A Multi-center Clinical Randomized Controlled Trial Of Acupuncture For Treating Functional Constipation

Objective:This research was a multi-center randomized controlled trail of acupuncture for treating functional constipation.In order to get the clinical efficacy,the change of quality of life and mental state in this trail, we punctured the body at different compatibility of acupoints such as compatibility of Tianshu(ST25) and Dachangshu(BL25), compatibility of Quchi(LIll) and Shangjuxu(ST37), compatibility of those four acupoints. The results of effect assessment would be helpful to preliminarily clarify the efficacy of acupuncture for treating functional constipation.Methods:In this trial,247patients of functional constipation were randomly assigned to four groups using central randomization:compatibility of back-shu point and front-mu piont group (group A), compatibility of He-sea point and lower He-sea piont group (group B), compatibility of back-shu point, front-mu point, He-sea point and lower He-sea piont group (group C) and control group (group D). Tianshu(ST25) and Dachangshu(BL25), were punctured in group A; Quchi(LI11) and Shangjuxu(ST37) were punctured in group B; Tianshu(ST25), Dachangshu(BL25), Quchi(LI11) and Shangjuxu(ST37) were punctured in group C; pillars of mosapride were taken orally in group D.Group A, group B all points were bilateral, group C were unilateral, the left and right sides were used interchangeably. After getting needle response, the stimulate of acupuncture would last30minutes by electric acupuncture apparatus at frequencies of20Hz. Each acupuncture session lasted for30minutes.The intensity was lower the degree of patients’ tolerance. Group D took pillars of mosapride citrate,5milligram per time,3times a day and continuously for4weeks. The research period had nine weeks. The treatment period was4weeks. Patients of group A, B and C were punctured in5times in first2weeks, and were punctured3times in last2weeks. There had16times in treatment period totally.The outcome included the times of defecation per week, stool quality, the degree of difficulty in defecation, health-related quality of life score(SF-36), self-rating anxiety scale (SAS), self-rating depression scale (SDS), value of acupuncture expection appraisal,etc. The following outcome measurements were assessed at begining, the second, fourth and eighth week after randomization:value of acupuncture expection appraisal were assessed at begining after randomization; the times of defecation per week, stool’quality, the degree of difficulty in defecation were assessed at begining, the second, fourth and eighth week; health-related quality of life score were assessed at begining and the fourth week; SAS and SDS were assessed at begining, the second and fourth week.Results:1. This trial was well completed and the characteristics of four groups were comparable in baseline(P>0.05).2. The results of study indicated preliminarily that the following outcomes among group A, B, C and D were not statistically significant (P>0.05). However, times of each group in four assessment compared before and after the therapy had a significant difference (P<0.01). The following outcomes among four groups were not statistically significant (P>0.05), but each group of four assessment compared before and after the therapy had a significant difference (P<0.01). In the comparison of the degree of difficulty in defecation, the differences among group A, B and D were not statistically significant(P>0.05),but the score of group C was lower than group D. Scores of each group in four assessment compared before and after the therapy had a significant difference (P<0.01).3. The SF-36scale scores of four groups was not statistically significant (P>0.05). however, Scores of some dimensions in groups had a significant difference, and there was some overlap in these different dimensions. 4. There was no significant difference among four groups in three assessment of SAS and SDS(P>0.05).In the group self-comparisons. Scores of SAS in group A and C was statistically significant, but Scores of SAS in group B and D was not. In the group self-comparisons of SDS, Group A had a significant difference (P<0.01), but other three groups had none. There was statistical correlation between the improvement of clinical symptoms and changes of SAS and SDS. If frequency of defecation increase, scores of SAS and SDS will dropped.5. There was no significant difference among four groups in value of acupuncture expection appraisal (P>0.05). In the correlation analysis, there was no statistical correlation between the acupuncture expection appraisal, improvement of clinical symptoms and changes of SAS.However, there was statistical correlation between value of acupuncture expection appraisal and changes of SDS. If value of acupuncture expection appraisal increase, scores of SDS will dropped.Conclusions:1. The results of study indicated preliminarily that the compatibility of points are effective treatment of functional constipation, its efficacy as the same as conventional drug treatment. Increasing trend with increasing treatment time, its therapeutic efficacy would increase and last in the follow-up period.But there was no statistical correlation between it and the acupuncture expection appraisal.2. The results of study indicated preliminarily that the improvement of quality of life of patients with functional constipation treat by acupuncture was limited,and different compatibility of acupoints would have different changes of dimensions.