Oats groupITT | Oats groupPP | Control group | |||||
---|---|---|---|---|---|---|---|
n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | p Value† | |
*Values are mean (SD) except for differences in the changes between groups, with 95% confidence intervals (CI) shown in parentheses. | |||||||
†Calculated using the Mann-Whitney U test. | |||||||
Oats groupITT, values calculated using the “intention to treat” principle; oats groupPP, values calculated using the “per protocol” principle. | |||||||
‡Villous atrophy is graded as: 1, partial; 2, subtotal; or 3, total villous atrophy. Grade 0 indicates absence of villous atrophy. | |||||||
§All participants of the primary oats intervention trial, values at the end of the intervention. | |||||||
¶Participants of the follow up trial, values at the end of the 6–12 month intervention. | |||||||
**Change, the five year follow up value minus the value obtained at 6–12 month. | |||||||
††The histomorphometric index was calculated as the mean of the indexes based on the biopsy specimen obtained from different levels of the small intestine behind the duodenal bulb. | |||||||
‡‡Duodenal mononuclear cell infiltration is graded as: 1, mild increase in the number of cells; 2, moderate increase; or 3, heavy increase. Grade 0 indicates normal infiltration. | |||||||
Villous atrophy: mean histopathology grade‡ | |||||||
6–12 months§ | 45 | 0.66 (0.42) | 47 | 0.65 (0.42) | |||
6–12 months¶ | 35 | 0.73 (0.39) | 23 | 0.75 (0.41) | 28 | 0.69 (0.41) | |
5 years | 35 | 0.19 (0.46) | 23 | 0.20 (0.41) | 28 | 0.21 (0.39) | |
Change** | 35 | −0.55 (0.54) | 23 | −0.55 (0.51) | 28 | −0.52 (0.45) | 0.54ITT/0.75PP |
Difference (95% CI) | 0.03 (−0.29; 0.23) | −0.14 (−0.41; 0.14) | |||||
Histomorphometric index†† | |||||||
6–12 months§ | 45 | 0.021 (0.003) | 47 | 0.020 (0.003) | |||
6–12 months¶ | 35 | 0.020 (0.003) | 23 | 0.021 (0.003) | 28 | 0.020 (0.003) | |
5 years | 35 | 0.017 (0.003) | 23 | 0.017 (0.003) | 28 | 0.017 (0.003) | |
Change** | 35 | −0.004 (0.003) | 23 | −0.004 (0.003) | 28 | −0.003 (0.003) | 0.50ITT/0.42PP |
Difference (95% CI) | −0.001 (−0.002; 0.000) | −0.001 (−0.003; 0.001) | |||||
Mononuclear cell infiltration: mean of graded histopathology‡‡ | |||||||
6–12 months§ | 45 | 0.74 (0.49) | 47 | 0.81 (0.59) | |||
6–12 months¶ | 35 | 0.82 (0.46) | 23 | 0.83 (0.39) | 28 | 0.89 (0.62) | |
5 years | 35 | 0.34 (0.83) | 23 | 0.38 (0.83) | 28 | 0.37 (0.69) | |
Change** | 35 | −0.48 (0.88) | 23 | −0.45 (0.89) | 28 | −0.58 (0.83) | 0.96ITT/0.85PP |
Difference (95% CI) | 0.10 (−0.34; 0.54) | 0.13 (−0.36; 0.62) |