| Objective1.Based on the systematic review of the previous literatures of acupuncture for the treatment of functional anorectal pain(FAP),to find the evidence-based medical evidence.2.To evaluate the clinical efficacy of acupuncture in the treatment of FAP and improving the quality of life and mental state of the patient by designing a standardized clinical randomized controlled trial,and to provide high quality clinical evidence.Methods1.Literature reviewElectronic searches were conducted through the following main databases:CNKI、VIP、WF、Pubmed、Embase and Cochrane Library.Manually retrieved other magazines could be taken if some full text of domestic literatures can not be found.The search time was up to November 2016.The clinical evaluation and meta-analysis of the retrieved clinical randomized controlled trials of FAP were conducted to evaluate the clinical efficacy.2.Clinical researchOn the basis of the CONSORT and the STRICTA standard,a single-prospective,randomized,controlled trial was designed.68 patients were randomly divided into two groups,acupuncture and biofeedback.Acupuncture group:The acupuncture points contained BL33,BL34,BL18,BL23,BL25.BL33,BL34:Using 3-inch needle into the sacral posterior hole,oblique insertion of 75 mm,toward the thigh root direction,the needle body and the human body longitudinal axis was 30°angle,and the skin was 60 0 angle,needle feeling can be radiated to the anus.BL18,BL23 and BL25 were all in the spine area,under the spinous process of T9,L2 and L4.Using 2 inch acupuncture points piercing 25 and 40 mm.Electro-acupuncture was added at the points of BL33 and BL34,selecting the continuous wave.Biofeedback group:The treatment program was maked according to the results of the pelvic floor surface electromyography.①Higher coefficient of variation(CV):Kegel training(contracting 10s-relaxing 10s-contracting 10s);②Higher resting amplitude and higher CV:Relaxation training and Kegel training;③Lower resting amplitude and higher CV:electrical stimulation and Kegel training;④Lower contraction amplitude and higher CV:triggered electrical stimulation and Kegel training.The core of the biofeedback training was the stability of the pelvic floor muscle.The two groups were all treated once daily for 30min,5 times a week for 2 weeks(10 times,1 course),2 courses of treatment(4 weeks,20 times).The follow-up period was 8 weeks.The primary outcome was VAS score;The secondary outcome indicators were SF-36,SDS and SAS.Results1.Literature ReviewA total of 186 articles were retrieved,including CNKI 35(18.8%),VIP 27(14.5%),WF 52(28%),Pubmed 48(25.8%),Embase 22(11.8%),Cochrance 2(1.1%).Finally,seven domestic literatures of randomized controlled studies were included in the study,including 5 journal articles,1 conference paper and 1 dissertation.In the incorporated literature,two articles had the description of random methods.There was no description of blindness.Jadad score showed that 4 articles were 2 points and 3 articles were 1 point.According to Meta analysis,the heterogeneity test results showed that χ2 was 1.84,P=0.87>0.05,and I2 = 0%<50%,using the fixed effect model.OR = 4.57,95%confidence interval,2,31～9.04,Z =4.36,P<0.0001,indicated that acupuncture treatment of FAP is effective and is better than the control group.2.Clinical research(1)Baseline dataFunctional anorectal pain always occurred in 50 to 70 years old female patients.The average course of the acupuncture group was 40.94 months,and in the biofeedback group was 42.48 months.The nature of pain was mainly manifested as falling pain.Pain was often located in the anus.In acupuncture group,38.2%of patients were diagnosed as LAS,53%were UFAP,and 8.8%were PF;In biofeedback group,47.05%of patients were diagnosed as LAS,47.05%were UFAP,and 5.9%were PF.The distribution of TCM syndromes in the acupuncture group were mainly liver-spleen disharmony(35.3%)and sinking of qi of middle-jiao(32.4%),while in the biofeedback group were mainly liver-spleen disharmony(38.2%)and qi stagnation and blood stasis(29.4%).There were 16 cases of outlet obstructive constipation,2 cases of fecal incontinence and 11 cases of stress urinary incontinence in the acupuncture group.While there were 18 cases of obstructive constipation,2 cases of fecal incontinence and 10 cases of stress urinary incontinence in the biofeedback group.FAP patients were often accompanied with psychological problems,there were 4 cases of depression and 10 cases of anxiety in the acupuncture group,and there were 3 cases of depression and 8 cases of anxiety in the biofeedback group.(2)Efficacy analysisVAS score:After 2 weeks of treatment,4 weeks of treatment and follow up,the VAS scores of the two groups were all lower than the baseline,the difference was statistically significant(P<0.01).After 2 weeks of treatment,the reduction of VAS score in the acupuncture group was lower than that in the biofeedback group,indicating that the short-term effect of acupuncture was more obvious.After 2 weeks of treatment,the score of UFAP in the acupuncture group was lower than that in the biofeedback group,the difference was statistically significant(P<0.05).After 4 weeks of treatment and follow up,the score of LAS in the biofeedback group was lower than that in the acupuncture group,the difference was statistically significant(P<0.05).After 4 weeks of treatment,the score of patients with syndrome of deficiency of liver and spleen in the acupuncture group was lower than that in the biofeedback group,the difference was statistically significant(P<0.05).After 4 weeks of treatment,the score of patients with anismus in the biofeedback group was lower than that in the acupuncture group.SF-36:After 4 weeks of treatment,the scores of PF,RP,RE and MH in the acupuncture group were higher than the baseline,the differences were statistically significant(P<0.05);After follow-up,the score of BP was also improved.After 4 weeks of treatment and follow-up,the scores of PF,RP,BP,GH,RE in the biofeedback group were higher than the baseline,the differences were statistically significant(P<0.05).In the term of MH,the efficacy of acupuncture was better than biofeedback.SDS and SAS:After 4 weeks of treatment,the scores of SDS and SAS in the two groups were all lower than the baseline.The treatment of acupuncture improved the efficacy of 100%in patients with depression,and improved the efficacy of 60%in patients with anxiety;Biofeedback therapy improved the efficiency of 66.7%in patients with depression,and improved the efficacy of 50%in patients with anxiety.(3)Compliance analysis2 patients in the acupuncture group only accepted 2 weeks treatment,the proportion of the patients with the compliance above 80%was 94.1%;1 patient in the biofeedback group only accepted 2 weeks treatment,the proportion of the patients with the compliance above 80%was 97.1%.(4)Safety analysisThere were 2 cases of adverse events in the acupuncture group,the incidence rate was 5.9%.There was 1 case of adverse event in the biofeedback group,the incidence rate was 2.9%.Both groups did not lead to withdrawal from the study of adverse events,no serious adverse events.Conlusion1.Limited inclusion literatures showed that the quality of the RCT literatures for FAP were generally low.There was lack of high quality and well designed RCT studies.Therefore,based on the CONSORT statement and STRICTA standard,it was possible to strengthen the standardization of clinical studies of acupuncture,which would be used to further validate the efficacy of acupuncture in the treatment of FAP.2.The study showed that acupuncture and biofeedback therapy can be a good improvement in pain symptoms of FAP patients,and have a certain sustained treatment effect.The best initial treatment for both treatments was 4 weeks.Acupuncture had an advantage in the treatment of patients with UFAP and with liver-spleen disharmony.Biofeedback had an advantage in the treatment of patients with LAS and with anismus.Acupuncture could better resolve the patient’s mental and psychological problems. |
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