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Title: Controlled Release Paroxetine Therapy Reduces Menopausal Hot Flash Symptoms

URL: http://jama.ama-assn.org/cgi/content/abstract/289/21/2827

JAMA 2003;289:2877-2834. "Paroxetine Controlled Release in the Treatment of Menopausal Hot Flashes: A Randomized Controlled Trial"
06/05/2003 01:35:45 PM
By Joene Hendry

Paroxetine CR (controlled release), a selective serotonin reuptake inhibitor, appears to substantially reduce hot flashes, indicating that it may be an effective alternative to current therapies for the treatment of this menopausal symptom. Dr. Vered Stearns of the University of Michigan Comprehensive Cancer Center in Ann Arbor, United States, and colleagues randomised 165 menopausal women, 18 years of age and older, to 6 weeks of daily paroxetine CR at 12.5 mg or 25.0 mg or placebo. Inclusion criteria included a minimum of 2 to 3 daily or at least 14 bothersome hot flashes per week, discontinuation of any hormone replacement therapy at least 6 weeks prior to inclusion, amenorrhoea, or bilateral oophorectomy at least 6 weeks prior to participation. Women with active cancer, or receiving radiation or chemotherapy were excluded, as well as those with an active psychiatric disorder, concurrent major depression, substance dependence, or intolerance to selective serotonin reuptake inhibitors. After 6 weeks of treatment, the daily hot flash composite scores, which rated frequency and severity of symptoms, were reduced from baseline by 62.2% in the 51 women in the lower dose and by 64.6% in the 58 women in the higher dose paroxetine groups. This compares with a 37.8% reduction in the 56 women on placebo. The baseline mean daily hot flash frequency was 7.1 in the lower dose and 6.4 in the higher dose paroxetine groups, and 6.6 in the placebo groups. After 6 weeks the participants reported a mean daily hot flash frequency of 3.8 in the lower dose, 3.2 in the higher dose, and 4.8 in the placebo groups. Twenty-nine percent of the women taking lower dose paroxetine and 30% of those taking the higher dose reported no hot flashes during the sixth week of treatment. This compares with 19.6% in the placebo group. The most frequently reported adverse events were mild to moderate headache, nausea, and insomnia, however, treatment was generally well tolerated and appeared to have little or no effect on sexual function over the study period. While this study provides new information on the treatment of hot flashes, the researchers conclude that the optimal dose of paroxetine for the treatment of menopausal hot flashes remains to be determined.

http://jama.ama-assn.org/cgi/content/abstract/289/21/2827

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