The Clinical Observation Of Dachengqi Decoction Acupoint Application In The Treatment Of Functional Constipation With Intestinal Excess-heat Syndrome

Objective:This study aimed to compare the clinical efficacy and safety of Dachengqi decoction acupoint application with polyethylene glycol(PEG)4000 in the treatment of functional constipation(FC)with intestinal excess-heat syndrome.To provide clinical research evidence for the selection and spread of the advantage scheme of FC with intestinal excess-heat syndrome.Method:84 FC with intestinal excess-heat syndrome patients were randomly divided into the observation group and the control group,42 patients in each group.The observation group was given Dachengqi decoction acupoint application once a day;the control group took PEG4000 20 g once a day;The study will continue for a period of 14 days.The study will focus investigation of the first bowl movement and constipation-related symptom scores as its primary outcome,patient assessment of constipation quality of life questionnaire(PAC-QOL)and TCM syndrome scale(TCMSS)will be included in secondary outcomes.Furthermore,the study will also determine compliance and safety.Result:1.Of 84 patients randmized,80 patients completed the treatment period,40 in each group.2.The two groups had the same baseline indicators(age,gender,height,weight,BMI,course of disease,symptoms,etc.)(P>0.05).3.The observation group had more earlier first bowl movement compared with the control group(0.87±0.54 d vs 1.63±0.47 d,P<0.05).4.Constipation-related symptom score: After the treatment,the each single symptom score and total score of both groups were decreased(P<0.05).Comparing two groups,there were no statistically significant after treatment in the total score of symptoms,Bristol stool form(BSF),defecation frequency,defecation time,straining,feeling of incomplete evacuation after bowel movement and sensation of anorectal obstruction(P>0.05),while the observation group had more lower score of abdominal pain and abdominal distention(P<0.05).5.PAC-QOL score: each groups had statistically significant differences in PAC-QOL total average score,physical discomfort,psychosocial discomfort,worry and anxiety,and satisfaction before and after treatment(P<0.05).There was no significant difference after treatment in PAC-QOL between the two groups(P>0.05).6.TCMSS: In the observation group,each single symptom score and the total score after treatment were significantly lower than that before treatment(P<0.05).In the control group,the scores of hard stool,abdominal distention or pain,flushed face or perturbed or fever,thirsted and bad breath,and the total score were also significantly different from those before treatment(P<0.05),there was no changes in the score of little and red urination,the tongue and pulse(P>0.05).1Comparing two groups,the observation group showed the significant changes in the score of abdominal distention or pain,little and red urination and total score(P<0.05),with other symptoms showed no changes(P<0.05).7.Compliance and safety assessment: Both groups had fine applications.There occurred 2 cases of adverse reaction in the observation group,3 case in the control group.There was no significant difference of the incidence of adverse events between two groups(P>0.05).Conclusion:1.Dachengqi decoction acupoint application and PEG4000 are both effective in treating FC with intestinal excess-heat syndrome.2.Dachengqi decoction acupoint application has more earlier first bowl movement than PEG4000.3.Both groups can relieve the constipation-related symptom and TCM syndrome,improve the quality of life.However,Dachengqi decoction acupoint applications are more effective in reliving abdominal pain,abdominal distention and TCM syndrome compared with PEG4000.4.Two groups have good compliance,and are both safe in the treatment of FCwith intestinal excess-heat syndrome,there is no serious adverse events occurred.