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Table 2 Rates of symptoms and Global Distress assessed by FPS-R at baseline and after treatment

From: Efficacy and tolerability of α-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial

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^

  1. *patients with significant episodes (score of > 2) of flatulence ≥ 3 days/week.
  2. **patients with visible abnormal distension ≥ 3 days/week.
  3. ***patients with abdominal spasm ≥ 3 days/week.
  4. mean of 21 measurements for each patient.
  5. ^p value < 0.05 was considered statistically significant.