Wu, M.F., Hilsenbeck, S. G., Tham, Y. L., Kramer, R., Elledge, R. M., Chang, J. C., & Friedman, L. C. (2009). The efficacy of sertraline for controlling hot flashes in women with or at high risk of developing breast cancer. Breast Cancer Research and Treatment, 118(2), 369-375.

The study evaluate the efficacy of sertraline for controlling hot flashes in women with or at high risk of breast cancer.

The study was organized by periods:

• Week 1: baseline
• Week 2: single-blind placebo run-in; those reporting hot flash score reductions of greater than 50% were then excluded.
• The remaining women received placebo or sertraline 25 mg/day and titrated weekly as needed to a maximum of 100 mg/day for weeks 3–6.

The study enrolled women aged 18 or older with personal or family history of carcinoma in situ or invasive breast cancer with reported hot flashes and a weekly hot flash score of greater than 15.

• N = 57 (randomized eligible) 
• N=53 (run-in phase)
• N=46 (assigned treatment)
• N = 41 completed treatment

Mean participant age was 55.8 years, and 95% had abreast cancer diagnosis.

Exclusion criteria included: progressive metastatic breast cancer, documented history of medication or treatment noncompliance, acute suicidal or homicidal ideation, any unstable clinically significant psychiatric condition including major depressive disorder, or concomitant use or use within 14 days of a monoamine oxidase inhibitor or another antidepressant drug, history of intolerable adverse reaction to sertraline, reduction of a weekly hot flash score by greater than 50% after placebo run-in.

A university cancer center hosted the study.

The study was randomized, double-blind, placebo-controlled.

Participants maintained a hot flash diary to record the number and severity of hot flashes per day.

Hot flash frequencies and scores suggested greater decline, but not statistically significant, in the sertraline-treated group compared with the placebo group.

The study was limited by its small sample size with reported insufficient statistical power to detect modest differences in hot flashes between groups. Study design did not take into account the possibility of pharmacokinetic interaction between sertraline and tamoxifen