Characteristics | Placebo (n=91) | Mesalazine (n=88) | p Value |
---|---|---|---|
Age, years (±SD) | 40.3 (12.2) | 41.0 (11.6) | 0.556 |
Female gender, n (%) | 54 (59.3) | 51 (58.0) | 0.851 |
Ethnic origin | 0.613 | ||
Caucasian, n (%) | 89 (97.8) | 85 (96.6) | |
African, n (%) | 1 (1.1) | 2 (2.3) | |
Asian, n (%) | 1 (1.1) | 0 | |
Other, n (%) | 0 (0) | 1 (1.1) | |
IBS subtype (3) | 0.481 | ||
IBS-D, n (%) | 39 (42.8) | 30 (34.1) | |
IBS-C, n (%) | 18 (19.8) | 18 (20.4) | |
IBS-M, n (%) | 34 (37.4) | 40 (45.5) | |
Abdominal pain score*† (±SD) | 4.5 (2.3) | 4.6 (2.5) | 0.930 |
Bloating score*† (±SD) | 5.0 (2.7) | 5.4 (2.8) | 0.377 |
IBS-QoL† (±SD) | 65.2 (16.4) | 62.9 (17.4) | 0.439 |
General well-being*† (±SD) | 4.1 (2.5) | 4.8 (2.5) | 0.074 |
SF-36† (±SD) | 65.1 (15.4) | 62.7 (16.0) | 0.324 |
Data are reported as number of patients (%) or mean±SD.
*These parameters were collected at the screening visit (week 2).
†Results are reported on intention-to-treat population.
QoL, quality of life; SF-36, short-form 36 items health survey.