Effects of Carboxymethylcellulose and CSP01 on Bowel Symptoms, Patients Completing Study
| Variables | Placebo (n = 9) | Carboxymethylcellulose (n = 11) | CSP01 (n = 19) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Post-Tx | Baseline | Post-Tx | Baseline | Post-Tx | ||||
| Stool frequency per day | 0.8 ± 0.4 | 0.9 ± 0.6 | 0.7 ± 0.4 | 0.8 ± 0.4 | 0.8 ± 0.3 | 1.0 ± 0.4 | 0.641 | ||
| Stool consistency per BM (BSFS 1-7) | 2.6 ± 1.1 | 2.7 ± 1.4 | 3.1 ± 1.1 | 3.6 ± 1.6 | 3.0 ± 1.2 | 3.8 ± 0.9 | 0.509 | ||
| Ease of passage scale per BM (1-7) | 3.9 ± 0.7 | 3.9 ± 0.6 | 3.5 ± 0.5 | 3.6 ± 0.6 | 3.6 ± 0.6 | 3.8 ± 0.4 | 0.098 | ||
| Number of CSBMs/day | 0.2 ± 0.3 | 0.3 ± 0.3 | 0.2 ± 0.2 | 0.3 ± 0.2 | 0.2 ± 0.2 | 0.3 ± 0.3 | 0.896 | ||
| Daily constipation severity (1-10) |
4.2 ± 2.5 | 3.9 ± 2.5 | 4.0 ± 1.3 | 3.3 ± 1.2 | 4.1 ± 2.1 | 3.5 ± 1.8 | 0.586 | ||
| Daily abdominal discomfort severity (1-10) |
3.8 ± 2.2 | 3.6 ± 2.6 | 3.6 ± 1.4 | 3.1 ± 1.4 | 3.9 ± 1.8 | 3.7 ± 1.9 | 0.796 | ||
| Daily bloating severity (1-10) |
4.7 ± 2.5 | 4.0 ± 2.8 | 4.4 ± 1.4 | 3.9 ± 1.2 | 4.4 ± 2.2 | 4.2 ± 2.2 | 0.443 | ||
| PAC-SYM |
15.3 ± 7.1 | 13.0 ± 8.0 | 17.5 ± 4.6 | 10.5 ± 4.8 | 18.0 ± 8.2 | 12.2 ± 7.3 | 0.422 | ||
| PAC-QOL |
30.9 ± 14.1 | 28.6 ± 16.1 | 31.4 ± 6.0 | 21.0 ± 4.1 | 39.7 ± 16.6 | 27.7 ± 18.4 | 0.161 | ||
a
bHigher values indicate increased severity of symptoms.
cHigher values indicate lower quality of life.
Tx, treatment; BM, bowel movement; BSFS, Bristol Stool Form Scale; CSBMs, complete spontaneous bowel movements; PAC-SYM, Patient Assessment of Constipation–Symptoms; PAC-QOL, Patient Assessment of Constipation–Quality of Life.
One patient in the placebo-treated irritable bowel syndrome with constipation group did not have a second wireless motility capsule colonic transit time because of a technical malfunction but did complete the symptom diary and was included in this analysis.