Paroxetine versus placebo for the management of vasomotor symptoms in surgical menopause: A pilot double-blind randomized clinical trial.

In 30 seconds

This pilot, double-blind, placebo-controlled randomized trial assessed paroxetine 20 mg/day for vasomotor symptoms in women under 48 years old who had recently undergone hysterectomy with bilateral salpingo-oophorectomy. Ninety women were randomized, and 90? No: 47 in the paroxetine group and 43 in the placebo group completed follow-up and were analyzed. At 12 weeks, mean Menopause Rating Scale scores were lower with paroxetine than placebo (16.9 ± 7.7 vs. 22.6 ± 6.1; mean difference -5.7, 95% CI -8.6 to -2.8; P < 0.001). Quality-of-life scores also improved more with paroxetine.

Key findings

• At 12 weeks, mean total Menopause Rating Scale scores were 16.9 ± 7.7 with paroxetine and 22.6 ± 6.1 with placebo (mean difference -5.7, 95% CI -8.6 to -2.8; P < 0.001).
• SF-36 scores were 91.0 ± 6.4 with paroxetine and 86.9 ± 4.8 with placebo (mean difference 4.1, 95% CI 1.7 to 6.5; P = 0.001).
• Headache, fatigue, and drowsiness were more frequent with paroxetine but were mild and transient; no serious adverse events occurred.
• Thirteen of 90 randomized participants dropped out (14.4%); intention-to-treat analysis showed consistent findings with slightly attenuated effect sizes.

Why it matters

Vasomotor symptoms after surgical menopause can be substantial, and this trial suggests paroxetine may reduce symptom burden while improving reported quality of life in this population. The findings add preliminary controlled evidence for a nonhormonal option, while the pilot design and attrition mean the size and reliability of benefit require confirmation.

What to keep in mind

This was a pilot trial with 90 randomized participants, 12 weeks of follow-up, and 14.4% attrition; the primary analysis was per protocol. The authors state that larger trials are needed.