Study On The Factors Influencing Acupuncture Adequacy In Explanatory Randomized Controlled Trial

Background and ObjectiveThe result of acupuncture explanatory randomized controlled trial(ERCT)is more closely related to acupuncture treatment protocol,sham control group protocol,and acupuncturist qualification.Evaluating only their methodological quality may result in failure to interpret acupuncture ERCT result and failure to apply acupuncture ERCT evidence.Since 1990,the evaluation of the adequacy of acupuncture protocol in clinical trials has been continuously proposed and the evaluation method has been attempted to made.The evaluation is focused on the acupuncture treatment details and sham acupuncture control.Due to certain limitations in their research method or research content,however,no consensus has been reached and neither has been widely used.There is an urgent need for an evaluation tool for the adequacy of acupuncture in ERCT that reflects the characteristics of acupuncture therapy.Based on this,our research team has systematically reviewed previous studies on the adequacy of acupuncture in clinical trials and defined the adequacy of acupuncture in ERCT,i.e.,the extent to which the true acupuncture protocol(treatment group)achieves the optimal therapeutic effect and the extent to which the sham acupuncture control protocol(control group)reduces the physiological therapeutic effect.Currently,our research team attempts to produce an evaluation tool for the adequacy of acupuncture in ERCT that reflects the characteristics of acupuncture therapy.First,the factors influencing it need to be studied and an item pool of the factors needs to be made,with a view to laying a foundation for the production of the evaluation tool for the adequacy of acupuncture in ERCT.MethodsLiterature research method,inductive analysis,and focus group discussion were used in our study.(1)Literature research method:This study was based on a wide range of literature(four parts:acupuncture expert experience literature,acupuncture traditional review,acupuncture ERCT,and Cochrane acupuncture systematic review)in order to fully characterize acupuncture therapy and to study the factors influencing the adequacy of acupuncture in ERCT.(2)Inductive analysis:The factors were summarized according to PICOS.PICOS was the basic framework for the construction of clinical issues,including population or patient(P),intervention(I),control(C),outcome(O),setting(S).(3)Focus group discussion:Semi-structured interview was conducted through a focus group discussion.Experts experienced in acupuncture clinical practice,acupuncture clinical trial,and acupuncture theory research were selected as interviewees in order to supplement the factors influencing the adequacy of acupuncture in ERCT sorted out from the previous four literature studies.ContentsWe conducted the study from the perspective of the factors influencing the effect of acupuncture and the factors influencing the effect of sham acupuncture,including(1)exploring the factors influencing the effect of acupuncture from the practitioner’s perspective from the expert experience literature;(2)analyzing the factors influencing the effect of acupuncture from the perspective of the practitioner,the patient,and the environment from the traditional reviews;(3)analyzing the influencing factors on sham acupuncture control effect by analyzing whether the type of sham acupuncture,inserted or not and different sites of sham acupuncture,influencing the result of acupuncture ERCT;(4)using Cochrane systematic reviews of acupuncture as an example,analyzing the factors influencing the adequacy of acupuncture in ERCT;(5)organizing focus group interviews discussing the acupuncture RCT published in the four major medical journals(JAMA,NEJM,Lancet,BMJ),to explore acupuncture clinicians’ and researchers’ perceptions of the adequacy of acupuncture in ERCT and the perceptions of its influencing factors.T he five parts complem ented each other,and the results of the five parts were summarized according to PICOS.The item pool of the influencing factors on the adequacy of acupuncture in ERCT was made.1.Analysis of the factors influencing the effect of acupuncture based on expert experienceThe journal articles of acupuncture clinical experts’ experience were searched in China National Knowledge Infrastructure(CNKI)and PubMed from the inception to September 4,2020.Data were extracted by Excel.The extraction contents included the diseases and the factors influencing the effect of acupuncture which the experts attached importance to.2.Analysis of the factors influencing the effect of acupuncture based on traditional reviewsThe traditional reviews on factors influencing