| Objective:To evaluation the clinical curative effect of the Sanren Wotou in the treatment of functional constipation(FC)with intestinal excess heat syndrome.With the first defecation time,constipation symptom scores,TCM syndrome score and constipation patients quality of life scale(PAC-QOL)as the index to evaluate the effect of the Sanren Wotou and advantages,it provides ideas and methods for the treatment of this disease and scientific theoretical basis for the popularization and application of medicated diet.Methods:From February 2022 to August 2022,72 patients with FC of intestinal excess heat syndrome who met the inclusion and exclusion criteria were recruited from the outpatient department of liver,spleen and stomach,nutrition department and health examination center of a third-class TCM hospital in Heilongjiang Province as research objects.The subjects were randomly divided into treatment group and control group,with 36 cases in each group.The control group was given health education of traditional Chinese medicine nursing and polyethylene glycol 4000 powder.The treatment group was given self-designed Sanren Wotou on the basis of the control group.The patients’ constipation symptoms,TCM syndrome and quality of life were investigated before and two weeks after treatment,and the patients’ first defecation time was recorded during treatment to fully explore the efficacy and safety of this program.Results:1.A total of 72 patients were recruited in this study,and a total of 68 patients completed the whole study treatment,with 34 patients in the treatment group and 34 patients in the control group.2.There was no significant difference in the general information(gender,age,course of disease,height,weight,educational background,eating habits,exercise habits and water intake)between the two groups(P>0.05).3.First defecation time:After treatment,the first defecation time was 1.00±0.41(d)in the treatment group and 1.79±0.55(d)in the control group,and the difference was statistically significant(P<0.01).4.Constipation symptom score:① Comparison between groups:After treatment,abdominal distension and improvement of Bristol fecal traits were significantly different between the two groups(P<0.05),There was no significant difference in difficulty,inadequate defecation,frequency and time of defecation(P>0.05).②Intra-group comparison:The improvement of constipation symptom score before and after treatment was significantly different in the treatment group(P<0.01);The improvement of constipation symptom score before and after treatment was significantly different in control group(P<0.01).5.TCM syndrome score:①Comparison between groups:After treatment,there were significant differences in the improvement of epigastric distension or pain,dry mouth and bad breath,and short red urine between the two groups(P<0.05),There was no significant difference in dry stool and restlessness(P>0.05).②Intra-group comparison:The improvement of TCM syndrome score before and after treatment was significantly different in the treatment group(P<0.01).There was significant difference in TCM syndrome score of control group before and after treatment(P<0.05).6.Life quality of constipation patients:①Comparison between groups:After treatment,the improvement of the four dimensions of PAC-QOL scale was significantly different between the two groups(P<0.01).②Intra-group comparison:The improvement of each dimension of PAC-QOL scale was significantly different in the treatment group before and after treatment(P<0.01);The improvement of each dimension of PAC-QOL scale before and after treatment was significantly different in the control group(P<0.01).7.Efficacy evaluation:The total effective rate was 91.2%in the treatment group and 76.5%in the control group.8.Safety evaluation:During the treatment period,there was 1 adverse reaction in the treatment group and 2 adverse reactions in the control group,and there was no significant difference in the incidence of adverse events between the two groups(P>0.05).Conclusion:1.The results of this study showed that the Sanren Wotou could shorten the time of first defecation in the FC patients with intestinal excess heat syndrome.2.The results of this study showed that the Sanren Wotou could improve the constipation symptoms of the FC patients with intestinal excess heat syndrome.3.The results of this study showed that the Sanren Wotou could improve the TCM syndrome score of the FC patients with intestinal excess heat syndrome.4.The results of this study showed that Sanren Wotou could improve the quality of life of the FC patients with intestinal excess heat syndrome. |
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