The Naomaitai Capsule Treatment Of Vascular Dementia Randomized Controlled Trials And Cost-effectiveness Analysis,

Objective1. Assess the benefits and adverse reaction of traditional Chinese medicine in the treatment of vascular dementia.2. Assess the clinical effects and safety of Naomaitai capsule on vascular dementia through randomized controlled trial.3. Compare the cost-effectiveness rates of Naomaitai capsule and hydergine tablet on vascular dementia, so as to find the economics value.Methods1. Randomized controlled trials on vascular dementia were collected, which aimed to compare the effects between traditional Chinese medicine and western medicine. The quality of included trials was evaluated and meta-analysis was conducted by RevMan 4.2.8.2. The trial was designed as a double-blinded double-dummy randomized controlled non-inferior trial. We evaluated the mental state, behavior capability and TCM syndrome effectiveness through the score of Mini-Mental State Examination, Blessed-Roth Behavior Scale and TCM syndrome, and had a description and analysis on adverse events.3. We collected cost and health outcome data through randomized controlled trial, and conducted cost-effectiveness and increment cost-effectiveness analysis.Results1. Systematic Review: We identified 8 studies including 823 patient and 8 traditional Chinese medicines. Compared with western medicine, traditional Chinese medicines are more effective in dementia effect and HDS, with total OR 1.86 (95% confidence interval 1.16 to2.97) and total WMD 1.80 (95% confidence interval 1.30 to 2.30). We didn't find obvious adverse reaction.2. Randomized controlled trial: 456 eligible subjects have been collected, 343 in Naomaitai capsule group and 113 in hydergine tablet group.The baseline of two groups, such as gender, age, culture degree, important previous history, drug treatment, complicated disease, the grade of MMSE, BBS and TCM syndrome, were comparable. There weren't statistics significance between two groups. Effectiveness analysis: (1) Intelligence effectiveness: The difference between two groups in effectiveness composition, excellence rate and effective power weren't statistics significance. (2) Behavior capability effectiveness: The difference of effectiveness composition, essential control rate and excellence rate between two groups weren't statistics significance. (3) TCM syndrome effectiveness: The difference of effectiveness composition, clinical recovery rate and excellence rate between two groups weren't statistics significance. (4) Total scores of TCM syndrome: There weren't statistics significance both in before-after change value and post-treatment group comparison.In this trial, we found 10 adverse events, 9 in Naomaitai capsule group and 1 in hydergine tablet group. But we can't confirm the relation between adverse events and medicines. 3. Cost-effectiveness analysis: 233 subjects were completed, 175 in Naomaitai capsule...