Table 1. Baseline Characteristics of Study Population.
| Characteristics | HN019 group (n = 112) | Placebo group (n = 117) |
|---|---|---|
| Age, mean (SD), y | 46.0 (10.2) | 44.1(10.2) |
| Age group, No. (%) | ||
| ≤45 y | 54 (48.2) | 66 (56.4) |
| >45 y | 58 (51.8) | 51 (43.6) |
| Sex, No. (%) | ||
| Female | 97 (86.6) | 97 (82.9) |
| Male | 15 (13.4) | 20 (17.1) |
| BMI | ||
| Mean (SD) | 22.8 (2.6) | 22.8 (2.4) |
| Range | 18.5-29.7 | 18.7-28.9 |
| Smoking status, No. (%) | ||
| Ever | 1 (0.9) | 2 (1.7) |
| Never | 111 (99.1) | 115 (98.3) |
| Stool frequency, mean (SD) | ||
| CSBM/wk | 0.73 (0.98) | 0.81 (1.03) |
| SBM/wk | 2.53 (1.46) | 2.51 (1.34) |
| BM/wk | 2.57 (1.44) | 2.54 (1.34) |
| Stool consistency, mean (SD) BSS scorea | 3.2 (1.1) | 3.1 (1.1) |
| Gut symptoms, mean (SD) VAS score, mmb | ||
| Abdominal pain | 4.8 (7.5) | 4.8 (8.8) |
| Degree of straining | 49.3 (24.9) | 51.0 (24.6) |
| Bloating | 10.8 (15.1) | 10.0 (12.2) |
| PAC-SYM, total scorec | 0.8 (0.5) | 0.8 (0.5) |
| PAC-QoL, total scorec | 1.3 (0.6) | 1.2 (0.6) |
| Use of rescue medication, No. (%) | ||
| Yes | 5 (4.5) | 5 (4.3) |
| No | 107 (95.5) | 112 (95.7) |
Abbreviations: BMI, body mass index (calculated as the weight in kilograms divided by the height in meters squared); BM, bowel movement; BSS, Bristol Stool Scale; CSBM, complete spontaneous BM; PAC-QoL, Patient Assessment of Constipation–Quality of Life; PAC-SYM, Patient Assessment of Constipation–Symptoms; SBM, spontaneous BM; VAS, visual analogue scale.
a
Scores range from 1 (separate hard lumps) to 7 (watery), with 3 to 5 indicating optimal.
b
Scores range from 0 to 100 mm, with greater scores indicating more severe symptoms.
c
Scores range from 0 (absent) to 4 (severe).