|
Symptoms
|
Baseline
|
At the end of treatment
|
|---|
|
α-galactosidase
|
Placebo
|
p-value
|
α-galactosidase
|
Placebo
|
p-value
|
|---|
|
(N = 27)
|
(N = 25)
|
(N = 27)
|
(N = 25)
|
|---|
|
Flatulence*: n, (%)
|
16 (59%)
|
12 (48%)
|
p = 0.42
|
5 (19%)
|
12 (48%)
|
p = 0.02^
|
|
Abdominal distension**: n, (%)
|
12 (44%)
|
14 (56%)
|
p = 0.41
|
8 (30%)
|
11 (44%)
|
p = 0.36
|
|
Abdominal spasm***: n, (%)
|
14 (52%)
|
14 (56%)
|
p = 0.76
|
4 (15%)
|
4 (16%)
|
p = 0.91
|
|
FPS-R†, mean ± SD
|
2.8 ± 1.8
|
2.3 ± 0.9
|
p = 0.22
|
2.0 ± 1.7
|
2.1 ± 1.1
|
p = 0.73
|
|
Difference between FPS-R at baseline and after treatment
| | | |
−0.8 ± 1.1
|
−0.2 ± 0.8
|
p = 0.02^
|
|
Number of days with severe bloating during treatment (mean ± SD)
| | | |
3.4 ± 3.6
|
5.4 ± 3.4
|
p = 0.03^
|
- *patients with significant episodes (score of > 2) of flatulence ≥ 3 days/week.
- **patients with visible abnormal distension ≥ 3 days/week.
- ***patients with abdominal spasm ≥ 3 days/week.
-
†mean of 21 measurements for each patient.
- ^p value < 0.05 was considered statistically significant.
