Objective: To explore the clinical efficacy and safety of modified Simo and Zengye Decoction in the treatment of functional constipation with qi stagnation and fluid deficiency.Methods:100 patients with functional constipation with Qi stagnation and Jin deficiency syndrome type who met the inclusion criteria were randomly divided into 50 cases in the treatment group and 50 cases in the control group.The treatment group was treated with modified Simo and Zengye-tang,and the control group was treated with oral compound polyethylene glycol electrolyte powder.The two groups were treated for 4 weeks and followed up after 4 weeks of withdrawal.The constipation severity score(CSS),TCM syndrome score and TCM syndrome recurrence were observed before and after treatment in the two groups of patients with functional constipation of Qi stagnation and Jin deficiency syndrome.Statistical analysis and comparison were carried out to explore the clinical efficacy and practical value of modified Simo and Zengye-tang in the treatment of functional constipation with Qi stagnation and deficiency.Results: 1.A total of 100 patients were enrolled in this study,of which 91 patients completed the clinical trial.There was no significant difference in gender,age and course of disease between the two groups before treatment(P>0.05).2.The total effective rate of TCM syndromes in the modified Simo and Zengye Decoction group was 91.84 %;the total effective rate of the compound polyethylene glycol electrolyte powder group was 69.05 %,and the difference was statistically significant(P<0.05).3.After treatment,the constipation severity(CSS)score was compared within the group,except for the defecation auxiliary method,there were statistically significant differences in the CSS symptom scores of the two groups before and after treatment(P<0.05).In terms of defecation auxiliary methods,there was a statistical difference before and after treatment in the treatment group(P<0.05),but there was no statistical difference before and after treatment in the control group(P>0.05).There was significant difference in constipation severity(CSS)score between the two groups(P<0.05).In terms of individual symptoms,there was a statistical difference between the two groups in improving incomplete defecation or anal bulge,abdominal distension and abdominal pain,and defecation assist methods(P<0.05);there was no significant difference in defecation frequency,defecation effort,toilet time,empty discharge times,and fecal nature(P>0.05).4.After treatment,the total scores of TCM syndromes and the scores of individual symptoms in the two groups were lower than those before treatment,and the difference was statistically significant(P<0.05).After treatment,the total scores of TCM syndrome between the two groups were statistically significant(P<0.05).There was no significant difference in dry stool,poor defecation,belching / sagittal frequency(P>0.05).There were statistically significant differences in depression,chest and abdomen fullness,dry mouth,upset and less sleep(P<0.05).5.Four weeks after the end of treatment,45 patients in the treatment group were followed up,4 patients relapsed,41 patients did not relapse,and the recurrence rate was 8.89%.In the control group,29 patients were followed up,10 patients relapsed,19 patients did not relapse,and the recurrence rate was 34.48%.The difference was statistically significant(P<0.05).Conclusion:(1)Both modified Simo and Zengye Decoction and compound polyethylene glycol electrolyte powder can reduce the severity score of constipation.The two groups of drugs had similar efficacy in defecation frequency,defecation effort,toilet time,daily empty discharge times,and fecal properties.In terms of incomplete defecation or anal bulge,abdominal pain,abdominal distension,and defecation auxiliary methods,the curative effect of modified Simo and Zengye Decoction is better than that of compound polyethylene glycol electrolyte powder.(2)In terms of TCM syndromes,the therapeutic effect on symptoms such as dry stool,unpleasant defecation,belching / sagittal frequency is equivalent to that of compound polyethylene glycol electrolyte powder,and the therapeutic effect on symptoms such as depression,chest and abdomen fullness,dry mouth and tongue,upset and less sleep is better than that of compound polyethylene glycol electrolyte powder.The comprehensive treatment effect is better than that of compound polyethylene glycol electrolyte powder,which has a good therapeutic effect on patients with constipation of qi stagnation and fluid deficiency.(3)There were no adverse reactions during the study,the recurrence rate was low,and the long-term efficacy was safe and reliable. |