Ondansetron effect on secondary outcomes
| ITT analysis (N=98) | PPA (N=90) | |||
|---|---|---|---|---|
| Treatment effect (95% CI) | p Value | Treatment effect (95% CI) | p Value | |
| Days per week with pain | −0.3 (−0.7 to 0.1) | 0.203 | −0.3 (−0.7 to 0.2) | 0.227 |
| Days per week with urgency | −1.1 (−1.5 to −0.6) | <0.001 | −1.1 (−1.6 to −0.7) | <0.001 |
| Days per week with bloating | −0.7 (−1.1 to −0.3) | 0.002 | −0.7 (−1.1 to −0.3) | 0.002 |
| Pain score (0–3) None (0), mild (1), moderate (2) or severe (3) | −0.10 (−0.22 to 0.03) | 0.119 | −0.10 (−0.23 to 0.02) | 0.103 |
| Urgency score(0–3) None (0), mild (1), moderate (2) or severe (3) | −0.32 (−0.45 to −0.18) | <0.001 | −0.33 (−0.47 to −0.19) | <0.001 |
| Bloating score(0–3) None (0), mild (1), moderate (2) or severe (3) | −0.13 (−0.27 to 0.01) | 0.070 | −0.12 (−0.26 to 0.02) | 0.103 |
| Stool frequency reduction, % | 11 (4 to 18) | 0.001 | 11 (4 to 18) | 0.002 |
| Whole gut transit time increase*, h | 10 (6 to 14) | <0.001 | 10 (6 to 14) | <0.001 |
| Right colon transit time increase, h | 2 (0 to 4) | 0.064 | 2 (0 to 4) | 0.082 |
| Left colon transit time increase, h | 6 (3 to 8) | <0.001 | 5 (3 to 8) | <0.001 |
Differences between ondansetron and placebo are presented.
*Numbers of patients available for analysis are 87/98 (89%) for ITT and 81/90 (90%) for PPA analysis. Lower numbers reflect patients who failed to take their markers or attend for the final X-ray.
ITT, intention-to-treat; PPA, per protocol analysis.