Gastrointestinal Symptom Score Changes From Baseline After 6 Weeks and 12 Weeks of Administration
| Variable | Time | NOVAponin | Placebo | P-value |
|---|---|---|---|---|
| Total Score | 6 wk-baseline | –11.21 ± 0.53 | –6.65 ± 0.70 | < 0.001 |
| 12 wk-baseline | –11.90 ± 0.52 | –7.61 ± 0.73 | < 0.001 |
|
| Upper abdominal pain | 6 wk-baseline | –1.66 ± 0.15 | –0.88 ± 0.16 | 0.001 |
| 12 wk-baseline | –1.61 ± 0.16 | –0.98 ± 0.17 | 0.009 |
|
| Abdominal cramps | 6 wk-baseline | –0.44 ± 0.12 | –0.31 ± 0.12 | 0.450 |
| 12 wk-baseline | –0.39 ± 0.13 | –0.24 ± 0.14 | 0.386 | |
| Feeling of fullness | 6 wk-baseline | –1.38 ± 0.14 | –0.88 ± 0.20 | 0.026 |
| 12 wk-baseline | –1.70 ± 0.15 | –1.04 ± 0.19 | 0.012 |
|
| Early satiety | 6 wk-baseline | –1.38 ± 0.17 | –0.92 ± 0.17 | 0.043 |
| 12 wk-baseline | –1.51 ± 0.16 | –1.08 ± 0.16 | 0.051 | |
| Loss of appetite | 6 wk-baseline | –0.77 ± 0.15 | –0.63 ± 0.19 | 0.408 |
| 12 wk-baseline | –0.79 ± 0.15 | –0.71 ± 0.19 | 0.574 | |
| Sickness | 6 wk-baseline | –1.13 ± 0.18 | –0.41 ± 0.19 | 0.015 |
| 12 wk-baseline | –1.26 ± 0.19 | –0.76 ± 0.18 | 0.089 | |
| Nausea | 6 wk-baseline | –1.26 ± 0.14 | –0.76 ± 0.16 | 0.032 |
| 12 wk-baseline | –1.25 ± 0.15 | –0.76 ± 0.16 | 0.024 |
|
| Vomiting | 6 wk-baseline | –0.41 ± 0.09 | –0.27 ± 0.09 | 0.261 |
| 12 wk-baseline | –0.46 ± 0.09 | –0.24 ± 0.10 | 0.076 | |
| Retrosternal discomfort | 6 wk-baseline | –0.69 ± 0.15 | –0.27 ± 0.14 | 0.079 |
| 12 wk-baseline | –0.74 ± 0.14 | –0.31 ± 0.13 | 0.062 | |
| Acid reflux/indigestion | 6 wk-baseline | –2.10 ± 0.13 | –1.29±0.17 | < 0.001 |
aP < 0.001, bP < 0.01, cP < 0.05; compared between groups: P-value for 2 sample t test or Wilcoxon rank sum test.
Data are presented as mean ± SE.