Table 2.
Comparison of the impact of VSL#3® and placebo on gastrointestinal symptoms (ITT-LOCF analysis).
| Baseline Mean ± SD |
Mean Change (±SD) from Baseline to Week 12 | Treatment Difference (Placebo Minus VSL#3) |
||||||
|---|---|---|---|---|---|---|---|---|
| Gastrointestinal Symptom | Placebo N = 56 |
VSL#3® N = 54 |
Placebo N = 53 |
VSL#3® N = 53 |
ETD | 95% CI | p-Value | Cohen’s d |
| Primary outcome: composite score of Pain + Bloating + Meteorism | 20.9 ± 5.6 | 20.7 ± 5.0 | −5.4 ± 6.6 | −6.5 ± 9.5 | 1.1 | −2.1 to 4.2 | 0.501 | 0.13 |
| Abdominal pain | 6.2 ± 2.5 | 6.1 ± 2.5 | −1.6 ± 3.2 | −2.4 ± 3.8 | 0.8 | −0.5 to 2.2 | 0.228 | 0.24 |
| Abdominal bloating | 7.8 ± 2.2 | 7.4 ± 2.1 | −2.1 ± 2.9 | −2.1 ± 3.6 | −0.0 | −1.3 to 1.3 | 0.976 | 0.01 |
| Meteorism | 6.9 ± 2.8 | 7.2 ± 2.5 | −1.7 ± 2.8 | −2.0 ± 3.5 | 0.3 | −1.0 to 1.5 | 0.668 | 0.08 |
| Flatulence | 6.5 ± 2.9 | 6.0 ± 2.3 | −1.3 ± 3.2 | −1.1 ± 4.0 | −0.2 | −1.6 to 1.2 | 0.788 | 0.05 |
| Constipation | 6.7 ± 3.5 | 6.1 ± 3.6 | −2.4 ± 3.8 | −1.6 ± 4.2 | −0.8 | −2.3 to 0.8 | 0.323 | 0.20 |
| Diarrhoea | 2.6 ± 3.5 | 4.6 ± 3.9 | −1.8 ± 3.8 | −3.1 ± 4.7 | 1.3 | −0.4 to 2.9 | 0.131 | 0.30 |
| Nausea | 3.3 ± 3.2 | 3.3 ± 3.3 | −2.4 ± 3.4 | −1.9 ± 4.0 | −0.5 | −2.0 to 0.9 | 0.468 | 0.14 |
| Vomiting | 0.7 ± 1.8 | 0.8 ± 2.3 | −0.5 ± 1.5 | −0.6 ± 1.9 | 0.2 | −0.5 to 0.8 | 0.645 | 0.09 |
| Belching | 4.2 ± 3.2 | 4.1 ± 3.5 | −0.6 ± 3.3 | −1.1 ± 2.8 | 0.4 | −0.8 to 1.6 | 0.487 | 0.14 |
| Dyspepsia | 6.2 ± 3.0 | 6.5 ± 2.9 | −2.7 ± 3.8 | −3.2 ± 3.5 | 0.5 | −0.9 to 1.9 | 0.510 | 0.13 |
CI, confidence interval; ETD, estimated treatment difference (positive figures favour VSL#3); ITT, intention-to-treat; FMS, fibromyalgia syndrome; LOCF, last observation carried forward; SD, standard deviation.