Table 5 Subgroup analysis for the 30 subjects with baseline K-MMSE scores of ≤ 28.

From: Effect of desalted Salicornia europaea L. ethanol extract (PM-EE) on the subjects complaining memory dysfunction without dementia: a 12 week, randomized, double-blind, placebo-controlled clinical trial

  

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

 
  1. The data are reported as the mean ± standard deviation. ADAS-K: Korean version of the Alzheimer's Disease Assessment Scale, ADAS-cog/non-cog: cognitive/non-cognitive domains of the ADAS-K, K-CWST: Korean version of the Color-Word Stroop Test, ADCS-ADL: Alzheimer's Disease Cooperative Study-Activities of Daily Living, SGDS: Short-form Geriatric Depression Scale, and CERAD-K: Korean version of the Consortium to Establish a Registry for Alzheimer's Disease. *P < 0.05, §P value for the PM-EE group and the placebo group, by paired t-test or Wilcoxon rank sum test † P value for the PM-EE group and the placebo group, by ANCOVA adjusted by baseline, and ‡ P value for the change from baseline, by paired t-test or Wilcoxon rank sum test, and the total number of study subjects required to reach a statistical significance.