| Objective: To evaluate the effectiveness and safety of acupuncture for patients with vascular cognitive impairment with no dementia(VCIND).Methods: This is a patient-blinded,randomized controlled trial.A total of 120 eligible patients participated in this trial.All the participants were randomly divided into acupuncture group and control group with the ratio of 1:1.The acupuncture group received real acupuncture treatment while the control group received sham acupuncture treatment.A total of 10 acupoints were used in both the two treatments,including Baihui(DU20),Shenting(GV24),Yintang(GV29),Sishencong(EX-HN1),,Shenmen(HT7),Neiguan(PC6),Sanyinjiao(SP6),Naohu(DU17),Renzhong(DU26),Fengchi(GB20).Both the two groups were treated three times per week for 8 weeks with needle retained for 30 minutes each time.The primary outcome was the cognitive score assessed by the Montreal Cognitive Assessment(Mo CA).The secondary outcomes were the scores of the Mini-Mental State Examination(MMSE),the Modified Barthel Index(MBI)and Depression self-rating scale(SDS).All the assessments were conducted at base line,and at 8 weeks later.The follow up assessments were performed with Mo CA and MMSE at the 2ed month after intervention.At the end of the treatment we also evaluated the blinding of the acupuncture.Intention-to-treat(ITT)analysis was used in this RCT.All the adverse events occurred during the whole trial were registered and handled timely.Results: A total of 53 participants in the acupuncture group completed the trial and Withdrawn 7,while a total of 50 participants in the control group finished the trial and Withdrawn 10.The total dropout rate was 14.16%.The comparison of demographic data,inducement,risk factors,associated underlying diseases,work-learning and daily living abilities,past related treatments,Mo CA scale,MMSE scale,BI scale,and SDS scale scores showed the two groups were balanced and comparable(P>0.05).Primary outcome(Mo CA): Comparison within the two groups:The scale of the 8th week of the electroacupuncture group was significantly higher than before the treatment(P<0.01);the score of the scale at 2 months of follow-up was higher than that baseline(P< 0.01),but the decrease was significant compared with the score at 8 weeks of treatment(P<0.01).The score of the 8th week of the control group were significantly higher than those before the treatment(P<0.01).After 2 months of follow-up,the scale scores were higher than baseline(P<0.05),but compared with the 8th week of treatment.There was a decrease(P<0.05).The results between the two groups: the scales scores of the electroacupuncture group were significantly different from the control group at the 8th week and 2 months after treatment.The scale of the treatment group was significantly higher than the control group(P<0.05,P <0.01).Secondary Outcome: 1)MMSE scale: comparison results within the group: the electroacupuncture group’s scale of the 8th week was significantly higher than the baseline(P<0.01);the score of the scale at 2 months of follow-up was higher than baseline.(P<0.01),but the score decreased compared with the 8th week of treatment(P<0.01).In the 8th week of the control group,the scores of the scales were significantly higher than those before the treatment(P<0.01).After 2months of follow-up,there was no significant difference with the baseline(P>0.05),and the scores decreased compared with the 8 weeks after treatment(P < 0.05).The results of the comparison between the two groups: the scores of the MMSE of the electroacupuncture group were significantly different with the control group at the 8th week and 2 months after treatment.The scale of the treatment group was significantlyhigher than that of the control group(P<0.05,P <0.01).2)MBI scale: The comparison within the group showed that the 8-week scale score of the electroacupuncture group was not significantly lower than before treatment(P>0.05),and there was no significant difference between the control group and the treatment group at the 8th week(P>0.05).Comparison between groups showed that there was no statistically significant difference in the scale of the treatment group and the control group after 8weeks of treatment(P>0.05).3)SDS scale: The comparison within the group showed that the scores of the 8-week electro-acupuncture group were significantly lower than those before treatment(P>0.05),and the scores of the control group for 8 weeks were also significantly different from before treatment(P >0.05).Comparison between groups showed that there was no statistically significant difference in the scale of the treatment group and the control group after 8 weeks of treatment(P>0.05).Conclusion: 1)The acupuncture treatment is able to increase the score of Mo CA and MMSE both in a short-term and long-term effect.2)Acupuncture can improve the score of the SDS scale in patients with VCIND,but there is no statistically significant difference compared with the placebo sham acupuncture group.(3)The acupuncture treatment is an safe therapy and has no serious adverse events in treating VCIND. |
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