Table 5 Subgroup analysis for the 30 subjects with baseline K-MMSE scores of ≤ 28.
PM-EE (n = 17) | Placebo (n = 13) | P value | Required sample number¶ (effect size) | ||
---|---|---|---|---|---|
ADAS-K | Baseline | 6.67 ± 4.81 | 6.31 ± 4.24 | 0.7692§ | 470 |
12 week | 5.20 ± 2.69 | 5.72 ± 4.20 | (0.128) | ||
Change | − 1.47 ± 2.80 | − 0.59 ± 3.90 | 0.2856† | ||
P value‡ | 0.0455* | 0.5957 | |||
ADAS-cog | Baseline | 6.61 ± 4.64 | 6.23 ± 4.21 | 0.7692§ | 566 |
12 week | 5.08 ± 2.44 | 5.49 ± 3.90 | (0.117) | ||
Change | − 1.53 ± 2.90 | − 0.74 ± 3.74 | 0.2949† | ||
P value‡ | 0.0448* | 0.4874 | |||
ADAS memory | Baseline | 5.31 ± 3.63 | 4.31 ± 2.29 | 0.6149§ | 346 |
12 week | 3.96 ± 2.27 | 3.64 ± 1.83 | (0.149) | ||
Change | − 1.35 ± 2.61 | − 0.67 ± 1.82 | 0.4257† | ||
P value‡ | 0.0481* | 0.2119 | |||
ADAS language | Baseline | 0.94 ± 0.90 | 1.23 ± 1.17 | 0.5373§ | 810 |
12 week | 1.00 ± 0.94 | 1.62 ± 2.02 | (0.098) | ||
Change | 0.06 ± 0.83 | 0.38 ± 2.14 | 0.7946† | ||
P value‡ | 0.7731 | 0.5296 | |||
ADAS executive function | Baseline | 0.35 ± 0.86 | 0.69 ± 1.49 | 0.6532§ | NA |
12 week | 0.12 ± 0.33 | 0.23 ± 0.44 | |||
Change | − 0.24 ± 0.83 | − 0.46 ± 1.45 | 0.9794† | ||
P value‡ | 0.2603 | 0.2735 | |||
ADAS-non cog | Baseline | 0.06 ± 0.24 | 0.08 ± 0.28 | 0.8845§ | 394 |
12 week | 0.12 ± 0.33 | 0.23 ± 0.44 | (0.140) | ||
Change | 0.06 ± 0.24 | 0.15 ± 0.38 | 0.4208† | ||
P value‡ | 0.3322 | 0.1654 | |||
K-CWST word reading valid answer (no) | Baseline | 110.65 ± 2.89 | 111.31 ± 2.21 | 0.1620§ | 154 |
12 week | 111.18 ± 2.90 | 111.31 ± 2.21 | (0.221) | ||
Change | 0.53 ± 1.59 | 0.00 ± 0.41 | 0.3385† | ||
P value‡ | 0.1876 | 1.0000 | |||
K-CWST word reading evaluation time (s) | Baseline | 73.94 ± 23.69 | 72.31 ± 20.91 | 1.0000§ | 172 |
12 week | 65.12 ± 17.58 | 70.46 ± 27.92 | (0.210) | ||
Change | − 8.82 ± 16.29 | − 1.85 ± 16.03 | 0.5025† | ||
P value‡ | 0.0402* | 0.6852 | |||
K-CWST color reading valid answer (no) | Baseline | 98.59 ± 26.34 | 107.69 ± 4.82 | 0.4100§ | 78 |
12 week | 106.82 ± 8.01 | 103.00 ± 16.23 | (0.306) | ||
Change | 8.24 ± 25.02 | − 4.69 ± 13.24 | 0.0184†* | ||
P value‡ | 0.1936 | 0.2256 | |||
K-CWST color reading evaluation time (s) | Baseline | 149.82 ± 48.12 | 140.08 ± 46.85 | 0.5300§ | 446 |
12 week | 133.29 ± 29.99 | 130.92 ± 36.24 | (0.132) | ||
Change | − 16.53 ± 30.17 | − 9.15 ± 24.98 | 0.6152† | ||
P value‡ | 0.0382* | 0.2111 | |||
ASCS-ADL | Baseline | 75.00 ± 0.00 | 74.92 ± 0.28 | 0.2818§ | 2672 |
12 week | 74.59 ± 0.80 | 74.62 ± 0.96 | (0.054) | ||
Change | − 0.41 ± 0.80 | − 0.31 ± 1.03 | 0.4796† | ||
P value‡ | 0.0486* | 0.3033 | |||
SGDS | Baseline | 4.18 ± 3.66 | 3.62 ± 3.18 | 0.6634§ | 262 |
12 week | 2.47 ± 3.30 | 2.62 ± 3.23 | (0.171) | ||
Change | − 1.71 ± 2.44 | − 1.00 ± 1.53 | 0.7491† | ||
P value‡ | 0.0109* | 0.0360 | |||
CERAD-K word list memory | Baseline | 18.76 ± 4.04 | 18.38 ± 4.93 | 0.8180§ | 13,230 |
12 week | 22.88 ± 3.02 | 22.69 ± 5.31 | (0.024) | ||
Change | 4.12 ± 3.90 | 4.31 ± 3.90 | 0.8958† | ||
P value‡ | 0.0005* | 0.0018* | |||
CERAD-K word delayed recall | Baseline | 7.65 ± 1.54 | 7.46 ± 1.51 | 0.7437§ | 3998 |
12 week | 8.35 ± 1.73 | 8.31 ± 1.97 | (0.044) | ||
Change | 0.71 ± 1.69 | 0.85 ± 1.46 | 0.8117† | ||
P value‡ | 0.1037 | 0.0591 | |||
CERAD-K word recognition | Baseline | 0.00 ± 0.00 | 0.00 ± 0.00 | – | NA |
12 week | 0.00 ± 0.00 | 0.00 ± 0.00 | |||
Change | 0.00 ± 0.00 | 0.00 ± 0.00 | – | ||
P value‡ | – | – |