Clinical Research Of Post-stroke Vascular Cognitive Impairment Treatment With Needling Therapy

ObjectiveThis randomized controlled clinical research adopts multi-disciplinary synchronic observation and analysis methods and objectively observe and evaluate the clinical effect and safety of needling therapy to treat post-stroke vascular cognitive impairment within the category of vascular cognitive impairment.MethodsThe case selection basis is listed as follows:DSM-Ⅳ; the diagnostic standards of vascular dementia issued by NINCDS and ADRDA; the standard of vascular cognitive impairment (VCI) issued by CSN; Diagnostic, Differentiation Types and Effect Evaluation Standards of Senile Dementia issued in 1990 by China Association for Traditional Chinese Medicine; the inclusion and exclusion criteria for clinical requirement. In this randomized controlled clinical trial, the qualified post-stroke vascular cognitive impairment subjects are divided into the Treatment Group and the Controlled Group at the rate of 1:1. The former adopts routine rehabilitation exercises and cognitive function training accompanied by needling therapy; the latter adopts only routine rehabilitation exercises and cognitive function training. The major acupoints selected in the Treatment Group are Baihui, Fengchi (double), Renzhong, and Shenmen (double). The supplementary acupoints are Kidney-shu and Taixi for kidney-deficiency type, Neiguan and Sanyinjiao for liver and kidney yin deficiency, Fenglong and Sanyinjiao for phlegm stagnation and Geshu and Xuanzhong for qi and blood stagnation. Needling methods:even forward needling for Baihui; upward oblique needling for Renzhong; oblique needling toward the opposite nasal tip for Fengchi; straight needling for Shenmen; routine needling for supplementary acupoints. Maintain the needle for 30 minutes after achieving qi. Treat every other day.10 times make a treatment course and observe 1 treatment course.Record the qualified subjects'age, gender, marriage status, education degree, important disease history, medication history, memory disorder history and family history. Record the major syndromes (marrow-reservoir deficiency, qi and blood deficiency, heart and spleen deficiency, liver and kidney deficiency and spleen and kidney deficiency, etc.) and the related accompanied symptoms and body signs. Conduct cognitive function evaluation with MMSE. Conduct the neuropsychological test with clock-drawing, figure identification test and FOM, DST, RVR and BNT. Conduct the social life function evaluation with ADL and FAQ. Conduct the diagnosis with Hachinski Ischemic Scale and CT or MR results. After the comparability of two groups is proved by the baseline material mentioned above, start the treatment according to the trial plan. During the treatment, observe at the time of clinic visit, and at the end of the first, second and third week after treatment. Record in detail the major effect indexes CGIC (Clinical Global Impression of Change, Guy 1976), the cognitive, daily activity and social function scores (MMSE score, FAQ score, ADL score, clock drawing score, FOM score, RVR score, DBT score, BNT score) and their changes. Examine once before and after treatment the lab examination items for safety, including blood, urine and stool routine tests, GPT, BUN, blood glucose, blood fat, electrocardiogram, CT and MRI tests. If special situation occurs or there's doubt about adverse reactions, conduct the examinations any time. Truthfully record the adverse reactions and analyze the possible causes, the severity degree of symptoms, the frequency and the lasting time, etc. If the symptoms are serious enough to stop medication, corresponding methods should be adopted immediately.After the research, collect the clinical material and input to computer. Set up the database for data management. Analyze and compare the clinical total effective power, the clinical symptoms and the body sign curative effect of the two groups after treatment and finally evaluate the clinical effect and safety objectively. Suitable statistical methods are chosen according to the data and the trial objectives. For the classified material, take X2 test. For the ranked material, use Radit analysis. The averages of the two samples are compared with t test or Wilcoxon rank sum test. For self circa comparison, take the t pair test or Wilcoxon pair rank sum test. Conduct the intention-to-treat analysis and the per-protocol subjects analysis. For the absence of the single indexes of the secondary effect indexes, substitute with that group's average. For the changes before and after treatment in aspects of cognition, daily activity and social functions and the interclass significance test, adopt