| Background and Objective:Pediatric tuina,as a non-pharmaceutical treatment of traditional Chinese medicine,gradually showed its potential advantages in the prevention and treatment of diarrhea diseases in children.In recent years,the research on pediatric in the treatment of pediatric diarrhea has been gradually increasing.At present,there is no research to summarize and evaluate the evidence of tuina for diarrhea.The methodological quality and reporting quality of RCTs were not evaluated as well;it was difficult for clinical decision in practice that different therapeutic effects reported in various literatures.Previous studies have found that children with diarrhea mainly occurred in children less than five years of age and acute diarrhea accounted for about 87%of children's diarrhea in China.The benefits and harms of pediatric tuina therapy for acute diarrhea in children were expected to evaluate.We summarized the current literature characteristics and the trend of tuina treatment of pediatric diarrhea base on members and percentage of year distributions,research type,and publication language,source of literature,authors and fund support and groups of tuina schools.To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs)of tuina therapy for childhood diarrhea,in order to fill in and analyze inadequate or unreported information,telephone surveys were conducted for the lack of clear reporting or inadequate reporting information in this process,to evaluate the benefits and harms of pediatric tuina as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children.This study may provide suggestions and enlightenment for future clinical practice and research design of tuina in the treatment of acute diarrhea in children.Methods:Part one:Bibliometric study on tuina therapy for pediatric diarrheaWe searched CNKI,Wan Fang,VIP,Sino Med,PubMed and Cochrane Library databases.The deadline for searching is from January 1,2004to January 1,2019.We summarized the current literature characteristics and the trend of tuina treatment of pediatric diarrhea base on members and percentage of year distributions,research type,and publication language,source of literature,authors,and fund support,groups of tuina schools et al.Part two:Evaluation of methodological and reporting quality of randomized controlled trials of Tuina therapy for childhood diarrheaWe identified trials by electronic searching of CNKI,VIP,China biomedical literature database,wan Fang database,Sino Med,PubMed database,The Cochrane Library,EMBASE.The deadline for searching is from their inception to January 1,2019.We included the literature on tuina therapy for childhood diarrhea.Two authors independently screened and extracted data.Based on the CONSORT statement of progress,the methodological quality and reporting quality of RCTs were evaluated,and the items prepared according to the STRICTA were used to evaluate the quality of RCTs intervention reports.We calculated the number of documents to each item in the CONSORT statement and to each item in the STRICTA evaluation criteria,and calculate the reporting rate of each item and indicator included in the trials.We summarized the number of outcome indicators commonly used in included trials.In order to fill in and analyze inadequate or unreported information,telephone surveys were conducted for the lack of clear reporting or inadequate reporting information in this process.We analyzed inadequate reporting information was coming from inadequate reporting by author or inadequate implementation of research itself,and explored the role of telephone surveys in filling in ambiguous information and analyzed its influencing factors.Part three:Pediatric Tui Na for acute diarrhea in children:A systematic review and meta-analysis of randomized clinical trialsThe inclusion criteria are the RCTs of tuina therapy for children diarrhea with etiological diagnosis of rotavirus infection.We searched six databases(CNKI,Wan Fang,VIP,Sino Med,the Cochrane Library and PubMed)from their inception to January 1st,2019.The language of is limited to Chinese and English,two authors extracted data and The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.We used RevMan5.3software for data analyses,for binary data using risk ratio(RR)with 95%confidence intervals(CI),for continuous outcomes data using mean difference(MD)with 95%CI.Sensitivity analysis and subgroup analysis was performed based on analysis methods and intervention types.Trial sequential analysis was used to estimate the sample size of systematic review base on TSA software.v0.9.The GRADEpro was used to generate a summary of finding table.We summarized the evidence summary table for the main relevant outcome results.Results:Part one:Bibliometric study on tuina therapy for pediatric diarrheaIncluding 560 trials,involving 5 systematic reviews(SR),209 randomized controlled trials(RCTs),one cohort study,69 clinical controlled trials(CCTs),232 case series(CSs)and 44 case reports(CRs),The number of literature on RCTs is increasing,while the number of literature on case series is decreasing.In the control design trials,there were 159 trials using tuina alone and 120 trials used tuina combined with other therapies.There is a certain amount of literature on the various types of tuina intervention.That illustrated that the research on the application of tuina therapy alone or in combination with other therapies in the future has feasibility and literature basis.The most articles were published on 181 journals in Chinese.The top three journals published papers were Chinese Manipulation&Rehabilitation Medicine,Chinese Manipulation&Rehabilitation Medicine,China's Naturopathy,the proportion of core journal literature in all journal papers is 22.52%(109/484),and few paper in foreign language with 0.89%(5/560)has been published.Only 4.82%(27/560)of articles were funded.The number of dissertations was mainly coming from Nanjing Universities of Traditional Chinese Medicine,Shandong universities of Traditional Chinese Medicine,Guangzhou Universities of Traditional Chinese Medicine and Beijing Universities of Traditional Chinese Medicine respect,all they were University of Traditional Chinese Medicine in Southeast China.The analysis of clinical research literature showed that the main characteristics of tuina were Shandong SanZiJing,Beijing NieJi and Hunan Xiang Xi.Other characteristic individual tuina is also on the rise,which mainly concentrated on the summary of case experiences,and has not formed a relevant theoretical form.Part two:Evaluation of methodological and reporting quality of randomized controlled trials of Tuina therapy for childhood diarrheaFifty-eight RCTs were included,all the included trials had a high risk bias on the random methods,allocation concealment and blinding of assessment.The methodological quality and reporting quality of RCTs of tuina in treating childhood diarrhea was low.The reports were mainly inadequate;it mainly focused on the random methods,allocation concealment,blinding,baseline