A Comparative Study Of The Current Evidence Of Qigong Clinical Research And Its Methodological Characteristics

Background and Objective:Qigong,as a traditional exercise,is very beneficial to improving people’s physical and mental health.In recent years,the clinical efficacy of Qigong has been confirmed in many clinical studies,involving a variety of diseases.However,there is no systematic collation and evaluation of the exact clinical research evidence of Qigong exercises.Evidence-based evidence on the clinical safety and effectiveness of Qigong therapy is insufficient,which limits the development and promotion of Qigong at the domestic and international scope.The clinical research of Qigong has its unique characteristics,such as a wide variety of exercises,the difficulties in the implement of blinding.The clinical research program should be designed according to the unique characteristics and advantages of Qigong itself.Randomized controlled trial(RCT)belongs to the top evidence in the "pyramid" of medical intervention evidence level and is the gold standard for the design of therapeutic clinical research methods.Its systematic review can provide reliable evidence for prevention and treatment for medical and health decisions,which directly affects the authenticity and generalization of its clinical efficacy.Cohort study is the main method of observational epidemiological research,which ranks second after RCT in efficacy evaluation and belongs to the second level of evidence "pyramid".At present,there is no research on systematic and comprehensive methodological analysis and quality evaluation of various Qigong methods.And the existing problems in effectiveness evaluation are not clear.As a result,methodological guidances and evidences are urgently needed for the clinical studies in Qigong.A bibliometric study on Qigong,a systematic review of Qigong for fibromyalgia syndrome,and a systematic comparative evaluation of the methodological characteristics and quality on two types of Qigong clinical research RCT and Cohort study were included in this thesis.The aim of this study is to obtain the current status of evidence,trend characteristics and limitations of Qigong efficacy evaluation;to explore the clinical efficacy and feasibility of Qigong effectiveness evaluation methods,and to provide reference for the design of Qigong clinical research methodology.With the research work,we can understand the current status of Qigong clinical research,evaluate its research quality,and establish the evidence basis for its methodological design,and provide evidence-based medicine and methodological recommendations for future Qigong clinical practice and health management.Methods:Part one:Evidence Base of Clinical Studies on Qi Gong:A Bibliometric AnalysisQigong clinical studies were retrieved and included:systematic review,randomized clinical trial,non-randomized controlled clinical studies,case series and case reports.SinoMed,CNKI,VIP database,Wan fang database,PubMed and the Cochrane Library were searched from inception to December 10,2018 without language restrictions.Bibliometric information,such as publication information,disease/condition,Qigong intervention and research results were extracted and analyzed.Part two:Qigong for fibromyalgia syndrome:A Systematic Review and Meta-analysis of Randomized Clinical TrialsRandomized controlled trial of Qigong for fibromyalgia syndrome was included.SinoMed,CNKI,VIP database,Wan fang database,PubMed,EMBASE,The Cochrane Library,Clinical Trials and Clinical trials in China.All databases were searched from inception to 10,July 2019 without language restrictions.The Cochrane risk assessment(risk of bias,ROB)tools were used for quality evaluation of the studies and Rev Man 5.3 software was used for meta-analysis,Binary variables were analyzed by relative risk(RR),and continuous variables were analyzed by mean difference(MD)or standardized mean difference(SMD),with 95%confidence intervals(CI).We evaluated the quality of evidence according to the GRADE("Grades of recommendation assessment,development and evaluation")evidence grading standards.Part three:Comparison of Methodological Characteristics of Randomized Controlled Trials and Cohort Studies of QigongThe included studies were randomized controlled trial(RCT)and cohort study of Qigong.SinoMed,CNKI,VIP database,Wan fang database,PubMed,EMBASE,The Cochrane Library.All databases were searched from inception to January 18,2020,without language restrictions.The Cochrane risk assessment(risk of bias,ROB)tools and the Newcastle-Ottawa Scale(NOS)were used to evaluate the methodology quality of the included RCT and cohort study.The contents of RCT quality evaluation included:random sequence generation,random allocation concealment,blinding of participates and trial personnel,the research quality was evaluated as high quality,low quality and unclear.The NOS scale includes 9 items in 3 columns:selection of study population(4 scores),comparability between groups(2 scores),and measurement of results(3 scores).The total score is up to 9 scores,the higher the score,the higher the quality.And comparative analysis of the methodological points of the two design reports and data extraction.Results:Part one:Evidence Base of Clinical Studies on Qi Gong:A Bibliometric AnalysisA total of 886 clinical studies were identified,including 47 systematic review,705 RCT,116 non-randomized controlled clinical studies,12 case series