the nonparametric statistics methods. Adopt the covariance analysis and repeated measurement analysis methods to analyze the major curative effect. Take the point-value as dependent variable, take trial methods, age, gender, education degree and disease severity and medication as covariance and analyze the interaction effect of factors in the model.ResultThis research collects 142 case reports with 22 withdrawals midway or not included in the clinical research. According to the Chinese and Western Medicine standards and inclusion standards, there are 120 qualified subjects who are randomly classified into two groups with 60 in the Treatment Group and 60 in the Controlled Group. All are clinic patients. No difference is found in the comparison of two groups in aspects of age, gender, dementia types, VCI severity, education degree, disease history, disease course, CT results, Chinese Medicine symptoms scores, medication before treatment, cognition, social and daily activity ability and compliance which indicates there's comparability at baseline level.After treatment, analysis with CGIC as the major effect index finds that in the intention-to-treat analysis, the two groups'CGIC averages are 3.38 (95%CI:3.07-3.68)和3.25 (95%CI:2.96-3.53) respectively and the difference has no significance; in the compliance analysis, the two groups'CGIC averages are 3.38 (95%CI:3.06-3.70) and 3.15 (95%CI:2.84-3.45) respectively and the difference has no significance which indicates the two groups'patients have high compliance to finish all the required courses. Take age, gender, and education degree and hypertension history as covariance and take groups as influencing factor, conduct the variance analysis of the repeated measurement of each secondary index. Result shows that the MMSE of two groups rise at 1 score every 4 weeks on average and the changes of the other indexes with time are not significant. The interclass difference of each index has no significance Covariance analysis results are:hypertension or not=0.09, gender=1.7, age=76.3, education degree level=1.8. Multivariate analysis shows the F value of Wilksλtest of the time effect of MMSE, FAQ, CDT, RVR and DST are 6.8,2.9,3.9,2.9 and 5.3 and the corresponding P value are 0.00, 0.04,0.01,0.04 and 0.002. The F value of Wilksλtest of the other indexes are all>0.1. The interclass comparison of each index shows the P value are all>0.1. In order to specify the possibility of false negative of two groups, that is to make clear the ability of statistics to find out the difference, conduct the calculation of Power of the comprehensive curative effect. In the analysis of compliance, Pc= (15+2)/60= 0.283 in the Controlled group and Pt= (9+1)/60= 0.166 in the Treatment Group. Statistical test power is 0.19<0.8.The research results confirm the knowledge about the etiology and syndromes of this disease. From Diagram 4 and 5, it can be found the frequency of marrow-reservoir deficiency, kidney deficiency and compound syndromes based on the former two types is 66%(91/138), the next are heart and spleen deficiency (18.84%) and qi and blood deficiency (15.22%). Stagnation is the major accompanied symptom and phlegm and fire follow it.In the safety and adverse effect observation, blood routine test, liver function test, BUN and electrocardiogram test are undertaken before treatment and no abnormality is found in the electrocardiogram recheck of subjects whose electrocardiogram test result is normal. The results above show that no abnormal change is found in the blood routine test, liver function test and the electrocardiogram test of patients after treatment. The safety observation shows that most subjects have received the blood routine test, ALT, BUN and the electrocardiogram test before and after treatment and finds that needling has no detriment for blood routine test and electrocardiogram. No adverse effect is found in the treatment.ConclusionIn the comparison of major curative effect and secondary indexes, the difference between the trial therapy and the controlted has no statistical significance. After controlling the effect of age, gender, education degree on curative effect with repeated measurement and analysis with covariance model, no significant interclass difference of each effect index is found. However with statistical test power calculation, it is found that the test power is low (0.19), so there is possibility of false negative which indicates that the negative result may be caused by inadequate number of samples. If sample number is enlarged, there's possibility of finding the statistical difference. To summarize, needling is a safe treatment method for VCI and its effect indicates the clinical significance.