Clinical secondary endpoint results
| EOT (11–12 weeks) | Between group comparison at 11–12 weeks (95% CI) | p Value | |
|---|---|---|---|
| Average abdominal pain score, mean (SD) | |||
| Placebo | 2.2 (2.1) | – | – |
| Mesalazine | 2.8 (2.1) | – | – |
| Mesalazine vs placebo | – | 0.07 (−0.54 to 0.68) | 0.83 |
| Number of days with urgency, median (IQR) | |||
| Placebo | 8 (1–13) | – | – |
| Mesalazine | 11 (5–14) | – | – |
| Mesalazine vs placebo | – | 1.22 (1.07 to 1.39)* | 0.003 |
| Average stool consistency, mean (SD) | |||
| Placebo | 4.7 (1.1) | – | – |
| Mesalazine | 4.7 (1.0) | – | – |
| Mesalazine vs placebo | – | 0.13 (−0.21 to 0.48) | 0.45 |
| Number of days with consistency score 6 or 7, median (IQR) | |||
| Placebo | 6 (2–9) | – | – |
| Mesalazine | 7 (2–11) | – | – |
| Mesalazine vs placebo | – | 1.09 (0.95 to 1.27) | 0.21 |
| Number of people with satisfactory relief of IBS symptoms, n (%) | |||
| Placebo | 24 (40.7%) | – | – |
| Mesalazine | 25 (43.9%) | – | – |
| Mesalazine vs placebo | – | 1.13 (0.51 to 2.47)† | 0.76 |
| Mean HADS anxiety score | |||
| Placebo | 6.9 (3.6) | – | – |
| Mesalazine | 7.5 (5.0) | – | – |
| Mesalazine vs placebo | – | 0.67 (−0.38 to 1.72) | 0.21 |
| Mean HADS depression score | |||
| Placebo | 3.7 (3.2) | – | – |
| Mesalazine | 4.7 (5.1) | – | – |
| Mesalazine vs placebo | – | 0.49 (−0.41 to 1.39) | 0.29 |
| Mean PHQ12-SS score (mean(SD)) | |||
| Placebo | 5.7 (3.9) | – | – |
| Mesalazine | 6.2 (4.4) | – | – |
| Mesalazine vs placebo | – | 0.49 (−0.76 to 1.74) | 0.45 |
*Incident rate ratio. †OR.
EOT, end of trial; HADS, Hospital and Depression Scale; PHQ12-SS, Patient Health Questionnaire-12 Somatic Symptom Scale.