Table 5.
Outcome Measurement | Group 1 1 Stick |
Group 2 2 Sticks |
Group 3 3 Sticks |
Group 4 Placebo |
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---|---|---|---|---|---|---|---|---|
Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
Bloating | ||||||||
Visit 1 | 2.72 | 2.61 | 0.65 | 0.83 | 1.31 | 1.00 | 0.96 | 0.68 |
Visit 2 | 1.25 | 1.68 | 1.71 | 2.13 | 1.82 | 1.93 | 0.77 | 0.73 |
Visit 3 | 1.46 | 1.76 | 2.49 | 3.05 | 1.90 | 1.28 | 0.53 | 0.58 |
Constipation | ||||||||
Visit 1 | 0.48 | 0.69 | 0.11 | 0.23 | 0.62 | 1.12 | 0.48 | 0.40 |
Visit 2 | 0.17 | 0.27 | 0.18 | 0.41 | 0.38 | 0.80 | 0.44 | 0.33 |
Visit 3 | 0.31 | 0.47 | 0.77 | 1.63 | 0.61 | 1.21 | 0.22 | 0.21 |
Diarrhea | ||||||||
Visit 1 | 0.00 | 0.00 | 0.26 | 0.66 | 0.01 | 0.04 | 0.43 | 0.68 |
Visit 2 | 0.14 | 0.42 | 0.27 | 0.49 | 0.25 | 0.49 | 1.13 | 2.50 |
Visit 3 | 0.46 | 0.71 | 0.49 | 0.85 | 0.31 | 0.56 | 0.82 | 1.48 |
Frequent Urination | ||||||||
Visit 1 | 1.66 | 2.08 | 0.77 | 0.89 | 2.08 | 2.64 | 1.41 | 1.63 |
Visit 2 | 2.16 | 2.03 | 2.13 | 2.13 | 3.79 | 2.24 | 1.93 | 1.72 |
Visit 3 | 1.64 | 1.24 | 2.23 | 2.60 | 2.99 | 2.65 | 1.54 | 1.50 |
Gas | ||||||||
Visit 1 | 0.91 | 1.23 | 1.26 | 1.52 | 1.36 | 1.05 | 0.95 | 0.85 |
Visit 2 | 1.16 | 1.23 | 1.91 | 1.85 | 1.77 | 1.46 | 1.12 | 1.12 |
Visit 3 | 1.00 | 1.44 | 1.96 | 2.51 | 1.71 | 1.36 | 0.73 | 0.75 |
Nausea | ||||||||
Visit 1 | 0.48 | 1.09 | 0.03 | 0.08 | 0.32 | 0.73 | 0.26 | 0.40 |
Visit 2 | 0.41 | 0.60 | 0.19 | 0.43 | 0.24 | 0.41 | 0.65 | 1.28 |
Visit 3 | 0.01 | 0.04 | 0.56 | 0.72 | 0.39 | 0.53 | 0.22 | 0.37 |
Stomach Fullness | ||||||||
Visit 1 | 2.37 | 2.04 | 2.52 | 2.43 | 2.38 | 2.30 | 1.88 | 2.06 |
Visit 2 | 1.77 | 2.19 | 2.53 | 2.46 | 3.50 | 2.46 | 0.58 | 0.65 |
Visit 3 | 1.65 | 2.22 | 3.08 | 2.60 | 2.86 | 2.12 | 0.67 | 0.85 |
Abdominal Cramping | ||||||||
Visit 1 | 0.29 | 0.77 | 0.11 | 0.15 | 0.32 | 0.52 | 0.16 | 0.24 |
Visit 2 | 0.08 | 0.21 | 0.22 | 0.52 | 0.98 | 1.23 | 0.16 | 0.24 |
Visit 3 | 0.12 | 0.37 | 1.42 | 2.19 | 0.47 | 0.84 | 0.26 | 0.42 |
Total Tolerability Score | ||||||||
Visit 1 | 8.46 | 7.23 | 5.71 | 5.12 | 8.40 | 5.21 | 6.53 | 4.20 |
Visit 2 | 7.13 | 5.05 | 9.12 | 8.45 | 12.73 | 7.63 | 6.78 | 4.77 |
Visit 3 | 6.65 | 5.60 | 13.26 | 14.04 | 11.23 | 5.72 | 4.99 | 3.94 |
Total tolerability score, bloating, abdominal cramping; interactions = significant interactions between treatment and time (p = 0.044, 0.039, and 0.010, respectively); frequent urination = visit 1 and 2 differ with time.