Systematic Reviews And Methodological Research Of Randomized Controlled Trials Of Acupuncture Treatment For Post-stroke Fecial And Urinary Disorder

Objective:To assess the efficacy and safety of acupuncture in the treatment of fecal and urinary disorder after stroke with systematic review and meta analysis,providing evidence of evidence-based medicine(EBM)for acupuncture in treating post-stroke dysfunction;and to investigate the problem of methodology of randomized controlled trials(RCTs)of acupuncture for post-stroke dysfunction,providing a reference for design and reports of future RCTs of acupuncture for post-stroke dysfunction,and improving the quality of clinical studies.Methods:Scientific and effective search retrieval strategies were designed.The comprehensive literature search included the following electronic databases:China National Knowledge Infrastructure(CNKI),Chinese Biological Medicine Database(CBM),VIP database(VIP),Wanfang Data(WAN FANG),Medline via PubMed,Embase and Cochrane Central Register of Controlled Trials,retrieved from the initial through December 31,2017.RCTs of acupuncture for fecal and urinary disorder after stroke were retrieved.Literature Manager Noteexpress2.0 was used to conduct the process of literature searching;and Excel 2010 was used to product the extraction table.Systematic review and meta-analysis,and the methodological quality of the trials were evaluated by the Cochrane risk of bias tool,and statistical analysis using stata14.0 software.Results:1.Meta analysis showed:(1)Systematic review of acupuncture treatment of constipation after stroke/Meta analysis showed that:in 22 studies,The total effective rate of acupuncture therapy in patients with post-stroke constipation[RR=1.21,95%CI(1.12,1.31),P<0.01]and cure rate[RR=1.97,95%CI(1.60,2.42),P<0.01].In improving constipation after stroke in patients with the diagnosis of disease and curative effect of traditional Chinese medicine standard"symptoms integral[WMD=2.39,95%CI(3.00,1.78),P<0.01],CCS rating scale[WMD=2.79,95%CI(4.74,0.84),P<0.01],PACQOL life quality scale[WMD=13.30,95%CI(17.68,8.92),P<0.01),serum content of SP[WMD=17.87,95%CI(6.69,29.06),P<0.01],the six aspects of statistical results shows that acupuncture can effectively improve constipation.But acupuncture compared with other treatments(blank)for the treatment of constipation after stroke in randomized controlled trials for the VIP content in serum[WMD=18.24,95%CI(-78.03,114.51),P=0.71>0.01],BSFS shit character[WMD=1.33,95%CI(-1.13,3.80),P=0.289>0.05],for the first time defecation time[WMD=-3.05,95%CI(-6.44,0.35),P=0.078>0.05]three aspects,the above three data compared with the control group,there is no statistical significance.(2)Systematic review of acupuncture treatment of urinary retention after stroke/Meta analysis showed that:in 10 studies,acupuncture total effective rate in improving urinary retention after stroke patients[RR=1.67,95%CI(1.3 4,2.07),P=0.000<0.01]that acupuncture can improve the urinary retention after stroke;In improving bladder residual urine volume[WMD=-75.79,95%CI(-222.70,71.1 2),P=0.312>0.05],shows that acupuncture treatment of urinary retention after stroke for bladder residual urine volume index was no significant difference compared with control group,acupuncture therapy for stroke patients with urinary retention after bladder residual amount may not have the effect of recovery.(3)Systematic review of acupuncture in the treatment of urinary incontinence after stroke/Meta analysis showed that:in 14 study,acupuncture total effective rate in improving urinary incontinence after stroke patients[RR=1.36,95%CI(1.18,1.57),P=0.000<0.01],bladder residual urine volume[WMD=-33.69,95%CI(-44.81,22.57),P=0.000<0.01],ICIQ-SF,scale[WMD=-3.51,95%CI(-7.01,0.01),P=0.049<0.05],the clinical symptoms rating scale[WMD=-1.78,95%CI(-2.23,-1.34),P=0.000<0.01],bladder capacity[WMD=29.52,95%CI(19.62,39.42),P=0.000<0.01],the statistical results show that the above five acupuncture therapy can effectively improve the clinical symptoms of urinary incontinence after stroke;For pad weight[WMD=-210.67,95%CI(-497.04,75.70),P=0.149>0.01],indicating that there was no statistically significant difference between acupuncture group and control group on the improvement of urinary incontinence pad test after stroke.3.Methodological results showed:all studies failed to report clinical trial registration and only one study reported sample size estimation;the baselines and randomization were not really conducted through the studies.Concealment,blinding,drop-off and withdraw were reported in a very low rate.ITT analysis was seldom reported.Acupuncture intervention was complex and diverse with unreasonable control interventions.Outcome measures were not standardized and also with seldom follow-ups.Conclusions:1.The quality of most included RCTs was poor,which indicated that the bias may reduce the confidence of the outcomes to some extent.2.Acupuncture intervention was safe and effective on motor dysfunction,dysphagia and aphasia in acute and recovery stages of stroke,but it was not sure on sequelae stage.In addition,it was also safe and effective for urinary disorder and depression after stroke.However,most included RCTs had poor quality,which prevent us from drawing a firm conclusion.More multi-center,large sample,high quality RCTs are still needed to prove the efficacy of acupuncture for function recovery after stroke.3.There were serious methodological defects on the random methods,interventions and control design,outcome evaluation,sample size estimation,follow-ups,and reports,which need to be improved in the future.Prospect:1.In future clinical studies to improve the quality of clinical randomized controlled trials,especially must pay attention to methodology,research,quality control and report specification makes acupuncture clinical scientific research,standardization and internationalization.2.Effectiveness randomized controlled trial,vigorously explore the overall effect of the real world,acupuncture,explanatory randomized controlled experiment was carried out at the same time,explore the mechanism of action of the specificity of the acupuncture effect,the clinical curative effect of acupuncture in the international recognition.3.According to the characteristics of acupuncture intervention effect with the existing evaluation system,to explore a set of fully embodies the comprehensive efficacy of acupuncture intervention characteristics evaluation system.