Table 2.
Change in Primary and Secondary Outcome Measures from Baseline to Week 72
| Outcome Measure | Saw Palmetto (N=176) | Placebo (N=181) | |||||
|---|---|---|---|---|---|---|---|
| Baseline Mean |
Week 72 Mean |
Change - Mean (95% CI) |
Baseline Mean |
Week 72 Mean |
Change - Mean (95% CI) |
P-value (1-sided) |
|
| Primary | |||||||
| AUASI score | 14.42 | 12.22 | −2.20 (−3.04, −0.36) |
14.69 | 11.70 | −2.99 (−3.81, −2.17) |
0.91 |
| Secondary | |||||||
| BPH Impact Index | 3.43 | 2.62 | −0.81 (−1.16. −0.46) |
3.70 | 2.47 | −1.23 (−1.60, −0.87) |
0.95 |
| AUASI QOL | 3.20 | 2.86 | −0.34 (−0.52, −0.16) |
3.23 | 2.74 | −0.49 (−0.67, −0.31) |
0.87 |
| AUA Nocturia | 2.09 | 1.84 | −0.36 (−0.72, 0) |
2.26 | 1.78 | −0.15 (−0.44, 0.13) |
0.19 |
| Peak flow rate (mL/sec) | 15.03 | 14.84 | −0.18 (−1.07, 0.70) |
14.78 | 13.99 | −0.79 (−1.58, 0) |
0.84 |
| Post-void residual (mL)* | 37.5 | 44.5 | 4.78 (−30.00, 52.00) |
43.00 | 42.00 | 1.17 (−33.00, 34.00) |
0.31* |
| PSA level (ng/ml) | 2.20 | 2.41 | 0.32 (−0.08, 0.73) |
1.93 | 2.07 | −0.19 (−0.53, 0.14) |
0.97 |
| IIEF erectile scale | 18.81 | 18.29 | −0.52 (−1.63, 0.59) |
19.92 | 18.86 | −1.06 (−2.11, −0.02) |
0.76 |
| MSHQ-EjD scale | 10.56 | 10.18 | −0.38 (−1.04, 0.28) |
11.18 | 11.09 | −0.09 (0.63, 0.45) |
0.25 |
| ICSmaleIS score | 3.44 | 2.96 | −0.48 (−0.80, −0.16) |
4.17 | 3.32 | −0.84 (−1.17, −0.51) |
0.94 |
| Jenkins sleep scale | 6.96 | 6.15 | −0.80 (−1.34, −0.27) |
7.75 | 6.12 | −1.63 (−2.25, −1.01) |
0.98 |
| NIH-CPSI scales | |||||||
| Pain* | 0 | 0 | 0 (−0.08, 0) |
0 | 0 | 0 (−1.00, 0) |
0.20* |
| Urinary symptom | 4.02 | 3.67 | −0.35 (−0.67, −0.03) |
4.27 | 3.41 | −0.86 (−1.22, −0.49) |
0.98 |
| QOL | 4.45 | 3.61 | −0.85 (−1.16, −0.53) |
4.57 | 3.49 | −1.08 (−1.39, −0.77) |
0.85 |
*
Median and interquartile range shown, P-value based on Wilcoxon rank sum test.