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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 LOCF

Week 24 PPS

Tianzhi (n = 232)

Donepezil (n = 233)

Placebo (n = 55)

p

Tianzhi (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)

0.004

155 (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)

0.025

2.19 (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)

0.411

0.46 (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