| Background:Chronic constipation is one of the most common gastrointestinal diseases in outpatient clinics,mainly characterized by reduced defecation frequency,dry and hard stool and difficult defecation process.Due to the long-term and repetitive course of the disease,it greatly affects the patient’s quality of life and brings great distress to the patient’s psychology.At present,the pathogenesis of chronic constipation has not been fully elucidated.The most recognized mechanisms now are colonic sensorimotor disorders and pelvic floor muscle dysfunction.The current treatment of chronic constipation is not satisfactory and the long-term drug treatment may be prone to electrolyte disorders,colon melanosis and other side effects.In recent years,transcutaneous electrical acustimulation(TEA),a new treatment method based on the theory of traditional Chinese acupuncture and moxibustion,has shown great potential on the treatment of chronic constipation.There have been several studies on TEA in the treatment of chronic constipation,but the sample size were small and most of them were a single center study.Besides,the inclusion type was limited to functional constipation.On the basis of previous studies,our study continues to expand the sample size and include patients with organic constipation caused by metabolic factors such as diabetes,which makes our study has more reference significance for the clinical treatment of chronic constipation in the future.Aim:The purpose of this study was to investigate the efficacy and mechanism of TEA on the improvement of symptoms in patients with chronic constipation.Methods:This study is a prospective,multi-center,single-blind randomized controlled research.From June 30,2020 to March 20,2021,51 patients with chronic constipation in outpatient clinics of Shanghai Changzheng Hospital,Shanghai Dongfang Hospital,and Shanghai Gongli Hospital were screened in this trial,11 of which were excluded and a total of 40 patients were included.These patients were divided into groups in the proportion of 1:1,randomly to group A and B.Each group was treated with electrical stimulation for 14 days.Group A: TEA treatment group,treated with TEA at Zusanli(ST36)point for 1 hour,twice a day for 2 weeks;Group B: Sham-TEA control group,treated with sham-TEA at sham point for 1 hour,twice a day for 2 weeks.Electrical stimulation parameters were same between groups.During 2 weeks of electrical stimulation,each patient needs to record a bowel movement diary.In addition,follow-up observations were performed before treatment,2 weeks after treatment,and 4 weeks after stopping treatment.The patient’s general situation,past medical history,physical examination,questionnaire survey and auxiliary examination results were collected,and the anorectal manometry and heart rate variability before and after electrical stimulation were measured.The paired analysis method was used to analyze the changes before and after the electrical stimulation treatment in each group,the variance analysis method was used to compare the difference in curative effect between the two groups,and the effect,mechanism and security of TEA in the treatment of chronic constipation was explored.Results:1.The efficacy of TEA in the treatment of chronic constipation1)Among the 40 patients with chronic constipation,there were 12 males and 28 females,with a male-to-female ratio of 1 : 2.33.Most of them were females.The main cause of chronic constipation were functional constipation(n = 32,62.5%).Other causes included diabetes(n = 7,35%)and thyroid diseases(n = 1,2.5%).There was no statistical difference in demography and clinical baseline between the two groups.2)After 2 weeks of treatment,the weekly spontaneous defecation frequency of patients with chronic constipation in TEA treatment group was significantly higher than that in sham-TEA treatment group(5.75 ± 2.65 vs.2.85 ± 1.76,P < 0.001).3)PAC-SYM scale and PAC-QOL scale were used to evaluate the symptoms of constipation and quality of life.The results showed that TEA significantly decreased the total scores of PAC-SYM(1.53 ± 0.14 vs.0.91 ± 0.16,P < 0.001)and PAC-QOL(1.79 ±0.16 vs.0.98 ± 0.18,P < 0.001)compared with baseline,suggesting that TEA treatment can significantly improve the related symptoms and quality of life of patients with chronic constipation.However,there was also a significant decrease in the total score of PAC-QOL scale in the sham TEA control group(1.74 ± 0.12 vs.1.32 ± 0.16,P = 0.024).4)After 2 weeks of electrical stimulation,the frequency of laxatives use in patients with chronic constipation was 0.45 ± 0.18 in TEA group and 1.65 ± 0.46 in sham-TEA group,indicating that TEA treatment could significantly reduce the frequency of laxative use(P = 0.020).At the same time,compared with sham-TEA,it also increased intestinal satisfaction(57.50 ± 4.91 vs.32.50 ± 6.06,P = 0.003)and reduced the days with abdominal distension(2.00 ± 0.49 vs.5.10 ± 0.97,P < 0.01).5)During the 4-week follow-up period,the number of spontaneous bowel movements per week in TEA group was significantly higher than that before treatment(1.60 ± 0.18 vs.4.10 ± 0.44,P < 0.001),while sham-TEA group was similar with baseline(1.55 ± 0.21 vs.,1.70 ± 0.21,P = 0.379).At the end of the sixth week of follow-up,the number of weekly spontaneous bowel movements in the TEA group was still significantly higher than that in the sham-TEA group(4.10 ± 0.44 vs.1.70 ± 0.21(P < 0.001),indicating that TEA has a lasting effect on improving the symptoms of chronic constipation and lasts at least one month.6)During the whole course of this study,there were no general and serious adverse events related to TEA treatment in both groups.2.The mechanisms of TEA in the treatment on chronic constipation1)Anorectal manometry was used to evaluate anorectal motility and sensory threshold.It was found that TEA treatment for 2 weeks could significantly reduce the threshold of first sensation(56.50 ± 29.43 vs.44.50 ± 19.86,P = 0.018)and desire of defecation(94.00± 33.47 vs.73.50 ± 28.15,P = 0.002),urge of defecation(142.00 ± 50.33 vs.116.00 ±33.93,P = 0.006),maximum tolerate volume(181.50 ± 54.70 vs.,148.00 ± 37.78,P <0.001),but there was no significant difference in these parameters between the sham TEA control group and baseline(all P > 0.001).2)The autonomic nerve function of patients with chronic constipation was evaluated by heart rate variability.The results showed that the vagus nerve excitability of patients with chronic constipation in TEA group was significantly increased compared with baseline(0.54 ± 0.09 vs.0.59 ± 0.09,P < 0.001),while sympathetic excitability decreased obviously(0.58 ± 0.09 vs.0.52 ± 0.10,P < 0.01).However,there was no significant difference in chronic constipation in sham-TEA control group(all P > 0.05).At the same time,TEA treatment for 2 weeks significantly decreased the sympathetic-vagal activity ratio in patients with chronic constipation(1.08 ± 0.10 vs.,0.88 ± 0.11,P < 0.001).Conclusion:TEA therapy significantly increased the number of spontaneous bowel movements,improved the symptoms of chronic constipation,reduced the frequency of drug use in patients with chronic constipation,,which greatly improved the quality of life and psychological status of patients,and the effect had a certain continuous effect.Its action mechanism may be ascribed to the improvement of rectal sensitivity and balancing autonomic nerve function. |
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