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Table 3 Comparison of constipation symptom score, weight, glycemic and lipid control in 53 patients with type 2 diabetes and chronic constipation before and after treatment with flaxseed and placebo

From: A randomized trial of the effects of flaxseed to manage constipation, weight, glycemia, and lipids in constipated patients with type 2 diabetes

Variable

Treatment group

P value**

Flaxseed

Placebo

Mean (SD)

Mean (SD)

Global constipation symptom scores

 Baseline

−1.38 (0.8)

−1.00 (1.4)

0.627

 After 4 week therapy

−1.77 (1.5)

− 1.74 (0.8)

0.257

 After 8 week therapy

−0.50 (1.7)

−1.76 (0.8)

0.016

 After 12 week therapy

1.08 (1.4)

−0.59 (1.4)

0.003

 P value*

< 0.001

0.003

 Change from baseline

2.46

0.41

0.008

 After 4 week without therapy

−0.42 (1.6)

−0.81 (1.5)

0.257

Bristol Stool Form Scale

 Baseline

1.35 (0.5)

1.26 (0.5)

0.975

 After 4 week therapy

2.38 (0.6)

1.59 (1.2)

0.026

 After 8 week therapy

2.96 (0.6)

1.33 (0.6)

< 0.001

 After 12 week therapy

3.31 (0.7)

1.85 (1.6)

0.005

 P value*

< 0.001

0.307

 Change from baseline

1.96

0.59

0.005

 After 4 week without therapy

1.92 (0.8)

1.44 (0.8)

0.057

Weight (kg)

 Baseline

75.4 (10.6)

73.1 (12.0)

0.578

 After 12 week therapy

71.6 (8.8)

73.1 (11.3)

0.749

 P value*

< 0.001

0.947

 Change from baseline

−3.8

0.0

< 0.001

Body mass index (kg/m2)

 Baseline*

29.1 (3.8)

28.7 (5.9)

0.976

 After 12 week therapy

27.6 (3.1)

28.6 (5.6)

0.375

 P value

< 0.001

0.930

 Change from baseline

−1.5

−0.1

< 0.001

FPG (mg/dl)

 Baseline

164.8 (45.2)

165.6 (43.5)

0.980

 After 4 week therapy

163.8 (45.1)

166.0 (42.5)

0.914

 After 8 week therapy

143.4 (34.2)

168.0 (38.5)

0.016

 After 12 week therapy

137.0 (26.4)

163.7 (39.5)

0.006

 P value*

0.018

0.483

 Change from baseline

−26.7

−1.9

0.011

 After 4 week without therapy

140.0 (26.5)

170.1 (50.3)

0.013

HbA1c (%)

 Baseline

8.4 (2.0)

8.0 (2.2)

0.239

 After 4 week therapy

8.2 (1.8)

8.9 (1.4)

0.740

 After 8 week therapy

7.7 (2.1)

8.6 (2.2)

0.675

 After 12 week therapy

7.7 (2.0)

9.0 (2.2)

0.101

 P value*

0.137

0.978

 Change from baseline

−0.8

1.0

0.001

 After 4 week without therapy

7.0 (1.5)

8.5 (1.2)

0.009

Cholesterol (mg/dl)

 Baseline

178.1 (31.2)

177.3 (33.7)

0.480

 After 4 week therapy

160.8 (31.1)

171.2 (30.1)

0.137

 After 8 week therapy

148.1 (31.9)

171.4 (37.8)

0.017

 After 12 week therapy

141.2 (31.9)

166.9 (39.8)

0.014

 P value*

< 0.001

0.311

 Change from baseline

−37.3

−10.4

0.085

 After 4 week without therapy

147.6 (29.7)

170.0 (34.3)

0.280

Triglyceride (mg/dl)

 Baseline

161.1 (39.1)

172.2 (81.2)

0.221

 After 4 week therapy

154.0 (45.3)

168.0 (58.0)

0.117

 After 8 week therapy

154.0 (48.8)

165.0 (56.6)

0.230

 After 12 week therapy

148.8 (45.7)

164.3 (56.3)

0.092

 P value*

0.045

0.045

 Change from baseline

−10.4

−11.4

0.283

 After 4 week without therapy

149.8 (40.1)

167.6 (58.3)

0.118

LDLC (mg/dl)

 Baseline

115.1 (22.4)

94.5 (23.1)

0.008

 After 4 week therapy

106.8 (22.5)

92.7 (26.6)

0.243

 After 8 week therapy

99.7 (21.1)

96.1 (27.6)

0.003

 After 12 week therapy

94.1 (19.9)

90.6 (17.9)

0.046

 P value*

< 0.001

0.482

 Change from baseline

−21.0

−4.3

0.010

 After 4 week without therapy

105.0 (24.6)

100.5 (31.4)

0.636

HDLC (mg/dl)

 Baseline

43.1 (8.8)

43.5 (7.2)

0.992

 After 4 week therapy

44.2 (9.3)

41.1 (7.9)

0.054

 After 8 week therapy

45.6 (9.2)

42.0 (6.1)

0.726

 After 12 week therapy

49.1 (7.9)

41.9 (10.0)

0.300

 P value*

0.316

0.607

 Change from baseline

4.7

−4.4

0.011

 After 4 week without therapy

42.5 (8.1)

40.7 (6.5)

0.969

Cholesterol/HDLC ratio (mg/dl)

 Baseline

4.3 (1.2)

4.2 (1.0)

0.771

 After 4 week therapy

3.9 (1.3)

4.4 (1.3)

0.052

 After 8 week therapy

3.4 (1.2)

4.2 (1.6)

0.220

 After 12 week therapy

3.0 (0.8)

4.2 (1.2)

0.048

 P value*

0.021

0.332

 Change from baseline

−1.4

−0.2

0.333

 After 4 week without therapy

3.6 (0.9)

4.5 (1.4)

0.636

  1. *Within group comparison
  2. **Comparison between flaxseed and placebo groups, adjusted for baseline age, gender, LDLC, and constipation symptoms