The Guideline Quality And Clinical Research Of Acupoint Application In Preventing Spleen-insufficiency Constitution Of Children

Objective:Acupoint application is effective for Children Spleen-insufficiency Constitution,which is a common type of children's constitutions.Referring to the "Practical Guideline for Preventive Treatment of Disease in TCM · Intervening Children Spleen-insufficiency Constitution by Acupoint Application(Formulation)"(Draft of evaluation),and now this study explored and evaluated its methodological quality,clinical consistency and efficacy,so that providing clinical support for further developing clinical guideline of "treating pre-disease" in children.Methods:The first part:the methodological quality evaluation was by inviting four experts of pediatrics of TCM,philology standardization and finishing "clinical guidelines research and evaluation sheet"with necessary explaination.For clinical consistency evaluation,we investigated 195 cases whose diagnosis conformed to the guideline from different regions and level of 8 medical institutions in nearly a year,then they should finish and submit "the questionnaires of case" in term of diagnosis,type of syndrome and treatment.After all,they should present it to project group.The second part was about preliminary clinical efficacy evaluation of the guideline.A randomized,parallel controlled method was used to carry out clinical studies on 50 cases of children with spleen-insufficiency constitution.50 cases were interfered by acupoint application therapy,treatment group of 30 cases,in which the content of application referred to the "Draft of evaluation",the control group of 20 cases,in which using comfort application,made of white rich with black rice(10:7).The course of treatment was 30 days which would be followed up for 6 months.And we observed and analyzed indicators before and after the intervention,to evaluate its efficacy and safety of two groups.Results:The first part:1.Four experts evaluated the guideline 2given 6 points,and 2 given 7 points,and deemed the quality of the guide was high.2.The consistency in terms of taboos,precaution,regulating were 100%,for diagnosis,and type of syndrome were 99%,in the terms of acupoint,medicine selection and preparation,there were 88%?64%?69%,and some experts advised that it should be more flexible in clinical practice.3.In 195 cases,the Spleen-insufficiency of Qi an Yin constitution were high portion with respectively 37.95%and 25.64%,and the consistency in the classification of Spleen-insufficiency Constitution was relatively high.The second part was about preliminary clinical efficacy evaluation of the guideline.1.Comparison before intervention:there was no difference between the two groups in terms of gender,age and Spleen-insufficiency Constitutions(P>0.05).2.Comparison after intervention in terms of the efficacy:(1)Comparison between the two groups:after 1,3,6 months,the effective rate were 73.33%?86.67%?86.67%in the experimental group,and 45%?55%?50%in the control group.The experimental group were superior to the control group(P<0.05).(2)The two groups in the term of main symptoms,secondary symptoms,total symptoms after treatment were improved(P<0.01).Comparison between two groups,after 3,6 months,the experimental group was better to the control group in the terms of improvement of main symptoms and total symptoms.3.After1,3,6 months,the times of exogenous diseases and the scores of complexion,shape,sweatiness,and appetite(only in the experimental group),strength(only in the experimental group),bowel movement were all decreased in two groups(P<0.01,P<0.05).And the improvement of times of exogenous diseases and the scores of complexion,sweatiness in the experimental group was superior to the control group(P<0.01,P<0.05).4.No obvious adverse reactions and side effects were observed in the two groups during the period of intervention.Conclusion:1.The methodological quality evaluation of the guide(Draft of evaluation)is generally high.2.The clinical consistency evaluation in the terms of taboos,precaution,regulating were 100%.3.The curative effect of intervention Children Spleen-insufficiency Constitution in the experimental group was better than that of control group.4.The treatment of the acupoint application therapy provided by the guideline(Draft of evaluation)on children with spleen-insufficiency constitution is effective and safety,provided support for its clinical application.