Compliance evaluation:(1)Dietary compliance rateThe mean dietary compliance rate of placebo+diet group was 93.4%,and that of TCM+diet group was 94.967%.(2)Medication compliance rateThe mean medication compliance rate in the TCM group was 90.328%,the mean medication compliance rate in the placebo+diet group was 96.282%,and the mean medication compliance rate in the TCM+diet group was 95.438%.Study 3:1 The content of acetic acid and caproic acid in stool samples of the traditional Chinese medicine group showed an upward trend after the intervention.The content of propionic acid,butyric acid,isobutyric acid,valeric acid and isovaleric acid showed a downward trend.2.After the intervention,the acetic acid content in the stool samples of the placebo+diet group increased significantly,the content of propionic acid,butyric acid,and caproic acid increased compared with before the intervention,and the content of valeric acid decreased compared with that before the intervention.The content of isobutyric acid and isovaleric acid decreased significantly compared with that before the intervention.3.The content of acetic acid and caproic acid in stool samples before and after intervention in the traditional Chinese medicine+diet group showed an upward trend.The content of propionic acid,butyric acid,isobutyric acid and valeric acid showed a downward trend.The content of isovaleric acid was significantly lower than before the intervention.Conclusion1.Vegetarian method and Qingjiangtiaochang prescription can significantly improve the frequency of complete spontaneous defecation per week,improve stool hardness,increase intestinal motility,relieve constipation symptoms,and improve the quality of life of patients with functional constipation.2.Vegetarian diet can significantly increase the content of short-chain fatty acids in feces of patients with functional constipation.Qingjiangtiaochang prescription may not improve the symptoms of constipation by regulating the content of short chain fatty acids in the intestine.The increased levels of acetic acid and caproic acid in the intestine may be the reason for the improvement of constipation symptoms. |
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