Table 3.

Baseline and 12-month values and change over time for Ki-67, Masood score, and cytomorphology.

Placebo N = 51SDG N = 101
MedianMedianP
Variable and time/changeMean ± SDMean ± SD(Mann–Whitney test)
Ki-67 (% positively stained cells by IHC)
 Baseline3.84.40.34
5.4 ± 4.35.9 ± 4.5
 12-month2.22.60.84
4.0 ± 4.44.5 ± 5.5
 Change over time−1.2−1.80.72
−1.4 ± 5.3−1.4 ± 6.0
 Relative change (percent)−40−440.70
5 ± 130−7 ± 109
 Within group (Wilcoxon test)0.0340.001
Masood score
 Baseline15150.90
14.5 ± 1.014.5 ± 0.9
 12-month14140.57
13.7 ± 1.913.9 ± 1.6
 Change over time−100.44
−0.8 ± 1.8−0.6 ± 1.8
 Within group (Wilcoxon test)0.0050.003
Categorical descriptorFrequenciesχ2
Baseline
 Hyperplasia9 (18%)17 (17%)0.92
 Borderline atypia16 (31%)29 (29%)
 Atypia26 (52%)55 (55%)
 12 months nonproliferative5 (10%)9 (9%)0.70
 Hyperplasia13 (26%)24 (24%)
 Borderline atypia11 (22%)22 (22%)
 Atypia22 (43%)46 (46%)
 Within group (Wilcoxon test)0.230.33