Stearns, V., Slack, R., Greep, N., Henry-Tilman, R., Osborne, M., Bunnell, C., … Isaacs, C. (2005). Paroxetine is an effective treatment for hot flashes: Results from a prospective randomized clinical trial. Journal of Clinical Oncology, 23, 6919–6930.doi:10.1200/JCO.2005.10.081
The study assessed the efficacy of paroxetine compared to placebo in reducing hot flashes in women with or without history of breast cancer.
There were four study arms:
Women with or without history of breast cancer having at least 14 hot flashes per week were eligible, of whom 279 women were screened, and 151 were randomly assigned. 107 patients completed study. Mean age was 53 years. More than 80% had prior history of breast cancer, and 60% were taking an antiestrogen.
Exclusion criteria: Concomitant use of cytotoxic chemotherapy, radiation therapy, estrogen or progesterone use, antidepressants, monoamine oxidase inhibitors, or treatments for hot flashes
The study was conducted in multi-institutional out-patient oncology clinics.
The trial was stratified, randomized, double-blind, cross-over, and placebo-controlled . Participants were stratified by age group (younger than 60 or older than 60) and antiestrogen use (yes or no).
Paroxetine 10 mg significantly reduced hot flash frequency and composite score by 40.6% and 45.6%, respectively compared to 13.7% and 13.7% for placebo (p = .0006 and p = .0008, respectively). Paroxetine 20 mg significantly reduced hot flash frequency and composite score by 51.7% and 56.1%, respectively compared to 26.6% and 28.8% for placebo (p = .002 and p = .004, respectively). Efficacy was similar between the two doses but women were less likely to discontinue low-dose paroxetine. Paroxetine 10 mg was associated with a significant improvement in sleep compared to placebo (p = .01).
Study attrition was a limitation: 39 women did not complete 9 weeks of therapy; 26 women did not return diaries.