A pilot trial assessing the efficacy of paroxetine hydrochloride (Paxil) in controlling hot flashes in breast cancer survivors.
BACKGROUND
Many breast cancer survivors suffer debilitating hot flashes. Estrogen, the drug of choice in perimenopausal women, is generally not recommenced to breast cancer survivors. Nonhormonal treatments are mostly disappointing. Anecdotal reports in our institution suggested that the selective serotonin-reuptake inhibitor, paroxetine hydrochloride, might be efficacious in alleviating hot flashes.


METHODS
Thirty women with prior breast cancer who were suffering at least two hot flashes a day entered a single institution pilot trial to evaluate paroxetine's efficacy in reducing the frequency and severity of hot flashes. After completing daily diaries for one week on no therapy, the 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 daily diaries throughout the study period, and a health-related symptom-assessment questionnaire and a quality-of-life rating scale in the first and sixth week of the study.


RESULTS
Twenty-seven women completed the six-week study period. The mean reduction 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: 66%-85%). There was a statistically significant improvement in depression, sleep, anxiety, and quality of life scores. Furthermore, 25 (83%) of the study participants chose to continue paroxetine therapy at the end of study. The most common adverse effect was somnolence, resulting in drug discontinuation 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 double-blind randomized placebo-controlled trial.
Stearns
V
V
Breast Cancer Program, Lombardi Cancer Center, Georgetown University School of Medicine, Washington, DC, USA.
Isaacs
C
C
Rowland
J
J
Crawford
J
J
Ellis
M J
MJ
Kramer
R
R
Lawrence
W
W
Hanfelt
J J
JJ
Hayes
D F
DF
D000328:Adult; D000368:Aged; D001007:Anxiety; D001943:Breast Neoplasms / Q000503:physiopathology* / Q000523:psychology / Q000534:rehabilitation; D016001:Confidence Intervals; D003863:Depression / Q000517:prevention & control; D005260:Female; D019584:Hot Flashes / Q000517:prevention & control*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D017374:Paroxetine / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012725:Sexual Behavior; D011795:Surveys and Questionnaires; D017741:Survivors
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors