Table 2.
Placebo (n = 74)
|
13-cis-RA + AT (n = 77)
|
9-cis-RA (n = 74)
|
||||
---|---|---|---|---|---|---|
Epithelial layer | Mean (95% CI) | Median (range) | Mean (95% CI) | Median (range) | Mean (95% CI) | Median (range) |
Basal layer | ||||||
Baseline† | 2.41 (1.85 to 2.97) | 1.70 (0 to 15.03) | 2.22 (1.79 to 2.65) | 1.78 (0 to 11.16) | 2.34 (1.71 to 2.97) | 1.58 (0 to 18.17) |
3 months† | 2.93 (2.22 to 3.65) | 2.32 (0 to 14.53) | 2.19 (1.64 to 2.74) | 1.75 (0 to 11.62) | 2.39 (1.41 to 3.37) | 1.54 (0.23 to 23.16) |
Modulation‡ | 0.39 (−0.41 to 1.18) | 0.10 (−12.12 to 11.14) | 0.07 (−0.67 to 0.81) | −0.23 (−9.87 to 9.7) | 0.11 (−1.27 to 1.48) | −0.01 (−17.88 to 22.45) |
P value§ | .24 | .66 | .94 | |||
Parabasal layer | ||||||
Baseline† | 6.10 (4.64 to 7.57) | 3.96 (0.76 to 33.62) | 5.46 (4.31 to 6.62) | 3.57 (0 to 27.70) | 5.81 (4.33 to 7.28) | 3.41 (0 to 31.58) |
3 months† | 7.16 (5.12 to 9.20) | 4.59 (0 to 38.10) | 4.24 (3.28 to 5.21) | 3.44 (0 to 20.23) | 4.03 (3.01 to 5.05) | 2.77 (0.28 to 15.40) |
Modulation‡ | 0.67 (−1.55 to 2.89) | 0.08 (−29.77 to 22.78) | −1.08 (−2.65 to 0.48) | −0.81 (−23.11 to 17.34) | −1.65 (−3.48 to 0.19) | −0.34 (−31.31 to 8.26) |
P value§ | .59 | .13 | .24 |
RA = retinoic acid; AT = α-tocopherol; CI = confidence interval. Ki-67 index is expressed as the mean (95% CI) and the median (range).
The statistics for baseline (n = 73 in the placebo group, n = 75 in the 13-cis-RA group, and n = 73 in the 9-cis-RA group) and 3-month (n = 56 in the placebo group, n = 64 in the 13-cis-RA group, and n = 49 in the 9-cis-RA group) measurements were based on all available samples.
Modulation of Ki-67 index (n = 55 in placebo group, n = 62 in 13-cis-RA group, and n = 48 in 9-cis-RA group) was calculated only on participants who had both baseline and 3-month measurements (Ki-67 at 3 months – Ki-67 at baseline); shown as mean (95% CI) and median (range).
Wilcoxon signed rank test was performed to test the statistical significance of the change in the median Ki-67 modulation in each treatment group. All statistical tests were two-sided.