| BackgroundWith the development of modern medicine,the diagnosis and treatment of diseases are not only determined by the personal experiences of clinicians,but also need to be supported by scientific evidence that has been strictly evaluated.Clinical Practice Guidelines(CPG)is an effective international approach to standardize medical practices,improve health care quality and control medical expenses.The formulation of a CPG is a process from evidence to recommendations.This process is complicated and tedious,and many factors need to be considered.At present,there is no method or manual to guide the evidence transformation of acupuncture or traditional Chinese medicine,and the clinical application rate is not high.PurposeTaking acupuncture for Type 2 Diabetes Mellitus(T2DM)as an example,we systematically explored the factors and existing problems that should be taken into consideration when translating acupuncture and moxibustion evidence into recommendations.Based on the EtD framework(Evidence to Decision Frameworks)of the GRADE working group,the supplementary opinions on the framework of acupuncture and moxibustion with characteristics were preliminarily formed to provide references for the future conversion of acupuncture and moxibustion Evidence into recommendation and the development of the manual of acupuncture and moxibustion CPG.MethodsThis study mainly includes the following contents:the key factors that should be considered in the process from evidence of acupuncture and moxibustion to the recommendations,namely,the quality of evidence,the analysis of advantages and disadvantages and health economics;To find the existing problems through the comparative evaluation of acupuncture and moxibustion CPG and the questionnaire survey.Questionnaire survey was conducted to investigate the usage of acupuncture and moxibustion CPG and the existing problems in its implementation,and to explore the acupuncture and moxibustion CPG style and innovative forms.The specific method is divided into the following four parts:1.We systematically searched PubMed,Embase,Cochrane CENTRAL,CNKI and CBM.RCTs of acupuncture and moxibustion for T2DM were included.The control measures were sham acupuncture or blank control group.Ongoing trials were searched at clinicaltrials.gov and the WHO international trial registration platform(ICTRP).The combination of free words and subject words is used in the search strategy.The main index words were combined with free and type 2 diabetes mellitus and acupuncture.The primary outcomes are glycemic control and the incidence of adverse events,and the secondary outcomes included lipid level,weight,BMI,and blood pressure control.All of outcomes are synthesised using a random-effect model.CONSORT and STRICTA were used to evaluate the reporting quality of the included studies.2.CNKI,PubMed and NHS EED were searched systematically.Retrieval strategies were combined with subject words and free words.The subject words of CBM and PUBMED are "acupuncture" and "cost and cost analysis/cost benefit analysis".Relevant researches of the complete economic evaluation of acupuncture and moxibustion and related therapies were included.The included literatures were systematically evaluated on health economics.3.AGREE II,RIGHT statements and GLIA were used to evaluate the methodological quality,report quality and implementability of evidence-based clinical practice guideline of acupuncture and moxibustion for diabetic peripheral neuropathy,which issued by Chinese acupuncture and moxibustion association.In order to facilitate the comparison and find out the gaps,diabetes related CPG of traditional Chinese medicine and western medicine,namely the evidence-based clinical practice guidelines for diabetes medicine(2016 edition)issued by the national clinical research base of traditional Chinese medicine,and the prevention and treatment guidelines for type 2 diabetes in China(2017 edition)issued by the Chinese medical association,were included for comparative analysis.4.Questionnaire survey was conducted to investigate the usage of acupuncture and moxibustion CPG and the existing problems in the practice.The questionnaire survey is mainly aimed at acupuncture and moxibustion clinicians.The development of the questionnaire mainly includes the clinical use of acupuncture and moxibustion guidelines and the opinions of clinical workers on the guidelines,the channels of clinical assistance for clinical acupuncture and moxibustion practitioners,the most needed guidance in clinical practice,and the discussion on how to improve the practicabiity of the guidel ines.Questionnaire was sent through social software and E-mail through the electronic questionnaire survey platform of questionnaire star(www.wjx.cn)website.Results1.A total of 21 studies,which comprised a