Table 4.
Comparison of the treatment effect between CCH1 and lactulose.
| Variables | Group, mean (95% CI) | ||
|---|---|---|---|
| CCH1 (n = 44) | Lactulose (n = 49) | Adjusted P ‡ | |
| Frequency of spontaneous bowel movement (SBM/wk)§ | |||
| Baseline (weeks −2~0) | 2.7 (1.9, 3.4) | 2.6 (2.0, 3.2) | 0.907 |
| Treatment (weeks 1~4) | 6.9† (6.1, 7.6) | 4.5† (3.5, 5.4) | <0.001 |
| Treatment (weeks 5~8) | 6.8† (6.0, 7.7) | 5.5† (4.5, 6.6) | 0.159 |
| Follow-up (weeks 9~12) | 3.7* (3.1, 4.4) | 5.2† (4.0, 6.4) | 0.084 |
| Frequency of rectal treatment (RT/wk)|| | |||
| Baseline (weeks −2~0) | 1.4 (1.1, 1.8) | 1.4 (1.1, 1.7) | 0.958 |
| Treatment (weeks 1~4) | 0.5† (0.4, 0.7) | 0.9† (0.7, 1.2) | 0.030 |
| Treatment (weeks 5~8) | 0.3† (0.2, 0.5) | 0.6† (0.4, 0.8) | 0.051 |
| Followup (weeks 9~12) | 1.0* (0.8, 1.3) | 0.8† (0.5, 1.1) | 0.561 |
| Amount of rescue laxative use (MgO/wk) | |||
| Baseline (weeks −2~0) | 0 (0, 0) | 0.4 (−0.1,0.8) | 0.083 |
| Treatment (weeks 1~4) | 0.2 (−0.1, 0.5) | 2.4* (1.1, 3.8) | 0.005 |
| Treatment (weeks 5~8) | 1.7 (−0.4, 3.9) | 10.4† (6.1, 14.7) | 0.002 |
| Followup (weeks 9~12) | 19.1† (14.9, 23.2) | 20.0† (14.5, 25.4) | 1.000 |
| Laxative cost (USD/wk)¶ | |||
| Treatment (weeks 1~4) | 1.4 (1.2, 1.5) | 4.7 (4.2, 5.2) | <0.001 |
| Treatment (weeks 5~8) | 1.5 (1.3, 1.7) | 5.0 (4.4, 5.7) | <0.001 |
Pairwise comparisons were performed for each treatment group with its baseline.
*P < 0.01; † P < 0.001.
‡ P value was adjusted by Bonferroni adjustment.
§SBM (spontaneous bowel movement) defined as stool passage without digital maneuver and without the use of suppository or enema on the same day.
||RT (rectal treatment) including enema, suppository use, or digital maneuver.
¶Laxative cost including the acquisition costs of study medication and rescue laxative.