
Study Outcomes
Treatment outcomes | Analysis | Lactulose (n = 69) |
Combination (n = 68) |
||||
---|---|---|---|---|---|---|---|
Lactulose vs Combination |
Lactulose vs |
Combination vs |
|||||
Treatment success rates at each visit | |||||||
Week 12 | ITT | 18/69 (26.1) | 28/68 (41.2) | 4/50 (8.0) | 0.086 | 0.019 | < 0.001 |
Week 6 | ITT | 40/69 (58.0) | 36/68 (52.9) | 12/50 (24.0) | 0.576 | < 0.001 | < 0.001 |
Week 2 | ITT | 39/69 (56.5) | 42/68 (61.8) | 19/50 (38.0) | 0.799 | 0.087 | 0.018 |
PP | 39/60 (65.0) | 42/61 (68.9) | 19/37 (51.4) | 0.702 | 0.206 | 0.091 | |
Clinical outcomes at week 2 | Lactulose(n = 60) | Combination(n = 61) | |||||
Stool frequency/week | PP | 4.05 ± 2.49 | 4.57 ± 2.91 | 3.69 ± 2.60 | 0.264 | ||
Incontinency/week | PP | 0.53 ± 1.69 | 0.56 ± 1.66 | 0.96 ± 3.63 | 0.627 | ||
Stool consistency | PP | 3.38 ± 1.23 | 3.54 ± 1.32 | 2.92 ± 1.04 | 0.051 | ||
Painful defecations/week | PP | 0.48 ± 0.5 | 0.64 ± 0.97 | 0.68 ± 0.75 | 0.359 | ||
Follow-up loss rate | ITT | 9/69 (13.0) | 7/68 (10.3) | 13/50 (26.0) | 0.616 | 0.072 | 0.025 |
Drug change rate during study period | ITT | 3/69 (4.3) | 7/68 (10.3) | 23/50 (46.0) | 0.511 | < 0.001 | < 0.001 |
Values are shown as n (%) or mean ± SD.