Evidence Analysis And Evaluation Of Randomized Controlled Trials Of Pediatric Tuina For Anorexia In Children Under 14 Years Old

Background and objectivePediatric anorexia is an eating disorder of childhood.It can affect up to 45% of children.Anorexia in children may lead to malnutrition,conditions such as rickets and scurvy,and may delay growth,effect cognitive ability and immunity,if it cannot be resolved it can last for a long time.Pediatric tuina,as a non-pharmaceutical therapy,has potential advantages for the treatment of anorexia.Many randomized controlled trials(RCTs)on pediatric tuina for anorexia in children under 14 years have been conducted.However,the methodological quality and intervention reporting quality of published RCTs have not attracted enough attention and professional evaluation from researchers,and the authenticity,reliability,and clinical reference value of the research results cannot be determined.This caused great confusion for clinicians when choosing evidence as a reference.Therefore,the aim of our study was to evaluate the methodological quality and intervention reporting quality of published RCTs on pediatric tuina for anorexia,and to evaluate the effects and safety of pediatric tuina as a non-pharmaceutical therapy for anorexia in children under 14 years old.Methods Part 1: Quality assessment of methodological and intervention reports about randomized controlled trial of pediatric tuina for anorexia in children under 14 years oldCNKI,Wanfang Database,VIP Database,PubMed,the Cochrane Library and Embase were searched from inception to December 2019.Literature that meeting the inclusion criteria were included.Two authors independently extracted data.Cochrane bias risk assessment criteria and modified the STRICTA reporting guideline were used to evaluate the methodological and intervention reporting quality of the included RCT.Part 2: Pediatric tuina for the treatment of anorexia in children under 14 years old: a systematic review and meta-analysis of randomized controlled trialAccording to the literature inclusion criteria established by part 2,the RCTs included in part 1 were screened again.Randomized controlled trials(RCT)comparing pediatric tuina with medicine for anorexia in children under 14 years old were included in this review.Two authors independently extracted data and assessed the risk of bias.We used Revman5.3 software for statistical analysis of data.We presented binary data as a risk ratio(RR)with 95% confidence interval(CI),and continuous data as a mean difference(MD)with 95% CI.Subgroup analysis was carried out for different types of control measures and different treatment courses,and sensitivity analysis was carried out based on patients' population,interventions and control,outcomes,and methodological difference.Significant effective rate(defined as appetite improved and food intake returning to 3/4 or more of normal intake)was used as primary outcome.Secondary outcomes included food intake,compliance and adverse events.Certainty of evidence for each key outcome was assessed using GRADE(Grading of Recommendations Assessment,Development and Evaluation criteria)approach to conduct management recommendations by the GRADEpro guideline development tool(GDT)online(https://gradepro.org/).The protocol of the review was registered on PROSPERO(https://www.crd.york.ac.uk/prospero/)with the registration ID as CRD42018105819.Results Part 1: Quality assessment of methodological and intervention reports about randomized controlled trial of pediatric tuina for anorexia in children under 14 years oldA total of 73 RCTs were included.The reporting rates of random sequence generation,allocation concealment,blind method,incomplete outcome data and baseline data were:36.99%(27/73)?2.74%(2/73)?4.11%(3/73)?79.45%(58/73)and 100%,respectively.Selective outcome reports,sample size estimates,trial protocol registration and information were not reported in any of the included publications.Methodological quality assessment showed that 73 RCTs had methodological problems of varying degrees and lacked high-quality.The quality evaluation of pediatric tuina reporting found that the reporting rate of providing the rationale for using pediatric tuina and the control setting were 63.01%(46/73)and 24.66%(18/73),respectively.The reporting rate of the qualifications of clinician and treatment setting were 16.44%(12/73)and 4.11%(3/73),respectively.The reported rates of individualized/non-individualized selection of pediatrictuina,single/bilateral manipulation of the massage site,the body reaction induced by the massage and whether other interventions were applied in the same period were 34.25%(25/73)?41.10%(30/73)?5.48%(4/73)and 43.84%(32/73),respectively.Part 2: Pediatric tuina for the treatment of anorexia in children under 14 years old: a systematic review and meta-analysis of randomized controlled trialsOf the included 29 RCTs involving 2688 children,the majority had a high or unclear risk of bias in terms of allocation concealment,blinding,and selective reporting.All trials compared tuina with western medicine(eg,Lysine inosite and vitamin B12,Zinc gluconate,etc)or Chinese herbs(eg,Sijunzi decoction,Pingwei San,etc).For significant effective rate,meta-analysis showed that tuina was superior to western medicine(risk ratio(RR)1.68,95% confidence interval(CI)[1.35,2.08],12 RCTs)and Chinese herbs(RR1.36,95% CI [1.20,1.53],20 RCTs).For food intake,9 trials evaluated it in the form of score(1 points,2 points,4 points and 6 points)calculated according to the reduction degree of food intake.The higher the score,the more serious the reduction degree of food intake.Six points represented the most serious.Six points represented the most serious.Meta-analysis showed tuina was superior to western medicine(mean difference(MD)-0.88,95% CI [-1.27,-0.50],2 RCTs)and Chinese herbs(MD-0.69,95% CI [-1.00,-0.38],8 RCTs)on increasing amount of food intake.Two trials reported compliance and six trials reported no adverse events occurred in pediatric tuina group.ConclusionCurrently,there is a lack of RCTs with high-quality methodology for the treatment of anorexia by pediatric tuina.The quality of methodological and intervention reporting in the literature was low.Low or very low certainty of evidence suggested pediatric tuina was beneficial and safe for the treatment of anorexia in children under 14 years old,whether compared with western medicine or Chinese medicine.Furthermore,well-designed RCTs with adequate sample sizes are needed to verify the effectiveness and safety of pediatric tuina in the treatment of anorexia in children.Future RCTs for pediatric tuina should be designed and reported in strict accordance with the Cochrane Bias Evaluation Criteria.A specific reporting guideline for tuina which could beachieved by adapting STRICTA is required in order to develop standards for reporting this intervention.