| Objective:This research is aim to evaluate the clinical efficacy of"Tiaoshen Yizhi"acupuncture therapy on post-stroke cognitive impairment no dementia(PSCIND).The mechanism of acupuncture is explored by detecting serum Amyloid Beta Peptide(Aβ1-42)level.Methods:Following the principle of randomized control,the diagnosis of PSCIND which listed in the Expert Consensus on Management of Post-Stroke Cognitive Impairment(PSCI)in 2017was used as the inclusion criteria.From July 2020 to April 2021,135 subjects were recruited from First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Changchun Hospital of Traditional Chinese Medicine,Affiliated Hospital of Changzhi Chinese Medicine Research Institute,Hunan Province Changsha Hospital of Traditional Chinese Medicine and the Second Teaching Hospital of Inner Mongolia University of Science and Technology Baotou Medical College.Subjects were randomly assigned to Acupuncture Group(AG),Sham Acupuncture Group(SAG)and Conventional Treatment Group(CTG)in a ratio of 1:1:1 by central randomization method.Three groups all accepted routine treatment of stroke.Patients in AG were treated with"Tiaoshen Yizhi"acupuncture therapy(GV20、EX-HN1、GB20、GB12、BL10、ST2、HT7、ST40、LR3、SP6、PC6).While,patients in SAG received non-meridian and non-acupoint shallow needling(beside the meridians of the non-acupuncture,inserting straightly and shallowly,hanging upon the skin).Needles were retained for 30 minutes,three times a week,12 weeks in total,follow-up for 24 weeks.Patients in CTG only accepted conventional treatment for 12 weeks.Montreal Cognitive Assessment(Mo CA),Mini-Mental State Examination(MMSE)and Neuropsychiatric Inventory(NPI)were evaluated before treatment,weeks 12,24 and 36.The concentration of Serum Aβ1-42 were detected before and after treatment.All statistical analysis will be handled by SPSS26.0 software.Ending:A total of 135 subjects were enrolled in 5 centers from July 2020 to April 2021,and 17subjects dropped out.Therefore,the Per Protocol Set(PPS)consisting of 118 cases was performed for curative effect analysis.The Safety Set(SS)of 135 cases was performed for safety analysis.Baseline data:there were no statistically significant differences between the three groups in basic information,such as age,sex,education level,course of disease,and the baseline data including Mo CA,MMSE,NPI and serum Aβ1-42 before treatment(P<0.05),with comparability.Outcome indicators(1)The primary outcome(Mo CA)Intra-group comparison:there were statistically significant differences at different visit in AG(x~2=51.78,P<0.001).Compared with baseline,the Mo CA score of AG was improved at weeks 12,and the difference was statistically significant(P<0.05).There were statistically significant differences at different visits in SAG(x~2=21.167,P<0.001).The difference was also statistically significant at weeks 24 and 36(P<0.001).The Mo CA score of SAG increased at weeks 24 and 36,and the difference was statistically significant(P<0.05).Comparison between groups:there were statistically significant differences at weeks 12,24 and 36(H=7.792,P<0.05;H=14.020,P<0.05;H=11.536,P<0.05).The Mo CA scores of AG at weeks 12,24 and 36 were higher than that of CTG at the same period,and the difference was statistically significant(P<0.05).The Mo CA scores of AG at weeks 24 and 36were higher than that of SAG at the same period,and the difference was statistically significant(P<0.05).There was no statistical difference between SAG and CTG at any visit(P>0.05).(2)Secondary outcomes(1)MMSEIntra-group comparison:there were statistically significant differences at different visit in AG(x~2=54.407,P<0.001).Compared with baseline,AG scores at weeks 12,24 and 36 were improved with statistical significance(P<0.001).There were statistically significant differences at different visit in SAG(x~2=9.674,P<0.05).SAG score increased at weeks 24,and the difference was statistically significant(P<0.05).Comparison between groups:there were statistically significant differences at weeks 24and 36(H=13.345,P<0.05;H=11.239,P<0.05).The Mo CA scores of AG at weeks 24 and36 were higher than that of CTG at the same period,and the difference was statistically significant(P<0.05).The Mo CA score of AG at weeks 36 was higher than that of SAG at the same period,and the difference was statistically significant(P<0.05).There was no statistical difference between SAG and CTG at any visit(P>0.05).(2)NPINPI severity:intra-group comparison:compared with baseline,there was no statistical difference among the three groups at any visit(P>0.05).Comparison between groups:There was no significant difference in NPI severity and its difference among the three groups at weeks 12(P>0.05).The severity of NPI in AG was lower than that in SAG at weeks 24 and36,and the difference was statistically significant(P<0.05).There was no statistical difference between SAG and CTG at weeks 12 and 24(P>0.05).NPI degree of distress of caregivers:Intra-group comparison:Compared with baseline,there was no statistical difference among the three groups at any visit(P>0.05).Comparison between groups:there was no statistical difference in NPI distress and its difference among the three groups at weeks 12 and 24(P>0.05).There were statistically significant differences at weeks 24 and 36(H=8.680,P<0.05;H=7.851,P<0.05).The degree of distress for caregivers in AG was lower than that of CTG at weeks 36,and the difference was statistically significant(P<0.05).There was no statistical difference between SAG and CTG at weeks 36(P>0.05).(3)Mechanism outcomeSerum Aβ1-42:intra-group comparison:at weeks 12,the concentration of serum Aβ1-42in three groups decreased compared with baseline,and the differences were statistically significant(t=2.946,P=0.05;t=2.509,P=0.05;t=2.816,P=0.05).Comparison between groups:at weeks 12,there was no significant difference in the concentration among the three groups and the difference(△Aβ1-42)before and after treatment(P>0.05).Conclusion:Based on the current research data,the following conclusions are drawn:1、"Tiaoshen Yizhi"acupuncture therapy could improve the cognitive function of patients with PSCIND effectively,and the acupuncture effect may last 3-6 months.2、"Tiaoshen Yizhi"acupuncture therapy may alleviate the severity and the distress of caregivers of PSCIND mental behavior symptoms to a certain extent.3、The correlation between the effect of"Tiaoshen Yizhi"acupuncture therapy and the concentration of serum Aβ1-42 is uncertain,which need further research. |
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