Clinical Study On The Treatment Of Stroke And Dementia (Vascular Mild Cognitive Impairment) With Tianma Awakening Capsule With Evidence Of Marrow Sea Deficiency

ObjectiveThe clinical efficacy of Tianma Waking Brain Capsules in the treatment of stroke and dementia(vascular mild cognitive impairment)with insufficient medulla oblongata was observed using Peiyuan Tongnao Capsules as a control.MethodsA randomized parallel control method was used;88 patients who met the diagnostic criteria were randomly divided into treatment and control groups according to the inclusion criteria of this subject.There were 44 cases in the treatment group of Tianma Awakening Brain Capsule and 44 cases in the control group of Peiyuan Tongnao Capsule,and the duration of treatment was 24 weeks in both groups.The Montreal Cognitive Assessment Scale,Chinese Medicine Evidence Scale,Connected Test and Simple Intelligence Mental Status Scale were performed before and after treatment to evaluate and score the efficacy.Results1.Comparison of efficacy: In terms of improving the TCM evidence score,the total effective rate of the treatment group and the control group were 81.39% and 80.0%,P>0.05 for the comparison of the two groups,and the efficacy of the two groups was comparable.2.Comparison of the efficacy of each TCM symptom: After 12 weeks and 24 weeks of treatment,the two groups showed improvement in mental retardation(memory loss),low back and leg weakness,dizziness and tinnitus,and tiredness and sleepiness compared to the pre-treatment period;comparison between groups: after 24 weeks of treatment,the treatment group was more effective than the control group in terms of dizziness and tinnitus and tiredness and sleepiness;the control group was more effective than the treatment group in terms of low back and leg weakness.3.Simple intelligent mental state scale scores: Within-group comparison: after 12 weeks and 24 weeks of treatment,P<0.05 in both groups compared with before treatment,suggesting that both Tianma Awakening Brain Capsule and Peiyuan Tongnao Capsule can improve cognitive function;P<0.05 in both groups compared with 12 weeks of treatment and 24 weeks,suggesting that 24 weeks of treatment is more effective than 12 weeks.Comparison between groups: after 24 weeks and 12 weeks of treatment,P>0.05,suggesting that there is no significant difference between the two groups in improving cognitive ability,that is,the efficacy is comparable.4.Montreal Cognitive Assessment Scale scores: After 12 weeks and 24 weeks of treatment,compared with the pre-treatment period,the P value was <0.05 in both groups,suggesting that both Tianma Awakening Capsule and Peiyuan Tongnao Capsule could improve cognitive function;compared with 24 weeks and 12 weeks of treatment,the P value was <0.05 in both groups,suggesting that 24 weeks of treatment was more effective than 12 weeks.After 12 weeks and 24 weeks of treatment,P>0.05 for the comparison between the two groups,suggesting that there was no significant difference between the two groups in improving cognitive ability.5.Executive function evaluation: After 24 weeks of treatment,the P value was >0.05 in both groups for intra-group comparison,suggesting that the improvement of executive function was not significant in the treatment and control groups;after 12 and 24 weeks of treatment,the P value was >0.05 for inter-group comparison,suggesting that there was no difference between the two groups in improving executive ability.Conclusion1.Definitive efficacy of Tianma Awakening Capsules in improving TCM evidence scores in patients with stroke and cachexia(vascular mild cognitive impairment)with good tolerability.2.In improving the cognitive function of patients with vascular mild cognitive impairment,Tianma Awakening Capsules were comparable in efficacy to Peiyuan Tongnao Capsules.3.In terms of improving executive function in patients with vascular mild cognitive impairment,neither Tianma Awakening Capsules nor Peiyuan Tongjiu Capsules were significantly effective.