Table 3.
Secondary Outcomes of Vasomotor Symptom (VMS) Severity, Bother, and Interference, at Week 8 by Treatment Group
| Intervention | Estradiol | Placebo | Difference1 | Venlafaxine | Placebo | Difference1 | ||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| N | N | Mean (95% CI) | p-value2 | N | N | Mean (95% CI) | p-value2 | |
| VMS Severity | 0.02 | 0.02 | ||||||
| Baseline | 97 | 146 | 0.1 (0.0, 0.2) | 96 | 146 | 0.0 (−0.1, 0.1) | ||
| Week 8 – baseline | 73 | 133 | −0.3 (−0.4, −0.1) | 86 | 133 | −0.2 (−0.3, 0.0) | ||
|
| ||||||||
| VMS Bother | 0.01 | 0.07 | ||||||
| Baseline | 97 | 146 | 0.1 (0.0, 0.2) | 96 | 146 | 0.0 (−0.2, 0.1) | ||
| Week 8 – baseline | 73 | 133 | −0.3 (−0.5, −0.1) | 86 | 133 | −0.2 (−0.3, 0.0) | ||
|
| ||||||||
| HFRDIS | <0.001 | 0.03 | ||||||
| Baseline | 90 | 141 | 4.2 (−1.7, 10.1) | 92 | 141 | 4.0 (−1.8, 9.8) | ||
| Week 8 – baseline | 86 | 132 | −9.3 (−15.3, −3.4) | 84 | 132 | −6.4 (−12.7, −0.1) | ||
CI = confidence interval; VMS = vasomotor symptoms; HFRDIS =Hot Flash-Related Daily Interference Scale20
1
Outcome differences between active treatment and placebo
2
P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week (4 or 8), and baseline outcome