Table 3.

Mean changes in clinical and self-reported parameters of a subset of KEEPS participants during and following treatment.

Outcome Variable		Overall	PL	t-E2	o-CEE	P-value
Changes during intervention
BMI (kg/m², change from BL to 48 mo)	N = 71	0.47 ± 1.39^*	1.08 ± 1.52^*	0.16 ± 1.28	−0.05 ± 1.00	0.007^a
WC (cm, change from BL to 48 mo)	N = 67	3.81 ± 6.95^*	5.77 ± 7.28^*	2.74 ± 6.57	1.56 ± 6.13	0.079
Health QOL (change in score from BL to 48 mo)	N = 74	−4.58 ± 4.83^*	−3.72 ± 4.96^*	−5.11 ± 4.90^*	−5.32 ± 4.56^*	0.365
Insomnia severity (change in score from BL to 48 mo)	N = 74	−0.51 ± 0.76^*	−0.43 ± 0.73^*	−0.62 ± 0.85^*	−0.52 ± 0.73^*	0.612
Changes over 3 years after HT intervention
BMI (kg/m², change from 48 to 84 mo)	N = 71	0.51 ± 1.97^*	0.65 ± 2.22	0.61 ± 1.28^*	0.19 ± 2.26	0.453
WC (cm, change from 48 to 84 mo)	N = 68	2.36 ± 7.11^*	1.82 ± 7.01	1.87 ± 7.13	3.92 ± 7.45	0.555
Health QOL (Change in score from 48 to 84 mo)	N = 71	−1.26 ± 3.51^*	−1.85 ± 3.53^*	−0.74 ± 3.76	−0.93 ± 3.21	0.687

Changes are reported as mean ± standard deviation; Kruskal-Wallis test was used to test for any difference in changes between the 3 treatment groups.

Abbreviations: PL, placebo; t-E2, transdermal; o-CEE, oral; HT, hormone therapy; BL, baseline; mo, months; BMI, body mass index; WC, waist circumference; QOL, quality of life.

P < 0.05 from Wilcoxon signed-rank test indicates a significant change over time within that group.

Based on pairwise comparisons from post-hoc testing, change in BMI in both treatment groups was significantly less than that in placebo group (t-E2 vs. PL, P = 0.015; o-CEE vs PL, P = 0.005).