Table 3.
Baseline characteristics of the patients (Safety Set).
| SRS + OB (n = 20) |
SRS + P-OB (n = 20) |
P-SRS + OB (n = 20) |
P-SRS + P-OB (n = 20) |
p-Value | |
|---|---|---|---|---|---|
| Age (year; mean; SD) | 42.90 (15.13) | 38.05 (15.27) | 41.65 (14.26) | 45.20 (13.56) | 0.392 a |
| Sex (n, %) | |||||
| Male | 17 (85.00) | 16 (80.00) | 16 (80.00) | 11 (55.00) | 0.118 b |
| Female | 3 (15.00) | 4 (20.00) | 4 (20.00) | 9 (45.00) | |
| Height (cm; mean; SD) | 170.55 (7.39) | 169.70 (5.96) | 170.50 (5.12) | 166.80 (9.42) | 0.308 c |
| Weight (Kg; mean; SD) | 72.80 (11.54) | 67.70 (13.79) | 69.00 (8.99) | 69.30 (15.02) | 0.615 c |
| BMI (kg/m2; mean; SD) | 25.06 (3.97) | 23.35 (3.75) | 23.72 (2.62) | 24.70 (3.55) | 0.604 a |
| Period of disease (year; mean; SD) | 12.58 (10.59) | 9.37 (7.05) | 11.45 (9.16) | 9.28 (11.57) | 0.263 c |
| History | |||||
| Surgical history (yes; n; %) | 9 (45.00) | 3 (15.00) | 7 (35.00) | 8 (40.00) | 0.200 a |
| Other diseases (yes; n; %) | 13 (65.00) | 7 (35.00) | 9 (45.00) | 11 (55.00) | 0.262 a |
| Prior medications (yes; n; %) | 7 (35.00) | 5 (25.00) | 5 (25.00) | 6 (30.00) | 0.880 a |
| CM (yes; n; %) | 12 (60.00) | 9 (45.00) | 8 (40.00) | 12 (60.00) | 0.466 a |
a: Kruskal-Wallis test, b: Chi-square test, c: A one-way analysis of variance (ANOVA) test. SRS = Samryungbaekchul-san; OB = otilonium bromide; P = placebo; SD = standard deviation; BMI = body mass index; CM = concomitant medication use, which did not affect the trial.