Randomized Controlled Clinical Trail Of Electroactupuncture For Fecal Incontinence

Fecal incontinence is a common and concealed problem in general population.The morbidities ranges between 1.4%and 18%in different groups,could be around 50%in nursing homes and up to 75%-80%in spinal trauma and rachischisis patients.These patients often have to modify their diet and living habits,avoid social activities,which seriously affects the quality of their lives.At present there is no domestic large-scale epidemiological studies,patients are often dispersed in variant clinic departments,and many patients suffer in silence,the actual number of patients with fecal incontinence may be larger than imagined.There are only a few domestic researches at present,which can not meet the requirement of clinic.The aging of Chinese population could make the contradiction more significant.There are many pathogenic factors of the disease.It is still a tough problem in treatment due to its complicated pathological changes,for the damage of nerve and anal sphincter often exists simultaneously.For the patients with severe fecal incontinence,the effects of various methods are still not satisfied.Furthermore,more invasive surgeries require higher technical level and often lead to more complications.And patients often have to suffer multiple surgeries,resulting in greater economic and psychological burden.Therefore,it is generally accepted that the treatment strategy is to choice the less invasive treatments preferentially,and then to choose a more invasive therapy when failed.In view of the above,in addition to a serious injury of anal sphincter which needs a sphincter repairing,neural electrical stimulation is becoming the first line choice of the treatment of various fecal incontinence after failure of conservative therapies due to its less invasive characteristic.Sacral nerve stimulation,as the one of neural electrical stimulation,has satisfied,repeatable long-term efficacy and quality of life improment in patinents with moderate and severe fecal incontinence.However,it is still not suitable for extensive use in China because it requires multiple surgeries to maintain the nerve stimulator,the risks of infection and other complications are still exist,and the medical expense is quite high at present.In recent years,the emerging tibial nerve stimulation therapy,originated from acupuncture,seems to make up for the deficiencies.However,it still can not meet the clinical needs because of the lack of theoretical guidance of traditional Chinese medicine and the single pathway of action.Traditional Chinese medicine electroacupuncture therapy is a kind of method to prevent and cure diseases by combining acupuncture with electric stimulation.Comparing with the above two methods,electroacupuncture is simpler,safer and cheaper,can also take effect in multi-pathways,which is an effective supplement to neural electrical stimulation.Yet there is still no controlled study between electroacupuncture and tibial nerve stimulation therapy in the treatment of fecal incontinence.This study was aiming this point.By means of summarying ancient literatures,modern researches and combining our clinical practice experiences,bilateral Zusanli,baliao,and Zusanli were selected to compare the clinical efficacy between electroacupuncture and tibial nerve stimulation therapy in the treatment of fecal incontinence.The purpose of this study is to provide practical evidence for improving the treatment of fecal incontinence and explore clues for new therapies.This study includes two parts:literature review and clinical trail.Section one:Literature review1.Historical evolution of fecal incontinence in traditional Chinese medicineThis review of was formed by the historical evolution of traditional Chinese medicine in the field of fecal incontinence.Six hundred and seventy-five ancient TCM writings were reviewed by manual and network retrieval.All the informations about fecal incontinence were included and classified by disease naming,knowledge of anatomy,etiology,pathogenesis and treatments.The earliest record of this disease is found in Nei jing.To the Sui Dynasty,"deficiency and cold" is declined to be the basic pathogenesis of fecal incontinence in Zhu Bing Yuan Hou Lun.Until the Ming Dynasty,etiology,pathogenesis and treatment methods became mature.The major treatments inlcuded TCM agencys and acupuncture treatment.Both treatments were acted via warming and nourishing,lifting and consolidating method.And the major usage acupuncture was moxibustion.Fecal incontinence was less described in TCM ancient literatures,but the understanding of its pathogenesis had been relatively mature,some of the treatment methods,especially acupuncture therapies,are still performed in practice.2.Research status and prospect of acupuncture in the treatment of fecal incontinenceThis review summarizes the relevant reports about the the acupuncture therapy in the treatment of fecal incontinence from 1977 to 2016.Clinical and experimental studies about acupuncture,electroacupuncture,moxibustion and other methords of acupuncture therapy were included.Current research status and effects of these methods were summarized.Then the problems in the present studies and future tends of relevant research were analyzed.The present results suggest that acupuncture therapy has great potential in the treatment of fecal incontinence.Especially since the emerging of electroacupuncture last century 50s,the treatment of fecal incontinence with traditional Chinese medicine was improved efficiently.curative effect.Due to the lack of well-designed and high-quality randomized controlled clinical trials,the difference of efficacy between traditional Chinese medicine(EA)and current electrical stimulation therapy is still unclear.3.Current status and and analysis of diagnosis and treatments of fecal incontinence in modern medicineThis review summarized the current status of diagnosis and treatment of fecal incontinence in modern medical field,including the diagnosis,epidemiology,examinations,conservative and surgical therapies.This paper analyzed the various methods of treatment about the efficacy,indications,advantages and disadvantages,and the strategy of fecal incontinence in modern medical treatment.Overall,because of its complex etiology,fecal