Table 2 Primary and secondary outcomes at baseline and 12 weeks.

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 = 26)

Placebo

(n = 27)

P value

Required sample number (effect size)

ADAS-K

Baseline

5.74 ± 4.12

6.26 ± 4.36

0.7962§

8262

12 week

4.40 ± 2.68

4.72 ± 3.44

 

(0.031)

Change

− 1.35 ± 2.57

− 1.54 ± 3.52

0.9645†

 

P value‡

0.0129*

0.0312*

  

ADAS-cog

Baseline

5.71 ± 3.99

6.18 ± 4.31

0.7962§

8090

12 week

4.32 ± 2.49

4.60 ± 3.24

 

(0.031)

Change

− 1.39 ± 2.64

− 1.58 ± 3.41

0.9858†

 

P value‡

0.0129*

0.0234*

  

ADAS memory

Baseline

4.51 ± 3.19

4.67 ± 3.38

0.8447§

4624

12 week

3.28 ± 2.20

3.23 ± 1.96

 

(0.041)

Change

− 1.23 ± 2.34

− 1.43 ± 2.51

0.9008†

 

P value‡

0.0127*

0.0065*

  

ADAS language

Baseline

0.96 ± 0.82

1.15 ± 0.95

0.4890§

11,172

12 week

0.96 ± 0.87

1.22 ± 1.58

 

(0.026)

Change

0.00 ± 0.75

0.07 ± 1.71

0.8891†

 

P value‡

1.0000

0.8235

  

ADAS executive function

Baseline

0.23 ± 0.71

0.37 ± 1.08

0.7167§

4974

12 week

0.08 ± 0.27

0.15 ± 0.36

 

(0.040)

Change

− 0.15 ± 0.67

− 0.22 ± 1.05

0.8114†

 

P value‡

0.2560

0.2815

  

ADAS-non cog

Baseline

0.04 ± 0.20

0.07 ± 0.27

0.5938§

NA

12 week

0.08 ± 0.27

0.11 ± 0.32

  

Change

0.04 ± 0.20

0.04 ± 0.34

1.0000†

 

P value‡

0.3269

0.5735

  

K-CWST word reading valid answer (no)

Baseline

111.04 ± 2.39

111.59 ± 1.55

0.0977§

174

12 week

111.46 ± 2.35

111.59 ± 1.55

 

(0.209)

Change

0.42 ± 1.30

0.00 ± 0.48

0.1603†

 

P value‡

0.1099

1.0000

  

K-CWST word reading evaluation time (sec)

Baseline

71.65 ± 20.07

79.44 ± 48.80

0.8101§

1438

12 week

64.81 ± 15.01

67.52 ± 20.17

 

(0.074)

Change

− 6.85 ± 14.24

− 11.93 ± 46.42

0.7621†

 

P value‡

0.0216*

0.1935

  

K-CWST color reading valid answer (no)

Baseline

102.42 ± 21.83

107.26 ± 4.92

0.9214§

190

12 week

108.23 ± 6.72

106.44 ± 11.64

 

(0.200)

Change

5.81 ± 20.39

− 0.81 ± 10.31

0.2313†

 

P value‡

0.1588

0.6846

  

K-CWST color reading evaluation time (s)

Baseline

139.15 ± 42.91

141.85 ± 45.43

0.9787§

408,430

12 week

125.08 ± 29.51

128.00 ± 34.76

 

(0.004)

Change

− 14.08 ± 27.19

− 13.85 ± 25.24

0.6307†

 

P value‡

0.0141*

0.0084*

  

ASCS-ADL

Baseline

75.00 ± 0.00

74.96 ± 0.19

0.3454§

808

12 week

74.58 ± 0.81

74.70 ± 0.78

 

(0.098)

Change

− 0.42 ± 0.81

− 0.26 ± 0.81

0.3519†

 

P value‡

0.0132*

0.1095

  

SGDS

Baseline

3.19 ± 3.29

2.81 ± 3.04

0.7454§

180

12 week

2.12 ± 2.76

2.63 ± 3.24

 

(0.205)

Change

− 1.08 ± 2.23

− 0.19 ± 2.00

0.4876†

 

P value‡

0.0208*

0.6346

  

CERAD-K word list memory

Baseline

19.46 ± 3.88

19.33 ± 4.50

0.9121§

7712

12 week

23.81 ± 3.51

23.44 ± 4.47

 

(0.032)

Change

4.35 ± 4.35

4.11 ± 3.06

0.8204†

 

P value‡

 < 0.0001*

 < 0.0001*

  

CERAD-K word delayed recall

Baseline

8.08 ± 1.49

7.59 ± 1.58

0.3102§

11,492

12 week

8.58 ± 1.58

8.00 ± 2.06

 

(0.026)

Change

0.50 ± 1.73

0.41 ± 2.08

0.9927†

 

P value‡

0.1522

0.3182

  

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, ‡ 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.
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