Background: More than one half of women report hot flashes during menopause. For about 20 percent of these women, symptoms are sufficiently severe to require treatment. Although hormone therapy is effective, many women find it unacceptable, which has led to studies of potential alternative treatments. Some studies have reported benefit from selective serotonin reuptake inhibitors (SSRIs), but overall results are inconclusive.
The Study: Grady and colleagues conducted a randomized placebo-controlled trial of sertraline (Zoloft), 100 mg per day, in women with hot flashes during or after menopause. They recruited symptomatic women 40 to 60 years of age who reported at least 14 hot flashes per week and requested treatment. Women taking hormone therapy, other SSRIs, or any medication believed to affect hot flashes or interact with sertraline were excluded from the study. Other exclusion criteria were significant liver or kidney disease, history of breast or ovarian cancer, and psychiatric illness.
The 49 women randomly assigned to placebo therapy were slightly older than the 50 assigned to sertraline (mean age was 52.6 versus 50.5 years). The placebo group also included more women who were white (67.3 versus 46.0 percent) and had graduate education (30.6 versus 8.0 percent). The mean number of hot flashes at the beginning of the study was not significantly different between the two groups (9.3 in the placebo group versus 8.6 in the intervention group).
Participants were asked to record the frequency and severity of hot flashes in a daily diary, and records were kept of medications taken and any perceived adverse effects of medications. The women also completed several questionnaires at the beginning and end of the study; these addressed general health, quality of life, menopausal symptoms, sleep quality, sexual function, and mood.
Results: After six weeks of treatment, the reported number of hot flashes had declined by 39.0 percent in the sertraline group and by 38.3 percent in the placebo group. The mean hot flash score also declined significantly in both groups, with no statistically significant difference between groups (42.2 percent decrease in the sertraline group and 40.6 percent decrease in the placebo group). Patients in the sertraline group reported significantly worse scores for sexual function and the physical component of the quality-of-life scores. They were also more likely to report dizziness and gastrointestinal symptoms than patients taking placebo.
Conclusion: The authors conclude that treatment with 100 mg sertraline per day did not improve the frequency or severity of hot flashes more than placebo, but was associated with unwanted adverse effects.
editor's note: At least eight randomized controlled trials have reported the impact of SSRIs on hot flashes. Four of these studies involved women with a history of breast cancer who were ineligible for hormone therapy. Three of the four published trials involving healthy women reported no statistically significant benefit from SSRI therapy, but the fourth reported 25 to 30 percentage points' improvement over placebo during treatment with paroxetine.1 While we await the results of further research into the effectiveness of specific SSRIs and other medications, careful consideration of these study results are more helpful than first apparent. Over six weeks, women in the placebo group reported an almost 40 percent reduction in the number and severity of hot flashes. These are clinically significant gains. Perhaps the message from these studies is that supportive care is important during menopause, regardless of the intervention selected.—a.d.w.