| BackgroundAcupuncture has been used as an effective treatment of the patients post-stroke for a long time. However, from the perspective of evidence-based medicine; there hasn't enough evidence of the exact effect of acupuncture's treatment for ischemic stroke's rehabilitation. Park an Sze had wrote systematic review about randomized-controlled trials published before 1990 and 2000, but got useful information barely. Domestic Zhang Shihong etc systematically reviewed 14 published-articles about acupuncture treatment in acute stroke (1208 patients in total) before August 2003,and the results showed that the control group (sham-acupuncture or non-acupunctured) compared with acupuncture group, the follow-up of the latter reduced final illness or needed-hospitalization significantly, the number of neurobehavioral scores improved significantly. When compared with fake acupuncture alone, two groups of follow-up final mortality or disabled toll and comprehensive neurobehavioral scores have no significant differences. China Guidelines of treatment on acute ischemic stroke 2010 ranked acupuncture as LevelⅡrecommendation (Class B Evidence), considered that curative effect from acupuncture needed further information, and suggested that therapists pick it out in conjunction with the patients'wish. So, does acupuncture exactly have effect? As a doctor, among numerous therapies, is it necessary that we choose acupuncture for ischemic stroke recovery as the treatments? Can patients benefit from the acupuncture treatment?As we known that clinical treatment is composed by many of the independent factors, which have different contribution to the totality, including specific and non-specific ones, and the relations among which is intricate. Its effects should include various components of the single and interactive functions. Chinese medicine has been regarded as a kind of complex interventions. There were foreign scholars deeming acupuncture as a complex intervention, with the qualitative research through the method of exploring its elements of complex interventions. A domestic study shows that domestic TCM clinical practice is a complex intervention as a whole. The effect of TCM medicine diagnosis is now the integrated elements from such as drugs, doctor's advice, psychological intervention, the relationship between doctors and patients interaction of adherence etc. And how to reflect the comprehensive results? The answer is to establish a set of evaluation system scientifically and reasonably. Based on this evaluation system, choosing a comprehensive effect of treatments can provide us with evidence for clinical decision, which is also the best way of demonstrating overall adjustment advantage of TCM.Comprehensive evaluation technology can offer a excellent platform for assessment of evaluation of TCM invention. Comprehensive evaluation refers to the assessed object with objective, fair and reasonable comprehensive evaluation, through some mathematical model will be a number of evaluation index "synthesis" as a integration, namely, the comprehensive evaluation value of a complex system of indexes of the total evaluation method. In this way, we can put several different treatments in order and choose the most appropriate method for patients.At present relevant areas have rare reports about comprehensive evaluation applications in the field in traditional Chinese medicine. In view of this, this research focuses on comprehensive evaluation of traditional Chinese medicine about complex effect assessment in the application intervention, and the further evaluation of preliminary exploration of acupuncture treatment of ischemic stroke recovery.Objectives1. In the field of comprehensive evaluation of Chinese medicine research, We put up with some tactics accord to the existing problems for a new way of evaluation of TCM.2. We probed the status quo of ischemic stroke recovery efficacy in-depth study. Meanwhile combining with the current assessment of comprehensive evaluation, I got the present medical advice and offered reference for clinical decision-making. MethodsThis study used the method of combining the qualitative research and quantitative research, specific contents and was as follow:1. Constructing a comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery1.1 Firstly, we analyzed studies of published literature in acupuncture treatment of ischemic stroke of recent 10years, got the main understanding of domestic similar index in status quo, and offered the advice of expert advice pool for the next step.1.2 Between Delphi method (Delphi) and AHP (Analytic Hierarchy Process, the AHP), we established recovery efficacy evaluation system and comprehensive evaluation model of acupuncture treatment of ischemic stroke at the first step.2. Randomized study of acupuncture treatment of ischemic stroke recoveryWe took a deep discussion of comparing of using classical Randomized controlled Randomized controlled trials (RCT) and comprehensive evaluation model, analyzed the two kinds of evaluations'superiority, and gave useful advice for clinical treatment.Result1. Constructing a comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery1.1 Analysis of published literature of acupuncture treatment of ischemic stroke study for recent 10yearsWe obtained 799 articles from which we selected 83 into randomized study. Situation of using the standards:(1)The neural function evaluationAll 83 study documents, have related neural function assessment scale, applied in the top four were the scoring standards of the 4th cerebrovascular disease meeting of stroke by 1995 (32/83,38.5%), the assessment standard of the 3nd cerebrovascular disease by 1986 (14/83,15.8%), the improved barthel index (13/83,15.6%) and Fugl-Meyer scale (8/83,9.6%).