Table 2.
Escitalopram | Placebo | Difference | ||||
---|---|---|---|---|---|---|
N | Mean (SD) | N | Mean (SD) | Mean (SD) | P value | |
Primary Outcomes | ||||||
Hot flashes / day1 | ||||||
Baseline | 104 | 9.88 (6.24) | 101 | 9.66 (4.88) | 0.22 (5.61) | |
Week 4 – baseline | 101 | −4.37 (4.39) | 99 | −2.49 (4.12) | −1.89 (4.26) | 0.001 |
Week 8 – baseline | 97 | −4.60 (4.28) | 97 | −3.20 (4.76) | −1.41 (4.53) | 0.004 |
Severity2 (1–3) | ||||||
Baseline | 104 | 2.16 (0.44) | 101 | 2.19 (0.45) | −0.04 (0.45) | |
Week 4 – baseline | 100 | −0.43 (0.54) | 97 | −0.23 (0.52) | −0.20 (0.53) | 0.003 |
Week 8 – baseline | 96 | −0.52 (0.58) | 96 | −0.30 (0.63) | −0.22 (0.61) | 0.003 |
Secondary Outcome | ||||||
Bother3 (1–4) | ||||||
Baseline | 104 | 3.12 (0.49) | 101 | 3.16 (0.52) | −0.04 (0.51) | |
Week 4 – baseline | 100 | −0.59 (0.70) | 97 | −0.29 (0.62) | −0.30 (0.66) | <0.001 |
Week 8 – baseline | 96 | −0.63 (0.73) | 96 | −0.39 (0.76) | −0.24 (0.75) | 0.013 |
Week 4 and 8 p-values from contrasts comparing Escitalopram vs. placebo at each visit in linear model of log hot flash frequency as a function of intervention arm and adjusted for race (p=0.07), clinical center (p=0.07), baseline log hot flash frequency (p<0.001), visit (week 4 or 8, p=0.04), and visit by intervention interaction (p=0.84).
Week 4 and 8 p-values from contrasts comparing Escitalopram vs. placebo at each visit in linear model of hot flash severity as a function of intervention arm and adjusted for race (p=0.02), clinical center (p=0.46), baseline hot flash severity (p<0.001), visit (week 4 or 8, p=0.15), and visit by intervention interaction (p=0.68).
Week 4 and 8 p-values from contrasts comparing Escitalopram vs. placebo at each visit in linear model of hot flash bother as a function of intervention arm and adjusted for race (p=0.02), clinical center (p=0.62), baseline hot flash bother (p<0.001), visit (week 4 or 8, p=0.07), and visit by intervention interaction (p=0.50).