The Literature Analysis And Evaluation Study Of Randomized Controlled Trials Guided By Jingjin Theory In The Past Five Years

Purpose: To improve the quality of the randomized controlled trial(randomized controlled trial,RCT)reported by the theory of tendons,this study collects 2013-2017 years of relevant RCT literature guided by the theory of tendons,according to the unified standard of the clinical trial report(Consolidated Standards of Reporting Trials,CONSORT)and acupuncture clinical trial intervention The Standards for Reporting Interventions in Clinical Trials of Acupuncture,STRICTA standard is applied to analyze the literature.To explore the quality of clinical trials and clinical trials in the past five years,and to expose the problems and deficiencies in the clinical trials of tendons,and to provide a basis for improving the design level of the clinical trials.Material and method: All the literature came from the January 2013-2017 December,CNKI,Wan Fang,VIP and other Chinese full text journals database,search key words including "tendons" "tendons" "tendons," "pain as an acupoint," "transverse collaterals","regular acupoint" and other related terms,"long circular needle" "needle knife" "needle knife" "needle" "water needle" "Silver needle","tendon reinforcement" and other related clinical tools,collect and screen literatures related to clinical trials of tendons.The basic information of the clinical trials was excerpted,including the basic information of the clinical trials,such as the number of tests,the periodicals,the year,the unit of the experiment,and other clinical trials.According to the CONSORT declaration,the intervention measures,the outcome indicators,the observation nodes,the sample size,the random method,the hidden grouping,the design of the blind method,the ITT description,and the safety of the clinical trials were collected.Information such as the whole situation,the test limited selfevaluation,the clinical registration information,and other information such as the treatment tool,the site of treatment,the amount of stimulation,the intervention measures,the background of the experimenter,the ethical situation and so on according to the STRICTA standard.The data statistics method was used to observe the measurement of RCT literature,including the changes in the number of papers in the annual clinical trial papers,the static and dynamic indexes,such as the distribution of the clinical trials,and the distribution of the clinical researchers.To analyze the index of the clinical test index of the tendons,the predominant disease,the distribution of the disease position,the method of treatment and the condition of the treatment.According to the design principles and methods of experimental design,the frequency statistics of random settings,control settings,and the setting of blind law are carried out in the design of statistical clinical trials.Results: 1.A total of 811 articles,including 592 clinical literature and 259 clinical trials,were retrieved in the five years of the five years,including 192 clinical trials.Over the years,the number of clinical trials reached a peak in 2013 and 2015,but dropped slightly in 2016,but the number and proportion of published papers were still higher than 2014.2.After searching,the clinical trials of tendons in the past five years were distributed in 27 provinces,municipalities and autonomous regions.Liaoning province carried out 34 clinical trials,ranking the top of the list.There are 26 projects in Guangxi Province,15 in Guangdong Province,13 in Zhejiang Province,11 in PLA(army hospital),11 in Beijing and 9 in Jiangsu province.Through analysis,the square root of the total provinces and regions is 51.56% of the total experimental number,and the first five provinces have become the core areas of the study.3.Of the 3 clinical trials in the past five years,98 clinical trials were funded by 90 scientific research projects,of which 12 were funded by the state,32 at the provincial and ministerial level projects,48 in the city hall projects and 5 by the hospital grade projects.4.Nearly five years clinical trials of tendons mainly concentrated in Department of orthopedics,neurology,rheumatology and other departments of the disease.The first ten were knee osteoarthritis,stroke(hemiplegia),cervical spondylosis,facial paralysis,myofascitis,periarthritis of shoulder,protrusion of lumbar intervertebral disc,epicondylitis of the humerus,lumbago,and ankle sprain.The top five treatment positions of meridian therapy were knee popliteal part,waist and back,head and face,shoulder,back and neck.From high to low,the criteria for the selection of diagnostic criteria for disease selection are to establish standards,to formulate standards for national health departments,to textbooks and treatises,to foreign related diagnostic standards and to self-made standards.5.The clinical intervention measures mainly include acupuncture,moxibustion,massage,cupping,and external application of traditional Chinese medicine.The acupuncture includes needle acupuncture,special needle acupuncture,electroacupuncture,warm acupuncture and so on.6.Clinical efficacy observation,including outcome indicators and observation indicators,were divided into subjective indicators,objective indicators and quality of life indicators.In the last five years,the results of the RCT outcome were all clinical.140 items set the subjective indexes except the evaluation of the curative effect.Among them,there were 79 tests of VAS or Mc Gill pain evaluation indexes,34 objective indexes were designed,and the quality of life and psychological state related indexes were designed in 4 tests.7.The quality analysis of clinical trials based on CONSORT and STRICTA shows that most tendons clinical trials are designed at a low quality level.Random designs were randomly divided into 15 unreported groups,and 95 tests mentioned random groups,but no specific random design method,a total of 90 group methods were described in detail,and 86 simple random methods(such as random numbers,lottery,computer design),and 2 experiments were adopted.Stratified random method(according to multiple center stratification).In the past five years,9 randomized trials were designed for randomized grouping.In the control design,the control group was set up in all the trials,of which 69.27% clinical trials were compared with another,and only 17.19% of the gold standard treatments used for the treatment were compared.In the past five years,only 1 papers mentioned the blindness of patients in the blind area.3 articles mentioned the blindness of statistics and evaluation personnel.In follow-up,23 clinical trials were followed up,of which 16 were followed up for more than 3 months,and 1 were followed up for many times.All trials were registered and ethical,and all trials were not mentioned in clinical trials and ethical batch numbers;ITT evaluation,and clinical trials There are 11 articles in the test literature that have been removed and eliminated.In the past five years,there were 21 adverse reactions in the record of adverse reactions,which accounted for the proportion of clinical trials in the year.Conclusions: 1.The clinical trials of meridians and tendons have been carried out extensively throughout the country,Liaoning has the leading edge in the clinical research of tendons in the whole country.2.Clinical trials are widely used in the treatment of bone injury,tendons in the Department of Traumatology,hemiplegia,shoulder pain and facial paralysis,which are closely related to the joint,muscle and soft tissue.3.The clinical trial design and report of low quality tendons in the past five years are still a lot.It is necessary to improve the level of experimental design,clinical trials,and need to standardize the technical terms and diagnostic standards.