Evaluation Of The Short And Long-term Effect On The Treatment Of Electro-acupuncture In Functional Constipation

Background:Functional constipation (FC) is a common gastrointestinal (GI) disease throughout the world.Patients suffering from chronic constipation note several symptoms, such as infrequent spontaneous bowel movements (< three bowel movements per week), straining in defecations,lumpy Or hard stools, sensation of incomplete evacuation after defecations,bloating and abdominal discomfort, excessive time spent on defecation, or even the need to use manual manipulation to facilitate defecation.There is currently no specific treatment for functional Constipation. Fibres,laxative therapy, biofeedback therapy and surgical treatment are the most commonly used treatment but nor of them is uniformly effective,and compliance with some of them is poor because of its side effects.There is a need for a safe, effective, non-toxic therapy for functional constipation. Acupuncture, which has a history of more than 3000 years, plays an important part in Traditional Chinese Medicine (TCM). Although the mechanism of acupuncture therapy for chronic constipation is not quite clear, clinical trials, which were performed to discuss the efficacy of acupuncture for chronic constipation in the past 20 years, indicate that acupuncture could relieve functional constipation in some aspects. However, the quality of evidence is limited because of the less rigorous study design, small sample size, and lack of randomization, control groups, strict inclusion criteria and unified standards of efficacy evaluation.Objective:The aim of the trial is to assess the therapeutic effects of EA and prucalopride on complete spontaneous bowel movements,spontaneous bowel movements,stool shape,defecate difficulty and quality of life in patients with severe functional constipation.And to prospective observe the long-term impact of EA so that determine whether the patients benefit in the long run.Methods:Total of 60 patients with severe functional constipation acupuncture clinic for the study, recruited from the Affiliated Hospital of Nanjing University of Chinese Medicine Department of Gastroenterology. In this randomized controlled trial, patients were randomly divided into Electro-acupuncture (EA) group and pharmaceutical group at the rate of 1:1. Acupoints choosen for EA treatment are bilateral ST25(Tianshu), SP14(Fujie), ST37(Shangjuxu), needling for 30 minutes each time, first 2 weeks of treatment 5 times/ weekjfollowed 6 weeks treatment 3 times/week; totally treated 28 times during the 8 week treatment period. Positive control group:prucalopride succinate tablets,2mg, early morning before breakfast,32 weeks of continuous use. Timepoint for observation and assessment are at baseline,first two weeks of treatment period, 3-8* week of treatment period, four weeks after the end of treatment,8 weeks after the end of treatment,12 weeks after the end of treatment and 24 weeks after the end of treatment. The main outcome was completely customize the number of bowel movements, resolve minor indicators for independent defecation, Bristol stool scale, defecation difficulty ratings scale, PAC-QOL scale. By observing the comparative efficacy of two groups of patients after treatment, patients 6 weeks completely customize the average weekly number of bowel movements accounted for the change in the percentage of the total number of bowel movements and treatment completely customize assess all aspects of the EA. By comparing the EA treatment period and follow-up in patients 9-12 weeks,9-16 weeks, average weekly 9 to 20 weeks,9 to 32 weeks each period completely customize defecation case number of the total number of percentage and completely customize the number of bowel movements, etc. resolve changes in indicators to assess the sustained effects of acupuncture treatment.Results:1. The task completion:60 patients had three cases falling (EA group 1 patients, the drug group 2 cases), acupuncture group 30 cases, the pharmaceutical group of 30 patients completed treatment and follow-up. Statistical analysis of the baseline, the two groups of patients demographic data, bowel symptoms and quality of life scores were no significant differences in the subject line with design standards. 2.Outcomes:(1) Main outcome:According to statistical analysis, there is significant change of CSBMs of patients in two groups after treatment compared with baseline. There was no difference between groups (2) Secondary outcomes:SBMs, Bristol stool form score, bowel problems score, PAC-QOL score of patients in two groups:There are significant differences in the comparison group before and after treatment, there was no significant difference between groups.Conclusion:1. Boht EA and prucalopride succinate tablets are able to improve bowel symptoms of functional constipation.Both increased patients with completely customize the frequency of defecation.2. EA therapy not only improves stool frequency and shorten the defecation cycle, but also soften stool stiffness, relieve constipation role.3. By comparing the patient each time the PAC-QOL scale score, find EA therapy also play a role in improving the quality of life of patients.4. Long-lasting efficacy of EA treatment maintain in a certain time period, patients benefit long-term. Compared with drugs, EA is equivalentefficacy but more stable, with a long-term benefit and no side effects. EA should be extended in the clinic.