| Objective:We aimed to observe the clinical effect of Self-made Laxative Decoction in the treatment of functional constipation(FC)in the elderly under the guidance of TCM theory,to verify the safety and effectiveness of Self-made Laxative Decoction,providing new methods for the treatment of elderly FC.Methods: Sixty-five elderly patients with FC(spleen and kidney deficiency type)were enrolled as volunteers.They were randomly divided into two groups,and there were 33 patients in the observation group and 32 patients in the control group.The patients of control group were treated with polyethylene glycol 4000,twice daily,10 g each time.The patients of observation group received Self-made Laxative Decoction treatment,1 dose /day,2 times / day.Both groups took 7 days as a period of treatment.Following3 periods of treatment,the patients rested for 2 days without any medication and then proceeded to the next period of treatment.There were 6 periods of treatment in total.The effect evaluation was performed by single-blind method,which means that the evaluator did not know the patient grouping,and the clinical efficacy of the patient was evaluated before treatment,3 weeks following treatment,and 6 weeks following treatment,via the main symptom score table of constipation;Self-evaluation questionnaire(patient assessment of constipation quality of life questionnaire,PAC-QOL)was used to evaluate the quality of life of patients before treatment and 6 weeks following treatment.We also assessed the recurrence rate 3 months following treatment and observed adverse events during treatment.Results: After 6 weeks of treatment,the total effective rate was 90.90%in the observation group and 84.38% in the control group.There was nosignificant difference(P>0.05).The comparison within the group found that the scores and the total score of the main symptoms of the two groups decreased after 3 weeks of treatment and 6 weeks of treatment,and the difference was statistically significant(P<0.05).There was a statistically significant difference in the scores of the main symptoms between the two groups after 3 weeks of treatment and 6 weeks of treatment(P<0.05).There was no significant difference in the scores and the total score of the main symptoms between the two groups before treatment(P>0.05).After 3 weeks of treatment,the scores and the total score of defecation time and symptoms of falling sensation in the observation group were larger than those in the control group,and the difference was statistically significant(P<0.05).After 6 weeks of treatment,the scores and the total score of the main symptoms of the observation group decreased more than the control group.The difference was statistically significant(P<0.05).There was no significant difference in the scores and the total score of PAC-QOL between the two groups before treatment(P>0.05).After 6 weeks of treatment,the physiology,psychology,anxiety,satisfaction and total score of the two groups were significantly lower than those before treatment(P<0.05).After 6 weeks of treatment,the scores and the total score of PAC-QOL of falling sensation in the observation group were larger than those in the control group,and the difference was statistically significant(P<0.05).The recurrence of the two groups after 3 months of treatment showed that the recurrence rate of the observation group was significantly lower than that of the control group(P<0.05).No adverse reactions occurred in the two groups in the course of treatment,indicating that the safety of the medication was fair.Conclusion: Self-made Laxative Decoction can effectively alleviate the symptoms of elderly FC,improving the quality of life for patients,which has long-lasting effect and good safety.It is worthy of promoting sclinical application. |