The Methodology Research Of Clinical Trial Design And Evaluation Of Functional Abdominal Pain Disorders In Children By Traditional Chinese Medicine Treatment

Objective The system systematically collects and collates the randomized controlled clinical trial literatures of children with functional abdominal pain(FAPDs)at home and abroad,summarizes,analyzes,and refines the technical points of clinical trial design and evaluation of children's FAPDs in traditional Chinese medicine,and locates,designs,and implements the clinical trials of traditional Chinese medicine in this disease,And comparison between different results,to provide reference and feasibility.Methods Formulate the criteria for inclusion and exclusion of documents,and search China How Net,Wanfang,China Biomedical Literature Database,Weipu,Pub Med,The Cochrane Library,and Embase databases,as well as clinical trial registration websites at home and abroad through a computer system.In November,RCT studies related to children's FAPDs were collected.Documents were sorted and screened using Note Express software,and risk bias was assessed for included studies.For the final included studies,carry out clinical positioning,overall design of the study,diagnostic and dialectical criteria,selection and withdrawal of subjects,dosing regimens,effectiveness evaluations,safety observations,and trial process information extraction.Summary and analysis.Results A preliminary search yielded 1453 references.After layer-by-layer screening,24 RCT studies were finally included.Including 15(62.5%)foreign research and 9(37.5%)domestic Chinese medicine research.Key points for the design and evaluation of children's FAPDs clinical trials,including:(1)Clinical positioning.Indication positioning of all 24 studies,15 studies(62.5%)were functional abdominal pain(FAP),including all 9 domestic Chinese medicine studies;9 studies(37.5%)were functional abdominal gastrointestinal diseases(AP)-FGIDs)and 2 or 3 of them in FAP,irritable bowel syndrome(IBS),and functional dyspepsia(FD).The goal of all 24 studies was to improve the symptoms of abdominal pain,that is,to reduce the severity of abdominal pain,reduce the number of abdominal pains / increase the number of painless days,shorten the time of onset of abdominal pain,or a comprehensive improvement goal based on these two or three goals.(2)The overall design of the test.There were 17 placebo-controlled studies(70.83%),of which 15 Western medicine studies were placebo-controlled;7 positive control(25.93%)were used,and the positive drugs included Chinese medicine,probiotics,anticholinergics,and prokinetic drugs,There is a lack of recognized effective positive drugs.(3)Diagnostic and dialectical standards.According to the diagnostic criteria for functional gastrointestinal diseases formulated by the Rome Professional Committee,the Western medicine diagnostic criteria for pediatric functional abdominal pain are formulated in 23 items(95.83%);the standard of TCM syndrome differentiation for pediatric functional abdominal pain is based on the Chinese industry standard of the People's Republic of China,There are 5 textbook standards for higher education institutions of Chinese medicine(20.83%).(4)The test children were included in the standard.The selected age range of the test children was 2 to 18 years,covering the most children in school age,with a total of 24 items(100%),followed by 22 items(91.67%)in preschool and 19 items(79.17%)in adolescence.The lower age limit is 2 to 8 years old,mostly distributed in 19 preschool age items(79.17%);the upper age limit is 12 to 18 years old,mostly distributed in 19 adolescence(79.17%).Four(16.67%)studies required baseline abdominal pain,two required a VAS score greater than 25 mm,one required a minimum of 40 mm,and one required a NRS score of not less than 4.(5)Exclusion criteria.24 studies were included,all of which established exclusion criteria related to pediatric FAPD disease.Among them,23(95.83%)studies excluded related organic diseases and other organic diseases;12(50%)studies were required to exclude FAPDs-related alarm symptoms;and 10 laboratory abnormalities(41.67%)were excluded.Ten(41.67%)studies established exclusion criteria related to the trial drug.(6)In terms of dosing schedule.Of the 9 TCM studies,only 8 were used as interventions(33.33%);and 15 of the 15 western medicine studies were conducted with probiotics / prebiotics as the intervention,with 9(60%).The course of treatment ranged from 2 to 12 weeks,of which the largest number of studies were designed for 4 weeks,with a total of 14(58.33%).In all the included studies,no basic treatment was designed.(7)Effectiveness evaluation.15 foreign western medicine studies(62.5%)all described the main evaluation indicators.Among them,5 studies(33.33%)were the degree,frequency or duration of abdominal pain,2 studies(13.33%)were defined as "complete remission / very improved" or "cured" according to this definition;7 studies(46.66 %)Is the severity of abdominal pain or "response","overall response",and "successful treatment" as defined;1 study(6.67%)was the number of days without abdominal pain.Nine domestic Chinese medicine studies(37.5%)did not directly describe the main evaluation indicators.Among them,6 studies(66.66%)mainly evaluated the "clinical efficacy" defined by the degree,frequency or duration of abdominal pain,2 studies(22.22%)mainly evaluated the symptomatic efficacy or points,and 1 study(11.11%)Mainly evaluated the severity of abdominal pain.(8)Safety observation.Of the 24 studies,21(87.5%)used clinical adverse events or adverse reactions as safety observation indicators,of which 12(57.14%)further described the adverse events / adverse reactions during the study.For external preparations of Chinese medicine,pay attention to observe skin irritation / allergic reactions.(9)Test process.Six(25%)western medicine studies were designed with an introduction period of 1 to 4 weeks,and 18(75%)of the included studies used a 4 to 6 month follow-up design.Conclision This study systematically collects,summarizes,and analyzes domestic and foreign pediatric functional abdominal pain randomized controlled studies,from clinical positioning,overall design of the trial,diagnostic and dialectical criteria,selection and withdrawal of subjects,treatment options,effectiveness evaluation,and safety Observation and test process aspects,extracted the technical points for the design and evaluation of clinical trials of functional abdominal pain in children,and provided a more reliable literature basis for the development of Technical guidelines for design and evaluation of clinical trials of traditional Chinese medicine for Functional Abdominal Pain in children.