Table 4.
Outcome results (ITT analysis).
| SRS + OB (n = 20) |
SRS + P-OB (n = 19) |
P-SRS + OB (n = 19) |
P-SRS + P-OB (n = 17) |
p-Value | |
|---|---|---|---|---|---|
| Primary Outcome: | |||||
| Degree of symptom improvement | |||||
| Week 8 | 1.67 ± 0.84 | 1.53 ± 0.62 | 1.76 ± 0.83 | 1.56 ± 0.51 | 0.867 * |
| Week 12 | 1.61 ± 0.61 | 1.59 ± 0.71 | 1.94 ± 0.66 | 1.87 ± 0.64 | 0.265 * |
| Symptoms relief rate(improved, n, %) |
|||||
| Week 8 | 8 (44.44) | 9 (52.94) | 8 (47.06) | 7 (43.75) | 0.949 † |
| Week 12 | 8 (44.44) | 9 (52.94) | 4 (23.53) | 4 (26.67) | 0.233 † |
|
Secondary Outcomes (Severity of D-IBS Symptoms): |
|||||
| Abdominal Pain | |||||
| Week 8 | −2.89 ± 1.84 | −2.71 ± 2.34 | −2.00 ± 2.60 | −1.94 ± 1.57 | 0.454 ‡ |
| Week 12 | −2.94 ± 2.34 a | −2.88 ± 2.39 a | −1.53 ± 1.50 a,b | −1.13 ± 2.07 b | 0.030 ‡ |
| Abdominal Discomfort | |||||
| Week 8 | −3.72 ± 1.87 a | −3.00 ± 1.54 a | −2.53 ± 2.35 a,b | −1.25 ± 2.02 b | 0.005 ‡ |
| Week 12 | −3.67 ± 2.11 a | −3.76 ± 1.82 a | −2.35 ± 1.66 b | −1.00 ± 1.85 c | < 0.001 ‡ |
| Satisfaction of Defecation | |||||
| Week 8 | −2.67 ± 3.05 | −2.94 ± 1.71 | −2.71 ± 2.69 | −3.25 ± 2.32 | 0.954 * |
| Week 12 | −3.33 ± 2.47 | −3.65 ± 2.00 | −2.47 ± 2.50 | −2.40 ± 2.13 | 0.310 ‡ |
| Quality of Life | |||||
| Week 8 | −3.17 ± 2.28 | −2.71 ± 2.37 | −2.65 ± 3.06 | −2.44 ± 2.03 | 0.941 * |
| Week 12 | −3.17 ± 2.18 | −3.47 ± 2.70 | −2.35 ± 2.29 | −1.80 ± 2.43 | 0.325 * |
| Frequency of Abdominal Pain | |||||
| Week 8 | −3.33 ± 2.11 | −3.00 ± 1.84 | −2.41 ± 2.79 | −2.38 ± 2.25 | 0.539 ‡ |
| Week 12 | −3.56 ± 2.01 d | −3.24 ± 2.46 d, e | −1.82 ± 1.42 e | −1.33 ± 2.44 e | 0.005 * |
| Frequency of Defecation | |||||
| Week 8 | −0.86 ± 1.23 | −0.76 ± 0.90 | −0.53 ± 0.70 | −.84 ± 0.85 | 0.723 ‡ |
| Week 12 | −0.89 ± 1.22 | −0.85 ± 1.20 | −0.59 ± 0.69 | −0.80 ± 1.01 | 0.706 * |
| Bristol Stool Form Scale | |||||
| Week 8 | −0.94 ± 1.06 | −1.35 ± 0.79 | −1.24 ± 0.90 | −1.44 ± 0.51 | 0.185 * |
| Week 12 | −1.33 ± 0.59 d | −1.41 ± 0.94 d | −0.65 ± 0.61 d | −0.80 ± 0.68 d, e | 0.003 * |
| Force used for Defecation | |||||
| Week 8 | −0.06 ± 0.24 | 0.00 ± 0.00 | 0.00 ± 0.35 | −0.06 ± 0.25 | 0.803 * |
| Week 12 | −0.06 ± 0.24 | −0.00 ± 0.00 | −0.06 ± 0.24 | −0.07 ± 0.26 | 0.783 * |
1. Values are mean ± standard deviation (SD), except symptoms relief rate. 2. The results reported as negative numbers indicate a decrease from the baseline. 3. The same letters indicate non-significant difference between the groups: (1) a,b,c: Duncan multiple range test; (2) d,e: Dwass-Steel-Critchlow-Fligner Method. 4. The statistical methods according to each symbol were used as follows: (1) *: Kruskal-Wallis test; (2) †: Chi-square test; (3) ‡: A one-way analysis of variance (ANOVA) test. ITT = intent-to-treat; SRS = Samryungbaekchul-san; OB = otilonium bromide; P = placebo; D-IBS = diarrhea-predominant irritable bowel syndrome.