| Functional constipation is a common clinical syndrome,which is a functional gastrointestinal disease.Its clinical manifestations have very large individual differences,both in the traditional sense of the reduction,but also covers the broader categories of defecation difficulties,including a variety of accompanying discomfort.Its pathogenesis relates to diet,physical activity,lifestyle,mental problems and abuse of laxatives and other factors,the physiological mechanism of disease is not yet clear.With the change of diet and the pace of life,in middle age,young people are increasingly common,the prevalence of people over the age of 60 is up to 22%.Functional constipation delayed healing,which affects people's quality of life,when combined with severe cardiovascular and cerebrovascular diseases,can even lead to death because of defecation difficulties.At present,treatment of functional constipation in Western medicine mainly use prescription or non-prescription drugs,especially a variety of laxatives.Slow transmission constipation can use laxatives with laxative drugs,but the effect of drug treatment of defecation disorders constipation is poor,evidence-based medicine recommended biological Feedback therapy(grade I evidence,A level recommended),but not generally carried out in China.Therefore,the efficacy and safety of Western medicine treatment of constipation have to be improved,can not provide satisfactory services for patients.Western medicine on the treatment of constipation patients and safety issues have to be improved.The treatment of constipation in Chinese medicine has a wealth of treatment system,we focus on the syndrome differentiation and the overall view for the characteristics of syndromes to be treated to ease the difficulty of defecation at the same time effectively solve the problem of the overall coordination of multiple organs.in addition to oral decoction,there are proprietary Chinese medicine treatment,acupuncture therapy,catgut embedding therapy,local enema,and application therapy.there are a variety of external treatment.Ancient doctors widely used outside the law,a large number of clinical reports apply umbilical treatment of constipation is safe and effective,but it is not well promoted.How to confirm the efficacy of traditional Chinese medicine deposited umbilical treatment of constipation?If comprehensive hospital can apply umbilical treatment of constipation or not?How can we contribute to the inheritance and development of traditional medicine in terms of the evaluation of efficacy,diagnosis and treatment of traditional medicine for the heritage from the perspective of the combination of Chinese and Western medicine?To answer these questions,we have done three things:1.We access to literature,complete two review which are the pathogenesis of functional constipation and Chinese and Western medicine treatment progress,we need deeply study relevant knowledge and to understand the current situation of Chinese and Western medicine treatment of constipation and development direction;2.Complete traditional Chinese medicine navel intervention functional constipation:Systematic reviews of randomized controlled trials,deeply understand of the use of deposited umbilical therapy for functional constipation clinical research status and catch the problem in the rule of law,efficacy evaluation and other aspects;3.We use randomized,double-blind,placebo-controlled clinical trials to reflect the general principles of syndrome differentiation,and we choose the patients with functional constipation as the object of study to observe the efficacy of Dachengqi Decoction in the treatment of solid solution,and to lay the foundation for further research,but also for clinical use to provide ideas and basis.First,systematic reviewObjective:This paper systematically assessed the efficacy and safety of umbilical therapy in patients with functional constipation.Methods:Randomized controlled trials(RCTs)comparing umbilical therapy with placebo,no intervention or conventional western medicine were included through searching seven databases(PubMed,Embase,The Cochrane Library,CBM,CNKI,Wanfang,VIP)and relevant references in accordance with the Cochrane standards.Study identification,data extraction and quality assessment were conducted by two reviewers independently.Results were pooled for data with low heterogeneity and not pooled with high heterogeneity.We use a funnel to detect possible disease bias.GRADEpro software was used to generate the evidence quality summary table for the main outcome indicators in the main control group included in the study.Results:Nine RCTs enrolling 945 patients were included.Six studies described the random sequence generation,one study used placebo,none study reported blinding of outcome assessment,sample size estimation and intention-to-treat analysis.Only three studies were included in meta-analyses because the others had high heterogeneity.The results showed that umbilical therapy had similar effect with conventional Western medicine(mosapride citrate,rhubarb and sodium bicarbonate tablets,Polyethylene glycol-4000)in treating patients with functional constipation on total effective rate(RR 1.10;95%CI 0.99 to 1.22;3 trials,n =120;I~2 =37%).Most of included studies supported that umbilical therapy combined with basic