Table 4.
Intercept and slope arm differences (with P value, 95% CI) for primary and secondary outcomes over the 28 days of intervention.
| Intercept (u) | Intercept (u) | Intercept difference (u) | Slope (u) | Slope (u) | Slope difference (u) | |
|---|---|---|---|---|---|---|
| P value | P value | P value | P value | P value | P value | |
| [95% CI] | [95% CI] | [95% CI] | [95% CI] | [95% CI] | [95% CI] | |
| Supplementation | Placebo | Suppl. − placebo | Supplementation | Placebo | Suppl. − placebo | |
| Primary outcome* | 1.195 | 0.347 | +0.848 | −0.181 | −0.258 | +0.077 |
| Functional dyspepsia | 0.017 | 0.513 | <0.001 | 0.619 | 0.504 | 0.542 |
| [0.215; 2.174] | [−0.692; 1.387] | [−1.190; −0.505] | [−0.893; 0.532] | [−1.015; 0.498] | [−0.326; 0.171] | |
|
| ||||||
| Secondary outcomes∧ | ||||||
| Epigastric fullness | 0.119 | 0.381 | −0.263 | −0.191 | 0.051 | −0.241 |
| 0.677 | 0.175 | 0.102 | 0.099 | 0.658 | <0.001 | |
| [−0.440; 0.678] | [−0.170; 0.932] | [−0.578; 0.053] | [−0.418; 0.036] | [−0.173; 0.274] | [−0.369; −0.114] | |
| Bloating | 0.709 | 1.145 | −0.437 | −0.133 | 0.034 | −0.167 |
| 0.020 | <0.001 | 0.011 | 0.283 | 0.779 | 0.017 | |
| [0.110; 1.308] | [0.555; 1.735] | [−0.774; −0.099] | [−0.376; 0.110] | [−0.205; 0.274] | [−0.304; −0.030] | |
| Early satiety | −0.266 | 0.222 | −0.488 | −0.053 | 0.045 | −0.098 |
| 0.375 | 0.453 | 0.004 | 0.675 | 0.707 | 0.148 | |
| [−0.855; 0.322] | [−0.358; 0.802] | [−0.820; −0.157] | [−0.289; 0.182] | [−0.188; 0.277] | [−0.231; 0.035] | |
| Nausea | 0.412 | 0.315 | +0.096 | −0.290 | 0.108 | −0.398 |
| 0.170 | 0.287 | 0.569 | 0.030 | 0.412 | <0.001 | |
| [−0.177; 1.001] | [−0.265; 0.895] | [−0.235; 0.428] | [−0.552; −0.029] | [−0.150; 0.365] | [−0.545; −0.251] | |
| Vomiting | 0.625 | 0.948 | −0.322 | 0.214 | 0.240 | −0.025 |
| 0.033 | 0.001 | 0.051 | 0.056 | 0.030 | 0.688 | |
| [0.050; 1.200] | [0.381; 1.514] | [−0.646; 0.002] | [−0.006; 0.434] | [0.023; 0.456] | [−0.149; 0.099] | |
| Epigastric pain | 2.133 | 2.306 | −0.174 | −0.204 | −0.031 | −0.173 |
| <0.001 | <0.001 | 0.022 | 0.036 | 0.745 | 0.002 | |
| [1.869; 2.397] | [2.046; 2.566] | [−0.322; −0.025] | [−0.396; −0.013] | [−0.220; 0.157] | [−0.281; −0.065] | |
In bold are shown the statistically significant evidences (P < 0.05).
*Estimated intercept and slope parameters (P value, 95% CI) of arm effects on functional dyspepsia (after 14 days and 28 days of treatment ) referred to variation (improving or not) from equal baseline conditions, adjusting for baseline values of the symptom severity scores (secondary outcomes) and dyspepsia typology. Therefore, patients reported their degree of functional dyspepsia variation on a symptomatic ordinal score (quantified by MCA), ranging from 0 (worsening or steadiness) to 3 (disappearance of symptoms).
∧Estimated intercept and slope parameters (P value, 95% CI) of arm effects on secondary outcomes, adjusted for dyspepsia typology, assessed using ordinal scores over time (baseline, after 14 days of treatment, and after 28 days of treatment). Patients reported their score (quantified by MCA), ranging from 0 (no symptoms) to 3 (severe symptoms).