Study Of Complex Interventions Of Tranditional Chinese Medicine On Ischemic Stroke Of Qi Deficiency And Blood Stasis Syndrome And Comprehensive Evaluation

1 BackgroundComplex intervention which includes behavioral interventions,health management and non-medicine therapy,is extremely common intervention model in clinical practice,it is gaining popularity in modern medicine.Related research focuses on implementation standardization,mechanisms of efficacy.Traditional Chinese Medicine has abundant exploration and practice in complex intervention.TCM theory,originates from holism,emphasizes the harmony between human being and nature.Treatments differ in terms of individual,season and locality.The thinking of complex interventions can be reflected in the creation of herbs decoction,combination of acupuncture and herbs,intervention for both internal and external,prevention and treatment before disease onset.Also,Chinese medicine complex intervention,is personalized and dynamic,has view of time and spaces.Recent one hundred year has witnessed that the use of prepared medicine or traditional Chinese medicine injection is generally combined with western medicine intervention.Common as complex intervention is,deep insight is lack.Currently,related research has not addressed critical issues such as how to clarify key scientific problems in the interventions,research framework and models.This study is an attempt to specific issues in complex intervention for further breakthrough.2 ObjectiveBased on the model of disease and syndromes in diagnose and treatment,this study targets methodology for multi-outcome and multi-index measurement in complex intervention.3 ContentPatients with acute ischemic stroke were recruited,qi deficiency and blood stasis score was stratified indicator.TCM and western medicine scales were used to evaluate efficacy.Joint model and second-order model were used for clinical data statistic and building primary and secondary outcomes.4 Method4.1 DesignMulti-centered,prospective,stratified,randomized controlled trial;stratified index based on the score of qi deficiency and blood stasis,the cutpoint was seven.Central randomized system was used.4.2 InterventionAll patients accepted same standard western medicine treatment which was consistent with China acute ischemic stroke diagnose and treatment guideline 2010,if Qi deficiency and blood stasis score ? 7,patients were randomly assigned to Dan Hong injection and western medicine group,Shen Mai injection and western medicine group,Dan Hong and Shen Mai injection and western medicine group,western medicine only group.Randomization proportion was 2:2:2:1;if Qi deficiency and blood stasis score<7,patients were randomly assigned to Dan Hong and Shen Mai injection and western medicine group and only western medicine group by 1:2;Treatment lasted 14 days,during which patient can choose acupuncture treatment and rehabilitation therapy.4.3 MeasurementsNational Institutes of Health Stroke Scale,Brunnstrom stages,modify Rankins scale Barthel scale;Qi deficiency and Blood stasis.4.4 StatisticsThe software SPSS 21.0 was used for descriptive statistics,MatLab R2016 was used for building comprehensive measurement index.5 ResultsMay 2013 to April 2016,15 hospitals,313 patients were included,follow-up was 3 month,45 dropouts,37 protocol violations,268 finished the trail,238 completed the measurement.Before and after treatment,there was significant differences in single index of National Institutes of Health Stroke Scale and Brunnstrom stages,there was no significant differences between groups.Mean number of Barthel score was 90 and mRS score was all above 0 at 90 days in every group which indicated that all treatment had good long-term effects,there was no significant differences between groups.Compared with those who used western medicine only group,combination of TCM injection showed better improvements in every index.There was significant differences between groups in Qi deficiency and blood stasis score(P<0.05).Data analysis with mixed-effects models found that ages,recurrence and complications can significantly influence the outcomes.Comprehensive measurement based on mRS?NIHSS?Brunnstrom indicated that combination of TCM injection had better efficacy.6 ConclusionCompared with western medicine group,the other three groups showed no significant differences in single outcome measurement.Comprehensive measurement based on second-order model can further explain the efficacy of TCM.In complex intervention research,comprehensive evaluation could better explain the efficacy.7 Creativity Methodological creativity:Based on pragmatic randomized control trail of stoke,joint model and second-order model were used for framing comprehensive evaluation of complex intervention which can better explain the treatment outcomes.