A Multi-center Clinical Randomized Controlled Trial Of Acupuncture For Treating Irritable Bowel Syndrome-Diarrhea

Aim:A multi-centered randomized trial was conducted to observe the effect of acupuncture and the mental improvement and life quality of patients to provide irritable bowel syndrome-diarrhea optimal points compatibility for the treatment of in clinics. The trail punctures were on the compatibility of Dachangshu (BT25) and Tianshu (ST25), compatibility of Shangjuxu (ST37) and Quchi (LI11) and compatibility of those four acupoints.Methods:The subjects come from the affiliated hospitals of Chengdu University of TCM (Chengdu Research Center), Hunan University of TCM (Hunan Research Center), Guang’anmen Hospital-China Academy of Chinese Medical Sciences (Beijing Research Center), Changchun University of TCM (Changchun Research Center), Shandong University of TCM (Shandong Research Center). They are in-patients, out-patients and students patients. In this trial,348patients of IBS-D were randomly assigned to four groups by the central randomization system:compatibility of large intestine He-sea point and lower He-sea point group (Group A), compatibility of large intestine back-shu point and front-shu point group (Group B), compatibility of large intestine back-shu point, front-mu point, He-sea point and lower He-sea point group (Group C) and the control group by positive medicine pillars of Loperamide. Quchi (LI11) and Shangjuxu (ST37) were punctured in Group A; Tianshu (ST25) and Dachangshu (BL25) in Group B; Tianshu (ST25), Dachangshu (BL25), Quchi (LI11) and Shangjuxu (ST37) in Group C. The acupoints were inserted bilaterally for Group A and B, unilaterally for Group C and the left and right side alternately. After qi arrival the patient will receive the electric acupuncture for30minutes at20Hz. The intensity of the electricity was decided by the tolerance of the patient. Since the trial started, the subjects from Group A, B, C had a5-day treatment, once a day, for first2weeks. In the third and fourth week, the subjects received treatment every other day, three times a week. After having two days off, the patients continued the same in the next week,16treatments in total. Group D orally took loperamide hydrochloride capsule3times per day,6mg daily, for4weeks. The research covered9weeks, including one-week baseline period,4-week treating period,4-week follow-up period. All the observations happened at the beginning, the2nd week, the4th week and8th week of the research.This study evaluated the times of defecation per week, characteristics of stool, maintaining time of normal defecation, which were evaluated respectively at the trial start, the second, and the fourth and eighth week survey table. Also, SDS and SAS were evaluated respectively at the start, the second and the fourth week. The evaluation of the expected value for acupuncture was evaluated at the start and the fourth week.Results:1. This trial completed numbers and the uncompleted numbers were nearly the some in the4groups. The general condition, physi-chemtests and effect criteria baseline in4groups were comparable (P>0.05).2. The study indicates remarkable differences in the frequency of defecation in the four assessments (P<0.01). The comparison among the four assessments indicates that the outcomes from Group A, C and D are statistically significant (P＜0.05); the outcomes from Group B and D are not statistically significant (P>0.05). The four assessments in each group indicate the remarkable differences in stool’s characteristics (P<0.01). There was no statistic significance among the4groups’ comparison of the stool shapes improvement (P>0.05). The four assessments in each group indicate the remarkable differences in maintaining time of normal defecation (P<0.01). There was no statistic significance among the4groups’comparison of maintaining time of normal defecation (P>0.05).3. The study indicates that the SF-36scores of groups was not statistically significant (P>0.05) while scores of some dimensions in groups had a significant difference, and there was some overlapping in these different dimensions.4. The study indicates that there were no significant differences in three assessments of SAS and SDS (P>0.05) among four groups. From the first to third evaluations, in the group self-comparisons of SAS, the scores of Group A, B and C were statistically significant (P<0.05), while the scores of Group D were not (P>0.05). In the group self comparisons of SDS, the scores from Group C were statistically significant (P<0.05), while the scores from other groups were not (P>0.05).Conclusions:1. The results of the study demonstrate that the variety of acupoints compatibility and medication group can effectively improve the symptoms of patients with IBS-D.2. The results show that the variety of acupoints compatibility and medication group can produce different improvement of patients’life quality.3. The results indicate that different compatibility of points can provide different improvement of patients’mental conditions, among which the compatibility of Tianshu (ST25), Dachangshu (BL25), Quchi (LI11) and Shangjuxu (ST37) brought about the best effect, while the medication group has no effect.