A controlled-release formulation of the selective serotonin reuptake inhibitor paroxetine significantly reduces menopause-related hot flash symptoms, according to a study in the June 4th issue of The Journal of the American Medical Association. Recent recognition of the health risks associated with long-term hormone replacement therapy places more emphasis on the effort to develop alternative treatments for symptoms associated with menopause.

The authors state that hot flashes are the most common complaint among women entering menopause and may continue for 5 years or longer. About 75 percent women will experience some hot flashes around the time of menopause, a proportion that translates into more than 25 million women in the United States.

Vered Stearns, M.D., and her American colleagues evaluated a selective serotonin reuptake inhibitor as treatment for hot flash symptoms. A total of 165 menopausal women who were experiencing 2 to 3 daily hot flashes participated in the study. To participate, women had to discontinue any hormone therapy for at least 6 weeks prior to enrollment. Women were excluded if they had any signs of active cancer of were undergoing chemotherapy or radiation therapy.

Participants were randomized into 3 arms: 51 women took 12.5 mg controlled-release paroxetine daily, 58 women took 25.0 mg controlled-release paroxetine daily, and 56 women took placebo. Participants were evaluated at baseline and at 1, 3, and 6 weeks. They kept daily hot flash diaries to document the frequency and severity of symptoms. A number was assigned to the severity of the hot flash and that number was multiplied by the daily number of hot flashes at that severity level to obtain a composite score.

"The mean reductions in the hot flash frequency composite score from baseline to week 6 were statistically significantly greater for those receiving paroxetine controlled-release than for those receiving placebo," the authors reported. "By week 6, the mean daily hot flash frequency went from 7.1 to 3.8 (mean reduction, 3.3) for those in the 12.5 mg daily and from 6.4 to 3.2 (mean reduction, 3.2) for those in the 25 mg daily paroxetine controlled-release groups and from 6.6 to 4.8 (mean reduction, 1.8) for those in the placebo group."

The most common adverse effects experienced by women receiving active treatment were headache, dizziness, and nausea, with fewer reports of such effects from women receiving the lower of the 2 doses.

"At study end, 63 (60.5 percent) of 104 women who received paroxetine controlled-release achieved a 50 percent or greater reduction in their hot flash composite scores," the authors noted.

They concluded, "Taken together with the findings of the Women’s Health Initiative, these data suggest that paroxetine controlled-release may have a place in the treatment armamentarium for women experiencing hot flashes."