therapy was more effective in improvement of the main symptom scores,compared with the same basic therapy alone.No serious adverse effects were reported for umbilical therapy in treating patients with functional constipation in included studies.The overall methodological quality was limited and the quality of evidence for main outcomes were“moderate”.Conclusion:Umbilical therapy showed some potential benefits for patients with functional constipation according to included studies in the improvement of total effective rate and the main symptom scores,and with no serious adverse effects.However,due to the limited quantity and quality of included evidence,and many data could not be pooled for analysis because of high heterogeneity,the therapeutic effect and safety of umbilical therapy for patients with functional constipation were not confirmed.More evidence from high quality clinical trials is warranted to support the use of umbilical therapy for patients with functional constipation.Second,clinical researchObjective:This paper confirms the clinical efficacy of Dachengqi Decoction in the treatment of functional constipation.Methods:We choose the patients with functional constipation as the object of study,disease in line with Rome III diagnostic criteria,Zheng Hou,including gastrointestinal heat syndrome and gas stagnation card.We use a randomized,double-blind,placebo-controlled clinical trial design and divide them into test group and control group.The experimental group was treated with Dachengqi Decoction(Rhubarb:Glauber's salt:Magnolia officinalis:Citrus aurantium 2:1:4:2)combined with oral lactulose treatment,the control group was treated with placebo plus umbilical combined with oral lactulose,treatment for 14 days.The main outcome indicators selected objective indicators of defecation frequency and the first defecation time,the secondary indicators combined with subjective indicators and objective indicators,they are self-assessment symptom score,quality of life satisfaction score,colon transmission index(barium retention site and quantity after 72 hours,colon transit index),Anorectal manometry indicators(sensory indicators,power indicators),the changes of defecation frequency,intestinal transmission function,rectal motility and subjective sensation were observed by means of PRO scale,colonic transit test,high-resolution rectal anal canal pressure and other methods before and after treatment.Adverse reactions were observed and treatment was completed The PRO scale was repeated four weeks later to assess long-term efficacy.The test is reported in accordance with the CONSORT statement.Results:(1)Baseline data showed that there was no statistically significant difference between the experimental group and the control group in the baseline data of the population characteristic data and the outcome index.(2)After treatment,the main outcome of the test group defecation frequency improved better than the control group(t=-5.39,P<0.001,95%CI:-2.28,-1.05);The first defecation time was shortened,compared with the control group was statistically significant(chi-square =4.85,P = 0.0275).(3)After treatment,the subjective indicators of outcome indicators improved.(T =-4.26,P<0.001;t =-2.36,P<0.05).The results showed that the improvement of defecation score and counseling symptom score was better than that of the control group.The overall satisfaction score of quality of life was better than that of the control group(t =-2.78,P<0.05,95%CI:-2.22,-0.36).(4)After treatment,the objective index of the outcome index was improved.The number of rectal and sigmoid barbium in the experimental group was significantly different from that in the control group(MEAN:-1.63,95%CI:-3.07,-0.19,P = 0.0267).After treatment,the classification of constipation was different,and the improvement of constipation was the most obvious.The changes of FSV,DSV,DTV and MTV in the anorectal rectal dynamics were significantly different between the two groups before and after treatment(P<0.001).The analgesic pressure The change of anal sphincter pressure during defecation was statistically significant(P<0.05)between the two groups before and after treatment,and the difference between the two groups was statistically significant(P<0.05).(5)After four weeks of discontinuation,the difference was statistically significant(P<0.001).There were significant differences between the two groups(P<0.001,95%CI:-2.23,-0.98),defecation score,stool score and palpitations The effect is better than the control group.(6)The incidence of adverse reactions in the test group is low,the degree is light,which did not affect the treatment.Conclusion:(1)Dachengqi Decoction of the clinical application of the clinical efficacy is positive,which can effectively alleviate the difficulty of defecation,improve the complication and patients are willing to accept.(2)It provides an effective and easy treatment for the Defecation disorders constipation of Western medicine is difficult to treat.(3)Combined with lactulose,Dachengqi Decoction can enhance the efficacy and reduce side effects.(4)The rational use of PRO scale combined with objective indicators measurement means is conducive to objective and comprehensive evaluation of the clinical efficacy of Chinese medicine therapy. |
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