incontinence is still difficult problem in clinic practice,often requires a comprehensive program considering multi-factors.Patients may experience a variety of treatments.The medical strategies is to gradual update thearpies from the less invasive drug and physical therapies to surgeries with more trauma and higher medical costs according to the situation of treating.In general,the more serious fecal incontinence is,the more complex and invasive treatment is.Surgeons have to choose more invasive method when the less invasive ones fail.Neural electrical stimulation,as the current research focus,is widely used with relative sitified efficacy and safety.Section two:Clinical studyObjective:To compare the effects of electroacupuncture and tibial nerve stimulation in the treatment of fecal incontinence.To provide practical evidence for improving the treatment of fecal incontinence and explore clues for new therapies.Methods:This is a randomized controlled clinic study.All the patients with fecal incontinence were randomly divided into 2 groups.The treatment group received electroacupuncture in bilateral eight Liao point,Sanyinjiao and Zusanli.After developing needle sensation by minor lifting,thrusting and twirling,an electric acupuncture apparatus is connected modified to the density wave,frequency of 2/15Hz,current in the range of 0.1-1.OmA until the patient can tolerant.All the needles were kept in position for 30 minutes.The control group was performed tibial nerve stimulation therapy.After acupuncture needles were inclined downwards 60 degrees thrusted into bilateral tibial nerve projection areas(about 5cm above the medial malleolus,2cm posterior to the tibial)for 2-2.5cm,same apparatus with same appelectrical stimulation parameters was connected.Two groups were treated three times a week for 8 weeks.And then follow-up was performed for up to 6 months after treatment.Episodes of fecal incontinence,Wexner fecal incontinence score and fecal incontinence quality of life score were recorded before and after treatment and every follow-up.The clinic effect standard:Cure:the anus function returns to normal completely;effective:the episodes of fecal incontinence reduce 50%or above;invalid:reduce lower than 50%or no obvious change after the treatment.Results:According to the randomized controlled clinical trial design,screening,excluding invalid and shedding cases,this study totally included 38 effective cases.Twenty cases were in the treatment group,18 cases in the control group of.Baseline analysis showed that there were no significant difference between the two groups in demographic data,course of disease,Wexner fecal incontinence score,etiology.Treatment results showed:1 effective rate:The treatment group cured 6 cases(30%),effective in 11 cases(55%),the total effective rate was 85%,the control group cured 2 cases(11.11%),effective in 12 cases(66.67%),the total effective rate was 77.78%.There was no significant difference between the two groups(P>0.05).2 Average episodes of fecal incontinence:The average episodes of fecal incontinence in the treatment group was 0-1.5 times a day(median 0.75),0-4.5 times(median 1.25)in the control group.Comparison in group:the number of fecal incontinence in two groups after treatment was significantly lower than that before treatment(P<0.05).Comparison between groups:At the end of treatment,there was significant difference between the two groups in the episodes of fecal incontinence(P<0.05),the treatment group was better than control group.3 Wexner fecal incontinence score:At the end of the treatment,Wexner score improvement rate was 66.31 ±27.31%in the treatment group and 42.87±30.52%in the control group.Comparison in group:Post-treatment Wexner incontinence score were significantly improved compared with that pre-treatment in both groups(P<0.05).Comparison between groups:There was significant difference between the two groups in the improvement of Wexner score(P<0.05),the treatment group was better than the control group.4 Fecal incontinence quality of life score:Comparison in group:Changes in lifestyle behavior restriction,self perception and social embarrassment score had significant difference in both groups(P<0.05),suggesting that the quality of life were significantly improved in the two groups.Comparison between groups:There was no significant difference between the two groups in the scores of each items and the total scores of the two groups(P>0.05).5 Follow-up results:All patients were followed for a period of 2 months after the end of treatment,with a maximum follow-up of 6 months.After statistical analysis,there was no significant difference between the two groups in the follow-up time span(P>0.05).At the end of the follow-up,most of the effects of the treatments in effective cases were maintained.Seven cases were cured,9 cases were effective in the the treatment group with the total efficitve rate of 80%.In the control group,4 cases recovered completely,9 cases of fecal incontinence in times of ease is more than 50%,the total efficive rate was 72.28%.There was no significant difference between the two groups(P>0.05).In the average episodes of fecal incontinence,the numbers were increased compared with that at the end of treatment,statistically significant difference was achieved(P<0.05).There was not significant change in the treatment group.There was no significant difference between the two groups in Wexner score and fecal incontinence quality of life score.Conclusion:This study was conducted with a randomized controlled clinical research method,to observe the effect of electroacupuncture and tibial nerve stimulation therapy in the treatment of fecal incontinence.The results showed that electroacupuncture therapy might be more effective in reducing episodes of fecal incontinence and Wexner fecal incontinence score than tibial nerve stimulation,two groups in improving the efficiency and quality of life have no significant difference.The follow-up results showed that there was no significant difference in terms of effective rate,Wexner score and quality of life score between groups.However,the average episodes was significantly higher in the tibial nerve stimulation than that in treatment group,suggesting that electroacupuncture might be capable of offering a better long-term effect.