Table 5.
Between and within group comparisons at weeks 8 and 12
|
WEEK 8 | |||||||
|---|---|---|---|---|---|---|---|
|
Study parameter |
A = Active product |
C = Control product |
A vs C |
||||
| n | Mean (week 12–baseline) (SD) | p value* (change from baseline) | n | Mean (week 12–baseline) (SD) | p value* (change from baseline) | p value** | |
|
IBS-SSS |
50 |
−58.30 (84.96) |
<0.001 |
40 |
−58.33 (73.37) |
<0.001 |
0.589 |
|
Birmingham IBS symptom scale | |||||||
| Constipation |
52 |
13.78 (24.47) |
<0.001 |
41 |
17.24 (22.61) |
<0.001 |
0.302 |
| Diarrhoea |
4.25 (13.78) |
0.210 |
2.15 (7.71) |
0.064 |
0.907 |
||
| Pain |
11.28 (18.88) |
<0.001 |
13.66 (16.80) |
<0.001 |
0.257 |
||
| Total score |
8.71 (13.09) |
<0.001 |
9.44 (9.75) |
<0.001 |
0.265 |
||
|
IBS specific symptoms | |||||||
| Pain |
53 |
−0.58 (1.24) |
0.012 |
41 |
−0.66 (1.43) |
0.002 |
0.292 |
| Bloating |
52 |
−0.80 (1.44) |
0.005 |
−0.85 (1.26) |
<0.001 |
0.408 |
|
| Flatulence |
53 |
−0.54 (1.28) |
0.002 |
40 |
−0.50 (1.08) |
0.004 |
0.864 |
| Composite score |
52 |
−1.95 (3.43) |
0.003 |
−1.96 (3.17) |
<0.001 |
0.374 |
|
| Stool frequency |
346 |
0.07 (0.95) |
0.303 |
276 |
0.10 (0.05) |
0.141 |
0.828 |
| Stool consistency |
290 |
0.18 (1.17) |
0.042 |
218 |
0.50 (1.23) |
0.001 |
0.098 |
| Bowel movement difficulty |
291 |
−0.43 (1.01) |
<0.001 |
224 |
−0.40 (0.78) |
<0.001 |
0.623 |
|
IBS Quality of life | |||||||
| Dysphoria |
53 |
14.66 (19.87) |
<0.001 |
41 |
9.29 (13.95) |
<0.001 |
0.508 |
| Activity interference |
8.20 (14.74) |
0.001 |
6.05 (12.99) |
0.001 |
0.924 |
||
| Body image |
11.95 (15.98) |
<0.001 |
8.54 (13.46) |
<0.001 |
0.735 |
||
| Health worry |
13.29 (17.81) |
<0.001 |
7.62 (15.19) |
0.002 |
0.428 |
||
| Food avoidance |
10.06 (17.63) |
<0.001 |
5.49 (17.84) |
0.039 |
0.372 |
||
| Social reaction |
10.85 (16.18) |
<0.001 |
6.71 (12.21) |
<0.001 |
0.462 |
||
| Sexual |
8.41 (18.31) |
0.006 |
7.05 (16.92) |
0.005 |
0.554 |
||
| Relationship |
7.23 (18.64) |
0.015 |
7.01 (9.88) |
<0.001 |
0.635 |
||
| Total score |
10.95 (13.14) |
<0.001 |
7.52 (10.22) |
<0.001 |
0.483 |
||
|
WEEK 12 | |||||||
|
IBS-SSS |
43 |
−61.02 (75.78) |
<0.001 |
33 |
−97.24 (90.17) |
<0.001 |
0.028 |
|
Birmingham IBS symptom scale | |||||||
| Constipation |
48 |
6.65 (22.56) |
0.039 |
35 |
17.52 (23.60) |
<0.001 |
0.011 |
| Diarrhoea |
|
3.27 (11.17) |
0.048 |
|
2.43 (10.60) |
0.133 |
0.889 |
| Pain |
|
10.28 (14.09) |
<0.001 |
|
15.24 (17.38) |
<0.001 |
<0.107 |
| Total score |
|
6.07 (9.62) |
<0.001 |
|
10.10 (10.78) |
<0.001 |
<0.022 |
|
IBS specific symptoms | |||||||
| Pain |
48 |
−0.59 (1.24) |
0.002 |
34 |
−1.04 (1.33) |
<0.001 |
0.016 |
| Bloating |
48 |
−0.58 (1.39) |
0.005 |
−1.35 (1.21) |
<0.001 |
0.006 |
|
| Flatulence |
48 |
−0.64 (1.04) |
0.001 |
−0.76 (1.23) |
<0.001 |
0.383 |
|
| Composite score |
48 |
−1.81 (3.03) |
<0.001 |
−3.16 (3.05) |
<0.001 |
0.011 |
|
| Stool frequency |
311 |
−0.07 (0.75) |
0.186 |
224 |
0.07 (0.82) |
0.464 |
0.211 |
| Stool consistency |
247 |
0.26 (1.22) |
0.045 |
181 |
0.31 (0.99) |
0.012 |
0.784 |
| Bowel movement difficulty |
246 |
−0.35 (0.99) |
<0.001 |
180 |
−0.36 (0.86) |
<0.001 |
0.329 |
|
IBS Quality of life | |||||||
| Dysphoria |
48 |
13.61 (20.12) |
<0.001 |
34 |
10.83 (10.68) |
<0.001 |
0.933 |
| Activity interference |
8.47 (12.31) |
<0.001 |
34 |
7.09 (8.73) |
<0.001 |
0.806 |
|
| Body image |
11.33 (14.16) |
<0.001 |
34 |
8.27 (14.08) |
0.005 |
0.857 |
|
| Health worry |
14.15 (21.01) |
<0.001 |
34 |
9.07 (13.19) |
<0.001 |
0.634 |
|
| Food avoidance |
8.16 (20.45) |
0.008 |
34 |
8.58 (13.37) |
<0.001 |
0.687 |
|
| Social reaction |
9.64 (17.15) |
<0.001 |
34 |
9.38 (8.74) |
<0.001 |
0.660 |
|
| Sexual |
8.07 (21.34) |
0.031 |
32 |
10.55 (16.53) |
<0.001 |
0.382 |
|
| Relationship |
7.03 (15.81) |
0.002 |
34 |
5.51 (9.22) |
<0.001 |
0.751 |
|
| Total score | 10.43 (12.92) | <0.001 | 34 | 8.83 (6.12) | <0.001 | 0.810 | |
*ANCOVA with centre as a random effect, baseline as a covariate and product as a fixed effect.
**Ordinal logistic regression with centre and product fixed effects.
Stool frequency, consistency and bowel movement difficulty were recorded daily and therefore n represents the number of data items (days) included in analysis for these items.