Loprinzi, C.L., Sloan, J.A., Perez, E.A., Quella, S.K., Stella, P.J., Mailliard, J.A., … Rummans, T.A. (2002). Phase III evaluation of fluoxetine for treatment of hot flashes. Journal of Clinical Oncology, 20, 1578–1583.
The study sought to assess the efficacy of fluoxetine for treatment of hot flashes in women with a history of breast cancer or a concern regarding the use of estrogen because of a breast cancer risk.
Patients received four weeks of fluoxetine (20 mg/day orally) versus an identical-appearing placebo. For the next four weeks, patients were crossed over to the alternative arm.
The study enrolled 81 women with a history of breast cancer or a perceived increased risk of breast cancer. Sevent-two patients completed the study. Their mean age was older than 50 years.
This was a placebo-controlled, double-blind, cross-over clinical trial.
Assessments included:
At the end of the first treatment period (four weeks), hot flash scores (frequency x average severity) decreased 50% inthe fluoxetine arm versus 36% in the placebo arm. Cross-over analysis showed a significantly greater improvement in hot flash scores with fluoxetine than placebo (p = .02). More than half (54%) of the patients reported depressive symptoms of at least mild severity at baseline compared with only 30% of patients after the first treatment period and 21% after the second treatment period. After five weeks of treatment, QOL did not differ between groups. After cross-over, QOL showed a relative improvement trend for fluoxetine compared to placebo.
Age and tamoxifen use were not adjusted for as potential confounding factors.