Background
Methods
Patients and study procedures
a. Rome III diagnostic criteria for functional constipation [22] | |
1. Must include* two or more of the following: - Straining during at least 25% of defecations - Lumpy or hard stools in at least 25% of defecations - Sensation of incomplete evacuation for at least 25% of defecations - Sensation of anorectal obstruction/blockage for at least 25% of defecations - Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) - Fewer than three defecations per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome *criteria fulfilled for the last 3 months. | |
b. Likert scale for the subjective evaluation of constipation [23] | |
0. Absent 1. Mild 2. Moderate 3. Severe 4. Very severe |
Explorative analysis of the OCTT
Statistical analysis
Results
Variable | Patients with SSc (n = 29) | Arm 1 (drug first, n = 16) | Arm 2 (drug after, n = 13) |
---|---|---|---|
Age, years | 54.4 ± 10.5 | 59 ± 9.2 | 48.8 ± 9.5* |
Disease duration, years | 12.3 ± 8.7 | 13.7 ± 9.9 | 10.7 ± 7.1 |
lcSSc, n (%) | 22 (75.8) | 12 (75%) | 10 (79.6) |
Autoantibody, n (%) | |||
ANA ACA Topo I | 27 (93.1) 18 (62.1) 9 (31) | 15 (93.7) 11 (68.8) 4 (25) | 12 (92.7) 7 (53.8) 5 (38.5) |
Likert GERD (0–4) | 2.24 ± 0.74 | 2.25 ± 0.68 | 2.23 ± 0.83 |
Likert constipation (0–4) | 2.24 ± 0.64 | 2.44 ± 0.63 | 2 ± 0.58 |
UCLA GIT 2.0 | 0.99 ± 1.,28 | 1.23 ± 1.65 | 0.69 ± 0.49 |
UCLA GIT 2.0 constipation | 1.27 ± 0.67 | 1.31 ± 0.68 | 1.21 ± 0.68 |
UCLA GIT 2.0 subscales | |||
Reflux Bloating Fecal soilage Diarrhea Social activities Emotional wellbeing | 1.01 ± 0.69 1.48 ± 0.9 0.51 ± 0.91 0.22 ± 0.41 0.72 ± 0.59 0.77 ± 0.78 | 1 ± 0.76 1.5 ± 0.97 0.61 ± 1.02 0.34 ± 0.47 0.83 ± 0.68 0.86 ± 0.85 | 1.02 ± 0.63 1.46 ± 0.85 0.38 ± 0.77 0.08 ± 0.28 0.59 ± 0.44 0.67 ± 0.71 |
Prucalopride improves the number of CSBMs and ameliorates constipation in patients with SSc
Variable | Change with prucalopridea
| Change without treatmenta
| Effect sizea
| Ratingb
|
p
|
---|---|---|---|---|---|
Likert GERD | -0.678 ± 0.108 | -0.001 ± 0.114 | -0.677 | NA | 7.8*10-5
|
Likert constipation | -1.282 ± 0.155 | 0.135 ± 0.158 | -1.417 | NA | 2.01*10-7
|
UCLA GIT 2.0 | -0.147 ± 0.061 | 0.021 ± 0.063 | -0.168 | Same | 0.047 |
UCLA GIT 2.0 Constipation | -0.672 ± 0.112 | 0.086 ± 0.115 | -0.758 | Much better | 5.4*10-5
|
UCLA GIT 2.0 Subscales | |||||
Reflux Bloating Fecal soilage Diarrhea Social activities Emotional wellbeing | -0.409 ± 0.094 -0.418 ± 0.088 -0.097 ± 0.133 0.367 ± 0.093 -0.106 ± 0.11 -0.214 ± 0.093 | 0.01 ± 0.096 -0.084 ± 0.09 0.074 ± 0.141 0.089 ± 0.097 -0.006 ± 0.112 0.017 ± 0.093 | -0.419 -0.334 -0.171 0.277 -0.1 -0.231 | Better Better Same Worse Better Same | 0.003 0.011 0.38 0.053 0.503 0.051 |