Table 2

Histopathological and histomorphometric values* of duodenal biopsies at the end of the intervention study at 6–12 months and after five years, in the oats and control groups

Oats groupITTOats groupPPControl group
nMean (SD)nMean (SD)nMean (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 years35 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 years35 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 years35 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)