acupuncture effect were searched in CNKI and PubMed from the inception to August 31,2021.Excel was used to extract the factors.3.Analysis of the factors influencing the effect of sham acupuncture control based on ERCTThe acupuncture ERCTs were searched in seven databases,including CNKI,Wanfang Data,VIP,CBM,PubMed,Embase,and Cochrane Central Register of Controlled Trials(CENTRAL).The search period was from January 1,2015 to December 31,2019.Excel was used for data extraction.The included articles were divided according to pain or non-pain diseases,and the type of sham acupuncture was classified according to whether it was penetrated and the sites of sham acupuncture.A chi-square test was applied to the dichotomous variables,and differences were considered statistically significant at P<0.05.4.The factors influencing the adequacy of acupuncture in ERCT based on Cochrane systematic reviews on acupunctureThe systematic reviews referred to the adequacy of acupuncture were searched in the Cochrane Database of Systematic Reviews(CDSR)from its inception to August 31,2021.The data extraction table was in Excel.The main extraction contents were the evaluating items and/or the influencing factors on the adequacy of acupuncture in ERCT.5.Focus group discussion on the adequacy of acupuncture in ERCT and its influencing factors based on the four major medical journalsThe acupuncture RCT articles in the four major medical journals were searched in PubMed and supplemented with manual retrieval.The search period was from its inception to April 2021.The basic information,acupuncture treatment,control protocol,acupuncturist qualification,primary outcome,result,conclusion and other information were extracted.The interview outline was made.With the method of focus group discussion,semi-structured interviews were conducted.The discussion results were analyzed by inductive analysis.Results1.Analysis of the factors influencing the effect of acupuncture based on expert experienceA total of 499 studies were included,covering 17 disease fields,of which the majority of studies focused on the neurological diseases,accounting for 27.7%,followed by the studies on the diseases of the musculoskeletal system or connective tissue,accounting for 11.8%.There were 296 experts included.The factors influencing the effect of acupuncture were summarized into six aspects,including(1)Diagnosis:Disease differentiation and syndrome differentiation,excess and deficiency differentiation,combination of the four diagnosis,sensory diagnosis under the needle,with the aid of modern diagnosis and treatment equipment,etc.(2)Acupoint selection:Acupoint selection according to meridian differentiation,local acupoint selection,acupoint selection according to viscera differentiation,finding acupoints according to the palpation with the pressing hand,selection of experience acupoints,the own acupoint sites,paying attention to the patient’s position and posture in the acupoint finding,the sequence of acupoint selection,etc.(3)Acupuncture manipulation:Finger strength,way of inserting needle,way of withdrawing needle,assistant of the pressing hand,direction of needle,reinforcing and reducing manipulation and its amount,depth of needle,needling sensation,etc.(4)Spirit adjustment by acupuncture:Selection of the tranquilizing acupoints,spirit adjustment by acupuncturists and patients,etc.(5)Treatment time:The timing of acupuncture intervention,the interval of treatment,the course of acupuncture,the time of needle retention,etc.(6)Combined with other therapies:Ear acupuncture,embedding,moxibustion,cupping,drugs,rehabilitation,etc.2.Analysis of the factors influencing the effect of acupuncture based on traditional reviewsA total of 90 articles were included,including pain diseases,insomnia,infertility,mild cognitive impairment,hypertension,cervical vertigo,stroke,insulin resistance,etc.The factors affecting the effect of acupuncture were summarized into three aspects:(1)Acupuncturist factor:Theoretical system,acupoint selection,acupuncture manipulation,treatment time,amount of stimulation,combination of other therapies,the characteristics of acupuncturist,doctor-patient interaction,etc.(2)Patient factor:Physical factors,psychological factors,etc.