Table 3.
Demographics, psychological assessments, stool diary results and markers of serotonin turnover in patients subdivided into those who met FDA “stool form responder” criteria and those who did not
| Variable | Stool form responder (n = 82) | Stool form nonresponder (n = 25) | P value |
|---|---|---|---|
| Age | 40 (12) | 45 (11) | .0539 |
| Sex (female), n (%) | 61 (74) | 16 (64) | .446 |
| Hospital Anxiety and Depression Scale | 14.7 (7.0) | 17.8 (8.3) | .0774 |
| Patient Health Questionnaire 12 | 7.4 (3.4) | 8.2 (3.9) | .3189 |
| Placebo whole gut transit (hours), median (IQR) | 18 (9‐31) | 10 (6.3‐24.8) | .0625 |
| Baseline days with abdominal pain, median (IQR) | 5 (3‐7) | 7 (5‐7) | .0175 |
| Baseline average abdominal pain score | 1.2 (0.7) | 1.8 (0.8) | .0023 |
| Baseline days with urgency, median (IQR) | 6 (4.8‐7) | 7 (6.5‐7) | .0014 |
| Baseline average urgency score, median (IQR) | 1.4 (1‐2) | 2.4 (1.6‐2.6) | <.0001 |
| Baseline days with bloating, median (IQR) | 6 (3‐7) | 6 (3.5‐7) | .498 |
| Baseline average bloating score | 1.3 (0.8) | 1.4 (0.9) | .4438 |
| Baseline average stool form | 5.3 (0.7) | 5.5 (0.8) | .2498 |
| Baseline average stool frequency, median (IQR) | 2.6 (1.9‐3.9) | 2.9 (1.9‐3.9) | .7266 |
| Biopsy 5‐HT (pmol/mg protein), median (IQR)a | 28.6 (18.3‐42) | 44.3 (25.5‐65.7) | .0642 |
| Biopsy 5‐HIAA (pmol/mg protein), median (IQR)a | 2.1 (1‐4.1) | 1.6 (1‐4) | .6567 |
| Biopsy 5‐HIAA /5‐HT, median (IQR)a | 0.06 (0.03‐0.20) | 0.03 (0.02‐0.08) | .2731 |
| Plasma 5‐HIAA (nmol/l), median (IQR)b | 16.5 (13.1‐19.8) | 16.3 (12.7‐18) | .7022 |
Data are mean (SD) unless stated. P values obtained from unpaired t tests and Mann‐Whitney tests for parametric and nonparametric data respectively.
Abbreviations: 5‐HT, serotonin; 5‐HIAA, 5‐Hydroxyindoleacetic acid.
a
Numbers in each group: n = 40 stool form responder; n = 9 stool form nonresponder.
b
Numbers in each group: n = 53 stool form responder; n = 10 stool form nonresponder.