Estrogen has been used successfully to treat menopausal hot flushes; however, recent findings about the risks of hormone therapy have made this a less desirable treatment option. Given the high prevalence of hot flushes, other treatments have attracted increasing attention. Selective serotonin reuptake inhibitors (SSRIs) have had promising results in breast-cancer patients with tamoxifen-induced hot flushes. Stearns and colleagues studied the efficacy of controlled-release (CR) paroxetine in the treatment of vasomotor symptoms in a general population.
Patients in the study had been menopausal and amenorrheic for at least 12 months or recently had oophorectomy, with a minimum of two to three hot flushes daily or 14 per week. They were not using hormone therapy. Patients were randomized in double-blind fashion to paroxetine CR in dosages of 12.5 mg per day or 25 mg per day, or to placebo, for six weeks. End points included mean change from baseline to the end of the study in the number of daily hot flushes and in questionnaire scores (i.e., Greene Climacteric Scale, a sleep disturbance visual analog scale, the Beck Anxiety Inventory, the Sheehan Disability Scale, and the clinician-rated Clinical Global Impression item). Paroxetine tolerability also was measured.
The 165 eligible participants were randomized to the three treatment groups. Over six weeks, the hot flush composite score was reduced by 62.2 and 64.6 percent in the lower and higher dose paroxetine group, respectively, compared with a reduction of 37.8 percent in the placebo group. Mean daily hot flush frequency decreased from 7.1 to 3.8 in the group taking 12.5 mg per day, from 6.4 to 3.2 in the group taking 25 mg per day, and from 6.6 to 4.8 in the group taking placebo. The odds of being a responder while taking paroxetine CR were almost four times that of those taking placebo, according to the Clinical Global Impression improvement rating. Greene Climacteric Scale scores were better in the treatment groups by the end of the study, mainly because of improvement in vasomotor symptoms. Treatment groups had a greater number of adverse events than the placebo group, especially in the higher dosage group.
The authors found that paroxetine produced a substantial reduction in menopausal vasomotor symptoms consistent with results of previous studies of SSRIs in the treatment of hot flushes in patients with breast cancer. At the end of the six-week study, 60.5 percent of women taking paroxetine CR had at least a 50 percent reduction in hot flush composite score. The drug was well tolerated, particularly in the lower dosage group. Both dosages were similarly effective. It is not known whether these findings would translate into long-term benefits, what the optimal dosages are, or what differences in efficacy there might be among antidepressants in this class. This trial included a low proportion of black and Asian women, so the study findings might not apply to them.