(3)Environment factor:Season,climate,hospital environment,social environment,etc.3.Analysis of the factors influencing the effect of sham acupuncture control based on ERCTA total of 74 acupuncture ERCTs were included,32 articles on pain diseases and 42 articles on non-pain diseases.The pain diseases included postoperative pain,postpartum pain,migraine,knee osteoarthritis pain,fibromyalgia,etc.The non-pain diseases included functional constipation,postoperative nausea and vomiting,post-chemotherapy nausea and vomiting,assisted reproduction,etc.By chi-square test,for the pain diseases,whether or not the sham acupuncture was penetrated and whether or not the sham acupuncture was at different sites did not influence the study result(P>0.05).For the non-pain diseases,whether or not the sham acupuncture was penetrated influenced the study result(P<0.05);whether or not the sham acupuncture was at different sites did not influence the study result(P>0.05).4.The factors influencing the adequacy of acupuncture in ERCT based on Cochrane systematic reviews on acupunctureA total of 49 acupuncture systematic reviews(SRs)were included.The influencing factors on the adequacy of acupuncture in ERCT were analyzed from the perspective of the intervention group in all the included SRs.In seven SRs,the type and effect of sham acupuncture were believed to have a certain impact on the adequacy of acupuncture in ERCT.The influencing factors mentioned on the intervention group were the theoretical basis of acupuncture,acupoint selection,acupuncture manipulation,acupuncture time,acupuncturist’ background,doctor-patient relationship.The influencing factors mentioned on the sham acupuncture group were the type of sham acupuncture and its rationality.5.Focus group discussion on the adequacy of acupuncture in ERCT and its influencing factors based on the four maj or medical journalsTwelve articles published in the four major medical journals from 2001 were included,including seven articles on pain diseases and five articles on gynecological diseases.There were two focus groups according to the two categories.Ten acupuncture clinicians,clinical researchers and basic theory researchers were interviewed.The factors influencing the adequacy of acupuncture in ERCT mentioned by the experts were categorized into seven topics:research basis(pilot trial and preliminary research basis),disease factor(the strength point of acupuncture in treating its superior conditions,the accuracy and refinement of inclusion criteria),treatment/control group protocols(differentiation such as meridian differentiation,palpation to find ashi point,acupuncture manipulation,acupuncture time,combination with other acupuncture therapies,sham acupuncture control),outcome(primary outcome and its evaluation time),acupuncturist factor(acupuncturist qualification,acupuncturist-patient communication,acupuncturist’s attitude,the fidelity of treatment/control group intervention),patient factor(patient’s previous acupuncture experience,patient’s lifestyle,female patient’s susceptibility to the interfering factors),and environmental factor(treatment environment).It was emphasized that the acupuncture protocol in ERCT should be based on the pilot trial and preliminary research basis.The experts opposed to making acupuncture protocol directly according to expert consensus and textbook,and emphasized that the evaluation time of the primary outcome should be determined according to the research issue and the effect law of acupuncture on the disease,etc.Sufficient acupuncture frequency and total treatment time should be paid attention to.ConclusionThrough a wide range of literature(acupuncture expert experience literature,acupuncture traditional review,acupuncture ERCT,Cochrane acupuncture systematic review)study and focus group discussion,the item pool of the influencing factors on the adequacy of acupuncture in ERCT is made,covering all aspects of PICOS and beyond.P factors include disease factors,physical factors,psychological factors,personality factors,previous acupuncture treatment experience,relevant professional knowledge,usual work and rest status,tonic,drug and health products misuse,the interfering factors that female patients are susceptible to.I factors include the theoretical basis of acupuncture,pilot trial and preliminary research basis,diagnostic modality,acupoint selection,acupoint finding,acupuncture manipulation,acupuncture time,other interventions,the characteristics of the physician,the fidelity of the treatment protocol implementation.C factors include the type of sham acupuncture control and its rationality,the fidelity of the control protocol implementation.O factors include the primary outcome and its evaluation time.S factors include season,climate,geographic environment,hospital environment,clinic environment,social environment,family environment.Other factors include the medical insurance reimbursement times.The results of the study can provide reference for the clinical acupuncture treatment,for the design,report and interpretation of the acupuncture protocol in clinical research,and lay a foundation for the production of the evaluation tool for the adequacy of acupuncture in ERCT.