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Table 2 Efficacy measure outcomes (Neuropsychological score changes) in three groups at week 24 ITT-LOCF and week 24 PPS population

From: Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial

 Week 24 LOCFWeek 24 PPS
Tianzhi (n = 232)Donepezil (n = 233)Placebo (n = 55)pTianzhi (n = 195)Donepezil (n = 202)Placebo
(n = 46)
p
VADAS-cog, mean (SD)− 6.12 (6.91)− 6.72 (7.95)− 3.47 (8.26)0.004− 6.66 (6.96)− 7.40 (8.21)− 3.70 (8.60)0.001
CIBIC-plus
 Improvement, N (%)171 (73.71)186 (79.82)32 (58.19)0.004155 (79.48)170 (84.13)27 (58.7)< 0.001
 Stable, N (%)51 (21.98)45 (19.31)11 (20.00)31 (15.90)30 (14.85)8 (17.39)
 Deterioration, N (%)10 (4.31)2 (0.86)12 (21.82)9 (4.61)2 (0.99)11 (23.91)
 NPI, mean (SD)− 3.03 (4.84)− 2.21 (5.45)− 0.36 (5.70)0.019− 2.96 (4.78)− 2.27 (5.45)− 0.27 (5.52)0.016
 MMSE, mean (SD)2.19 (2.52)2.61 (2.60)1.35 (2.67)0.0252.19 (2.53)2.62 (2.61)1.32 (2.69)0.023
 TMT-A, mean (SD)− 12.86 (30.80)− 20.60 (34.97)− 11.92 (37.38)0.009− 12.97 (30.85)− 20.76 (35.11)− 12.94 (37.86)0.015
 TMT-B, mean (SD)− 28.91 (63.96)− 33.96 (70.53)− 34.26 (63.08)0.439− 29.18 (64.02)− 33.92 (69.13)− 35.04 (63.59)0.523
 ADL, mean (SD)− 1.84 (5.42)− 1.84 (6.03)− 0.96 (6.32)0.859− 1.87 (5.41)− 1.88 (6.04)− 1.00 (6.33)0.856
 CDT, mean (SD)0.46 (1.10)0.58 (1.15)0.40 (1.18)0.4110.46 (1.11)0.59 (1.15)0.47 (1.14)0.521
  1. VADAS-cog vascular dementia assessment scale-cognitive subscale, CIBIC-plus clinician’s interview-based impression of change-plus care interview, NPI Neuropsychiatric Inventory, MMSE mini-mental state examination, ADL activity of daily living scale, CDT clock drawing test, TMT-A trail making test part A, TMT-B trail making test part B, ITT intent-to-treat, LOCF last observation carried forward, PPS per protocol set
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