Table 2. Demographic and Baseline Characteristics of Patients Who Responded to Placeboa.
| Characteristic | Response to placebo, No. (%) | |
|---|---|---|
| Yes (n = 14) | No (n = 16) | |
| Age, mean (SD), y | 13.8 (0.9) | 14.3 (0.8) |
| Female | 12 (85.7) | 12 (75.0) |
| Diagnosis | ||
| Functional abdominal pain | 7 (50.0) | 9 (56.3) |
| Irritable bowel syndrome | 7 (50.0) | 7 (43.8) |
| Duration of symptoms, mean (SD), y | 2.4 (0.6) | 3.9 (0.8) |
| Pain intensity at baseline, mean (SD) | 46.8 (3.4) | 44.9 (4.4) |
| FDI score, mean (SD) | 10.9 (2.2) | 8.8 (1.5) |
| Moderate or severe disability | 5 (35.7) | 4 (25.0) |
| Anxiety | 4 (28.6) | 9 (56.3) |
| PedsQL score, mean (SD) | 56.2 (2.7) | 57.2 (2.0) |
| PedsQL GI score, mean (SD) | 72.7 (3.3) | 75.0 (1.8) |
| CDI score, mean (SD) | 11.4 (1.9) | 11.1 (1.8) |
| CSI score, mean (SD) | 25.6 (3.3) | 26.6 (3.9) |
| CBT | 6 (42.9) | 5 (31.3) |
| No. of medications, mean (SD) | 2.6 (0.6) | 3.2 (0.6) |
| Neuromodulation | 3 (21.4) | 5 (31.3) |
| Use of hyoscyamine before the trial | 4 (28.6) | 6 (37.5) |
| Expectation that placebo will work | 13 (92.9) | 10 (62.5) |
Abbreviations: CBT, cognitive behavioral therapy; CDI, Children’s Depression Inventory; CSI, Children’s Somatization Inventory; FDI, Functional Disability Inventory; PedsQL, Pediatric Quality of Life Inventory; PedsQL GI, Pediatric Quality of Life Inventory Gastrointestinal Symptom Module.
a
There were no clinically meaningful differences when comparing both groups. There was a tendency for those who did not respond to placebo to have more anxiety (P = .07).