Descriptive statistics by treatment group and by week for abdominal pain/discomfort, bloating, general well-being, IBS-QoL and SF-36
| Mesalazine (n=86) | Placebo (n=86) | p Value | ||
|---|---|---|---|---|
| Abdominal pain/discomfort intensity | ||||
| Mean (SD) | Baseline (week 2) | 4.59 (2.54) | 4.50 (2.34) | |
| Mean change versus baseline (SD) | End of treatment | −1.07 (2.54) | −1.21 (2.36) | |
| End of follow-up | −1.07 (2.63) | −0.85 (2.94) | ||
| Least squares means (SE)*** | 1384.18 (63.80) | 1394.80 (58.80) | 0.903* | |
| Bloating intensity | ||||
| Mean (SD) | Baseline (week 2) | 5.37 (2.77) | 4.97 (2.65) | |
| Mean change versus baseline (SD) | End of treatment | −1.30 (2.63) | −0.88 (2.54) | |
| End of follow-up | −0.93 (2.35) | −1.25 (3.15) | ||
| Least squares means (SE)*** | 1305.12 (62.41) | 1418.13 (57.06) | 0.184* | |
| General well-being | ||||
| Mean (SD) | Baseline (week 2) | 4.75 (2.45) | 4.11 (2.50) | |
| Mean change versus baseline (SD) | End of treatment | 0.53 (2.50) | 1.31 (2.84) | |
| End of follow-up | 0.39 (2.68) | 1.43 (3.87) | ||
| Least squares means (SE)*** | 1283.61 (61.55) | 1314.83 (57.24) | 0.712* | |
| IBS-QoL total score | ||||
| Mean (SD) | Baseline | 62.93 (17.36) | 65.16 (16.41) | |
| Mean change versus baseline (SD) | End of treatment | 7.06 (12.89) | 5.81 (11.60) | |
| End of follow-up | 9.34 (13.28) | 6.52 (14.30) | ||
| Least squares means (SE)* | 7.89 (1.41) | 6.12 (1.40) | 0.374** | |
| SF-36 total score | ||||
| Mean (SD) | Baseline | 62.68 (16.01) | 65.09 (15.38) | |
| Mean change versus baseline (SD) | End of treatment | 5.78 (12.90) | 5.74 (13.44) | |
| End of follow-up | 8.17 (14.27) | 7.60 (15.63) | ||
| Least squares means (SE)** | 125.98 (7.37) | 125.19 (7.35) | 0.940*** | |
*Least squares means and p value from an ANCOVA model for repeated measures on ranks of change versus baseline, considering as effects treatment, visit and interaction visit–treatment and as covariate value at week 1, value at week 2.
**Least squares means and p value from an ANCOVA model for repeated measures on original values/on ranks. ***Of change versus baseline, considering as effects treatment, visit and interaction visit–treatment and as covariate value at baseline.
QoL, quality of life; SF-36, short-form 36 items health survey.