total of 1,943 participants,were included in the final meta-analysis.All the trials were high or unclear in the risk of bias.Compared with sham acupuncture or no acupuncture plus baseline treatment control,acupuncture plus baseline treatment yield a mean reduction in fasting blood glucose(FBG)of 1.21mmol/l(95%Cl 1.56 to 0.87),a mean reduction in 2-hour postprandial blood glucose(2h BG)of 2.13mmol/l(2.79 to 1.46),an improved mean reduction in glycated haemoglobin(HAlc)of 1.12%(1.62 to 0.62).Two of the trials reported no significant adverse effects in acupuncture combined therapy.Our results also show acupuncture can improve blood lipid and blood pressure control(diastolic blood pressure may not clinical significant),reduce the fasting insulin level and weight.From the evaluation of CONSORT and STRICTA,the reporting quality of the included literature reports is low,which is mainly reflected in the generation and allocation of random sequences,blinding,sample size calculation,trial registration,conflicts of interests,details of acupuncture,background of therapists and other aspects.2.There were 37 articles on health economics of acupuncture and moxibustion,including 17 in Chinese and 20 in English.Except for allergic rhinitis and common irritable bowel syndrome(except severe irritable bowel syndrome),acupuncture is cost-effective(the cost of all the diseases analyzed was below the threshold).There were 11 diseases reported in Chinese literature and 13 diseases in English literature.German publications account for the largest proportion of English literature.CEA(82.4%)is the most commonly used economic evaluation method in Chinese literature,while CUA(75%)is the most commonly used economic evaluation method in English literature.All the Chinese literature used a patient perspective,while 75%of the English literature used a social or government perspective.Incremental analysis was used in 35.3%of the Chinese literature,and sensitivity analysis was used in 23.5%,while 85%and 80%of the English literature were used,respectively.3.AGREE II of acupuncture CPG in scope and purpose,stakeholder involvement,rigor of development,clarity of presentation,application,editorial independence were 94.4%,55.6%,56.3%,66.7%,16.7%,0.0%respectively;TCM CPG were 94.4%,44.4%,52.1%,55.6%,12.5%,75.0%,western medicine CPG were 100.0%,50.0%,41.7%,88.9%,79.2%and 58.3%,respectively.Acupuncture CPG scored in 7 domains of RIGHT statement 50.0%,87.5%,60.0%,28.6%,100.0%,0.0%and 0.0%in of basic information,background,evidence,recommendations,evaluation and quality assurance,funding and conflict of interest,and other information,respectively.The score of TCM CPG was 50.0%,62.5%,40.0%,28.6%,0.0%,25.0%and 0.0%,respectively.The score of CPG in western medicine were 100.0%,75.0%,40.0%,28.6%,0.0%,25.0%and 33.3%,respectively.Acupuncture CPG in GLIA scale global consideration,executability,decidability,validity,flexibility,effect on the nursing process,measurability,novelty/innovation were 77.8%,0.0%,0.0%,50.0%,66.7%,50.0%,0.0%,66.7%,respectively;the TCM CPG were 55.6%,0.0%,0.0%,50.0%,66.7%,50.0%,0.0%,66.7%,respectively;The western medicine CPG were 77.8%,100.0%,100.0%,100.0%,66.7%,50.0%,100.0%and 100.0%,respectively.4.125 valid questionnaires were eventually received.The respondents came from 19 provinces or municipalities,with Beijing accounting for 39.2%.More than 80%of the respondents in this questionnaire are clinicians,and the most professionals is acupuncture.The questionnaire consists of 16 questions.The detailed results are shown in the paper.Conclusion1.There is very low level of evidence that compared with sham acupuncture or no acupuncture plus basic treatments,acupuncture plus basic treatment can improve blood glucose control,blood lipid and blood pressure levels and reduce body weight in the management of T2DM.Since acupuncture combined with hypoglycemic drugs can achieve better blood glucose control than hypoglycemic drugs alone,considering its overall benefits to the endocrine system,acupuncture can he used as a supplementary therapy for patients with diabetes with obesity or metabolic disorders.F uture research needs to address issues such as whether long-term acupuncture treatment can reduce the incidence of diabetes complications,reduce mortality,improve quality of life and the health economics of acupuncture.In addition,the methodological quality and reporting quality of the included studies were poor,which not only reflected the poor transparency and planning of clinical research on acupuncture and moxibustion,but also seriously affected the clinical evaluation of acupuncture and moxibustion.2.In the included studies,acupuncture was cost-effective in most diseases.It also suggests that acupuncture has different cost-benefit ratios for different diseases,even at different stages