Study On The Clinical Effect Of Deep Needling With Electric Acupuncture On Severe Functional Constipation And The Correlation Between Intestinal And Lung Syndromes

Objective1 To evaluate and confirm the effectiveness and safety of electroacupuncture and deeply needling method for treating severe functional constipation through clinical randomized controlled trials.2 To observe the effect of electroacupuncture treatment for severe functional constipation and change of intestine syndromes and lung syndromes and their correlationship by TCM Syndromes Scale Table.Methods1 Literature reviewThrough the ancient and modern literature retrieval on acupuncture treatment of constipation,to discuss the effect of deep needling and electroacupuncture treatment on functional constipation.Through the ancient and modern literature search on the relationship between the lung syndromes and the large intestine syndromes,to discuss their mutual transmission and acupuncture treatment based on the theory of the interior-exterior relationship of the lung and large intestine.2 Clinical studies2.1 Grouping70 cases of severe functional constipation in accordance with the inclusive criteria were randomly divided into treatment group(Electroacupuncture group,EA)and control group(sham EA group,shamEA),35 cases in each group.2.2 Treatment method(1)The treatment group(Electroacupuncture group,EA)Acupoints:(bilaterally)Tianshu(ST25),Fujie(SP14),Shangjuxu(ST37).Manipulation Methods:For Tianshu(ST25)and Fujie(SP14),3 inch stainless steel needles were adopted to insert skin quickly,and then slowly vertical deep needling,until the parietal peritoneum,no insertion and twisting.Then the needle handles of the above points were horizontally and bilaterally connected to the electrodes of the electroacupuncture device.The device is adjusted according to the following standard:A sparse-dense wave should be applied,with a frequency of 15Hz and a current intensity between 0.1mA-1.0mA until the abdominal muscle vibrates slightly.For Shangjuxu(ST37),filiform needles(1.5 inch)were vertically inserted 1 inch,then slightly and uniformly lifted and thrusted three times until Deqi(the desired sensation).During the retaining needle period,the needles were manipulated every 10 minutes.Totally there are three times.The course and the duration of treatment:the duration of 30 minutes are recommended for each treatment.And the course which is 5 times per week in the first two weeks and 3 times per week in the rest 6 weeks are recommended,namely 8 weeks and 28 times of treatment in total.(2)The control group(sham EA group,ShamEA)Acupoints:The non-acupoints located beside the bilateral Tianshu(ST25),Fujie(SP14)and Shangjuxu(ST37),which are respectively described as next-to-Tianshu(ST25),next-to-Fujie(SP14),next-to-Shangjuxu(ST37)in the following content.Location:The next-to-Tianshu(ST25)is 1 cun lateral to Tianshu(ST25),in the middle point of line linking the Spleen and the Stomach meridian.The next-to-Fujie(SP14)is 1 cun lateral to the Fujie(SP14),also in the middle point of the line linking the Spleen and the Stomach meridian.The next-to-Shangjuxu(ST37)is lateral to the Shangjuxu(ST37),in the middle point of the line linking the Gallbladder and the Stomach meridian.One inch stainless steel needles were adopted to insert 0.3-0.5 inch,no insertion and twisting.The needle handles of both points were connected to the special electrodes of the electroacupuncture device.The frequency and the current intensity are respectively set as 15Hz and 0.5mA.Special electric wires were made for this group,in the middle of which were cut while they look the same as the normal ones.That is to say,although the device is turned on,indicating a successful connection,there is actually no electricity through the wire.The frequency and the course of the treatment are the same as the treatment group.Patients are informed that effective and slight current is put in,which may hardly feel by the body,but it is really put out by the device.2.3 Observation Indicators2.3.1 Constipation curative effect(1)Spontaneous Bowel Movements(SBM):Compared to the baseline,the average of weekly SBM increased during the period of 4 weeks treatment and 8 weeks treatment.(2)Defecate Difficulty:Compared to the baseline,the average of weekly increase or decrease during the period of 4 weeks treatment and 8 weeks treatment.2.3.2 TCM syndromes scale tableCompared to the baseline,according to the score changes of intestine and lung syndromes in the cure period of week 1 to week 4,week 1 to week 8,evaluate the correlationship of intestine syndromes and lung syndromes.2.4 Safety evaluation Adverse events during the trial and patient acceptance.Results1 Constipation treatment results1.1 Comparison of general information and defecation before the treatment 70 subjects,fall off 1 case during the research,included in the study of 35 cases in the treatment group,34 cases in the control group.Using chi square X list of inspection,there was no significant different comparasion of the sex ratio among the two groups(P>0.05).Using independent sample t-test analysis,there was no significant different comparasion of average age,course of disease and defecation situation before the treatment between the two groups(P>0.05).1.2 SBMThrough variance analysis,it shows a statistically significant difference of SBM at different time points(P<0.01).And there were statistically difference in two groups(P<0.05).1.3 Difficult defecation scoreThrough variance analysis,it shows a statistically difference of difficult defecation at different time points(P<0.01).And there were statistically difference in two groups(P<0.01).2 Evaluation of correlationship between intestine syndromes and lung syndromes2.1 Comparison before the treatmentUsing independent sample t-test analysis,there was no significant different comparasion of intestine syndromes and lung syndromes scores between the two groups before the treatment(P>0.05).2.2 Intestine syndromes comparisonThrough variance analysis,it shows a statistically significant difference of intestine syndromes at different time points(P<0.01).And there were statistically difference in two groups(P<0.05).2.3 Lung syndromes comparisonThrough variance analysis,it shows a statistically significant difference of lung syndromes at different time points(P<0.01).And there were statistically difference in two groups(P<0.05).2.4 Correlationship of total scores between intestine syndromes and lung syndromesThrough Spearman analysis,it shows a strong positive relationship(r=0.622,P<0.01).Using linear regression analysis,it shows that the total scores of intestine syndromes and lung syndromes have a strong positive linear relationship(P=0.000).The regression equation is:Lung syndromes score=9.289+0.411 x Intestine syndromes score.3 Safety evaluationDuring the test,there were 7 cases with local itching,pain and skin bruises,all of their symptoms disappeared within 2-48 h.The patients of EA group have more discomfort feeling than sham EA group,but both can be accepted by patients.It proves that electroacupuncture and deeply needling method are safe.Conclusions1 It is safe and effectiveness to treat severe functional constipation by electroacupuncture and deeply needling Tianshu(ST25),Fujie(SP14)and normally needling Shangjuxu(ST37).2 Constipation can lead to lung disease.Both intestine and lung syndromes can be relieved when treating constipation by electroacupuncture.It has obvious correlationship between the improvement of intestine syndromes and lung syndromes.