| Objective:By observing and evaluating the clinical effect of Tiaochangtongfu decoction in the treatment of functional constipation(spleen deficiency qi stagnation type),this paper discusses the symptoms of functional constipation(spleen deficiency qi stagnation type)and the improvement of quality of life,objectively evaluates its efficacy and safety,and provides a theoretical basis for clinical application of Tiaojingtongfu decoction in the treatment of functional constipation(spleen deficiency qi stagnation type).Methods:According to the inclusion and exclusion criteria,64 patients(Functional Constipation,FC)with functional constipation with spleen deficiency and qi stagnation were selected.According to the "random number table method",they were randomly divided into treatment group and control group,each group was 32 cases.The treatment group was treated with Tiaochangtongfu decoction,and the control group was treated with trimebutine maleate tablets.The proportion of patients with complete spontaneous defecation(SCBM)≥3times a week,TCM symptoms scores,TCM syndrome efficacy,quality of life self-rating scale(PAC-QOL scale)and symptom self-rating(PAC-SYM scale)were observed for 2 weeks and 4weeks respectively.Results:4 cases fell off during the study,30 cases in the treatment group and 30 cases in the control group that finally completed the trial.1.General informationThe average age of the treatment group was 49.3±12.94 years,that of the control group was 48.53±14.46 years.were comparable between the two groups(P>0.05).2.The proportion of patients with SCBM≥an average of 3 times a week.There was no difference between the two groups SCBM≥three times a week before treatment(P > 0.05),which was comparable.After two weeks and four weeks treatment,the proportion of SCBM≥3times each week in the treatment group was30%and 36.7%,and the control group was33.3% and 40%.There was no significant difference between the two groups(P≥0.05).3.TCM symptoms scoresThere was no difference in TCM symptom score between the two groups before treatment(P>0.05),which was comparable.After two weeks treatment,there was a significant difference in the total scores of TCM symptoms between the two groups(P<0.05),suggesting that the treatment group was superior to the control group with symptoms of defecation effort,abdominal distension with abdominal pain,emotional unobstructed aggravation,chest and flank stuffiness,fatigue after stool,fatigue and lazy speech.Compared within the group,the total scores of TCM symptoms of the two groups were both lower than before treatment and the difference was statistically significant(P<0.05),indicating that the two groups had curative effect on improving constipation symptoms,among which the treatment group improved each symptom better than before treatment,the difference was statistically significant(P<0.05).Except unconspicuous emotional unobstructed aggravation,fatigue after stool,fatigue and lazy speech,the rest of the symptoms were significantly improved(P<0.05).After 4 weeks of treatment,there was a significant difference in the total scores of symptoms between the two groups(P<0.05),and the effect of the treatment group was better than that of the control group in the aspects of defecation effort,abdominal distension with abdominal pain,emotional unobstructed aggravation,chest and flank stuffiness,fatigue after stool,fatigue and lazy speech(P<0.05).Compared within the group,the total scores of TCM symptoms of the two groups were both lower than before treatment and the difference was statistically significant(P<0.05),indicating that the two groups had curative effect on improving constipation symptoms,among which the treatment group improved each symptom better than before treatment,the difference was statistically significant(P<0.05).Except unconspicuous fatigue after stool,fatigue and lazy speech,the rest of the symptoms were significantly improved(P<0.05).4.Traditional Chinese Medicine SyndromeAfter 2 weeks and 4 weeks of treatment,the total effective rate of the treatment group was70.0%and93.3%,and that of the control group was33.3%and70.0%.There was a significant difference between the two groups(P<0.05),suggesting that the effect of the treatment group was better than that of the control group.5.Patient-Assessment of Constipation Quality of Life,PAC-QOLThere was no difference in PAC-QOL scores between the two groups before treatment(P>0.05),which was comparable.After 2 weeks of treatment,the total scores and 4dimensions scores of the two groups were significantly lower than those before treatment(P<0.05),in which the treatment group was better than the control group in the four dimensions of physical discomfort,psychosocial discomfort,anxiety and satisfaction(P<0.05).After 4 weeks of treatment,the total scores and 4 dimensions scores of the two groups decreased significantly compared with those before treatment(P<0.05).Among them,the curative effect of the treatment group was better than that of the control group in the four dimensions of physical discomfort,psychosocial discomfort,anxiety and satisfaction(P<0.05).6.Patient-Assessment of Constipation Symptom,PAC-SYMThere was no difference in PAC-SYM scores between the two groups before treatment(P>0.05),which was comparable.After 2 weeks of treatment,the total scores and 3dimensions scores of the two groups were significantly lower than before treatment,and the difference was statistically significant(P<0.05).The effects of the treatment group on 3dimensions of fecal traits,rectal symptoms,abdominal symptoms and total scores were better than those of the control group(P<0.05).After 4 weeks of treatment,the total scores and 3 dimensions scores of the two groups were significantly lower than before treatment,and the difference was statistically significant(P<0.05),in which the treatment group was better than the control group in terms of total scores and 3 dimensions,and the difference was statistically significant(P<0.05).Conclusion :1.Both Tiaochangtongfu decoction and Tramebutine maleate tablets have certain clinical effect in treating spleen deficiency and qi stagnation type FC,and Tiaochangtongfu decoction has better effect,especially in defecation effort,abdominal distension with abdominal pain,emotional unobstructed aggravation,chest and flank stuffiness,fatigue after stool,fatigue and lazy speech of TCM symptoms.2.Tiaochangtongfu decoction and timebutine maleate tablets can both improve thequality of patients’ life.Tiaochangtongfu decoction has more advantages in improving patients’ physical discomfort,psychological and social discomfort,anxiety and satisfaction.3.Tiaochangtongfu decoction and trimebutine maleate tablets can both improve the symptoms of constipation patients.Tiaochangtongfu decoction is more effective in improving fecal traits,rectal symptoms and abdominal symptoms.4.Tiaochangtongfu decotion has good safety and no obvious side effects. |
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