Table 4

Between and within group comparisons at week 4
Study parameter Active product Control product Active versus control
n Mean (week 4–baseline) (SD) p value* (change from baseline) n Mean (week 4–baseline) (SD) p value* (change from baseline) p value**
IBS-SSS 41 −53.35 (81.98) <0.002 44 −31.11 (78.57) 0.010 0.233
Birmingham IBS symptom scale
Constipation 59 9.44 (20.40) <0.001 49 15.10 (21.59) <0.001 0.131
Diarrhoea 59 3.88 (12.26) 0.007 2.22 (10.17) 0.106 0.616
Pain 60 7.89 (14.70) <0.001 11.22 (18.34) <0.001 0.367
Total score 60 6.10 (10.83) <0.001 8.28 (11.10) <0.001 0.251
IBS specific symptoms
Pain 60 −0.33 (1.19) 0.087 49 −0.61 (1.36) 0.001 0.109
Bloating −0.66 (1.35) <0.001 48 −0.68 (1.12) <0.001 0.432
Flatulence −0.51 (1.24) <0.001 49 −0.36 (1.07) 0.0017 0.955
Composite score −1.48 (3.03) 0.002 49 −1.69 (2.99) <0.001 0.264
Stool frequency 417 0.07 (0.89) 0.202 341 0.04 (0.85) 0.607 0.648
Stool consistency 341 0.13 (1.20) 0.240 269 0.31 (1.30) 0.007 0.184
Bowel movement difficulty 341 −0.24 (0.97) 0.004 271 −0.28 (0.89) 0.011 0.450
IBS Quality of life
Dysphoria 60 9.78 (16.89) <0.001 50 7.53 (15.54) 0.002 0.875
Activity interference 60 5.68 (10.97) 0.003 50 5.07 (13.77) 0.008 0.769
Body image 60 6.63 (16.28) <0.001 50 8.13 (17.37) 0.004 0.134
Health worry 60 7.92 (15.20) 0.001 50 5.75 (16.17) 0.009 0.958
Food avoidance 60 9.58 (16.01) 0.002 50 4.42 (18.76) 0.078 0.121
Social reaction 60 7.33 (14.23) 0.003 50 4.17 (14.10) 0.029 0.769
Sexual 59 4.24 (15.68) 0.171 48 4.17 (20.36) 0.125 0.853
Relationship 60 7.15 (15.54) <0.001 50 1.92 (12.43) 0.217 0.139
Total score 60 7.60 (10.88) <0.001 50 5.69 (12.60) 0.004 0.979

*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.

Roberts et al.

Roberts et al. BMC Gastroenterology 2013 13:45   doi:10.1186/1471-230X-13-45

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