Parameter | WThE | Placebo | Delta change | p-value1 | |||||||||
Baseline | 4 weeks | Baseline | 4 weeks | WThE | Placebo | ||||||||
Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | ||
Gastrointestinal symptoms | |||||||||||||
Stagnant gas/bloated abdomen | 1.84 | 1.31 - 2.36 | 0.99 | 0.60 - 1.38 | 1.81 | 1.41 - 2.21 | 1.10 | 0.85 - 1.36 | −0.84 | −1.30; −0.39 | −0.71 | −1.05; −0.36 | 0.6091 |
Gas leakage/flatulence | 1.78 | 1.26 - 2.30 | 1.13 | 0.81 - 1.46 | 1.79 | 1.36 - 2.23 | 1.27 | 0.87 - 1.66 | −0.65 | −1.03; −0.26 | −0.53 | −0.86; −0.19 | 0.0946t |
Feeling of fullness/tightness due to constipation | 1.56 | 0.98 - 2.14 | 0.78 | 0.41 - 1.14 | 1.76 | 1.37 - 2.15 | 1.28 | 0.91 - 1.65 | −0.79 | −1.20; −0.37 | −0.48 | −0.84; −0.13 | 0.2503 |
Grumbling in the gastrointestinal tract | 1.43 | 0.92 - 1.94 | 0.69 | 0.33 - 1.04 | 1.10 | 0.66 - 1.53 | 0.72 | 0.42 - 1.03 | −0.75 | −1.20; −0.29 | −0.37 | −0.74; 0.00 | 0.1851 |
Abdominal discomfort/pain | 0.98 | 0.58 - 1.39 | 0.39 | 0.09 - 0.69 | 1.12 | 0.78 - 1.46 | 0.69 | 0.34 - 1.05 | −0.60 | −0.98; −0.21 | −0.43 | −0.75; −0.10 | 0.4849 |
Mean gastrointestinal score | 1.52 | 1.07 - 1.97 | 0.80 | 0.52 - 1.07 | 1.52 | 1.18 - 1.85 | 1.01 | 0.75 - 1.28 | −0.72 | −1.09; −0.36 | −0.50 | −0.76; −0.25 | 0.2972 |
Feeling of incomplete emptying | 1.61 | 1.05 - 2.17 | 1.12 | 0.67 - 1.58 | 1.59 | 1.18 - 1.99 | 1.17 | 0.85 - 1.50 | −0.48 | −0.87; −0.10 | −0.41 | −0.79; −0.04 | 0.8816 |
GSRS questionnaire | |||||||||||||
Diarrhea | 1.54 | 1.18 - 1.91 | 1.41 | 1.06 - 1.76 | 1.51 | 1.22 - 1.80 | 1.68 | 1.33 - 2.03 | −0.14 | −0.51; −0.24 | 0.18 | −0.16; −0.52 | 0.1199 |
Indigestion | 3.34 | 2.74 - 3.94 | 2.56 | 2.23 - 2.90 | 3.43 | 2.93 - 3.93 | 2.98 | 2.59 - 3.36 | −0.77 | −1.28; 0.27 | −0.45 | −0.92; −0.01 | 0.3246 |
Constipation | 3.04 | 2.38 - 3.70 | 2.13 | 1.76 - 2.49 | 3.56 | 3.08 - 4.04 | 2.86 | 2.35 - 3.37 | −0.91 | −1.37; −0.45 | −0.70 | −1.15; −0.25 | 0.4917 |
Abdominal pain | 2.53 | 2.10 - 2.96 | 1.74 | 1.47 - 2.00 | 2.47 | 2.08 - 2.87 | 2.10 | 1.76 - 2.44 | −0.79 | −1.16; −0.43 | −0.37 | −0.71; −0.03 | 0.0834t |
Reflux | 1.87 | 1.37 - 2.36 | 1.34 | 1.10 - 1.58 | 1.76 | 1.32 - 2.20 | 1.64 | 1.23 - 2.06 | −0.53 | −0.96; −0.10 | −0.12 | −0.44; −0.20 | 0.1591 |
Total score | 12.29 | 10.54 - 14.04 | 9.15 | 8.38 - 9.92 | 12.71 | 11.08 - 14.35 | 11.24 | 9.83 - 12.65 | −3.15 | −4.43; −1.87 | −1.48 | −2.77; −0.18 | 0.0607t |