of the same disease.As a treatment,the evaluation of health economics of acupuncture and moxibustion has its complexity.At present,the evidence of health economics related to acupuncture and moxibustion is still scarce.The lack of such research means that it is impossible to evaluate the economic cost and resource saving of acupuncture and moxibustion in the treatment of diabetes,which is a serious obstacle to medical decision-making.Compared with the English literature,the domestic literature on acupuncture and moxibustion health economics still have a large gap in methodology,mainly including the evaluation method,perspective,sensitivity analysis and incremental analysis of health economics.In the future,experts from related disciplines are required to join in.In addition,there are still some problems in Chinese literature,such as cost calculatio,short research period and improper control measures.Because the health and economic environment at domestic and abroad are quite different,the research results of health economics from abroad cannot be directly applied to China.As acupuncture is highly dependent on human resources,it requires less material resources.With the abundance of material resources and the increase of human resources,the future application of acupuncture and moxibustion is facing challenges.It is increasingly important to reduce the cost of acupuncture and moxibustion from the perspective of health economics.This paper also discusses the methods to reduce the cost of acupuncture and moxibustion from the perspective of health economics.In the future,more experts are required to pay attention to this field.3.At present,the process of transforming evidence of acupuncture and moxibustion CPG into recommendation opinions is not clear,there is no clear methodological guidance,and the factors to be considered in the process of transformation are not clear.From the perspective of comparative evaluation,the main problems of the recommendation opinions include not giving specific outcomes and benefits,insufficient individualized information,poor measurability and undefinable nature,etc.The recommendation of acupuncture and moxibustion CPG takes acupuncture and moxibustion methods as the main form of recommendation,and the main symptoms and complications as the main basis for subgroup classification.These positive explorations are worthy of reference in the future.At present,many guidebooks provide tools for reference.On the basis of referring to these tools and combining with the characteristics of acupuncture and moxibustion,we can form scientific and practical recommcndations.4.At present,clinical practitioners of acupuncture and moxibustion generally do not have a deep understanding of clinical practice guidelines of acupuncture and moxibustion,but they have a strong desire to have uniformed standards and follow relevant guidelines.Although the published clinical practice guidelines of acupuncture and moxibustion have achieved some results,they still have not got rid of the shackles of compiling textbooks before.The main problems include insufficient promotion,poor credibi lity,no evaluation criteria for efficacy and lack of consideration for wi IIingness of patients.As the acupuncture and moxibustion guidelines are derived from the latest evidence in current clinical studies,they also reflect the low quality of clinical research on acupuncture and moxibustion and the lack of evidence-based concepts of clinical acupuncture and moxibustion personnel.The implementation of clinical guidelines is a key step of evidence-based transformation,while the research on the feasibility of clinical practice guidelines of acupuncture and moxibustion is still blank,and more experts need to pay attention to this field in the future.5.Based on the characteristics of acupuncture and moxibustion and EtD frameworks,this study developed a supplementary opinion on the acupuncture evidence transformation framework.Additional comments include considering the role of acupuncture in the treatment,recommending different acupuncture methods as outline,ensuring the measurability of recommendations and diversifying individual information.This study fills the research gap of the acupuncture field from evidence to recommendation,and provides references for the future developments of acupuncture CPG.In the future,the exploration of evidence transformation requires the more multidisciplinary experts to join in.In the exploration,we should pay close attention to the current achievements in the method of evidence transformation.On this basis,combined with the evidence of acupuncture and the clinical practice characteristics of acupuncture,we can continuously improve the quality of recommendations of acupuncture CPG. |
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