(2)Syndromes index of TCMThere are 10 articles (12%) in all evaluating the syndromes effect assessment of ischemic stroke. (3)Quality of life(QL)There only 2 articles (2.4%) in all the documents reporting a final survival quality analysis of treatment.(4)Destination end index17 articles (20.5%) adopted ending index to evaluate, four articles (4.8%) reported a final disability incidence treatment; four papers (4.8%) for treatment of literature research kept 3-6 months of follow-up, including 3 articles reported the comparison of follow-up of the final neural function defect scale.Only 1 article reported follow-up of final mortality, dots and recurrence rate; nine articles (10.8%) reported the literature and compared the incidence of adverse acupuncture; there are 9 (10.8%) documents describing the standard that serious adverse reactions appeared, including 7 reports having no adverse reactions,2 reports having adverse reactions but better description.(5)Substitution index19 articles (22.9%) reported the changes of final physicochemical indexes, except for the observation of infarction area before and after treatments, TCD changes. More biological index observed, have hemorheology (4/83), malondialdehyde (3/83), endothelin (2/83), thrombosis, grain (2/83), prostaglandins (2/83) and super oxide of enzyme (2/guhya 83), etc.On the whole, the selection of evaluation standards is in chaos and lack of acupuncture intervention from multiple dimensions of ischemic strokes curative effect. However, it is a serious work to build up a regular and acceptable evaluation.1.2 The establishment of comprehensive evaluation model of acupuncture treatment of ischemic stroke recovery based on the Delphi method and the AHP1.2.1 The first round of expert adviceThe first round of expert advice were issued 15 questionnaires, ten copies of all questionnaire returned. And we withdraw all the questionnaires with complete requirements, whose recovery is 66.7%, experts actively coefficient is 66.7%, the expert's authority coefficient is 0.82. Using coordinate coefficient W inspection, Kendall coordinate coefficient W weigh.40, P< 0.01, show that the index rating with consistency by experts.From the concentration standpoint coefficient reflecting importance's index, one class index of neural function, quality of life, the destination index, syndromes, physical and chemical index were 4.10±0.74,4.50±0.52,4.30±0.79,3.70±0.68,2.80±0.63. The physicochemical index hasn't reached screening standards, showing that experts generally agreed that it was not necessary to adopt it in acupuncture interventions in ischemic stroke recovery in the evaluation. In the secondary indexes, besides affiliate hemorrheology of physiochemical index and infarction area of changes, biochemical indicators are not reach screening standards, other dimensions secondary indexes all with satisfactory.1.2.2 Second round of expert adviceThe second round of expert-consulting has sent questionnaires, with 11 copies back of all 15. And the withdrawal questionnaires were all come up with complete requirements, questionnaire survey 73.3%, experts actively coefficient 73.3%, authority for 73.3%, Kendall coordinate coefficient W for 0.83, P< 0.01, pointed out t experts' grading with high consistency. The centralization, one class index of neural function, quality of life, the destination index, syndromes and physiochemical index concentration coefficient are respectively 4.46±0.52,4.73±0.47,4.55±0.52,4.18±0.41,3.09±0.70, physical and chemical index still hasn't reached screening standards.After two previous rounds of expert consultation, meanwhile, after discussions from leading groups, we initially have established acupuncture treatment of ischemic stroke recovery efficacy evaluation system.1.2.3 Third round of expert consultationIn order to improve the quality of Delphi method, letting experts fully express their ideas, this expert consultation's main purpose is to how to rate Saaty amd make explanations to experts with examples, and let experts try to fill the blanks, and notice problems, and correct them in time.11 questionnaires in recovery, there were 3 copies finished inappropriately, compared with 72.7% accuracy of satty score. And the main problems are:(1) the performance in the binary compared with their mistakes, when rating assignment contradictions; (2) on the other hand they were appeared inconsistent, n and 1/n asymmetry. After the prompt communications, experts basically mastered specific rating process. 1.2.4 The fourth round of expert consultationThe main purpose of this experts'consultation of each index is Saaty. And ratings were issued, recovered 11 questionnaires which were all with complete requirements, that questionnaire survey was73.3%, experts actively coefficient was 73.3%, and the experts authority coefficient for 0.83, all indexes of Kendall inspection by expert assignment, coordinate coefficient for the 0.865, w. significant test, P< 0.01, presentation that expert assignment have very good consistency.The final assignment is set by various medians defined by experts, establishing judgment matrix, calculating the initial weights and normalizing the weight coefficient, and the final determination. All that is concluded the preliminary linear model of comprehensive evaluation of acupuncture intervention ischemic stroke recovery are as follow: Among them:Y meant synthetic evaluation scores;Clamps its X1 X2 X3, X4, respectively, said four primary index evaluation score;X11, respectively X122 said the first primary index next 2 clamps its XI two-level index single score;X31 X33 X32, respectively, said the third one class index next three X3 two-level index single score;X42 X41, respectively for the first four primary