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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