Change in duodenal polyp burden from baseline
| Change (month 6–baseline), mean (SD) | |||||||
| No. of participants | Baseline, mean (SD) | Month 6, mean (SD) | Absolute change mean (SD) | % change, mean (SD) | % change (95% CI) | P value | |
| Duodenal polyp burden, mm | |||||||
| All evaluable participants | 42 | 137.2 (112.42) | 97.2 (81.52) | −40.0 (64.42) | −29.6 (31.94) | −39.6 to −19.7 | <0.0001* |
| Severity of duodenal polyposis | |||||||
| Spigelman 3 | 32 | 159.6 (119.18) | 114.1 (85.06) | −45.4 (71.79) | −27.0 (32.65) | −38.7 to −15.2 | <0.0001* |
| Spigelman 2 | 10 | 65.6 (34.34) | 42.9 (32.61) | −22.7 (26.80) | −38.1 (29.55) | −59.2 to −16.9 | 0.0028* |
| APC genetic mutation | |||||||
| Yes | 36 | 143.8 (117.41) | 101.4 (84.48) | −42.3 (69.11) | −29.1 (33.61) | −40.5 to −17.8 | <0.0001* |
| No | 6 | 97.7 (70.39) | 71.5 (60.16) | −26.2 (18.05) | −32.4 (21.14) | −54.6 to −10.2 | 0.0133* |
| Rash acneiform/maculopapular | |||||||
| Yes | 23 | 145.6 (138.29) | 99.7 (95.13) | −45.9 (82.69) | −31.4 (37.00) | −47.4 to −15.4 | 0.0005* |
| No | 19 | 127.0 (72.21) | 94.1 (63.71) | −32.9 (31.62) | −27.5 (25.33) | −39.7 to −15.2 | 0.0002* |
| Sex | |||||||
| Female | 19 | 136.5 (87.05) | 103.2 (66.97) | −33.3 (33.68) | −26.0 (22.76) | −37.0 to −15.0 | <0.0001* |
| Male | 23 | 137.7 (131.73) | 92.2 (93.05) | −45.6 (82.07) | −32.6 (38.18) | −49.1 to −16.0 | 0.0005* |
| Median age | |||||||
| ≤42 | 21 | 128.8 (98.67) | 85.7 (81.85) | −43.1 (40.20) | −39.1 (23.44) | −49.8 to −28.5 | <0.0001* |
| >42 | 21 | 145.6 (126.59) | 108.6 (81.55) | −37.0 (82.90) | −20.1 (36.76) | −36.8 to −3.3 | 0.0211* |
*Paired t-test of observed mean change, %, against 0%.
†Paired signed-rank test of observed median change, %, against 0%.
APC, aerobic plate count; FAP, familial adenomatous polyposis.