Table 2.
Bowel habit assessments (n = 52)
| Endpoint | Run-in period | Follow-up |
||
|---|---|---|---|---|
| Weeks 3–4 | Weeks 9–12 | Weeks 21–24 | ||
| Mean CSBMs/week of ≥3 | 0 (0) | 26 (50.0)** | 20 (38.5)** | 17 (32.7)** |
| Increase of ≥1 CSBM/week | – | 38 (73.1) | 31 (59.6) | 23 (44.2)†† |
| CSBMs/week | 0.6 ± 0.5 | 2.8 ± 1.5** | 2.4 ± 1.4**†† | 1.8 ± 1.6**†† |
| SBMs/week | 2.1 ± 0.7 | 5.0 ± 1.4** | 4.6 ± 1.6**†† | 3.2 ± 1.4**†† |
| Percent of BMs with normal consistency (score = 3, 4 or 5) | 25.4 ± 20.2 | 52.1 ± 19.9** | 42.0 ± 21.0**†† | 35.8 ± 26.3*†† |
| Percent of BMs with none or mild straining (score = 1 or 2) | 19.2 ± 15.6 | 40.2 ± 23.6** | 34.1 ± 23.3**†† | 29.6 ± 25.0**†† |
| Percent of BMs with none or mild incompleteness (score = 1 or 2) | 37.8 ± 30.7 | 51.1 ± 18.1** | 47.0 ± 17.5**†† | 44.6 ± 28.5**† |
| Number of days with laxative use or enema/week | 1.0 ± 0.4 | 0.2 ± 0.4** | 0.4 ± 0.6**†† | 0.6 ± 0.6**†† |
BMs, bowel movements; SBMs, spontaneous bowel movements; CSBMs, complete spontaneous bowel movements. Continuous data are presented as mean ± standard deviation, while categorical data are presented as number (%). *P < 0.05, **P < 0.01 for the comparison with baseline; †P < 0.05, ††P < 0.01 for the comparison with week interval 3–4.