index X4 said the two secondary indexes under single score.2. Randomized study of acupuncture treatment of ischemic stroke recovery2.1 Results of RCT2.1.1 Baseline comparisonAge on admission gender proportion, and syndromes of TCM before treatment Barthel index, proportion, MRS score, SS-QOL NIHSS scores, TCM syndromes score, health rating scale of two groups of patients was not statistically significant by inspection, suggesting that the two groups of baseline have equilibrium.2.1.2 Two groups NIHSS scores compared before and after treatmentAfter repeated measurement analysis of variance, the time between the two treatment groups have statistically significant changes to cope with different NIHSS scores. The treatment group was not better than control group in NIHSS scores reduction.2.1.3 Comparisons of two groups before and after the treatment SS-QOL scoresAfter repeated measurement of anova, different treatment group changes between SS-QOL score are not statistically significant as the change of time. Compared with the control one, the treatment group have no statistical difference in increasing SS-QOL scoring.2.1.4 Comparisons of TCM syndrome score of two groups before and after the treatmentAfter repeated measurement of anova, different treatment group of TCM syndrome scores'change have a statistically significant as the change of time. The treatment group in reducing syndromes scoring is not better than the control.2.1.5 Comparisons of Two groups' traditional Chinese medicine health scale score before and after the treatmentAfter repeated measurement of anova, in the different group, TCM health scores'change was statistically significant along with time of change. The treatment group, compared with the control, was not statistically significant in reducing Chinese medicine health scoring.2.1.6 Comparisons of two groups'Barthel index before and after treatmentBarthel index according to our state practices will have two classification variables (more than 60> divided into dependence, while<=60 independent) analysis, via a chi-square test, as compared with control, the treatment group Barthel scoring in improving was not statistically significant (P>0.05).2.1.7 Comparisons of outcome events(1)Mortality and morbidity at the end of follow-upAfter 3-month telephone interview, two groups all did not appear deaths; MRS for disabled by over three, the treatment group 41 patients had 17 cases of disability (41.7%), the control group in 42 cases has 21 of disability (50%), which after a chi-square test was not statistically significant (P> 0.05).(2)RecurrenceThree months later we have follow-up after discharge. The treatment group of 41 patients relapsing four (9.8%),42 patients relapsing 5 (11.9%), was not statistically significant (P> 0.05) by comparison.(3)Adverse reaction rate45 cases in treatment group having 2 persons (4.4 percent) appear no tolerance of pain and the control of 45 patients were all no serious adverse reactions.2.1.8 Compliance analysisTwo people in the treatment group quit because of no tolerance of pain (adverse reaction), one person exits because of complications and stop acupuncturing and other rehabilitation treatment midway.1 person because patients'families want to exit; The control group has 2 because of complications and stop acupuncturing and of other rehabilitation therapy to exit test, and 1 person exits initiatively. 2.2 Results of Comprehensive evaluationTwo groups of each index numeric via after converting get normalized matrix value, finally going into the comprehensive evaluation equations respectively after normalized generation. It is concluded that the comprehensive evaluation value:the control group 0.48, the treatment group 0.42, treatments>controls, when displaying on the treatment scheme selection, the treatment group should be optimization.Conclusion1. Through the analysis of acupuncture treatment of ischemic stroke study published literature in recent 10 years, we find that acupuncture treatment of ischemic stroke in clinical research before with evaluation index selection are very casual, chaos. A lot of evaluation index selection have nothing in order and cannot reflect relevant research purpose. We should establish a set of scientific and reasonable efficacy evaluation system.2. Based on the Delphi method and analytic hierarchy process, we constructed acupuncture intervention in ischemic stroke recovery efficacy evaluation system, and established the comprehensive evaluation model, finding that daily living skills, quality of life, the destination indicators acupuncture intervention ischemic stroke recovery is the most important effect assessment of evaluation index.3. Through randomized study, we found that, compared with fake acupuncture, acupuncture can not improve patients'ischemic stroke neurologic deficits ratings and rating syndromes, at the same time, compared with a sham, acupuncture's serious adverse reactions have an increasing trend; In the closest of evaluation indicators with patients such as mortality, follow-up, daily living skills and living quality, acupuncture, show no advantage that we should discover more in the future.4. Based on comprehensive evaluation value, we adopt comprehensive evaluation models:the treatment group (acupuncture combined with modern rehabilitation)have efficacy overall than in control group (sham acupuncture combined with modern rehabilitation), and suggest choosing it in ischemic stroke recovery during clinical practice;5. Based on the characteristics of TCM complex intervention, the comprehensive evaluation model takes advantages of revealing them, and is suitable for different intervention scenario selections which deserves further promotion.
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