| BackgroundIn 2014,Hinman published an essay about acupuncture compared to sham acupuncture for chronic knee pain.The essay concluded that acupuncture had no specific effect on knee pain.In 2016,the National Institutes of Health(NIH)abolished the recommendation that acupuncture therapy for low back pain according to previous trials.In response to the two events,the overseas TCM community attribute it to the improper design of the trial.In China,the clinical trials on acupuncture and moxibustion,especially randomized controlled trials,has increased year by year.But the quality of these trials were low,according to the reseachers.Are the defects in control design of foreign trails common or not?What are the major defects in trials published in china?And what extent these defects are?Any advices for the improvement?ObjectiveThe purpose of the study is to review the design of control from randomized controlled trials of simple obesity treated with acupuncture,summarize the problems of design and put give advices on it so that this review at final could provide a reference.MethodsThe first is the literature retrieval.Three kinds of databases featured Chinese,English and Japanese,were searched for randomized controlled trials of acupuncture treatment for simple obesity,published from January 1,2007 to January 1,2017,and then screened according to the inclusion and exclusion criteria of literature.The second part is information extraction.After screening,the document information data table is created by Excel 2016 to extract the literature information.The items and contents of the extraction include:(1)The basic information of the literature:the name of the literature,the date of publication,the location of the author,the author,the journal name,the funds and subjects of the journals,SCI or core journals.(2)The purpose of the study:the purpose of the trial.(3)Baseline information:demographic indicators,outcome measures,baseline data,statistical examination,whether TCM syndrome differentiation were equally allocated to the treatment group and the control group.(4)Intervention information:There are two types.First,the control group and the treatment group are the same kind of acupuncture therapy:basic control settings,treatment group and control group of acupoints,needling,depth,technique and instrument specifications,other auxiliary treatment,course of treatment;second,the control group and the treatment group is not same kind of therapy:the therapy,treatment,treatment frequency.The third step is unifying data.After extracting the literature information,the purpose of the experiment is summarized into four types,and the English letters A,B,C and E,and the basic types of the control are also the same so as to further deal with it.The fourth step is to deal with information by bibliometrics,to dismantle all the items extracted and to carry out quantitative statistics separately,and the results are described with graphs and tables.The fifth step is based on the analysis of the diagram reflected,and combs the problems in the research and design.ResultsThe baseline:gender,age,duration of three basic demographic indicators,the complete set of literature accounted for only 49%,the rest are not complete,even with 2 references no demographic indicators;statistical test for demographic indicators,were included in the index design because only half of the literature can do is complete,the test is only half the number are 68,although demographic indicators did not design documents that there are 2,but did not consider the test index documents that there are 10.In addition,only about 43%(60)of the study conducted statistical tests on the observation indicators used by the Institute before intervention.76 articles on patients with the syndrome differentiation of TCM,but not in the 42 articles of different types of baseline test to confirm the allocation of patients in the treatment group and control group is not balanced,10 papers consider the distribution of patients with different syndromes in the number of equilibrium,but failed to combined with the severity of the syndrome type,24 articles were included in the same kind of syndrome type of patients,but also did not consider that although similar syndromes of patients,but the severity of the situation may be different,in the distribution is not noticed.Intervention:the design of different research purposes,the design of the problem is different.To observe the therapeutic effect of acupuncture on obesity and observe the test of the influence of one factor of acupuncture therapy on curative effect,there are many researches on these two purposes,and there are still many problems in contrast design.To observe the curative effect of acupuncture therapy for obesity for the purpose of the control design of the study,in 63 articles,accounting for about 70%of the control design according to the literature did not choose the correct type of control(such studies should choose the positive control,blank control,placebo control,experimental control or combination).In addition,even if the control chose the correct type of literature,still have their own problems:the study of positive control design by using the literature,the design of control are set of security problems in the western medicine,not according to the severity of complications and select the most appropriate drug design,diet and exercise control diet and exercise control of to the current standards;the design of comfort acupuncture control more than general literature can not meet the basic requirements of the two placebo control design;experimental control complexity overlook simple obesity,simple in comparison with therapy and treatment group project.In order to explore the influence of acupuncture therapy or acupoint manipulation on the effect of acupuncture on obesity,there were no excessive administration factors.ConclusionAccording to the review,the baseline contrast and the intervention measures are not well designed.Some trials published abroad that had concluded there was no significant difference between the effect of authentic acupuncture and sham acupuncture,this may related to the defective design of the control.Also,the design quality of the control in China is lack of qulaity.This wastes resources and time.Advices on problems:When designing the intervention,the researchers need to determine the type of control according to the purpose of the study:if it is to observe the effect of acupuncture and moxibustion therapy,then positive control,experimental control,placebo control or blank control is optional.The experimental control needs to think about the particularity of the disease and the individual,placebo control,although it can minish the placebo effect,but it is more difficult and controversial considering its design,the blank control clinical trial has been less applied.Besides the pick of the control type,for the positive control,it needs to be designed with reference to the current guide or expert consensus,and also considered the application of the patients in the group;the design of the placebo acupuncture control needs to be no specific therapeutic effect,and simulated the treatment of the experimental group,both in appearance and sensation.If it is a factor from acupuncture therapy to be observed,such as acupoint selection and manipulation,it should be treated as a processing factor in this trial. |
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