Table 2.
Variables | Placebo | MAG-EPA | Difference between Group | |||||
---|---|---|---|---|---|---|---|---|
Mean (SE) | MD (95% CI) | p-Value * | Mean (SE) | MD (95% CI) | p-Value * | MD (95% CI) | p-Value ** | |
EPIC-26 | ||||||||
Urinary Incontinence | ||||||||
Randomization | 94.7 (2.0) | 0.0 | 94.5 (1.9) | 0.0 | ||||
3 Months Post-RP | 47.9 (3.4) | −46.8 (−54.3; −39.4) | <0.0001 | 36.8 (3.3) | −57.6 (−65.1; −50.1) | <0.0001 | −9.8 (−19.2; −0.4) | 0.04 |
6 Months Post-RP | 66.7 (3.6) | −28.0 (−36.0; −20.1) | <0.0001 | 58.6 (3.7) | −35.8 (−43.9; −27.8) | <0.0001 | −6.6 (−16.6; 3.5) | 0.20 |
9 Months Post-RP | 69.3 (3.5) | −25.4 (−32.8; −18.1) | <0.0001 | 67.0 (3.5) | −27.4 (−35.0; −19.9) | <0.0001 | −0.5 (−10.0; 9.0) | 0.92 |
12 Months Post-RP | 73.2 (3.5) | −21.5 (−28.7; −14.3) | <0.0001 | 66.5 (3.6) | −27.9 (−35.4; −20.5) | <0.0001 | −3.7 (−13.4; 6.0) | 0.45 |
Urinary irritation | ||||||||
Randomization | 85.6 (2.1) | 0.0 | 83.1 (2.0) | 0.0 | ||||
3 Months Post-RP | 78.5 (2.1) | −7.1 (−11.9; −2.2) | 0.005 | 79.1 (2.0) | −4.1 (−8.9; 0.8) | 0.10 | 1.6 (−3.9; 7.1) | 0.57 |
6 Months Post-RP | 85.3 (1.8) | −0.3 (0.1; 8.8) | 0.90 | 87.8 (1.8) | 4.7 (0.4; 8.9) | 0.03 | 2.6 (−1.8; 7.0) | 0.24 |
9 Months Post-RP | 86.9 (1.8) | 1.4 (−2.3; 5.1) | 0.47 | 87.3 (1.8) | 4.1 (0.4; 7.8) | 0.03 | 1.7 (−2.4; 5.8) | 0.42 |
12 Months Post-RP | 86.6 (1.7) | 1.0 (−3.0; 5.1) | 0.62 | 88.8 (1.7) | 5.6 (1.5; 9.6) | 0.007 | 3.5 (−0.8; 7.8) | 0.11 |
Sexual function | ||||||||
Randomization | 65.7 (3.7) | 0.0 | 62.8 (3.6) | 0.0 | ||||
3 Months Post-RP | 19.6 (2.8) | −46.1 (−53.4; −38.9) | <0.0001 | 17.7 (2.8) | −45.1 (−52.3; −37.8) | <0.0001 | −1.8 (−9.0; 5.4) | 0.62 |
6 Months Post-RP | 26.3 (3.3) | −39.4 (−46.8; −31.9) | <0.0001 | 26.2 (3.3) | −36.6 (−44.1; −29.2) | <0.0001 | −0.4 (−8.6; 7.9) | 0.93 |
9 Months Post-RP | 32.0 (3.5) | −33.7 (−40.8; −26.6) | <0.0001 | 30.5 (3.5) | −32.3 (−39.5; −25.2) | <0.0001 | −1.8 (−10.4; 6.7) | 0.67 |
12 Months Post-RP | 36.0 (3.8) | −29.7 (−37.2; −22.3) | <0.0001 | 31.5 (3.8) | −31.3 (−38.8; −23.8) | <0.0001 | −4.5 (−14.0; 5.0) | 0.35 |
Bowel function | ||||||||
Randomization | 92.8 (1.7) | 0.0 | 90.2 (1.6) | 0.0 | ||||
3 Months Post-RP | 91.3 (1.6) | −1.5 (−5.2; 2.2) | 0.42 | 89.7 (1.7) | −0.5 (−4.2; 3.2) | 0.77 | −0.8 (−5.2; 3.7) | 0.72 |
6 Months Post-RP | 93.0 (1.4) | 0.2 (−2.8; 3.2) | 0.90 | 91.4 (1.3) | 1.2 (−1.8; 4.3) | 0.43 | −1.0 (−4.3; 2.3) | 0.55 |
9 Months Post-RP | 93.0 (1.7) | 0.2 (−3.4; 3.8) | 0.93 | 90.8 (1.7) | 0.6 (−3.2; 4.2) | 0.76 | −0.4 (−4.5; 3.7) | 0.84 |
12 Months Post-RP | 95.2 (1.3) | 2.4 (−0.5; 5.2) | 0.11 | 94.0 (1.2) | 3.8 (0.9; 6.7) | 0.009 | −0.6 (−3.4; 2.2) | 0.69 |
Hormonal function | ||||||||
Randomization | 85.9 (2.0) | 0.0 | 88.3 (1.9) | 0.0 | ||||
3 Months Post-RP | 85.8 (1.9) | −0.1 (−3.8; 3.6) | 0.96 | 88.2 (1.8) | −0.1 (−3.8; 3.7) | 0.97 | 0.9 (−3.4; 5.3) | 0.66 |
6 Months Post-RP | 88.1 (1.6) | 2.2 (−1.3; 5.8) | 0.21 | 88.2 (1.5) | −0.1 (−3.6; 3.4) | 0.96 | −0.3 (−3.9; 3.4) | 0.89 |
9 Months Post-RP | 87.5 (1.6) | 1.6 (−1.7; 4.9) | 0.33 | 89.4 (1.5) | 1.2 (−2.2; 4.5) | 0.49 | 1.4 (−2.2; 5.0) | 0.43 |
12 Months Post-RP | 86.6 (1.7) | 0.7 (−2.5; 4.0) | 0.66 | 89.2 (1.7) | 1.0 (−2.2; 4.2) | 0.55 | 1.6 (−2.0; 5.3) | 0.36 |
IPSS | ||||||||
Voiding and storage Problem | ||||||||
Randomization | 9.0 (0.9) | 0.0 | 8.8 (0.8) | 0.0 | ||||
3 Months Post-RP | 11.2 (0.9) | 2.2 (0.1; 4.3) | 0.04 | 10.3 (0.9) | 1.5 (−0.6; 3.6) | 0.17 | −0.9 (−3.2; 1.4) | 0.43 |
6 Months Post-RP | 7.7 (0.7) | −1.2 (−3.0; 0.5) | 0.17 | 7.8 (0.7) | −1.0 (−2.7; 0.8) | 0.28 | 0.1 (−1.6; 1.8) | 0.91 |
9 Months Post-RP | 7.3 (0.7) | −1.7 (−3.3; 0.0) | 0.05 | 6.5 (0.7) | −2.3 (−4.0; −0.6) | 0.007 | −0.9 (−2.7; 0.8) | 0.30 |
12 Months Post-RP | 6.9 (0.7) | −2.1 (−3.8; −0.4) | 0.02 | 5.9 (0.6) | −2.9 (−4.6; −1.2) | 0.0008 | −1.1 (−2.8; 0.5) | 0.17 |
Notes: MAG-EPA: monoacylglyceride-conjugated eicosapentaenoic acid; RP: radical prostatectomy. * p-value were obtained by mixed models adjusted for age. BMI and NCCN risk; ** p-value were obtained by mixed models adjusted for age, BMI, NCCN risk, and baseline score.