| Objective:The objective is to have a preliminary evaluation on the effect and safety of deep needling treatment of functional constipation at Tianshu.Methods:95 cases satisfied the inclusion criteria were randomly divided into observation group control group 1 and group 2, according to the ratio of 2:1:1, with deep needling at bilateral Tianshu, Lactulose Oral Solution prescription and shallow needling at bilateral Tianshu correspond-ingly. The effect of these three methods is compared in the field of defecate frequency, Cleveland Constipation Score (CCS), patient satisfact ion and other changes to improve the situation of defecation. and analyze the correlation.Results:The key outcome indicators:1, in improving defecate frequ-ency per week, the deep acupuncture group increased by an average defecate frequency 2.49times, medicine group increased by 2.20 times and shallow acupuncture group increased 2.05 times (all P<0.01); but no difference among the three groups significance (P>0.05) 2, After 4 weeks the cases of defecate frequency per week above 4 times:deep needling group increased by 71.1%, medicine group increased by 45.0%, shallow acupuncture group increased by 55.0%(all P<0.01);with the comparison among the three groups P>0.05. Evaluation of secondary outcomes:1, Cleveland Constipation Score (CCS):Compared with baseline, deep needling group score reduced 5.82, with the improve rate 44.7%(P<0.01), medicine group and shallow acupuncture group were 3.10 and 5.0(27.0% and 37.7%, both P<0.01), deep needling group has significantly better effect than the other control groups,when three groups compared (P<0.05).2. patients with symptoms self-assessment in effort to improve the degree of need great effort to defecateb, the sense of defecation incompletely, the stool texture, abdominal pain, bloating discomfort are all effective (P<0.05) Among the three groups, there is significantly different in improving the sense of defecation incompletely (P<0.05), Others ar non-statistically sign ificant(P>0.05);3patient satisfaction:patients satisfaction of the three groups before and after treatment was significant difference (P= <0.05).4. the first self-defecation time:the first time self-defecation time of the medicine group was 31.58 hours, deep needling group was 38.46 hours, shallow acupuncture group was 48.50 hours, the first time defecate independently among three groups was no significant(P>0.05).Clinical follow-up after treatment: 4 weeks,12 weeks,6 months after treatment, the defecate frequency perweek of three groups were signific-antly different(P<0.05).Safety Evaluation:39 patients were treated for deep needling at Tianshu, there was one case has minor complaints of pain when acupuncturting, slowing down the speed, pain can lighten and the treatment can be continued. There were no diarrhea, borborygmus, halo needle, hematoma, abdominal infection and other adverse reactions.Conclusion:With the method of deep needling at Tianshu for functional constipation is effective, the recent efficacy is comparable to lactulose oral solution, the efects after 1 month,3 months and 6-month are better than lactulose oral solution. In improving the con-stipation-related symptoms and patient satisfaction deep needling at Tianshu are superior than Lactulose; The effect of deep needling at Tianshu for functional constipation has a relationship with the depth of the acupuncture needles deep needling in the improvement of constipation symptoms, patient satisfaction and the efects after 1 month,3 months and 6 month are better than than shallow needling. Preliminary observations show that deep needling at Tianshu for functional constipation is safe. |