A pilot trial assessing the efficacy of paroxetine hydrochloride (Paxil (R)) in controlling hot flashes in breast cancer survivors

Background: Many breast cancer survivors suffer debilitating hot flashes. E strogen, the drug of choice in perimenopausal women, is generally not recom menced to breast cancer survivors. Nonhormonal treatments are mostly disapp ointing. Anecdotal reports in our institution suggested that the selective serotonin-reuptake inhibitor, paroxetine hydrochloride, might be efficaciou s in alleviating hot flashes. Patients and methods: Thirty women with prior breast cancer who were suffer ing at least two hot flashes a day entered a single institution pilot trial to evaluate paroxetine's efficacy in reducing the frequency and severity o f hot flashes. After completing daily diaries for one week on no therapy, t he women received open-label paroxetine, 10 mg daily for one week, followed by four weeks of paroxetine, 20 mg daily. The women completed hot-flash da ily diaries throughout the study period, and a health-related symptom-asses sment questionnaire and a quality-of-life rating scale in the first and six th week of the study. Results: Twenty-seven women completed the six-week study period. The mean r eduction of hot flash frequency was 67% (95% confidence interval (95% CI): 56%-79%). The mean reduction in hot flash severity score was 75% (95% CI: 6 6%-85%). There was a statistically significant improvement in depression, s leep, anxiety, and quality of life scores. Furthermore, 25 (83%) of the stu dy participants chose to continue paroxetine therapy at the end of study. T he most common adverse effect was somnolence, resulting in drug discontinua tion in two women, and dose reduction in two women. One woman discontinued drug due to anxiety. Conclusions: Paroxetine hydrochloride is a promising new treatment for hot flashes in breast cancer survivors, and warrants further evaluation in a do uble-blind randomized placebo-controlled trial.