TABLE 2.
Summary results for each study group and period
| Period 1 | Period 2 | Period 3 | Statistical tests: Fixed effects | |||||
|---|---|---|---|---|---|---|---|---|
| Gluten | Control | Washout | Gluten | Control | Period*group | Period | Group | |
| Primary outcome | p‐values | p‐values | p‐values | |||||
| Average VAS, 0‐100 mm | 24.4 (2.2) | 21.8 (2.2) | 17.5 (1.9) | 19.6 (2.2) | 22.1 (2.2) | 0.15 | 0.03 | 0.99 |
| Key secondary outcomes | ||||||||
| SF‐36 Mental Component Score, score: 0–100 | 48.3 (1.7) | 48.7 (1.6) | 48.5 (1.3) | 51.4 (1.6) | 49.5 (1.8) | 0.52 | 0.10 | 0.54 |
| SF‐36 Physical Component Score, score: 0‐100g | 51.0 (0.8) | 51.5 (0.8) | 51.8 (0.6) | 50.7 (0.8) | 52.2 (0.8) | 0.59 | 0.73 | 0.69 |
| WEMWBS: 14–70 | 50.4 (1.3) | 51.9 (1.1) | 51.9 (0.8) | 51.9 (1.1) | 52.3 (1.2) | 0.67 | 0.28 | 0.28 |
| Other secondary outcomes | ||||||||
| VAS1 / Abdominal pain, 0‐100 mm | 29.1 (3.5) | 18.4 (3.3) | 17.7 (2.9) | 19.0 (3.4) | 28.0 (3.5) | 0.00 | 0.90 | 0.65 |
| VAS2 / Bloating, 0‐100 mm | 37.4 (4.1) | 30.7 (4.0) | 25.8 (3.6) | 29.2 (4.0) | 34.5 (4.1) | 0.07 | 0.27 | 0.73 |
| VAS3 / Flatulence, 0‐100 mm | 34.9 (3.8) | 32.6 (3.7) | 26.3 (3.3) | 30.6 (3.7) | 32.7 (3.9) | 0.51 | 0.31 | 0.97 |
| VAS4 / Borborygmi 0‐100 mm | 23.2 (3.4) | 27.1 (3.4) | 18.6 (3.0) | 23.7 (3.4) | 19.5 (3.4) | 0.15 | 0.04 | 0.92 |
| VAS5 / Diarrhoea 0‐100 mm | 15.9 (2.9) | 13.5 (2.9) | 11.9 (2.5) | 14.6 (3.0) | 15.8 (3.1) | 0.53 | 0.77 | 0.72 |
| VAS6 / Constipation 0‐100 mm | 20.6 (3.2) | 20.0 (3.1) | 14.8 (2.7) | 13.8 (3.2) | 16.1 (3.2) | 0.62 | 0.00 | 0.64 |
| VAS7 / Incomplete evacuation after toilet visit, 0‐100 mm | 29.4 (3.9) | 28.0 (3.8) | 26.2 (3.3) | 28.7 (3.8) | 38.3 (3.9) | 0.09 | 0.02 | 0.04 |
| VAS8 / Nausea, 0‐100 mm | 29.0 (3.7) | 20.5 (3.6) | 16.2 (3.1) | 17.9 (3.6) | 22.5 (3.7) | 0.05 | 0.02 | 0.34 |
| VAS9 / Burping, 0‐100 mm | 12.8 (2.5) | 18.4 (2.5) | 10.9 (2.2) | 12.0 (2.5) | 6.3 (2.6) | 0.01 | <0.00 | 0.97 |
| VAS10 / dyspepsia, 0‐100 mm | 11.0 (2.1) | 12.2 (2.0) | 6.8 (1.7) | 8.3 (2.0) | 6.7 (2.1) | 0.47 | 0.00 | 0.87 |
Notes: Values are Least‐Squares Means (SE) unless otherwise stated.
Statistical tests are based on a repeated‐measures linear mixed‐effects model (participants modelled as a random effects variable).