Table 2 |
||||||
Rates of symptoms and Global Distress assessed by FPS-R at baseline and after treatment | ||||||
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.
Di Nardo et al.
Di Nardo et al. BMC Gastroenterology 2013 13:142 doi:10.1186/1471-230X-13-142