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 | |
Number of duodenal polyps | |||||||
All evaluable participants | 42 | 44.6 (36.97) | 31.7 (30.24) | −12.8 (22.96) | −10.7 (16.82) | −15.9 to −5.4 | 0.0002* |
Severity of duodenal polyposis | |||||||
Spigelman 3 | 32 | 49.8 (39.59) | 36.3 (32.82) | −13.5 (24.30) | −9.7 (13.07) | −14.4 to −5.0 | 0.0002* |
Spigelman 2 | 10 | 27.8 (20.41) | 17.2 (12.14) | −10.6 (18.99) | −13.7 (26.21) | −32.5 to 5.0 | 0.1322* |
APC genetic mutation | |||||||
Yes | 36 | 46.1 (38.36) | 32.1 (31.31) | −14.0 (24.25) | −11.9 (15.86) | −17.3 to −6.6 | <0.0001* |
No | 6 | 35.3 (28.05) | 29.7 (25.09) | −5.7 (11.67) | −3.2 (21.89) | −26.1 to 19.8 | 0.7388* |
Rash acneiform/maculopapular | |||||||
Yes | 23 | 45.5 (45.18) | 29.5 (32.74) | −16.0 (26.96) | −10.4 (15.90) | −17.3 to −3.6 | 0.0047* |
No | 19 | 43.5 (24.81) | 34.4 (27.55) | −9.1 (16.89) | −11.0 (18.31) | −19.8 to −2.2 | 0.0108† |
Sex | |||||||
Female | 19 | 40.2 (23.85) | 32.1 (23.42) | −8.1 (11.20) | −7.1 (10.72) | −12.3 to −1.9 | 0.0097* |
Male | 23 | 48.2 (45.28) | 31.4 (35.43) | −16.8 (29.05) | −13.6 (20.32) | −22.4 to −4.8 | 0.0039* |
Median age | |||||||
≤42 | 21 | 44.2 (29.60) | 32.8 (32.04) | −11.5 (18.71) | −11.9 (18.60) | −20.4 to −3.5 | 0.0081* |
>42 | 21 | 44.9 (43.87) | 30.7 (29.08) | −14.2 (26.96) | −9.4 (15.19) | −16.4 to −2.5 | 0.0099* |
*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.