and 6 case reports.The study involved 14 countries,the top five were:China,the United States,Korea,the United Kingdom,and Sweden.The top 5 diseases/conditions were diabetes,chronic obstructive pulmonary disease,hypertension,stroke,and cervical spondylosis.In the included 886 clinical studies reports,Ba Duan Jin was the most frequently used in 492(55.5%),followed by Health Qigong 107(12.1%),Dao Yin Shu 85(9.6%),Wu Qin Xi 67(7.6%)and Yi Jin Jing 66(7.4%).The most frequently used comparisons in RCT were maintaining normal lifestyle unchanged 149(18.1%),others included conventional treatment,western medicine,Chinese herbal medicine,acupuncture,health education,psychological therapy,Yoga,Tai Chi.The most frequently reported outcomes were physical function 561(63.3%),quality of life 87(9.8%),symptoms 80(9.0%),pain 77(8.7%)and mental health indicators 61(6.9%).Beneficial results from practicing Qigong were reported in 97%of studies.Part two:Qigong for fibromyalgia syndrome:A Systematic Review and Meta-analysis of Randomized Clinical TrialsA total of 10 RCT with 542 participants were included.There are 3 Chinese and 7 English studies.The risk of methodological bias in the 10 studies is high,and the methodological quality was low.In terms of pain improvement,Qigong group was better than sham Qigong(sham Qigong:The body movements are the same as Qigong,but there is no meditation and formula,and self-breathing do not need to be coordinated with body movements during exercise)and aerobic exercise(SMD=-1.44,95%CI[-2.77,-0.11])and(SMD=0.96,95%CI[0.10,1.81]),Qigong combined with drug group(including Chinese medicine and western medicine)was more effective than the drug group(MD=-8.94,95%CI[-15.69,-2.1 9]);In terms of quality of life improvement,Qigong group was superior to sham Qigong and aerobic exercise(SMD=-1.83,95%CI[-3.27,-0.39])and(SMD=0.98,95%CI[0.13,1.84]);Qigong combination drug group had the same effect as the drug group(MD=-3.98,95%CI[-10.93,2.97]);FIQ、SF-36、CHAQ、QOML、WHOQOL-BREF scale were used to evaluate the quality of life.Only one study reported adverse event related to practicing Qigong(one right shoulder pain and a patient’s foot fasciitis).GRADE analysis showed low-level evidence for Qigong for fibromyalgia syndrome.Part three:Comparison of Methodological Characteristics of Randomized ControlledTrials and Cohort Studies of QigongThis study included a total of 895 studies.Among them,749(83.7%)RCT were published in Chinese,73(8.2%)published in English,69(7.7%)cohort study published in Chinese and 4(0.5%)published in English.822 RCT with an average of 90 participants per trial,with a minimum sample size of 10 and a maximum of 1973,cohort study with an average of 142 participants per trial,with a minimum sample size of 12 and a maximum of 1721.177(21.5%)RCT and 11(15.1%)cohort study reported the number of withdrawals,shedding,drop out,x2=1.7,p=0.2,the difference was not statistically significant.A total of 822 RCT were included,of which 287(34.9%)reported random allocation methods,which were evaluated as low risk of bias.34(4.1%)were grouped according to the order of visits,which was evaluated as high risk of bias.41(5.0%)reported allocation concealment,which were evaluated as low risk of bias.57(13.6%)were blinded and evaluated as low risk of bias.177(21.5%)reported the number of withdraw,shedding,drop out,which were evaluated as low risk of bias.33(4.0%)reported in detail the method of determining the sample size,which were evaluated as low risk of bias;A total of 73 cohort studies were included,and most of the NOS scores were 3～6 scores 103(91.2%),including 9 scores were 0 studies.8 scores and 2 studies(2.7%),7 scores and 2 studies(2.7%),6 scores and 15 studies(20.6%),5 scores and 24 studies(32.9%),4 scores and 12 studies(16.4%),3 scores and 12 studies(16.4%),2 scores and 6 studies(2.7%),with an average of 4.6 scores.Conclusions:Part one:Evidence Base of Clinical Studies on Qi Gong:A Bibliometric AnalysisQigong research publications have been increasing gradually.The design,Qigong intervention,and outcomes were inconsistent.There is an urgent need to develop a set of reporting standards for various interventions of Qigong.Further trials of more rigorous,multi-center,enough sample size and cohort study are needed to verify the effects of Qigong in health and disease management.Part two:Qigong for fibromyalgia syndrome:A Systematic Review and Meta-analysis of Randomized Clinical TrialsThis evidence suggests that Qigong may have potential efficacy in reducing pain and improving quality of life in patients with fibromyalgia,and it is relatively safe.However,its methodological quality was low,and the number of studies was small.In the future,more RCT with strict design and large samples are needed to further verify the efficacy and safety of Qigong for fibromyalgia syndrome.Part three:Comparison of Methodological Characteristics of Randomized ControlledTrials and Cohort Studies of QigongAt present,the quality of Qigong clinical efficacy evaluation methodologies of RCT and cohort study are not high.In the study design and methodology,there are problems such as low registration rate of research protocols,high risk of research bias,and irregular reporting standards.To expand the methodological thinking of Qigong clinical research and the methodological quality of real-world research such as cohort study.This will provide more evidence-based studies for clinical research on Qigong.