integrity,sample size estimation and registration of research protocols.That was reported46.56%,5.17%,8.62%,72.41%,0%,respectively.Telephone survey of 31 articles reported "Random" but without specific random method description,seven(22.58%)of articles were able to contact the research authors,one study(3.23%),the author described the"random"in her article as referring to others,but did not actually perform random operations and sample size estimation,etc.But six(19.35%)of them responded by refusing anything answer,reasons for not being able to contact the author include being unable to contact,unanswered,unable to find the person and invalid telephone number,etc.Problems with the quality of interventions reporting include:The theoretical basis,the details of intervention,the treatment frequency and response,and the qualifications of tuina operators.The rate of reporting were 56.89%,6.89%,17.24%,respectively,the outcome measurement of outcome indicators for diarrhea such as the total effective rate,the duration of diarrhea,frequency of diarrhea,changes of stool volume,and diarrhea accompanying symptoms were reported 100%,22.41%,8.62%,3.44%and 5.17%,respectively.Nine trials clearly reported no adverse reactions and adverse events both in the tuina group and the control group.Two trials reported adverse reactions in the montmorillonite powder group,involving choking milk,constipation,anorexia,nausea and vomiting.Part three:Pediatric Tui Na for acute diarrhea in children:A systematic review and meta-analysis of randomized clinical trialsTotally 30 RCTs were included,involving 2861 children with acute diarrhea.Most of the included trials had high or unclear risk of bias.The proportion of boy and girl was about 1.41:1.The mean age of children is 1.79±0.76 years old.The average course of disease was 3.01±1.14 days.The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three session treatment(RR 1.49,95%CI 1.34-1.66,n=972),and also superior to montmorillonite combined with probiotics after three-session treatment(RR2.04,95%CI 1.49-2.78,n=533,)and after six session treatment(RR1.52,95%CI 1.34-1.73,n=631,)in improving clinical cure rate.Tuina significantly decreased the duration of acute diarrhea(hrs)(MD-10.57h,95%CI-14.79 to-6.35h,n=510,)and daily stool frequency(MD-1.71times,95%CI-2.37 to-1.04,n=217,after three session treatment).Four trials reported the outcome of adverse events.Among them,three trials reported that no adverse event occurred in both pediatric Tui Na and control groups.One trial reported two choking of milk and one constipation in montmorillonite group,No adverse event related to pediatric Tui Na was reported in the included trials.The quality of evidence of included trials was generally moderate to low.TSA was performed with the data from 19 trials reporting the cure rate of acute diarrhea at day 3,involving 1575 participants.The result of TSA illustrated that the meta-analysis of the cure rate after 3 days treatmentment has a certain power on result,but the number of samples and trials required for TSA has not yet been reached.GRADE approach for each important outcome.Tuina for acute diarrhea in children 3 days and 6 days cure rate of evidence quality was evaluated as medium quality,other outcome indicators of evidence quality were mainly evaluated as low quality.Conclusions:The number of clinical literatures on tuina treatment of pediatric diarrhea showed an increasing trend.The literature evidence of tuina therapy for pediatric diarrhea is changing to the evaluation of the efficacy of randomized controlled trials;the level of evidence is gradually increasing.At present,some special tuina schools have published relevant clinical literature,there were few literatures published in core and foreign language journals.At present,the application of tuina therapy in treatment for pediatric diarrhea has not been widely recognized in the international community,and is still in the stage of development.The journals of publishing related articles usually were scattered.At present,the proportion of fund papers in the field of tuina for pediatric diarrhea is low.Some tuina schools have published few clinical literatures.Certain literature publishing had certain advantages and foundation in future research and inheritance.We should actively excavate and inherit tuina schools in the future.The quality of the literature reports and intervention is rather low.In the RCTs of tuina therapy for pediatric diarrhea should be strictly designed and implemented in accordance with relevant standards.To improve the quality of methodological reports of clinical research,we must pay attention to the use and reporting of randomization,blind methods,the standardized reporting of baseline data,the scientific treatment of incomplete outcomes and the estimation of sample size and the registration of schemes in future research.The RCTs intervention reports should concentrate on therapeutic environment,details of tuina treatment,degree of operator,improving the reporting quality of interventions.The number of authors who can be contacted by telephone survey is relatively small,and how to identify and judge the bias risk of articles that only report"random"is one of the key points of future research.Future research can be based on the ONSORT for non-drug development to conduct interviews with magazine editors and exploring the possibility of improving the quality of reports in the process of publishing articles.Future research should follow the requirement report of trial design as far as possible.On the other hand,researchers in related fields should work together and establish reference standards for clinical trial intervention report of tuina therapy based on the characteristics of tuina.This review showed that abdomen rubbing,chiropractic,spleen meridian and large intestine meridian was mainly used for tuina in treatment of acute diahhrea.The results demonstrated that tuina for acute diahhrea was superior to montmorillonite or montmorillonite powder combined probiotics therapy in clinical cure rate,duration of diarrhea.Doctors should actively explore the efficacy and safety of tuina therapy for acute diarrhea in children by referring to current evidence,diarrhea condition and patients'willingness.Considering that the overall methodology of the study is not high,and tuina practice is a complex intervention.It is closely related to the method of selecting acupoints,operation skills and doctor's experience.So we at present cannot draw a convincing conclusion on the efficacy and safety of tuina in the treatment of acute diarrhea in children.However,rigorously designed RCTs are warranted to confirm the findings for low or uncertain quality of trials including.The conclusions at present should be carefully generalized.Future research should pay attention to the analysis of the therapeutic effects of tuina on diarrhea of different types,different diarrhea course and the participant ages. |
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