TABLE 2.
Overview of Results
| 1 mo | 4 mo | 6 mo | 12 mo | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E (N=50) | C (N=54) | E (N=50) | C (N=54) | Statistics | E (N=50) | C (N=54) | Statistics | E (N=50) | C (N=54) | Statistics | |||||||
| Primary Outcome* | — | Proportion (%) | Adjusted Proportion Difference | Wald CI | P | Proportion (%) | Adjusted Proportion Difference | Wald CI | P | Proportion (%) | Adjusted Proportion Difference | Wald CI | P | ||||
| LARS category improvement | — | — | 38.30 | 19.61 | −0.2040 | −0.365; −0.042 | 0.0415 | 47.83 | 21.28 | −0.2630 | −0.042; −0.105 | 0.0091 | 40.00 | 34.88 | −0.1000 | −0.273; 0.074 | 0.3897 |
| Secondary outcomes † | Mean (SD) | Mean (SD) | Value | Standard Error | P | Mean (SD) | Value | Standard Error | P | Mean (SD) | Value | Standard Error | P | ||||
| LARS score | 36.20 (5.70) | 37.20 (4.42) | 29.9 (8.09) | 33.80 (7.70) | −3.1340 | 1.5888 | 0.0496 | 26.80 (10.30) | 30.60 (8.89) | −3.3765 | 1.8174 | 0.0643 | 29.40 (9.69) | 29.70 (9.09) | 0.1836 | 1.9579 | 0.9254 |
| COREFO score | 45.10 (19.40) | 45.30 (18.90) | 31.1 (17.00) | 36.30 (18.40) | −5.3905 | 2.5699 | 0.0369 | 28.40 (17.80) | 29.00 (15.80) | −1.0715 | 2.5962 | 0.6801 | 27.10 (16.90) | 28.20 (15.10) | −1.1730 | 2.7912 | 0.6746 |
| NRS | 5.50 (2.80) | 6.06 (2.61) | 4.21 (2.42) | 4.96 (2.80) | −0.2449 | 0.4919 | 0.6190 | 4.00 (2.32) | 3.96 (2.69) | 0.5335 | 0.4928 | 0.2800 | 4.04 (2.70) | 4.00 (2.29) | 0.6364 | 0.6294 | 0.3129 |
| BM/24 h‡ | 6.81 (3.85) | 6.16 (3.33) | 3.97 (2.39) | 5.12 (4.10) | −1.6624 | 0.7503 | 0.0277 | 4.08 (2.37) | 4.76 (3.98) | −1.0709 | 0.7256 | 0.1414 | 3.83 (2.20) | 4.06 (3.02) | −0.9298 | 0.7699 | 0.2284 |
| BM during day‡ | 6.01 (4.03) | 5.04 (2.96) | 3.51 (2.32) | 4.11 (3.70) | −1.3622 | 0.7282 | 0.0627 | 3.64 (2.41) | 3.93 (3.17) | −1.0811 | 0.7205 | 0.1349 | 2.95 (1.84) | 3.28 (1.83) | −1.3320 | 0.6837 | 0.0526 |
| BM during night‡ | 0.77 (0.93) | 0.72 (0.66) | 0.41 (0.68) | 0.67 (0.86) | −0.3158 | 0.1909 | 0.0994 | 0.33 (0.43) | 0.60 (1.10) | −0.2606 | 0.1971 | 0.1875 | 0.41 (0.62) | 0.33 (0.46) | −0.0241 | 0.1998 | 0.9040 |
| SL/24 h‡ | 2.02 (3.15) | 1.55 (2.88) | 0.36 (0.84) | 0.83 (2.11) | −0.9447 | 0.5651 | 0.0959 | 0.54 (1.30) | 0.35 (0.61) | −0.4342 | 0.5186 | 0.4034 | 0.24 (0.42) | 0.27 (0.54) | −0.5676 | 0.5531 | 0.3059 |
| Liquid SL during day‡ | 0.79 (1.82) | 0.64 (1.67) | 0.09 (0.22) | 0.32 (1.28) | −0.3760 | 0.3710 | 0.3119 | 0.26 (1.00) | 0.13 (0.33) | −0.0783 | 0.3488 | 0.8226 | 0.04 (0.11) | 0.11 (0.27) | −0.2918 | 0.3386 | 0.3897 |
| Solid SL during day‡ | 0.80 (1.53) | 0.41 (0.83) | 0.17 (0.54) | 0.37 (0.80) | −0.5854 | 0.2579 | 0.0241 | 0.16 (0.49) | 0.11 (0.36) | −0.3910 | 0.2592 | 0.1327 | 0.09 (0.23) | 0.10 (0.27) | −0.4155 | 0.2472 | 0.0941 |
| Liquid SL during night‡ | 0.17 (0.45) | 0.11 (0.36) | 0.02 (0.07) | 0.02 (0.11) | −0.0559 | 0.0835 | 0.5037 | 0.03 (0.10) | 0.05 (0.12) | −0.0638 | 0.0848 | 0.4522 | 0.03 (0.12) | 0.01 (0.05) | −0.0565 | 0.0846 | 0.5051 |
| Solid SL during night‡ | 0.21 (0.53) | 0.06 (0.18) | 0.06 (0.30) | 0.10 (0.31) | −3.1340 | 1.5888 | 0.0496 | 0.08 (0.32) | 0.02 (0.09) | −3.3765 | 1.8174 | 0.0643 | 0.08 (0.25) | 0.01 (0.09) | 0.1836 | 1.9579 | 0.9254 |
| Clusters/day§ | 1.01 (1.4) | 0.92 (1.13) | 0.55 (0.90) | 0.85 (1.26) | −5.3905 | 2.5699 | 0.0369 | 0.47 (0.71) | 0.63 (0.76) | −1.0715 | 2.5962 | 0.6801 | 0.50 (0.70) | 0.57 (0.65) | −1.1730 | 2.7912 | 0.6746 |
| Urgency episodes/day§ | 3.08 (3.46) | 2.85 (3.05) | 0.86 (1.65) | 1.45 (1.73) | −0.2449 | 0.4919 | 0.6190 | 0.91 (1.68) | 1.13 (1.71) | 0.5335 | 0.4928 | 0.2800 | 0.86 (1.76) | 1.06 (1.46) | 0.6364 | 0.6294 | 0.3129 |
| SF-12, PCS | 33.80 (4.32) | 33.4 (3.63) | 31.70 (3.88) | 33.10 (3.76) | −1.7625 | 0.9471 | 0.0639 | 32.60 (3.50) | 32.20 (3.44) | 0.0776 | 0.8622 | 0.9284 | 32.50 (3.33) | 33.50 (3.78) | −1.6075 | 0.9298 | 0.0850 |
| SF-12, MCS | 28.00 (4.55) | 27.8 (4.48) | 27.50 (4.60) | 27.20 (3.96) | 0.0346 | 1.0086 | 0.9727 | 27.10 (4.53) | 26.60 (3.94) | 0.3599 | 0.9893 | 0.7163 | 27.60 (4.32) | 27.40 (4.34) | 0.5113 | 1.0286 | 0.6195 |
Bold values indicate statistically significant P < 0.005.
*
Cochran-Mantel-Haenzel.
†
Linear mixed-effect models.
‡
Average frequency.
§
Average number.
C indicates control; E, experimental; BM, bowel movements; CI, confidence interval; MCS, Mental Component Score; PCS, Physical Component Score; SL, stool leakage.