Supplementary Discussion On GRADE Evidence Of Moxibustion For The Treatment Of Female Urinary Incontinence Construction Of Evidence Body For Acupuncture Guideline

Background:Urinary incontinence(UI)is clinically manifested by involuntary urinary leakage and may bring about complications such as urinary tract infections and dermatitis,affecting the quality of life of patients,and is one of the major chronic diseases threatening the physical and mental health of adult women.The common types include Stress Urinary incontinence(SUI),Urgency Urinary incontinence(UUI)and Mixed Urinary incontinence(MUI).The incidence of this disease is positively correlated with age,and as the aging of our population continues to progress,the prevalence of UI is increasing year by year,posing a serious burden to individuals and society.In recent years,international interest in acupuncture for the treatment of UI in women has gradually increased due to the publication of several high-quality clinical studies.on September 30,2020,the Clinical Practice Guidelines for Acupuncture for Female Urinary Incontinence was approved by the World Federation of Acupuncture Societies(WFAS),aiming to provide international acupuncture practitioners with clinical practice protocols for acupuncture for the treatment of UI in women.At present,our group has constructed three clinical questions about moxibustion for female UI based on the modified Delphi method.However,the current clinical evidence about acupuncture for UI is mostly milli-needle and electro-acupuncture than western medical treatments,but the evidence-based medical evidence about moxibustion for this disease is still insufficient.Based on this,this study conducted a systematic evaluation and GRADE evidence quality rating of the clinical research literature on moxibustion combined with pelvic floor muscle training for the treatment of UI in women to provide an evidence-based medical rationale for moxibustion for the treatment of UI in women.Objective:To adopt the research idea of systematic evaluation in evidence-based medicine,based on Meta-analysis method,to explore the effectiveness and safety of moxibustion for the treatment of UI in women and to form specific treatment protocols,and the results obtained can provide some evidence-based medical evidence for the Clinical Practice Guidelines for Female Urinary Incontinence,which will provide a scientific basis for the standardization and standardization of moxibustion for the treatment of UI in women,as well as for the construction of evidence-based acupuncture clinical The body of evidence for the guidelines was explored methodologically.Methods:Computer searches of CNKI,WanFang Data,VIP,SinoMed,Web of Science,Pubmed,EMBASE,and Cochrane Library databases were conducted to collect randomized controlled trials(RCTs)of moxibustion for female urinary incontinence,with a search time frame of build to December 31,2021.Two investigators independently screened the literature,and if no direct evidence corresponding to the clinical question was found,indirect evidence was provided for the corresponding clinical question by means of expert consultation,and after extracting the information and evaluating the risk of bias of the included studies,Meta-analysis was performed using RevMan 5.3 software,and the GRADE tool was used to evaluate the quality of the body of evidence for different outcomes and to produce the corresponding summary table of evidence.Results:A total of 1090 papers were searched,and no direct evidence was found after screening.32 papers were finally included as indirect evidence after expert consultation.PICO1 included 4 case series studies of moxibustion for UI in women and 9 RCTs of moxibustion for post-stroke incontinence.meta-analysis showed that moxibustion reduced the number of 24-hour urinary incontinence compared to pre-treatment[MD=-2.28,95%CI(-2.46,-2.10),p<0.0001]and reduced the International Continence in Women with UI Advisory Committee Incontinence Questionnaire(ICIQ-SF)scores[MD=-4.82,95%CI(-4.93,-4.71),P<0.0001]and reduced 1-hour urine pad test leakage[MD=-4.49,95%CI(-4.73,-4.25),P<0.0001].Compared with no intervention,moxibustion reduced the number of 24-hour urinary incontinence[MD=-0.76,95%CI(-1.44,-0.08),P=0.03],increased incontinence quality of life scale(I-QOL)scores[MD=8.95,95%CI(5.29,12.61),P<0.00001],and decreased ICIQ-SF scores[MD=-2.90,95%CI(-3.82,-1.98),P<0.00001]and did not increase adverse events[RR=2.57,95%CI(0.31,21.27),P=0.38].The GRADE evaluation showed that the quality of evidence for the studies included in PICO1 was all very low quality.One RCT of moxibustion for UI in women was included in PICO2.Meta-analysis showed that moxibustion was comparable to modified pelvic floor muscle training(pelvic floor muscle training+biofeedback)in reducing ICIQ-SF scores[post-treatment:MD=1.35,95%CI(-1.93,-4.63),P=0.42;6-month post-treatment follow-up:MD=0.25,95%CI(-2.43,2.93),P=0.85].Compared with modified pelvic floor muscle training,moxibustion did not increase the incidence of adverse events[RR=7.00,95%CI(0.38,127.32),P=0.19].The GRADE evaluation showed that the quality of evidence for the studies included in PICO2 was very low quality.PICO3 included 18 RCTs of moxibustion for UI in women.meta-analysis showed that moxibustion combined with pelvic floor muscle function training/oral western medication reduced the number of incontinences to a greater extent than pelvic floor muscle training/oral western medication[post-treatment:SMD=-2.47,95%CI(-3.77,-1.16),P=0.0002;4-week post-treatment follow-up:SMD=-0.79,95%CI(-0.92,-0.66),P<0.00001].Compared to pelvic floor muscle training,moxibustion combined with pelvic floor muscle functional training improved patients’ quality of life to a greater extent[SMD=1.35,95%CI(1.03,1.67),P<0.00001]and reduced ICIQ-SF scores[post-treatment:MD=-2.52,95%CI(-3.54,-1.50),P<0.00001;post-treatment 4 week/8-week follow-up:MD=-2.40,95%CI(-2.87,-1.93),P<0.00001],reduction in 24-h leakage[post-treatment:MD=-1.61,95%CI(-2.16,-1.50),P<0.00001;4-week post-treatment follow-up:MD=-1.64,95%CI(-2.21,-1.07),P<0.00001]and reduction in 1-hour urine pad test leakage[post-treatment:MD=-2.02,95%CI(-2.44,-1.60),P<0.00001;4-week/8-week post-treatment follow-up:MD=-2.99,95%CI(-5.63,-0.36),P=0.03].In terms of improving the mean and maximum urinary flow rates,pelvic floor muscle training/oral western medicine and moxibustion combined with pelvic floor muscle functional training/oral western medicine were comparable[mean urinary flow rate:MD=0.5,95%CI(-5.81,6.82),P=0.88],[maximum urinary flow rate:MD=1.2,95%CI(-2.03,4.43),P=0.47].And combining moxibustion with pelvic floor muscle function training did not increase the incidence of adverse effects[RR=3.09,95%CI(0.33,28.97),P=0.32].The GRADE evaluation showed that the quality of evidence of the studies included in PICO3 were all of very low quality.Conclusion:1.Moxibustion is effective in improving urinary incontinence symptoms,improving patients’ quality of life,and has a good safety profile.However,the risk of bias in the included studies was high and the level of evidence was low,and more high-quality clinical studies are needed to validate the findings.2.In the absence of direct evidence,indirect evidence based on multidisciplinary expert consultation can be an important addition to the body of evidence for acupuncture clinical practice guidelines.