Table 2.
Study parameters at week 8 and changes from baseline in all patients (mean ± SD)
| Test group (n = 58) | Control group (n = 59) | P value1 | |||||||
| Baseline | wk 8 | Δ wk 8 | P value | Baseline | wk 8 | Δ wk 8 | P value | ||
| Abdominal symptoms | |||||||||
| Abdominal pain or discomfort (VAS) | 34.05 ± 18.55 | 12.93 ± 14.99 | -21.12 | 0 | 33.05 ± 19.94 | 16.5 ± 17.7 | -16.53 | < 0.001 | 0.26 |
| Frequency of abdominal pain or discomfort/d | 1.73 ± 2.03 | 0.84 ± 0.83 | -0.89 | 0.004 | 1.21 ± 1.17 | 0.7 ± 0.8 | -0.48 | 0.001 | 0.214 |
| Abdominal distension or bloating (VAS) | 44.40 ± 21.99 | 25.86 ± 18.1 | -18.53 | 0 | 39.83 ± 20.82 | 28.8 ± 21.2 | -11.02 | < 0.001 | 0.096 |
| Flatulence/d | 5.19 ± 4.01 | 5.69 ± 5.08 | 0.5 | 0.391 | 4.98 ± 2.88 | 5.5 ± 4.0 | 0.51 | 0.266 | 0.991 |
| Bowel habits | |||||||||
| Defecation frequency/wk | 6.38 ± 5.98 | 7.23 ± 4.28 | 0.85 | 0.289 | 5.69 ± 3.87 | 6.7 ± 4.2 | 1.04 | 0.052 | 0.843 |
| Defecation duration (min) | 8.68 ± 6.35 | 7.47 ± 4.95 | -1.22 | 0.07 | 8.85 ± 5.59 | 6.7 ± 3.9 | -2.12 | < 0.001 | 0.301 |
| Urgency | 23 (39.7%) | 16 (27.6%) | -7 | 0.118 | 22 (37.3%) | 22 (37.3%) | 0 | 1 | 0.146 |
| Straining | 39 (67.2%) | 22 (37.9%) | -17 | 0 | 37 (62.7%) | 20 (33.9%) | -17 | 0.002 | 0.959 |
| Feeling of incomplete evacuation | 39 (67.2%) | 19 (32.8%) | -20 | 0 | 44 (74.6%) | 23 (39.0%) | -21 | < 0.001 | 0.815 |
| Stool consistency (BSS) | 3.95 ± 1.64 | 3.72 ± 1.02 | -0.22 | 0.274 | 3.53 ± 1.59 | 3.88 ± 1.15 | 0.36 | 0.047 | 0.118 |
| Bowel habit satisfaction (VAS) | 32.33 ± 17.53 | 59.48 ± 19.21 | 27.16 | 0 | 31.95 ± 18.22 | 47.5 ± 20.1 | 15.51 | < 0.001 | 0.01 |
| Discomfort related to daily life (VAS) | 36.21 ± 22.54 | 21.98 ± 19.91 | -14.22 | 0 | 30.93 ± 17.58 | 22.9 ± 17.5 | -8.05 | 0.007 | 0.199 |
| Improvement in overall IBS symptoms (VAS) | 64.2 ± 17.0 | 50.4 ± 20.5 | < 0.001 | ||||||
1
Comparison between both groups. IBS: Irritable bowel syndrome; VAS: Visual analog scale; BSS: Bristol stool scale.