Table 2.
Changes in IPSS.
| IPSS | FAS analysis | PP analysis | ||||||
|---|---|---|---|---|---|---|---|---|
| Treatment group (n = 14) | Control group (n = 14) | Mean difference | P value† | Treatment group (n = 13) | Control group (n = 10) | Mean difference | P value† | |
| Baseline | 15.00 (12.05, 17.95) | 15.29 (11.31, 19.26) | 15.31 (12.17, 18.44) | 16.60 (11.36, 21.84) | ||||
| Week 3 | 10.57 (7.01, 14.14) | 13.71 (9.83, 17.59) | −2.84 (−5.43, −0.26) | .0313* | 10.77 (6.91, 14.62) | 15.40 (9.81, 20.99) | −3.29 (−6.35, −0.23) | .0363* |
| Difference | −4.43 (−6.50, −2.36) | −1.57 (−3.22, 0.07) | −4.54 (−6.78, −2.30) | −1.20 (−3.16, 0.76) | ||||
| P value‡ | .0005* | .0611 | .0009* | .1995 | ||||
| Week 6 | 8.79 (5.78, 11.80) | 13.85 (10.57, 17.14) | −4.80 (−7.67, −1.94) | .0010* | 8.92 (5.37, 12.48) | 15.30 (10.78, 19.82) | −5.28 (−8.45, −2.10) | .0025* |
| Difference | −6.21 (−8.32, −4.10) | −1.43 (−3.47, 0.61) | −6.38 (−8.82, −3.95) | −1.30 (−3.59, 0.99) | ||||
| P value‡ | <.0001* | .1686 | <.0001* | .2308 | ||||
| Week 12 | 8.51 (5.54, 11.48) | 12.37 (8.55, 16.18) | −3.76 (−7.16, −0.36) | .0304* | 8.70 (5.56, 11.84) | 13.93 (9.47, 18.39) | −4.27 (−7.83, −0.72) | .0184* |
| Difference | −6.49 (−8.68, −4.30) | −2.92 (−5.60, −0.24) | −6.61 (−8.90, −4.31) | −2.67 (−5.55, 0.22) | ||||
| P value‡ | <.0001* | .0332* | <.0001* | .0700 | ||||
Data expressed as mean (95% confidence interval).
FAS = full analysis set, IPSS = International Prostate Symptom Score, PP = per protocol.
†
Analysis of covariance.
‡
Paired t test.
*
Significant difference.